Manual Labcorp 3.0.0

Central Laboratory
Services Manual
AstraZeneca AB
Protocol: D5244C00001
Labcorp Project #: 211576

Region: EMEA
Version: 3.0.0
Manual Created:
30 October 2022
Manual Created:
30 May 2023
211576_TMEA Manual Created: 30 Oct 22 Page 1 Manual Revised: 30 May 23 Version 3.0.0
TABLE OF CONTENTS
History of Change
Data Privacy Notice And Opt Out for Future Studies
Version Explanation
Section 1: General Introduction, Holidays, and Contact Numbers

Xcellerate Welcome Letter
Public Holidays
Labcorp CLS Customer Service Contact Numbers
Kit Information
General Information - Supply/Resupply
How to adjust your kit inventory
Use of Duplicate Labels Page
Investigator Order Notification Service
Section 2: Study-Specific Instructions and Procedures

Laboratory Visit Schedule
Specimen Collection Procedures
Centrifuge Instructions
Draw Order
Blood Smear Preparation
Draw Tube Adapter Procedures
Adaptation Vacutainer Monovette
Biotin Interference
Clean Catch Urine
Urine Dipsticks Instructions
Urine Pregnancy Instructions
Instructions for Completing Requisition Forms
Project Specific Requisition Forms
Section 3: Pack & Ship Instructions

General Information
Packaging and Shipping of Samples
Additional Pack & Ship Instructions
Section 4: Get Result

Reference Ranges/Alerts and Flags
Project Specific Reference Ranges and/or Alerts and Flags
Section 5: Laboratory Certifications
English_TableOfContents_Update: 20230530 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
INF ORM A TI ON N O T IC E
LAB C OR P C EN TR A L L AB OR AT OR Y S ER VI C ES
E FF E CT IV E J UN E 2 02 1
Branding Update Regarding

Materials
As we entered 2021, we announced our plans to transition from Covance to the Labcorp brand name —
showcasing our unique combination of drug development and diagnostic capabilities through one
powerful, unified brand. Beginning in the end of June 2021, Covance by Labcorp will be known globally as
Labcorp Drug Development.
Although our name is changing, your studies will continue to be delivered by the same talented,
committed teams, on the same scientific instruments, with the same tireless commitment to patients.
As our new branding and name is deployed, we will be phasing out any remaining items that have the
Covance name and logo. During this transition period, you may still receive some items with the Covance
name and logo in combination with our new Labcorp Drug Development branding and logo. This includes
but is not limited to collection, packaging, and shipping materials, your investigator manual, and other
training documents. As such, some investigator manuals and other training documents created before the
name change may bear the Covance name and branding while the translation of those same materials
may bear the new name and branding if they were completed after the name change. Over time, new
items will fully transition to the new branding and bear the new name and logo.
Have additional questions? Contact our Investigator Support team by using the number for your location
that can be found in this manual.
Please retain a copy of this notice in your study files for documentation purposes.
labcorp.com
For Internal Use Only: All ● LN 50947 ● English ● 23June2021 ● WLK

History of Change
DateCreated/
Project Work Type Description Standard Page
Revised
211576 New Manual 30‐Oct‐22 New Manual 0
0 Mod. Std Page 28-Dec-22 Updated: annual holiday dates CustomClosed_EMEA
211576 Mod. Manual 13‐Jan‐23 Updated: Version Number from 1.0.0 to 2.0.0 (cover page) 0
Added: Manual revised date (cover page)
Updated: History of Change (Manual)
Added: Reflex groups "DUOD BIOP SUPERIOR H PYLORI. DUOD BIOP TRANSV ASC H PYLORI. DUODENAL BIOP DESCEND H
PYLORI. DUODENAL BIOPSY BULB H PYLORI" (VTS)
Updated: Study specific notes (VTS)
Updated: Collection Instructions for test group "SM TSLP, SM URINE BIOMARKERS, SM DIST ESO TISSUE RNA(SPC)
Added: AD question for visit "VISIT 1" (REQ)
Removed: Conditional testing table at Visits"GASTRIC/DUODENAL BIOPSIES,ESOPHAGEAL BIOPSIES"(Req)
Added: Test group "HERPES SIMPLEX VIRUS IGM CE"(Vts,Spc,Req)
Added: OR16455, OR16733, OR16737, OR16740, OR16742, OR16747, OR16749, OR16751, OR16734, OR16738, OR16741,
OR16743, OR16748, OR16750, OR16752, OR16735, OR16736, OR16732, OR16739, OR16746, OR16744, OR16745, OR16753,
OR16754, OR16755, OR16756, OR16757, OR16758, OR16759, OR16760, OR16761, OR16762, OR16763 Reference Range (Get
Result Section)
Added: ORT34003, ORT34025, ORT34046, ORT33950, ORT33951, ORT33947, ORT34331, ORT34327, ORT34329, ORT34325
Sponsor Flagging (Get Result Section)
0 Mod. Std Page 16-Jan-23 Updated: typo "circum-stances" to correctly read as "circumstances" under "Courier Pick-up Information" section. GeneralInformationPackagingShipping_ContRed
0 Mod. Std Page 3-Feb-23 Updated: ISO15189 certification EURLaboratoryCertifications

Updated: Dr. Lewest CV
211576 Mod. Manual 3‐Feb‐23 Updated: Version Number from 2.0.0 to 2.1.0 (cover page) 0
Updated: Manual revised date (cover page)
Updated: Collection instruction and shipping condition for Test group "SM URINE BIOMARKERS" (SPC)
211576 Mod. Manual 3‐Mar‐23 Updated: Version Number from 2.1.0 to 2.2.0 (cover page) 0
Added: Standard page "English_UrineDipsticksAutionNotice_UDS4" (Manual)
211576 Mod. Manual 30‐May‐23 Updated: Version Number from 2.2.0 to 3.0.0 (cover page) 0
Updated: Visit name from Visit 15 (EOT) to Visit 15, Visit 17 (FU2) to FU2 (VTS, SPC, REQ)
Updated: Test group CMV to CMV IGM IGG (VTS, SPC, All applicable REQS)
Added: Visit Active Treatment Extension Period (VTS, SPC, REQ)
Updated: Occurrence for visit: IPD visit (VTS)
Added: Test groups CHEMISTRY PANEL, CRP, LIPID PANLE for visit: FU2 (VTS, SPC, REQ)
Updated: Test groups DIST ESOPHAGUS, PROX ESOPHAGUS to required for visit: Esophageal biopsies (VTS, SPC, REQ)
Updated: Collection instructions for Test groups SM URINE BIOMARKERS, URINE CULTURE, URINE MICRO PANEL, DUOD BIOP
SUPERIOR DUOD, DUOD BIOP TRANSVER ASCEN, DUODENAL BIOP DESCENDING, DUODENAL BIOPSY BULB, GASTRIC BIOP
INCISURA, GASTRIC BIOPSY ANTRUM, GASTRIC BIOPSY BODY, DIST ESOPHAGUS, MID ESOPHAGUS, PROX ESOPHAGUS(SPC)
Updated: PVC Codes for visits: UNSCHEDULED/RETEST, PREGNANCY CONFIRMATION, GASTRIC/DUODENAL BIOPSIES (REQS)
Updated: AD notes (All applicable REQS)
Added: Standard page: How to adjust your kit inventory.pdf (Manual)
Added: Groups OP121, OP127, OP114, OP115, OP116, OP111, OP112, OP103, OP106, OP122, OP134, OR17028, OP107,
OP110, OP109, OP129, OP130, OP132, OP123, OP124, OP125, OP126, OP117, OP118, OP119, OP120, OP135, OP136, OP137,
OP138, OP139, OP140, OP141, OP142, OP143, OP144 Reference ranges (Get Result Section)
Removed: JF flag on Eosinophils (%) >/= 5%. This criteria is only applicable if ALT or AST is ≥ 3 × ULN. AF and BF flag trainer
updated to refer to eosinophila criteria Sponsor flag (Get Result Section)
Definitions of Abbreviations:
A2=Appendix 2: Labcorp CLS & Labcorp VCL Contacts
A3=Appendix 3: Courier Information
A5=Appendix 5: Revision History
AD=Administrative statement or question.
DEMO=Demographics
DOC=Day of collection
GIP=General Information Pages
REQ or REQS=Requisition(s)
SH=Sample Handling
SIG=Signature Page
SPC=Specimen collection (page(s) with collection narrative)
TOC=Table of contents
UDS=Urine drug screen
VTS=Visit test schedule
Note: Reference Ranges, Alerts and Flagging standard modifications listed above are Labcorp‐driven modifications and may not apply to project‐specific reference range sets. Please discuss
reference ranges, alerts and flags with your project manager.
Labcorp CLS Version Control Process

Labcorp CLS currently uses a 3 decimal version control process (1.0.0) where:
• The first digit indicates a sponsor driven modification (1.0.0)
• The second digit indicates a Labcorp driven modification (1.1.0)
• The third digit indicates a standard page update (1.1.1)
All digits after the first digit will restart with a new sponsor driven modification (2.0.0)
DATA PRIVACY NOTICE AND OPT OUT FOR FUTURE STUDIES
IMPORTANT: The policy and actions below pertain only to future clinical studies managed by Labcorp Central
Laboratory Services’s clinical development division. All other inquiries should be directed to the Labcorp Central
Laboratory Services Contact Numbers, listed towards the end of this manual. For Kit ordering, kit questions, and
kit inventory updates, please go to http://www.drugdevelopment.labcorp.com/kitordering.
If you do not wish for Labcorp Central Laboratory Services to retain your personal information for evaluation purposes
(see disclaimer below), please complete and send the below form to Labcorp Central Laboratory Services via e-mail
at xkb@Labcorp.com, via fax to [609.419.2840,] or via mail to [Labcorp Central Laboratory Services, 210 Carnegie
Center, Princeton, New Jersey 08540-6233 USA, c/o General Counsel]. Please note that this e-mail address should
not be used to contact Labcorp Central Laboratory Services for general inquiries, it is only used for the purpose
of managing your data for future studies. You may also contact Labcorp Central Laboratory Services via this e-mail
address if you: i) want to confirm the accuracy of the personal information Labcorp Central Laboratory Services has
retained about you; ii) would like to update your personal information; and/or iii) have any complaint regarding
Labcorp Central Laboratory Services’s use of your personal information.
I do NOT wish to be considered for future clinical studies, and I do NOT wish to be contacted by Labcorp
Central Laboratory Services for other clinical trials in the future.
* Investigator Name:
Institution Name (if applicable):
* Address:
* Town/City: * State/Province/Region:
* Postal Code: * Country:
* Telephone: * E-mail:
* - Required
I would like to UPDATE my personal information below, where I may be considered and contacted for
future clinical studies.
* Investigator Name:
Institution Name (if applicable):
* Address:
* Town/City: * State/Province/Region:
* Postal Code: * Country:
* Telephone: * E-mail:
* - Required
Disclaimer: Information about investigator performance in connection with the use and/or return of materials in any laboratory test kit will be
collected and used by Labcorp Central Laboratory Services and/or its affiliates to help evaluate clinical studies, investigators, and institutions for
future clinical studies. This information may be included in databases of Labcorp Central Laboratory Services and/or its affiliates for the purpose of
identifying skills, facilities and other information relevant to the performance of services for clinical trials. Labcorp Central Laboratory Services will
take reasonable steps to protect the security of such personal information retained; however such personal information may be transferred outside
of your country (including countries which may not have been assessed as having adequate privacy laws). Nevertheless, Labcorp Central Laboratory
Services takes reasonable steps to ensure that its affiliates, agents, subsidiaries and suppliers comply with its standards of privacy regardless of their
location.
English_LabPrivacy_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
LABCORP LABORATORY MANUAL VERSION RATIONALE
Labcorp Central Laboratory Services has a three digit version system in place for our laboratory manuals.
Third digit
First digit
Second digit
This version system takes sponsor requested updates, internally requested updates, and standard page
updates into account.
First Digit:
Sponsor requested updates: this occurs when the sponsor requests a change to the manual. As this digit
increases it will return the subsequent two digits to zero.
Second Digit:
Internal requested updates: this occurs with a Labcorp Central Laboratory Services related change to manual.
This digit will increase with each Labcorp Central Laboratory Services related change or return to zero with a
Sponsor requested change.
Third Digit:
Standard page updates: this occurs with a standard page change. This digit will increase with each standard
page related change or return to zero with a Sponsor requested change.
With the above as an explanation, here is an example.
Third digit, since the last sponsor

request there has been one
First digit, there has
Second digit, since the standard page update to the
been one sponsor
last sponsor request manual.
requested changes to
there have been three
this manual.
internal updates.
All changes will be accompanied by a Manual Revised date change. This information will be present on the cover of the
manual as well as the footer on all pages of the manual.
English_Version_Explanation_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
1
Section Break
L AB CO RP CEN TR AL L ABO R ATO RY SER VI CES
Welcome to Xcellerate® Lab

Investigator Portal
STUDY PREPARATION
Xcellerate Lab Investigator Portal is the delivery method for study
laboratory information including on-screen results, lab reports, alerts,
eQueries, training materials, laboratory manuals, and site communications. Here are some key things you need to
know about this application.
Access
1. New users will receive a Welcome Email containing a link to the Password Manager.
2. New users can use the “Click here” link from your Welcome Email or go to Login Screen on Xcellerate Lab
Investigator Portal at: https://xip.labcorp.com
3. Enter the required fields to receive an email containing a link to reset / create your password.
*Note: The link is only valid for 30 minutes once email is received.
4. Enter the required fields to create new or reset your password.
• Minimum length: 8
• Maximum length: 32
• At least one upper case letter
• At least one lower case letter
• At least one numeric character
• At least one special character
• Should not contain user’s name
5. Password Manager will send a Password Reset Successful Notification email.
*Note: Passwords expire in 90 day cycles. You can return to the Password Manager at any given time in
the future to reset your password.
Training
Xcellerate Lab Investigator Portal users have a variety of training options available to them including general
navigation training, quick reference guides, and a recorded live demo. These training tools are located under the
Application Training tab within the portal. Review this information in preparation for your first subject visits.
Navigating the System

Home Page/Dashboard
The home page provides access to study-specific data and documents via study cards. There are also non-
study specific links at the top of the page for General Communications, General Lab Manuals, General Training
Materials and Application Training. User Settings can be reviewed or modified from the drop-down menu on
the homepage. Lastly, links to important Announcements and Common Links are available on the right side of
the home page.
labcorp.com
Study Cards
Each study card provides links to documents including Lab reports (also includes Result Alerts, Data Revisions
and Cancellations), Lab Manuals, Site Actions, Communications, Training Materials and eQueries. For each
category, the number of unread documents will display on the study card. Clicking on the link will take you
directly to the selected category tab. Once in the tab, you will see a menu on the left side of the screen where
you can navigate to the various categories of study specific information.
Set Your Preferences in User Settings
When documents are posted to the application, an email is generated; preferences by default are IMMEDIATE
for Result Alerts and eQueries, and DAILY for all other document types. Three email preferences are available
for each document type: Immediate, Daily, and None. We recommend that you set the preference to Daily
with the exception of Result Alerts and eQueries in order to minimize the number of emails received.
You can also choose your document language preferences in the General tab of User Settings. Please note
that not all documents are translated; however, if you select a language other than English, any documents
translated in your selected language will be displayed as your default.
View, Filter, and Print Documents
When you are in a category page (i.e. Lab Reports, Lab Manuals, etc.) unread documents will be bolded and
the Status will be unchecked. If any user at your site has read a document, the Status will be checked, but it
will remain bolded until you read it. You can hover over a check mark in the status column to see who at your
site has read a document. You have the ability to filter for unread documents only. Once you download a
document, the Status is checked and the line is no longer bolded.
There are options to select one or multiple documents and to save or print them in batches. More
information is available in the navigation training.
*Note: Using the Preview button (eye icon) to review a lab report will not count the document as a “read”
report. You must download the report to count as read.
On-Screen Results
This feature allows a Standard Test Result view, Subject view and Microbiology view of near real-time access
to lab results in addition to customized trend charts to show trends over time. While this feature does not
replace the Lab Reports and Alerts and should not be used for regulatory submission, it offers a quick view of
test results for efficient study management.
eQueries
This feature provides the ability for sites to receive and respond to queries within the application allowing for
quicker issue resolution. The number indicator on the study card indicates any unresolved queries for your
study. An Immediate email notification will be sent to your site when a new eQuery is opened. For further
details, refer to the eQuery Quick Reference Guide found within the Application Training tab.
Kit Inventory
This feature provides the ability to monitor the amount of each kit type that is on-hand at the investigator
site(s). Always inform Labcorp CLS is any kits are borrowed from another location, lost, damaged, transfered,
and/or expired, so the kit inventory can be accurately adjusted. Labcorp CLS does not track kit expiration.
English_XcellerateWelcomeLetter_Update: 20220815
Support
Need help with tool navigation, content information, user name and password reset support? These and many
other tips can be found in the Application Training tab at the top of every screen. If you still need support, contact
the Investigator Support Team.
English_XcellerateWelcomeLetter_Update: 20220815
LABCORP CENTRAL LABORATORY SERVICES OBSERVED HOLIDAYS
Important considerations
Local courier service (pickup and delivery) may be limited prior to, during and following observed holidays
in the country to which you are shipping specimens. It is imperative that you check local service schedules in
advance of the holiday. Listed below are important considerations when planning your patient visits during
the holidays.
- Your courier service reserves the right to observe earlier than usual pick-up times during the holidays. Call
your courier service for local pick-up schedules.
- During the December/National holidays, schedule your pickups in advance of the holiday where possible.
- Call early in the day to schedule your pickup.
- When a holiday is observed on Monday, avoid laboratory collections on the preceding Saturday (i.e. Labor
Day). (Not applicable to Japan)
- Frozen specimens should NOT be shipped on the day before the observed holiday.
Send frozen specimens on the next available business day. (Not applicable to Japan)
- If shipping specimens on Friday, mark airway bill for Saturday delivery. (Not applicable for Japan)
- Specimens with short stabilities (eg. lymphocyte subsets, reticulocyte counts, etc.) should not be collected on
the day prior to the holiday. (Not applicable to Japan)
- For sites with 24 hours delivery time to Labcorp Central Laboratory Services, do not schedule any shipment 24
hours before one of the dates on the next pages. (Not applicable for Japan)
- For sites with 48 hours delivery time to Labcorp Central Laboratory Services, do not schedule any shipment 48
hours before one of the dates on the next pages. (Not applicable for Japan)
Holiday reminders are also available on the Labcorp Central Laboratory Services website:
https://drugdevelopment.labcorp.com/content/dam/covance/pdf/holidays.pdf
English_Custom Closed/Public Holidays EMEA 1/2_Update: 20220107 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
LABCORP CENTRAL LABORATORY SERVICES OBSERVED HOLIDAYS
Europe, Middle East and Africa (specimens sent to Geneva)
2023 2024 2025
01 January 01 January 01 January New Year’s Day

07 April 1 29 March 1 18 April 1 Good Friday
10 April 01 April 21 April Easter Monday
18 May 09 May 29 May Ascension Day
29 May 20 May 09 June Whit Monday
01 August 01 August 01 August Swiss National Day
07 September 05 September 11 September Jeûne Genevois
25 December 25 December 25 December Christmas Day
31 December 31 December 31 December Restauration de la
République
1
Limited operations within Labcorp Central Laboratory Services this day due to Easter Good Friday period.
English_Custom Closed/Public Holidays EMEA 2/2_Update: 20221208 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
CONTACT NUMBERS TO CALL LABCORP CENTRAL LABORATORY SERVICES
) To call Labcorp Central Laboratory Services in Geneva from:

Monday - Friday: 8h00 - 19h00 (Geneva time = GMT +1)
Saturday: 10h00 - 17h00 (Geneva time = GMT +1)
If you need urgent assistance outside of Geneva working hours you may call
Investigator Support in Indianapolis at +1 317 271 1200 (then press 1)
Austria Hungary Portugal

Belgium Ireland Slovakia
Bulgaria Israel Slovenia
Cyprus Italy Liechtenstein Spain + 800 88 77 44 11 (Tel)
Denmark Luxemburg Sweden + 800 88 77 44 22 (Fax)
France Netherlands Switzerland
Germany Norway United Kingdom
Croatia + 800 8877 4411 (Tel) or

0800 223061 (Tel)
0800 22 30 60 (Fax)
Czech Republic 800 142 083 (Tel)

800 142 787 (Fax)
Finland 990 800 88 77 44 11 (Tel)

990 800 88 77 44 22 (Fax)
Greece 00 800 4112 871 141 (Tel)

00 800 4112 871 140 (Fax)
Latvia 800 031 43 (Tel)

800 031 01 (Fax)
Lithuania 8800 30262 (Tel)

8800 30124 (Fax)
Monaco 800 93 185 (Tel)

800 93 184 (Fax)
Poland +800 8877 4411 (Tel) or

0-0800 4111 231 (Tel)
+800 8877 4422 (Fax) or
0-0800 4111 230 (Fax)
Romania 08008 9 52 14 (Tel)

08008 9 52 13 (Fax)
Russia 8 800 333 73 39 (Tel) or

8 800 201 71041 (Tel)
8 800 333 73 38 (Fax) or
8 800 201 81041 (Fax)
Ukraine 0800504643 (Tel)

0800504642 (Fax)
English_Labcorp Central Laboratory Services Contact Numbers EMEA 1/2_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
CONTACT NUMBERS TO CALL LABCORP CENTRAL LABORATORY SERVICES
) To call Labcorp Central Laboratory Services in Geneva from:

Monday - Friday: 8h00 - 19h00 (Geneva time = GMT +1)
Saturday: 10h00 - 17h00 (Geneva time = GMT +1)
If you need urgent assistance outside of Geneva working hours you may call
Investigator Support in Indianapolis at +1 317 271 1200 (then press 1)
South Africa 00 800 88 77 44 11 (Tel) or

0800998424 (Tel)
800 88 77 44 22 (Fax)
Turkey 00 800 419 871 141 (Tel)
00 800 419 871 140 (Fax)
Callers in countries that do not have a LCLS Toll Free Line, please call +41 58 822 7901 (Fax +41 58
822 7521) OR ask your local telephone operator for a collect call to
+41 58 822 7000.
Courier Contact information can be found on the Investigator & Study Staff Website, along with Dangerous Goods
Training requirements and other important information:
https://drugdevelopment.labcorp.com/customers/investigators/investigator-study-team.html
English_Labcorp Central Laboratory Services Contact Numbers EMEA 2/2_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
KIT INFORMATION
NOTE: To obtain the highest quality specimens possible, it is recommended all collection supplies
! be stored between 4°C to 25°C (39°F to 77°F). If an incident occurs where the storage conditions
for a lab kit are in question, contact your study Monitor or CRA. If you need to replace kits, contact
Covance Central Labs.
•• Kits are protocol, investigator and visit specific.
Select the correct kit accordingly.
•• Please check kit expiration dates before using

the kit!
Some tubes used for the collection of samples have
expiration dates. These dates are defined by tube
manufacturers.
To ensure the validity of the tubes contained in the
collection kit, expiration dates are printed on the
outside of the kit box. The expiration date of each
kit corresponds to the shortest expiration date of
the tube(s) within the kit.
Please do not collect specimens in expired

containers!
Specimens received in an expired container which
includes an additive will be canceled as: “Sample
drawn in expired tube: Testing not performed.”
If you have expired tubes please use the online
web tool at http://www.covance.com/kitordering or
call Covance CLS to have these kits replaced and
your inventory updated. Note: Using the online tool
is the preferred method for tracking purposes.
•• A unique accession number is assigned to each kit

and its requisition form. Within the kit, specimen
containers and the requisition have the same
accession number (bar code).
Do not interchange the tubes and/or requisition

forms between kits!
Labeling samples with unique identifiers:

Complete the labels with appropriate identifiers
(screening number and/or patient number) using a
blue or black ball point or indelible ink pen.
Errors in specimen labeling cause delays in
reporting patient results and in some cases
require testing to be cancelled.
•• Each container label is pre-printed with a barcode

and an accession number.
Bulk Supplies
Depending on your protocol, additional items may
be provided. For some studies, no bulk supply is
provided.
Note: Information about investigator performance in connection with the use and/or return of materials in any laboratory
test kit will be collected and used by Covance and/or its affiliates to help evaluate clinical studies and to evaluate
investigators for future clinical studies.
English_Kit Information_Update: 20180430 ©2003-2018 Labcorp CLS
SUPPLY/NO AUTOMATIC RESUPPLY
Resupply
! There is no automatic resupply for this study. All material (kits, shipping material and documents, bulk
supplies, etc...) needed for the laboratory visits must be ordered using the Web Resupply form.
There is no supply of shipping boxes for Israel and Africa. Investigators in these countries are requested to order boxes
from their couriers each time they request a pick-up.
To request additional supplies, please contact the appropriate Kit Inventory Center listed below:
For sites in Europe, Middle East and Africa contact Kit Inventory Center in Geneva
Web Resupply: http://www.drugdevelopment.labcorp.com/kitordering
Phone: Please refer to Section 1 (Toll Free Contact Numbers) of this Labcorp Central Laboratory Services.
All supply orders need to be ordered by 12:00 p.m. local time in order to be processed. Orders received after 12:00
p.m. local time will be processed the following business day (Monday - Friday)
Refer to your Web resupply form for delivery days.

■ Please note there will be an expedited fee for orders requested with less than the standard turn around time.
■ Reminder: If you are located in an extended delivery area your delivery may take longer than the standard turn
around time.
**PLEASE NOTE: The preferred method of communication for all kit ordering, questions and kit inventory updates
included, is through the website. Go to the above link, select your region, complete ALL of Section A, comment box
(for questions) and security check. Section B only needs to be completed for kit orders. Labcorp Central Laboratory
Services is able to reply to your comments within the web based tool. **
English_Supply/No Automatic Resupply EMEA_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
LAB C OR P C EN TR A L L AB O R AT OR Y S ER VI C ES
How to adjust your kit inventory
Labcorp Central Laboratory Services uses a manual and an

automatic resupply system for kits. The automatic resupply system
is triggered through monitoring kit inventory at your site. The system does not monitor kit expiration
automatically. Use these instructions to notify us of expired kits. You can also notify Labcorp Investigator
support by telephone or inform the Study Monitor and they will liaise with Labcorp. We will adjust the
system to reflect your current inventory. If the adjusted inventory is below the minimum value, kit
resupply will be triggered. If your study is not on auto resupply, please follow the below guidelines to
inform us about the physical inventory at site.
Materials and Equipment Required to Order Kits

PC or laptop with internet access | Paper or electronic lab manual | Requisition form for the study
Completing Section A – Study Details
Use the instructions from “How to order kits online” to complete Section A of the kit ordering form. You
do not need to complete the Delivery Type portion of Section A.
Completing Section B – Comment Box

Use the comment section of the kit
ordering form to notify us of expired,
damaged, misplaced, transferred
and discarded kits.
You may use a single form to adjust

your kit inventory and to manually
order new kits. Complete the Lab Kit
portion of section B if you are also
ordering kits.
There is no need to complete the

Lab Kit portion of section B if you are
only requesting an inventory
adjustment.
drugdevelopment.labcorp.com
©2022 Laboratory Corporation of America® Holdings All rights reserved.
 Provide the quantity of kits that should be
removed from inventory, including the accession
number
 List the number of kits currently in site inventory
 Provide the accession numbers for kits transferred

from one site to another site
drugdevelopment.labcorp.com
How to Use Covance Duplicate Labels
► Designed to facilitate sample information entry in RAVE (for applicable studies)
► Designed to support sample reconciliation & decrease queries
► Set up for return containers of all samples
► To be kept with the source documentation at site (pasted on the copy of the
requisition form or specimen collection sheet / HBS log)
Example
Summary
► Duplicate labels contain the exact same information as the label applied on each
return container (and have the same unique ID)
► The purpose of having duplicate labels is to support the sample oversight process
at the sites
INVESTIGATOR ORDER NOTIFICATION SERVICE
Email Notifications
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English_InvestigatorOrderNotificationService_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
2
Section Break
LABORATORY VISIT SCHEDULE FOR PROTOCOL D5244C00001
AstraZeneca AB
VISIT NAME Visit 1 Visit 2 Visit 3 Visit 5 Visit 8 Visit 10 Visit 12 Visit 15
VISIT TYPE
RQ RQ RQ RQ RQ RQ RQ RQ
(RQ=Required, Opt=Optional, U=Unscheduled)
OCCURRENCE week -8 to -2 week 0 week 4 +/-5d week 12 +/-5d week 24 +/-5d week 32 +/-5d week 40 +/-5d week 52 +/-5d
KIT TYPE 1 2 3 4 5 6 7 U-1

Whole Blood sample for Hematology, WBC with differential Specimen Type
HEMATOLOGY&DIFFERENTIAL PANEL Whole Blood X X X X X X X X
Serum clinical chemistry Specimen Type
CHEMISTRY PANEL Serum X X X X X X X X
CRP Serum X X X X X X X X
LIPID PANEL Serum X X X X X X X X
Serology, HBV, HBC, HIV-1, HIV-2
HEPATITIS B SURFACE AG Serum X
HEPATITIS C ANTIBODY Serum X
HIV 1/2 AG/AB SCREEN Serum X
27
HIV-1/2 AB SUPPLEMENTAL Serum R
HIV-1/HIV-2 QUALITATIVE RNA Plasma
Urinalysis - Urine micro panel and urine culture
URINE CULTURE Urine C C C C C C
URINE MICRO PANEL Urine C C C C C C
Serum sample for pregnancy (females WOCBP only) or FSH
15
FSH Serum R
35
SERUM BETA HCG Serum R
PK
TEZE PK Serum X X X X X
ADA and nAB
TEZE ADA NAB Serum X X X X
Total IgE
TOTAL IGE Serum X X X X X X X
Whole blood transcriptomics
SM WHOLE BLOOD TRANSCRIPTOMICS Whole Blood X X X
Gastric/Duodenal tissue for pathology - eligibility
4,5,6
DUOD BIOP SUPERIOR DUOD Wet Tissue
7,8,9
DUOD BIOP TRANSVER ASCEN Wet Tissue
3,11,12
DUODENAL BIOP DESCENDING Wet Tissue
10,13,14
DUODENAL BIOPSY BULB Wet Tissue
18,19,20
GASTRIC BIOP INCISURA Wet Tissue
16,21,22
GASTRIC BIOPSY ANTRUM Wet Tissue
17,23,24
GASTRIC BIOPSY BODY Wet Tissue
Esophageal tissue for biomarker analyses and histopathology

1,2
DIST ESOPHAGUS Wet Tissue
28,29,30,31,32,33,34
MID ESOPHAGUS Wet Tissue
PROX ESOPHAGUS Wet Tissue
Esophageal tissue for biomarker analyses - RNA
SM DIST ESO TISSUE RNA Tissue
Serum Biomarkers
SERUM BIOMARKERS Serum X X X X X X X
SM TSLP Serum X X
Urine Biomarkers
SM URINE BIOMARKERS Urine X X X X X X
Whole blood for genomics initiative (optional)
SM GENETIC BLOOD SAMPLE Whole Blood
% IRON SATURATION
ALPHA-1 ANTITRYPSIN Serum
ANTI SMOOTH MUSCLE ANTIBODY Serum
ANTINUCLEAR ANTIBODY Serum
CERULOPLASMIN Serum
CHEMISTRY PANEL HYS LAW Serum
CMV IGM IGG Serum
COAGULATION HYS LAW Plasma
EBV Serum
FERRITIN Serum
25
HBV DNA COBAS 6800 Plasma
26
HCV RNA COBAS 6800 Plasma
HEPATITIS A IGM ANTIBODY Serum
HEPATITIS B CORE AB IGM IGG Serum
HEPATITIS B SURFACE ANTIGEN Serum
HEPATITIS C VIRUS ANTIBODY IGG Serum
HERPES SIMPLEX IGG PANEL CE Serum
HERPES SIMPLEX VIRUS IGM CE Serum
HEV IGM Serum
HEV RNA Plasma
IRON PANEL Serum
LIVER KIDNEY MICROSOME (LKM) Serum
TRANSFERRIN Serum
Management of Study Intervention Related Reactions
SERUM TRYPTASE 60MIN Serum
SERUM TRYPTASE AT DISCHARGE Serum
SERUM TRYPTASE EVENT Serum
X Mandatory testing
O Optional testing
R Reflex testing
C Conditional testing
English_Visit Test Schedule_Update: 20230530 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
AstraZeneca AB
Active Treatment Pregnancy Gastric/Duodenal

