HFL705 - Cobas 4800 HIF Manual 1.02 PDF

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cobas 4800 system

Host Interface Manual
Software Version 1.02
DRAFT
cobas 4800 system Host interface Manual
Table of Contents
General 1
Target audience.................................................................................... 1
References .................................................................................... 1
....................................................................................
Document Revision History 1
.................................................................................... 2
Contacts, Trademarks
Glossary .................................................................................... 3
Overview 4
....................................................................................
Communication Overview 4
....................................................................................
Communication layers 5
Workflow 6
....................................................................................
Communication Scenarios 6
.................................................................................... 6
Work Order Inquiry
Result export .................................................................................... 8
Message types 8
.................................................................................... 8
General Information
.................................................................................... 8
Full Run Inquiry
.................................................................................... 8
Full Order Response
.................................................................................... 10
Test Result Export
FLAGS .................................................................................... 13
Test Result Export workflow 16
Roche Diagnostics DRAFT March 2010

Page i Host Interface manual
Host interface Manual cobas 4800 system
ASTM Protocol 17
COBAS 4800 ....................................................................................
ASTM Record Definitions 19
....................................................................................
Inquiry records Mappings (ASTM) 20
H Segment.................................................................................... 20
P Segment .................................................................................... 21
Q Segment.................................................................................... 21
L Segment .................................................................................... 21
....................................................................................
Inquiry Response Mapping 22
H Segment.................................................................................... 22
P Segment .................................................................................... 23
O Segment.................................................................................... 23
L Segment .................................................................................... 24
Inquiry/response examples
.................................................................................... 25
....................................................................................
Results Mapping (ASTM) 26
H Segment.................................................................................... 26
P Segment .................................................................................... 27
O Segment.................................................................................... 27
R Segment .................................................................................... 28
L Segment .................................................................................... 28
....................................................................................
Results Example ASTM 29
HL7 Protocol 31
COBAS 4800 ....................................................................................
HL7 Record Definitions 32
....................................................................................
Inquiry Records mapping (HL7) 33
Inquiry Mapping
.................................................................................... 33
Inquiry Response Mapping
.................................................................................... 35
....................................................................................
Results Mapping (HL7) 37
Result Example HL7

.................................................................................... 40

Host Interface manual Page ii
Communication setup 42
.................................................................................... 42
Network connection
.................................................................................... 42
Instrument Setup
Simulator 43
.................................................................................... 43
Installing simulators
.................................................................................... 43
HL7 Simulator
Setting up the simulator connection
.................................................................................... 46
Connection....................................................................................
test 49
Sending an....................................................................................
order to the system 50
Receiving results from the system.
.................................................................................... 54
.................................................................................... 57
ASTM Simulator
Troubleshooting / logfiles 58
Known restrictions 58

Page iii Host Interface manual
General
1 General
Target audience
The intended audience for this manual is Host Interface programmers and the Roche Field engineers supporting the
system.
References
[1] HL 7 Documentation Version 2.4, Health Level Seven, Ann Arbor MI, USA, www.HL7.org
[2] ASTM Documentation 1394 LIS2
Note: Although ASTM and HL7 are the base of the data exchange, the result transmission
is not a strict ASTM or HL7 format.
The system presents CT/NG or HPV as global blocks of results and transmits them as such.
See the Result topics for the respective ASTM and HL7 formats for details.
Document Revision History
Document Version Revision Date
1.0 January 2009
1.02 Manual rev 02 March 2010
Copyright 2009, 2010, Roche Diagnostics Ltd. All rights reserved.
Rev 02: Corrected some errors and omissions.

Clarified the target audience of manual and simulators.
Added definition Client / server.
Added complete results fields tables
Added examples multiple flags
Added information regarding media types
Added information regarding order handling (Tubes without orders) at various places.
Timeout for order response from LIS increased to 180 seconds.
This manual applies to Software Version 1.02
Information in this document is subject to change without notice. No part of this document may be reproduced or
transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written
permission of Roche Diagnostics GmbH.
Every effort has been made to ensure that all the information contained in this manual is correct at the time of publishing.
However, Roche Diagnostics Ltd. reserves the right to make any changes necessary without notice as part of ongoing
product development.
Document references
These are internal Roche references

DVS Number: 05702950001
Material Number: 10330010

Host Interface manual Page 1
General
Contacts, Trademarks
Contact Addresses
Manufacturer Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
Distribution Roche Diagnostics GmbH

Sandhofer Strae 116
D-68305 Mannheim
Germany
Distribution in the US Roche Diagnostics

9115 Hague Road
PO Box 50457
Indianapolis, IN 46250
USA
Questions or comments regarding the contents of this manual can be directed to the address below or to your Roche
representative.
Roche Diagnostics Ltd.

Global Service Support
Forrenstrasse
6343 Rotkreuz, Switzerland
email: rotkreuz.gssmdi@roche.com
Trademarks
cobas is a trademark of Roche.
Other brands or product names are trademarks of their respective holders.

Page 2 Host Interface manual
General
Glossary
MTS Medium Throughput System This name is sometimes used inside the protocol.
Where the Acronym MTS is used, it means the cobas 4800 system..
A&D Amplification and detection. The system will only perform Amplification and detection on already
prepared MWP, using the z 480 instrument.
The A&D runs are not supported by the LIS workflow.
AnD Same meaning as A&D - Often used inside records as the "&" character would be interpreted as
separator and therefore cannot be used.
Full run Samples will be prepared into a MWP by the cobas x 480, then the plate will be transferred manually
to the cobas z 480 for the A&D run.
GUID Stands for Global Unique Identifier.
A unique identifier created by the system. It is a 128 bits number written in a pattern of hexadecimal
numbers similar to : 3F2504E0-4F89-11D3-9A0C-0305E82C3301
It is used to identify a unique run in the transmission records.
MWP Microwell plates.
Transformer A software module that conforms XML communication files to the communication server.
cobas x 480 The cobas x 480 prepares the samples.
instrument The cobas x 480 is loaded with samples, consumables and reagents. After sample preparation, the
multiwell plate with the PCR-ready samples is unloaded, sealed, and transferred to the cobas z 480 for
amplification and detection.
cobas z 480 The cobas z 480 utilizes fluorescence to detect nucleic acids amplified by using realtime
analyzer PCR methodology. the loading and unloading of the multiwell plate is done manually.

General
2 Overview
The structure of the document is as follow
The topic General describes general functions of the subsystem or the unit having influence on the implementation.
This chapter contains no specifications but provides background information and context information for the
specifications stated in the next chapter. The goal is to increase the legibility of the document.
Topic HL7 contains all the specifications for the HL7 protocol.
Topic ASTM contains all the specifications for the ASTM protocol.
Communication Overview
The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol.
The connection is TPC/IP over ethernet.

The RS-232 connection is not supported by the system.
The cobas 4800 system offers two transmission protocols: -ASTM

-HL 7
The communication is realized by xml files which are exchanged and evaluated between cobas 4800 sw <-> Transformer
and Transformer <-> cobas 5000 IT Communications Server.
Client /Server structure

The communication is always established by the cobas 4800 control unit; the cobas 4800 system is always the TCP/IP client
and the LIS is always the TCP/IP server.

Overview
Communication layers
As all the communication is based on network connections, this manual addresses mostly the upper layer (application)
related topics.
This layer corresponds to the upper layer in the well known OSI model:

Overview
3 Workflow
Communication Scenarios
The following table shows the communication scenarios existing for the cobas 4800.
Table 1 Communications Scenarios

Name Description Input Output
Work Order The cobas 4800 ask the LIS Run Type, Test Type, Sample For each sample: Sub
Inquiry Full to get order details for one Ids Test Type, Media Type
or more Samples
Work Order This mode is not supported Run Type, Test Type, Id of the For each sample: Sub
Inquiry A&D by the LIS workflow MWP Test Type, Media Type,
Only MWP Position
Test Result The cobas 4800 System Run Id, Run Type, Test Type -
Upload sends the test result of a Run Sub Test Type, Media Type,
to the LIS Test Result, Flags, Sample Id,
Test Time Stamp, Order Time
Stamp, Accepted Flag
Once the LIS has been enable by Roche support, the LIS must always respond to order requests.
There is no possibility to work with "results sending only" and manually ordering.
If the LIS cannot respond to order requests, the system cannot run tests unless the LIS is disabled again to work completely
offline.
Work Order Inquiry
Figure 1 Work Order Inquiry
The Work Order Inquiry Scenario is described In Figure 1.

If a cobas 4800 user starts a run to test samples it loads the samples or the MWP plate. After the plate loading, the cobas
4800 system starts the above inquiry sequence to the LIS server.

Workflow
Missing orders:
When sample numbers are received that do not have a corresponding test request in the Host system, the whole sample
record must be skipped.
No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure.
See in Each protocol for details.
When order numbers are skipped, the mismatch will be signaled on the screen as shown below (1):
(Mismatch occurred between loaded and expected samples
Please press "Unload Sample" )
The sample positions are indicated in (2)
Possible correcting actions :
1. Unload the sample rack(s), remove the indicated sample tubes (2), reload the sample rack. or
2. Unload the sample rack, add orders to the indicated samples into the LIS system, reload the sample rack(s)
Work order inquiry timeout:

The timeout after a work order inquiry from the instrument is currently set at 180 seconds and cannot be changed.
The complete work order list has to be completely transmitted within these 180 seconds, otherwise a timeout message will
result.

Workflow
Result export
The results can be manually exported to the LIS using the selected protocol (ASTM or HL7).
The LIS has to be enabled to be able to export the results.

If the system works in offline mode and tests are ordered manually , results cannot be exported via LIS.
The total transmission time should not exceed 120 seconds otherwise the last results may not be transmitted.
4 Message types
General Information
The Full run, the A&D Only run and the result export have different data to transfer.
The following tables show the detail of this data.
Full Run Inquiry

Table 2 Full Run Inquiry
cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Run Type Full QPD-3-2 Q-5-6
Test Type CT/NG QPD-3-1 Q-5-4
Software MTS MSH-3 H-5-3
Version 0.9.1.0843 MSH-4 H-5-4
Sample Ids (1-94) 100101001 QPD-4 Q-3
Full Order Response

Table 3 Full Order Response
cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Run Type Full OBR-4-3 O-5-6
Test Type CT/NG OBR-4-1 O-5-4
Software LIS MSH-3-1 H-5-3
Version 6.3 MSH-4-1 H-5-4
Sample Id 0010212 OBR-3-1 O-3-1
SubTestType NG OBR-4-2 O-5-5
Media Type UT OBR-15 O-16

Message types
Table 4 Possible values SubTestType (order response)
Type Possible values for subtype field (order response)
CT/NG CT/NG
CT
NG
HPV HPV High Risk Panel + Genotyping
HPV High Risk Panel
Table 5 * Possible values media
Type Test subtype Possible value Media names

field Media Type
CT/NG CT UT = UniTrans
UUT = Urine UniTrans
NG
CT/NG
HPV HPV High Risk PC = PreserveCyt
Panel SP = SurePath original tube is not validated on cobas 4800
HPV16
PC and SP are used, whether the samples are in original
HPV18 containers or in secondary tube round base 13mL

Message types
Test Result Export

Table 6 Test Result Export
Test Result Example HL7 ASTM

Export Mapping Mapping
Start Time 2008-10-14T13:49:39 OBR-7 R-12
End Time 2008-10-14T13:50:45 OBR-8 R-13
Test Type CT/NG OBR-4 R-3
Run Type Full OBR-4 O-4
Run Id 83b6f32c-d31b-49a8-8239-13be65486ea3 MSH-10 O-4;H-5-1
User Id Laboperator OBX-16 R-11
Software MTS MSH-3 H-5-3
Version 0.9.3.0847 MSH-4 H-5-4
Created Admin ORC-10 O-17
Creation Date 2008-06-11T15:56:58 ORC-7-4 O-8
Plate Id (A&D AD000012 OBX-3;OBR-3 O-3;H-5
Only)
For each
Sample
Test Result Examples: OBX-5-1 R-4-1
Invalid ;
CT POS, NG POS ;
See Test results combination 11 tables

for all possibilities.
Flag Pattern M1,M3 OBX-5-2 R-4-2
Sub Test Type CT OBR-4 R-3
Sample Id 100101001 OBX-3;OBR-3 O-3;H-5
Media Type UUT OBR-15 O-16
Order Date 2008-10-14T13:50:38 OBR-27 O-15
Accepted Flag False OBX-11 O-26
MWP Position A5 OBX-3;OBR-3 O-3;H-5
Test result Possible values (Samples)

invalid positive (POS) negative (NEG)
Test result Possible values (Controls)

invalid Valid

Message types
Test results combination tables :

Table 7
cobas 4800 CT/NG Test Result Report and Interpretation
CT POS, NG POS CT Positive, NG Positive. Specimen is positive for the presence of both
CT and NG DNA.
CT NEG, NG NEG CT Negative*, NG Negative*. Neither CT nor NG DNA, if present,

could be detected.
CT POS, NG NEG CT Positive, NG Negative*. Specimen is positive for the presence of CT

DNA.
NG DNA, if present, could not be detected.
CT POS, NG Invalid CT Positive, NG Invalid.

Specimen is positive for the presence of CT DNA.
NG result is Invalid. Original specimen should be re-tested to obtain
valid NG result.
CT NEG, NG POS CT Negative*, NG Positive. CT DNA, if present, could not be detected.

Specimen is positive for the presence of NG DNA.
CT Invalid, NG Positive.
CT Invalid, NG POS CT result is Invalid. Original specimen should be re-tested to obtain

valid CT result.
Specimen is positive for the presence of NG DNA.
CT Invalid, NG NEG CT Invalid, NG Negative*. CT result is Invalid. Original specimen

should be re-tested to obtain valid CT results.
NG DNA, if present, could not be detected.
CT NEG, NG Invalid CT Negative*, NG Invalid. CT DNA, if present, could not be detected.

NG result is Invalid. Original specimen should be re-tested to obtain
valid NG result.
Invalid CT Invalid, NG Invalid. Both CT and NG results are Invalid. Original

specimen should be re-tested to obtain valid CT and NG results.
Failed No Result for Specimen Consult the cobas 4800 system Operators
Manual for instructions to review run flags and recommended actions.
Original specimen should be re-tested to obtain valid CT and NG
results.

Message types
Table 8
cobas 4800 HPV Test Result Report and Interpretation

SubTest HPV High Risk Panel:
HR HPV POS High Risk HPV Positive Specimen is positive for the DNA of any one
of, or combination of, the following high risk HPV types: 16, 18, 31,
33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.
HR HPV NEG High Risk HPV Negative* HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52,
56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set
threshold.
High Risk HPV Invalid Results are invalid. Original specimen should be
Invalid re-tested to obtain valid result.
Failed No Result for Specimen Consult the cobas 4800 system Operators
Manual for instructions to review run flags and recommended actions.
Original specimen should be re-tested to obtain valid result.
SubTest HPV High Risk Panel Plus Genotyping:
Other High Risk HPV Positive, HPV16 Positive, HPV18 Positive.
Other HR HPV POS, HPV16 POS, HPV18 Specimen is positive for HPV types 16 and 18 DNA and the DNA of
POS any one of, or combination of, the following high risk HPV types: 31,
33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.
Other High Risk HPV Positive, HPV16 Positive, HPV18 Negative*.
Other HR HPV POS, HPV16 POS, HPV18 Specimen is positive for HPV type 16 DNA and the DNA of any one
NEG of, or combination of, the following high risk HPV types: 31, 33, 35,
39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 18 DNA was undetectable
or below the pre-set threshold.
Other High Risk HPV Positive, HPV16 Negative*, HPV18 Positive.
Other HR HPV POS, HPV16 NEG, HPV18 Specimen is positive for HPV type 18 DNA and the DNA of any one
POS of, or combination of, the following high risk HPV types: 31, 33, 35,
39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 16 DNA was undetectable
or below the pre-set threshold.
Other High Risk HPV Positive, HPV16 Negative*, HPV18 Negative*.
Other HR HPV POS, HPV16 NEG, HPV18 Specimen is positive for the DNA of any one of, or combination of, the
NEG following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,
66, 68. HPV types 16 and 18 DNA were undetectable or below the pre-
set threshold.
Other High Risk HPV Negative*, HPV16 Positive, HPV18 Positive.
Other HR HPV NEG, HPV16 POS, HPV18 HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were
POS undetectable or below the pre-set threshold. Specimen is positive for
HPV types 16 and 18 DNA.
Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Positive.
Other HR HPV NEG, HPV16 NEG, HPV18 HPV types 16, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA
POS were undetectable or below the pre-set threshold. Specimen is positive
for HPV type 18 DNA.
Other High Risk HPV Negative*, HPV16 Positive, HPV18 Negative*.
Other HR HPV NEG, HPV16 POS, HPV18 HPV types 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA
NEG were undetectable or below the pre-set threshold. Specimen is positive
for HPV type 16 DNA.
Other HR HPV NEG, HPV16 NEG, HPV18 Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Negative*.
NEG HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
DNA were undetectable or below the pre-set threshold.
Invalid Invalid. The results are Invalid. Original specimen should be re-tested to
obtain valid results.
No Result for Specimen Consult the cobas 4800 system Operators
Failed Manual for instructions to review run flags and recommended actions.
Original specimen should be re-tested to obtain valid results.