VISIT NAME FU2 IPD visit Unscheduled/Retest GX SAMPLE Esophageal biopsies Hy s Law
Extension Period confirmation biopsies
VISIT TYPE
Opt RQ U U Opt U RQ Opt U
(RQ=Required, Opt=Optional, U=Unscheduled)
week 64 +/-7d or
Visit 2; may be
later for subjects
4 weeks after final taken at any visit
OCCURRENCE - participating in - - - - -
IP dose +/-5d until the last study
active treatment
visit
extension period
KIT TYPE U-8 U-2 U-3 U T-1 U-4 U-5 U-6 U-7
Whole Blood sample for Hematology, WBC with differential Specimen Type
HEMATOLOGY&DIFFERENTIAL PANEL Whole Blood X X X O
Serum clinical chemistry Specimen Type
CHEMISTRY PANEL Serum X X X O
CRP Serum X X X O
LIPID PANEL Serum X X X O
Serology, HBV, HBC, HIV-1, HIV-2
HEPATITIS B SURFACE AG Serum O
HEPATITIS C ANTIBODY Serum O
HIV 1/2 AG/AB SCREEN Serum O
HIV-1/2 AB SUPPLEMENTAL27 Serum R
HIV-1/HIV-2 QUALITATIVE RNA Plasma O
Urinalysis - Urine micro panel and urine culture
URINE CULTURE Urine C O
URINE MICRO PANEL Urine C O
Serum sample for pregnancy (females WOCBP only) or FSH
FSH 15 Serum O
35
SERUM BETA HCG Serum X
PK
TEZE PK Serum X X
ADA and nAB
TEZE ADA NAB Serum X X O
Total IgE
TOTAL IGE Serum X O
Whole blood transcriptomics
SM WHOLE BLOOD TRANSCRIPTOMICS Whole Blood X
4,5,6
DUOD BIOP SUPERIOR DUOD Wet Tissue X
7,8,9
DUOD BIOP TRANSVER ASCEN Wet Tissue X
3,11,12
DUODENAL BIOP DESCENDING Wet Tissue X
10,13,14
DUODENAL BIOPSY BULB Wet Tissue X
18,19,20
GASTRIC BIOP INCISURA Wet Tissue X
16,21,22
GASTRIC BIOPSY ANTRUM Wet Tissue X
17,23,24
GASTRIC BIOPSY BODY Wet Tissue X

1,2
DIST ESOPHAGUS Wet Tissue X
28,29,30,31,32,33,34
MID ESOPHAGUS Wet Tissue R
PROX ESOPHAGUS Wet Tissue X
Esophageal tissue for biomarker analyses - RNA
SM DIST ESO TISSUE RNA Tissue C
Serum Biomarkers
SERUM BIOMARKERS Serum X
SM TSLP Serum
Urine Biomarkers
SM URINE BIOMARKERS Urine X
Whole blood for genomics initiative (optional)
SM GENETIC BLOOD SAMPLE Whole Blood X
% IRON SATURATION O
ALPHA-1 ANTITRYPSIN Serum O
ANTI SMOOTH MUSCLE ANTIBODY Serum O
ANTINUCLEAR ANTIBODY Serum O
CERULOPLASMIN Serum O
CHEMISTRY PANEL HYS LAW Serum O
CMV IGM IGG Serum O
COAGULATION HYS LAW Plasma O
EBV Serum O
FERRITIN Serum O
25
HBV DNA COBAS 6800 Plasma R
26
HCV RNA COBAS 6800 Plasma R
HEPATITIS A IGM ANTIBODY Serum O
HEPATITIS B CORE AB IGM IGG Serum O
HEPATITIS B SURFACE ANTIGEN Serum O
HEPATITIS C VIRUS ANTIBODY IGG Serum O
HERPES SIMPLEX IGG PANEL CE Serum O
HERPES SIMPLEX VIRUS IGM CE Serum O
HEV IGM Serum O
HEV RNA Plasma O
IRON PANEL Serum O
LIVER KIDNEY MICROSOME (LKM) Serum O
TRANSFERRIN Serum O
Management of Study Intervention Related Reactions
SERUM TRYPTASE 60MIN Serum O
SERUM TRYPTASE AT DISCHARGE Serum O
SERUM TRYPTASE EVENT Serum O
X Mandatory testing
O Optional testing
R Reflex testing
C Conditional testing
AstraZeneca AB
REFLEX TESTING
If Anatomic Location-Biopsy 8 Equal To distal esophagus AND

1
PVC Not Equal To V8, then a DIST ESOPHAGUS IHC EU will automatically be performed.
2
If Anatomic Location-Biopsy 8 Equal To distal esophagus AND
PVC Not Equal To V8, then a DIST ESOPHAGUS IHC HALO EU will automatically be performed.
3
If Anatomic Location-Biopsy 6 Equal To duodenum descending, then a DUOD BIOP DESCEND H PYLORI EU will automatically
be performed.
4
If Anatomic Location-Biopsy 5 Equal To superior duodenum, then a DUOD BIOP SUPERIOR DUO PROC EU will automatically
be performed.
5
If Anatomic Location-Biopsy 5 Equal To superior duodenum, then a DUOD BIOP SUPERIOR DUO REV EU will automatically
be performed.
6
If Anatomic Location-Biopsy 5 Equal To superior duodenum, then a DUOD BIOP SUPERIOR H PYLORI EU will automatically
be performed.
7
IfAnatomic Location-Biopsy 7 Equal To transverse ascendant, then a DUOD BIOP TRANS ASC H PYLO EU will automatically
be performed.
8
If Anatomic Location-Biopsy 7 Equal To transverse ascendant, then a DUOD BIOP TRANSVER ASC PROC EU will automatically
be performed.
9
If Anatomic Location-Biopsy 7 Equal To transverse ascendant, then a DUOD BIOP TRANSVER ASC REV EU will automatically
be performed.
10
If Anatomic Location-Biopsy 4 Equal To duodenal bulb, then a DUOD BIOPSY BULB H PYLORI EU will automatically
be performed.
11
If Anatomic Location-Biopsy 6 Equal To duodenum descending, then a DUODENAL BIOP DESCEND PROC EU will automatically
be performed.
12
If Anatomic Location-Biopsy 6 Equal To duodenum descending, then a DUODENAL BIOP DESCEND REV EU will automatically
be performed.
13
If Anatomic Location-Biopsy 4 Equal To duodenal bulb, then a DUODENAL BIOPSY BULB PROC EU will automatically
be performed.
14
If Anatomic Location-Biopsy 4 Equal To duodenal bulb, then a DUODENAL BIOPSY BULB REV EU will automatically
be performed.
15
If Women < 50 years who have been amenorrheic for > 12 months ? is Equal To Yes, then a FSH will automatically
be performed.
16
If Anatomic Location-Biopsy 1 Equal To gastric antrum, then a GASTRIC BIOP ANTRUM H PYLO EU will automatically
be performed.
17
If Anatomic Location-Biopsy 2 Equal To gastric body, then a GASTRIC BIOP BODY H PYLORI EU will automatically
be performed.
18
If Anatomic Location-Biopsy 3 Equal To gastric incisura stomach, then a GASTRIC BIOP INCISUR H PYLO EU will automatically
be performed.
19
If Anatomic Location-Biopsy 3 Equal To gastric incisura stomach, then a GASTRIC BIOP INCISURA PROC EU will automatically
be performed.
20
If Anatomic Location-Biopsy 3 Equal To gastric incisura stomach, then a GASTRIC BIOP INCISURA REV EU will automatically
be performed.
21
If Anatomic Location-Biopsy 1 Equal To gastric antrum, then a GASTRIC BIOPSY ANTRUM PROC EU will automatically
be performed.
AstraZeneca AB
22
If Anatomic Location-Biopsy 1 Equal To gastric antrum, then a GASTRIC BIOPSY ANTRUM REV EU will automatically
be performed.
23
If Anatomic Location-Biopsy 2 Equal To gastric body, then a GASTRIC BIOPSY BODY PROC EU will automatically
be performed.
24
If Anatomic Location-Biopsy 2 Equal To gastric body, then a GASTRIC BIOPSY BODY REV EU will automatically
be performed.
25
If Hepatitis B Core Total Equal To Positive, then a HBV DNA COBAS 6800 will automatically
be performed.
26
If Hepatitis C Virus Antibody Equal To Equivocal Or Positive, then a HCV RNA COBAS 6800 will automatically
be performed.
27
If HIV 1/2 Ag/Ab Screen, Siemens Equal To Repeatedly Reactive, then a HIV-1/2 AB SUPPLEMENTAL will automatically
be performed.
28
If Anatomic Location-Biopsy 9 Equal To middle esophagus, then a MID ESOPHAGUS HPF EOS BLK1 EU will automatically
be performed.
29
be performed.
30
be performed.
31
be performed.
32
If Anatomic Location-Biopsy 9 Equal To middle esophagus, then a MID ESOPHAGUS HPF EU will automatically
be performed.
33
If Anatomic Location-Biopsy 9 Equal To middle esophagus, then a MID ESOPHAGUS HSS EU will automatically be performed.
34
If Anatomic Location-Biopsy 9 Equal To middle esophagus, then a MID ESOPHAGUS PROCESS EU will automatically be performed.
35
If the question: “Female/of Childbearing pot.?” Equal To Yes, then a Serum Beta hCG will automatically be performed.
SPECIALTY VISIT DEFINITIONS:
Kit - Visit 15
Use this kit to collect samples at EOT visit.
Kit - Active Treatment Extension Period

Use this kit to collect samples at
V16, V18 and V21 for participants who continue into the active treatment extension period.
Kit - FU2
Use this kit to collect samples at FU2.
Kit - IPD visit

This kit should be used in case of IP discontinuation visit (IPD visit).
Please check Clinical Study Protocol section 7.1 for details.
Kit - Unscheduled/Retest
This kit can be used:
– central testing of serum tryptase following an anaphylactic reaction in case local testing is not feasible
– to repeat or follow-up safety related testing at any time during the trial. .
Make sure that you order all needed tests.
AstraZeneca AB
SPECIALTY VISIT DEFINITIONS:
Kit - GX SAMPLE)
Use this kit to obtain whole blood sample for genomics initiative (optional testing).
This sample should ONLY be collected from adult patients who have provided informed consent for the genetic research sample
collection.
The preference is to have the sample collected at Visit 2. However, it can also be collected at any later visit.
Please check CSP Appendix D for details..
Kit -Pregnancy confirmation

Use this kit in case urine pregnancy test is positive.
This kit can also be used to repeat serum beta hCG test if needed for Visit 1.
Kit - Esophageal biopsies

Use this kit to collect esophageal tissue for biomarker analyses and histopathology at Visit 1, Visit 8, Visit 15.
Esophageal tissue may also be collected at IPD visit - see Clinical Study Protocol, Table 3, footnote “f” and Table 4, footnote “e” for
details.
Kit - Gastric/Duodenal biopsies

Use this kit (if needed) to collect gastric/duodenal biopsies for pathology assessment. The kit may be used at the following visits:
Visit 1
Visit 8
Visit 15
The biopsy of the stomach/duodenum will be done only if gross abnormalities are seen on EGD or there are clinical signs and symptoms
that indicate that gastric or small intestinal conditions are possibilities.
Kit - Hy s Law
This kit will be used after Potential Hy’s Law criteria are met by the Patient (please check Clinical Study Protocol Appendix E for details).
Hy’s Law kit can only be used after the discussion with AstraZeneca Study Physician took place and the decision was made which tests
should be performed.
Important! Please always consult AstraZeneca representative before using Hy’s Law kit.
STUDY SPECIFIC NOTES:
Sponsor is collecting 01-Jul and the subject’s birth year as the date of birth (DOB) for all subjects in this study. Labcorp CLS reference
ranges, alerts, flags and age-dependent calculations will be based on the generic DOB provided by the investigator. It is the responsibility
of the investigator to ensure these parameters are aligned with the real subject age and that the subject meets the age requirement
for the study.
Esophagogastroduodenoscopy (EGD)
During the screening/run-in period the EGD should be performed as soon as possible (recommended within 5 days) following eligibility
confirmation from additional testing (eg, laboratory blood tests). This is due to the turnaround time for centrally read histology results
needed for randomization (up to 5 weeks).
After randomization esophageal biopsy results will not be reported to the investigational sites to maintain blinding.
For a participant who discontinued study intervention, the EGD should be performed at Week 24 (V8) and Week 52 (V15a visit), rather
than the IPD visit. If it cannot be performed at Week 24 (V8) and Week 52 (V15a visit), the EGD should be performed at the IPD visit if
>/= 12 weeks have elapsed since the prior EGD.
There are separate laboratory kits that need to be used for biopsy samples collection:
• Kit name for esophageal biopsy collection: “Esophageal biopsies”
• Kit name for gastric/duodenal biopsy collection: “Gastric/Duodenal biopsies”
AstraZeneca AB
Additionally, some of the bulk supplies need to be used:

• Neutral Buffered Formalin
• Ethanol 70%
• Cassettes for biopsy tissue
• Square foam pad for biopsy cassette
Closely monitor kit and supplies inventory and make sure to order missing items well in advance.
Please note the requirements for esophageal biopsies collection.

▪4-6 biopsies will be taken from the distal esophagus (which includes 2 biopsies for biomarker analysis) – required
▪2-4 biopsies from the proximal esophagus – required
▪2-4 biopsies from the middle esophagus - strongly recommended
Sample collection
During treatment period all laboratory samples should be obtained prior to study intervention administration.
Urinalysis
Urine sample will be analyzed locally using dipstick. Following tests would be analyzed: Blood, Protein, Glucose.
In case positive or “trace” dipstick result for any of these 3 parameters is observed, urine sample will be sent to the Central Laboratory
for confirmatory analysis.
Perform urine dipstick at site, using the provided material in bulk supplies following procedure in below order:
1-Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device (blue lid
with protective sticker, provided within kit). Collect at least 20 mL of urine.
2- Use a sterile pipette to transfer and drop urine onto the dipstick from the urine collection device, ensuring to not contaminate the
original urine sample. If the dipstick is “positive”, the urine specimen could then be sent to Labcorp for analysis as following:
3- Place the blue lid back on device and place it on level surface. Peel back protective sticker to expose rubber-covered cannula. Firmly
push the urine culture tube (for URINE CULTURE) onto the integrated transfer port. Hold in position until flow stops. The urine sample
must fill the container between the minimum fill line (3mL) and the maximum of 4 mL indicated by the tick mark at the top of the
label. Do not manually fill or overfill. Mix tube 8-10 times by inversion. If tube is not pre-labeled, place the label from the appropriate
Labcorp CLS visit kit on the urine culture tube. Record the subject number on the label. Refrigerate immediately at 2°C to 8°C until
shipment.
4- Remove the blue lid and use a clean pipette. Transfer specimen from urine collection cup into tube with preservative tablet labeled
URINALYSIS.
Do not fill above 7 mL mark. Screw cap on tightly.
Ship Urinalysis tube ambient on day of collection. Store sample ambient until shipment.
AstraZeneca AB
Ship Urine Culture tube refrigerated on day of collection. Store sample refrigerated until shipment.
Hematology and Differential Panel

During treatment period blood eosinophil count and percentage, basophil and monocyte counts will be redacted from the central
laboratory reports to maintain blinding.
Pregnancy testing
Urine pregnancy test needs to be performed for women of childbearing potential starting from Visit 2 at each treatment visit except
FU1 Visit.
The test should be done before study intervention administration. A positive urine test result must be confirmed with serum β-hCG
analysed at Central Laboratory (“Pregnancy confirmation” kit needs to be used).
Hy’s Law kit

Hy’s Law kits are NOT included into start-up kit shipment. One Hy’s Law kit should be ordered manually after first Patient is randomized
at the site.
The expectation is that only one Hy’s Law kit will be ordered per site. After this kit is used or expired new one can be re-ordered.
Laboratory results
The laboratory results should be signed and dated and retained at site as source data for laboratory variables.
SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL D5244C00001
AstraZeneca AB
Some immunoassay tests may exhibit interference when samples are collected from a person who is consuming a supplement with
a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask patients about biotin
supplementation. Physicians should be aware that high levels of biotin supplementation may have an impact over a period of at
least 72 hours. See the list of assays with potential interference immediately following the specimen collection procedures.
SERUM
TESTS VISITS COLLECT RETURN

AMBIENT
CHEMISTRY PANEL, DAY OF COLLECTION
CRP, Visit 1
1 x 4.0 mL gold top serum 1 x plastic vial
LIPID PANEL separation tube CHEMISTRY TO: LABCORP CLS
1. Fill tube completely.

2. Thoroughly mix the blood by inverting the tube five times.
3. Allow blood to clot for 30 to 60 minutes (tube standing upright).
4. Promptly centrifuge at 1500 to 2000 x g for no less than 15 minutes until clot and serum are separated.
5. Use pipette provided, avoid touching the surface of the gel with the pipette tip, and promptly transfer the serum into the
appropriately labeled vial(s).
6. Re-cap immediately.
SERUM

Visit 2, AMBIENT
Visit 3, DAY OF COLLECTION
Visit 5,
Visit 8,
CHEMISTRY PANEL, Visit 10,
CRP, Visit 12,
1 x 2.5 mL red top serum 1 x plastic vial
LIPID PANEL Visit 15, separation tube CHEMISTRY TO: LABCORP CLS
Active Treatment
Extension Period,
FU2,
IPD visit
SERUM

AMBIENT
CHEMISTRY PANEL, DAY OF COLLECTION
CRP, Unscheduled/Retest*
1 x 3.5 mL gold top serum 1 x plastic vial
LIPID PANEL separation tube CHEMISTRY TO: LABCORP CLS

* Optional/Conditional testing or All testing Optional/Conditional at Visit; ** Reflex testing

English_Specimen Collection Procedures_Update: 20230530 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
AstraZeneca AB
SERUM

AMBIENT
HEPATITIS B SURFACE
DAY OF COLLECTION
AG, Visit 1,
1 x plastic vial
HEPATITIS C Unscheduled/Retest* 1 x 2.5 mL red top serum
HEP B SURFACE AG HEP C TO: LABCORP CLS
ANTIBODY separation tube
VIRUS AB
SERUM

AMBIENT
HIV 1/2 AG/AB Visit 1, DAY OF COLLECTION
SCREEN Unscheduled/Retest* 1 x 2.5 mL red top serum 1 x plastic vial
separation tube HIV 1/2 AG/AB SCREEN TO: LABCORP CLS

SERUM

AMBIENT
DAY OF COLLECTION
1 x plastic vial
TOTAL IGE, TOTAL IGE
Unscheduled/Retest*
FSH 1 x 2.5 mL red top serum
separation tube TO: LABCORP CLS
1 x plastic vial
FSH
5. Use pipette provided, avoid touching the surface of the gel with the pipette tip, and promptly transfer the serum equally into
each of the appropriately labeled vial(s).

AstraZeneca AB
SERUM

FROZEN
aliquot 1 -70/80°C
Visit 2, MONTHLY
Visit 3, 1 x cryovial TO: LABCORP CLS
Visit 5,
TEZE PK Visit 8, FROZEN
1 x 3.5 mL gold top serum
Visit 15, separation tube aliquot 2 -70/80°C
FU2, NEXT AVAILABLE
IPD visit SHIPMENT
1 x cryovial
TO: LABCORP CLS

2. Mix by gentle inversion 5 times.
3. Once mixed – please, document the time on the HBS Log (this would be “Sample Process start time” on the HBS Log).
4. Allow blood to clot for 30 minutes at room temp.
5. Centrifuge within 2 hours of collection at 1100g -1300g for 15 minutes.
6. Use pipette to transfer all of the serum equally into the two 2mL tubes.
7. Document the time on the HBS Log (this would be “Sample Process stop time” on the HBS Log).
8. Immediately freeze upright at -70/80°C (or -20°C if -70/80°C storage not available).
Samples should be shipped to Labcorp CLS frozen, on monthly basis, however, in different shipments.
Ship the aliquot 1 in different shipment than aliquot 2 (it can be done in the next available shipment of frozen samples).
SERUM

FROZEN
aliquot 1 -70/80°C
Visit 2, MONTHLY
Visit 5, 1 x cryovial TO: LABCORP CLS
Visit 8,
TEZE ADA NAB Visit 15, FROZEN
1 x 5.0 mL gold top serum
FU2, separation tube aliquot 2 and aliquot 3 -70/80°C
IPD visit, NEXT AVAILABLE
Unscheduled/Retest* SHIPMENT
2 x cryovials
TO: LABCORP CLS

2. Mix by gentle inversion 5 times.
3. Once mixed – please, document the time on the HBS Log (this would be “Sample Process start time” on the HBS Log).
4. Allow blood to clot for 30 minutes at room temp.
5. Centrifuge within 2 hours of collection at 1100g -1300g for 15 minutes.
6. Use pipette to transfer all of the serum equally into the three 2mL tubes.
7. Document the time on the HBS Log (this would be “Sample Process stop time” on the HBS Log).
8. Immediately freeze upright at -70/80°C (or -20°C if -70/80°C storage not available).
Samples should be shipped to Labcorp CLS frozen, on monthly basis.

Ship aliquot 2 and 3 in different shipment than aliquot 1 (these two aliquots can be shipped in the next available shipment of frozen
samples).

AstraZeneca AB
SERUM

Visit 1, AMBIENT
Visit 3,
Visit 5,
TOTAL IGE
Visit 8, 1 x 2.5 mL red top serum 1 x plastic vial
Visit 12, separation tube TOTAL IGE TO: LABCORP CLS
Visit 15,
FU2
SERUM

aliquot with uneven FROZEN
numbers -70°C
Visit 1, MONTHLY
Visit 2,
Visit 3, 6 x cryovials TO: LABCORP CLS
Visit 5, FROZEN
SERUM BIOMARKERS
Visit 8, 3 x 5.0 mL gold top serum -70°C
Visit 12, separation tubes aliquot with even numbers
NEXT AVAILABLE
Visit 15, SHIPMENT AFTER FIRST
FU2 SHIPMENT
6 x cryovials
TO: LABCORP CLS
1. Draw maximum volume of blood for the size tubes provided.

2. Immediately upon blood draw, gently invert 5 times. Do not wait until all tubes are drawn as this will result in unusable clotted
samples.
3. Allow blood to clot for 30 minutes at room temperature.
4. Centrifuge within 2 hours of collection at 1100-1300 x g for 15 minutes.
5. Transfer a minimum of 0.5 mL of serum into each of (12) 2-mL cryotubes provided using an adjustable single-channel pipette.
6. Immediately freeze cryovials upright at -70°C.
Ship aliquots frozen to Labcorp CLS.

Ship aliquots monthly in separate shipments. Ship aliquot with uneven numbers in 1st shipment and aliquots with even numbers in
the next available shipment after first shipment.
In case storage at -70°C is not available, ship aliquot with uneven numbers in next available shipment and aliquot with even numbers
in the next available shipment after first shipment.
Note for sites: Please do not send empty tubes.

If insufficient volume is collected for full aliquots, dispense volume such that at least aliquots with uneven numbers (i.e. A1, A3, A5,
A7, A9 and A11) are fully filled (i.e., 0.5 mL), with the remaining volume dispensed into aliquots with even numbers. Discard unused/
empty tubes.

AstraZeneca AB
SERUM

FROZEN
A1 -70°C OR COLDER
MONTHLY
1 x cryovial TO: LABCORP CLS
Visit 1, FROZEN
SM TSLP
Visit 2 1 x 2.5 mL red top serum -70°C OR COLDER
separation tube A2
NEXT AVAILABLE
SHIPMENT AFTER FIRST
SHIPMENT
1 x cryovial
TO: LABCORP CLS
1. Draw maximum volume of blood for the size tube provided.

2. Immediately upon blood draw, gently invert 5 times. Do not wait until all tubes are drawn as this will result in unusable clotted
samples.
3. Allow blood to clot for 30 minutes at room temperature.
4. Centrifuge within 2 hours of collection at 1100-1300 x g for 15 minutes.
5. Transfer a minimum of 0.5 mL of serum into each of (2) 2-mL cryotubes provided.
6. Immediately freeze cryovials upright at -70°C or colder.
Ship aliquots frozen to Labcorp CLS.

Ship aliquots monthly in separate shipments. Ship A1 in 1st shipment and A2 in the next available shipment after first shipment.
In case storage at -70°C is not available, ship A1 in next available shipment and A2 in the next available shipment after first shipment
Note for sites: Please do not send empty tubes.

If insufficient volume (less than 1ml) is collected for two full aliquots, dispense volume such that at least one aliquot is fully filled (i.e.,
0.5ml), with the remaining volume dispensed into a second aliquot.
If less than 0.1ml is available for the second aliquot, please discard the second aliquot. Please record the approximate volumes for
both aliquots on the requisition form.
SERUM

AMBIENT
DAY OF COLLECTION
SERUM BETA HCG Pregnancy confirmation
1 x 2.5 mL red top serum 1 x plastic vial
separation tube SERUM BETA HCG TO: LABCORP CLS

SERUM

FROZEN
-20°C
SERUM TRYPTASE DAY OF COLLECTION
Unscheduled/Retest 1 x plastic vial
EVENT* 1 x 2.5 mL red top serum
SERUM TRYPTASE EVENT
FROZEN
7. Freeze immediately at -20°C until shipment.
AstraZeneca AB
SERUM

FROZEN
-20°C
SERUM TRYPTASE DAY OF COLLECTION
60MIN* 1 x 2.5 mL red top serum
SERUM TRYPTASE 60MIN
FROZEN
SERUM

FROZEN
-20°C
SERUM TRYPTASE AT DAY OF COLLECTION
DISCHARGE* 1 x 2.5 mL red top serum
SERUM TRYPTASE
DISCHARGE FROZEN
PLASMA

FROZEN
HIV-1/HIV-2 -20°C
Unscheduled/Retest* DAY OF COLLECTION
QUALITATIVE RNA 1 x 2.0 mL lavender top
1 x cryovial
EDTA tube TO: LABCORP CLS
2. Mix immediately by gently inverting the tube at least 8 to 10 times.
3. Promptly centrifuge at 1500 to 2000 x g for no less than 15 minutes until cells and plasma are separated.
4. Use pipette provided to promptly transfer all the plasma into the appropriately labeled plastic vial(s).

AstraZeneca AB
WHOLE BLOOD
TESTS VISITS COLLECT / RETURN

Visit 1, AMBIENT
Visit 3,
Visit 5,
Visit 8,
Visit 10,
HEMATOLOGY&DIFFERENTIAL
Visit 12,
PANEL
Visit 15, 1 x 2.0 mL lavender top EDTA tube, 1 x double glass TO: LABCORP CLS
Active Treatment slide mailer
Extension Period,
FU2,
IPD visit,
Unscheduled/Retest*
1. The tube contains enough vacuum to fill to the required volume.
2. Fill until blood flow stops.
3. The tube will not appear full.
5. Make blood smears with blood from the lavender top tube using the Diff-Safe dispenser.
6. Make two slides.
7. Allow to air dry.
8. Write the accession number on the frosted part of each slide using a pencil.
9. Place both slides in blue slide mailer.
10. Remove the Diff-Safe from the tube!
11. Do not forget to ship the tube after using it for the hematology slides.
NOTE: The best source of information in confirmation of hematology results is the blood smear slide prepared by you at the time of
draw. Your diligence in slide preparation increases the opportunity to provide hematology results.

AstraZeneca AB
WHOLE BLOOD

FROZEN
-20°C TO -30°C
MONTHLY
Visit 1, 1 x 2.5 mL PAXgene™ blood RNA tube

TO: LABCORP CLS
SM WHOLE BLOOD Visit 8,
TRANSCRIPTOMICS Visit 15, FROZEN
IPD visit -20°C TO -30°C
IN A SEPARATE
1 x 2.5 mL PAXgene™ blood RNA tube SHIPMENT
TO: LABCORP CLS
NOTE: Ensure that the PAXgene Blood RNA Tube is at room temperature (18 °C to 25 °C) prior to use.
1. Utilize the 2 x 2.5 mL PAXgene Blood RNA Tubes provided.

2. Collect blood specimens by venipuncture according to phlebotomy best practices document / standard methods.
3. Prevent Backflow. Hold the PAXgene Blood RNA Tube vertically, below the blood donor’s arm, during blood collection. Release
the tourniquet as soon as blood starts to flow into the tube. Make sure tube additives do not touch stopper or end of needle
during venipuncture.
CAUTION: PAXgene Blood RNA Tubes contain a chemical additive and it is important to avoid backflow from the tube to eliminate
possible patient adverse reaction.
4. Allow at least 10 seconds for a complete blood draw to take place. Ensure that the blood has stopped flowing into the tube
before removing a tube from the holder.
5. After draw immediately mix by gentle inversion 10 times. Inadequate or delayed mixing may result in inaccurate test results.
One inversion is a complete turn of the wrist, 180 degrees, and back per the figure below.
6. Stand the PAXgene Blood RNA Tube(s) upright in a wire rack at room temperature for 2-3 hours (tubes may be left at ambient
for up to 72 hours max).
7. Transfer upright to a standard freezer (-20 to -30°C). Do not use a styrofoam tray as this may cause tubes to crack.
NOTE: If tubes are to be kept below -20°C, freeze them first at between -20 to -30°C for at least 24 hours, then transfer them to ≤
-70°C.
NOTE: Frozen PAXgene Blood RNA Tubes are subject to breakage upon impact. To reduce the risk of breaking during shipment, frozen
tubes should be treated in the same manner as glass tubes. Enclose the PAXgene Blood RNA Tubes in the bubble wrap provided and
ship samples on dry ice to Labcorp CLS monthly. Ship each tube in a separate shipment.
Do not place the tubes directly in contact with dry ice.

AstraZeneca AB
WHOLE BLOOD

FROZEN
-20°C OR BELOW
MONTHLY
SM GENETIC BLOOD SAMPLE GX SAMPLE
1 x 6.0 mL lavender top EDTA tube
TO: LABCORP CLS
This sample should ONLY be collected from patients who have provided informed consent for the genetic research sample.
1. Draw 6 mL of blood in a lavender top K2EDTA tube (maximum volume).

2. Mix immediately by gentle inversion 8 – 10 times. DO NOT SHAKE.
3. Freeze immediately at-20°C or below. DO NOT CENTRIFUGE.
4. Keep frozen at -20°C or below until shipment.
5. Ship frozen on dry ice to Labcorp CLS monthly.

AstraZeneca AB
URINE

FROZEN
A1+A2 -20°C OR BELOW
MONTHLY
1 x 10.0 mL yellow top conical tube,
Visit 1,
2 x cryovials TO: LABCORP CLS
Visit 2,
Visit 3,
SM URINE FROZEN
Visit 5,
BIOMARKERS -20°C OR BELOW
Visit 8,
A3+A4 NEXT AVAILABLE
Visit 15, 1 x 4oz sterile spec container SHIPMENT AFTER
IPD visit only to be used at visits without FIRST SHIPMENT
collection of urinalysis and urine 2 x cryovials
culture samples TO: LABCORP CLS
At visits without collection of urinalysis and urine culture samples:

1. Collect clean-catch/mid-stream urine in a preservative-free, sterile container.
2. If urine cannot be processed within 2 hours of collection, it should be stored at 2 to 8°C.
3. Urine stored at 2 to 8°C must be brought to room temperature and mixed by gently swirling. primary storage container, while
the lid is on (this reduces temperature-dependent sedimentation of proteins and crystals).
4. Room temperature urine is transferred into a 10 ml tube and centrifuged at 1500 RCF for 5 minutes.
5. Supernatant is aliquoted into 500 μl aliquots in cryogenic vials and frozen at -20°C or below.
6. If 500 μl cannot be reached in the last tube distribute remaining sample volume equally across the tubes aliquoted into. Discard
unused/empty tubes.
7. All frozen samples must be shipped on dry ice to the central lab after initial freezing point without thawing the frozen cryogenic
vials.
8. Vials should be stored at -20°C or below until shipment.
At visits with collection of urinalysis and urine culture samples:

1. After following the instructions to collect and process urine samples for urine culture and urine micro panel/urinalysis, use
remaining urine sample in urine collection cup to proceeded to collect urine biomarkers as last urine sample. Urine culture and
urine micro panel/urinalysis need to be collected and processed first, before preparing the urine biomarker samples.
2. Room temperature urine is transferred into a 10 ml tube and centrifuged at 1500 RCF for 5 minutes.
3. Supernatant is aliquoted into 500 μl aliquots in cryogenic vials and frozen at -20°C or below.
4. If 500 μl cannot be reached in the last tube distribute remaining sample volume equally across the tubes aliquoted into. Discard
unused/empty tubes.
5. All frozen samples must be shipped on dry ice to the central lab after initial freezing point without thawing the frozen cryogenic
vials.
6. Vials should be stored at -20°C or below until shipment.
Shipping:
Ship aliquots frozen to Labcorp CLS. Ship aliquots monthly in separate shipments. Ship A1 + A2 in 1st shipment and A3 + A4 in the
next available shipment after first shipment.
In case storage at -70°C is not available, ship A1 + A2 in next available shipment and A3 + A4 in the next available shipment after first
shipment.

AstraZeneca AB
URINE

URINE MICRO PANEL: AMBIENT
DAY OF COLLECTION
Visit 1,
Visit 2, 1 x 10.0 mL orange top conical
tube TO: LABCORP CLS
Visit 5,
URINE CULTURE*, Visit 8, URINALYSIS
URINE MICRO PANEL* Visit 10, URINE CULTURE: REFRIGERATED
Visit 15, 1 x Urine Cup, blue lid DAY OF COLLECTION
IPD visit, with protective sticker
Unscheduled/Retest 1 x 5.0 mL gray top urine culture
URINE CULTURE
1. Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device
(blue lid with protective sticker, provided within kit). Collect at least 20 mL of urine.
2. Use a sterile pipette to transfer and drop urine onto the dipstick from the urine collection device, ensuring to not contaminate
the original urine sample. If the dipstick is “positive”, the urine specimen could then be sent to Labcorp for analysis as following:
3. Place the blue lid back on device and place it on level surface. Peel back protective sticker to expose rubber-covered cannula.
Firmly push the urine culture tube (for URINE CULTURE) onto the integrated transfer port. Hold in position until flow stops. The
urine sample must fill the container between the minimum fill line (3 mL) and the maximum of 4 mL indicated by the tick mark
at the top of the label. Do not manually fill or overfill. Mix tube 8-10 times by inversion. If tube is not pre-labeled, place the
label from the appropriate Labcorp CLS visit kit on the urine culture tube. Record the subject number on the label. Refrigerate
immediately at 2°C to 8°C until shipment.
4. Remove the blue lid and use a clean pipette. Transfer specimen from urine collection cup into tube with preservative tablet
labeled URINALYSIS.

AstraZeneca AB
WET TISSUE

DUOD BIOP SUPERIOR DUOD, AMBIENT
DUOD BIOP TRANSVER IMMEDIATELY
ASCEN, FOLLOWING PROCESS
DUODENAL BIOP DESCRIBED BELOW
Gastric/Duodenal
DESCENDING,
biopsies*
DUODENAL BIOPSY BULB,
7 x 60 mL blue cap containers, 7 x ethanol, 14 x labels,
GASTRIC BIOP INCISURA, 7 x cassettes, 14 x biopsy foams TO: LABCORP CLS
GASTRIC BIOPSY ANTRUM,
GASTRIC BIOPSY BODY
As recommended by Sydney protocol, the gastric biopsies needed depending on the anatomic location are:
2 biopsies from antrum

2 biopsies from body
1 from incisura in the stomach
Duodenal biopsies that may be needed depending on the findings are:
1 duodenal bulb
1 superior duodenum
1 descending
1 transverse ascendant
If gastric biopsies are required then investigators should follow either the Sydney Protocol (2 biopsies from antrum, 2 biopsies from
body and 1 from incisura in the stomach as this is typical for Helicobacter pylori investigation - likely to be the biggest trigger for
these) or their local site guidelines.
Collect the biopsies from the prioritized anatomic locations. Needed number of biopsies (depending on the findings) is provided
above.
Each anatomic location should have its own formalin container to put the samples in.
Example:
If there are samples taken from 3 gastric regions then 3 formalin jars/containers are used (one for each region) and 3 tissue cassettes
are needed.
If for example the samples are also taken from duodenum, there should be up to 4 formalin jars/containers used (one for each region)
and up to 4 tissue cassettes needed.
Biopsy collection material is provided as bulk supply and loose label are provided within the kit for each anatomic location. Please
apply labels per collected anatomic location to formalin container and ethanol container.
1. Place all biopsies from a single anatomic location into one tissue cassette. Biopsies are to be placed between two foam pads and
the cassette closed securely.
2. Place the cassette into a jar containing 10% neutral buffered formalin for fixation for 12 -24 hours at room temperature. Ensure
tissue cassette is fully submerged.
3. After fixation, transfer the tissue cassettes to 70% ethanol. Ensure tissue cassette is fully submerged.
4. Keep samples at ambient temperature. Ship at ambient conditions immediately to the central lab.
5. Discard of 10% neutral buffered formalin according to local regulations.
Note: If biopsy is collected on a Friday tissue must be transferred from 10% neutral buffered formalin to 70% ethanol on Saturday.
Shipping to the central lab can happen on Saturday or wait until Monday. Keep samples in ambient conditions until shipment.

AstraZeneca AB
WET TISSUE

AMBIENT
IMMEDIATELY
DIST ESOPHAGUS, FOLLOWING PROCESS
MID ESOPHAGUS**, Esophageal biopsies DESCRIBED BELOW
PROX ESOPHAGUS
3 x 60 mL blue cap containers, 3 x ethanol, 6 x labels,
3 x cassettes, 6 x biopsy foams TO: LABCORP CLS
Eosinophilic esophagitis (EoE) is a rare inflammatory disease of the esophagus that requires careful endoscopic and histopathological
analyses. The inflammation is patchy in the esophagus with areas of eosinophilic infiltration and inflamed tissue with adjacent non-
inflamed tissue with little or no eosinophils present. In addition, the inflamed esophageal tissue is inherently fragile and must be
handled with care. Therefore, it is critical that the endoscopic procedure and processing of multiple esophageal biopsy specimen
taken throughout the length of the esophagus, targeted to esophageal areas that appear inflamed, are carefully performed to ensure
proper diagnosis and monitoring of disease activity.
Biopsy collection material is provided as bulk supply and loose label are provided within the kit for each anatomic location. Please
apply labels per collected anatomic location (promixal, mid, and distal) to formalin container and ethanol container.
1. Collection of 2-4 biopsies in the prioritized anatomic locations, proximal and distal esophagus is required.
2. Collection of 2-4 biopsies from the middle esophagus collection site is optional but strongly recommended.
3. Each anatomic location should have its own formalin container to put samples in. Example: If there are samples taken from all
3 esophageal levels, there should be 3 formalin jars (one for proximal, one for distal and one for mid) that have 2-4 biopsies in
tissue cassettes sent for testing.
4. Place all biopsies (2-4) from a single anatomic location into a jar containing 10% neutral buffered formalin as per routine clinical
practice. Allow for sample fixation to occur for more than 12 but no more than 24 hours at room temperature. Ensure tissue
samples are fully submerged in the 10% neutral buffered formalin.
5. After fixation, carefully transfer all biopsies (2-4) from a single anatomic location into one tissue cassette. Biopsies are to be
placed between two foam pads and the cassette closed securely. Place the tissue cassette into the 70% ethanol jar (one cassette
per jar). Ensure all tissue samples are fully submerged in the 70% ethanol within the cassette.
Keep samples at ambient temperature.

Ship at ambient conditions immediately to Labcorp CLS.
Discard of 10% neutral buffered formalin according to local regulations.
Note: If biopsy is collected on a Friday tissue must be transferred from 10% neutral buffered formalin to 70% ethanol on Saturday.
Shipping to the central lab can happen on Saturday or wait until Monday. Keep samples in ambient conditions until shipment.

AstraZeneca AB
TISSUE

FROZEN
A1 -20°C
NEXT AVAILABLE
SHIPMENT
1 x RNALater Tissue Protect tube
SM DIST ESO TISSUE TO: LABCORP CLS
Esophageal biopsies*
RNA FROZEN
A2 -20°C
NEXT AVAILABLE
SHIPMENT AFTER A1
1 x RNALater Tissue Protect tube
TO: LABCORP CLS
1. Perform a visual check for RNA later level. The tubes are prefilled with 1 mL RNA later. Indicate on the requisition form that
RNAlater volume has been verified.
2. Two biopsies are to be taken from the distal esophagus. The biopsies should be taken from a visibly inflamed area, if present. In
the absence of visibly inflamed tissue, representative biopsies of distal tissue should be taken.
3. The tissue sample is to be placed immediately into the cryotube with the RNAlater after extraction - one biopsy into each of the
two tubes.
4. Without any cleaning procedure, place the tissue of the distal esophagus into the cryotube with the RNAlater and submerge the
tissue so that the RNAlater is fully surrounding the sample. The tissue should be free floating in the RNAlater without any tissue
pressed against the walls of the cryotube.
5. Keeping the tube in the up-right position, incubate the sample in the RNAlater in a refrigerator at 2 to 8°C for at least overnight
(more than 16 hours) BEFORE freezing at -20°C. If samples are collected on Friday, incubation at 2 to 8°C over the weekend is
acceptable.
6. All frozen samples must be shipped on dry ice to the central lab after initial - 20°C freezing point without thawing the frozen
RNA later tube. Ship aliquots in separate shipments (Ship A1 with next available shipment. Ship A2 with next available shipment
after A1.).

AstraZeneca AB
HY’S LAW KIT

SERUM

AMBIENT
DAY OF COLLECTION
1 x plastic vial
FERRITIN TO: LABCORP CLS
ANTI SMOOTH MUSCLE
ANTIBODY, FROZEN
Hy s Law*
ANTINUCLEAR ANTIBODY, 1 x 3.5 mL gold top serum -70°C
FERRITIN separation tube DAY OF COLLECTION
1 x plastic vial
ANTI SMOOTH MUSC, ANA
FROZEN TO: LABCORP CLS

5. Use pipette provided, avoid touching the surface of the gel with the pipette tip, and promptly transfer the serum equally into
each of the appropriately labeled vial(s).
SERUM

CHEMISTRY PANEL HYS AMBIENT
LAW, DAY OF COLLECTION
CERULOPLASMIN,
Hy s Law*
% IRON SATURATION, 1 x 3.5 mL gold top serum 1 x plastic vial
ALPHA-1 ANTITRYPSIN, separation tube CHEMISTRY TO: LABCORP CLS
IRON PANEL
SERUM

FROZEN
-20°C
1 x plastic vial DAY OF COLLECTION
CMV FROZEN
CMV IGM IGG,
Hy s Law*
EBV 1 x 3.5 mL gold top serum
separation tube FERRITIN TO: LABCORP CLS
1 x plastic vial
EBV FROZEN
5. Use pipette provided, avoid touching the surface of the gel with the pipette tip, and promptly transfer 1.0 mL of the serum into
the plastic vial labeled CMV FROZEN and the remainder of the serum into the plastic vial labeled EBV FROZEN.

AstraZeneca AB
HY’S LAW KIT

SERUM

HEPATITIS A IGM ANTIBODY, AMBIENT
HEPATITIS B CORE AB IGM IGG, DAY OF COLLECTION
HEPATITIS B SURFACE
Hy s Law* 1 x plastic vial
ANTIGEN, 1 x 5.0 mL gold top serum
HEP A, HEP B SURF, HEP B TO: LABCORP CLS
HEPATITIS C VIRUS ANTIBODY separation tube
CORE, HEP C
IGG
SERUM

FROZEN
-20°C
HERPES SIMPLEX IGG DAY OF COLLECTION
Hy s Law* 1 x plastic vial
PANEL CE 1 x 2.5 mL red top serum separation
HERPES SIMPLEX
IGG PANEL FROZEN
5. Use pipette provided, avoid touching the surface of the gel with the pipette tip, and promptly transfer all the serum into the
appropriately labeled plastic vial(s).
SERUM

FROZEN
HERPES SIMPLEX -20°C
VIRUS IGM CE Hy s Law* DAY OF COLLECTION
1 x 2.5 mL red top serum separation
1 x plastic vial

AstraZeneca AB
HY’S LAW KIT

SERUM

FROZEN
-20°C
HEV IGM Hy s Law* DAY OF COLLECTION
1 x 2.5 mL red top serum separation 1 x plastic vial
tube HEV IGM FROZEN TO: LABCORP CLS
SERUM

FROZEN
LIVER KIDNEY -20°C
Hy s Law* DAY OF COLLECTION
MICROSOME (LKM) 1 x 2.5 mL red top serum separation
1 x plastic vial
SERUM

FROZEN
-20°C
TRANSFERRIN Hy s Law* DAY OF COLLECTION
1 x 2.5 mL red top serum separation 1 x plastic vial
tube TRANSFERRIN FROZEN TO: LABCORP CLS

AstraZeneca AB
HY’S LAW KIT

PLASMA

FROZEN
-20°C
DAY OF COLLECTION
COAGULATION HYS
Hy s Law*
LAW 1 x 1.8 mL 3.2% blue top 1 x plastic vial
sodium citrate tube COAGULATION FROZEN TO: LABCORP CLS
1. The tube contains enough vacuum to fill to the required volume.

2. Fill until blood flow stops.
3. The tube will not appear full.
4. If the draw tube is less than 90% of the fill line, the sample should be recollected.
5. When using a winged blood collection set (butterfly needle with attached tubing) and the citrate tube is the first tube being
drawn, first draw a discard tube using a non-additive tube.
6. The discard tube does not need to be filled completely.
8. Prior to centrifugation, gently rock the tube back and forth while examining the sample for visible clots.
9. If visible clot seen, recollect the sample.
11. Use pipette provided to promptly transfer the plasma into the appropriately labeled plastic vial(s).
12. Do NOT touch or pipette the interface (hazy layer between the cells and plasma).
PLASMA

FROZEN
HBV DNA COBAS 6800**, -70°C
Hy s Law DAY OF COLLECTION
HCV RNA COBAS 6800** 1 x 6.0 mL lavender top
1 x cryovial
3. Whole blood can be stored no longer than 6 hours at 2-30°C prior to centrifugation.
4. Promptly centrifuge at 1200 to 1500 x g for no less than 15 minutes at room temperature until cells and plasma are separated.
5. Use sterile pipette provided to transfer the plasma into the sterile labeled cryovials.
7. If -70°C storage is not available, then samples can be stored at -20°C for a maximum of one month from collection date.
PLASMA

FROZEN
-70°C
HEV RNA Hy s Law* DAY OF COLLECTION
1 x 3.0 mL lavender top
1 x plastic vial
4. Use pipette provided to promptly transfer all the plasma into the appropriately labeled plastic vial(s).

CENTRIFUGE INSTRUCTIONS
Nomograph for calculating the centrifuge speed:
Radius Speed
SCALE A SCALE B
g
SCALE C
Using the RCF Nomograph

To determine the relative centrifugal
field (RCF), place a straightedge
on the nomograph connecting the
known speed (rpm) and the known
ROTATING RADIUS - CENTIMETERS
rotating radius. The point at which

ROTATING RADIUS - INCHES
the straightedge intersects the RCF B
SPEED - REVOLUTIONS PER MINUTE

axis is the field.
RELATIVE CENTRIFUGAL FORCE - GRAVITIES
For example, if the rotating radius is

10 cm and the speed is 3,000 rpm,
the relative centrifugal field is 1,000 C
• g (gravity)
If the field and the radius are known,
the corresponding speed can be
determined.
To calculate RCF
RCF = 0.00001118 • r • N2
RCF = relative centrifugal
A field (gravities)
r = rotating radius
(centimeters)
N = rotating speed
(revolutions per min)
The distance measured from the rotor axis to the tip of the liquid inside the tubes at the greatest horizontal distance
from the rotor axis is the rotating tip radius. The radius is listed for your convenience in the speed and force tables.
Rotating Axis
ROTATING RADIUS ROTATING RADIUS

ANGLE ROTORS HORIZONTAL ROTORS
English_Centrifuge Instructions_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
Order of Draw
The following provides the recommended order of draw according to the Clinical and Laboratory
Standards Institute (CLSI H3-A6, Vol 27, No 26, 8.10)
Recommended Order of Draw for Tube Collections

Cap Color Collection Tube
Draw First
Blood Cultures
Citrate Tube*
*When using a winged blood collection set (butterfly needle with the
attached tubing) for venipuncture and a coagulation (citrate) tube is
the first tube needed, first draw a discard tube using a nonadditive
tube. The discard tube need not be filled completely.
Serum Tube
Heparin Tube
EDTA
Draw Last Fluoride (Glucose) Tube
Note: Always follow your facility’s recommendation or SOP for order of draw should they differ from the
above.
English_DrawOrder_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
BLOOD SMEAR PREPARATION
1. Write the accession number (to be found on the 2. After mixing the hematology tube, insert the Diff-
hematology tube and/or the requistion form) on Safe dispenser into the rubber stopper.
the frosted end of both hematology slides using
a pencil. It is important that the slides are
properly identified with the accession number
to allow appropriate sample tracking and
archiving.
3. Turn the tube upside down and press the Diff- 4. Holding the second slide at a 30° angle, pull the
Safe dispenser against the slide, 0.5 cm from the slide towards the drop of blood until contact is
frosted end. Discontinue pressure the instant the made.
drop appears.
Remove the Diff-Safe dispenser and

! discard it in an approved medical waste
container. Do not forget to ship the
tube with the hematology slides!
5. Allow the droplet to draw completely across the 6. Repeat the process for the other slide. Allow the
edge of the slide. Gently push the second slide slides to air dry thoroughly while lying flat. Return
forward (only allowing the weight of the slide to be slides to plastic mailer(s) for shipment.
applied on the glass surface).
English_Blood Smear Preparation 1/2_Update: 20131204 ©2003 Covance CLS
BLOOD SMEAR PREPARATION
AND DIFF-SAFE SAFETY TIPS
BLOOD SMEARS
Examples of well-made slides Examples of incorrect slides! !
DIFF-SAFE
IMPORTANT: Instructions for Use
After the blood smear Place tube into the specimen If the Diff-Safe is not
preparation, please REMOVE collection bag WITHOUT the removed properly, the blood
the Diff-Safe from the tube. Diff-Safe. will spill into the specimen
collection bag, and the
samples will be useless.
! Please remove the Diff-Safe from the tube!
English_Blood Smear Preparation 2/2_Update: 20131204 ©2003 Covance CLS
SINGLE USE NEEDLE PROTECTION DEVICE INSTRUCTIONS
INSTRUCTIONS FOR USE:
Holding both pink shield and While holding the needle firmly, a) Rotate pink safety shield back
green cap, twist and remove screw holder onto needle until it toward the holder.
white cap. fits securely. b) Twist and pull green needle
cap straight off.
Perform venipuncture according Immediately after removing DO NOT remove needle from
to your facility’s established needle from vein, cover needle holder. Dispose of the needle
procedures. by pushing pink safety shield and holder as one unit into
forward with thumb until an nearest sharps container. DO
audible click is heard. DO NOT NOT REUSE.
attempt to engage shield by
pressing against hard surface.
IMPORTANT SAFETY TIPS

• DO NOT REUSE HOLDER
• Holder threads are designed to be used ONLY ONCE. Reuse of holder is potentially
unsafe and could result in serious injury or exposure to bloodborne pathogens.
• Once holder has been attached to the needle, DO NOT UNWIND it to readjust, or to BD Vacutainer Systems
change needles. Preanalytical Solutions
• Dispose of needle and holder as a single unit. 1 Becton Drive
Franklin Lakes, NJ 07417
BD, BD Logo and Eclipse are trademarks of Becton, Dickinson and Company. ©2002 BD.
English_Venipuncture Needle Protection Device_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
PROCEDURE FOR SARSTEDT MONOVETTE® DRAWING SYSTEM
Monovette® Tube
Monovette® tubes are collection containers that behave similarly to vacuum tubes. However, they have a unique appearance
and differences in handling such as: vacuum must be manually created, an adaptor must be used, and Monovette tubes use
a turn and lock system.
Items needed to perform blood draw using a butterfly needle and Monovette Tube
Monovette® tube
Butterfly assembly with multi-adapter
1. Prepare the Monovette® tubes by pulling back the plunger until it firmly locks into place and an audible click is heard. Break off
the plunger. This creates the vacuum for the tubes.
2. Attached the Monovette® adapter by screwing it onto the butterfly needle.
3. For small volume Monovette tubes, Labcorp Central Laboratory Services will provide a clear discard tube. After performing the
venipuncture, insert and push the clear Monovette® discard tube onto the adapter and turn clockwise to lock. Allow the line to
fill with blood. It is not necessary to fill the discard tube. This step is simply needed to prime the butterfly line. Once the line
is primed, remove the tube by twisting it counterclockwise. Discard this tube according to your sites’ biohazard procedures.
4. Fill the remaining Monovette® tubes as directed.
Non-Monovette® Tube
Monovette® tubes can be used with other vacuum tubes in a single stick. The transition between these tubes is quick and easy.
This process is described below.
Items needed to perform blood draw using a butterfly needle and non-Monovette® Tube.
Vacutainer Holder Non-Monovette® Tube
Butterfly assembly with multi-adapter
1. Unscrew the adapter from the 2. Screw the needle of the butterfly 3. Insert non-Monovette® tube(s) into
butterfly needle. assembly into the standard holder; blood will flow into the tube
needle holder. until the vacuum is filled.
English_Adaptation Procedure for Vacutainer and Monovette_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
BIOTIN INTERFERENCE
Biotin (Vitamin B7) May Interfere with Lab Tests
Labcorp Central Laboratory Services would like to make Clinicians aware that some assays can be affected by high levels of biotin
in a patient’s serum/plasma. High dose biotin may be prescribed in the treatment of multiple sclerosis or dermatologic conditions.
Thinking it is a contributor to keratin, some people take biotin supplements hoping to improve their hair, skin and nails. Over-the-
counter formulations are available under a variety of names including Vitamin B7, Vitamin H and coenzyme R. These may contain
nearly 1,000 times the Institute of Medicine-recommended daily dose of 30 mcg.
Many laboratory immunoassays utilize the interaction of biotin with streptavidin. Patient samples with high levels of biotin can
interfere with these tests, causing falsely high or falsely low results depending on the assay mechanism. Physicians should be
aware that high levels of biotin supplementation may have an impact over a period of at least 72 hours.
The following are some recommendations for Health Care Providers from the FDA Safety Communication on Biotin:
• Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and
nail growth.
• Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin
technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient’s specimen.
• If a lab test result doesn’t match the clinical presentation of your patient, consider biotin interference as a possible source of
error.
• Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements
for hair, skin, and nail growth in levels that may interfere with lab tests.
• Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following
potentially incorrect laboratory test results due to biotin interference.
Immunoassy tests with potential interference by Biotin Supplimentation
Note: This list is subject to change as new assays are validated.
Assay Assay
Adrenocorticotropic hormone (ACTH) Hepatitis C Antibody (HCV)
Amyloid beta 1-42 HIV Ag/Ab combo (cHIV)
anti-cyclic citrullinated peptides (CCP) Homocysteine
Anti-Hepatitis B e-antigen (a-Hbe) Human Chorionic Gonadotropin (beta-hCG)
Anti-Mullerian Hormone (AMH) Inhibin A
Anti-thyroglobulin antibody, quantitative (ATG) Insulin
Anti-thyroid peroxidase (ATPO), quant Insulin-Like Growth Factor 1 ( IGF-1)
Beta2 Microglobulin Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3)
Beta-crosslaps Interleukin-6 (IL-6)
CA 19-9 N Terminal ProBNP (NT proBNP)
CA15-3 Osteocalcin
CA19-9 Parathyroid Hormone (PTH),Intact
Calcitonin Placental Growth Factor (PIGF)
C-peptide Procalcitonin
Creatine Kinase (CK)MB Procollagen I Intact N-Terminal (P1NP)
Direct Renin Prolactin
Estradiol Sex hormone-binding globulin (SHBG)
Free T4 Soluble fms-like tyrosine kinase-1 (sFlt-1)
Gastrin Thyroglobulin
Hepatitis A antibody Total (HAVT) Total T3
Hepatitis B core Antibody (HBc Ab) Total Tau
Hepatitis B Core IgM Antibody (HBc IgM Ab) Troponin I Ultra
Hepatitis B e Antigen (HBe Ag) Troponin T
Hepatitis B surface Antibody Qual (anti-HBs II ) Troponin T, Gen 5
Hepatitis B surface Antibody Quant (HBs Ab Quant) Troponin T-hs
Hepatitis B Surface Antigen (HBs Ag)
English_Biotin Interference_Update: 20120430 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SPECIMEN COLLECTION PROCEDURES FOR CLEAN CATCH URINE
URINE CULTURE
These procedures are standard. In case there are additional, specific instructions for the
sampling, please refer to the requisition form.
The patient must first be prepared for a clean catch of the urine.
Patients should cleanse themselves with towelettes as follows:
Female
Separate the labia. Wipe inner labial folds front to back in a single motion with first towelette.
Wipe down through center of labia with second towelette.
Male
Wipe head of penis in a single motion with first towelette. Repeat with second towelette. If not
circumcised, hold foreskin back before cleaning.
The patient should void the first part of the specimen into the toilet bowl. The remainder of the
specimen should be secured in the collection cup provided in bulk supplies.
1. Collecting at least 20mL of urine 2. Then, hold a few seconds 3. Remove tube. Mix immediately
in the collection cup will ensure until the tube has filled. The by inverting 8 to 10 times. Ship
enough urine is available to fill urine sample must fill the tube as directed on the requisition.
the tube. Replace the cap on between the “min fill” line
the cup and transfer the urine (3mL) and the maximum of
sample into the urine culture approximately 4mL indicated
tube. To fill the tube you must by the tick mark at the top of
invert it and press it into the the label. Do not manually fill
channel. or overfill.
English_Clean Catch Urine Collection Procedure_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
URINE DIPSTICK COLLECTION INSTRUCTIONS
UDS4
URS-11 • URS-10 • URS-9 • URS-8 • URS-8L • URS-7 • URS-6 • URS-6L •
URS-5K • URS-5S • URS-4B • URS-4S • URS-3 • URS-3K • URS-2K •
URS-2P • URS-1B • URS-1G • URS-1K • URS-1P
For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone,
Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic
Acid in urine
Before use, check the vial label for expiration date. Expired strips should not be used.
! Do not use after 90 days of breaking the foil seal.
Urine Reagent Strips are for in vitro diagnostic use. Do not touch areas of Urine Reagent Strips.
Store at room temperature between 15°-30°C (59°-86°F) and out of direct sunlight. Do not use after
expiration date.
All unused strips must remain in the original bottle. Transfer to any container may cause reagent strips to deteriorate
and become nonreactive. Do not remove desiccant from bottle. Do not open container until ready to use.
Collect urine in a clean container Remove from the bottle only enough Completely immerse reagent areas of
and test as soon as possible. strips for immediate use and the strip in fresh, well-mixed urine.
Do not centrifuge. The use replace cap tightly. Remove the strip immediately to
of urine preservatives is not avoid dissolving out the reagent
recommended. If testing cannot areas. While removing, touch the
be performed within one hour side of the strip against the rim
after voiding, refrigerate the of the urine container to remove
specimen immediately. Allow excess urine.
refrigerated specimen to return
to room temperature before
testing.
Blot the lengthwise edge of the Compare each reagent to its After reporting results, appropriately
strip on an absorbent paper corresponding color blocks on dispose of the test stick.
towel to further remove excess the color chart and read at the
urine and avoid running over times specified. Proper read
(contamination from adjacent time is critical for optimal
reagent pads.) results. Obtain results by direct
color chart comparison.
NOTE: Changes in color after 2 minutes are of no diagnostic value.