Message types
FLAGS
Result Interpretation Table 9
Flag Source Severity Description

Code
R1 RI Error General exception raised.
R2 RI Error The Well Result List is null or empty.
R3 RI Error The Well Result Node is invalid.
R4 RI Error The Result Interpretation Parameters Node is null.
R5 RI Error The Result Interpretation Parameters Node is invalid.
R6 RI Error Input Xml Nodes mapping failed.
R7 RI Error The Result Interpretation provides 4-dyes result interpretation.
R8 RI Error The test ingredients have not been specified.
R9 RI Error The test should have at least one target and at least one internal control.
R10 RI Error The probes have not been specified.
R11 RI Error The Well Result Node attributes are invalid.
R12 RI Error The Algorithm Results Node is incomplete.
R13 RI Error The Qualitative Interpretation Tables Node is invalid.
R14 RI Error The Result Table Node is invalid.
R15 RI Error The SubTest type or the ResultTable is invalid.
R16 RI Error The Intermediate-Result Interpretation failed.
R17 RI Error The Well-Result Interpretation failed.
R18 RI Error The Multi-Well Result Interpretation failed.
R19 RI Error The Ct ranges for the intermediate interpretation are invalid.
R20 RI Warning The positive external control is invalid.
R21 RI Warning The negative external control is invalid.
Multiple or other reason Table 10

Code
M1 SW Error Software error. Additional information can be found in messages and the trace
log files.
M2 Other Error Aborted by the user
M5 SW Warning PCR run only with a user defined sample preparation
M6 SW Warning The connection to the instrument was temporarily lost
Note: One Result can have several flags.

Message types
Calculation Table 11

Code
C1 CP Error General exception raised.
C2 CP Error The RawData node is null.
C3 CP Error The CalculationParameters node is null.
C4 CP Error The RawData node is invalid.
C5 CP Error The CalculationParameters node is invalid.
C6 CP Error Input XmlNodes mapping failed.
C7 CP Error The HpvCtng-CalculationPackage provides 4-dyes result interpretation.
C8 CP Error The test ingredients have not been specified.
C9 CP Error The test should have at least one target and at least one internal control.
C10 CP Error The probes have not been specified.
C11 CP Error The computation algorithm has not been specified.
C12 CP Error The specified algorithm is not supported by this calculation package.
C13 CP Error The specified algorithm version is not supported by this calculation package.
C14 CP Error The calculation parameters for the numeric algorithm are incomplete.
C15 CP Error The fluorescence measurements data is incomplete.
C101 XT Error The CrossTalk compensation has failed.
C102 XT Error The CrossTalkMatrix is null.
C103 XT Error The Background vector is null.
C104 XT Error CrossTalk Matrix has invalid entries.
C105 XT Error The length of the background vector is not equal with CrossTalkMatrix
filter combinations count.
C106 XT Error Matrix coefficients calculation has failed.
C107 XT Error Matrix inversion has failed.
C108 XT Error Resolution matrix size and channel count do not match.
C121 XT Error The RawData node is null.
C122 XT Error The CalculationParameters node is null.
C123 XT Error The RawData node is invalid.
C124 XT Error The CalculationParameters node is invalid.
C125 XT Error General exception raised.
C221 KA2 Error The RawData node is null.
C222 KA2 Error The AlgorithmParameters node is null.
C223 KA2 Error The RawData node is invalid.

Message types
C224 KA2 Error The AlgorithmParameters node is invalid.
C225 KA/KA2 Error General exception raised.
C301 ELCA Warning CurvatureFailure
C302 ELCA Error InterceptOutOfRange
C303 ELCA Error SlopeOutOfRange
C304 ELCA Warning CurveFitFailure
C305 ELCA Warning AFIMinFailure
C306 ELCA Error DataRangeFailure
C307 ELCA Info InsufficientCurvature
C308 ELCA Info DeclineCorrected
C309 ELCA Error CTOutOfRange
C321 ELCA Error The RawData node is null.
C322 ELCA Error The CalculationParameters node is null.
A&D errors Table 12

Code
Z1 AnDI Error Hardware or software error from the instrument.
The run was aborted.
SPI errors Table 13

Code
X1 SPI Error Hardware or software error from the instrument. The run was aborted.
X2 SPI Info Barcode was entered manually.
X3 SPI Error Clot detected for a sample. This sample will have an invalid result.
X4 SPI Error Not enough liquid while processing a sample. This sample will have an invalid
result.
X5 SPI Error Reagent onboard time exceeded when the user tried to start the sample
preparation process. The run was aborted.
X6 SPI Error Working Master Mix with extract timed out after sample preparation has finished.
The run was aborted.
X7 SPI Error Error during processing of external control. Run results will be invalid.
X8 SPI Error Hardware or software error from the instrument. Processing of the sample was
aborted.

Message types
5 Test Result Export workflow
Figure 2 Test Result Export
After a test run the results are shown to the user and become available to be exported. Figure 2 shows this scenario.

Test Result Export workflow
6 ASTM Protocol
The cobas 4800 ASTM protocol also implements the ASTM E1381-91 Low Level Protocol, although this is not the focus of
this manual. No changes can be made at this level and because the system is implemented over a network communication,
it just acts as an intermediate level inside the application layer, transmitting the data to the upper ASTM layer.
The short description of the ASTM lower layer is here for information.
Message example with intermediate frame:
c4800 00:08:17,763 [ENQ]

HOST 00:08:17,763 [ACK]
c4800 00:08:17,883 [STX]1H|\^&|||MTS^c9507f52-37bc-43d4-bba6-360fb
74bd898ÔrderFileValidator^1.0.0.0918^1394.LIS2
|||||LIS|TSREQ^REAL|P|1|20091001085217|[CR][ETX
]80[CR][LF]
HOST 00:08:17,883 [ACK]
c4800 00:08:17,983 [STX]2P|1|[CR][ETX]BB[CR][LF]
HOST 00:08:17,983 [ACK]
c4800 00:08:18,103 [STX]3Q|1|^RDR0003406\RDR0003408\RDR0003407\RDR
0003405\RDR0003404\RDR0003403\RDR0003424\RDR000
3423\RDR0003422\RDR0003421\RDR0003420\RDR000341
9\RDR0003418\RDR0003417\RDR0003416\RDR0003415\R
DR0003414\RDR0003413\RDR0003412\RDR0003411\RDR0
003410\RDR0[ETB]5D[CR][LF]
HOST 00:08:18,113 [ACK]
c4800 00:08:18,203 [STX]4003409\RDR0000829\RDR0003494||^^^CT/NG^^F
ull|[CR][ETX]FB[CR][LF]
HOST 00:08:18,203 [ACK]
c4800 00:08:18,314 [STX]5L|1|[CR][ETX]BA[CR][LF]
HOST 00:08:18,314 [ACK]
c4800 00:08:18,414 [EOT]
Frame Configurations
For Middle Frame
<STX> FN text <ETB>

C1 C2 <CR><LF>
For Last Frame
<STX> FN text <ETX>

C1 C2 <CR><LF>
C1C2 represent the checksum characters.
Control character (characters enclosed in < >

<ENQ> is control character (HEX 05)
<STX> is control character (HEX 02)
<ETB> is control character (HEX 17)
<CR> is control character (HEX 0D)
<LF> is control character (HEX 0A)
<ETX> is control character (HEX 03)
<ACK> is control character (HEX 06)

ASTM Protocol
Maximum Length of the Frame
For one frame, maximum of 240 characters for text, 7 characters for frame control characters (not included in the 240).
Messages equal to or less than 240 characters are transmitted as one final frame.
Messages greater than 240 characters are split into frames that have character lengths that fall within the 240-character
limit.
The only or final remaining frame becomes the last frame and is indicated by <ETX>. All others are intermediate (middle)
frames and are indicated by <ETB>.
Results timeout:
Timeout for messages sent by the cobas 4800 system: From the ENQ, the transmission including multiple frames should
not exceed 120 seconds. Intermediate frames sent past this time will not be sent, the system will close the transmission with
an EOT,

ASTM Protocol
COBAS 4800 ASTM Record Definitions

Message Structure
The Message structures are defined in the syntax also used in [2 1 ]
Work order inquiry

H Record MESSAGE HEADER SEGMENT
P Record Patient Record (empty, needed by protocol)
Q Record Query information
L Record ASTM message closing record
Work order response

O Record Order information
: Following O records until end of message
:
Test result export

R Record Result information
R Record Result information
: Following O / R records until end of message
:

ASTM Protocol
cobas 4800 Field mappings

The tables in topic Inquiry records Mappings (ASTM) 20 are showing the mappings between the cobas 4800 xml file and
the xml file which the host interface needs to work with.
Inquiry records Mappings (ASTM)

H Segment
Table 14 ASTM Inquiry Message Header

Segment Type Comment Values Required
Name and
Number
H-1 String The character H identifies the record as a message H Yes
header record
H-2 String Component, Repetition, Escape and Subcomponent |^ \ & Yes
delimiter exactly in this order
H-5-1 String Name of the application which sent this message MTS Yes
H-5-2 GUID GUID representing the unique identifier of this 128-Bit-Integer Yes
message given from MTS by its xml-filename Min. Value = 0
Max. Value =
FFFFFFFF-FFFF-
FFFF-FFFF-
FFFFFFFFFFFF
H-5-3 String The name or shortcut of the user which create the Any string Yes
message
H-5-4 String The version of the sending software 0.9.4.0847 Yes
H-5-5 Number Protocol version used as a version check to make 1394.LIS2 Yes
sure that this message is interpreted correctly
H-10 String Name of the application which has to receive this LIS Yes
message
H-11-1 String Message type TSREQ (e.g Yes
used to delegate the tasks to the analyzer TSREQ^REAL)
H-11-2 String Event trigger REAL (e.g Yes
H-12 String Processing mode (processing priority) P Yes
P = Production
H-13 Number Version number currently a constant number set 1 Yes
to 1
H-14 DateTime DateTime of the message put by the creating system YYYYMMDDhhmm Yes
on creation of this message ss
e.g.
20081122121212