English_Urine Dipsticks_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
URINE DIPSTICK COLLECTION INSTRUCTIONS
UDS4
Expected Values
Glucose: Small amounts of glucose are normally excreted by the kidney. Concentrations as little as 0.1 g/dl glucose,
read either at 10 or 30 seconds, may be significantly abnormal if found consistently. At 10 seconds, results should be
interpreted qualitatively; for semi-quantitative results, read at 30 seconds only.
Bilirubin: Normally, no bilirubin is detectable in urine by even the most sensitive method. Even trace amounts of
bilirubin are sufficiently abnormal to require further investigation. Atypical colors (colors produced which are different
than the negative or positive color blocks shown on the Color Chart) may indicate that bilirubin derived bile pigments
are present in the urine sample and are possibly masking the bilirubin reaction.
Ketone: Normally, no ketones are present in urine. Detectable levels of ketone may occur in urine during physiological
stress conditions such as fasting, pregnancy, and frequent strenuous exercise. In starvation diets, or in other abnormal
carbohydrate metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones
are elevated.
Specific Gravity: Random urine may vary in specific gravity from 1.003-1.040+. Twenty-four hour urine from normal
adults with normal diets and normal fluid intake will have a specific gravity of 1.016-1.022. In severe renal damage, the
specific gravity is fixed at 1.010, the value of the glomerular filtrate.
Blood: Any green spots or green color developing on the reagent area within 40 seconds is significant and the urine
should be examined further. Blood is frequently, but not invariably found in the urine of menstruating females.
pH: newborn: 5.0-7.0 thereafter: 4.5-8.0 average: 6.0.
Protein: In 24-hour urine, 1-14 mg/dl of protein may be excreted by the normal kidney. A color matching any color
block greater than trace indicates significant proteinuria. For urine with high specific gravity, the test area may most
closely match the trace color block even though only normal concentrations of protein are present. Clinical judgment
is needed to evaluate the significance of trace results.
Urobilinogen: In a healthy population, the normal urine urobilinogen range obtained with this test is 0.2-1.0 Ehrlich
Unit/dl. A result of 2.0 EU/dl may be of clinical significance and the same patient sample should be evaluated further.
Nitrite: Normally no detectable amount of nitrite is present in urine. The nitrite area will be positive in a proportion
of cases of significant infection, depending on how long the urine specimens were retained in the bladder prior to
collection. Retrieval of positive cases with the nitrite test range from as low as 40%, in instances where little bladder
incubation occurred, to as high as 80% in instances where a minimum of 4
hours incubation occurred.
Leukocytes: Normal urine specimens generally yield negative results with this test. A trace result may be of
questionable clinical significance and it is recommended that the test be repeated using a fresh sample from the same
patient. Repeated trace and positive results are of clinical significance.
Ascorbic Acid: The daily urinary output of ascorbic acid varies with the intake; output is approximately half of the
intake. The average urinary output ranges from 20-30 mg/day. If ascorbic acid is detected in urine, stop taking ascorbic
acid for 24 hours and retest.
False negative and weak reaction of glucose, blood and bilirubin may be observed if:
Glucose: more than 50 mg/dl ascorbic acid in the sample.
Bilirubin: more than 50 mg/dl ascorbic acid in the sample.
Blood: more than 10 mg/dl ascorbic acid in the sample.
English_Urine Dipsticks_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SPECIMEN COLLECTION PROCEDURES FOR
URINE PREGNANCY TEST
SASTM Pregnancy PROCEDURE

Materials Provided
1. Test device containing monoclonal mouse-hCG colored conjugate
Urine hCG antibody coated on a membrane.
2. Disposable specimen dropper.
READ ALL INSTRUCTIONS Materials Required But Not Provided
BEFORE BEGINNING THE ASSAY Specimen collection container.
INTENDED USE Directions For Use

SASTM Pregnancy Urine is a visual and rapid test for the qualitative The pouch must be at room temperature before opening to avoid
determination of human chorionic gonadotropin (hCG) in urine to aid in the condensation of moisture on the membrane. Allow specimen and/or
early detection of pregnancy. This test is for professional use only. controls to reach room temperature prior to testing.
1. Remove the test device from the protective pouch and place it on a
SUMMARY AND EXPLANATION flat surface. Label the device with patient or control identifications.
The detection of hCG (human chorionic gonadotropin) in serum and 2. Dispense 4 drops (approximately 0.15 mL) of urine into the round
urine has proven valuable in the presumptive diagnosis of pregnancy. sample well (see illustration below). Wait for colored lines to appear.
This glycoprotein hormone is secreted by the developing placenta after 3. Read results at 4 minutes. Positive results may be observed in
fertilization. The hCG hormone doubles approximately every 2.2 days during as short as 30 seconds depending on the concentration of hCG.
the 1st trimester.1 Detectable levels start at 5 mIU/mL during the first week The presence of the control line is not indicative of the test being
of gestation and rise to 100,000 mIU/mL at 2 to 3 months. A slower rise may completed. Wait the entire 4 minutes for the completion of the test.
be associated with high risk abortions.2 Values decline between 10% and READ UNDER DIRECT LIGHT TO AVOID INTERFERENCE OF
15% of peak concentrations during the 2nd and 3rd trimesters.3 False results SHADOWS IN THE T AND C WINDOWS.
may occur due to certain pathological conditions. See “Limitations of the
Procedure.”
PRINCIPLE OF THE TEST

SASTM Pregnancy Urine is a rapid qualitative test to detect the presence of
hCG in urine. The test utilizes a combination of monoclonal and polyclonal
antibody reagents to selectively detect elevated levels of the hCG in urine.
The assay is conducted by the addition of a urine specimen into the test
device sample well and observing for the formation of colored lines. The
specimen migrates via capillary action along the membrane and reacts with INTERPRETATION OF RESULTS
the colored conjugate. A positive specimen reacts with the hCG-specific Negative Results
antibody colored conjugate and forms a colored line in the T (test) window. The test is negative if a colored line appears only in the C (control) window.
Absence of this colored line suggests a negative result. To serve as a control (See illustration).
for the procedure, a colored line in the C (control) window will always appear
regardless of the presence or absence of hCG. Positive Results
The test is positive if one colored line appears in the T (test) window and
one colored line appears in the C (control) window (See illustration). Any
REAGENTS colored line in the T (test) window should be considered positive. Colored
Test device containing monoclonal mouse-hCG colored conjugate and hCG lines may be lighter or darker than each other. Specimens with hCG levels
antibody coated on a membrane. near the threshold of the test may develop color (faint lines) overtime after
the 4 minute reading. In such cases another test should be performed with
PRECAUTIONS a new specimen in 48-72 hours. A line that appears after 15 minutes should
1. For In-Vitro diagnositc use only. be ignored.
2. The test device should be discarded in a proper biohazard container
after testing. Invalid Results
3. Do not use kit beyond expiration date. The test is invalid if no colored line appears in the C (control) window even
4. The test device should remain in the sealed pouch until ready for if a colored line appears in the T (test) window. If no colored line appears
use. in the C (control) window, add 1 to 2 additional drops of urine and wait an
additional 4 minutes. If colored line still does not appear in the C (control)
STORAGE AND STABILITY window, the test is invalid and should be repeated using another test device.
The test kit is to be stored at room temperature (15º - 30ºC) for the duration
of the shelf-life. The test device must remain “sealed” in the pouch until
ready for use.
SPECIMEN COLLECTION AND PREPARATION

The urine specimen must be collected into a clean, dry container, either
plastic or glass. Specimens collected at random may be used; however,
the first morning urine generally contains the highest concentration of
hormone. A urine sample exhibiting visible precipitates should be filtered,
centrifuged, or allowed to settle (obtaining clear aliquots) before testing. NEGATIVE POSITIVE
Gross hematuria may prevent an accurate reading of test results by masking
the positive line.
Specimen Storage-Urine specimens may be refrigerated (2º - 8ºC) and

stored up to 72 hours prior to assay. If specimens are refrigerated, they must
be equilibrated to room temperature (15º - 30ºC) before testing.
English_Specimen Collection Procedure for Urine Pregnancy Test_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SPECIMEN COLLECTION PROCEDURES FOR
URINE PREGNANCY TEST
QUALITY CONTROL Standard (75/537). The addition of LH (300 mIU/mL), FSH (1000 mIU/mL),
Each test device includes a built-in procedural control. The appearance of and TSH (1000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/
a Control Line in the C region of the assay is a positive procedural control. mL hCG) urine showed no cross-reactivity.
Correct procedural technique, specimen flow and assay performance is
confirmed when a colored line appears in the C (control) area of the cassette. Interfering Substances
If the colored line fails to appear in the C (control) area, the test result is The following potentially interfering substances were added to negative (0
invalid. A clear background is an internal negative procedural control. The mIU/mL hCG) and positive (25 mIU/mL hCG) urine samples:
background color should be white to light pink and should not interfere
with the reading of the test result. If a more intensely red background color
Acetaminophen
appears, it may interfere with the ability to read the test result, therefore the 20 mg/dL
Acetylsalicylic Acid
test should be repeated. Users should follow their state and local regulations 20 mg/dL
and guidelines regarding GLP requirements. Ascorbic Acid 20 mg/dL
Atropine 20 mg/dL
Caffeine 20 mg/dL
LIMITATIONS OF THE PROCEDURE Gentisic Acid 20 mg/dL
1. False negative results may occur when levels of hCG are below Glucose 2 g/dL
the sensitivity level of the test. When pregnancy is still suspected, Hemoglobin 1 mg/dL
a first morning urine specimen should be collected 48 hours later Bilirubin 2 mg/dl
and tested. Triglycerides 450 mg/dL
2. Elevated levels of hCG may be found in trophoblastic disease,
choriocarcinoma, and embryonal cell carcinoma. Islet cell tumors None of the substances at the concentration tested interfered in the assay.
may also produce hCG as well as other carcinomas.4
3. Detectable levels of hCG may remain several weeks following REFERENCES
normal pregnancy, delivery by cesarean section, spontaneous or 1. Schwartz S, Berger P, and Wick G: Epitope-selective monoclonal
therapeutic abortion.5 antibody based immunoradiometric assay of predictable specificity
4. Ectopic pregnancies may produce very low levels of hCG. A for differential measurement of choriogonadotropin and its subunits,
negative test therefore does not exclude ectopic pregnancy. If this
6
Clin Chem 31:1322-1328, 1985.
condition is suspected, further testing using a quantitative test may 2. Kaplin LA, Pesce AJ. Clinical Chemistry Theory, Analysis, &
be desirable. Abnormally high levels of hCG may be seen in molar Correlation, 2nd Edition, Missouri, 1989, C.V. Mosby Co., p. 944.
pregnancies. Samples from abnormal pregnancies are beyond the 3. Braunstein GD, Rasor J, Adler D, Danzer H, Wade ME: Serum
intended use for qualitative hCG tests. human chorionic gonadotropin levels through normal pregnancy.
5. Approximately one third of all conceptions end in natural Am J Obstet Gynecol, 126: 678-681, 1976.
termination. This may produce positive results when testing early 4. Jacobs DS, et al: Laboratory Test Handbook, 2nd Ed., Ohio, 1990,
7
in the pregnancy, followed by negative results after the natural Lexi-Comp Inc., pp. 224, 305-307.
termination. Low positive results may be confirmed by retesting 5. Steier JA, Bergso P, Myking OL: Human chorionic gonadotropin in
with a first morning urine specimen collected 48 hours later. maternal plasma after induced abortion, spontaneous abortion, and
6. This test provides a presumptive diagnosis for pregnancy. removed ectopic pregnancy. Obstet Gynecol 64: 391-394, 1984.
Physicians should evaluate all clinical and laboratory findings 6. Thorneycroft IH: When you suspect ectopic pregnancy. Diagnosis
before making a definitive diagnosis. January: 67-82, 1976.
7. A viscous specimen (high specific gravity) may exhibit a slower flow 7. Wilcox EG, Weinberg CR, O’Connor JF, et al: Incidence of early
rate, therefore requiring more time for the test to be completed. loss of pregnancy. N Eng J Med 319: 189-194, 1988.
8. A high dose “hook effect” may occur where the intensity of sample 8. Fernando SA, Wilson, GS: Studies of the hook effect in the one-
line decreases as the concentration of hCG increases. If a “hook step sandwich immunoassay. J Immunol Meth 15: 47-66, 1992.
effect” is suspected, dilution of specimens may increase color 9. Primus FJ, Kelly EA, Hansen HJ, Golde, et al: “Sandwich”-type
intensity of the sample line.8 immunoassay of carcinoembryonic antigen in patients receiving
9. This test is designed to be a qualitative test only and does not murine monoclonal antibodies for diagnosis and therapy. Clin
correlate directly to quantitative hCG tests. The intensity of color Chem 34: 261-4: 1988.
in a positive line should not be evaluated as “quantitative or 10. Schroff, RW, Foon KA, Beatty SM, et al: Human anti-mouse
semiquantitative”. immunoglobulin responses in patients receiving monoclonal
10. Sensitive immunoassays may demonstrate false positive results antibody therapy. Cancer Res 45:879-85: 1985.
with specimens containing heterophilic antibodies. Assays may
also exhibit false-positive or false negative results with specimens
containing human anti-mouse antibodies. These specimens may To Order:
come from patients receiving preparations of mouse monoclonal Phone: 1-800-275-2326
antibodies for diagnosis or therapy or ave been exposed to mice. Fax: 210-699-6545
If the qualitative interpretation is inconsistent with the clinical
evaluation, results should be confirmed by an alternate hCG Cataolg # 087430--N
method. 9,10
70-pi-sas-pu
EXPECTED VALUES Revised 10-14
Negative results are expected in healthy non-pregnant women and healthy
men. Healthy pregnant women have hCG present. The amount will vary with Authorised Representative
gestational age and between patients. SAS™ Pregnancy Urine can detect
hCG levels as low as 25 mIU/mL in urine. MegaCor GmBH,
Europaplatz 1
PERFORMANCE CHARACTERISTICS 88131 Lindau
Accuracy by Comparison GERMANY
A total of 111 blind clinical samples from suspected pregnant women
were studied by different clinics and laboratories. Samples were assayed
with SAS™ Pregnancy Urine and another commercially available one-step
membrane test according to assay procedure. Both methods showed 43
positive and 68 negative results. The results demonstrated a 100% overall
accuracy of SAS™ Pregnancy Urine compared to the other commercially
available test.
Sensitivity & Specificity
SAS™ Pregnancy Urine detects hCG concentrations of 25 mIU/mL and
greater in urine. It has been standardized to World Health Organization Third
International
English_Specimen Collection Procedure for Urine Pregnancy Test_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
INSTRUCTIONS FOR COMPLETING REQUISITION FORMS
Please complete all the required information with a blue or black ball point pen. Improper Requisition Notations:
This information is required for patient identification and result reporting.
Any errors or missing details with regard to patient demographics will

! cause a delay in the reporting of the results until information is verified!
Make sure and use the correct format or when marking the checkboxes!
Proper Requisition Notations:
Accession No. THE ACCESSION NUMBER IS THE

REFERENCE NUMBER FOR «Bar_req»
«Requisition_n» COMMUNICATION WITH LABCORP.
Labcorp Central Laboratory Services LP
8211 SciCor Dr. VISIT: XXX
Indianapolis, IN 46214-2985
Tel: 866.762.6209
VISIT (CHECK ONE  OR )
Return this page with Samples VISIT: VISIT 1_XXX (PVC=1)

VISIT 2
Check one or
VISIT 3 Visit (if applicable). See above.
Laboratory Requisition Form SUBJECT/PATIENT INFORMATION
Page 2 of 3 Pharmaceutical Company_XXX
XXX-part Protocol: XXX XXX
- 1. Patient Number
Investigator : «Inv_n» Site Number Subject Number
Birthdate Day Month Year
Complete year
Instructions: 0 1 J AN 2. Birthdate
Complete all boxes on this requisition with a blue or Male Female
Sex
black ball point pen. Failure to complete all boxes will
delay reports.  2. Sex (Check appropriate box)
COLLECTION INFORMATION
Please check that all patient identifiers are complete,
consistent and correct, and that each container has the Collection Date Day Month Year 3 Specimen Collection Date
Complete month field in English
same accession number, when packing specimens for (Example: 01 JAN 2001)
shipment! 24 Hour Clock
Collection Time 3. Specimen Collection Time
(Record Midnight as 23:59) :
THIS SECTION TO BE COMPLETED BY SITE PERSONNEL ONLY
Requisition Completed by Name and phone number of the person
Full name in capital letters
Phone number completing the requisition
Of the person completing the requisition
Is subject a female of childbearing potential?

(Check one  or  - mandatory for females)
N/A Check the appropriate box (if
Yes No
If answer is “YES”, the Serum Beta hCG will be automatically performed. No additional applicable to your site). See above.
serum required.
Patient weight:
kg Write in appropriate number
(Mandatory)
(if applicable to your site)
Collection Date Collection Time Not
XXX
XXX
(DD-MMM-YYYY) (24 hr clock) Collected 1. Information required for patient

Timepoint : X identification.
Timepoint : X 2. Information required in order to
Mark the Not Collected box when the time point was not able to be collected. provide age and gender for specific
OPTIONAL TESTING - Please mark the box(es) or to ensure proper ordering of optional test(s)! reference ranges
If you fail to mark the checkbox, testing may be ordered per Labcorp policy without investigator notification.
3. Information required to calculate
Test Group_XXX Test Group_XXX Test Group_XXX
specimen stability.
Comments:
For Labcorp Use Only Optional Testing. Check Appropriate

Employee Tube Count
Validation
Internal Comments: box (if applicable)
Visa Amb Frz Refrig Slides
Write your comments here

WHITE COPY- LABCORP YELLOW COPY-XXX PINK COPY- INVESTIGATOR
«Bar_req» «Label_6» ADDITIONAL TESTING IS NOT ALLOWED «Bar_req» For Labcorp Central Laboratory
1 XXXXXX PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. XX XXXXXX Services internal use only. Please do
not write in this section.
Optional Testing:
Please check the box (es) to ensure proper ordering of optional test(s)! If you fail to mark the checkbox, testing may be ordered per Labcorp
Central Laboratory Services policy without investigator notification. If you initially mark the requisition to order the optional test and would
like to cancel, please draw a single line through the marked test then initial, date, and note that the “test was marked in error”.
English_Instructions for Completing Requisition Forms_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
Accession No.
«Bar_req»
THE ACCESSION NUMBER IS THE
REFERENCE NUMBER FOR
Labcorp Central Laboratory Services S.à.r.l. Page 1 of 4
Rue Moïse-Marcinhes 7
1217 Meyrin Geneva Switzerland
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Laboratory Requisition Form

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT 1
DO NOT RETURN THIS PAGE
Testing For This Visit
Please refer to the Laboratory Manual for detailed sample collection, preparation, and handling instructions.
Associated Test Groups(s) Draw Container Return Container Shipment Condition
HEMATOLOGY&DIFFERENTIAL 1 x 2.0 mL lavender top EDTA tube,1 x double glass slide mailer Ambient
PANEL
CHEMISTRY PANEL, 1 x 4.0 mL gold top serum 1 x plastic vial Ambient
CRP, separation tube
LIPID PANEL
TOTAL IGE 1 x 2.5 mL red top serum 1 x plastic vial Ambient
separation tube
HEPATITIS B SURFACE AG, 1 x 2.5 mL red top serum 1 x plastic vial Ambient
HEPATITIS C ANTIBODY separation tube
HIV 1/2 AG/AB SCREEN 1 x 2.5 mL red top serum 1 x plastic vial Ambient
separation tube
SERUM BIOMARKERS 3 x 5.0 mL gold top serum 12 x cryovials Frozen
separation tubes
SM TSLP 1 x 2.5 mL red top serum 2 x cryovials Frozen
separation tube
SM URINE BIOMARKERS 1 x 10.0 mL yellow top conical tube 4 x cryovials Frozen
SM WHOLE BLOOD 2 x 2.5 mL PAXgene™ blood RNA tubes Frozen
TRANSCRIPTOMICS
URINE CULTURE*, 1 x urine cup 1 x 10.0 mL orange top conical tube, 1 x 5.0 mL gray top Ambient/Refrigerated
URINE MICRO PANEL* urine culture tube
* Conditional
Please refer to CSP to determine order of assessments. Blood and urine sample collection should take place after ECG (locally read) and before EGD
and biopsies.
In case of re-screening, all study procedures scheduled for Visit 1 should be repeated at the re-screening visit, with the exception of the EGD and
biopsies.
No NCR «Label_6» «Bar_req»

Keep on file for your records. DO NOT return to Labcorp.
1 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
1-Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device (blue lid with protective
sticker). Collect at least 20 mL of urine.
2- Use a sterile pipette to transfer and drop urine onto the dipstick from the urine collection device, ensuring to not contaminate the original urine
sample. If the dipstick is “positive”, the urine specimen could then be sent to Labcorp for analysis as following:
3- Place the blue lid back on device and place it on level surface. Peel back protective sticker to expose rubber-covered cannula. Firmly push the urine
culture tube (for URINE CULTURE) onto the integrated transfer port. Hold in position until flow stops. The urine sample must fill the container between
the minimum fill line (3mL) and the maximum of 4 mL indicated by the tick mark at the top of the label. Do not manually fill or overfill. Mix tube 8-10
times by inversion. If tube is not pre-labeled, place the label from the appropriate Labcorp CLS visit kit on the urine culture tube. Record the subject
number on the label. Refrigerate immediately at 2°C to 8°C until shipment.
4- Remove the blue lid and use a clean pipette. Transfer specimen from urine collection cup into tube with preservative tablet labeled URINALYSIS
If the urine dipstick was abnormal, please indicate this on the requisition form (comments section) and also please send the sample for URINE MICRO
PANEL/ URINALYSIS and URINE CULTURE so that urinalysis can be run at the central laboratory.

1 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT 1

SUBJECT/PATIENT INFORMATION
ECode E «Inv_n»
Laboratory Requisition Form Site Number Subject Number
2-part
AstraZeneca AB Birthdate Day Month Year
Protocol: D5244C00001 0 1 J U L
Investigator: «Inv_n» Sex Male Female
Instructions:
Complete all boxes on this requisition with a blue or black COLLECTION INFORMATION
ball point pen. Failure to complete all boxes will delay Collection Date Day Month Year
reports. Complete month field in English

(Example: 01 JAN 2001)
24 Hour Clock
Please check that all patient identifiers are complete, Collection Time
consistent and correct, and that each container has the (Record Midnight as 23:59) :
same accession number, when packing specimens for THIS SECTION TO BE COMPLETED BY SITE PERSONNEL ONLY
shipment!
Requisition Completed By
Phone Number
Of the person completing the
requisition
Is subject a WOCBP ?  No  Yes

If answer is “YES”, the SERUM BETA HCG will be automatically performed.
No additional serum required.
Women < 50 years who have been amenorrheic for > 12 months ?  No  Yes
If answer is “YES”, the FSH will be automatically performed. No additional
serum required.
Volume of SM TSLP A1 in uL uL (0 decimal)
Comment
For Labcorp Use Only

Employee Tube Count Internal Comments
Validation
WHITE COPY-LABCORP PINK COPY-INVESTIGATOR

«Bar_req» «Label_6» ADDITIONAL TESTING IS NOT ALLOWED «Bar_req»
1 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. GM 230113
Accession No.
«Bar_req»
Labcorp Central Laboratory Services LP Page 4 of 4
8211 SciCor Dr.
Indianapolis, IN 46214-2985
Tel: 866.762.6209
Return this page with Samples

VISIT 1
Laboratory Requisition Form ECode E «Inv_n»
2-part Site Number Subject Number
AstraZeneca AB Day Month Year
Collection Date
Investigator: «Inv_n» (Example: 01 JAN 2001)
CONDITIONAL TESTING - Please mark the box(es)  or  to ensure proper ordering of test(s)!
Condition Sample
Submit sample when a positive dipstick result for U-Blood, U-Protein, or U-

URINE CULTURE and
Glucose is observed.  URINE CULTURE/QUANT
Mark this box if URINE CULTURE sample is submitted.
Glucose is observed.  URINE MICRO PANEL
Mark this box if URINE MICRO PANEL sample is submitted.
Comment

Validation

1 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
HEMATOLOGY&DIFFERENTIAL 1 x 2.0 mL lavender top EDTA tube, 1 x double glass slide mailer Ambient
PANEL
CHEMISTRY PANEL, 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
CRP,
LIPID PANEL
TOTAL IGE 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
SERUM BIOMARKERS 3 x 5.0 mL gold top serum separation tubes 12 x cryovials Frozen
TEZE ADA NAB 1 x 5.0 mL gold top serum separation tube 3 x cryovials Frozen
TEZE PK 1 x 3.5 mL gold top serum separation tube 2 x cryovials Frozen
SM TSLP 1 x 2.5 mL red top serum separation tube 2 x cryovials Frozen
URINE CULTURE*, 1 x urine cup 1 x 10.0 mL orange top conical tube, 1 x 5.0 mL gray Ambient/Refrigerated
URINE MICRO PANEL* top urine culture tube
* Conditional
PK samples should be collected pre-dose.

2 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB

2 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
(DD-MMM-YYYY) (24 hr clock) Collected
:  X

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT 2
Collection Date
TEZE ADA NAB

:  X
Condition Sample

URINE CULTURE and
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
HEMATOLOGY&DIFFERENTIAL PANEL 1 x 2.0 mL lavender top EDTA tube, 1 x double glass slide mailer Ambient
CRP,
LIPID PANEL
SM URINE BIOMARKERS 1 x 4oz sterile spec container, 1 x 10.0 mL yellow top conical tube 4 x cryovials Frozen

3 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X
Comment

Validation

«Requisition_n»
COMMUNICATION WITH LABCORP.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
PANEL
CRP,
LIPID PANEL
* Conditional

4 211576 AKR 221030
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB

4 211576 AKR 221030
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X

TEZE ADA NAB
:  X

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT 5
Collection Date
Condition Sample

URINE CULTURE and
Comment

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
PANEL
CHEMISTRY PANEL, 1 x 2.5 mL red top serum 1 x plastic vial Ambient
LIPID PANEL
separation tube
separation tubes
TEZE ADA NAB 1 x 5.0 mL gold top serum 3 x cryovials Frozen
separation tube
TEZE PK 1 x 3.5 mL gold top serum 2 x cryovials Frozen
separation tube
TRANSCRIPTOMICS
* Conditional

5 211576 AKR 221030
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB

5 211576 AKR 221030
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X

TEZE ADA NAB
:  X

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT 8
Collection Date
Condition Sample

URINE CULTURE and
Comment

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
PANEL
LIPID PANEL
* Conditional

6 211576 AKR 221030
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition
Condition Sample

URINE CULTURE and
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
CRP,
LIPID PANEL

7 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
HEMATOLOGY&DIFFERENTIAL 1 x 2.0 mL lavender top EDTA tube,1 x double glass slide mailer Ambient
PANEL
LIPID PANEL
separation tube
separation tubes
separation tube
separation tube
TRANSCRIPTOMICS
* Conditional
Use this kit to collect samples at visit 15 (visit 15 would be EOT visit for the Patients who do not participate in the active treatment extension). EOT
Visit 15 should be scheduled 364 days after the randomization or later.

U-1 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
1- Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device (blue lid with
protective sticker, provided within kit). Collect at least 20 mL of urine.
3- Place the blue lid back on device and place it on level surface. Peel back protective sticker to expose rubber-covered cannula. Firmly push the
urine culture tube (for URINE CULTURE) onto the integrated transfer port. Hold in position until flow stops. The urine sample must fill the container
between the minimum fill line (3mL) and the maximum of 4 mL indicated by the tick mark at the top of the label. Do not manually fill or overfill. Mix
tube 8-10 times by inversion. If tube is not pre-labeled, place the label from the appropriate Labcorp CLS visit kit on the urine culture tube. Record
the subject number on the label. Refrigerate immediately at 2°C to 8°C until shipment.
If the urine dipstick was abnormal, please indicate this on the requisition form (comments section) and also please send the sample for URINE
MICRO PANEL/ URINALYSIS and URINE CULTURE so that urinalysis can be run at the central laboratory.

U-1 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X

TEZE ADA NAB
:  X

Validation

U-1 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT 15
Protocol: D5244C00001 Collection Date
Condition Sample

URINE CULTURE and
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: ACTIVE TREATMENT EXTENSION PERIOD
CHEMISTRY PANEL 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
CRP
LIPID PANEL

U-8 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: ACTIVE TREATMENT EXTENSION PERIOD
 Visit 16 (PVC=V16)
Laboratory Requisition Form  Visit 18 (PVC=V18)
2-part
AstraZeneca AB  Visit 21 (PVC=V21)
Investigator: «Inv_n»
ECode E «Inv_n»
Instructions: Site number Subject number
Complete all boxes on this requisition with a blue or black Day Month Year
Birthdate
ball point pen. Failure to complete all boxes will delay
0 1 J U L
reports.
Male Female
Sex
Please check that all patient identifiers are complete,
consistent and correct, and that each container has the COLLECTION INFORMATION
same accession number, when packing specimens for Day Month Year
Collection Date
shipment! Complete month field in English
24 Hour Clock
Collection Time
Phone Number
requisition
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT FU2
CRP,
LIPID PANEL

U-2 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT FU2

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X

TEZE ADA NAB
:  X
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» IPD VISIT
PANEL
LIPID PANEL
separation tube
separation tube
SM URINE BIOMARKERS 1 x 10.0 mL yellow top conical 4 x cryovials Frozen
tube
TRANSCRIPTOMICS
* Conditional
This kit should be used during Investigational Product discontinuation visit (IPD visit). Refer to CSP, section 7.1 for details.
For a participant who discontinued study intervention, the EGD should be performed at Week 24 (V8) and Week 52 (V15a visit), rather than the
IPD visit. If it cannot be performed at Week 24 (V8) and Week 52 (V15a visit), the EGD should be performed at the IPD visit if >/= 12 weeks have
elapsed since the prior EGD.

U-3 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» IPD VISIT
1-Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device (blue lid with
protective sticker). Collect at least 20 mL of urine.

U-3 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples IPD VISIT

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition

TEZE PK
:  X

TEZE ADA NAB
:  X

Validation

U-3 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

IPD VISIT
Condition Sample

URINE CULTURE and
Comment

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: UNSCHEDULED/RETEST
PANEL*
CHEMISTRY PANEL*, 1 x 3.5 mL gold top serum separation tube 1 x plastic vial Ambient
CRP*,
LIPID PANEL*
FSH*, 1 x 2.5 mL red top serum separation tube 2 x plastic vials Ambient
TOTAL IGE*
HEPATITIS B SURFACE AG*, 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
HEPATITIS C ANTIBODY*
HIV 1/2 AG/AB SCREEN* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
HIV-1/HIV-2 QUALITATIVE RNA* 1 x 2.0 mL lavender top EDTA tube 1 x cryovial Frozen
SERUM TRYPTASE EVENT* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
SERUM TRYPTASE 60MIN* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
SERUM TRYPTASE AT DISCHARGE* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
TEZE ADA NAB* 1 x 5.0 mL gold top serum separation tube 3 x cryovials Frozen
* Optional
Pay close attention to indicate correct visit on requisition form in order to ensure data blinding.
If the kit is used to do the re-test related to the previous visit - mark this visit on the Requisition Form.
If the kit is used for additional, not planned, unscheduled visit - mark "Unscheduled" on the Requisition Form.

U 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: UNSCHEDULED/RETEST
1-Collect urine sample proceeding with a midstream clean-catch (refer to details in lab manual) using the specific urine device (blue lid with
protective sticker). Collect at least 20 mL of urine.

U 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: UNSCHEDULED/RETEST

Visit  See table below
2-part ECode E «Inv_n»
AstraZeneca AB Site Number Subject Number
Protocol: D5244C00001 Birthdate Day Month Year
Investigator: «Inv_n» 0 1 J U L
Instructions: Sex Male Female
Complete all boxes on this requisition with a blue or black

reports. Day Month Year
Collection Date
Please check that all patient identifiers are complete, (Example: 01 JAN 2001)
consistent and correct, and that each container has the 24 Hour Clock
Collection Time
same accession number, when packing specimens for (Record Midnight as 23:59) :
shipment!
Phone Number
requisition
Visit Visit
(Check one  or  - mandatory) (Check one
 Visit 1 (PVC=V1)  Visit 2 (PVC=V2)  Visit 3 (PVC=V3)

 Visit 18 (PVC=V18)  Visit 21 (PVC=V21)  IPD visit (PVC=IPD)
 FU2 (PVC=FU2)  Unscheduled (PVC=UNSCH)

Validation

U 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT: UNSCHEDULED/RETEST
TEZE ADA
NAB
:  X
TRYPTASE
SERUM
EVENT :  X
60MIN :  X
DISCHARGE :  X
Mark the Not Collected box when the time point was not able to be collected.

Validation

U 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

VISIT: UNSCHEDULED/RETEST
OPTIONAL TESTING - Please mark the box(es)  or  to ensure proper ordering of optional test(s)!
 CHEMISTRY PANEL  CRP
 LIPID PANEL  FSH
 TOTAL IGE  HEMATOLOGY&DIFFERENTIAL PANEL
 HEPATITIS B SURFACE AG  HEPATITIS C ANTIBODY
 HIV 1/2 AG/AB SCREEN  HIV-1/HIV-2 QUALITATIVE RNA
 SERUM TRYPTASE 60MIN and  SERUM TRYPTASE AT DISCHARGE and
TRYPTASE 60MIN COLL D/T TRYPTASE AT DISCHARGE COLL D/T
 SERUM TRYPTASE EVENT and  TEZE ADA NAB
TRYPTASE EVENT COLL D/T (Internal note: Order
TEZE ADA NAB PR and
TEZE ADA NAB BU1 and
TEZE ADA NAB BU2 and
SM TEZE ADA NAB BU1 and
SM TEZE ADA NAB BU2 and
TEZE ADA NAB COLLECTION D/T)
 URINE CULTURE and  URINE MICRO PANEL
URINE CULTURE/QUANT
Comment

Validation

U 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: GX SAMPLE
SM GENETIC BLOOD SAMPLE 1 x 6.0 mL lavender top EDTA tube Frozen
This sample should ONLY be collected from adult Patients who have provided informed consent for the genetic research sample.
Genomics Initiative samples will not be collected from adolescents Patients.
The sample should be collected at Visit 2, however, if for any reason sample is not drawn at V2, it may be taken at any later visit until the last study
visit.
Only one sample should be collected per participant for genetics during the study.
At Visit 2 sample should be collected pre-dose.

T-1 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: GX SAMPLE

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

T-1 211576 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: PREGNANCY CONFIRMATION
SERUM BETA HCG 1 x 2.5 mL red top serum separation tube 1 x plastic vial Ambient
This kit should only be used in case there is a positive result for urine pregnancy test. Check CSP, section 8.2.5.1 for details. The kit can also be
used in case serum β-HCG needs to be retested for any reason.

U-4 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: PREGNANCY CONFIRMATION

Visit  See table below
2-part ECode E «Inv_n»
AstraZeneca AB Site Number Subject Number
Protocol: D5244C00001 Birthdate Day Month Year
Investigator: «Inv_n» 0 1 J U L
Instructions: Sex Male Female

reports. Day Month Year
Collection Date
Please check that all patient identifiers are complete, (Example: 01 JAN 2001)
consistent and correct, and that each container has the 24 Hour Clock
Collection Time
same accession number, when packing specimens for (Record Midnight as 23:59) :
shipment!
Phone Number
requisition
Visit Visit
(Check one  or  - mandatory) (Check one

 IPD visit (PVC=IPD)  FU2 (PVC=FU2)  Unscheduled (PVC=UNSCH)
Comment

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: ESOPHAGEAL BIOPSIES
DIST ESOPHAGUS, 6 x labels, 3 x 60 mL blue cap containers, 3 x ethanol, , 3 x cassettes, 6 x biopsy foams Ambient
MID ESOPHAGUS**,
PROX ESOPHAGUS
SM DIST ESO TISSUE RNA* 2 x RNALater Tissue Protect tubes Frozen
* Conditional
In order to comply with the General Data Protection Regulation (GDPR), it is MANDATORY to redact all personal identifiable
information when submitting Anatomic Pathology samples and/or pathology reports.
This kit should be used to collect esophageal biopsy samples related to Visit 1, Visit 8, Visit 15.
The kit may also be used at IPD visit - see Clinical Study Protocol, Table 3, footnote "f" for details.
Esophageal biopsies and Gastric/Duodenal biopsies kits are NOT interchangeable. Esophageal biopsies kit can NOT be used to collect
gastric/duodenal biopsies. Gastric/Duodenal biopsies kit can NOT be used to collect esophageal biopsies.