ASTM Protocol
P Segment
The MTS software doesnt have any patient informations but the ASTM protocol does need a P record.
Table 15 ASTM Inquiry Patient Information

Name and
Number
P-1 String The character P identifies the record as a patient P Yes
record
P-2 Number For the first patient transmitted, 1 shall be entered, 1 Yes
for the second, 2, ... until the last as defined
Q Segment
Table 16 ASTM Inquiry Request Information

Name and
Number
Q-1 String This field is coded as Q. Q Yes
Q-2 Number For the first patient transmitted, 1 shall be entered, 1 Yes
Q-3-2 String List of specimens separated by \ or 020404~789043 Yes
The Plate Id for AnD Only runs (AnD workflow not 2~098398 or
supported) AD0000034
Q-5-4 String Test type. Example CT/NG or HPV ^^^CT/NG Yes
^^Full
Q-5-6 Run type - Can only be Full ^^^CT/NG^^ Yes
(Not supported SpiOnly, AnDiOnly) Full
L Segment
ASTM Inquiry L Segment (Message Terminator)
Name and
Number
L-1 String This field is coded as L. L Yes
L-2 int The Terminator field 1 Yes

ASTM Protocol

H Segment
This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment.
Table 17 ASTM Response Message Header

Name and
Number
H-1 String The character H identifies the record as a H Yes
message header record
H-2 String Component, Repetition, Escape and |^ \ & Yes
Subcomponent delimiter exactly in this order
H-5-1 String Name of the application which sent this message LIS Yes
Max. Value = FFFFFFFF-
FFFF-FFFF-FFFF-
FFFFFFFFFFFF
H-5-3 String The name or shortcut of the user which create Any string Yes
the message
H-5-4 String The version of the sending software 6.2 Yes
H-5-5 Number Protocol version used as a version check to 1394.LIS2 Yes
make sure that this message is interpreted
correctly
H-10 String Name of the application which has to receive this MTS Yes
message
H-12 String Processing mode (processing priority) P Yes
P = Production
H-13 Number Version number currently a constant number 1 Yes
set to 1
H-14 DateTime DateTime of the message put by the creating YYYYMMDDhhmmss Yes
system on creation of this message e.g. 20081122121212

ASTM Protocol
P Segment
The cobas 4800 software does not have any patient information but the ASTM protocol does need a P record.
Table 18 ASTM Response Patient Information

Name and
Number
P-1 String The character P identifies the record as a patient P Yes
record
P-2 Number For the first patient transmitted, 1 shall be entered, 1 Yes
O Segment
This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment.
The test order segment is holding all information related to a sample.
Note: Missing orders. For samples that do not have a corresponding test request in the Host system, the whole O segment
record must be skipped.
Table 19 ASTM Response Test Order

Name and
Number
O-1 String The character assigned to the order record shall O Yes
be O
O-2 Number Set ID for each order which is transmitted a Continuous ID starting by 1 Yes
own number is set starting from 1 to n 1, 2, n
O-3-1 String Unique identifier of the sample usually a 0001301ÂD0000013Â6 Yes
barcode assigned to the sample (Specimen ID)
O-3-2 String Plate ID only for "AnD Only" runs (see 0001301ÂD0000013Â6 NO
Note 1)
O-3-3 String MWP Position only for "AnD Only" runs 0001301ÂD0000013Â6 NO
O-5-4 String Identifies the testtype of the sample ^^^CT/NG^NG^Full Yes
Known values are:
- CT/NG
- HPV
O-5-5 String Identifies the sub test type of a sample. Can be ^^^CT/NG^NG^Full YES
different for each sample but must be a sub type
of the TestType.
Values, see Table 9
O-5-6 String Identifies the runtype of the sample ^^^CT/NG^NG^Full Yes
Allowed values are:
- Full = Full run of all system components
- AnDiOnly = AmpDetect only. See Note 1
O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSS Yes
e.g. 20081203143400 (Note see
restriction
58 )
O-16 String Media Type. Allowed values, see Table 9 String ex: UT Yes
O-17 String Contents the user who has created the order admin Yes
Note 1: A&D mode not supported by LIMS workflow

ASTM Protocol
L Segment
ASTM response L Segment (Message Terminator)
Name and
Number

ASTM Protocol
Inquiry/response examples
outgoing - ASTM:
H|\^&|||MTS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394.
LIS2|||||LIS|TSREQ^REAL|P|1|20090403081313|
P|1|
Q|1|^15200049\15200059\15200043\15200073\15200013\15200071\15200041
\15200011\15200069\15200039\15200009\15200067\15200037\15200007\15200065
\15200035\15200005\15200093\15200063\15200033\15200003\15200091\15200061
\15200031\15200027||^^^CT/NG^^Full|
L|1|
incoming - ASTM:
H|\^&|||LIS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394.
LIS2|||||MTS|TSREQ^REAL|P|1|20090403083315|
P|1
O|1|15200049^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none
O|9|15200069^^||^^^CT/NG^CT^Full|||20090403083315||||||||UT|none
O|10|15200039^^||^^^CT/NG^NG^Full|||20090403083315||||||||UT|none
O|11|15200009^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UT|none
O|12|15200067^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UUT|none
O|13|15200037^^||^^^CT/NG^NG^Full|||20090403083315||||||||UUT|none
L|1
Note: When sample numbers are received that do not have a corresponding test request in the Host system, the whole
sample record must be skipped.
No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure.
Example: If the sample numbers 15200065 and 15200027 do not have a test for cobas 4800, the lines marked in bold in the
ASTM response from the Host would not exist.

ASTM Protocol
Results Mapping (ASTM)

H Segment
This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment.
Table 20 ASTM Response Message Header

Name and
Number
H-1 String The character H identifies the record as a H Yes
message header record
H-2 String Component, Repetition, Escape and |^ \ & Yes
Subcomponent delimiter exactly in this order
H-5-1 String Name of the application which sent this message LIS Yes
Max. Value = FFFFFFFF-
FFFF-FFFF-FFFF-
FFFFFFFFFFFF
H-5-3 String The name or shortcut of the user which create Any string Yes
the message
H-5-4 String The version of the sending software 6.2 Yes
H-5-5 Number Protocol version used as a version check to 1394.LIS2 Yes
make sure that this message is interpreted
correctly
H-10 String Name of the application which has to receive this MTS Yes
message
H-12 String Processing mode (processing priority) P = Production Yes
H-13 Number Version number currently a constant number 1 Yes
set to 1
H-14 DateTime DateTime of the message put by the creating YYYYMMDDhhmmss Yes
system on creation of this message e.g. 20081122121212

ASTM Protocol
P Segment
The cobas 4800 software does not have any patient information but the ASTM protocol does need a P record.
Table 21 ASTM Response Patient Information

Name and
Number
P-1 String The character P identifies the record as a patient record P Yes
P-2 Number For the first patient transmitted, 1 shall be entered, for 1 Yes
the second, 2, ... until the last as defined
O Segment
This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment.
The test order segment is holding all information related to a sample.
Table 22 ASTM Test Order

Name and
Number
O-1 String The character assigned to the order record shall be O O Yes
O-2 Number Set ID for each order which is transmitted a own Continuous ID starting by Yes
number is set starting from 1 to n 1
1, 2, n
O-3-1 String Unique identifier of the sample usually a barcode 0001301ÂD0000013Â6 Yes
assigned to the sample (Specimen ID)
O-3-2 String Plate ID only for AnD Only runs 0001301ÂD0000013Â6 NO
O-3-3 String MWP Position only for AnD Only runs 0001301ÂD0000013Â6 NO
O-4 String Run type of the test Full or AnD Only Yes
O-5-4 String Identifies the testtype of the sample ^^^CT/NG^NG^Full Yes
allowed values are:
- CTNG
- HPV
O-5-5 String Identifies the sub test type of a sample. Can be ^^^CT/NG^NG^Full YES
diffrent for each sampl but must be a sub type of the
TestType. See Table 9
O-5-6 String Identifies the runtype of the sample ^^^CT/NG^NG^Full Yes
Allowed values are:
- AnDiOnly = AmpDetect only
O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSS Yes
e.g. 20081203143400
O-16 String Media Type String ex: UT Yes
Allowed values see Table 9
O-17 String Contents the user who has created the order admin Yes
O-26 String Type of Results: F=Final Results; P=preliminary F or P Yes
results depends of the result export flag
ccepted.
F Means result was accepted
P Means result was not accepted (yet)

ASTM Protocol
.
R Segment
Note:
The Host system may have to further parse the result block if a further separation of individual subcomponents is required
. See the tables 11 for details and possible combinations inside result blocks.
Table 23 ASTM Result Record