U-5 211576 HK 230530
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: ESOPHAGEAL BIOPSIES

APH
2-part
AstraZeneca AB  Visit 15 (PVC=EOT/V15)
Protocol: D5244C00001  IPD visit (PVC=IPD)
Investigator: «Inv_n» SUBJECT/PATIENT INFORMATION
Instructions:
ECode E «Inv_n»
Site Number Subject Number
ball point pen. Failure to complete all boxes will delay Day Month Year
reports. Birthdate
0 1 J U L
Male Female
Please check that all patient identifiers are complete, Sex
consistent and correct, and that each container has the
same accession number, when packing specimens for COLLECTION INFORMATION
shipment! Day Month Year
Requisition Completion Date
24 Hour Clock
Requisition Completion Time
Phone Number
requisition

Validation

APH Return this page with Samples APH
«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

APH VISIT: ESOPHAGEAL BIOPSIES
AstraZeneca AB
Day Month Year
Use a separate container for each anatomic location. Label each container with the appropriate label that specifies the anatomic location.
Anatomic location Number of Date placed Time Date placed in Time placed in
tissue pieces in formalin placed in 70% ethanol 70% ethanol
formalin
V proximal esophagus v Not collected

v v
v v
v middle esophagus v Not collected
v v
v v
v distal esophagus v Not collected
v v
v v

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

AstraZeneca AB
Day Month Year
Esophageal tissue for biomarker analyses – for RNA
Anatomical location of biopsy for RNA
v distal esophagus v other esophagus v Not Collected
v v v
RNA later volume in the tube verified
v Yes v No v Not Collected
(1mL) v v v
v v v
Date of biopsy collection
v (DD-MMM-YYYY): _______________
Date v v
Time of biopsy collection

Time (24 hr format) ___:___
Date sample is frozen at -20 °C

Date (DD-MMM-YYYY): _______________
Time sample is frozen at -20 °C

Time (24 hr format) ___:___
Comment

Validation

«Requisition_n»
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

AstraZeneca AB
Day Month Year
CONDITIONAL TESTING - Please mark the box(es) or to ensure proper ordering of test(s)!
Condition Sample
Collect distal esophageal biopsies in RNA later buffer at Visit 1, Visit 8, Visit 15.
SM DIST ESO TISSUE RNA
Mark this box if SM DIST ESO TISSUE RNA sample is submitted.

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: GASTRIC/DUODENAL BIOPSIES
DUOD BIOP SUPERIOR DUOD**, 7 x 60 mL blue cap containers, 7 x ethanol, 14 x labels, 7 x cassettes, 14 x biopsy Ambient
DUOD BIOP TRANSVER ASCEN**, foams
DUODENAL BIOP DESCENDING**,
DUODENAL BIOPSY BULB**,
GASTRIC BIOP INCISURA**,
GASTRIC BIOPSY ANTRUM**,
GASTRIC BIOPSY BODY**
**Reflex
In order to comply with the General Data Protection Regulation (GDPR), it is MANDATORY to redact all personal identifiable
information when submitting Anatomic Pathology samples and/or pathology reports.
The kit will only be used if stomach/duodenum biopsy needs to be performed i.e. in case gross abnormalities are seen on EGD or there are clinical
signs and symptoms for this.
Esophageal biopsies and Gastric/Duodenal biopsies kits are NOT interchangeable. Esophageal biopsies kit can NOT be used to collect
gastric/duodenal biopsies. Gastric/Duodenal biopsies kit can NOT be used to collect esophageal biopsies.
Use a separate container for each anatomic location. Label each container with the appropriate label that specifies the anatomic location.

U-6 211576 GM 230113
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: GASTRIC/DUODENAL BIOPSIES

APH
2-part
AstraZeneca AB  Visit 15 (PVC=V15)
Protocol: D5244C00001  IPD visit (PVC=IPD)
Investigator: «Inv_n» SUBJECT/PATIENT INFORMATION
Instructions:
ECode E «Inv_n»
Site Number Subject Number
ball point pen. Failure to complete all boxes will delay Day Month Year
reports. Birthdate
0 1 J U L
Please check that all patient identifiers are complete, Sex Male Female
consistent and correct, and that each container has the

same accession number, when packing specimens for COLLECTION INFORMATION
shipment! Day Month Year
24 Hour Clock
Requisition Completion Time
Phone Number
requisition

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

APH VISIT: GASTRIC/DUODENAL BIOPSIES
Protocol: D5244C00001 Requisition Completion Date
Anatomic location Number Date placed Time placed in Date placed in Time placed in
of tissue in formalin formalin 70% ethanol 70% ethanol
pieces
gastric antrum Not collected
gastric body Not collected
gastric incisura Not collected

stomach
duodenal bulb Not collected
superior Not collected

duodenum
duodenum Not collected

descending
transverse Not collected

ascendant

Validation

Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: HY S LAW
CHEMISTRY PANEL HYS LAW*, 1 x 3.5 mL gold top serum separation tube 1 x plastic vial Ambient
% IRON SATURATION*,
ALPHA-1 ANTITRYPSIN*,
CERULOPLASMIN*,
IRON PANEL*
HEPATITIS A IGM ANTIBODY*, 1 x 5.0 mL gold top serum separation tube 1 x plastic vial Ambient
HEPATITIS B CORE AB IGM IGG*,
HEPATITIS B SURFACE ANTIGEN*,
HEPATITIS C VIRUS ANTIBODY IGG*
CMV IGM IGG*, 1 x 3.5 mL gold top serum separation tube 2 x plastic vials Frozen
EBV*
COAGULATION HYS LAW* 1 x 1.8 mL 3.2% blue top sodium citrate tube 1 x plastic vial Frozen
HERPES SIMPLEX IGG PANEL CE * 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
HERPES SIMPLEX VIRUS IGM CE* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
HEV IGM* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
HEV RNA* 1 x 3.0 mL lavender top EDTA tube 1 x plastic vial Frozen
LIVER KIDNEY MICROSOME (LKM)* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
HBV DNA COBAS 6800**(1), 1 x 6.0 mL lavender top EDTA tube 1 x cryovial Frozen
HCV RNA COBAS 6800**(1)
TRANSFERRIN* 1 x 2.5 mL red top serum separation tube 1 x plastic vial Frozen
ANTI SMOOTH MUSCLE ANTIBODY*, 1 x 3.5 mL gold top serum separation tube 2 x plastic vials Ambient/Frozen
ANTINUCLEAR ANTIBODY*,
FERRITIN*
* Optional **Reflex
(1) Whole blood can be stored no longer than 6 hours at 2-30°C prior to centrifugation. Promptly centrifuge at 1200 to 1500 x g for no less than 15
minutes at room temperature.

U-7 211576 HK 230530
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521

2-part
AstraZeneca AB
Investigator: «Inv_n» VISIT: HY S LAW
Hy's Law kit can only be used after the discussion with AstraZeneca Study Physician took place and the decision was made on which tests should be
done.
Please always consult AstraZeneca representative before using Hy's Law kit.
Each time HEPATITIS B CORE AB IGM IGG and HEPATITIS C VIRUS ANTIBODY IGG are collected, also collect the tube for HBV DNA COBAS 6800 and
HCV RNA COBAS 6800 for possible reflex test(s).

U-7 211576 AKR 221030
Accession No.
«Bar_req»
Tel: 0041 58 822 7901
Fax: 0041 58 822 7521
Return this page with Samples VISIT: HY S LAW

ECode E «Inv_n»
2-part
Instructions:

24 Hour Clock
shipment!
Phone Number
requisition
OPTIONAL TESTING - Please mark the box(es)  or  to ensure proper ordering of optional test(s)!
 IRON PANEL and  HEPATITIS C VIRUS ANTIBODY IGG
% IRON SATURATION (Internal note: also order SM112186)
 CERULOPLASMIN  CHEMISTRY PANEL HYS LAW
 HEV IGM  ANTI SMOOTH MUSCLE ANTIBODY
 ANTINUCLEAR ANTIBODY  FERRITIN
 CMV IGM IGG  EBV
 COAGULATION HYS LAW  HEPATITIS A IGM ANTIBODY
 HEPATITIS B CORE AB IGM IGG  HEPATITIS B SURFACE ANTIGEN
(Internal note: also order SM112186)
 TRANSFERRIN  HERPES SIMPLEX IGG PANEL CE
 LIVER KIDNEY MICROSOME (LKM)  HEV RNA
 HERPES SIMPLEX VIRUS IGM CE  ALPHA-1 ANTITRYPSIN
Comment

Validation

3
Section Break
GENERAL INFORMATION FOR PACKAGING AND SHIPPING
Labcorp Central Laboratory Services shipping material is designed in accordance with IATA
! regulations!
Air waybills and shipping labels may only be used one time!
Consolidated Shipments: (All Countries except Japan)

For your convenience, shipping materials provided by Labcorp Central Laboratory Services are not protocol specific.
Please consolidate sample shipments of like condition (ambient or frozen) to Labcorp Central Laboratory Services
whenever possible.
Courier Pick-up Information

Prior to shipping your first specimens, we recommend that you call the courier to define your site as a new pickup
location for shipments to Labcorp Central Laboratory Services. This will facilitate the process when you are ready for
your first shipment. Labcorp Central Laboratory Services will be billed directly for all transportation costs.
Please be sure to inquire about your local service schedules and the latest time of day that you can call to arrange
for a pick-up. Timely pick-ups will ensure samples are shipped within stability for testing.
While most samples are specified to be shipped day of collection, we realize there are times when circumstances do
not permit this to occur.
• Late afternoon sample collection after last call-in or pick-up availability for courier service
• Dry ice may not be available the same day as frozen sample collection
• Pick-up is missed by courier service
In the event that samples cannot be shipped the day of collection, they should be stored under the condition they
are to be shipped. These samples should then be shipped to Labcorp Central Laboratory Services the very next day
of availability.
• AMBIENT samples should remain at ambient temperature – Do not refrigerate
• REFRIGERATED samples should remain between 2°C and 8°C
• FROZEN samples should remain frozen at the appropriate temperature
For Latin America, Australia, New Zealand and Asia (except Japan):
When contacting courier, also inquire about local export requirements.
Shipping boxes (Countries except Japan when BML takes care of the sample pick-up)
Containers must be securely packed in their shipping box. Please check by gently shaking the box after packaging.
If the containers are loose, repack the box by filling the empty spaces with paper.
Materials Safety Data Sheets

MSDS sheets for chemical products used in Labcorp Central Laboratory Services studies may be accessed at the
following website:
http://covancesearch.complyplus.com/. The website allows you to search for the MSDS sheets by product name or
container code. If you have any questions, please contact Labcorp Central Laboratory Services EHS at +13172735369.
English_General Information for Packaging and Shipping_Update: 20221230 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
PACKAGING PROCEDURES - CONSOLIDATING SHIPMENTS
AMBIENT, REFRIGERATED OR FROZEN

BIOLOGICAL SUBSTANCE, CATEGORY B
Notify your courier of your shipment!
Problems/questions concerning packaging procedures? Contact Covance using our toll-free number.
When possible, please consolidate shipments

Consolidating your sample shipments is a way to save you and your staff time by
reducing the number of shipping cartons prepared for shipment to Covance.
! Your sponsor also benefits by reduced transportation cost for protocols.
Send samples for more than one patient and/or more than one sponsor or
protocol in a single shipment.
NOTE: Actual shipping cartons

may differ from pictures
Please note that shown here.
patient samples can

ONLY be shipped back
to Covance with the
appropriate outer
carton.
(see figure to
the right)
Key points:
1. Always consolidate patient sample shipments by condition: ambient, refrigerated, or frozen.
2. Be sure each patient’s samples and the completed requisition for that patient are packaged together in their own
Specimen Collection Bag, by shipping condition.
3. The Ambient shipping box will hold 2 to 4 lab kits containing ambient samples.
4. The Frozen shipping box will hold 1 to 2 Specimen Collection Bags of samples per frozen shipment.
5. Be sure to allow ample space for dry ice in your frozen shipments as you will need 3 kgs of dry ice per shipment
(2 Kg for North America) when using Covance supplied packaging. Use of courier supplied packaging may require more
dry ice. Please follow your courier recommendation for the amount of dry ice to use.
6. Use the appropriate air waybill depending on sample condition (ambient/refrigerated or frozen).
7. Please ensure the outer packaging used for transport of any Biological Substance, Category B material is marked and
labeled according to the ICAO/IATA requirements.
EXAMPLE OF CONSOLIDATED SHIPMENT
Sponsor #1
Sponsor #3
Sponsor #2
Note: Contact Covance to inquire about special packaging designed to send large numbers
of samples per shipment if you are participating in a study with high daily patient volume.
English_Packaging Procedure Consolidated Shipments_Update: 20131118 ©2012 Covance CLS
GENERAL INFORMATION RELATED TO THE TRANSPORT
OF YOUR SAMPLES FOR EUROPE, MIDDLE EAST AND AFRICA
We strongly recommend that you contact your local courier office, for TNT and Marken, or the DHL EKAS Team, a week
before the first patient is due to enter the study in order to ensure that everything is settled regarding sample pick-up.
The shipping documentation enclosed as example in this manual will help you to fill in the DHL, TNT and Marken
shipping documents.
Should your site be dealing with another transportation company, please follow the instructions given when the pick-
up is requested or at the moment of the pick-up.
For TNT shipments when calling the courier for a pick-up, please mention that your package is a diagnostic shipment
for Labcorp Central Laboratory Services (Geneva, Switzerland) on a “Receiver pays” basis.
Some Local TNT offices may require investigation centers to have a site specific account number. Please check when
first contacting your TNT local station if your site should need such an account number. If so, please follow their
instructions and once you have the number, write it down, next to the courier’s phone number, as the account number
must be quoted each time you call for a pick-up.
For DHL Shipments please contact the DHL Ekas Team as per courier arrangements provided.
Country specific information
Israel:
Labcorp Central Laboratory Services does not provide airway bills to sites located in Israel. All investigators are requested
to fill in any additional documents which could be requested by the courier. Shipping boxes are also provided by the
courier at the time it performs the pick-up. Please specify whether your samples are ambient and/or frozen, so the
appropriate boxes are provided.
South Africa:
Shipping boxes and documents are provided by the courier at the time it performs the pick-up. Please specify whether
your samples are ambient and/or frozen, so the appropriate materials are provided.
Should you identify any problems in relation to the courier arrangements or the information on this page, please
contact Labcorp Central Laboratory Services immediately.
English_EUR General Information for Transport of Samples_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SPECIFIC INFORMATION FOR THE SAMPLES PICK-UP
FOR EUROPE, MIDDLE EAST AND AFRICA
Q Your study has standard pick-up only (Monday through Friday) except if otherwise specified. If delivery
period to Labcorp Central Laboratory Services is 48 hours, please do not send any samples on Fridays.
Please note that your manual does not contain site specific pick-up information. Labcorp Central
Laboratory Services will supply the relevant details by fax within 7 days. Should you need them earlier
due to a patient visit or should you find that you have still not received the information after this
delay, please contact Labcorp Central Laboratory Services using the toll free number supplied.
Should you identify any problems in relation to the courier, please contact Labcorp Central Laboratory
Services immediately.
English_EUR Pick-up Information_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
PACKAGING PROCEDURES - ALL COUNTRIES
AMBIENT

! Problems/questions concerning packaging procedures? Call us using our toll-free number.
1. Insert the tube(s) into the 2. Fold the white copy of the 3. Take a Gel Pak and fill it to
Specimen Collection Bag completed requisition form and the indicator line with cool tap
containing an absorbent pack. place it into the pocket on the water. Seal the bag.
Place bag on flat surface to reverse side of the Specimen
minimize wrinkles, especially at Collection Bag. The bar code
adhesive sealing area. Remove must be visible.
tape liner to expose adhesive.
Fold along bag opening so star
is inside of box shape. Press
from center to edge to seal.
Do NOT place sharps into
collection bag.
4. Lightly press the absorbent 5. Place the Specimen Collection 6. Place the Gel Pak into the white
pack to expel its contents. Bag on top of the Gel Pak. kit box. Do NOT ship sharps to
Massage the bag until water Wrap the Gel Pak around the Covance.
has been absorbed and a gel Specimen Collection Bag,
material has formed. sandwiching the specimens
Expel the air from the Gel Pak in the middle. Do not insert
and reseal. the specimen containers
directly into the Gel Pak!
Important: Ensure the Hema-
tology sample is placed in
the fold of the Gel Pak.
Continued on next page...
English_Packaging Procedure Ambient_Update: 20190429 ©2003-2017 Covance CLS
AMBIENT
...continued from previous page.
Note:
If the kit box is too large to place
in the ambient shipping carton,
wrap a rubberband around the Gel
Pak. Place the Gel Pak containing
the specimen collection bag inside
the large zip bag.
7. Insert the kit into the zip bag. 8. Place the zip bag into the Place the zip bag into the shipping
shipping carton. Fill empty carton. Fill empty spaces with
spaces with cushioning material cushioning material (i.e. paper).
(i.e. paper).

may differ from
pictures shown here.
9. Seal the shipping carton 10. US domestic shipments: Complete and affix the airway bill to the
securely. Affix the label with designated spot on the box.
your address on the box as Rest of world: Insert the shipping documentation into the
indicated on the picture above. transparent pouch ensuring that the airway bill remains visible.
Note: Your shipment may Affix the pouch to the cardboard box on the “Place airway bill here”
be delayed if the label is not section.
affixed to the box.
GEL PAK SAFETY TIPS
IMPORTANT: INSTRUCTIONS FOR USE
Please take the specimen collection bag and WRAP the Gel Pak AROUND the specimen
place it on the Gel Pak. collection bag.
CAUTION:
DO NOT put the specimen collection bag DO NOT put the tubes DIRECTLY INTO
INTO the Gel Pak! the Gel Pak!
PACKAGING PROCEDURES - ALL COUNTRIES EXCEPT
ASIA PACIFIC/LATIN AMERICA
COMBINED AMBIENT-REFRIGERATED
Place refrigerant pack in freezer overnight before packaging!
1. Insert the tube(s) into the Specimen 2. Place one frozen refrigerant pack 3. Place a layer of paper towels on
Collection Bag containing an into the styrofoam container. top of the refrigerant pack. Place
absorbent pack. Place bag on the Specimen Collection Bag
flat surface to minimize wrinkles, containing refrigerated specimens
especially at adhesive sealing into the styrofoam. Place a second
area. Remove tape liner to expose layer of paper towels on top of the
adhesive. Fold along bag opening specimen collection bag followed
so star is inside of box shape. Press by a second refrigerant pack. Fill
from center to edge to seal. Do NOT excess space with filler paper.
place sharps into collection bag.
4. Replace the styrofoam lid. 5. Place the cardboard spacer on 6. For the ambient tubes, repeat
top of the styrofoam. step 1. Then fold the white copy
of the completed requisition form
and place it into the pocket on
the reverse side of the Specimen
Collection Bag. The bar code
must be visible.
7. Take a Gel Pak and fill it to the 8. Lightly press the absorbent pack 9. Place the Specimen Collection
indicator line with cool tap water. to expel its content. Massage the Bag on top of the Gel Pak. Wrap
Seal the bag. bag until water has been absorbed the Gel Pak around the Specimen
and a gel materiel has formed. Collection Bag, sandwiching the
Expel the air from the Gel Pak and specimens in the middle. Do not
Important: Ensure the Hema-tology reseal. insert the specimen containers
sample is placed in the fold of the directly into the Gel Pak!
Gel Pak.
English_Packaging Procedure Combo Ambient Refrigerated_Update: 20190429 ©2003 Covance CLS
PACKAGING PROCEDURES - ALL COUNTRIES EXCEPT
COMBINED AMBIENT-REFRIGERATED
10. Place the specimen collection 11. Insert the kit into the zip bag. Do 12. Place the zip bag into the
bag wrapped in the Gel Pak NOT ship sharps to Covance. cardboard box. Fill empty
into the white kit box. spaces with cushioning material
(i.e. paper).
Note:
If the kit box is too large to place in the ambient shipping carton,
wrap a rubber band around the Gel Pak. Place the Gel Pak
containing the specimen collection bag inside the large zip bag.
Place the zip bag into the shipping carton. Fill empty spaces with
cushioning material (i.e. paper).

shown here.
13. Seal the shipping carton securely. Affix the 14. US domestic shipments: Complete and affix the
label with your address on the box as indicated airway bill to the designated spot on the box.
on the picture above. Rest of world: Insert the shipping documentation into
Note: Your shipment may be delayed if the the transparent pouch ensuring that the airway bill
label is not affixed to the box. remains visible. Affix the pouch to the cardboard box
on the “Shipping documents” section.
IMPORTANT: Covance Combo shippers are pre-printed with the required markings for Dry Ice
(Frozen) shipments. Ensure that the “Dry Ice UN1845” and the Miscellaneous diamond markings
are concealed/masked for all refrigerant shipments.
English_Packaging Procedure Combo Ambient Refrigerated_Update: 20190429 ©2003 Covance CLS
FROZEN
! Ship no more than 120 mL in a Specimen Collection bag and no more than two Specimen
Collection bags per 2.0 kilograms of dry ice!
1. Insert the tube(s) into the 2. Fold the white copy of the 3. Fill half of the styrofoam
Specimen Collection Bag completed requisition form and container with dry ice and
containing an absorbent pack. place it into the pocket on the insert the Specimen Collection
Place bag on flat surface to reverse side of the Specimen Bag(s). Then completely fill the
minimize wrinkles, especially at Collection Bag. The bar code styrofoam container with dry
adhesive sealing area. Remove must be visible. ice.
tape liner to expose adhesive. Do NOT ship sharps to
Fold along bag opening so star Covance.
is inside of box shape. Press
from center to edge to seal. Do
NOT place sharps into collection
bag.
4. Replace the styrofoam lid.

Problems/questions concerning packaging procedures? Call us using our toll-free number.
English_Packaging Procedure Frozen Specimen_Update: 20200402 ©2003 - 2020 Covance CLS
FROZEN

shown here.
label with your address on the box as indicated shipping document to the designated spot on the box.
on the picture above. Rest of world: Insert the shipping documentation into
Note: Your shipment may be delayed if the the transparent pouch ensuring that the airway bill
label is not affixed to the box. remains visible. Affix the pouch to the cardboard box
on the “Shipping documents” section.
English_Packaging Procedure Frozen Specimen_Update: 20200402 ©2003 - 2020 Covance CLS
PACKAGING PROCEDURES - all countries Except
COMBINED AMBIENT-FROZEN
US/Canada/Puerto Rico: Ship no more than 10 specimens per 2.0 kilograms of dry ice!
Rest of World: Ship no more than 10 specimens per 3 kilograms of dry ice!
1. Place the tube(s) into a 2. Fill half of the styrofoam 3. Replace the styrofoam lid.
Specimen Collection Bag container with dry ice and
containing an absorbent pack. insert the Specimen Collection
Place bag on flat surface to Bag(s). Then completely fill the
minimize wrinkles, especially styrofoam container with dry ice.
at adhesive sealing area.
Remove tape liner to expose Do NOT ship sharps to Covance.
adhesive. Fold along bag
opening so star is inside of
box shape. Press from center
to edge to seal. Do NOT place
sharps into collection bag.
4. Place the cardboard spacer 5. For the ambient tubes, repeat 6. Take a Gel Pak and fill it to the
on top of the styrofoam. step 1. Then fold the white copy indicator line with cool tap water.
of the completed requisition form Seal the bag.
and place it into the pocket on
the reverse side of the Specimen
Collection Bag. The bar code
must be visible.
7. Lightly press the absorbent 8. Place the Specimen Collection

pack to expel its content. Bag on top of the Gel Pak. Wrap Important: Ensure the Hema-
Massage the bag until water the Gel Pak around the Specimen tology sample is placed in the
has been absorbed and a gel Collection Bag, sandwiching the fold of the gel pak.
material has formed. Expel specimens in the middle. Do not
the air from the Gel Pak and insert the specimen containers
reseal. directly into the Gel Pak! Continued on next page...
English_Packaging Procedure Combo Ambient Frozen_Update: 20200402 ©2003 - 2020 Covance CLS
PACKAGING PROCEDURES - all countries Except
COMBINED AMBIENT-FROZEN
9. Place the specimen collection 10. Insert the kit into the zip bag. 11. Place the zip bag into the
bag wrapped in the Gel Pak into cardboard box. Fill empty
the white kit box. Do NOT ship spaces with cushioning
sharps to Covance. material (i.e. paper).
Note:
If the kit box is too large to place
in the shipping carton, wrap a
rubber band around the Gel Pak.
Place the Gel Pak containing the
specimen collection bag inside the
large zip bag.
Place the zip bag into the shipping
carton. Fill empty spaces with
cushioning material (i.e. paper).

shown here.
label with your address on the box as indicated airway bill to the designated spot on the box.
on the picture above. Rest of world: Insert the shipping documentation
Note: Your shipment may be delayed if into the transparent pouch ensuring that the airway
the label is not affixed to the box. bill remains visible. Affix the pouch to the cardboard
Verify the amount of dry ice in kilograms on box on the “Shipping documents” section.
the UN1845 label.
English_Packaging Procedure Combo Ambient Frozen_Update: 20200402 ©2003 - 2020 Covance CLS
SHIPPING DOCUMENTS
ARE PROVIDED IN LARGE COLOR-CODED ENVELOPES
The protocol specific shipping documents are provided in the appropriate envelope with the start-up
! material. They are not automatically resupplied.
Order additional envelopes by using the web address/link http://www.covance.com/kitordering or
by contacting Covance CLS.
The envelope with text in RED

contains your shipping documents
for ambient, refrigerated or combo
ambient-refrigerated specimens.
The envelope with text in BLUE

contains your shipping documents
for frozen or combo ambient-frozen
specimens.
The envelope with

text in GREEN
contains your shipping
documents for
miscellaneous
(including any special
shipping documents
not included in the
two other envelopes)
and/or dangerous
goods specimens
English_Shipping Documents_Update: 20140815 ©2003 Covance CLS
SHIPPING DOCUMENTS - EUROPE AND MIDDLE EAST
ALL TEMPERATURES
MEDICAL EXPRESS LABEL: WAYBILL DOC LABEL:
Refer to the content indicated under “Pack & Ship Instructions” to select the appropriate Airway bill for your
samples (Ambient, Frozen, etc).
For MEDICAL EXPRESS LABEL:

Affix on the shipping box. One label to be adhered onto one shipping box.
For ARCHIVE DOC LABEL:

Place one copy into the plastic pouch that must be affixed on the shipping box with the Proforma Invoice copies
And kindly retain another copy (photocopy the waybill doc label or write the Air waybill manually) for your own
reference.
PLEASE NOTE:
The DHL AWB is valid for 24 months as of their creation date. After that time, their reference number is no longer
active in the DHL database, preventing the package to be inserted in the network for shipment.
We suggest that you review the DHL AWB documents you have on hand and discard any that were created more than
24 months ago. The created date can be found in the upper right hand corner of the document.
You can always order new DHL AWB via our website (https://drugdevelopment.labcorp.com/customers/
investigators/order-a-kit.html).
Have additional questions? Contact our Investigator Support team by using the number for your location that can be
found https://invp.covance.com/ContactUs/contact-us.pdf.
English_EUR DHL Shipping Documents_Update: 20220606 Copyright ©2022 Laboratory Corporation of America® Holdings. All rights reserved.
SHIPPING DOCUMENTS - EUROPE AND MIDDLE EAST
ALL TEMPERATURES
B A
Marken will supply all sites with pre-

printed airway bills. When shipping
samples please ensure that you complete
the following sections:
Information to be completed on day of
collection:
A Date
B Name and/or signature
C Packages and weight

E D F
D Total weight. Mean estimated
weight (average) of your parcel
after sampling done:
0.8 Kg (ambient)
1.0 Kg (refrigerated)
E Number of boxes
F Quantity of Specimen collection

Bags
Call your courier
A
B
English_EUR MarkenShipping Documents_Update: 20070809 ©2003 Covance CLS
Section Break
REFERENCE RANGES/ALERTS AND FLAGS
The reference ranges are age, gender specific and represent a heterogeneous clinical trials patient population. Flags are
indicated in the laboratory report.
The unstated word “to” is implied by the “dash” appearing in age specific reference ranges. A range such as “0-59 years”
and “59-150 years” means: “0 up to but not including 59 years” and “59 up to but not including 150 years”.
The “H” and “L” flags will always be printed. Your sponsor may request different or additional flags than the ones listed
below. Notification of the sponsor flags will occur only if requested by the sponsor.
Note: Reference ranges and alert flags included in the Investigator Manual are for reference purposes only. Reference
ranges and alert flags which are sex and/or age specific can change during the course of a clinical trial. Therefore,
reference ranges and alert flags that print on the Labcorp Central Laboratory Services report should be used for
patient management.
Flag Represents Meaning Notification
H High Flag Patient’s result is outside of the reference No Notification Beyond H/L on
L Low Flag range. Report
HT High Telefacsimile Patient’s result is outside of the reference Available on eSite Access, check
LT Low Telefacsimile range significantly enough to warrant online. Also, Sponsor May
notification. Request Telephone Notification.
HP High Panic Patient’s result is outside of the Available on eSite Access,

LP Low Panic reference range with potentially critical check online and Telephone
implications for the patient. Notification to Investigator Site
(and Sponsor if
requested).
+d Delta Patient’s current result has changed No Notification Beyond +d/-d on
-d Delta (delta) from the patient’s baseline value. Report
EX Exclusions Patient’s value is an exclusion according Notification as Directed by

to protocol requirements. EX flags are Sponsor
protocol specific. Investigator should
refer to the protocol to validate the EX
flag.
On standard lab reports the “date received in laboratory” is the date of the first sample to arrive at Labcorp.
Subsequent samples may arrive at a later date, but this date will not be updated. It will always be the date of the
first container (sample).
The “date reported in laboratory” will be updated as new results are reported until the last result is reported or all
samples are confirmed to have arrived or will not arrive.
A Container Report can be pulled by the Sponsor from LabLink+ that shows the date of arrival in the Labcorp
laboratory for each of the containers (samples) associated with the accession number.
Reporting holds
Your laboratory reports will be held for data clarification when:
- Patient data on the requisition form is missing, incomplete, or inconsistent with previous records.
- Additional data requested on the requisition form is missing.
- A kit refers to a visit that has been received earlier or to a visit out of sequence.
When the issue has been clarified, the laboratory report will be released. In case of a clinically important alert, the
investigator in question will be contacted immediately.
English_Reference Ranges/Alerts and Flags_eSA_Update: 20220323 Copyright ©2021-2022 Laboratory Corporation of America® Holdings. All rights reserved.
Run: 26-May-23 Reference Range Report (Clinical) Page: 1
4:24 AM Reported in: S.I. Units Project: 211576
Group: SM TSLP VOLUME A1
Test Ethnic Sex Age Range Alert Flags Effective Date

____________________________________________________________________________________________________________________________________________________________________________
18-Nov-2022
Volume A1 (AMT50066) Both 0Y-150Y uL
COVANCE CLS SA COVANCE CLS 7 rue Moise Marcinhes Meyrin CHE 1217 058-8227000 058-8227521

Group: SM TSLP VOLUME A2

____________________________________________________________________________________________________________________________________________________________________________
18-Nov-2022
Volume A2 (AMT50067) Both 0Y-150Y uL
Group: FERRITIN