Segment Type Comment Values Require
Name and d
Number
R-1 String The record type ID is coded as R. R Yes
R-2 Number Set ID for each order which is transmitted a own Continuous ID starting Yes
number is set starting from 1 to n by 1
1, 2, n
R-3-4 String Identifies the testtype of the sample ^^^CT/NG^NG^Full Yes
Known values are:
- CT/NG
- HPV
R-3-5 String Identifies the sub test type of a sample. Can be diffrent ^^^CT/NG^NG^Full YES
for each sampl but must be a sub type of the TestType Ex:
CT see table 9
R-3-6 String Identifies the runtype of the sample ^^^CT/NG^NG^Full Yes
Allowed values are:
R-4-1 String Application package defined test result e.g. Positive, see Positive^M1\M2 Yes
table 10 .
R-4-2 String Flags for the test result See example 30 Positive^M1\M2 Yes
R-4-3 String CT-Values of the controls CT_DYE1^NaN^ NO
CT_DYE5^NaN^
CT_DYE3^NaN^
CT_DYE0^NaN
R-11 String User who has run the test laboperator Yes
R-12 DateTime Time when the test was started on the instrument YYYYMMDDHHMMS Yes
S
e.g. 20081203143400
R-13 DateTime Time when the test was finished on the instrument YYYYMMDDHHMMS Yes
S
e.g. 20081203143400
L Segment

Name and
Number

ASTM Protocol
Results Example ASTM

(Simulator log)
outgoing - ASTM:
c4800 00:11:52,652 [ENQ]

HOST 00:11:52,652 [ACK]
c4800 00:11:52,762 [STX]1H|\^&|||MTSê5052475-cdb3-4c13-97d4-2bb43
467e75f^^1.0.0.0918^1394.LIS2|||||LIS|TSREQ^REA
L|P|1|20091001085550|[CR][ETX]FA[CR][LF]
HOST 00:11:52,782 [ACK]
c4800 00:11:52,872 [STX]2P|1|[CR][ETX]BB[CR][LF]
HOST 00:11:52,872 [ACK]
c4800 00:11:52,982 [STX]3O|1|0NCL010145A03DCÂD6002095^B1||CT/NG^F
ull|||20090825020548|||||||20090825143017|NegCt
rl||||||||||F|[CR][ETX]B0[CR][LF]
HOST 00:11:52,992 [ACK]
c4800 00:11:53,092 [STX]4R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\NaN\
CT_DYE5\34.949874877929688\CT_DYE1\NaN|||||||La
bmanager|20090825140628|20090825170656|[CR][ETX
]7F[CR][LF]
HOST 00:11:53,102 [ACK]
c4800 00:11:53,203 [STX]5O|2|1C1M014196A012RÂD6002095Â1||CT/NG^F
ull|||20090825020548|||||||20090825143017|PosCt
rl||||||||||F|[CR][ETX]B4[CR][LF]
HOST 00:11:53,213 [ACK]
c4800 00:11:53,313 [STX]6R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\36.5
50521850585938\CT_DYE5\35.303115844726562\CT_DY
E1\35.388565063476562|||||||Labmanager|20090825
140628|20090825170656|[CR][ETX]B4[CR][LF]
HOST 00:11:53,323 [ACK]
c4800 00:11:53,423 [STX]7O|3|RDR0003428ÂD6002095^H1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
||F|[CR][ETX]98[CR][LF]
HOST 00:11:53,433 [ACK]
c4800 00:11:53,533 [STX]0R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGPOS^||
|||||Labmanager|20090825140628|20090825170656|[
CR][ETX]B4[CR][LF]
HOST 00:11:53,543 [ACK]
c4800 00:11:53,643 [STX]1O|4|RDR0003430ÂD6002095^G1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
||F|[CR][ETX]8B[CR][LF]
HOST 00:11:53,653 [ACK]
c4800 00:11:53,753 [STX]2R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGPOS^||
|||||Labmanager|20090825140628|20090825170656|[
CR][ETX]B6[CR][LF]
HOST 00:11:53,753 [ACK]
c4800 00:11:53,854 [STX]3O|5|RDR0003432ÂD6002095^F1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
||F|[CR][ETX]8F[CR][LF]
HOST 00:11:53,864 [ACK]
c4800 00:11:53,964 [STX]4R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGPOS^|
||||||Labmanager|20090825140628|20090825170656|
[CR][ETX]C0[CR][LF]
HOST 00:11:53,974 [ACK]
c4800 00:11:54,074 [STX]5O|6|RDR0003433ÂD6002095Ê1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
HOST 00:11:54,084 [ACK]
c4800 00:11:54,184 [STX]6R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGNEG^|

ASTM Protocol
||||||Labmanager|20090825140628|20090825170656|
[CR][ETX]C2[CR][LF]
HOST 00:11:54,194 [ACK]
c4800 00:11:54,294 [STX]7O|7|RDR0003435ÂD6002095^C1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
HOST 00:11:54,304 [ACK]
c4800 00:11:54,404 [STX]0R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGNEG^
X2|||||||Labmanager|20090825140628|200908251706
56|[CR][ETX]4E[CR][LF]
HOST 00:11:54,414 [ACK]
c4800 00:11:54,515 [STX]1O|8|RDR0003436ÂD6002095^D1||CT/NG^Full||
|20090825020548|||||||20090825141222|UT||||||||
HOST 00:11:54,525 [ACK]
c4800 00:11:54,625 [STX]2R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGNEG^
|||||||Labmanager|20090825140628|20090825170656
|[CR][ETX]C6[CR][LF]
HOST 00:11:54,635 [ACK]
c4800 00:11:54,725 [STX]3L|1|[CR][ETX]B8[CR][LF]
HOST 00:11:54,735 [ACK]
c4800 00:11:54,835 [EOT]
Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings.
example |CTPOS,NGNEG^| should look in reality: |CT POS, NG NEG^|
The character used in the transmission is a regular space (Hex 20).
Example multiple flags (R segment only, simulator log)
outgoing - ASTM:
c4800 06:53:16,137 [STX]6R|1|^^^HPV^HPVHighRiskPanel+Genotypi

ng^Full|Failed^X3\X4\X1|||||||GT|20091211133042
|20091211153236|[CR][ETX]69[CR][LF]

ASTM Protocol
7 HL7 Protocol
Minimal Layer Protocol
The data framing uses the MLLP, Minimal Lower Layer Protocol defined in the HL7
standard.
HL7 messages are embedded in block delimited by special (non printable) characters.
<start_block>data<end_block><CR>
The values of the special characters are <VT> for the start block and <FS> for the end block. See table below.
<start_block> Start Block character (1 byte) ASCII <VT>
Data (variable number of bytes) The HL7 data is comprised of any displayable ASCII characters
and the carriage return character, <CR>.
<end_block> End Block character (1 byte) ASCII <FS>.

.
<CR> Carriage Return (1 byte)
Char (ASCII) Dcimal Octal Hex Name

VT 011 013 0B Vertical Tab
FS 028 034 1C File Separator
CR 013 015 0D Carriage Return
Graphical representation of data framing:
<VT> HL7 data <FS><CR>

HL7 Protocol
COBAS 4800 HL7 Record Definitions

The tables in the topic Inquiry Records mapping (HL7) 33 show the mappings between the cobas 4800 xml file and the
HL7 segment / records file which the host interface needs to work with.
Message Structure
The Message structures are defined in the syntax also used in [1] 1
Work order inquiry

MSH MESSAGE HEADER SEGMENT
QPD QUERY PARAMETER DEFINITION
RCP RESPONSE CONTROL PARAMETER SEGMENT
Work order response

{
ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR
{
OBR OBSERVATION REQUEST SEGMENT
}
}
Test result export

{
ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR + OBX
{
OBR OBSERVATION REQUEST SEGMENT
OBX OBSERVATION/RESULT SEGMENT
}
}

HL7 Protocol
Inquiry Records mapping (HL7)

Inquiry Mapping
MSH Segment (Message Header)
Table 24 HL7 Inquiry Message Header

Name and
Number
MSH-1 String Field delimiter | Yes
MSH-2 String Component, Repetition, Escape and Subcomponent ^~\& Yes
MSH-3 String Name of the application which sent this message MTS Yes
MSH-4 String The version of the sending software e.g. 1.3.5 Yes
MSH-5 String Name of the application which has to receive this message LIS Yes
MSH-7 DateTime DateTime of the message YYYYMMDDhh Yes
mmss
e.g.
20081122121212
MSH-9-1 String Message type code see HL7 Doc.: QBP (QBP^Q11) Yes
[1] Table 0076 - Message type
MSH-9-2 String Trigger event code see HL 7 Doc.: Q21 (QBP^Q11) Yes
[1] Table 0003 - Event type
MSH-10 GUID Message Id Generated by the Transformer Software 128-Bit-Integer Yes
Min. Value = 0
Max. Value =
FFFFFFFF-FFFF-
FFFF-FFFF-
FFFFFFFFFFFF
MSH-11 String Processing mode (processing priority) P = Production Yes
see HL7 Doc.:
[1] Table 0103 - Processing ID
MSH-12 Number HL7 Version ID used as a version check to make sure that 2.4 Yes
this message is interpreted correctly
see HL7 Doc.:
[1] Table 0104 Version ID
MSH-17 String Country ISO code used for currency-, datetime- and other [A-Z]{3} Yes
specifications. e.g. CHE =
[1] Table 0399 Country code Switzerland, USA
= United States
MSH-18 String Character char set used for the whole message - see HL7 UTF-8 Yes
Doc.:
[1] Table 0211 Alternate character sets
The COBAS 4800 project has decided to use the not
documented character set UTF-8