____________________________________________________________________________________________________________________________________________________________________________
L H 30-Nov-2007
Ferritin (BAT344) Female 0Y-18Y ug/L
No Ref Rng
18Y-150Y 11.0-306.8 ug/L <11.0 >306.8
Male 0Y-18Y ug/L
No Ref Rng
18Y-150Y 23.9-336.2 ug/L <23.9 >336.2
Key:
Alert flags: H High
L Low

Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
FSH (BAT442) Female 0D-8D <=3.40 IU/L >3.40
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
8D-15D <=1.00 IU/L >1.00
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
15D-4Y <=3.30 IU/L >3.30
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
4Y-7Y <=3.30 IU/L >3.30
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
7Y-9Y <=11.10 IU/L >11.10
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
9Y-11Y 0.40-6.90 IU/L <0.40 >6.90
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
Continued...
FSH (BAT442) Female 11Y-12Y 0.40-9.00 IU/L <0.40 >9.00
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
12Y-13Y 1.00-17.20 IU/L <1.00 >17.20
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
13Y-14Y 1.80-9.90 IU/L <1.80 >9.90
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
14Y-15Y 0.90-12.40 IU/L <0.90 >12.40
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10

Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
Continued...
FSH (BAT442) Female 15Y-16Y 0.90-12.40 IU/L <0.90 >12.40
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
16Y-17Y 0.90-12.40 IU/L <0.90 >12.40
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
17Y-18Y 1.20-9.60 IU/L <1.20 >9.60
Units:IU/L
Tanner Stages
I:0.40-6.70
II:0.50-8.70
III:1.20-11.40
IV:0.70-12.80
V:1.00-11.60
Foll:3.90-8.80
Midcyc:4.50-22.50
Lut:1.80-5.10
18Y-150Y Follicular:
3.90-8.80 IU/L
Midcycle:
4.50-22.50 IU/L
Luteal:
1.80-5.10 IU/L
Postmenopausal:
16.70-113.60 IU/L
Male 0D-8D <=3.00 IU/L >3.00
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
Continued...
FSH (BAT442) Male 8D-15D <=1.40 IU/L >1.40
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
15D-4Y <=2.50 IU/L >2.50
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
4Y-7Y <=6.70 IU/L >6.70
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
7Y-9Y <=4.10 IU/L >4.10
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
9Y-11Y <=4.50 IU/L >4.50
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
11Y-12Y 0.40-8.90 IU/L <0.40 >8.90
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90

Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
Continued...
FSH (BAT442) Male 12Y-13Y 0.50-10.50 IU/L <0.50 >10.50
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
13Y-14Y 0.70-10.80 IU/L <0.70 >10.80
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
14Y-15Y 0.50-10.50 IU/L <0.50 >10.50
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
15Y-16Y 0.40-18.50 IU/L <0.40 >18.50
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
16Y-17Y <=9.70 IU/L >9.70
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
17Y-18Y 2.20-12.30 IU/L <2.20 >12.30
Units:IU/L
Tanner Stages
I:<=3.70
II:<=12.20
III:<=17.40
IV:0.30-8.20
V:1.10-12.90
Group: FSH

____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jul-2015
Continued...
FSH (BAT442) Male 18Y-150Y 1.30-19.30 IU/L <1.30 >19.30
Key:
Alert flags: H High
L Low

Group: COAGULATION HYS LAW

____________________________________________________________________________________________________________________________________________________________________________
L H HT 28-Oct-2014
PT (CGT283) Both 0Y-150Y 9.7-12.3 sec <9.7 >12.3 >39.999999
____________________________________________________________________________________________________________________________________________________________________________
L H 15-Aug-2014
INR (CGT564) Both 0Y-150Y Patient not taking <0.8 >3.0

oral anticoagulant:
0.8 - 1.2
Patient taking
oral anticoagulant:
2.0 - 3.0
Key:
Alert flags: H High
HT High - Telephone
L Low
Group: HEPATITIS B CORE AB IGM IGG

____________________________________________________________________________________________________________________________________________________________________________
09-Jun-2008
HBc Total (CNT68) Both 0Y-18Y Normal is Negative
18Y-150Y Normal is Negative

Group: HEPATITIS A IGM ANTIBODY

____________________________________________________________________________________________________________________________________________________________________________
24-Jun-2019
HAV IgM (CNT532) Both 0Y-18Y Normal is Negative
Group: HEPATITIS C VIRUS ANTIBODY IGG

____________________________________________________________________________________________________________________________________________________________________________
28-Jun-2019
HCV ab (CNT534) Both 0Y-18Y Normal is Negative
____________________________________________________________________________________________________________________________________________________________________________
EX RX 29-May-2020
HCV ab {Visit Visit 1 EXC}

Both 0Y-18Y
EX: Positive
RX: Equivocal
18Y-150Y
EX: Positive
RX: Equivocal
Key:
Alert flags: EX Exclusion
RX POSSIBLE EXCLUSION

Group: HEPATITIS C ANTIBODY

____________________________________________________________________________________________________________________________________________________________________________
28-Jun-2019
HCV ab (CNT534) Both 0Y-18Y Normal is Negative
____________________________________________________________________________________________________________________________________________________________________________
EX RX 29-May-2020
HCV ab {Visit Visit 1 EXC}

Both 0Y-18Y
EX: Positive
RX: Equivocal
18Y-150Y
EX: Positive
RX: Equivocal
Key:
Group: HEPATITIS B SURFACE ANTIGEN

____________________________________________________________________________________________________________________________________________________________________________
30-Sep-2019
HBsAgII (CNT550) Both 0Y-18Y Normal is Negative
____________________________________________________________________________________________________________________________________________________________________________
RX 21-Oct-2022
HBsAgII {Visit Visit 1 EXC}

Both 0Y-18Y
RX: Positive, Positive, Confirmed
18Y-150Y
Key:
Alert flags: RX POSSIBLE EXCLUSION

Group: HEPATITIS B SURFACE AG

____________________________________________________________________________________________________________________________________________________________________________
30-Sep-2019
HBsAgII (CNT550) Both 0Y-18Y Normal is Negative
____________________________________________________________________________________________________________________________________________________________________________
RX 21-Oct-2022
HBsAgII {Visit Visit 1 EXC}

Both 0Y-18Y
18Y-150Y
Key:
Alert flags: RX POSSIBLE EXCLUSION
Group: HIV 1/2 AG/AB SCREEN

____________________________________________________________________________________________________________________________________________________________________________
25-Jan-2017
HIV1/2 Scr (CNT449) Both 0Y-150Y Ref Rng:
Non-Reactive

Group: LIVER KIDNEY MICROSOME (LKM)

____________________________________________________________________________________________________________________________________________________________________________
H 13-Nov-2019
LKM Ab (ERT3159) Both 0Y-150Y Negative:<0.0-20.0 >20.0
Units
Equivocal:20.1-24.9
Units
Positive:>24.9
Units
Key:
Alert flags: H High
Group: HIV-1/HIV-2 QUALITATIVE RNA

____________________________________________________________________________________________________________________________________________________________________________
16-May-2022
HIV-1 RNA (ERT6386) Both 0Y-150Y Abnormal:Reactive
Normal:Non-Reactive
____________________________________________________________________________________________________________________________________________________________________________
16-May-2022
HIV-2 RNA (ERT6387) Both 0Y-150Y Abnormal:Reactive
Normal:Non-Reactive

Group: HBV DNA COBAS 6800

____________________________________________________________________________________________________________________________________________________________________________
25-Oct-2021
HBV DNA (GET2052) Both 0Y-150Y IU/mL No Ref Rng
Group: HCV RNA COBAS 6800

____________________________________________________________________________________________________________________________________________________________________________
25-Oct-2021
HCV RNA (GET2054) Both 0Y-150Y IU/mL No Ref Rng

Group: BLASTS

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Blasts (HMT97) Both 0Y-150Y 0% >0
Key:
Alert flags: HT High - Telephone
Group: EOSINOPHIL, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 14-Feb-1997
Eos,Immat (HMT49) Both 0Y-150Y 0% >0
Key:
Alert flags: H High

Group: BLASTS

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Blasts (HMT94) Both 0Y-150Y 0 GI/L >0.00
Key:
Group: LYMPHOCYTE, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Prolymph (HMT81) Both 0Y-150Y 0 GI/L >0
____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Ly,Immunob (HMT83) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Ly,Plasmcy (HMT84) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Lymph,Reac (HMT85) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Lymphoblas (HMT86) Both 0Y-150Y 0 GI/L >0.00

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Atyp Lymph (HMT95) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Lymphoma C (HMT80) Both 0Y-150Y 0 GI/L >0.00

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Sezary,Abs (HMT72) Both 0Y-150Y 0 GI/L >0
Key:
Alert flags: H High
HT High - Telephone

Group: MONOCYTE, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Promonocyt (HMT87) Both 0Y-150Y 0 GI/L >0
____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Mono,Immat (HMT89) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Monoblast (HMT88) Both 0Y-150Y 0 GI/L >0.00
Key:
Alert flags: H High
HT High - Telephone
Group: EOSINOPHIL, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 31-Mar-2011
Eos,Immat (HMT75) Both 0Y-150Y 0 GI/L >0
Key:
Alert flags: H High

Group: WBC, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Baso,Immat (HMT74) Both 0Y-150Y 0 GI/L >0
____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Plasma Pre (HMT77) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Plasma Imm (HMT78) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Plasma Cel (HMT79) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Malign,NOS (HMT76) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Hairy Cell (HMT82) Both 0Y-150Y 0 GI/L >0.00

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
NRBC (HMT98) Both 0Y-150Y 0% >0.00

____________________________________________________________________________________________________________________________________________________________________________
09-Dec-1992
CBC Commt: (HMT99) Both 0Y-150Y
Key:
Alert flags: H High
HT High - Telephone
Group: HEMATOLOGY&DIFFERENTIAL PANEL

____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT HP 28-Oct-2014
HGB (HMT40) Female 0D-1D 135-220 g/L <80 <100 <135 >220 >229.999999 >239.999999
1D-8D 135-220 g/L <80 <100 <135 >220 >229.999999 >239.999999
8D-15D 125-210 g/L <80 <100 <125 >210 >219.999999 >229.999999
15D-31D 100-200 g/L <80 <90 <100 >200 >219.999999 >229.999999
31D-4M 100-140 g/L <80 <90 <100 >140 >189.999999 >209.999999
4M-7M 100-140 g/L <80 <90 <100 >140 >189.999999 >209.999999
7M-2Y 105-135 g/L <80 <90 <105 >135 >189.999999 >209.999999
2Y-3Y 110-140 g/L <80 <90 <110 >140 >189.999999 >209.999999
3Y-6Y 118-147 g/L <80 <90 <118 >147 >189.999999 >209.999999
6Y-12Y 112-155 g/L <80 <90 <112 >155 >189.999999 >209.999999
12Y-59Y 116-164 g/L <60 <80 <116 >164 >189.999999 >229.999999
59Y-150Y 115-158 g/L <60 <80 <115 >158 >189.999999 >229.999999
Male 0D-1D 135-220 g/L <80 <100 <135 >220 >229.999999 >239.999999
1D-8D 135-220 g/L <80 <100 <135 >220 >229.999999 >239.999999
8D-15D 125-210 g/L <80 <100 <125 >210 >219.999999 >229.999999
15D-31D 100-200 g/L <80 <90 <100 >200 >219.999999 >229.999999
31D-4M 100-140 g/L <80 <90 <100 >140 >189.999999 >209.999999
4M-7M 100-140 g/L <80 <90 <100 >140 >189.999999 >209.999999
7M-2Y 105-135 g/L <80 <90 <105 >135 >189.999999 >209.999999
2Y-3Y 110-140 g/L <80 <90 <110 >140 >189.999999 >209.999999
3Y-6Y 110-145 g/L <80 <90 <110 >145 >189.999999 >209.999999
6Y-12Y 112-155 g/L <80 <90 <112 >155 >189.999999 >209.999999
12Y-59Y 127-181 g/L <60 <80 <127 >181 >189.999999 >229.999999
59Y-150Y 125-170 g/L <60 <80 <125 >170 >189.999999 >229.999999
____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT 28-Oct-2014
HCT (HMT2) Female 0D-1D 0.42-0.60 <0.24 <0.30 <0.42 >0.60 >0.65
1D-8D 0.42-0.60 <0.24 <0.30 <0.42 >0.60 >0.65
8D-15D 0.39-0.60 <0.24 <0.30 <0.39 >0.60 >0.65
15D-31D 0.31-0.55 <0.24 <0.27 <0.31 >0.55 >0.60
31D-4M 0.28-0.42 <0.24 <0.27 <0.28 >0.42 >0.55
4M-7M 0.28-0.42 <0.24 <0.27 <0.28 >0.42 >0.55
7M-2Y 0.33-0.40 <0.24 <0.27 <0.33 >0.40 >0.50
2Y-3Y 0.33-0.42 <0.24 <0.27 <0.33 >0.42 >0.50
3Y-6Y 0.35-0.44 <0.24 <0.27 <0.35 >0.44 >0.50
6Y-12Y 0.34-0.44 <0.24 <0.27 <0.34 >0.44 >0.50
12Y-59Y 0.34-0.48 <0.18 <0.34 >0.48 >0.50
59Y-150Y 0.34-0.48 <0.18 <0.34 >0.48 >0.50
Male 0D-1D 0.42-0.60 <0.24 <0.30 <0.42 >0.60 >0.65
1D-8D 0.42-0.60 <0.24 <0.30 <0.42 >0.60 >0.65
8D-15D 0.39-0.60 <0.24 <0.30 <0.39 >0.60 >0.65
15D-31D 0.31-0.55 <0.24 <0.27 <0.31 >0.55 >0.60
31D-4M 0.28-0.42 <0.24 <0.27 <0.28 >0.42 >0.55
4M-7M 0.28-0.42 <0.24 <0.27 <0.28 >0.42 >0.55


____________________________________________________________________________________________________________________________________________________________________________
Continued...
HCT (HMT2) Male 7M-2Y 0.33-0.40 <0.24 <0.27 <0.33 >0.40 >0.50
2Y-3Y 0.33-0.42 <0.24 <0.27 <0.33 >0.42 >0.50
3Y-6Y 0.33-0.43 <0.24 <0.27 <0.33 >0.43 >0.50
6Y-12Y 0.34-0.44 <0.24 <0.27 <0.34 >0.44 >0.50
12Y-59Y 0.39-0.54 <0.18 <0.39 >0.54 >0.55
59Y-150Y 0.37-0.51 <0.18 <0.37 >0.51 >0.55
____________________________________________________________________________________________________________________________________________________________________________
LT L H 28-Oct-2014
RBC (HMT3) Female 0D-1D 3.9-5.5 TI/L <3.0 <3.9 >5.5

1D-8D 3.9-6.0 TI/L <3.0 <3.9 >6.0
8D-15D 3.6-6.0 TI/L <3.0 <3.6 >6.0
15D-31D 3.0-5.5 TI/L <2.0 <3.0 >5.5
31D-4M 2.7-5.5 TI/L <2.0 <2.7 >5.5
4M-7M 3.1-4.5 TI/L <2.0 <3.1 >4.5
7M-2Y 3.7-6.0 TI/L <2.0 <3.7 >6.0
2Y-3Y 4.4-5.0 TI/L <3.0 <4.4 >5.0
3Y-6Y 4.1-5.2 TI/L <3.0 <4.1 >5.2
6Y-12Y 3.7-6.0 TI/L <3.0 <3.7 >6.0
12Y-59Y 4.1-5.6 TI/L <2.8 <4.1 >5.6
59Y-150Y 3.9-5.5 TI/L <2.8 <3.9 >5.5
Male 0D-1D 3.9-5.5 TI/L <3.0 <3.9 >5.5
1D-8D 3.9-6.0 TI/L <3.0 <3.9 >6.0
8D-15D 3.6-6.0 TI/L <3.0 <3.6 >6.0
15D-31D 3.0-5.5 TI/L <2.0 <3.0 >5.5
31D-4M 2.7-5.5 TI/L <2.0 <2.7 >5.5
4M-7M 3.1-4.5 TI/L <2.0 <3.1 >4.5
7M-2Y 3.7-6.0 TI/L <2.0 <3.7 >6.0
2Y-3Y 4.1-5.1 TI/L <3.0 <4.1 >5.1
3Y-6Y 4.1-5.3 TI/L <3.0 <4.1 >5.3
6Y-12Y 3.7-6.0 TI/L <3.0 <3.7 >6.0
12Y-59Y 4.5-6.4 TI/L <2.8 <4.5 >6.4
59Y-150Y 4.0-5.8 TI/L <2.8 <4.0 >5.8
____________________________________________________________________________________________________________________________________________________________________________
L H 20-Oct-1993
MCV (HMT4) Female 0Y-1D 98-120 fL <98 >120

1D-8D 88-120 fL <88 >120
8D-15D 86-120 fL <86 >120
15D-31D 85-110 fL <85 >110
31D-4M 77-110 fL <77 >110
4M-7M 74-108 fL <74 >108
7M-2Y 70-90 fL <70 >90
2Y-3Y 75-88 fL <75 >88

____________________________________________________________________________________________________________________________________________________________________________
L H 20-Oct-1993
Continued...
MCV (HMT4) Female 3Y-6Y 74-89 fL <74 >89
6Y-12Y 76-93 fL <76 >93
12Y-59Y 79-98 fL <79 >98
59Y-150Y 80-100 fL <80 >100
Male 0Y-1D 98-120 fL <98 >120
1D-8D 88-120 fL <88 >120
8D-15D 86-120 fL <86 >120
15D-31D 85-110 fL <85 >110
31D-4M 77-110 fL <77 >110
4M-7M 74-108 fL <74 >108
7M-2Y 70-90 fL <70 >90
2Y-3Y 75-88 fL <75 >88
3Y-6Y 74-89 fL <74 >89
6Y-12Y 76-93 fL <76 >93
12Y-59Y 79-96 fL <79 >96
59Y-150Y 80-100 fL <80 >100
____________________________________________________________________________________________________________________________________________________________________________
WBC (HMT7) Female 0D-15D 8.30-17.60 GI/L <1.00 <4.00 <8.30 >17.60 >29.999999 >49.999999
15D-31D 6.90-15.00 GI/L <1.00 <3.00 <6.90 >15.00 >29.999999 >49.999999
31D-61D 6.10-13.80 GI/L <1.00 <3.00 <6.10 >13.80 >29.999999 >49.999999
61D-7M 6.80-16.20 GI/L <1.00 <3.00 <6.80 >16.20 >29.999999 >49.999999
7M-2Y 6.40-15.50 GI/L <1.00 <3.00 <6.40 >15.50 >29.999999 >49.999999
2Y-6Y 5.50-12.50 GI/L <1.00 <3.00 <5.50 >12.50 >29.999999 >49.999999
6Y-12Y 4.35-13.65 GI/L <1.00 <2.00 <4.35 >13.65 >29.999999 >49.999999
12Y-18Y 4.35-13.15 GI/L <1.00 <2.00 <4.35 >13.15 >29.999999 >49.999999
18Y-59Y 3.80-10.70 GI/L <1.00 <2.00 <3.80 >10.70 >29.999999 >49.999999
59Y-150Y 3.80-10.70 GI/L <1.00 <2.00 <3.80 >10.70 >29.999999 >49.999999
Male 0D-15D 8.60-14.90 GI/L <1.00 <4.00 <8.60 >14.90 >29.999999 >49.999999
15D-31D 7.40-13.30 GI/L <1.00 <3.00 <7.40 >13.30 >29.999999 >49.999999
31D-61D 6.00-13.70 GI/L <1.00 <3.00 <6.00 >13.70 >29.999999 >49.999999
61D-7M 6.60-15.60 GI/L <1.00 <3.00 <6.60 >15.60 >29.999999 >49.999999
7M-2Y 6.30-15.40 GI/L <1.00 <3.00 <6.30 >15.40 >29.999999 >49.999999
2Y-6Y 5.50-12.30 GI/L <1.00 <3.00 <5.50 >12.30 >29.999999 >49.999999
6Y-12Y 4.35-13.65 GI/L <1.00 <2.00 <4.35 >13.65 >29.999999 >49.999999
12Y-18Y 4.35-13.15 GI/L <1.00 <2.00 <4.35 >13.15 >29.999999 >49.999999
18Y-59Y 3.80-10.70 GI/L <1.00 <2.00 <3.80 >10.70 >29.999999 >49.999999
59Y-150Y 3.80-10.70 GI/L <1.00 <2.00 <3.80 >10.70 >29.999999 >49.999999
____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT 03-Nov-2014
Neutrophil (HMT8) Female 0D-1D 6.00-26.00 GI/L <1.00 <2.00 <6.00 >26.00 >40.00
1D-8D 2.00-21.00 GI/L <0.75 <1.00 <2.00 >21.00 >40.00


____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT 03-Nov-2014
Continued...
Neutrophil (HMT8) Female 8D-15D 1.00-10.00 GI/L <0.50 <0.75 <1.00 >10.00 >40.00
15D-31D 1.00-9.50 GI/L <0.50 <0.75 <1.00 >9.50 >11.00
31D-4M 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
4M-7M 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
7M-2Y 1.50-9.60 GI/L <0.50 <1.00 <1.50 >9.60 >12.00
2Y-3Y 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
3Y-6Y 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
6Y-12Y 1.35-8.15 GI/L <0.50 <1.00 <1.35 >8.15 >11.00
12Y-18Y 1.65-8.15 GI/L <0.50 <1.00 <1.65 >8.15 >11.00
18Y-59Y 1.96-7.23 GI/L <0.50 <1.00 <1.96 >7.23
59Y-150Y 1.96-7.23 GI/L <0.50 <1.00 <1.96 >7.23
Male 0D-1D 6.00-26.00 GI/L <1.00 <2.00 <6.00 >26.00 >40.00
1D-8D 2.00-21.00 GI/L <0.75 <1.00 <2.00 >21.00 >40.00
8D-15D 1.00-10.00 GI/L <0.50 <0.75 <1.00 >10.00 >40.00
15D-31D 1.00-9.50 GI/L <0.50 <0.75 <1.00 >9.50 >11.00
31D-4M 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
4M-7M 1.00-9.00 GI/L <0.50 <0.75 <1.00 >9.00 >11.00
7M-2Y 1.50-9.40 GI/L <0.50 <1.00 <1.50 >9.40 >12.00
2Y-3Y 1.35-8.65 GI/L <0.50 <1.00 <1.35 >8.65 >11.00
3Y-6Y 1.35-8.65 GI/L <0.50 <1.00 <1.35 >8.65 >11.00
6Y-12Y 1.35-8.15 GI/L <0.50 <1.00 <1.35 >8.15 >11.00
12Y-18Y 1.65-8.15 GI/L <0.50 <1.00 <1.65 >8.15 >11.00
18Y-59Y 1.96-7.23 GI/L <0.50 <1.00 <1.96 >7.23
59Y-150Y 1.96-7.23 GI/L <0.50 <1.00 <1.96 >7.23
____________________________________________________________________________________________________________________________________________________________________________
LT L H HT 26-Dec-2000
Lymphocyte (HMT9) Female 0D-1D 2.00-11.00 GI/L <0.50 <2.00 >11.00 >25.00
1D-8D 2.00-17.00 GI/L <0.50 <2.00 >17.00 >25.00
8D-15D 2.00-17.00 GI/L <0.50 <2.00 >17.00 >25.00
15D-31D 2.50-17.00 GI/L <0.50 <2.50 >17.00 >25.00
31D-4M 2.50-16.00 GI/L <0.50 <2.50 >16.00 >25.00
4M-7M 3.00-15.00 GI/L <0.50 <3.00 >15.00 >25.00
7M-2Y 1.70-6.70 GI/L <1.30 <1.70 >6.70 >10.00
2Y-3Y 1.50-10.00 GI/L <1.00 <1.50 >10.00 >25.00
3Y-6Y 1.50-8.00 GI/L <1.00 <1.50 >8.00 >25.00
6Y-12Y 1.15-6.65 GI/L <1.15 >6.65
12Y-18Y 0.95-5.25 GI/L <0.95 >5.25
18Y-59Y 0.91-4.28 GI/L <0.91 >4.28
59Y-150Y 0.80-3.00 GI/L <0.80 >3.00
Male 0D-1D 2.00-11.00 GI/L <0.50 <2.00 >11.00 >25.00
1D-8D 2.00-17.00 GI/L <0.50 <2.00 >17.00 >25.00
8D-15D 2.00-17.00 GI/L <0.50 <2.00 >17.00 >25.00
15D-31D 2.50-17.00 GI/L <0.50 <2.50 >17.00 >25.00

____________________________________________________________________________________________________________________________________________________________________________
LT L H HT 26-Dec-2000
Continued...
Lymphocyte (HMT9) Male 31D-4M 2.50-16.00 GI/L <0.50 <2.50 >16.00 >25.00
4M-7M 3.00-15.00 GI/L <0.50 <3.00 >15.00 >25.00
7M-2Y 1.70-6.50 GI/L <1.30 <1.70 >6.50 >10.00
2Y-3Y 1.50-10.00 GI/L <1.00 <1.50 >10.00 >25.00
3Y-6Y 1.50-8.00 GI/L <1.00 <1.50 >8.00 >25.00
6Y-12Y 1.15-6.65 GI/L <1.15 >6.65
12Y-18Y 0.95-5.25 GI/L <0.95 >5.25
18Y-59Y 0.91-4.28 GI/L <0.91 >4.28
59Y-150Y 0.80-3.00 GI/L <0.80 >3.00
____________________________________________________________________________________________________________________________________________________________________________
L H 13-Jul-2006
Monocytes (HMT10) Female 0D-4D 0.20-2.20 GI/L <0.20 >2.20

4D-8D 0.20-2.20 GI/L <0.20 >2.20
8D-15D 0.10-2.90 GI/L <0.10 >2.90
15D-31D 0.20-5.00 GI/L <0.20 >5.00
31D-61D 0.20-2.10 GI/L <0.20 >2.10
61D-180D 0.60-1.90 GI/L <0.60 >1.90
180D-2Y 0.30-1.50 GI/L <0.30 >1.50
2Y-6Y 0.50-1.10 GI/L <0.50 >1.10
6Y-12Y 0.40-0.90 GI/L <0.40 >0.90
12Y-18Y 0.40-0.90 GI/L <0.40 >0.90
18Y-150Y 0.12-0.92 GI/L <0.12 >0.92
Male 0D-4D 0.20-1.80 GI/L <0.20 >1.80
4D-8D 0.20-2.20 GI/L <0.20 >2.20
8D-15D 0.30-3.00 GI/L <0.30 >3.00
15D-31D 0.20-3.50 GI/L <0.20 >3.50
31D-61D 0.30-2.70 GI/L <0.30 >2.70
61D-180D 0.50-1.90 GI/L <0.50 >1.90
180D-2Y 0.40-2.00 GI/L <0.40 >2.00
2Y-6Y 0.30-1.20 GI/L <0.30 >1.20
6Y-12Y 0.30-0.90 GI/L <0.30 >0.90
12Y-18Y 0.40-1.30 GI/L <0.40 >1.30
18Y-150Y 0.12-0.92 GI/L <0.12 >0.92
____________________________________________________________________________________________________________________________________________________________________________
H 13-Jul-2006
Eosinophil (HMT11) Female 0D-4D 0.00-0.20 GI/L >0.20

4D-8D 0.00-0.50 GI/L >0.50
8D-15D 0.00-0.60 GI/L >0.60
15D-31D 0.00-0.50 GI/L >0.50
31D-61D 0.00-0.20 GI/L >0.20
61D-180D 0.00-0.10 GI/L >0.10
180D-2Y 0.00-0.20 GI/L >0.20


____________________________________________________________________________________________________________________________________________________________________________
H 13-Jul-2006
Continued...
Eosinophil (HMT11) Female 2Y-6Y 0.00-0.20 GI/L >0.20
6Y-12Y 0.00-0.20 GI/L >0.20
12Y-18Y 0.00-0.20 GI/L >0.20
18Y-150Y 0.00-0.57 GI/L >0.57
Male 0D-4D 0.00-0.30 GI/L >0.30
4D-8D 0.00-0.80 GI/L >0.80
8D-15D 0.00-0.60 GI/L >0.60
15D-31D 0.00-0.90 GI/L >0.90
31D-61D 0.00-0.50 GI/L >0.50
61D-180D 0.00-0.40 GI/L >0.40
180D-2Y 0.00-0.30 GI/L >0.30
2Y-6Y 0.00-0.20 GI/L >0.20
6Y-12Y 0.00-0.30 GI/L >0.30
12Y-18Y 0.00-0.30 GI/L >0.30
18Y-150Y 0.00-0.57 GI/L >0.57
____________________________________________________________________________________________________________________________________________________________________________
RX 20-Aug-2020
Eosinophil {Visit Visit 1 EXC}

Female 0D-4D >1.50
4D-8D >1.50
8D-15D >1.50
15D-31D >1.50
31D-61D >1.50
61D-180D >1.50
180D-2Y >1.50
2Y-6Y >1.50
6Y-12Y >1.50
12Y-18Y >1.50
18Y-150Y >1.50
Male 0D-4D >1.50
4D-8D >1.50
8D-15D >1.50
15D-31D >1.50
31D-61D >1.50
61D-180D >1.50
180D-2Y >1.50
2Y-6Y >1.50
6Y-12Y >1.50
12Y-18Y >1.50
18Y-150Y >1.50

____________________________________________________________________________________________________________________________________________________________________________
RX 20-Aug-2020
Eosinophil {Visit Visit 2 EXC}
Female 0D-4D >1.50
4D-8D >1.50
8D-15D >1.50
15D-31D >1.50
31D-61D >1.50
61D-180D >1.50
180D-2Y >1.50
2Y-6Y >1.50
6Y-12Y >1.50
12Y-18Y >1.50
18Y-150Y >1.50
Male 0D-4D >1.50
4D-8D >1.50
8D-15D >1.50
15D-31D >1.50
31D-61D >1.50
61D-180D >1.50
180D-2Y >1.50
2Y-6Y >1.50
6Y-12Y >1.50
12Y-18Y >1.50
18Y-150Y >1.50
____________________________________________________________________________________________________________________________________________________________________________
H 29-Sep-1993
Basophils (HMT12) Both 0Y-150Y 0.00-0.20 GI/L >0.20

____________________________________________________________________________________________________________________________________________________________________________
H 13-Jul-2006
Eosinophil (HMT18) Female 0D-4D 0.0-3.9 % >3.9

4D-8D 0.0-7.5 % >7.5
8D-15D 0.0-4.1 % >4.1
15D-31D 0.0-5.4 % >5.4
31D-61D 0.0-3.1 % >3.1
61D-180D 0.0-2.8 % >2.8
180D-2Y 0.0-3.1 % >3.1
2Y-6Y 0.0-3.3 % >3.3
6Y-12Y 0.0-4.0 % >4.0
12Y-18Y 0.0-4.1 % >4.1
18Y-150Y 0.0-6.8 % >6.8
Male 0D-4D 0.0-2.9 % >2.9
4D-8D 0.0-5.4 % >5.4
8D-15D 0.0-5.0 % >5.0
15D-31D 0.0-7.0 % >7.0