HL7 Protocol
QPD - Query Parameter Definition
Table 25 HL7 Inquiry Query Parameter Definition

Name and
Number
QPD-1 String This field contains the name of the query FullRunQuery or YES
AnDOnlyQuery
QPD-3 String Test Specification contains the Test Type and the Run CT/NG^FULL YES
Type (only "Full" supported)
QPD-4 String All Samples or the Plate ID of the MWP Plate AD0000012 or YES
0001~0002~000
3~0004
RCP - Response Control Parameter Segment
Table 9 HL7 Inquiry Response Control Parameter Segment

Name and
Number
RCP-1 String Query priority For cobas 4800 always I=Immediate I YES
RCP-3 String Response modality For cobas 4800 always R=Real Time R YES

HL7 Protocol

Table 26 HL7 Response Message Header

Name and
Number
MSH-2 String Component, Repetition, Escape and Subcomponent ^~\& Yes
MSH-3-1 String Name of the application which sent this message LIS Yes
MSH-4-1 String The version of the sending software 6.2 Yes
MSH-5-1 String Name of the application which has to receive this message MTS Yes
MSH-7 DateTime DateTime of the message YYYYMMDDhhm Yes
mss
e.g.
20081122121212
MSH-9-1 String Message type code see HL7 Doc.: OML (OMLÔ21) Yes
[1] Table 0076 - Message type
MSH-9-2 String Trigger event code see HL 7 Doc.: O21 (OMLÔ21) Yes
MSH-10 GUID Message Id Generated by the Transformer Software 128-Bit-Integer Yes
Min. Value = 0
Max. Value =
FFFFFFFF-FFFF-
FFFF-FFFF-
FFFFFFFFFFFF
see HL7 Doc.:
MSH-12 Number Version ID used as a version check to make sure that 2.4 Yes
this message is interpreted correctly
see HL7 Doc.:
The value is mapped from the current thread of the Switzerland, USA =
Transformer application United States
[1] Table 0399 Country code
MSH-18 String Character char set used for the whole message - see HL7 UTF-8 Yes
Doc.:
The cobas 4800 project has decided to use the not
documented character set UTF-8

HL7 Protocol
ORC Segment (Common Order)
Table 11 HL7 Response Common Order

Name and
Number
ORC-1 Number Set ID for each order which is transmitted a own Continuous ID Yes
number is set starting from 1 to n starting by 1
1, 2, n
ORC-7-4 DateTime This field contains the creation time of the order out of 20081202154500 YES
the cobas 4800 order file
ORC-10 String This field contains the identity of the user who actually e.g ADMIN YES
created the order out of the cobas 4800 order file.
OBR Segment (Observation Request)

This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message version 2.4
observation request segment.
The observation request segment is holding all information related to a sample.
Table 12 HL7 Response Observation Request

Name d
OBR-1 Number Set ID for each order which is transmitted a Continuous ID starting by Yes
own number is set starting from 1 to n 1
1, 2, n
OBR-3-1 String Unique identifier of the sample usually a 0001301 YES
barcode assigned to the sample ÂD0000013Â6
OBR-3-2 String Plate ID only for A&D Only runs. 0001301ÂD0000013 NO
See Note 1 Â6
OBR-3-3 String MWP Position only for A&D Only runs 0001301ÂD0000013^ NO
A6
OBR-4-1 String Identifies the testtype of the sample CT/NG^NG^Full Yes
Known values are:
CTNG - HPV
OBR-4-2 String The sub test type of a sample. Values, see CT/NG^NG^Full YES
Table 9
OBR-4-3 String Identifies the runtype of the sample CT/NG^NG^Full Yes
Allowed values are: See Note 1
- SpiOnly = Sample Extraction only
OBR-15 String Media Type String ex: UT Yes
Allowed values : see Table 9
OBR-27 XML Xml DateTime of the message put by the YYYYMMDDhhmmss Yes
DateTime creating system on creation of this message e.g. 20081122121212
Note 1 : Only "Full" is supported by the HIF workflow.
Note 2 : Missing orders For samples that do not have a corresponding test request in the Host system, the whole ORC +
OBR segment records pair must be skipped.

HL7 Protocol
Results Mapping (HL7)

Table 13 HL7 Result Message Header
Segment Type Comment Values Requir
Name and ed
Number
MSH-2 String Component, Repetition, Escape and Subcomponent delimiter ^ ~ \ & Yes
exactly in this order
MSH-3-1 String Name of the application which sent this message MTS Yes
MSH-4-1 String The version of the sending software 0.9.4.847 Yes
MSH-5-1 String Name of the application which has to receive this message LIS Yes
MSH-7 DateTime DateTime of the message YYYYMMDDhh Yes
mmss
e.g.
20081122121212
MSH-9-1 String Message type code see HL7 Doc.: ORU Yes
[1] Table 0076 - Message type (ORUÔ21)
MSH-9-2 String Trigger event code see HL 7 Doc.: O21 (ORUÔ21) Yes
MSH-10 GUID Message Id Generated by the Transformer Software TBD Yes
see HL7 Doc.:
MSH-12 Number Version ID used as a version check to make sure that this 2.4 Yes
message is interpreted correctly
see HL7 Doc.:
[1] Table 0399 Country code Switzerland, USA
= United States
MSH-18 String Character char set used for the whole message - see HL7 Doc.: UTF-8 Yes
The cobas 4800 project has decided to use the not documented
character set UTF-8
ORC Segment (Common Order)

Table 14 HL7 Result Common Order
Segment Type Comment Values Requir
Name and ed
Number
ORC-1 Number Set ID for each order which is transmitted a own number is Continuous ID Yes
set starting from 1 to n starting by 1
1, 2, n
ORC-7-4 DateTime This field contains the creation time of the order out of the 20081202154500 YES
cobas 4800 order file
ORC-10 String This field contains the identity of the user who actually created e.g ADMIN YES
the order out of the cobas 4800 order file.

HL7 Protocol
OBR - Segment (Observation Request)
This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message observation
request segment.
The observation request segment is holding all information related to a sample.
Table 15 HL7 Result Observation Request

Name and d
Number
OBR-1 Number Set ID for each order which is transmitted a own Continuous ID Yes
1, 2, n
OBR-3-1 String Unique identifier of the sample usually a barcode 0001301ÂD000001 YES
assigned to the sample 3Â6
OBR-3-2 String Plate ID only for AnD Only runs 0001301ÂD000001 NO
3Â6
OBR-3-3 String MWP Position only for AnD Only runs 0001301ÂD000001 NO
3Â6
OBR-4-1 String Identifies the testtype of the sample CT/NG^NG^FULL YES
Known values are:
CT/NG - HPV
OBR-4-2 String The sub test type of a sample CT/NG^NG^FULL YES
See possible value table 9 :
OBR-4-3 String The run type of the test CT/NG^NG^FULL YES
OBR-7 DateTime Time the test was started on the instrument YYYYMMDDhhmms YES
s
e.g. 20081122121212
OBR-8 DateTime Time the test was finished on the instrument YYYYMMDDhhmms YES
s
e.g. 20081122121212
OBR-15 String Allowed values are: UUT YES
See table 9
OBR-27 DateTime Time when the order was created YYYYMMDDhhmms YES
s
e.g. 20081122121212

HL7 Protocol
OBX - Segment (Observation / Result Segment)
Note:
The Host system may have to further parse the result block if a further separation of individual subcomponents is required
. See the tables 11 for details and possible combinations inside result blocks.
Table 16 HL7 Result Observation / Result Segment

Name and d
Number
OBX-1 String Set ID for each order which is transmitted a own Continuous ID Yes
1, 2, n
OBX-2 String This field contains the format of the observation ST YES
value in OBX For the cobas 4800 the format is ST
= String Data
OBX-3-1 String Unique identifier of the sample usually a barcode 0001301ÂD000001 YES
assigned to the sample 3Â6
OBX-3-2 String Plate ID only for AnD Only runs 0001301ÂD000001 NO
3Â6
OBX-3-3 String MWP Position only for AnD Only runs 0001301ÂD000001 NO
3Â6
OBX-5-1 String Application package defined test result e.g. Postive, Positive^M1~M2 YES
Failed, See table 10
OBX-5-2 String Flags for the test result Positive^M1~M2 YES
OBX-5-3 String CT-Values of the controls CT_DYE1^NaN^ NO
CT_DYE5^NaN^
CT_DYE3^NaN^
CT_DYE0^NaN
OBX-11 String Accepted Flag possible values are: Final results = F F or P YES
or Final results = P it depends on the accepted
flags from the cobas 4800 result export file
F Means result was accepted
P Means result was not accepted (yet)
OBX-16 String User of the instrument who run the test laboperator YES

HL7 Protocol
Result Example HL7

HL7 Result Export (Simulator log)
c4800 10:14:27,257 [VT]
c4800 10:14:27,257 MSH|^~\&|MTS|1.0.0.0918|LIS||20090918101319||OR
UÔ21|9a7b5dab-8049-4ba8-83b7-6e8aefcbbed1|P|2.
5.1|||||CHE|UTF-8|[CR]
c4800 10:14:27,257 ORC|1||||||^^^20090826114803||||[CR]
c4800 10:14:27,257 OBR|1||0NCL010145A037YÂD6002084^B1|HPV^N/A^Ful
l|||20090826120921|20090826154328|||||||NegCtrl
||||||||||||20090826114803|[CR]
c4800 10:14:27,257 OBX|1|ST|0NCL010145A037YÂD6002084^B1||Valid^^C
T_DYE3~NaN~CT_DYE5~NaN~CT_DYE1~NaN~CT_DYE0~NaN|
|||||P|||||Labmanager|[CR]
c4800 10:14:27,273 ORC|2||||||^^^20090826114803||||[CR]
c4800 10:14:27,273 OBR|2||R0000814ÂD6002084^G1|HPV^HPVHighRisk
Panel+Genotyping^Full|||20090826120921|200908
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,273 OBX|2|ST|R0000814ÂD6002084^G1||OtherHRHPVNE
G,HPV16POS,HPV18NEG^||||||P|||||Labmanager|
[CR]
c4800 10:14:27,288 ORC|3||||||^^^20090826114803||||[CR]
c4800 10:14:27,288 OBR|3||R0000815ÂD6002084^F1|HPV^HPVHighRisk
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,288 OBX|3|ST|R0000815ÂD6002084^F1||OtherHRHPVNE
G,HPV16NEG,HPV18POS^||||||P|||||Labmanager|
[CR]
c4800 10:14:27,288 ORC|4||||||^^^20090826114803||||[CR]
c4800 10:14:27,304 OBR|4||R0000816ÂD6002084^D1|HPV^HPVHighRisk
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,304 OBX|4|ST|R0000816ÂD6002084^D1||OtherHRHPVPO
S,HPV16NEG,HPV18NEG^||||||P|||||Labmanager|
[CR]
c4800 10:14:27,304 ORC|5||||||^^^20090826114803||||[CR]
c4800 10:14:27,304 OBR|5||R0000817ÂD6002084Ê1|HPV^HPVHighRisk
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,320 OBX|5|ST|R0000817ÂD6002084Ê1||OtherHRHPVPO
S,HPV16POS,HPV18NEG^||||||P|||||Labmanager|
[CR]
c4800 10:14:27,320 ORC|6||||||^^^20090826114803||||[CR]
c4800 10:14:27,320 OBR|6||R0000819ÂD6002084^C1|HPV^HPVHighRisk
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,335 OBX|6|ST|R0000819ÂD6002084^C1||OtherHRHPVPO
S,HPV16POS,HPV18POS^||||||P|||||Labmanager|
[CR]
c4800 10:14:27,335 ORC|7||||||^^^20090826114803||||[CR]
c4800 10:14:27,335 OBR|7||R0000818ÂD6002084^H1|HPV^HPVHighRisk

HL7 Protocol
26154328|||||||PC||||||||||||20090826114803|[CR
]
c4800 10:14:27,335 OBX|7|ST|R0000818ÂD6002084^H1||OtherHRHPVIn
valid,HPV16Invalid,HPV18POS^||||||P|||||Lab
manager|[CR]
c4800 10:14:27,351 ORC|8||||||^^^20090826114803||||[CR]
c4800 10:14:27,351 OBR|8||2H1M015776A02IGÂD6002084Â1|HPV^N/A^Ful
l|||20090826120921|20090826154328|||||||PosCtrl
||||||||||||20090826114803|[CR]
c4800 10:14:27,351 OBX|8|ST|2H1M015776A02IGÂD6002084Â1||Valid^^C
T_DYE3~37.381362915039062~CT_DYE5~35.7265472412
10938~CT_DYE1~36.203384399414062~CT_DYE0~35.940
170288085938||||||
Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings.
example OtherHRHPVPOS should look in reality: Other HR HPV POS
The character used in the transmission is a regular space (Hex 20).
Example multiple flags (OBX segment only, simulator log)
outgoing - HL7:
c4800 08:05:32,833 OBX|79|ST|A2482185ÂD6201793^D3||Failed^X3~X4~X1||

||||F|||||GT|[CR]

HL7 Protocol
8 Communication setup
Network connection
The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol.
The network address of the instrument is normally determined by the installation of a cobas IT firewall.
To change the network address, you must log into the operating system as local Administrator.
Please ask the Roche service representative.
Instrument Setup
By default the HIF modules are not installed, for the instrument setup, please refer to the Network Configuration Guide
cobas 4800 system.
This installation has to be performed by qualified Roche service personnel.
Once the software for host interface has been installed, some parameters can be changed to match the requirements of the
LIS system.
The default protocol after installation is HL7. To change to ASTM, or back to HL7, change the target IP (LIS system) or the
port, see the the Network Configuration Guide cobas 4800 system.

Communication setup
9 Simulator
Installing simulators
Roche has developed specific host simulators to make simple testing of the ASTM or HL7 protocol, for the cobas 4800
Instrument.
This software can be installed on Windows computers and are intended to be used only by Roche trained personnel.
When used as an instrument simulator, the goal is to provide only a quick test tool for testing the transmission formats.
Please keep in mind that the simulator does not react like a real instruments in all situations.
The simulator is intended to be used for several Roche instruments, periodically new ones will
be added.
From version 2.0 on, all the host interface tools come together in a common installation package.
They will be installed by default under Host Interface tools.
Requirements
The Roche ASTM/HL7 simulators can be installed on Windows XP computers.
The user needs administrator rights to be able to install the host tools package properly.
After the basic installation of the "Host tools" package, some patches may be required depending on the simulator you
intend to use.
Please ask the Roche service representative for further information.
Software requirement:
Windows XP professional SP2, with current patches.
Access to network settings
Recommended hardware:
Any computer able to run Windows XP professional.
Network card
HL7 Simulator
Roche has developed a specific host simulator to make simple testing of the HL7 protocol, for
the cobas 4800 Instrument.
To start the simulator, simply select from the stat menu as shown.

Simulator
You must accept the disclaimer to be able to start the program.

Simulator

Simulator
Setting up the simulator connection

Some parameters must be setup before the cobas 4800 system is able to communicate with the simulator.
The simulator must be set up as a server. That is, it will listen on a defined port. Port 5555 is often used as a default.
The server IP address is the address of the network card and cannot be changed for a server.
It comes from the network settings of the computer hosting the simulator.
This is the same as the LIS address that must be set on the cobas 4800 when installing or setting up the Host. See
Instrument setup 42

Simulator
Select the Instrument "cobas 4800" from the drop down list and "Host" as shown. This has the effect of enabling the
correct responses from the simulator to the selected type of instrument.
Note: The simulator can also simulate a cobas 4800 system, but this mode goes beyond the scope of this manual

Simulator
Once parameters are setup correctly the simulator will start listening on the defined port. Once every minute, the cobas
4800 communication server will attempt a connection on the defined IP address and port.
If the simulator is reached, the connection indicator will turn from yellow to green as shown.
Additionally, the IP address of the connected system will appear in the lower part of the blue box (Remote).
At this point the simulator can be used and will display the HL7 records received and sent.

Simulator
Connection test
When the simulator is connected, the connection test gives a possibility to check the responsiveness of the client.
In some circumstances, the simulator may erroneously indicate an active connection.

This can be the case if there are elements in the network that where temporarily disconnected.
If the LIS seems unresponsive although the connection is displayed as active, make the connection check.
In case of test failure, close the simulator and restart it. If the connection is not re-established within two minutes,
shutdown the cobas 4800 system and restart it.

Simulator
Sending an order to the system

Actually, you cannot "send" an order, as the instrument is always master.
The simulator is able to reply to an order request. For this it must have certain information in its
database. You can edit this database manually to prepare a correct answer to instrument queries.
Simulator Database:
The simulator has a small database where basic records can be stored. The simulator will use its
database records to respond to the instrument requests.
If the instrument sends a request related to a certain Sample ID, the simulator will search its
database for a matching record.
If one is found, the simulator will attempt to generate an order upload, using the information
stored in the simulator database record.
To open the database on the simulator:
Then in the DB, select the table as shown.

Simulator
You can generate new records, either blank ones:
Or duplicate existing ones and editing them:

Simulator
Editing the duplicate record:

Simulator
There are further fields on the right that can be edited: (Use lower slide bar to view them).
Note: Be aware that the simulator does not perform any check on the type of data. Verify with the
protocol definitions that you enter valid data. For example, if you type a number where another
type is required, an error will probably be generated at the instrument level and the order rejected.
(see also restrictions 58 )

Simulator
Receiving results from the system.