____________________________________________________________________________________________________________________________________________________________________________
H 13-Jul-2006
Continued...
Eosinophil (HMT18) Male 31D-61D 0.0-5.4 % >5.4
61D-180D 0.0-3.5 % >3.5
180D-2Y 0.0-2.0 % >2.0
2Y-6Y 0.0-2.4 % >2.4
6Y-12Y 0.0-4.8 % >4.8
12Y-18Y 0.0-2.8 % >2.8
18Y-150Y 0.0-6.8 % >6.8
____________________________________________________________________________________________________________________________________________________________________________
Platelets (HMT13) Female 0D-1D 200-400 GI/L <100 <110 <200 >400 >699.999999
1D-8D 200-400 GI/L <100 <110 <200 >400 >699.999999
8D-15D 200-400 GI/L <100 <110 <200 >400 >699.999999
15D-31D 200-400 GI/L <100 <110 <200 >400 >699.999999
31D-4M 200-400 GI/L <100 <110 <200 >400 >699.999999
4M-7M 200-400 GI/L <100 <110 <200 >400 >699.999999
7M-2Y 200-400 GI/L <100 <110 <200 >400 >699.999999
2Y-3Y 252-582 GI/L <100 <110 <252 >582 >699.999999
3Y-6Y 240-570 GI/L <100 <110 <240 >570 >699.999999
6Y-12Y 130-394 GI/L <100 <110 <130 >394 >699.999999
12Y-60Y 140-400 GI/L <25 <50 <140 >400 >699.999999
60Y-150Y 130-394 GI/L <25 <50 <130 >394 >699.999999
Male 0D-1D 200-400 GI/L <100 <110 <200 >400 >699.999999
1D-8D 200-400 GI/L <100 <110 <200 >400 >699.999999
8D-15D 200-400 GI/L <100 <110 <200 >400 >699.999999
15D-31D 200-400 GI/L <100 <110 <200 >400 >699.999999
31D-4M 200-400 GI/L <100 <110 <200 >400 >699.999999
4M-7M 200-400 GI/L <100 <110 <200 >400 >699.999999
7M-2Y 200-400 GI/L <100 <110 <200 >400 >699.999999
2Y-3Y 252-582 GI/L <100 <110 <252 >582 >699.999999
3Y-6Y 240-570 GI/L <100 <110 <240 >570 >699.999999
6Y-12Y 130-394 GI/L <100 <110 <130 >394 >699.999999
12Y-60Y 140-400 GI/L <25 <50 <140 >400 >699.999999
60Y-150Y 130-394 GI/L <25 <50 <130 >394 >699.999999
Key:
Alert flags: H High
HP High Panic
HT High - Telephone
L Low
LP Low Panic
LT Low - Telephone
Group: NEUTROPHIL, ADDITIONAL

____________________________________________________________________________________________________________________________________________________________________________
H 29-Sep-1993
Bands (HMT20) Both 0Y-150Y 0.00-0.27 GI/L >0.27
____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Metamyelo (HMT93) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Myelocyte (HMT92) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
H 19-Jul-1994
Promyelocy (HMT91) Both 0Y-150Y 0 GI/L >0

____________________________________________________________________________________________________________________________________________________________________________
HT 19-Jul-1994
Myeloblast (HMT90) Both 0Y-150Y 0 GI/L >0.00
Key:
Alert flags: H High
HT High - Telephone

Group: HIV-1/2 AB SUPPLEMENTAL

____________________________________________________________________________________________________________________________________________________________________________
15-Mar-2016
HIV-1 Ab (IMT1946) Both 0Y-150Y Negative
____________________________________________________________________________________________________________________________________________________________________________
15-Mar-2016
HIV-2 Ab (IMT1947) Both 0Y-150Y Negative
____________________________________________________________________________________________________________________________________________________________________________
15-Mar-2016
HIV Interp (IMT1948) Both 0Y-150Y Negative
Group: HEV IGM

____________________________________________________________________________________________________________________________________________________________________________
16-Feb-2016
Hep E IgM (IMT1938) Both 0Y-150Y Normal=Negative

Group: ANTI SMOOTH MUSCLE ANTIBODY

____________________________________________________________________________________________________________________________________________________________________________
16-Aug-2017
ASMA (IMT1075) Both 0Y-150Y Ref Rng: Negative
Group: EDN

____________________________________________________________________________________________________________________________________________________________________________
L H 05-Jan-2020
EDN Serum (IMT2499) Both 0Y-150Y 10.00-66.40 ng/mL <10.00 >66.40
Key:
Alert flags: H High
L Low

Group: ANTINUCLEAR ANTIBODY

____________________________________________________________________________________________________________________________________________________________________________
H 03-Jun-2021
ANA (IMT2732) Both 0Y-150Y Negative
H: 1:40, 1:80, 1:160, 1:320, 1:640, 1:1280
, 1:2560, >1:2560
Key:
Alert flags: H High
Group: CMV

____________________________________________________________________________________________________________________________________________________________________________
19-Apr-2019
CMV IgG (LNT48) Both 0Y-150Y Ref Rng: Negative
____________________________________________________________________________________________________________________________________________________________________________
19-Apr-2019
CMV IgM (LNT51) Both 0Y-150Y Negative

Group: EBV

____________________________________________________________________________________________________________________________________________________________________________
23-Apr-2019
EBV IgG (LNT55) Both 0Y-18Y No Ref Rng
18Y-150Y Ref Rng: Negative
____________________________________________________________________________________________________________________________________________________________________________
23-Apr-2019
EBV IgM (LNT54) Both 0Y-18Y Ref Rng:Negative
18Y-150Y Ref Rng:Negative
Group: DUOD BIOP DESCEND H PYLORI EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaDes (OPT1753) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
IniRptDesn (OPT1754) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
BtCtrApDes (OPT1755) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
NCRacptDes (OPT1756) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
HPResDescn (OPT1757) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
RptTstDesc (OPT1758) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CmntDescen (OPT1759) Both 0Y-150Y

Group: DUOD BIOP SUPERIOR DUO REV EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SiteDesc (OPT1780) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaDesc (OPT1781) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
EosCn1Des (OPT1782) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DgAbDesc (OPT1785) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DuodDesc (OPT1786) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CrHprDesc (OPT1787) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
ChrDuoDesc (OPT1788) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
OtAbDesc (OPT1789) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CommentDes (OPT1790) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
PathoDesc (OPT1791) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DateRevDes (OPT1792) Both 0Y-150Y
Group: DUOD BIOP SUPERIOR H PYLORI EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaSup (OPT1746) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
IniRtSup (OPT1747) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
BtCtrAcSup (OPT1748) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
NCRacptSup (OPT1749) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
HPylrRsSup (OPT1750) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
RepTstSup (OPT1751) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CommentSup (OPT1752) Both 0Y-150Y

Group: DUOD BIOP TRANS ASC H PYLO EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SmEvTrAsn (OPT1760) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
IniRptTrAs (OPT1761) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
BtCtAcTrAs (OPT1762) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
NCRAcpTrAs (OPT1763) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
HPylRsTrAs (OPT1764) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
RptTsTrnAs (OPT1765) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CmntTraAsc (OPT1766) Both 0Y-150Y
Group: DUOD BIOP TRANSVER ASC REV EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SitTrnAsc (OPT1806) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaTrAs (OPT1807) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
EosCn1TrAc (OPT1808) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DgAbTraAsc (OPT1811) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DuodTraAsc (OPT1812) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CrHypTrAs (OPT1813) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
ChrTraAsc (OPT1814) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
OthAbTraAs (OPT1815) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
ComentTrAs (OPT1816) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
PathTraAsc (OPT1817) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DateTraAsc (OPT1818) Both 0Y-150Y

Group: DUOD BIOPSY BULB H PYLORI EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaBlb (OPT1739) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
IniRpBlb (OPT1740) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
BtCtrApBul (OPT1741) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
NCRacptBlb (OPT1742) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
HPylrRsBlb (OPT1743) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
RptTstBlb (OPT1744) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CommntBulb (OPT1745) Both 0Y-150Y
Group: DUODENAL BIOP DESCEND REV EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SiteSup (OPT1793) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaSupr (OPT1794) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
EosCn1Sup (OPT1795) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DgAbSupr (OPT1798) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DuodSupr (OPT1799) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CrHprsSupr (OPT1800) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
ChrDuoSupr (OPT1801) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
OtAbSupr (OPT1802) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CommentSup (OPT1803) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
PathoSupr (OPT1804) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DateRvwSup (OPT1805) Both 0Y-150Y

Group: DUODENAL BIOPSY BULB REV EU

____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SiteBulb (OPT1767) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
SamEvaBlb (OPT1768) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
EosCn1Bulb (OPT1769) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DgAbBulb (OPT1772) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DuodBulb (OPT1773) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CrHpVlAtBl (OPT1774) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
ChrDuoBlb (OPT1775) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
OtAbBlb (OPT1776) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
CommentBlb (OPT1777) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
PathoBulb (OPT1778) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
08-Apr-2023
DateRevBlb (OPT1779) Both 0Y-150Y
Group: GASTRIC BIOP ANTRUM H PYLO EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvaAnt (OPT1683) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
IniRptAnt (OPT1684) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
BCtrlAnt (OPT1685) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
NCRactAnt (OPT1686) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
HPylRsAnt (OPT1687) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
ReptstAnt (OPT1688) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
CommentAnt (OPT1689) Both 0Y-150Y

Group: GASTRIC BIOP BODY H PYLORI EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvaBody (OPT1690) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
IniRptBody (OPT1691) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
BtchCtrBd (OPT1692) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
NCRacptBd (OPT1693) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
HPylRsBd (OPT1694) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
RptTstBody (OPT1695) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
CmntBody (OPT1696) Both 0Y-150Y
Group: GASTRIC BIOP INCISUR H PYLO EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvaInc (OPT1676) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
IniRptInc (OPT1677) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
BtCtrInc (OPT1678) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
NCRacptIni (OPT1679) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
HPylRsInc (OPT1680) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
RepTstInc (OPT1681) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
CommentInc (OPT1682) Both 0Y-150Y

Group: GASTRIC BIOP INCISURA REV EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SiteIncisr (OPT1697) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvIncs (OPT1698) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosCn1Incs (OPT1699) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DiaAbnIncs (OPT1704) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosGasIncs (OPT1705) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
McChIncsr (OPT1706) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
OtAbnIncsr (OPT1707) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
ComntIncsr (OPT1708) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
Path Incsr (OPT1709) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DtRevIncis (OPT1710) Both 0Y-150Y
Group: GASTRIC BIOPSY ANTRUM REV EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SiteAntrum (OPT1711) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvaAntr (OPT1712) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosC1Antrm (OPT1713) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DiaAbnAntm (OPT1718) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosGasAntr (OPT1719) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
McChAntru (OPT1720) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
OtAbnAntru (OPT1721) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
ComntAntrm (OPT1722) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
PathAntrm (OPT1723) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DtRevAntrm (OPT1724) Both 0Y-150Y

Group: GASTRIC BIOPSY BODY REV EU

____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
Site Body (OPT1725) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
SamEvalBd (OPT1726) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosC1 Body (OPT1727) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DiaAbBody (OPT1732) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
EosGasBody (OPT1733) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
McGrnChBd (OPT1734) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
OthAbnBody (OPT1735) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
ComntBody (OPT1736) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
Path Body (OPT1737) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
07-Apr-2023
DtRevBody (OPT1738) Both 0Y-150Y
Group: DIST ESOPHAGUS HPF EOS BLK1 EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SmpEvPrx1 (OPT1900) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
EsCnt1Prx1 (OPT1901) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PeakEsPrx1 (OPT1906) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
ComntPrx1 (OPT1908) Both 0Y-150Y


____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023


____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
Group: DIST ESOPHAGUS HPF EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SiteEsoPrx (OPT1897) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PathEsoPrx (OPT1898) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
DatEsoPrx (OPT1899) Both 0Y-150Y

Group: DIST ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Site Dist (OPT1978) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Eval Dist (OPT1979) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsZnHpDist (OPT1980) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EsInfGrDs (OPT1981) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbscGrdDis (OPT1982) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfLyGrDis (OPT1983) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DIS GrDis (OPT1984) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfAltGrDs (OPT1985) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpGrDis (OPT1986) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrFbDis (OPT1987) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsZnHpDis (OPT1988) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EsInfStDs (OPT1989) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbsStgDis (OPT1990) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfLyStgDs (OPT1991) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DISStgDis (OPT1992) Both 0Y-150Y No Ref Rng
Group: DIST ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfAltStDs (OPT1993) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpStgDis (OPT1994) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrFbStDs (OPT1995) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
ComntDis (OPT1996) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Path Dis (OPT1997) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DatRevDis (OPT1998) Both 0Y-150Y

Group: MID ESOPHAGUS HPF EOS BLK1 EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SmpEvaMid1 (OPT1861) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
EoCnt1Mid1 (OPT1862) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PekEo#Mid1 (OPT1867) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
ComentMid1 (OPT1869) Both 0Y-150Y

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SmEvaMid2 (OPT1870) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PkEos#Mid2 (OPT1876) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023


____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PkEos#Mid3 (OPT1885) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
ComntwMid3 (OPT1887) Both 0Y-150Y

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PkEo#Mid4 (OPT1894) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023

Group: MID ESOPHAGUS HPF EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SiteEsoMid (OPT1858) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PathEsoMid (OPT1859) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
DateEsoMid (OPT1860) Both 0Y-150Y
Group: MID ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Site Mid (OPT1957) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Eval Mid (OPT1958) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsZnHpMid (OPT1959) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EsInfGrMid (OPT1960) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbsGrdmid (OPT1961) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfLyGrMid (OPT1962) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DIS GrMid (OPT1963) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfAlGMid (OPT1964) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpCGrMid (OPT1965) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrFbGrMd (OPT1966) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsHyStgMid (OPT1967) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EosStgMid (OPT1968) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbsStgMid (OPT1969) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrAlStgMid (OPT1970) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DISStgMid (OPT1971) Both 0Y-150Y No Ref Rng

Group: MID ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrAlStgMid (OPT1972) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpCStgMd (OPT1973) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrFbStMd (OPT1974) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Comnt Mid (OPT1975) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Path Mid (OPT1976) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DtRevMid (OPT1977) Both 0Y-150Y
Group: PROX ESOPHAGUS HPF EOS BLK1 EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SmEvaDist1 (OPT1822) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
Ecnt1Dist1 (OPT1823) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PkEs#Dist1 (OPT1828) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
Comm Dist1 (OPT1830) Both 0Y-150Y


____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
EosCntDst2 (OPT1832) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
EosCn2Dst2 (OPT1833) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023


____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
EosCntDst4 (OPT1850) Both 0Y-150Y eos/hpf No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
Group: PROX ESOPHAGUS HPF EU

____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
SitEsoDist (OPT1819) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
PatEsDist (OPT1820) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
11-Apr-2023
DtEsodist (OPT1821) Both 0Y-150Y

Group: PROX ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Site Proxi (OPT1936) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
Eval Prox (OPT1937) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsZnHpPrx (OPT1938) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EsInfGrPrx (OPT1939) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbscsGrPrx (OPT1940) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfLyGrPrx (OPT1941) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DIS GrProx (OPT1942) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrfAlGrPrx (OPT1943) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpCGrPrx (OPT1944) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrFbGrPx (OPT1945) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
BsHyStgPrx (OPT1946) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
EosStgProx (OPT1947) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
AbsStgProx (OPT1948) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrLyrStgPx (OPT1949) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DISStgProx (OPT1950) Both 0Y-150Y No Ref Rng
Group: PROX ESOPHAGUS HSS EU

____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
SrAlStgPrx (OPT1951) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DyEpStgPrx (OPT1952) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
LmPrStgPrx (OPT1953) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
CmntProx (OPT1954) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
PathProx (OPT1955) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
13-Apr-2023
DtRevProx (OPT1956) Both 0Y-150Y

Group: TEZE PK BU

____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezepelBU1 (ORT26388) Both 0Y-150Y ng/mL No Ref Rng
Group: TEZE PK PR

____________________________________________________________________________________________________________________________________________________________________________
15-Aug-2018
Tezepelum (ORT19665) Both 0Y-150Y ng/mL No Ref Rng

Group: TEZE ADA NAB BU1

____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezQualBU1 (ORT26427) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezeTitBU1 (ORT26428) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezenABBU1 (ORT26429) Both 0Y-150Y No Ref Rng
Group: TEZE ADA NAB BU2

____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezQualBU2 (ORT26430) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezeTitBU2 (ORT26431) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
21-May-2020
TezenABBU2 (ORT26432) Both 0Y-150Y No Ref Rng

Group: TEZE ADA NAB PR

____________________________________________________________________________________________________________________________________________________________________________
15-Aug-2018
Tezep Qual (ORT19662) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
15-Aug-2018
TezepTiter (ORT19663) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
15-Aug-2018
Tezep Nab (ORT19664) Both 0Y-150Y No Ref Rng
Group: HERPES SIMPLEX VIRUS IGM CE

____________________________________________________________________________________________________________________________________________________________________________
13-Oct-2022
HSV 1+2IgM (ORT33876) Both 0Y-150Y No Ref Rng

Group: DIST ESOPHAGUS IHC EU

____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
TrypStDt (ORT33462) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
TCD (ORT33419) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
TTC (ORT33420) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
TTSPCC (ORT33421) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
T%PC (ORT33422) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
TrypTisA (ORT33423) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
CD3DtSt (ORT33463) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD3CDen (ORT33424) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD3TCC (ORT33425) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD3TSPCC (ORT33426) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD3%PC (ORT33427) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD3TisA (ORT33428) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022

____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
CD4/8DtSt (ORT33464) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
01-Sep-2022
CD4+CD8+CD (ORT33439) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
4+/8+/4+8+ (ORT33440) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4DtStn (ORT33465) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4CDen (ORT33441) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4TCC (ORT33442) Both 0Y-150Y No Ref Rng


____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4TSPCC (ORT33443) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4%PC (ORT33444) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
IgG4TisA (ORT33445) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7DtSt (ORT33466) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7CDen (ORT33452) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7TCC (ORT33453) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7TSPCC (ORT33454) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7%PC (ORT33455) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
2D7TisA (ORT33456) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDN DtSt (ORT33467) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDNCD (ORT33446) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDNSD (ORT33447) Both 0Y-150Y stain/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDNTCC (ORT33448) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDNTSPCC (ORT33449) Both 0Y-150Y No Ref Rng

____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDN%PC (ORT33450) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
EDNTisA (ORT33451) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
ChmDtStn (ORT33468) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
ChmCDen (ORT33457) Both 0Y-150Y Cells/mm2
No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
ChmTCC (ORT33458) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
ChmTSPCC (ORT33459) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
Chm%PC (ORT33460) Both 0Y-150Y % No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
ChmTisA (ORT33461) Both 0Y-150Y mm2 No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
Comment (ORT33469) Both 0Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
Pathologst (ORT33470) Both 0Y-150Y
____________________________________________________________________________________________________________________________________________________________________________
02-Sep-2022
DtRev (ORT33471) Both 0Y-150Y

Group: HERPES SIMPLEX IGG PANEL CE

____________________________________________________________________________________________________________________________________________________________________________
21-Feb-2023
HrSmpV1IgG (ORT34777) Both 0Y-150Y Negative result:
< 0.9
Borderline result:
0.9-1.0
Positive result:
> or equal to 1.1
____________________________________________________________________________________________________________________________________________________________________________
21-Feb-2023
HrSmpV2IgG (ORT34778) Both 0Y-150Y Negative result:
< 0.9
Borderline result:
0.9-1.0
Positive result:
> or equal to 1.1
Group: HEV RNA

____________________________________________________________________________________________________________________________________________________________________________
19-Jan-2018
HEV RNA (ORT18327) Both 0Y-150Y No Ref Rng

Group: SERUM TRYPTASE 60MIN

____________________________________________________________________________________________________________________________________________________________________________
L H 17-Mar-2020
Trp 30-90m (PAT212) Both 0Y-18Y ug/L No Ref Rng
18Y-150Y 2.2-13.2 ug/L <2.2 >13.2
Key:
Alert flags: H High
L Low
Group: SERUM TRYPTASE AT DISCHARGE

____________________________________________________________________________________________________________________________________________________________________________
L H 13-Sep-2019
Tryp Dis (PAT198) Both 0Y-18Y ug/L No Ref Rng
18Y-150Y 2.2-13.2 ug/L <2.2 >13.2
Key:
Alert flags: H High
L Low

Group: SERUM TRYPTASE EVENT

____________________________________________________________________________________________________________________________________________________________________________
L H 13-Sep-2019
Tryp Eve (PAT196) Both 0Y-18Y ug/L No Ref Rng
18Y-150Y 2.2-13.2 ug/L <2.2 >13.2
Key:
Alert flags: H High
L Low
Group: IRON PANEL

____________________________________________________________________________________________________________________________________________________________________________
L H 05-Dec-2019
Total Iron (RCT2338) Female 0D-49D 17.9-44.8 umol/L <17.9 >44.8
49D-1Y 7.2-17.9 umol/L <7.2 >17.9
1Y-11Y 9.0-21.5 umol/L <9.0 >21.5
11Y-18Y 5.4-28.6 umol/L <5.4 >28.6
18Y-150Y 5.4-28.6 umol/L <5.4 >28.6
Male 0D-49D 17.9-44.8 umol/L <17.9 >44.8
49D-1Y 7.2-17.9 umol/L <7.2 >17.9
1Y-11Y 9.0-21.5 umol/L <9.0 >21.5
11Y-18Y 9.0-30.4 umol/L <9.0 >30.4
18Y-150Y 9.0-30.4 umol/L <9.0 >30.4
____________________________________________________________________________________________________________________________________________________________________________
L H 16-Nov-2014
UIBC (RCT3331) Both 0Y-150Y 23.3-67.1 umol/L <23.3 >67.1

____________________________________________________________________________________________________________________________________________________________________________
L H 16-Aug-2017
TIBC (RCT2356) Female 0Y-1Y umol/L No Ref Rng

1Y-6Y 48.0-78.9 umol/L <48.0 >78.9
6Y-10Y 43.0-90.9 umol/L <43.0 >90.9
10Y-14Y 56.9-102.9 umol/L <56.9 >102.9
14Y-18Y 54.1-101.0 umol/L <54.1 >101.0
18Y-150Y 37.6-80.6 umol/L <37.6 >80.6
Male 0Y-1Y umol/L No Ref Rng
1Y-6Y 48.0-78.9 umol/L <48.0 >78.9
6Y-10Y 43.0-90.9 umol/L <43.0 >90.9
10Y-14Y 54.1-90.9 umol/L <54.1 >90.9
14Y-18Y 51.9-102.0 umol/L <51.9 >102.0
18Y-150Y 37.6-80.6 umol/L <37.6 >80.6
Key:
Alert flags: H High
L Low

Group: CHEMISTRY PANEL HYS LAW

____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 30-Oct-2014
GGT (RCT3) Female 0M-6M 15-132 U/L <15 >132 >200 >300
6M-1Y 1-39 U/L <1 >39 >50 >100
1Y-10Y 0-24 U/L >24 >50 >100
10Y-18Y 0-33 U/L >33 >150 >300
18Y-59Y 4-49 U/L <4 >49 >245 >980
59Y-150Y 5-50 U/L <5 >50 >250 >1000
Male 0M-6M 12-122 U/L <12 >122 >200 >300
6M-1Y 1-39 U/L <1 >39 >50 >100
1Y-10Y 0-24 U/L >24 >50 >100
10Y-18Y 0-51 U/L >51 >250 >300
18Y-59Y 10-61 U/L <10 >61 >305 >1220
59Y-150Y 10-50 U/L <10 >50 >250 >1000
____________________________________________________________________________________________________________________________________________________________________________
L H 30-Oct-2014
LDH (RCT1408) Female 0M-1M 145-765 U/L <145 >765

1M-1Y 190-420 U/L <190 >420
1Y-3Y 165-395 U/L <165 >395
3Y-6Y 135-345 U/L <135 >345
6Y-9Y 140-280 U/L <140 >280
9Y-12Y 120-260 U/L <120 >260
12Y-15Y 100-275 U/L <100 >275
15Y-18Y 105-230 U/L <105 >230
18Y-150Y 53-234 U/L <53 >234
Male 0M-1M 125-735 U/L <125 >735
1M-1Y 170-450 U/L <170 >450
1Y-3Y 155-345 U/L <155 >345
3Y-6Y 155-345 U/L <155 >345
6Y-9Y 145-300 U/L <145 >300
9Y-12Y 120-325 U/L <120 >325
12Y-15Y 120-290 U/L <120 >290
15Y-18Y 105-235 U/L <105 >235
18Y-150Y 53-234 U/L <53 >234
Key:
Alert flags: H High
HP High Panic
HT High - Telephone
L Low
Group: LIPID PANEL

____________________________________________________________________________________________________________________________________________________________________________
L H 05-Mar-2019
HDLC4 (RCT4546) Both 0Y-150Y 1.03-1.55 mmol/L <1.03 >1.549999
____________________________________________________________________________________________________________________________________________________________________________
L H 06-May-1997
Triglycer (RCT19) Female 0Y-10Y 0.40-1.24 mmol/L <0.40 >1.24

10Y-15Y 0.42-1.48 mmol/L <0.42 >1.48
15Y-20Y 0.44-1.40 mmol/L <0.44 >1.40
20Y-30Y 0.41-1.63 mmol/L <0.41 >1.63
30Y-40Y 0.44-1.99 mmol/L <0.44 >1.99
40Y-50Y 0.51-2.42 mmol/L <0.51 >2.42
50Y-60Y 0.59-2.96 mmol/L <0.59 >2.96
60Y-150Y 0.63-2.71 mmol/L <0.63 >2.71
Male 0Y-10Y 0.34-1.13 mmol/L <0.34 >1.13
10Y-15Y 0.36-1.41 mmol/L <0.36 >1.41
15Y-20Y 0.42-1.67 mmol/L <0.42 >1.67
20Y-30Y 0.50-2.81 mmol/L <0.50 >2.81
30Y-40Y 0.56-3.62 mmol/L <0.56 >3.62
40Y-50Y 0.62-3.69 mmol/L <0.62 >3.69
50Y-60Y 0.65-3.61 mmol/L <0.65 >3.61
60Y-150Y 0.65-2.94 mmol/L <0.65 >2.94
____________________________________________________________________________________________________________________________________________________________________________
L H 06-May-1997
Cholest (RCT20) Female 0Y-1Y 2.40-6.72 mmol/L <2.40 >6.72

1Y-6Y 2.51-5.51 mmol/L <2.51 >5.51
6Y-10Y 3.15-5.40 mmol/L <3.15 >5.40
10Y-15Y 3.21-5.61 mmol/L <3.21 >5.61
15Y-20Y 3.23-5.48 mmol/L <3.23 >5.48
20Y-30Y 3.31-5.64 mmol/L <3.31 >5.64
30Y-40Y 3.65-6.21 mmol/L <3.65 >6.21
40Y-50Y 4.01-6.85 mmol/L <4.01 >6.85
50Y-60Y 4.42-7.53 mmol/L <4.42 >7.53
60Y-70Y 4.86-8.28 mmol/L <4.86 >8.28
70Y-150Y 5.35-9.10 mmol/L <5.35 >9.10
Male 0Y-1Y 2.40-6.72 mmol/L <2.40 >6.72
1Y-6Y 2.51-5.51 mmol/L <2.51 >5.51
6Y-10Y 3.26-4.94 mmol/L <3.26 >4.94
10Y-15Y 3.36-5.28 mmol/L <3.36 >5.28
15Y-20Y 2.95-5.12 mmol/L <2.95 >5.12
20Y-30Y 3.31-6.10 mmol/L <3.31 >6.10
30Y-40Y 3.88-6.83 mmol/L <3.88 >6.83
40Y-50Y 4.19-7.24 mmol/L <4.19 >7.24
50Y-60Y 4.40-7.53 mmol/L <4.40 >7.53
60Y-70Y 4.53-7.71 mmol/L <4.53 >7.71
70Y-150Y 4.58-7.76 mmol/L <4.58 >7.76

Group: LIPID PANEL

____________________________________________________________________________________________________________________________________________________________________________
L H 22-Apr-2019
LDL Calc (RCT4589) Female 0M-2M mmol/L No Ref Rng
2M-1Y 0.83-3.03 mmol/L <0.83 >3.03
1Y-2Y 0.83-3.03 mmol/L <0.83 >3.03
2Y-5Y 0.98-3.62 mmol/L <0.98 >3.62
5Y-10Y 1.76-3.62 mmol/L <1.76 >3.62
10Y-15Y 1.76-3.52 mmol/L <1.76 >3.52
15Y-18Y 1.53-3.54 mmol/L <1.53 >3.54
18Y-20Y 1.53-3.54 mmol/L <1.53 >3.54
20Y-25Y 1.47-4.11 mmol/L <1.47 >4.11
25Y-30Y 1.84-4.24 mmol/L <1.84 >4.24
30Y-35Y 1.81-4.03 mmol/L <1.81 >4.03
35Y-40Y 1.94-4.45 mmol/L <1.94 >4.45
40Y-45Y 1.91-4.50 mmol/L <1.91 >4.50
45Y-50Y 2.04-4.81 mmol/L <2.04 >4.81
50Y-55Y 2.28-5.20 mmol/L <2.28 >5.20
55Y-60Y 2.30-5.43 mmol/L <2.30 >5.43
60Y-65Y 2.59-5.79 mmol/L <2.59 >5.79
65Y-70Y 2.38-5.72 mmol/L <2.38 >5.72
70Y-150Y 2.48-5.33 mmol/L <2.48 >5.33
Male 0M-2M mmol/L No Ref Rng
2M-1Y 0.83-3.03 mmol/L <0.83 >3.03
1Y-2Y 0.83-3.03 mmol/L <0.83 >3.03
2Y-5Y 0.98-3.62 mmol/L <0.98 >3.62
5Y-10Y 1.63-3.34 mmol/L <1.63 >3.34
10Y-15Y 1.66-3.44 mmol/L <1.66 >3.44
15Y-18Y 1.60-3.36 mmol/L <1.60 >3.36
18Y-20Y 1.60-3.36 mmol/L <1.60 >3.36
20Y-25Y 1.71-3.80 mmol/L <1.71 >3.80
25Y-30Y 1.81-4.27 mmol/L <1.81 >4.27
30Y-35Y 2.02-4.78 mmol/L <2.02 >4.78
35Y-40Y 2.09-4.89 mmol/L <2.09 >4.89
40Y-45Y 2.25-4.81 mmol/L <2.25 >4.81
45Y-50Y 2.51-5.22 mmol/L <2.51 >5.22
50Y-55Y 2.30-5.09 mmol/L <2.30 >5.09
55Y-60Y 2.28-5.25 mmol/L <2.28 >5.25
60Y-65Y 2.15-5.43 mmol/L <2.15 >5.43
65Y-70Y 2.53-5.43 mmol/L <2.53 >5.43
70Y-150Y 2.28-4.81 mmol/L <2.28 >4.81
____________________________________________________________________________________________________________________________________________________________________________
L H 28-Jan-1994
VLDL-C (RCT101) Both 0Y-150Y 0.18-0.88 mmol/L <0.18 >0.88
Key:
Alert flags: H High
L Low
Group: CRP

____________________________________________________________________________________________________________________________________________________________________________
L H 07-Aug-2020
CRPHS (RCT4588) Both 0D-21D 0.1-4.1 mg/L <0.1 >4.1
21D-2M mg/L No Ref Rng
2M-15Y 0.1-2.8 mg/L <0.1 >2.8
15Y-18Y mg/L No Ref Rng
18Y-150Y 0.0-5.0 mg/L >5.0
Key:
Alert flags: H High
L Low

Group: SERUM BETA HCG

____________________________________________________________________________________________________________________________________________________________________________
HT HP 12-Jan-2022
BhCG Qual (RCT3580) Female 0Y-56Y Ref Rng: Negative
HP: Borderline, Positive
56Y-150Y Ref Rng: Negative
HT: Borderline
HP: Positive
Male 0Y-56Y No Ref Rng
56Y-150Y No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
EX 28-Nov-2019
BhCG Qual {Visit Visit 1 EXC}

Female 0Y-56Y
EX: Positive
56Y-150Y
EX: Positive
Male 0Y-56Y
EX: Positive
56Y-150Y
EX: Positive
____________________________________________________________________________________________________________________________________________________________________________
HT HP 12-Jan-2022
BhCG Quant (RCT3579) Female 0Y-56Y Units: mIU/mL >4.999999

Pre-menopausal
<5.0: Negative
5.0-24.9:Borderline
>/= 25.0: Positive
56Y-150Y Units: mIU/mL >7.099999 >24.999999
Post Menopausal
</= 7.0: Negative
7.1-24.9:Borderline
>/= 25.0: Positive
Male 0Y-56Y mIU/mL No Ref Rng
56Y-150Y mIU/mL No Ref Rng
Key:
HP High Panic
HT High - Telephone
Group: ALPHA-1 ANTITRYPSIN