Once the LIS systems have been installed by a Roche engineer, the system must be configured to work with LIS:
To configure cobas 4800 software for LIS communication, the user must first open cobas 4800 software and log in with
username FSE. Only a user with administrator rights to the application can switch the LIS on.
Go to 1)utilities tab, select 2) configuration tab, select 3) System Settings and 4) enable the checkbox LIS present.
Exit cobas 4800 software.
TO be able to transmit results, once the LIS has been activated, it is necessary to log in as
1. Open the cobas 4800 Software

2. Login with user name FSE
Go to 1) result tab, select 2) performed run, select 3) sample, click 4) Export
All results present in the page will be transmitted, even if only one is selected.

Simulator
Results received by the simulator will be stored in the database as shown below.

Simulator

Simulator
ASTM Simulator
Roche has developed a specific host simulator to make simple testing of the ASTM protocol, for
the cobas 4800 Instrument.
This software can be used on Windows XP computers and can be delivered upon request.
Contact your Roche Diagnostics representative.
The simulator is intended to be used for several Roche instruments, periodically new ones will
be added.
Requirements
The Roche ASTM simulator can be installed on Windows XP computers and is part of the complete host tools package.
refer to the previous topic HL7 simulator, the ASTM simulator works in a very similar way and shares the loacl simulator
database with the HL7 simulator.
The user needs administrator rights to be able to install the host tools package properly.
Software requirement:
Windows XP professional SP2, with current patches.
Access to network settings
Recommended hardware:
Any computer able to run Windows XP professional.
Network card
Setting up and operating the ASTM simulator

To setup and operate the ASTM simulator as a host, read the HL7 simulator sections 43 .
The ASTM simulator operates in a very similar way and shares the simulator datatabase for cobas 4800.

Simulator
10 Troubleshooting / logfiles
Troubleshoting:
Most errors in the incoming communications i.e. a missing parameter in a filed, will result in a timeout message on the
instrument.
Errors generated by the conversion from incoming HTML or ASTM are not passed to the application, the Transformer
program will only pass XML files if the parsing or the different fields succeeds. If any error occur it will just stop parsing
the information and do nothing, therefore if the application is awaiting an answer, it will just timeout. To find the source
of the problem, see the logfiles section.
If the cobas 4800 system has an active connection to the host system but fails to request order information after loading
sample racks, one possible cause is the "operator" is not logged into the operating system of the cobas 4800 control unit.
If an administrator is logged into the windows operating system, the LIS service will connect to the ASTM or HL7 server
but the system will not be able to communicate.
Corrective action: log off the administrator user in Windows, the system will automatically re-log as "operator"
Logfiles:
In the directory c:\data\log, the trafic for the selected protocol is logged:
Hl7_trace.log for the Hl7 data exchange.

astm_trace.log for the astm data exchange.
The transformation activity of the transformer program .xml <=> active protocol is logged in the file cserver.log
cserver logfiles are collections of incremental files like cserver.log.1, cserver.log.2 .......
As soon as the cserver.log reaches a size of 1025 kB, a number is appended to the extension and a new cserver.log is
created.
In the directory C:programm files\Roche diagnosticsAG\cobas_4800_v1.0.0.0918\bin\log\

the file MTS-Transformer-session-trace-file.log contains the parsing activity for the active protocol.
To find the captured errors, open the file with the windows notepad program and make a search fro "ERROR".
You may find some limited indications about protocol errors. (e.g an incorrect type or missing mandatory parameter).
11 Known restrictions
Workflow:
Only the Full run is supported by LIS. The "A&D" and "Sample extraction only" modes are not supported by the LIS
system.
The timeout after an order request from the instrument is currently set at 30 seconds and cannot be changed.
Because of this relatively short time out, it is recommended to use only direct network connections between the LIS and
the cobas 4800 system. Avoid any bottlenecks, i.e. converters to RS232 serial line. Order processing on the LIS should be
optimized to avois a timeout when loading the maximum samples.
Troubleshooting errors:
In case of protocol errors (i.e. the LIS sending an incorrect data type or unexpected values), the instrument will report
LIS system does not answer (timeout) in most cases.
This can be misleading, however some information might be available in the logfiles. See Troubleshooting 58
ASTM:

Known restrictions
O segment in order response:
Field O-8 if left blank will not create a failure, although this is documented as required field.
HL7:
No Known problem

Keywords index
-A-
A&D 3, 8, 13
A&D Only 6
active connection 49
AnD 3
ASCII 31
ASTM simulator 57
-C-
Calculation 13
checksum 17
Client /Server structure 4
cobas x 480 3
cobas z 480 3
Control character 17
-D-
data framing 31
-E-
empty orders 6
error 13, 50
errors 58
-F-
FLAGS 13
Frame
final frame 17
intermediate frame 17
Length of the Frame 17
Middle Frame 17
Full 6
Full run 3, 8
-G-
GUID 3, 20, 22, 26, 33, 35
-H-
host simulator 43
-I-
inquiry timeout 6
installation Manual 42
-L-
layer 5
Logfiles 58
-M-
Media Type 8
Message Terminator 24
Micro Well Plate 3
Minimal Layer
Minimal Layer Protocol 31
Missing orders 6, 23, 35
MLLP 31
MTS 3
MWP 3
MWP plate 6
-N-
Network Configuration Guide 42
-O-
order request 50
OSI model 5
-P-
patient information 23, 27
physical connection 4
-R-
requirement 43
Requirements 43
reserveCyt 8
Results timeout 17
run 8
Run Type 6, 8
-S-
server 6, 46
server IP address 46
simulator 43, 57
Database 50
Simulator database 50
Simulator Database 50
special characters
FS 31
VT 31
SPI 13
SubTestType 8
SurePath 8
-T-
TCP/IP client 4
TCP/IP server 4
Test Type 6, 8
timeout 6, 58
Timeout (Results) 17
Transformer 4
transmit results 54
-U-
UniTrans 8
Urine UniTrans 8
-W-
Warning 13
Work Order 6
Work order inquiry timeout 6
Workflow 58
Personal notes:
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
2009 Roche Diagnostics Ltd. Switzerland
19-Mar-10

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cobas 4800 system

Result export .................................................................................... 8

Test Result Export workflow 16

Roche Diagnostics DRAFT March 2010

Result Example HL7

Roche Diagnostics DRAFT March 2010

Roche Diagnostics DRAFT March 2010

Document Version Revision Date

1.0 January 2009

1.02 Manual rev 02 March 2010

Copyright 2009, 2010, Roche Diagnostics Ltd. All rights reserved.

Rev 02: Corrected some errors and omissions.

This manual applies to Software Version 1.02

These are internal Roche references

Roche Diagnostics DRAFT March 2010

Distribution Roche Diagnostics GmbH

Distribution in the US Roche Diagnostics

Roche Diagnostics Ltd.

Other brands or product names are trademarks of their respective holders.

Roche Diagnostics DRAFT March 2010

Roche Diagnostics DRAFT March 2010

The connection is TPC/IP over ethernet.

The cobas 4800 system offers two transmission protocols: -ASTM

Client /Server structure

Roche Diagnostics DRAFT March 2010

Roche Diagnostics DRAFT March 2010

Table 1 Communications Scenarios

Work Order Inquiry

Figure 1 Work Order Inquiry

The Work Order Inquiry Scenario is described In Figure 1.

Roche Diagnostics DRAFT March 2010

The sample positions are indicated in (2)

Possible correcting actions :

Work order inquiry timeout:

Roche Diagnostics DRAFT March 2010

The LIS has to be enabled to be able to export the results.

Full Run Inquiry

cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Full Order Response

cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Roche Diagnostics DRAFT March 2010

Table 4 Possible values SubTestType (order response)

Type Possible values for subtype field (order response)

Table 5 * Possible values media

Type Test subtype Possible value Media names

Roche Diagnostics DRAFT March 2010

Test Result Export

Test Result Example HL7 ASTM

See Test results combination 11 tables

Test result Possible values (Samples)

Test result Possible values (Controls)

Roche Diagnostics DRAFT March 2010

Test results combination tables :

cobas 4800 CT/NG Test Result Report and Interpretation

CT NEG, NG NEG CT Negative*, NG Negative*. Neither CT nor NG DNA, if present,

CT POS, NG NEG CT Positive, NG Negative*. Specimen is positive for the presence of CT

CT POS, NG Invalid CT Positive, NG Invalid.

CT NEG, NG POS CT Negative*, NG Positive. CT DNA, if present, could not be detected.

CT Invalid, NG POS CT result is Invalid. Original specimen should be re-tested to obtain

CT Invalid, NG NEG CT Invalid, NG Negative*. CT result is Invalid. Original specimen

CT NEG, NG Invalid CT Negative*, NG Invalid. CT DNA, if present, could not be detected.

Invalid CT Invalid, NG Invalid. Both CT and NG results are Invalid. Original

CT NEG, NG NEG CT Negative, NG Negative. Neither CT nor NG DNA, if present,