____________________________________________________________________________________________________________________________________________________________________________
L H 06-Jul-2020
AAT (RCT5109) Both 0Y-150Y 0.90-2.00 g/L <0.90 >2.00
Key:
Alert flags: H High
L Low

Group: CERULOPLASMIN

____________________________________________________________________________________________________________________________________________________________________________
L H 01-Sep-2020
Cerulo (RCT5150) Female 0Y-150Y 0.160-0.450 g/L <0.160 >0.450
Male 0Y-150Y 0.150-0.300 g/L <0.150 >0.300
Key:
Alert flags: H High
L Low
Group: TOTAL IGE

____________________________________________________________________________________________________________________________________________________________________________
L H 13-Aug-2021
IgE (RCT5450) Both 0Y-150Y 0.80-495.00 IU/mL <0.80 >495.00
Key:
Alert flags: H High
L Low

Group: CHEMISTRY PANEL

____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 04-Dec-2019
Total Bili (RCT1) Both 0D-14D 3-200 umol/L <3 >200 >256.999999 >341.999999
14D-18Y 3-21 umol/L <3 >21 >61.999999 >204.999999
18Y-150Y 3-21 umol/L <3 >21 >61.999999 >204.999999
____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 17-Nov-2020
Alk Phos (RCT5252) Female 0D-15D 83-248 U/L <83 >248 >496 >1240
15D-1Y 122-469 U/L <122 >469 >938 >2345
1Y-10Y 142-335 U/L <142 >335 >670 >1675
10Y-13Y 129-417 U/L <129 >417 >834 >2085
13Y-15Y 57-254 U/L <57 >254 >508 >1270
15Y-17Y 50-117 U/L <50 >117 >234 >585
17Y-19Y 45-87 U/L <45 >87 >435 >1740
19Y-150Y 35-104 U/L <35 >104 >520 >2080
Male 0D-15D 83-248 U/L <83 >248 >496 >1240
15D-1Y 122-469 U/L <122 >469 >938 >2345
1Y-10Y 142-335 U/L <142 >335 >670 >1675
10Y-13Y 129-417 U/L <129 >417 >834 >2085
13Y-15Y 116-468 U/L <116 >468 >936 >2340
15Y-17Y 82-331 U/L <82 >331 >662 >1655
17Y-19Y 55-149 U/L <55 >149 >745 >2980
19Y-150Y 40-129 U/L <40 >129 >645 >2580
____________________________________________________________________________________________________________________________________________________________________________
EX 18-Jan-2021
Alk Phos {Visit Visit 1 EXC}

Female 0D-15D >496
15D-1Y >938
1Y-10Y >670
10Y-13Y >834
13Y-15Y >508
15Y-17Y >234
17Y-19Y >174
19Y-150Y >208
Male 0D-15D >496
15D-1Y >938
1Y-10Y >670
10Y-13Y >834
13Y-15Y >936
15Y-17Y >662
17Y-19Y >298
19Y-150Y >258

____________________________________________________________________________________________________________________________________________________________________________
EX 18-Jan-2021
Alk Phos {Visit Visit 2 EXC}
Female 0D-15D >496
15D-1Y >938
1Y-10Y >670
10Y-13Y >834
13Y-15Y >508
15Y-17Y >234
17Y-19Y >174
19Y-150Y >208
Male 0D-15D >496
15D-1Y >938
1Y-10Y >670
10Y-13Y >834
13Y-15Y >936
15Y-17Y >662
17Y-19Y >298
19Y-150Y >258
____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 12-Feb-2019
ALT (SGPT) (RCT4) Female 0Y-1Y <=54 U/L >54 >100 >200
1Y-4Y 6-34 U/L <6 >34 >100 >200
4Y-7Y 6-34 U/L <6 >34 >100 >200
7Y-10Y 6-34 U/L <6 >34 >100 >200
10Y-18Y 6-34 U/L <6 >34 >200 >300
18Y-150Y 4-43 U/L <4 >43 >215 >860
Male 0Y-1Y <=54 U/L >54 >100 >200
1Y-4Y 6-34 U/L <6 >34 >100 >200
4Y-7Y 6-34 U/L <6 >34 >100 >200
7Y-10Y 6-34 U/L <6 >34 >100 >200
10Y-18Y 6-43 U/L <6 >43 >200 >300
18Y-150Y 5-48 U/L <5 >48 >240 >960
____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
ALT (SGPT) {Visit Visit 1 EXC}

Female 0Y-1Y >108
1Y-4Y >68
4Y-7Y >68
7Y-10Y >68
10Y-18Y >68
18Y-150Y >86
Male 0Y-1Y >108
1Y-4Y >68
4Y-7Y >68


____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
Continued...
ALT (SGPT) Male 7Y-10Y >68
10Y-18Y >86
18Y-150Y >96
____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
ALT (SGPT) {Visit Visit 2 EXC}

Female 0Y-1Y >108
1Y-4Y >68
4Y-7Y >68
7Y-10Y >68
10Y-18Y >68
18Y-150Y >86
Male 0Y-1Y >108
1Y-4Y >68
4Y-7Y >68
7Y-10Y >68
10Y-18Y >86
18Y-150Y >96
____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 12-Feb-2019
AST (SGOT) (RCT5) Female 0Y-1Y 10-80 U/L <10 >80 >200 >300
1Y-4Y 10-56 U/L <10 >56 >100 >200
4Y-7Y 10-48 U/L <10 >48 >100 >200
7Y-18Y 10-40 U/L <10 >40 >100 >200
18Y-150Y 8-40 U/L <8 >40 >200 >800
Male 0Y-1Y 10-80 U/L <10 >80 >200 >300
1Y-4Y 10-69 U/L <10 >69 >100 >200
4Y-7Y 10-59 U/L <10 >59 >100 >200
7Y-18Y 10-40 U/L <10 >40 >100 >200
18Y-150Y 8-40 U/L <8 >40 >200 >800
____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
AST (SGOT) {Visit Visit 1 EXC}

Female 0Y-1Y >160
1Y-4Y >112
4Y-7Y >96
7Y-18Y >80
18Y-150Y >80
Male 0Y-1Y >160
1Y-4Y >138
4Y-7Y >118

____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
Continued...
AST (SGOT) Male 7Y-18Y >80
18Y-150Y >80
____________________________________________________________________________________________________________________________________________________________________________
EX 22-Mar-2019
AST (SGOT) {Visit Visit 2 EXC}

Female 0Y-1Y >160
1Y-4Y >112
4Y-7Y >96
7Y-18Y >80
18Y-150Y >80
Male 0Y-1Y >160
1Y-4Y >138
4Y-7Y >118
7Y-18Y >80
18Y-150Y >80
____________________________________________________________________________________________________________________________________________________________________________
GGT (RCT3) Female 0M-6M 15-132 U/L <15 >132 >200 >300
6M-1Y 1-39 U/L <1 >39 >50 >100
1Y-10Y 0-24 U/L >24 >50 >100
10Y-18Y 0-33 U/L >33 >150 >300
18Y-59Y 4-49 U/L <4 >49 >245 >980
59Y-150Y 5-50 U/L <5 >50 >250 >1000
Male 0M-6M 12-122 U/L <12 >122 >200 >300
6M-1Y 1-39 U/L <1 >39 >50 >100
1Y-10Y 0-24 U/L >24 >50 >100
10Y-18Y 0-51 U/L >51 >250 >300
18Y-59Y 10-61 U/L <10 >61 >305 >1220
59Y-150Y 10-50 U/L <10 >50 >250 >1000
____________________________________________________________________________________________________________________________________________________________________________
Urea Nitr (RCT6) Both 0Y-18Y 1.4-8.6 mmol/L <1.4 >8.6 >12.5 >17.9
18Y-70Y 1.4-8.6 mmol/L <1.4 >8.6 >17.899999 >35.699999
70Y-80Y 1.4-10.4 mmol/L <1.4 >10.4 >17.899999 >35.699999
80Y-150Y 1.4-12.1 mmol/L <1.4 >12.1 >17.899999 >35.699999
____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 28-Jan-2015
Creatinine (RCT408) Female 0M-1M 14-57 umol/L <14 >57 >88 >133
1M-1Y 5-30 umol/L <5 >30 >88 >133
1Y-4Y 5-39 umol/L <5 >39 >88 >133


____________________________________________________________________________________________________________________________________________________________________________
L H HT HP 28-Jan-2015
Continued...
Creatinine (RCT408) Female 4Y-7Y 14-48 umol/L <14 >48 >88 >133
7Y-10Y 14-57 umol/L <14 >57 >88 >133
10Y-13Y 23-66 umol/L <23 >66 >106 >150
13Y-16Y 31-75 umol/L <31 >75 >133 >177
16Y-18Y 40-83 umol/L <40 >83 >177 >265
18Y-50Y 31-101 umol/L <31 >101 >302 >605
50Y-70Y 31-101 umol/L <31 >101 >302 >605
70Y-80Y 31-110 umol/L <31 >110 >329 >658
80Y-150Y 31-128 umol/L <31 >128 >385 >769
Male 0M-1M 14-83 umol/L <14 >83 >106 >133
1M-1Y 5-39 umol/L <5 >39 >88 >133
1Y-4Y 5-39 umol/L <5 >39 >88 >133
4Y-7Y 14-48 umol/L <14 >48 >88 >133
7Y-10Y 23-57 umol/L <23 >57 >88 >133
10Y-13Y 23-66 umol/L <23 >66 >106 >150
13Y-16Y 23-83 umol/L <23 >83 >133 >177
16Y-18Y 40-101 umol/L <40 >101 >177 >265
18Y-50Y 40-110 umol/L <40 >110 >329 >658
50Y-70Y 40-119 umol/L <40 >119 >358 >716
70Y-80Y 40-137 umol/L <40 >137 >411 >822
80Y-150Y 40-145 umol/L <40 >145 >435 >870
____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT HP 28-Nov-2011
Glucose (RCT11) Both 0Y-150Y 3.9-5.6 mmol/L <2.2 <2.5 <3.9 >5.6 >16.7 >22.2
____________________________________________________________________________________________________________________________________________________________________________
Uric Acid (RCT8) Female 0M-1M 59-274 umol/L <59 >274 >416 >476
1M-1Y 65-321 umol/L <65 >321 >416 >476
1Y-4Y 107-297 umol/L <107 >297 >416 >476
4Y-7Y 119-303 umol/L <119 >303 >416 >476
7Y-10Y 107-327 umol/L <107 >327 >416 >476
10Y-13Y 149-393 umol/L <149 >393 >595 >714
13Y-16Y 131-381 umol/L <131 >381 >595 >714
16Y-18Y 137-404 umol/L <137 >404 >595 >714
18Y-50Y 125-428 umol/L <125 >428 >595 >773
50Y-70Y 149-446 umol/L <149 >446 >595 >773
70Y-150Y 149-446 umol/L <149 >446 >595 >773
Male 0M-1M 71-232 umol/L <71 >232 >416 >476
1M-1Y 71-333 umol/L <71 >333 >416 >476
1Y-4Y 125-333 umol/L <125 >333 >416 >476
4Y-7Y 107-327 umol/L <107 >327 >416 >476
7Y-10Y 107-321 umol/L <107 >321 >416 >476

____________________________________________________________________________________________________________________________________________________________________________
Continued...
Uric Acid (RCT8) Male 10Y-13Y 131-393 umol/L <131 >393 >595 >714
13Y-16Y 184-416 umol/L <184 >416 >595 >714
16Y-18Y 232-488 umol/L <232 >488 >595 >714
18Y-50Y 125-488 umol/L <125 >488 >595 >773
50Y-70Y 149-494 umol/L <149 >494 >595 >773
70Y-150Y 149-494 umol/L <149 >494 >595 >773
____________________________________________________________________________________________________________________________________________________________________________
Calcium (RCT183) Both 0Y-2Y 2.25-2.74 mmol/L <1.50 <1.75 <2.25 >2.74 >3.12 >3.37
2Y-18Y 2.10-2.57 mmol/L <1.50 <1.75 <2.10 >2.57 >3.12 >3.37
18Y-150Y 2.07-2.64 mmol/L <1.50 <1.75 <2.07 >2.64 >3.12 >3.37
____________________________________________________________________________________________________________________________________________________________________________
LP LT L H 04-Nov-2014
Phosphorus (RCT9) Both 0Y-1Y 1.36-2.62 mmol/L <.810001 <1.36 >2.62

1Y-5Y 1.03-1.97 mmol/L <.810001 <1.03 >1.97
5Y-10Y 1.03-1.97 mmol/L <.650001 <1.03 >1.97
10Y-15Y 1.00-1.94 mmol/L <.650001 <1.00 >1.94
15Y-150Y 0.71-1.65 mmol/L <0.32 <0.65 <0.71 >1.65
____________________________________________________________________________________________________________________________________________________________________________
L H 21-Jan-2015
CK (RCT14) Female 0Y-1Y 18-134 U/L <18 >134

1Y-4Y 18-134 U/L <18 >134
4Y-7Y 18-147 U/L <18 >147
7Y-10Y 18-295 U/L <18 >295
10Y-13Y 18-184 U/L <18 >184
13Y-16Y 18-187 U/L <18 >187
16Y-18Y 18-169 U/L <18 >169
18Y-150Y 26-192 U/L <26 >192
Male 0Y-1Y 18-183 U/L <18 >183
1Y-4Y 18-163 U/L <18 >163
4Y-7Y 18-158 U/L <18 >158
7Y-10Y 18-354 U/L <18 >354
10Y-13Y 18-363 U/L <18 >363
13Y-16Y 18-363 U/L <18 >363
16Y-18Y 18-408 U/L <18 >408
18Y-150Y 39-308 U/L <39 >308
____________________________________________________________________________________________________________________________________________________________________________
Sodium (RCT15) Both 0Y-18Y 132-147 mmol/L <120 <125 <132 >147 >155 >165
18Y-59Y 132-147 mmol/L <120 <125 <132 >147 >155 >165


____________________________________________________________________________________________________________________________________________________________________________
Continued...
Sodium (RCT15) Both 59Y-150Y 135-145 mmol/L <120 <125 <135 >145 >155 >165
____________________________________________________________________________________________________________________________________________________________________________
LP LT L H HT HP 11-Jul-2016
Potassium (RCT16) Both 0Y-1Y 3.7-5.6 mmol/L <2.6 <3.0 <3.7 >5.6 >6.0 >6.9
1Y-18Y 3.5-5.2 mmol/L <2.6 <3.0 <3.5 >5.2 >5.8 >6.9
18Y-59Y 3.5-5.2 mmol/L <2.6 <3.0 <3.5 >5.2 >6.0 >6.9
59Y-150Y 3.5-5.2 mmol/L <2.6 <3.0 <3.5 >5.2 >6.0 >6.9
____________________________________________________________________________________________________________________________________________________________________________
L H 25-Apr-1997
Chloride (RCT18) Both 0Y-18Y 94-112 mmol/L <94 >112

18Y-150Y 94-112 mmol/L <94 >112
Key:
H High
HP High Panic
HT High - Telephone
L Low
LP Low Panic
LT Low - Telephone
Group: CMV IGM IGG

____________________________________________________________________________________________________________________________________________________________________________
03-Feb-2022
CMV IgM (RCT5687) Both 0Y-150Y Ref Rng:
Non Reactive
____________________________________________________________________________________________________________________________________________________________________________
17-Jan-2023
CMV IgG (RCT5984) Both 0Y-150Y Ref Rng :
Non Reactive

Group: % IRON SATURATION

____________________________________________________________________________________________________________________________________________________________________________
L H 24-Jan-2011
% Saturatn (RCT2362) Female 0Y-18Y No Ref Rng
18Y-150Y 0.15-0.50 <0.15 >0.50
Male 0Y-18Y No Ref Rng
18Y-150Y 0.20-0.50 <0.20 >0.50
Key:
Alert flags: H High
L Low
Group: TRANSFERRIN

____________________________________________________________________________________________________________________________________________________________________________
L H 09-Jul-2008
TRF (SCT2999) Female 0Y-18Y g/L No Ref Rng
18Y-150Y 2.500-3.800 g/L <2.500 >3.800
Male 0Y-18Y g/L No Ref Rng
18Y-150Y 2.150-3.650 g/L <2.150 >3.650
____________________________________________________________________________________________________________________________________________________________________________
20-Jun-2008
CDT (SCT2998) Both 0Y-18Y mg/L No Ref Rng
18Y-150Y mg/L No Ref Rng
____________________________________________________________________________________________________________________________________________________________________________
H 20-Jun-2008
%CDT (SCT3000) Both 0Y-18Y % No Ref Rng

18Y-150Y <2.47% >2.469999
Key:
Alert flags: H High
L Low

Group: IGG4

____________________________________________________________________________________________________________________________________________________________________________
L H 29-Jul-2022
IgG Sub 4 (SCT4476) Both 0Y-2Y 0.01-0.78 g/L <0.01 >0.78
2Y-4Y 0.01-0.54 g/L <0.01 >0.54
4Y-6Y 0.02-1.12 g/L <0.02 >1.12
6Y-8Y 0.00-0.98 g/L <0.00 >0.98
8Y-10Y 0.02-0.95 g/L <0.02 >0.95
10Y-12Y 0.02-1.15 g/L <0.02 >1.15
12Y-14Y 0.04-1.36 g/L <0.04 >1.36
14Y-18Y 0.11-1.57 g/L <0.11 >1.57
18Y-150Y 0.03-2.01 g/L <0.03 >2.01
Key:
Alert flags: H High
L Low
Group: CELLULAR ELEMENTS

____________________________________________________________________________________________________________________________________________________________________________
H HT 06-Jul-2006
RBC (UAT18) Female 0Y-18Y 0-8 /HPF >8 >150
18Y-150Y 0-8 /HPF >8 >150
Male 0Y-18Y 0-3 /HPF >3 >150
18Y-150Y 0-3 /HPF >3 >150
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
RBC Clumps (UAT68) Both 0Y-18Y Ref Rng:Not present
18Y-150Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
H HT 06-Jul-2006
WBC (UAT17) Female 0Y-18Y 0-12 /HPF >12 >150

18Y-150Y 0-12 /HPF >12 >150
Male
0Y-18Y 0-5 /HPF >5 >150
18Y-150Y 0-5 /HPF >5 >150
____________________________________________________________________________________________________________________________________________________________________________
12-May-2006
WBC Clumps (UAT23) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Trans Epi (UAT46) Both 0Y-18Y 0 /HPF
18Y-150Y 0 /HPF
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Renal Epi (UAT44) Both 0Y-18Y 0 /HPF
18Y-150Y 0 /HPF
____________________________________________________________________________________________________________________________________________________________________________
12-May-2006
Squam Epi (UAT45) Both 0Y-18Y 0-3 /HPF
18Y-150Y 0-3 /HPF
Key:
Alert flags: H High
HT High - Telephone

Group: CASTS

____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Hyal Casts (UAT19) Both 0Y-18Y 0 /LPF
18Y-150Y 0 /LPF
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Epi Casts (UAT30) Both 0Y-18Y 0 /LPF
18Y-150Y 0/ LPF
____________________________________________________________________________________________________________________________________________________________________________
H 08-May-2006
WBC Casts (UAT21) Both 0Y-18Y 0 /LPF >0

18Y-150Y 0 /LPF >0
____________________________________________________________________________________________________________________________________________________________________________
H 08-May-2006
RBC Casts (UAT22) Both 0Y-18Y 0 /LPF >0

18Y-150Y 0 /LPF >0
____________________________________________________________________________________________________________________________________________________________________________
H 08-May-2006
Gran Casts (UAT20) Both 0Y-18Y 0/ LPF >0

18Y-150Y 0 /LPF >0
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Fat Casts (UAT31) Both 0Y-18Y 0 /LPF
18Y-150Y 0 /LPF
____________________________________________________________________________________________________________________________________________________________________________
H 08-May-2006
Cell Casts (UAT69) Both 0Y-18Y 0 /LPF >0

18Y-150Y 0 /LPF >0
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
BroadCasts (UAT70) Both 0Y-18Y 0 /LPF
18Y-150Y 0 /LPF
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Waxy Casts (UAT71) Both 0Y-18Y 0 /LPF
18Y-150Y 0 /LPF
Key:
Alert flags: H High
Group: CRYSTALS

____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Trip Phos (UAT33) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Ca Ox (UAT34) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Ca Phos (UAT35) Both 0Y-18Y Ref Rng:Not present
18Y-150Y Ref Rng:Not Present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Ca Carb (UAT37) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Uric Acid (UAT38) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Amorphous (UAT39) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Am Biurate (UAT75) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
Bilirubin (UAT76) Both 0Y-18Y Ref Rng:Not present

HT: Present
HT: Present
____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
Leucine (UAT72) Both 0Y-18Y Ref Rng:Not present

HT: Present
HT: Present
____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
Tyrosine (UAT74) Both 0Y-18Y Ref Rng:Not present

HT: Present

Group: CRYSTALS

____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
Continued...
Ur Tyrosine Crystals Both
HT: Present
____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
Cystine (UAT73) Both 0Y-18Y Ref Rng:Not present

HT: Present
HT: Present
Key:
Group: MICROORGANISMS

____________________________________________________________________________________________________________________________________________________________________________
12-May-2006
Bacteria (UAT16) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
12-May-2006
Yeast Bud (UAT36) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
12-May-2006
Yeast Hyph (UAT66) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
H 11-May-2006
Trich (UAT41) Both 0Y-18Y Ref Rng:Not present

H: Present
H: Present
Key:
Alert flags: H High

Group: MISCELLANEOUS ELEMENTS

____________________________________________________________________________________________________________________________________________________________________________
HT 11-May-2006
OvFat Body (UAT27) Both 0Y-18Y Ref Rng:Not present
HT: Present
HT: Present
____________________________________________________________________________________________________________________________________________________________________________
H 11-May-2006
Fat (UAT28) Both

H: Present
H: Present
____________________________________________________________________________________________________________________________________________________________________________
10-May-2006
Mucous (UAT67) Both 0Y-18Y Ref Rng:Not present
____________________________________________________________________________________________________________________________________________________________________________
11-May-2006
Sperm (UAT40) Both 0Y-18Y Ref Rng:Not present
Key:
Alert flags: H High
HT High - Telephone
Project Sponsor Flags Technical 25-MAY-23 07:24 PM
Page: 1
Project: 211576
Ages Paramenter Reach Value Negative Positive

Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
HIV1/2 Scr Both 0Y 999Y

SLC50=Repeatedly Repeatedly DF
HIV-1 RNA Both 0Y 999Y

ERC1077=Reactive Reactive A EX
HIV-2 RNA Both 0Y 999Y

ERC1077=Reactive Reactive A EX
HPylRsInc Both 0Y 999Y

ORC77=Positive Positive RX
HPylRsAnt Both 0Y 999Y

HPylRsBd Both 0Y 999Y

HPylrRsBlb Both 0Y 999Y

HPylrRsSup Both 0Y 999Y

HPResDescn Both 0Y 999Y

HPylRsTrAs Both 0Y 999Y

PkEs#Dist1 Both 0Y 999Y <15 <15 RX
PekEo#Mid1 Both 0Y 999Y <15 <15 RX
PkEos#Mid2 Both 0Y 999Y <15 <15 RX
PkEos#Mid3 Both 0Y 999Y <15 <15 RX
PkEo#Mid4 Both 0Y 999Y <15 <15 RX
PeakEsPrx1 Both 0Y 999Y <15 <15 RX

Page: 2
Project: 211576
D5244C00001
Continued

HPIncRslt Both 0Y 999Y

HPAntmRslt Both 0Y 999Y

HPBdyRslt Both 0Y 999Y

PeakPro Both 0Y 999Y <15 <15 RX
PeakMid Both 0Y 999Y <15 <15 RX
PeakDist Both 0Y 999Y <15 <15 RX
HPDuodReEU Both 0Y 999Y

HPSprResEU Both 0Y 999Y

HPTrAsRsEU Both 0Y 999Y

HPDsResEU Both 0Y 999Y

Total Bili Both 0D 14D >23.3 >399 SF

14D 18Y >2.3 >40 SF
18Y 999Y >2.3 >40 SF
BhCG Qual Female 0Y 56Y

ALC01=Borderline Borderline CF
SLC02=Positive Positive DX
56Y 999Y
Male 0Y 56Y
56Y 999Y
ALT (SGPT) Female 0Y 1Y >161 >161 AF

>269 >269 IF
>431 >431 GF
Page: 3
Project: 211576
D5244C00001
Continued

ALT (SGPT) Continued 1Y 4Y >101 >101 AF

>169 >169 IF
>271 >271 GF
4Y 7Y >101 >101 AF
>169 >169 IF
>271 >271 GF
7Y 10Y >101 >101 AF
>169 >169 IF
>271 >271 GF
10Y 18Y >101 >101 AF
>169 >169 IF
>271 >271 GF
18Y 999Y >128 >128 AF
>214 >214 IF
>343 >343 GF
Male 0Y 1Y >161 >161 AF
>269 >269 IF
>431 >431 GF
1Y 4Y >101 >101 AF
>169 >169 IF
>271 >271 GF
4Y 7Y >101 >101 AF
>169 >169 IF
>271 >271 GF
7Y 10Y >101 >101 AF
>169 >169 IF
>271 >271 GF
10Y 18Y >128 >128 AF
>214 >214 IF
>343 >343 GF
18Y 999Y >143 >143 AF
>239 >239 IF
>383 >383 GF
AST (SGOT) Female 0Y 1Y >239 >239 BF

>399 >399 HF
>639 >639 FF
1Y 4Y >167 >167 BF
>279 >279 HF
>447 >447 FF
4Y 7Y >143 >143 BF
>239 >239 HF
>383 >383 FF
7Y 18Y >119 >119 BF
>199 >199 HF
>319 >319 FF
18Y 999Y >119 >119 BF
>199 >199 HF
>319 >319 FF
Male 0Y 1Y >239 >239 BF
>399 >399 HF

Page: 4
Project: 211576
D5244C00001
Continued

AST (SGOT) Continued >639 >639 FF

1Y 4Y >206 >206 BF
>344 >344 HF
>551 >551 FF
4Y 7Y >176 >176 BF
>294 >294 HF
>471 >471 FF
7Y 18Y >119 >119 BF
>199 >199 HF
>319 >319 FF
18Y 999Y >119 >119 BF
>199 >199 HF
>319 >319 FF
Flags: AF Sponsor Flag

BF Sponsor Flag
CF Possible Discontinuation
DF Possible Exclusion
DX Discontinuation
EX Exclusion
FF Sponsor Flag
GF Sponsor Flag
HF Sponsor Flag
IF Sponsor Flag
JF Possible Discontinuation
SF Sponsor Flag
Section Break
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211576_TMEA
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Certificate OF ISO 15189
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Manual Created: 30 Oct 22

King Abdulaziz Medical City - MNGHA
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Labcorp Central Laboratory Services S.a.r.l. CAP dark blue ink
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Riyadh, Saudi Arabia
Abdulaziz A. Al-Ajlan, MD
Page 197
CAP # 4658701
CAP# 2739801
The organization named above is granted this accreditation in accordance with the recognized
International Standard ISO 15189:2012, Medical Laboratories – Requirements for quality and
competence. This accreditation demonstrates competence for a defined scope and the operation
of a laboratory quality management system.
Effective From May X, 202X

October through
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April October
XX, 202X22, 2025
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Gaurav Sharma MD, FCAP Emily E. Volk, MD, FCAP

Chair, CAP 15189 Committee President , College of American Pathologists
The scope of this accreditation includes the Quality Management System

System and
and the
the disciplines
disciplines of
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Anatomic Pathology,
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Chemistry,
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Flow Cytometry, Hematology, Cytopathology,
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Microbiology, Hematology,
Molecular Histocompatibility
Pathology and Urinalysis. Testing,
Immunology, Microbiology, Molecular Pathology, Transfusion Medicine, and Urinalysis.
Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
Manual Revised: 30 May 23 Version 3.0.0

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https://drugdevelopment.labcorp.com/customers/investigators/investigator-tools-and-resources/accreditations-and-certifications.html
https://www.covance.com/customers/investigators/investigator-tools-and-resources/accreditations-and-certifications.html
https://www.covance.com/customers/investigators/investigator-tools-and-resources/accreditations-and-certifications.html
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10
Central Laboratory Services
Indianapolis Shanghai
8211 SciCor Drive Building 9, No.338 Jialilue Road
Indianapolis, IN 46214-2985 USA Zhangjiang Hi-Tech Park
Tel. (317) 271-1200 (local calls) Shanghai 201203
Fax: (317) 616-2362 China Tel: +86 21 6192 6100
Fax: +86 21 6104 1530
Geneva
Rue Moïse-Marcinhes 7 Tokyo
1217 Meyrin/Genève-CH CB Lab c/o BML General Laboratory
Tel: 0041 58 822 7901 1361-1 Matoba Kawagoe-shi
Fax: 0041 58 822 7521 Saitama 350-1101 Japan
Japan Toll free: 0120-123-905
Singapore Direct line: +81-3-6837-9536
1 International Business Park Fax: +81-3-6220-3667
The Synergy, #04-14
Singapore 609917
Tel. 65-6560-8793
Fax. 65-6565-5901
Laboratory regulatory certifications available at:

https://www.drugdevelopment.labcorp.com/customers/investigators/investigator-tools-
and-resources/accreditations-and-certifications.html

Manual Labcorp 3.0.0

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Manual Labcorp 3.0.0

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Central Laboratory

Labcorp Project #: 211576

Section 1: General Introduction, Holidays, and Contact Numbers

Section 2: Study-Specific Instructions and Procedures

Section 3: Pack & Ship Instructions

Section 4: Get Result

Section 5: Laboratory Certifications

Branding Update Regarding

For Internal Use Only: All ● LN 50947 ● English ● 23June2021 ● WLK

0 Mod. Std Page 3-Feb-23 Updated: ISO15189 certification EURLaboratoryCertifications

Labcorp CLS Version Control Process

With the above as an explanation, here is an example.

Third digit, since the last sponsor

Welcome to Xcellerate® Lab

Navigating the System

- Call early in the day to schedule your pickup.

Europe, Middle East and Africa (specimens sent to Geneva)

2023 2024 2025

01 January 01 January 01 January New Year’s Day

) To call Labcorp Central Laboratory Services in Geneva from:

Austria Hungary Portugal

Croatia + 800 8877 4411 (Tel) or

Czech Republic 800 142 083 (Tel)

Finland 990 800 88 77 44 11 (Tel)

Greece 00 800 4112 871 141 (Tel)

Latvia 800 031 43 (Tel)

Lithuania 8800 30262 (Tel)

Monaco 800 93 185 (Tel)

Poland +800 8877 4411 (Tel) or

Romania 08008 9 52 14 (Tel)

Russia 8 800 333 73 39 (Tel) or

Ukraine 0800504643 (Tel)

) To call Labcorp Central Laboratory Services in Geneva from:

South Africa 00 800 88 77 44 11 (Tel) or

•• Please check kit expiration dates before using

Please do not collect specimens in expired

•• A unique accession number is assigned to each kit

Do not interchange the tubes and/or requisition

Labeling samples with unique identifiers:

•• Each container label is pre-printed with a barcode

Refer to your Web resupply form for delivery days.

How to adjust your kit inventory

Labcorp Central Laboratory Services uses a manual and an

Materials and Equipment Required to Order Kits

Completing Section A – Study Details

Completing Section B – Comment Box

You may use a single form to adjust

There is no need to complete the

 List the number of kits currently in site inventory

 Provide the accession numbers for kits transferred

KIT TYPE 1 2 3 4 5 6 7 U-1

Esophageal tissue for biomarker analyses and histopathology

Active Treatment Pregnancy Gastric/Duodenal

Esophageal tissue for biomarker analyses and histopathology

If Anatomic Location-Biopsy 8 Equal To distal esophagus AND

SPECIALTY VISIT DEFINITIONS:

Kit - Active Treatment Extension Period

Kit - IPD visit

SPECIALTY VISIT DEFINITIONS:

Kit -Pregnancy confirmation

Kit - Esophageal biopsies

Kit - Gastric/Duodenal biopsies

STUDY SPECIFIC NOTES:

STUDY SPECIFIC NOTES: