Sysmex CA-1500 System Reference Guide 3.05 DXDCM 0900ac6d8005f093-1421696006187

®
Sysmex CA-1500 System
Reference Guide 3.05
Not for use in the USA
This document is Siemens Healthcare Diagnostics Reference Guide

version number 3.05 for Sysmex® CA-1500 System. From January 2015,
this document is the only relevant source for assay application
information on the Sysmex® CA-1500 System.
The Reference Guide contains a complete list of all assays evaluated and
released by Siemens. Information in this document supersedes
information in earlier versions of the Reference Guide or Application
Sheets.
Document ID: RG-32-01-3.05

Sysmex® CA-1500 System
Trademarks
Actin, BCS, BCT, Berichrom, Ci-Trol, Dade, Data-Fi, INNOVANCE, Innovin, Multifibren, Pathromtin,
ProC, Thromboclotin and Thromborel are trademarks of Siemens Healthcare Diagnostics.
** STA is a trademark of Diagnostica Stago.
SYSMEX is a trademark of SYSMEX CORPORATION.
Note
Siemens Healthcare Diagnostics has validated the provided instructions, reagents, instruments, software and
customizable features for this system to optimize product performance and meet product specifications. User
defined modifications are not supported by Siemens as they may affect performance of the system and test
results. It is the responsibility of the user to validate any modifications made to these instructions, instruments,
reagents or software provided by Siemens.
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
Reference Guide 3.05 - not for use in the USA - 2

Revision History
Document Date Changes
Reference Guide 2015-01 New Application Sheets
3.05 None
Deleted Application Sheet

D-Dimer with D-Dimer PLUS; D-Dimer with Advanced D-Dimer
Revised Application Sheets

General changes
Application Sheets not listed below may contain sections highlighted in blue which
indicate editorial corrections without changes to content. These corrections may
lead to a higher version of concerned Application Sheets.
Newly symbols for the reagents and controls (in accordance with IFU) used.
Implementation of an Appendix II “Symbol names of required Materials”.
Changes in detail
Free Protein S with INNOVANCE® Free PS Ag
On-board Stability: Additional Notes
Previous Reference - See respective Reference Guide
Guide Versions


Table of Contents
Normal printed version number: Current version of the Application Sheet, no changes to the previous
Reference Guide
Bold version number: New Application Sheet version in this Reference Guide
Version Application Sheet Page

PT
®
11 PT seconds with Thromborel S ............................................................................................................................7
®
14 PT % with Thromborel S.....................................................................................................................................10
®
11 PT INR with Thromborel S..................................................................................................................................13
13 PT INR calibrated with Thromborel® S .................................................................................................................16
®
12 Derived Fibrinogen with Thromborel S ...............................................................................................................19
® ®
12 PT seconds with Dade Innovin .........................................................................................................................22
® ®
14 PT % with Dade Innovin ...................................................................................................................................25
12 PT INR with Dade Innovin® ................................................................................................................................28
®
® ®
11 PT INR calibrated with Dade Innovin ................................................................................................................31
12 Derived Fibrinogen with Dade® Innovin® ..............................................................................................................34
APTT
12 APTT with Dade® Actin® Activated Cephaloplastin Reagent ................................................................................37
® ®
12 APTT with Dade Actin FS Activated PTT Reagent ...........................................................................................40
14 APTT with Dade® Actin® FSL Activated PTT Reagent .........................................................................................43
®
13 APTT with Pathromtin SL ...................................................................................................................................46
Fibrinogen
®
14 Fibrinogen with Multifibren U ..............................................................................................................................49
14 Fibrinogen with Dade® Thrombin Reagent ...........................................................................................................53
Thrombin Time / Batroxobin Time

13 Thrombin Time with Test Thrombin Reagent .......................................................................................................57
11 Thrombin Time with Thromboclotin® ....................................................................................................................60
11 Batroxobin Time with Batroxobin Reagent ...........................................................................................................63
Clotting Assays
®
12 Coagulation Factor II with Thromborel S ............................................................................................................66
10 Coagulation Factor II with Dade® Innovin® ...........................................................................................................69
®
10 Coagulation Factor V with Thromborel S ...........................................................................................................72
10 Coagulation Factor V with Dade Innovin® ...........................................................................................................75
®
®
10 Coagulation Factor VII with Thromborel S ..........................................................................................................78
10 Coagulation Factor VII with Dade Innovin® .........................................................................................................81
®
®
10 Coagulation Factor X with Thromborel S ............................................................................................................84
10 Coagulation Factor X with Dade Innovin® ...........................................................................................................87
®
® ®
11 Coagulation Factor VIII with Dade Actin Activated Cephaloplastin Reagent.....................................................90
11 Coagulation Factor VIII with Dade Actin® FS Activated PTT Reagent ................................................................93
®
® ®
11 Coagulation Factor VIII with Dade Actin FSL Activated PTT Reagent ..............................................................96
12 Coagulation Factor VIII with Pathromtin® SL .......................................................................................................99
® ®
11 Coagulation Factor IX with Dade Actin Activated Cephaloplastin Reagent.....................................................102
11 Coagulation Factor IX with Dade Actin® FS Activated PTT Reagent ................................................................105
®
® ®
11 Coagulation Factor IX with Dade Actin FSL Activated PTT Reagent ..............................................................108

® ®
11 Coagulation Factor XI with Dade Actin Activated Cephaloplastin Reagent.....................................................111
® ®
11 Coagulation Factor XI with Dade Actin FS Activated PTT Reagent ................................................................114
® ®
09 Coagulation Factor XI with Dade Actin FSL Activated PTT Reagent ..............................................................117
®
12 Coagulation Factor XI with Pathromtin SL .......................................................................................................120
® ®
12 Coagulation Factor XII with Dade Actin Activated Cephaloplastin Reagent....................................................123
11 Coagulation Factor XII with Dade Actin® FS Activated PTT Reagent ...............................................................126
®
® ®
10 Coagulation Factor XII with Dade Actin FSL Activated PTT Reagent .............................................................129
13 Coagulation Factor XII with Pathromtin® SL .......................................................................................................132
12 Lupus Anticoagulant with LA 1 Screening Reagent / LA 2 Confirmation Reagent..............................................135
13 Protein C System with ProC® Global ..................................................................................................................139
®
12 Factor V Leiden with ProC Global / Factor V Deficient Plasma ........................................................................143
15 Factor V Leiden with Factor V Leiden Assay ......................................................................................................147
®
11 APC Resistance with ProC Ac R ......................................................................................................................151
13 Protein C with Protein C Reagent ......................................................................................................................155
11 Protein S with Protein S Ac ................................................................................................................................158
Chromogenic Assays
05 Antithrombin with INNOVANCE® Antithrombin ...................................................................................................161
®
13 Antithrombin III with Berichrom Antithrombin III (A) ..........................................................................................164
®
12 Heparin with Berichrom Heparin .......................................................................................................................167
®
06 Heparin (LMW) with Berichrom Heparin ...........................................................................................................170
®
06 Heparin (UF) with Berichrom Heparin...............................................................................................................173
®
14 Protein C with Berichrom Protein C ..................................................................................................................176
®
13 α2-Antiplasmin with Berichrom α2-Antiplasmin ..................................................................................................179
®
12 Plasminogen with Berichrom Plasminogen.......................................................................................................182
14 Coagulation Factor VIII with Factor VIII Chromogenic Assay .............................................................................185
Immunoassays
10 D-Dimer with INNOVANCE® D-Dimer ................................................................................................................188
®
03 Free Protein S with INNOVANCE Free PS Ag .................................................................................................193
12 von Willebrand Factor with vWF Ag ...................................................................................................................196
Others
03 von Willebrand Factor with INNOVANCE® VWF Ac ...........................................................................................201
Appendix I
®
Information on CA CLEAN I, CA CLEAN II and Dade CA System Buffer .........................................................206
Appendix II
Symbol names of required Materials ..................................................................................................................207

®
Application Sheet for Page 1 of 3
PT seconds with
®
Thromborel S
For additional information, limitations and interferences please refer to
the Instructions for Use of the analyzer and check current Instructions
for Use for reagents, controls and calibrators and tables of assigned/
analytical values.
The parameters defined in this application sheet have been developed by Siemens Healthcare Diagnostics to provide optimal product
performance with the assay and instrument combination. Any modification to these parameters may affect performance of this and other
assays in use on your system and the resulting assay values. It is the responsibility of the user to validate any modifications and their impact
on all assay results. Results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation
and other findings.
The application sheet lists all combinations of controls and calibrators for use with the reagent and instrument system; other combinations
are not validated or supported by Siemens.
Materials Required
Material REF Size On-board position
®
Thromborel S B1 - B10 or C1 - C10
OUHP 4/10 mL B1 - B10 or C1 - C10
Ci-Trol CONTROL 1 B4244-10 1 mL D1 - D14 or any position on sample rack
Ci-Trol CONTROL 2 B4244-20 1 mL
Dade® Ci-Trol® 1 291070 1 mL
® ®
Dade Ci-Trol 2 291071 1 mL
® ®
CONTROL N ORKE 1 mL
BC Vial Kit — OVKE 5 / 15 mL —
Additional Notes
-/-
On-board Stability
Material Name in Test Protocol Time [h]
®
Thromborel S PT THS 24
® ®
Ci-Trol CONTROL 1/ Dade Ci-Trol 1 8
® ®
® ®
CONTROL N 8
The stability data presented here were established under controlled laboratory conditions. Due to differences in laboratory environmental
conditions and reagent vial filling volumes, the on-board stability may deviate from the above-mentioned values.
Interference Studies
No interferences up to ...
Triglycerides mg/dL 453
Hemoglobin mg/dL 1000
Bilirubin mg/dL 12

®
PT seconds with
®
Thromborel S
Performance Characteristics
The following studies were conducted using specimens collected in 3.2 % sodium citrate solution.
Method Comparison
Predicate Device Regression Equation r
Thromborel® S on BCT® System y = 1.04 x - 0.51 0.998
r = Correlation Coefficient
Precision
The coefficient of variation of the analytical system (total CV) on the same lot of control plasma should be less than 5 %.
Within Run Run to Run Total
CV (%) CV (%) CV (%)
CONTROL N 0.6 2.0 2.1
Pathological plasma pool 0.6 3.0 3.0
Measuring Range
Refer to the Instructions for Use of the analyzer for additional information.
Expected Values
In a study with ostensibly healthy subjects the following data were obtained:
Unit: s
th th
Comments n Median 2.5 - 97.5 Percentile
— 155 10.8 9.8 - 12.2
Reference intervals vary from laboratory to laboratory depending on the population, the technique and reagent lot. Therefore, each
laboratory must establish its own reference intervals or verify them whenever one or more of the aforementioned variables are changed.
For more information on establishing reference intervals see CLSI document C28-A3, “How to Define and Determine Reference Intervals in
the Clinical Laboratory; Approved Guideline.”
Bibliography Manufacturer
Refer to the Instructions for Use of the reagent. Siemens Healthcare Diagnostics Products GmbH
35041 Marburg / Germany
USA Distributor
Siemens Healthcare Diagnostics Inc.
Newark, DE 19714 USA

®
PT seconds with
®
Thromborel S
Test Protocol Standard Curve Calibration

Settings - Analysis Settings - Test Protocol The assay is not calibrated.
Parameter PT
Sample Vol. 50 µL
Diluent Vol. None 0 µL
Rinse None
Second Dilution 0 µL
Rinse None
Factor Plasma None 0 µL
Rinse (Pre./Post.) None None

First Reagent PT THS 100 µL 180 sec
Push-out Solution No 0 µL
Rinse (Pre./Post.) None x 0 None x0
Second Reagent None 0 µL 0 sec
Third Reagent None 0 µL 0 sec
Detector Clot for PT THS
Sens Low Sens
Maximum Time 120 sec
Data Check Number of Replicates

Settings - Data Check Settings - Analysis Settings
- Select param. Param. PT - Replic. No. of Replicates 1
[Unit] s
Detector Settings
Settings - Analysis Settings
- Detector Settings End Point [%] 50

®
PT % with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
PT-Multi CALIBRATOR OPAT rack position
D1 - D14 or sample 6 x 11mL
-5 D1 - D14 or sample rack position 1 - 5
® ®
CONTROL N ORKE 1 mL
Additional Notes
-/-
On-board Stability
®
Ci-Trol CONTROL 1/ Dade® Ci-Trol® 1 8
® ®
CONTROL N 8
Bilirubin mg/dL 12

®
PT % with
®
Thromborel S
Method Comparison
1. System Comparison (material: Thromborel® S with Calibration Plasmas)
2. Comparison of calibrators (material: Thromborel® S with Calibration Plasmas or with PT-Multi Calibrator)
® ®
1. Thromborel S on BCT System y = 1.08 x - 2.44 0.996
2. Thromborel® S with Calibration Plasmas on Sysmex® CA-1500 System y = 1.02 x + 0.87 0.999
Precision
The following studies have been calibrated with Calibration Plasmas.
CV (%) CV (%) CV (%)
CONTROL N 0.9 3.4 3.6
Measuring Range
The measuring range is defined by the concentration of the calibrators used.
Expected Values
Unit: % of norm
th th
— 155 104 82 - 126
Reference intervals may vary from laboratory to laboratory. Therefore, each laboratory should establish its own reference intervals.
USA Distributor

®
PT % with
®
Thromborel S

Settings - Analysis Settings - Test Protocol Calculation Parameter Settings
Parameter PT Settings - Analysis Settings - More - Parameter Settings
Sample Vol. 50 µL - Calc. Para 1
Diluent Vol. None 0 µL Parameter PT%
Rinse None Unit %
Second Dilution 0 µL Number Format XXX.X
Diluent Vol. None 0 µL Calc. Method Log-Log Pt-Pt
Rinse None Standard Curve - Analysis Setting
Calibration Mode Manual Dilution
Calibrator PT-Multi CALIBRATOR
Rinse (Pre./Post.) None None Buffer (OVB)
Push-out Solution No 0 µL Refer to the Table of Analytical Values for the lot specific
calibrator value.
Second Reagent None 0 µL 0 sec Repl.
Push-out Solution No 0 µL Calib. or Dil Ratio 1 PTMult1 2
Rinse (Pre./Post.) None x 0 None x0 Calib. or Dil Ratio 2 PTMult2 2
Third Reagent None 0 µL 0 sec Calib. or Dil Ratio 3 PTMult3 2
Detector Clot for PT THS Calib. or Dil Ratio 6 --- ---
Sens Low Sens

- Select param. Param. PT% - Replic. No. of Replicates 1
[Unit] %
- Report Limit lower (<) 5.0 % Detector Settings
upper (>) 130.0 % Settings - Analysis Settings
Standard Curve (example only)

A new standard curve must be established when changing a reagent lot, after major maintenance or service, if indicated by quality control
results and when required by laboratory control procedures and/or government regulations.
PT%
% s
118.0 10.1
66.0 14.1
43.0 19.1
23.0 34.8
13.0 60.5
Remarks
®
PT-Multi Calibrator Level 6 is not used in combination with Thromborel S.
If DFbg is used, data for DFbg master curve have to be re-entered after PT% calibration has been performed.

®
PT INR with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
STANDARD PLASMA ORKL rack position
D1 - D14 or sample 1 mL
1 D1 - D14 or sample rack position 1
® ®
CONTROL N ORKE 1 mL
Additional Notes
-/-
On-board Stability
®
® ®
CONTROL N 8
Bilirubin mg/dL 12

®
PT INR with
®
Thromborel S
Method Comparison
Thromborel® S on BCT® System y = 0.99 x + 0.00 0.998
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.5 2.0 2.0
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
PT INR with
®
Thromborel S

Parameter PT Calculation Parameter Settings
Sample Vol. 50 µL Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL - Calc. Para 3
Rinse None Parameter PT INR
Second Dilution 0 µL Unit —
Diluent Vol. None 0 µL Number Format XX.XX
Rinse None Calc. Method ISI
Factor Plasma None 0 µL Standard Curve - Manual Entry
Enter the Normal seconds = MNPT and the ISI.
Sens Low Sens

- Select param. Param. PT INR - Replic. No. of Replicates 1
[Unit] —
Detector Settings
Remarks
System specific MNPT and ISI have to be used.
The Mean Normal PT (MNPT) can be established with Standard Human Plasma. To use Standard Human Plasma, it has to be measured at
least twice and the obtained clotting time has to be divided by the ratio given for the PT reagent in the lot-specific Table of Analytical Values
of the plasma.
ISI values for prothrombin time must be entered directly as they appear on the lot-specific table of ISI values. Any changes of the reagent lot,
software (upgrades), major service, etc., require verification of the ISI value. Failure to enter the correct ISI value will cause incorrect
International Normalization Ratio (INR) results.

®
PT INR calibrated with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
® ®
CONTROL N ORKE 1 mL
Additional Notes
-/-
On-board Stability
®
® ®
CONTROL N 8
Bilirubin mg/dL 12

®
®
Thromborel S
Method Comparison
Calibration with MNPT and ISI using Thromborel® S on Sysmex® CA-1500 System y = 0.88 x + 0.14 1.000
Precision
CV (%) CV (%) CV (%)
Ci-Trol CONTROL 3/ Dade® Ci-Trol® 3 0.9 2.0 2.2
CONTROL N 0.4 0.8 0.9
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
®
Thromborel S

Diluent Vol. No 0 µL Parameter PT INR
Rinse None Unit —
Second Dilution 0 µL Number Format XX.XX
Diluent Vol. None 0 µL Calc. Method Calibration
calibrator value.
Detector Clot for PT THS Calib. or Dil Ratio 6 --- ---
Sens Low Sens

[Unit] —
- Report Limit lower (<) 0.80 Detector Settings
upper (>) 6.00 Settings - Analysis Settings

PT INR
— s
0.92 10.4
1.26 14.6
1.67 20.2
2.68 33.8
4.89 64.5
Remarks
®
PT-Multi Calibrator Level 6 is not used in combination with Thromborel S.

®
Derived Fibrinogen with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
® ®
Additional Notes
-/-
On-board Stability
®
Triglycerides mg/dL --- *
Hemoglobin mg/dL 40
Bilirubin mg/dL 60
* Turbid samples are not suitable for Derived Fibrinogen determinations, as they may lead to abnormally low values. Interference of turbid
samples may occur even if triglyceride concentrations are within the normal range. Any questionable result should be followed up with a
more definitive quantitative method.
Limitations
Blood plasma substitutes that contain hydroxyethyl starch (HES) may interfere with the analysis. In a study with a HES solution (130/0.4) no
interference was observed up to 3 g HES per liter plasma.

®
®
Thromborel S
Method Comparison
Dade® Thrombin Reagent on Sysmex® CA-1500 System y = 1.20 x - 0.18 0.928
Precision
The coefficient of variation of the analytical system (within-device CV) on the same lot of control plasma should be less than 10 %.
Mean Repeatability Within-Device/Lab

(g/L) CV (%) CV (%)
Normal plasma pool 2.8 1.9 2.5
Measuring Range
Expected Values
Unit: g/L
Comments n Mean Median 2.5th - 97.5th Percentile
— 124 2.9 2.8 2.1 - 4.1
USA Distributor

®
®
Thromborel S

Settings - Analysis Settings - Test Protocol Important Note:
Parameter PT The recommendation for the Number Format in Calculation
Sample Vol. 50 µL Parameter Settings differs from the information that is given
Diluent Vol. None µL in the Instructions for Use of the analyzer. Please check your
Host System for correct interpretation of transmitted results
Rinse None
whenever the Number Format will be changed.
Calculation Parameter Settings
Diluent Vol. None 0 µL Settings - Analysis Settings - More - Parameter Settings
Rinse None - Calc. Para 4
Parameter DFbg
Unit g/L or mg/dL
Rinse (Pre./Post.) None None Number Format XXX.X or XXXX
Calc. Method Lin-Lin Linear Regression
Standard Curve - Manual Entry
Enter the Derived Fibrinogen g/L or mg/dL concentrations
and the delta H of the master curve specified for the analyzer
Push-out Solution No 0 µL in the lot dependend table of values of the reagent.
Sens Low Sens

- Select param. Param. DFbg - Replic. No. of Replicates 1
[Unit] g/L or mg/dL
Detector Settings

Verify the standard curve with the master curve provided with the PT reagent after each change of the reagent lot, and modify the standard
curve if necessary.
DFbg
g/L delta H
2.1 65
4.1 146

®
PT seconds with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin B4212
B1 - B10 or C1 - C10 10/20 mL B1 - B10 or C1 - C10
® ®
® ®
CONTROL N ORKE 1 mL A1
[1]
CA CLEAN II — —
Additional Notes
[1]
For additional information please refer to the Appendix I.
On-board Stability
® ®
Dade Innovin PT INN 48
® ®
CONTROL N 8
Bilirubin mg/dL 60

®
PT seconds with
® ®
Dade Innovin
Method Comparison
Dade® Innovin® on Sysmex® CA-6000 System y = 0.97 x + 0.09 0.999
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.5 0.6
Measuring Range
Expected Values
Unit: s
th th
— 155 10.4 9.6 - 11.5
USA Distributor

®
PT seconds with
® ®
Dade Innovin

Parameter PT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent PT INN 100 µL 180 sec
Rinse (Pre./Post.) None x 0 Clean II x1
Detector Clot for PT Innovin (R)
Sens Low Sens

- Select param. Param. PT - Replic. No. of Replicates 1
[Unit] s
Detector Settings
Remarks
As an alternative test protocol it is permitted to extend the Maximum Time to 300 seconds when long coagulation times are expected.

®
PT % with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin B4212
B1 - B10 or C1 - C10 10/20 mL B1 - B10 or C1 - C10
® ®
CONTROL N ORKE 1 mL
CA CLEAN II —[1] —
Additional Notes
[1]
On-board Stability
Dade® Innovin® PT INN 48
® ®
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 48

®
PT % with
® ®
Dade Innovin
Method Comparison
Test system for the first method comparison:
1. Dade® Innovin® with InnoCal Set
Test system for the second method comparison:
2. Dade® Innovin® with PT-Multi Calibrator (comparison of calibrators)
® ®
1. Thromborel S on BCT System y = 1.17 x - 9.25 0.982
2. Dade® Innovin® with InnoCal Set on Sysmex® CA-1500 System y = 1.00 x + 0.10 0.998
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.7 1.0 1.1
Measuring Range
Expected Values
Unit: % of norm
th th
— 155 101 79 - 118
USA Distributor

®
PT % with
® ®
Dade Innovin

Diluent Vol. None 0 µL Parameter PT%
Rinse None Unit %
calibrator value.
Detector Clot for PT Innovin (R) Calib. or Dil Ratio 6 PTMult6 2
Sens Low Sens

- Select param. Param. PT% - Replic. No. of Replicates 1
[Unit] %

PT%
% s
103.0 10.7
64.0 12.8
42.0 16.0
22.0 26.1
12.0 42.7
9.0 50.7
Remarks
If DFbg is used, data for DFbg master curve have to be re-entered after PT% calibration has been performed.

®
PT INR with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin B4212
B1 - B10 or C1 - C10 10/20 mL B1 - B10 or C1 - C10
STANDARD PLASMA ORKL rack position
® ®
CONTROL N ORKE 1 mL
CA CLEAN II A1 —[1] — A1
Additional Notes
[1]
On-board Stability
® ®
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 48

®
PT INR with
® ®
Dade Innovin
Method Comparison
Dade® Innovin® on Sysmex® CA-6000 System y = 0.99 x - 0.01 0.999
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.5 0.6
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
PT INR with
® ®
Dade Innovin

Parameter PT Calculation Parameter Settings
Rinse None Parameter PT INR
Rinse None Calc. Method ISI
Factor Plasma None 0 µL Standard Curve - Manual Entry
Enter the Normal seconds = MNPT and the ISI.
Sens Low Sens

[Unit] —
Detector Settings
Remarks
System specific MNPT and ISI have to be used.
The Mean Normal PT (MNPT) can be established with Standard Human Plasma. To use Standard Human Plasma, it has to be measured at
least twice and the obtained clotting time has to be divided by the ratio given for the PT reagent in the lot-specific Table of Analytical Values
of the plasma.
ISI values for prothrombin time must be entered directly as they appear on the lot-specific table of ISI values. Any changes of the reagent lot,
software (upgrades), major service, etc., require verification of the ISI value. Failure to enter the correct ISI value will cause incorrect
International Normalization Ratio (INR) results.

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin B1 - B10 or C1 - C10
B4212 10/20 mL B1 - B10 or C1 - C10
PT-Multi CALIBRATOR OPAT 6 x 1 mL D1 - D14 or sample rack position 1 - 6
® ®
CONTROL N ORKE 1 mL
CA CLEAN II —[1] —
Additional Notes
[1]
On-board Stability
® ®
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 60

®
® ®
Dade Innovin
Method Comparison
Calibration with MNPT and ISI using Dade® Innovin® on Sysmex® CA-1500 System y = 0.97 x + 0.02 1.000
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.3 0.5
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
® ®
Dade Innovin

Diluent Vol. None 0 µL Parameter PT INR
Rinse None Unit —
Diluent Vol. None 0 µL Calc. Method Calibration
calibrator value.
Detector Clot for PT Innovin (R) Calib. or Dil Ratio 6 PTMult6 2
Sens Low Sens

[Unit] —
- Report Limit lower (<) 0.80 Detector Settings
upper (>) 6.00 Settings - Analysis Settings

PT INR
— s
0.96 10.0
1.16 12.0
1.44 15.1
2.14 23.1
3.66 38.5
4.84 50.8

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212 10/20 mL B1 - B10 or C1 - C10
® ®
Additional Notes
[1]
On-board Stability
® ®
Triglycerides mg/dL ---*
Bilirubin mg/dL 24
* Turbid samples are not suitable for Derived Fibrinogen determinations, as they may lead to abnormally low values. Interference of turbid
samples may occur even if triglyceride concentrations are within the normal range. Any questionable result should be followed up with a
more definitive quantitative method.
Limitations

®
® ®
Dade Innovin
Method Comparison
Dade® Thrombin Reagent on Sysmex® CA-1500 System y = 1.25 x - 0.55 0.848
Precision

(g/L) CV (%) CV (%)
Measuring Range
Expected Values
Unit: g/L
— 124 2.7 2.6 1.8 - 4.0
USA Distributor

®
® ®
Dade Innovin

Parameter PT The recommendation for the Number Format in Calculation
Diluent Vol. None 0 µL in the Instructions for Use of the analyzer. Please check your
Rinse None
Parameter DFbg
Unit g/L or mg/dL
Calc. Method Lin-Lin Linear Regression
Standard Curve - Manual Entry
Enter the Derived Fibrinogen g/L or mg/dL concentrations
and the delta H of the master curve specified for the analyzer
Push-out Solution No 0 µL in the lot dependend table of values of the reagent.
Sens Low Sens

- Select param. Param. DFbg - Replic. No. of Replicates 1
[Unit] g/L or mg/dL
Detector Settings

Verify the standard curve with the master curve provided with the PT reagent after each change of the reagent lot, and modify the standard
curve if necessary.
DFbg
g/L delta H
1.8 39
4.0 85

®
APTT with
® ®
Dade Actin Activated Cephaloplastin Reagent
analytical values.
and other findings.
Materials Required
ACTIN B1 - B10 orB4218-1/-2
C1 - C10 2/10 mL B1 - B10 or C1 - C10
® ®
® ®
CONTROL N ORKE 1 mL
CaCl2 SOLUTION C1 - C10 ORHO 15 mL C1 - C10
Additional Notes
-/-
On-board Stability
ACTIN APTT ACT 48
® ®
® ®
CONTROL N 8
CaCl2 SOLUTION CaCl2 48
Bilirubin mg/dL 12

®
APTT with
® ®
Method Comparison
Dade® Actin® Activated Cephaloplastin Reagent on Sysmex® CA-6000 System y = 0.95 x + 1.02 0.988
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.6 1.1 1.9
Measuring Range
Expected Values
Unit: s
th th
Comments n Mean Median 5 - 95 Percentile
— 111 26.7 26.6 22.7 - 31.8
USA Distributor

®
APTT with
® ®

Parameter APTT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent APTT ACT 50 µL 60 sec
Second Reagent CaCl2 50 µL 240 sec
Detector Clot for APTT Actin (R)
Sens Low Sens

- Select param. Param. APTT - Replic. No. of Replicates 1
[Unit] s
Detector Settings

®
APTT with
® ®
Dade Actin FS Activated PTT Reagent
analytical values.
and other findings.
Materials Required
ACTIN FS B1 - B10B4218-20/-100
or C1 - C10 2/10 mL B1 - B10 or C1 - C10
® ®
® ®
CONTROL N ORKE 1 mL
Additional Notes
-/-
On-board Stability
ACTIN FS APTT FS 48
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 2.4

®
APTT with
® ®
Method Comparison
Dade® Actin® FS Activated PTT Reagent on Sysmex® CA-6000 System y = 1.01 x - 0.30 0.997
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.5 1.1 1.8
Measuring Range
Expected Values
Unit: s
th th
— 111 25.2 25.1 22.1 - 28.1
USA Distributor

®
APTT with
® ®

Parameter APTT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent APTT FS 50 µL 60 sec
Detector Clot for APTT FS
Sens Low Sens

[Unit] s
Detector Settings

®
APTT with
® ®
Dade Actin FSL Activated PTT Reagent
analytical values.
and other findings.
Materials Required
ACTIN FSL B1 - B10 or C1 - C10
B4219 2/10 mL B1 - B10 or C1 - C10
® ®
® ®
CONTROL N ORKE 1 mL
Additional Notes
-/-
On-board Stability
ACTIN FSL APTT FSL 48
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 12

®
APTT with
® ®
Method Comparison
Dade® Actin® FSL Activated PTT Reagent on Sysmex® CA-6000 System y = 1.00 x + 0.15 0.995
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.1 1.4 2.4
Measuring Range
Expected Values
Unit: s
th th
— 111 27.6 27.3 25.0 - 31.3
USA Distributor

®
APTT with
® ®

Parameter APTT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent APTT FSL 50 µL 60 sec
Detector Clot for APTT FSL
Sens Low Sens

[Unit] s
Detector Settings
Remarks
According to Sysmex' troubleshooting instructions (CA series Measurement Evaluation and Check Methods), the Maximum Time can be
extended to 600 seconds, if an Analysis Time Over error still persists with the measurement.

®
APTT with
®
Pathromtin SL
analytical values.
and other findings.
Materials Required
®
Pathromtin SL B1 - B10 OQGS 5 mL B1 - B10
® ®
CONTROL N ORKE 1 mL
Additional Notes
The reagent must be gently inverted (5 to 8 times) to mix before first use.
On-board Stability
Pathromtin® SL APTT PSL 48
® ®
® ®
CONTROL N 8
Bilirubin mg/dL 6

®
APTT with
®
Pathromtin SL
Method Comparison
Pathromtin® SL on BCT® System y = 1.07 x - 1.26 0.997
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.4 2.5 3.4
Measuring Range
Expected Values
Unit: s
th th
— 100 31.2 30.9 26.4 - 37.5
USA Distributor

®
APTT with
®
Pathromtin SL

Parameter APTT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent APTT PSL 50 µL 60 sec
Detector Clot for APTT PSL
Sens Low Sens

[Unit] s
Detector Settings

®
Fibrinogen with
®
Multifibren U
analytical values.
and other findings.
Materials Required
®
Multifibren U B1 - B10 OWZG 2/5 mL B1 - B10
FIBRINOGEN CALIBRATOR OQVK rack position
® ®
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
[1]
CA CLEAN II A1 — — A1
Additional Notes
[1]
On-board Stability
®
Multifibren U Fbg MFU 48
® ®
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 24
Limitations
The presence of elevated triglyceride concentrations or any other turbidity in the sample may interfere with the analysis.

®
Fibrinogen with
®
Multifibren U
Method Comparison
Multifibren® U on BCT® System y = 0.98 x - 0.18 0.957
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.1 3.4 4.0
CONTROL P 3.3 2.9 4.2
Measuring Range
Expected Values
Unit: g/L
th th
— 149 2.7 2.6 2.0 - 3.7
USA Distributor

®
Fibrinogen with
®
Multifibren U

Parameter Fbg The recommendation for the Number Format in Calculation
Diluent Vol. None 0 µL in the Instructions for Use of the analyzer. Please check your
Rinse None
Parameter Fbg
Unit g/L or mg/dL
First Reagent Fbg MFU 100 µL 60 sec
Calc. Method Log-Log Pt-Pt
Standard Curve - Analysis Setting
Second Reagent None 0 µL 0 sec Calibration Mode Manual Dilution
Push-out Solution No 0 µL Calibrator Fib. Calibrator Kit
Rinse (Pre./Post.) None x 0 None x0 Buffer (OVB)
Third Reagent None 0 µL 0 sec Refer to the table of assigned values for the lot specific
Push-out Solution No 0 µL calibrator value.
Rinse (Pre./Post.) None x 0 None x0 Repl.
Detector Clot for Fbg.MFU Calib. or Dil Ratio 1 FbgStd.1 2
Sens Low Sens Calib. or Dil Ratio 2 FbgStd.2 2
Maximum Time 150 sec Calib. or Dil Ratio 3 FbgStd.3 2
Calib. or Dil Ratio 4 FbgStd.4 2
Data Check Calib. or Dil Ratio 5 FbgStd.5 2
Settings - Data Check Calib. or Dil Ratio 6 FbgStd.6 2
- Select param. Param. Fbg
[Unit] g/L or mg/dL
Number of Replicates
- Report Limit lower (<) 0.7 g/L or 70 mg/dL Settings - Analysis Settings
upper (>) 8.0 g/L or 800 mg/dL - Replic. No. of Replicates 1
Detector Settings

®
Fibrinogen with
®
Multifibren U

Fbg
g/L s
8.0 7.5
5.4 8.7
3.5 11.1
2.4 14.0
1.1 26.0
0.7 48.1
Remarks
The detector may be changed to 'Clot for TTO‘ as an option. In this case it is crucial to modify the analysis parameter for this assay. The
necessary technical modification has to be done by a Siemens representative.

®
Fibrinogen with
®
Dade Thrombin Reagent
analytical values.
and other findings.
Materials Required
FIBRINOGEN DETERMINATION — B4233-15SY Kit —
THROMBIN REAGENT B1 - B10 — 1 mL B1 - B10
FIBRINOGEN STANDARD — rack position
OV BUFFER (OVB) E1 — 15 mL E1
THROMBIN REAGENT B1 - B10 B4233-25/-27
or C1 - C10 1/5 mL B1 - B10 or C1 - C10
STANDARD PLASMA (SHP) ORKL rack position
® ®
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
Data-Fi FIBRINOGEN CONTROL B4233-22 1 mL
[1]
CA SYSTEM BUFFER (OVB) — — E1
OV BUFFER (OVB) B4234-25 15 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
[1]
On-board Stability
THROMBIN REAGENT Fbg 32
® ®
CONTROL N 6
CONTROL P 8
Data-Fi FIBRINOGEN CONTROL 8
CA SYSTEM BUFFER (in GW5 or GW15 vials) 8
OV BUFFER (in GW5 or GW15 vials) 8

®
Fibrinogen with
®
Bilirubin mg/dL 6
Limitations
If samples are measured in a 1:5 dilution, any presence of elevated triglycerides or any other turbidity in the sample may interfere the
analysis.
Method Comparison
® ®
Dade Thrombin Reagent on Sysmex CA-6000 System y = 0.96 x + 1.46 0.990
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.6 2.7 3.1
CONTROL P 6.4 3.5 7.0
Measuring Range
Expected Values
Unit: g/L
Comments n Mean Median 5th - 95th Percentile
— 149 2.56 2.50 1.95 - 3.40
USA Distributor

®
Fibrinogen with
®

Parameter Fbg The recommendation for the Number Format in Calculation
Diluent Vol. OVB 90 µL in the Instructions for Use of the analyzer. Please check your
Rinse None
Parameter Fbg
Unit g/L or mg/dL
Rinse (Pre./Post.) None None Number Format XX.XX or XXXX
First Reagent Fbg 50 µL 180 sec
Calc. Method Log-Log Pt-Pt
Standard Curve - Analysis Setting
Rinse (Pre./Post.) None x 0 Clean I x1
Second Reagent None 0 µL 0 sec Calibration Mode Auto Dilution
Push-out Solution No 0 µL Calibrator SHP or Fibrinogen Standard
Rinse (Pre./Post.) None x 0 None x0 Buffer OVB
Third Reagent None 0 µL 0 sec Refer to the Table of Analytical Values for the lot specific
Push-out Solution No 0 µL calibrator value.
Rinse (Pre./Post.) None x 0 None x0 Repl.
Detector Clot for Fbg Calib. or Dil Ratio 1 2/1 2
Sens High Sens Calib. or Dil Ratio 2 3/2 2
Maximum Time 100 sec Calib. or Dil Ratio 3 1/1 2
Calib. or Dil Ratio 4 1/2 2
Data Check Calib. or Dil Ratio 5 1/3 2
Settings - Data Check Calib. or Dil Ratio 6 --- ---
- Select param. Param. Fbg
[Unit] g/L or mg/dL
Number of Replicates
- Report Limit lower (<) 0.50 g/L or 50 mg/dL Settings - Analysis Settings
upper (>) 10.00 g/L or 1000 mg/dL - Replic. No. of Replicates 1
- Redil. Limits ON / OFF ON
lower (-) 0.90 g/L or 90 mg/dL Detector Settings
upper (+) 5.00 g/L or 500 mg/dL Settings - Analysis Settings

®
Fibrinogen with
®

Fbg
g/L s
5.00 3.9
3.75 4.8
2.50 6.9
1.25 13.1
0.83 19.7
Remarks
The automatic redilution of samples is not available in the „Micro Mode“. Sample results outside the concentration range of the standard
curve are extrapolated, and therefore, have a higher potential to be inaccurate. Therefore, results of samples measured in the
„Micro Mode“ may only be released if the results are within the concentration range of the standard curve.

®
Thrombin Time with
Test Thrombin Reagent
analytical values.
and other findings.
Materials Required
TEST THROMBIN OWHM Kit —
REAGENT DILUENT — 50 mL
REAGENT B1 - B10 or C1—
- C10 5 mL B1 - B10 or C1 - C10
® ®
CONTROL N ORKE 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
-/-
Limitations
If the Thrombin Time is longer than the reference interval, determine the fibrinogen concentration. Report Thrombin Time if the fibrinogen
concentration is below or equal to 5 g/L. Do not report Thrombin Time if the fibrinogen concentration is higher than 5 g/L.
On-board Stability
REAGENT Test Thr 48
CONTROL N 8
Bilirubin mg/dL 6

®
Thrombin Time with
Method Comparison
Test Thrombin Reagent on Sysmex® CA-6000 System y = 0.77 x + 4.84 0.980
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.3 1.8 2.8
Heparinized plasma 2.6 4.4 5.1
Measuring Range
Expected Values
Unit: s
— 107 17.2 17.2 16.0 - 18.6
USA Distributor

®
Thrombin Time with

Parameter TT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent Test Thr 100 µL 60 sec
Detector Clot for TT
Sens Low Sens

- Select param. Param. TT - Replic. No. of Replicates 2
[Unit] s
- Replic. Limits Difference Limit 15 % Detector Settings

®
Thrombin Time with
®
Thromboclotin
analytical values.
and other findings.
Materials Required
®
Thromboclotin C1 - C10 281007 10 mL C1 - C10
® ®
CONTROL N ORKE 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
-/-
Limitations
If the Thrombin Time is longer than the reference interval, determine the fibrinogen concentration. Report Thrombin Time if the fibrinogen
concentration is below or equal to 7 g/L. Do not report the Thrombin Time if the fibrinogen concentration is higher than 7 g/L.
On-board Stability
®
Thromboclotin Thromboc 48
® ®
CONTROL N 8
Bilirubin mg/dL 36

®
Thrombin Time with
®
Thromboclotin
Method Comparison
Thromboclotin® on Sysmex® CA-6000 System y = 1.14 x - 5.11 0.932
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.3 2.4 2.7
Measuring Range
Expected Values
Refer to the Instructions for Use of the reagent.
USA Distributor

®
Thrombin Time with
®
Thromboclotin

Parameter TT
Sample Vol. 100 µL
Rinse None
Rinse None

First Reagent Thromboc 100 µL 60 sec
Detector Clot for TT.TCL
Sens Low Sens

- Select param. Param. TT - Replic. No. of Replicates 1
[Unit] s
Detector Settings

®
Batroxobin Time with
Batroxobin Reagent
analytical values.
and other findings.
Materials Required
Batroxobin REAGENT B1 - B10 OUOV 5 mL B1 - B10
CONTROL N ORKE 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
-/-
On-board Stability
Batroxobin REAGENT Batrox 48
CONTROL N 8
Bilirubin mg/dL 48

®
Batroxobin Reagent
Method Comparison
Batroxobin Reagent on BCT® System y = 0.88 x + 5.24 0.993
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.8 0.5 1.0
Measuring Range
Expected Values
Unit: s
th th
— 127 18.6 18.5 17.7 - 19.9
USA Distributor

®
Batroxobin Reagent

Parameter BXT
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent Batrox 100 µL 60 sec
Detector Clot for other
Sens Low Sens

- Select param. Param. BXT - Replic. No. of Replicates 1
[Unit] s
Detector Settings

®
Coagulation Factor II with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
FACTOR II DEFICIENT D1 - D14 OSGR 1 mL D1 - D14
CONTROL N ORKE 1 mL D1 - D14 or any position on sample rack
CONTROL P OUPZ 1 mL
CA SYSTEM BUFFER (OVB) —[1] — E1
Additional Notes
Thromborel® S has to be mixed carefully every 8 h on board.
[1]
On-board Stability
Thromborel® S PT THS 24
FACTOR II DEFICIENT II 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
®
Thromborel S
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 4.1 5.4 6.7
CONTROL P 3.2 2.0 3.6
Measuring Range
Expected Values
Refer to the Coagulation Factors II, VII and X Deficient Plasma Instructions for Use.
USA Distributor

®
®
Thromborel S

Parameter II Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter II %
Rinse None Unit %
Factor Plasma II 50 µL
Calibration Mode Auto Dilution
Calibrator SHP
Rinse (Pre./Post.) None None Buffer OVB
calibrator value.
Push-out Solution No 0 µL Calib. or Dil Ratio 1 3/2 2
Rinse (Pre./Post.) None x 0 None x0 Calib. or Dil Ratio 2 1/1 2
Third Reagent None 0 µL 0 sec Calib. or Dil Ratio 3 1/2 2
Detector Clot for Ext.F. Assay Calib. or Dil Ratio 6 1/16 2
Sens Low Sens

- Select param. Param. II % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

II %
% s
145.5 18.3
97.0 20.6
48.5 25.9
24.2 34.1
9.7 51.4
6.1 71.9

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212 10/20 mL B1 - B10 or C1 - C10
FACTOR II DEFICIENT D1 - D14 OSGR 1 mL D1 - D14
STANDARD PLASMA (SHP) D1 - D14 or sample 1 mL
ORKL rack position 1 D1 - D14 or sample rack position 1
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
FACTOR II DEFICIENT II 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
® ®
Dade Innovin
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.9 4.0 4.9
CONTROL P 2.2 0.6 2.1
Measuring Range
Expected Values
USA Distributor

®
® ®
Dade Innovin

Parameter II Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter II %
Rinse None Unit %
Factor Plasma II 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. II % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

II %
% s
145.5 15.5
97.0 18.8
48.5 25.2
24.2 37.0
9.7 71.0
6.1 95.6

®
Coagulation Factor V with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
FACTOR V DEFICIENT D1 - D14 ORSM 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
®
FACTOR V DEFICIENT V 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
®
Thromborel S
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.4 5.1 5.6
CONTROL P 1.5 1.2 1.9
Measuring Range
Expected Values
Refer to the Coagulation Factor V Deficient Plasma Instructions for Use.
USA Distributor

®
®
Thromborel S

Parameter V Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter V%
Rinse None Unit %
Factor Plasma V 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. V% - Replic. No. of Replicates 1
[Unit] %
Detector Settings

V%
% s
138.0 21.0
92.0 23.9
46.0 29.7
23.0 36.6
9.2 47.4
5.8 54.9

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212 10/20 mL B1 - B10 or C1 - C10
FACTOR V DEFICIENT D1 - D14 ORSM 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
FACTOR V DEFICIENT V 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 12

®
® ®
Dade Innovin
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 4.6 4.3 6.1
CONTROL P 3.9 2.8 4.6
Measuring Range
Expected Values
Refer to the Coagulation Factor V Deficient Plasma Instructions for Use.
USA Distributor

®
® ®
Dade Innovin

Parameter V Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter V%
Rinse None Unit %
Factor Plasma V 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. V% - Replic. No. of Replicates 1
[Unit] %
Detector Settings

V%
% s
138.0 15.9
92.0 17.8
46.0 21.1
23.0 26.3
9.2 34.0
5.8 40.4

®
Coagulation Factor VII with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
FACTOR VII DEFICIENT D1 - D14 OTXV 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
®
FACTOR VII DEFICIENT VII 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 12

®
®
Thromborel S
Method Comparison
Thromborel® S on BCT® System y = 0.87 x - 0.66 0.984
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.4 3.7 4.3
CONTROL P 2.1 4.7 5.2
Measuring Range
Expected Values
USA Distributor

®
®
Thromborel S

Parameter VII Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter VII %
Rinse None Unit %
Factor Plasma VII 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. VII % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

VII %
% s
139.5 19.6
93.0 22.5
46.5 28.3
23.2 36.2
9.3 49.6
5.8 58.0

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212 10/20 mL B1 - B10 or C1 - C10
FACTOR VII DEFICIENT D1 - D14 OTXV 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
FACTOR VII DEFICIENT VII 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 27

®
® ®
Dade Innovin
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.5 1.5 2.7
CONTROL P 2.3 2.1 3.0
Measuring Range
Expected Values
USA Distributor

®
® ®
Dade Innovin

Parameter VII Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter VII %
Rinse None Unit %
Factor Plasma VII 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. VII % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

VII %
% s
145.5 17.8
97.0 20.9
48.5 28.5
24.2 39.1
9.7 61.9
6.1 78.2

®
Coagulation Factor X with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Thromborel S OUHP
B1 - B10 or C1 - C10 4/10 mL B1 - B10 or C1 - C10
FACTOR X DEFICIENT D1 - D14 OTXY 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
®
FACTOR X DEFICIENT X 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
®
Thromborel S
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.3 3.4 3.7
CONTROL P 1.5 2.8 3.2
Measuring Range
Expected Values
USA Distributor

®
®
Thromborel S

Parameter X Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter X%
Rinse None Unit %
Factor Plasma X 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. X% - Replic. No. of Replicates 1
[Unit] %
Detector Settings

X%
% s
148.5 22.2
99.0 26.0
49.5 34.3
24.8 47.2
9.9 73.0
6.2 92.6

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212 10/20 mL B1 - B10 or C1 - C10
FACTOR X DEFICIENT D1 - D14 OTXY 1 mL D1 - D14
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
FACTOR X DEFICIENT X 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
® ®
Dade Innovin
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.8 1.3 2.1
CONTROL P 1.6 1.3 2.0
Measuring Range
Expected Values
USA Distributor

®
® ®
Dade Innovin

Parameter X Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter X%
Rinse None Unit %
Factor Plasma X 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. X% - Replic. No. of Replicates 1
[Unit] %
Detector Settings

X%
% s
148.5 17.6
99.0 20.4
49.5 26.7
24.8 36.1
9.9 58.6
6.2 76.4

®
Coagulation Factor VIII with
® ®
analytical values.
and other findings.
Materials Required
ACTIN B1 - B10 orB4218-1/-2
C1 - C10 2/10 mL B1 - B10 or C1 - C10
FACTOR VIII DEFICIENT D1 - D14 OTXW 1 mL D1 - D14
STANDARD PLASMA (SHP) D1 - D14 or sample
ORKL rack position 1
1 mL D1 - D14 or sample rack position 1
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN APTT ACT 48
FACTOR VIII DEFICIENT VIII 4
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 36

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.9 1.5 2.3
CONTROL P 2.3 5.9 6.3
Measuring Range
Expected Values
Refer to the Coagulation Factors VIII, IX, XI and XII Deficient Plasma Instructions for Use.
USA Distributor

®
® ®

Parameter VIII Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter VIII %
Rinse None Unit %
Factor Plasma VIII 50 µL
Calibrator SHP
calibrator value.
Second Reagent CaCl2 50 µL 240 sec Repl.
Detector Clot for Int.F. Assay Calib. or Dil Ratio 6 1/32 2
Sens Low Sens

- Select param. Param. VIII % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

VIII %
% s
182.0 50.2
136.5 53.4
91.0 58.6
45.5 67.2
11.4 85.6
2.8 105.6

®
® ®
analytical values.
and other findings.
Materials Required
ACTIN FS B1 - B10B4218-20/-100
or C1 - C10 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN FS APTT FS 48
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Dade® Actin® FS Activated PTT Reagent on Sysmex® CA-6000 System y = 1.05 x + 3.66 0.993
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 4.5 5.4
CONTROL P 3.6 8.0 8.7
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Diluent Vol. No 0 µL Calc. Method Log-Log Pt-Pt
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

VIII %
% s
182.0 69.1
136.5 73.6
91.0 80.2
45.5 91.6
11.4 114.6
2.8 138.8

®
® ®
analytical values.
and other findings.
Materials Required
B4219 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 31

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.6 3.3 3.6
CONTROL P 1.8 4.3 4.6
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

VIII %
% s
182.0 64.6
136.5 68.0
91.0 74.1
45.5 84.4
11.4 109.4
2.8 134.4

®
®
Pathromtin SL
analytical values.
and other findings.
Materials Required
®
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 5

®
®
Pathromtin SL
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 4.3 3.9 5.6
CONTROL P 5.2 8.3 9.7
Measuring Range
Expected Values
USA Distributor

®
®
Pathromtin SL

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

VIII %
% s
182.0 57.6
136.5 60.8
91.0 65.9
45.5 74.7
11.4 96.0
2.8 118.8

®
Coagulation Factor IX with
® ®
analytical values.
and other findings.
Materials Required
ACTIN B1 - B10 orB4218-1/-2
C1 - C10 2/10 mL B1 - B10 or C1 - C10
FACTOR IX DEFICIENT D1 - D14 OTXX 1 mL D1 - D14
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN APTT ACT 24
FACTOR IX DEFICIENT IX 2
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 36

®
® ®
Method Comparison
Dade® Actin® Activated Cephaloplastin Reagent on Sysmex® CA-6000 System y = 1.04 x - 3.51 0.990
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.8 5.0 5.3
CONTROL P 3.3 2.8 4.2
Measuring Range
Expected Values
USA Distributor

®
® ®

Parameter IX Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter IX %
Rinse None Unit %
Factor Plasma IX 50 µL
Calibrator SHP
calibrator value.
Detector Clot for Int.F. Assay Calib. or Dil Ratio 6 --- ---
Sens Low Sens

- Select param. Param. IX % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

IX %
% s
145.5 52.0
97.0 57.3
48.5 66.1
12.1 88.8
3.0 114.6

®
® ®
analytical values.
and other findings.
Materials Required
ACTIN FS B1 - B10B4218-20/-100
or C1 - C10 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN FS APTT FS 24
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 1.8 3.4
CONTROL P 2.3 3.6 4.3
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

IX %
% s
145.5 61.8
97.0 67.8
48.5 76.6
12.1 100.8
3.0 125.1

®
® ®
analytical values.
and other findings.
Materials Required
B4219 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 36

®
® ®
Method Comparison
Dade® Actin® FSL Activated PTT Reagent on Sysmex® CA-6000 System y = 1.05 x - 2.52 0.973
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.4 1.8 2.9
CONTROL P 3.8 3.8 5.2
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

IX %
% s
145.5 46.7
97.0 50.7
48.5 57.4
12.1 75.3
3.0 96.2

®
Coagulation Factor XI with
® ®
analytical values.
and other findings.
Materials Required
ACTIN B1 - B10 orB4218-1/-2
C1 - C10 2/10 mL B1 - B10 or C1 - C10
FACTOR XI DEFICIENT D1 - D14 OSDF 1 mL D1 - D14
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN APTT ACT 48
FACTOR XI DEFICIENT XI 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.1 4.7 5.2
CONTROL P 2.1 6.9 7.3
Measuring Range
Expected Values
USA Distributor

®
® ®

Parameter XI Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter XI %
Rinse None Unit %
Factor Plasma XI 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. XI % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

XI %
% s
139.5 51.6
93.0 56.2
46.5 64.4
11.6 85.0
2.9 105.9
0.7 120.3

®
® ®
analytical values.
and other findings.
Materials Required
ACTIN FS B1 - B10B4218-20/-100
or C1 - C10 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN FS APTT FS 48
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.8 5.6 6.3
CONTROL P 3.2 1.9 3.6
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

XI %
% s
139.5 75.9
93.0 83.6
46.5 98.2
11.6 132.0
2.9 166.6
0.7 193.5

®
® ®
analytical values.
and other findings.
Materials Required
B4219 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.5 10.2 10.4
CONTROL P 2.3 11.7 12.0
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

XI %
% s
139.5 76.1
93.0 83.8
46.5 98.3
11.6 131.6
2.9 166.5
0.7 194.8

®
®
Pathromtin SL
analytical values.
and other findings.
Materials Required
®
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 6

®
®
Pathromtin SL
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 4.0 4.9 6.2
CONTROL P 5.2 9.9 11.1
Measuring Range
Expected Values
USA Distributor

®
®
Pathromtin SL

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

XI %
% s
139.5 61.2
93.0 67.0
46.5 76.9
11.6 99.0
2.9 118.0
0.7 128.3

®
Coagulation Factor XII with
® ®
analytical values.
and other findings.
Materials Required
ACTIN B1 - B10 orB4218-1/-2
C1 - C10 2/10 mL B1 - B10 or C1 - C10
FACTOR XII DEFICIENT D1 - D14 OSDG 1 mL D1 - D14
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN APTT ACT 24
FACTOR XII DEFICIENT XII 8
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.3 5.7 6.1
CONTROL P 1.7 2.5 3.0
Measuring Range
Expected Values
USA Distributor

®
® ®

Parameter XII Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 45 µL Parameter XII %
Rinse None Unit %
Factor Plasma XII 50 µL
Calibrator SHP
calibrator value.
Sens Low Sens

- Select param. Param. XII % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

XII %
% s
142.5 44.3
95.0 48.0
47.5 55.3
11.9 92.6
3.0 169.4

®
® ®
analytical values.
and other findings.
Materials Required
ACTIN FS B1 - B10B4218-20/-100
or C1 - C10 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
ACTIN FS APTT FS 24
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.8 2.9 4.0
CONTROL P 1.5 1.4 2.0
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Detector Clot for Int.F. Assay Calib. or Dil Ratio 6 - -
Sens Low Sens

[Unit] %
Detector Settings

XII %
% s
142.5 51.9
95.0 56.0
47.5 63.0
11.9 91.8
3.0 167.8

®
® ®
analytical values.
and other findings.
Materials Required
B4219 2/10 mL B1 - B10 or C1 - C10
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 48

®
® ®
Method Comparison
Dade® Actin® FSL Activated PTT Reagent on Sysmex® CA-6000 System y = 1.01 x - 3.70 0.993
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.8 4.5 4.8
CONTROL P 1.6 2.3 2.8
Measuring Range
Expected Values
USA Distributor

®
® ®

Rinse None Unit %
Calibrator SHP
calibrator value.
Detector Clot for Int.F. Assay Calib. or Dil Ratio 6 - -
Sens Low Sens

[Unit] %
Detector Settings

XII %
% s
142.5 52.0
95.0 56.0
47.5 63.5
11.9 90.5
3.0 164.7

®
®
Pathromtin SL
analytical values.
and other findings.
Materials Required
®
CONTROL P OUPZ 1 mL
[1]
Additional Notes
[1]
On-board Stability
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
®
Pathromtin SL
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 2.2 3.7
CONTROL P 2.5 1.2 2.6
Measuring Range
Expected Values
USA Distributor

®
®
Pathromtin SL

Rinse None Unit %
Calibrator SHP
calibrator value.
Sens Low Sens

[Unit] %
Detector Settings

XII %
% s
150.0 50.3
100.0 54.4
50.0 61.7
12.5 106.1
6.3 146.6

®
Lupus Anticoagulant with
LA 1 Screening Reagent / LA 2 Confirmation Reagent
analytical values.
and other findings.
Materials Required
LA 1 REAGENT OQGP 2 mL B1 - B10
LA 2 REAGENT OQGR 1 mL
LA CONTROL 1 OQWE 1 mL
LA CONTROL 2 OQWD 1 mL
Additional Notes
[1]
On-board Stability
LA 1 REAGENT LA1 24
LA 2 REAGENT LA2 24
CONTROL N 8
LA CONTROL 1 8
LA CONTROL 2 6
Bilirubin mg/dL 60

®
Method Comparison
LA 1 on Sysmex® CA-6000 System y = 0.89 x + 1.29 0.997
LA 1 / LA 2 on Sysmex® CA-6000 System y = 0.92 x - 0.01 0.994
Precision
CV (%) CV (%) CV (%)
LA 1: CONTROL N 1.2 1.8 2.2
LA 1: LA CONTROL 2 0.9 0.9 1.2
LA 2: CONTROL N 0.3 0.3 0.4
LA 2: LA CONTROL 2 0.5 0.3 0.5
LA 1 / LA 2 Ratio: CONTROL N 1.1 2.0 2.3
LA 1 / LA 2 Ratio: LA CONTROL 2 1.1 0.8 1.3
Measuring Range
Expected Values
Unit: s
LA 1 124 33.7 33.3 29.6 - 38.9
LA 2 124 35.4 35.4 33.2 - 37.8
LA 1 / LA 2 Ratio (no unit) 124 0.95 0.95 0.87 - 1.07
USA Distributor

®

Parameter LA1
Sample Vol. 100 µL
Rinse None
Rinse None

First Reagent LA1 100 µL 240 sec
Detector Clot for LA1
Sens Low Sens

- Select param. Param. LA1 - Replic. No. of Replicates 2
[Unit] s
Remarks
To obtain the ratio, LA1 and LA2 assays have to be requested simultaneously.

®

Parameter LA2 Calculation Parameter Settings
Rinse None Parameter LA R
Rinse None Calc. Method —

First Reagent LA2 100 µL 240 sec
Detector Clot for LA2
Sens Low Sens

- Select param. Param. LA2 - Replic. No. of Replicates 2
[Unit] —
Remarks
In order to guarantee reliable analysis results it is crucial to modify the analysis parameter for this assay. The necessary technical
modification is not described in this Application Sheet and it has to be done by a Siemens representative.
To obtain the ratio, LA1 and LA2 assays have to be requested simultaneously.
To calculate the ratio automatically, the following setting has to be entered before samples are measured with LA1 and LA2:
Settings/Analysis Settings/More/Add Calc Parm.: select an available Calc. position 1 - 4
Param.: Parameter selection: LA2 / LA R
Param.: Parameter selection: LA1 / LA1 sec
Select [/]
Param.: Parameter selection: LA2 / LA2 sec

®
Protein C System with
®
ProC Global
analytical values.
and other findings.
Materials Required
®
ProC Global — OQLS Kit —
REAGENT APTT — 5 mL B1 - B10
ACTIVATOR — 2 mL
BUFFER — 2 mL
D1 - D14 or sample 1
ProC CONTROL OQKE 1 mL
Additional Notes
REAGENT APTT must be gently inverted (5 to 8 times) to mix before first use.
[1]
On-board Stability
REAGENT APTT APTTGlo 8
ACTIVATOR ActProC 8
BUFFER BufProC 8
CONTROL N 8
ProC CONTROL 8
Bilirubin mg/dL 60

®
®
ProC Global
Method Comparison
ProC® Global on BCT® System y = 0.98 x + 0.00 0.961
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.5 2.4 2.8
Measuring Range
Expected Values
USA Distributor

®
®
ProC Global

Parameter PCAT Calculation Parameter Settings
Rinse None Parameter PCAT NR

First Reagent ActProC 50 µL 20 sec
Second Reagent APTTGlo 50 µL 40 sec
Third Reagent CaCl2 50 µL 220 sec
Sens Low Sens

- Select param. Param. PCAT - Replic. No. of Replicates 1
[Unit] —
Detector Settings
Remarks
To calculate the Normalized Ratio (NR) automatically, the following setting has to be entered before samples are measured with PCAT and
PCAT.0:
Settings/Analysis Settings/More/Add Calc Parm.: select an available Calc. position 1 - 4.
Param.: Parameter selection: PCAT / PCAT NR
Param.: Parameter selection: PCAT / PCAT sec
Select [/]
Param.: Parameter selection: PCAT.0 / PCAT.0 sec
Select [/] and enter the calculated RatioSHP with the numeric keys
Select [*] and enter the Sensitivity value with the numeric keys
Sensitivity value (SV): It is provided in the Table of Analytical Values of the respective Lot of Standard Human Plasma.
To define the RatioSHP Standard Human Plasma has to be measured at least twice for PCAT and PCAT.0 and the obtained clotting time for
PCAT has to be divided by the obtained clotting time for PCAT.0 .
To obtain the ratio, PCAT and PCAT.0 assays always have to be requested simultaneously.

®
®
ProC Global

Parameter PCAT.0
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent BufProC 50 µL 20 sec
Sens Low Sens

- Select param. Param. PCAT.0 - Replic. No. of Replicates 1
[Unit] s
Detector Settings

®
Factor V Leiden with
®
ProC Global / Factor V Deficient Plasma
analytical values.
and other findings.
Materials Required
®
ProC Global — OQLS Kit —
REAGENT APTT — 5 mL B1 - B10
ACTIVATOR — 2 mL
BUFFER — 2 mL
FACTOR V DEFICIENT ORSM
D2, D4, D6, D8, D10, D12, D141 or
mLE2 D2, D4, D6, D8, D10, D12, D14 or E2
CA CLEAN I E3 964-0631-3 50 mL E3
[1]
CA CLEAN II A1 — — A1
Additional Notes
Coagulation Factor V Deficient Plasma has to be defined as buffer.
REAGENT APTT must be gently inverted (5 to 8 times) to mix before first use.
[1]
On-board Stability
REAGENT APTT APTTGlo 8
ACTIVATOR ActProC 8
BUFFER BufProC 8
FACTOR V DEFICIENT FV.B 8
CONTROL N 8
ProC CONTROL 8
Bilirubin mg/dL 60

®
®
Method Comparison
ProC® Global / Factor V on BCT® System y = 0.93 x + 0.05 0.977
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.0 1.6 1.9
Measuring Range
Expected Values
Refer to the ProC® Global Instructions for Use.
USA Distributor

®
®

Parameter FVPCAT Calculation Parameter Settings
Diluent Vol. FV.B 40 µL - Calc. Para 2
Rinse Clean I Parameter FVPC NR

First Reagent ActProC 50 µL 20 sec
Sens Low Sens

- Select param. Param. FVPCAT - Replic. No. of Replicates 1
[Unit] —
Detector Settings
Remarks
Limitations for Sysmex® CA-1500 Systems with wand barcode reader for reagents: Please note that barcode recognition for Coagulation
Factor V Deficient Plasma is not possible if deficient plasma is defined as buffer.
To calculate the Normalized Ratio (NR) automatically, the following setting has to be entered before samples are measured with FVPCAT
and FVPCAT0:
Settings/Analysis Settings/More/Add Calc Parm.: select an available Calc. position 1 - 4.
Param.: Parameter selection: FVPCAT / FVPC NR
Param.: Parameter selection: FVPCAT / FVPCAT sec
Select [/]
Param.: Parameter selection: FVPCAT0 / FVPCAT0 sec
Select [/] and enter the calculated RatioSHP with the numeric keys
Select [*] and enter the Sensitivity value with the numeric keys
Sensitivity value (SV): It is provided in the Table of Analytical Values of the respective Lot of Standard Human Plasma.
To define the RatioSHP Standard Human Plasma has to be measured at least twice for FVPCAT and FVPCAT0 and the obtained clotting time
for FVPCAT has to be divided by the obtained clotting time for FVPCAT0.
To obtain the ratio, FVPCAT and FVPCAT0 assays always have to be requested simultaneously.

®
®

Parameter FVPCAT0
Sample Vol. 10 µL
Diluent Vol. FV.B 40 µL
Rinse Clean I
Rinse None

First Reagent BufProC 50 µL 20 sec
Sens Low Sens

- Select param. Param. FVPCAT0 - Replic. No. of Replicates 1
[Unit] s
Detector Settings

®
Factor V Leiden Assay
analytical values.
and other findings.
Materials Required
Factor V Leiden Assay — OQYI Kit —
Activator — 2 mL B1 - B10
PR3V Reagent — 4 mL
CA SYSTEM BUFFER (OVB) B1 - B10 or C1—-[1]C10 — B1 - B10 or C1 - C10
OV BUFFER (OVB) C1 - C10 B4234-25 15 mL C1 - C10
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Dade® CA System Buffer and Dade® Owren´s Veronal Buffer have to be defined as reagent (FVLOVB).
Although stated otherwise in the Instructions for Use make sure to incubate Control Plasma N for 30 minutes at +15 °C to +25 °C
after reconstitution.
[1]
On-board Stability
Activator FVLAct 24
PR3V Reagent FVLPR3V 24
CONTROL N 8
ProC CONTROL 8
Bilirubin mg/dL 60

®
Method Comparison
Factor V Leiden Assay on BCS® System y = 0.92 x + 0.15 0.967
Precision
The following precision data were established.
CV (%) CV (%) CV (%)
CONTROL N 1.2 2.4 2.6
ProC CONTROL 1.4 1.7 2.2
Decision Limit for Result Evaluation

A cut-off of 1.8 has been validated in a performance evaluation study for the Sysmex® CA-1500 System. Due to differences in sample
population, collection technique and instrumentation, each laboratory should establish its own cut-off.
Measuring Range
0.74 - 5.91
Expected Values
Unit: —
— 128 3.78 3.75 2.85 - 4.71
USA Distributor

®

Parameter FVL.Act Calculation Parameter Settings
Rinse None Parameter FVL R

First Reagent FVLAct 50 µL 60 sec
Second Reagent FVLPR3V 50 µL 240 sec
Detector Clot for other2
Sens Low Sens

- Select param. Param. FVL.Act - Replic. No. of Replicates 1
[Unit] —
Detector Settings

®

Settings - Analysis Settings - Test Protocol See previous page.
Parameter FVL.OVB
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent FVLOVB 50 µL 60 sec
Second Reagent FVLPR3V 50 µL 240 sec
Sens Low Sens

- Select param. Param. FVL.OVB - Replic. No. of Replicates 1
[Unit] —
Detector Settings
Remarks
To obtain the ratio, FVL.Act and FVL.OVB assays always have to be requested simultaneously.
To calculate the ratio automatically, the following setting has to be entered before samples are measured with FVL.Act and FVL.OVB:
Settings - Analysis Settings - More - Add Calc Parm.: select an available Calc. position 1 - 4
Param.: Parameter selection: FVL.Act / FVL R
Param.: Parameter selection: FVL.Act / FVL.Act sec
Select [/]
Param.: Parameter selection: FVL.OVB / FVL.OVB sec
Note:
Based on the system's immanent data interpretation method, results of the Factor V Leiden Assay may be reported with Analysis Time Over
(ATO) error flags. Results marked with an ATO error flag should be interpreted according to the Troubleshooting Guide for Factor V Leiden
Assay.
modification has to be done by a Siemens representative.

®
APC Resistance with
®
ProC Ac R
analytical values.
and other findings.
Materials Required
®
ProC Ac R — OPBC Kit —
ACTIVATOR B1 - B10 — 2 mL B1 - B10
REAGENT — 4 mL
CA SYSTEM BUFFER (OVB) B1 - B10 or C1—-[1]C10 — B1 - B10 or C1 - C10
OV BUFFER (OVB) C1 - C10 B4234-25 15 mL C1 - C10
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Dade® CA System Buffer and Dade® Owren´s Veronal Buffer have to be defined as reagent (AcROVB).
Although stated otherwise in the Instructions for Use make sure to incubate Control Plasma N for 30 minutes at +15 °C to +25 °C
after reconstitution.
[1]
On-board Stability
ACTIVATOR AcRAct 24
REAGENT AcRPR3V 24
CONTROL N 8
ProC CONTROL 8
Bilirubin mg/dL 60

®
APC Resistance with
®
ProC Ac R
Method Comparison
ProC® Ac R on BCS® System y = 0.92 x + 0.15 0.967
Precision
The following precision data were established.
CV (%) CV (%) CV (%)
CONTROL N 1.2 2.4 2.6
ProC CONTROL 1.4 1.7 2.2
Decision Limit for Result Evaluation

A cut-off of 1.8 has been validated in a performance evaluation study for the Sysmex® CA-1500 System. Due to differences in sample
population, collection technique and instrumentation, each laboratory should establish its own cut-off.
Expected Values
Unit: —
th th
— 128 3.78 3.75 2.85 - 4.71
USA Distributor

®
APC Resistance with
®
ProC Ac R

Parameter AcR.Act Calculation Parameter Settings
Rinse None Parameter AcR R

First Reagent AcRAct 50 µL 60 sec
Second Reagent AcRPR3V 50 µL 240 sec
Sens Low Sens

- Select param. Param. AcR.Act - Replic. No. of Replicates 1
[Unit] —
Detector Settings

®
APC Resistance with
®
ProC Ac R

Settings - Analysis Settings - Test Protocol See previous page.
Parameter AcR.OVB
Sample Vol. 50 µL
Rinse None
Rinse None

First Reagent AcROVB 50 µL 60 sec
Second Reagent AcRPR3V 50 µL 240 sec
Sens Low Sens

- Select param. Param. AcR.OVB - Replic. No. of Replicates 1
[Unit] —
Detector Settings
Remarks
To obtain the ratio, AcR.Act and AcR.OVB assays always have to be requested simultaneously.
To calculate the ratio automatically, the following setting has to be entered before samples are measured with AcR.Act and AcR.OVB:
Settings - Analysis Settings - More - Add Calc Parm.: select an available Calc. position 1 - 4
Param.: Parameter selection: AcR.Act / AcR R
Param.: Parameter selection: AcR.Act / AcR.Act sec
Select [/]
Param.: Parameter selection: AcR.OVB / AcR.OVB sec
Note:
®
Based on the system's immanent data interpretation method, results of the ProC Ac R Assay may be reported with Analysis Time
Over (ATO) error flags. Results marked with an ATO error flag should be interpreted according to the Troubleshooting Guide for
®
ProC Ac R Assay.
modification has to be done by a Siemens representative.

®
Protein C with
Protein C Reagent
analytical values.
and other findings.
Materials Required
PROTEIN C COAG — OQYG Kit —
ACTIVATOR B1 - B10 — 3 mL B1 - B10
DEFICIENT D2, D4, D6, D8,—D10, D12, D141 or
mLE2 D2, D4, D6, D8, D10, D12, D14 or E2
REAGENT APTT C1 - C10 — 10 mL C1 - C10
CONTROL P OUPZ 1 mL
CA CLEAN I A2 and E3964-0631-3 50 mL A2 and E3
Additional Notes
Protein C Deficient Plasma (DEFICIENT) has to be defined as buffer.
Limitations for Sysmex® CA-1500 Systems with wand barcode reader for reagents: Please note that barcode recognition for DEFICIENT is
not possible if deficient plasma is defined as buffer.
On-board Stability
ACTIVATOR PC.A.cl 48
REAGENT APTT PC.APTT 48
DEFICIENT PC.DefP 8
CONTROL N 8
CONTROL P 8
Hemoglobin mg/dL n,d,
Bilirubin mg/dL 48
Limitations
Hemolyzed samples are not suitable for protein C determination.
Higher levels of lipids or turbid samples can lead to falsely elevated or decreased values.

®
Protein C with
Protein C Reagent
Method Comparison
Protein C Reagent on BCS® System y = 1.00 x - 2.46 0.995
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.3 1.8 2.8
CONTROL P 3.1 2.5 3.9
Measuring Range
Expected Values
USA Distributor

®
Protein C with
Protein C Reagent

Parameter PC.clot Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. PC.DefP 45 µL Parameter PC.clot
Rinse Clean I Unit %
Diluent Vol. None 0 µL Calc. Method Lin-Lin Linear Regression
Calibrator SHP
Rinse (Pre./Post.) None None Buffer PC.DefP
First Reagent PC.A.cl 50 µL 20 sec
calibrator value.
Second Reagent PC.APTT 50 µL 40 sec Repl.
Third Reagent CaCl2 50 µL 280 sec Calib. or Dil Ratio 3 1/2 2
Detector Clot for other Calib. or Dil Ratio 6 0/1 2
Sens Low Sens

- Select param. Param. PC.clot - Replic. No. of Replicates 1
[Unit] %
Detector Settings

PC.clot
% s
0.0 42.7
12.5 53.6
25.0 65.5
50.0 93.5
100.0 139.7
150.0 190.5

®
Protein S with
Protein S Ac
analytical values.
and other findings.
Materials Required
Protein S Ac — OPAP Kit —
DEFICIENT D2, D4, D6, D8,—D10, D12, D14, E1 or E2D2, D4, D6, D8, D10, D12, D14, E1 or E2
1 mL
REAGENT — 2 mL B1 - B10 or C1 - C10
ACTIVATOR — 5 mL
CONTROL P OUPZ 1 mL
CA CLEAN I A2 and E3964-0631-3 50 mL A2 and E3
Additional Notes
DEFICIENT, REAGENT and ACTIVATOR must be placed on-board for 30 minutes in order to reach +15 °C.
DEFICIENT has to be defined as buffer.
Limitations for Sysmex® CA-1500 Systems with barcode reader for reagents: Please note that barcode recognition for DEFICIENT is not
possible if deficient plasma is defined as buffer.
On-board Stability
DEFICIENT PSAcDP 3
REAGENT PSAcAPC 3
ACTIVATOR PSAcStR 3
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
Protein S with
Protein S Ac
Method Comparison
Protein S on STA** System y = 0.96 x + 1.53 0.919
Precision
The coefficient of variation of the analytical system (total CV) on the same lot of control plasma should be less than 15 % for abnormal
plasma and less than 10 % for normal plasma.

CV (%) CV (%) CV (%)
CONTROL N (average) 4.8 2.4 5.1
CONTROL P (average) 7.0 4.8 8.2
Measuring Range
Expected Values
Unit: %
men 125 --- 104.3 74.5 - > 130.0
women with oral contraceptives 44 --- 81.5 51.5 - 117.8
women without oral contraceptives 49 --- 90.0 59.4 - 118.4
all subjects 218 97.3 95.4 60.2 - > 130.0
USA Distributor

®
Protein S with
Protein S Ac

Parameter PSAc Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. PSAcDP 95 µL Parameter PSAc%
Rinse None Unit %
Diluent Vol. PSAcDP 27 µL Calc. Method Log-Log Pt-Pt
Rinse Clean I Standard Curve - Analysis Setting
Calibrator SHP
Rinse (Pre./Post.) None None Buffer PSAcDP
First Reagent PSAcAPC 58 µL 20 sec
calibrator value.
Second Reagent PSAcStR 145 µL 110 sec Repl.
Rinse (Pre./Post.) None x 0 Clean I x1 Calib. or Dil Ratio 2 1/1 3
Detector Clot for PSAc Calib. or Dil Ratio 6 --- ---
Sens Low Sens

- Select param. Param. PSAc% - Replic. No. of Replicates 2
[Unit] %
- Replic. Limits Difference Limit 3 % - Detector Settings End Point [%] 50

A new standard curve must be established when changing a reagent vial, after major maintenance or service, if indicated by quality control
PSAc%
% s
11.1 91.0
29.7 101.3
53.4 113.6
89.0 126.4
133.5 139.2

®
Antithrombin with
®
INNOVANCE Antithrombin
analytical values.
and other findings.
Materials Required
®
INNOVANCE Antithrombin — OPFH Kit —
REAGENT — 2.7/6.5 mL B1 - B10 or C1 - C10
SUBSTRATE — 2.7/6.5 mL
BUFFER D2, D4, D6, D8,—D10, D12, D14, mL- E3 D2, D4, D6, D8, D10, D12, D14, E1 - E3
5/12E1
® ®
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
-/-
On-board Stability
REAGENT ATReag 24
SUBSTRATE ATSub 24
BUFFER ATBuf 24
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
Antithrombin with
®
Method Comparison
Berichrom® Antithrombin III (A) on Sysmex® CA-1500 System y = 0.98 x + 2.27 0.953
Precision

(% of norm) CV (%) CV (%)
CONTROL N 89.0 1.4 3.6
CONTROL P 29.6 2.9 6.4
Measuring Range
Expected Values
Unit: % of norm
th th
Comments n Mean Median 2.5 - 97.5 Percentile
— 150 94.4 93.8 80 - 111
USA Distributor

®
Antithrombin with
®

Parameter AT Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. ATBuf 110 µL Parameter AT%
Rinse None Unit %
Diluent Vol. None 0 µL Calc. Method Log-Lin Linear Regression
Calibrator SHP
Rinse (Pre./Post.) None None Buffer ATBuf
First Reagent ATReag 80 µL 20 sec
calibrator value.
Second Reagent ATSub 80 µL 200 sec Repl.
Detector Chromogenic for AT3 Calib. or Dil Ratio 6 1/20 2
Sens/Wavelength Low Sens / 405 nm Inc
Analysis Range 38 sec

- Select param. Param. AT% - Replic. No. of Replicates 1
[Unit] %
Detector Settings
- Detector Settings Analysis Range [s] 6 - 18

AT%
% dOD
135.0 0.301
90.0 0.523
67.5 0.674
45.0 0.890
22.5 1.134
4.5 1.391

®
Antithrombin III with
®
Berichrom Antithrombin III (A)
analytical values.
and other findings.
Materials Required
Berichrom AT III OWWR Kit —
REAGENT THR DILUENT — 30/100 mL
REAGENT THR C1 - C10 — 5/15 mL C1 - C10
SUBSTRATE B1 - B10 — 3 mL B1 - B10
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
[1]
On-board Stability
REAGENT THR AT3Thro 24
SUBSTRATE AT3Subs 48
CONTROL N 8
CONTROL P 8
CA SYSTEM BUFFER (in GW5 or GW15 vials) OVB 8
OV BUFFER (in GW5 or GW15 vials) OVB 8
Bilirubin mg/dL 21.9

®
®
Method Comparison
Berichrom® Antithrombin III (A) on BCT® System y = 0.97 x - 4.72 0.998
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.3 4.6 4.8
CONTROL P 2.7 7.6 8.1
Measuring Range
Expected Values
Unit: % of norm
th th
— 308 91.9 91.4 78.1 - 108.9
USA Distributor

®
®

Parameter BCAT3 Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 112 µL Parameter BCAT3 %
Rinse None Unit %
Calibrator SHP
First Reagent AT3Thro 175 µL 40 sec
calibrator value.
Rinse (Pre./Post.) Clean I x 1 Clean I x1
Second Reagent AT3Subs 33 µL 220 sec Repl.

- Select param. Param. BCAT3 % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

BCAT3 %
% dOD
144.0 0.219
96.0 0.554
48.0 0.898
24.0 1.054
12.0 1.144
0.0 1.213

®
Heparin with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
Berichrom HEPARIN OWLD Kit —
REAGENT FX DILUENT — 10 mL
REAGENT AT — 1 mL B1 - B10
SUBSTRATE — 2 mL
REAGENT FX C1 - C10 — 10 mL C1 - C10
STANDARD PLASMA (SHP) ORKL
see “Additional Notes” 1 mL see “Additional Notes”
Ci-Trol HEPARIN CONTROL 1 B4224-50 1 mL D1 - D14 or any position on sample rack
Ci-Trol HEPARIN CONTROL 2 B4224-60 1 mL
CONTROL N ORKE 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Standard Human Plasma without heparin has to be defined as buffer (SHPBuf) for calibration purposes. On-board-position: Reagent holder
position D2, D4, D6, D8, D10, D12, D14 or E2.
Calibration plasma (Standard Human Plasma with heparin) has to be defined as calibrator SHPHep. On-board-Position: Reagent holder D1 -
D14 or sample rack position 1.
[1]
On-board Stability
REAGENT AT AT3Reag 8
REAGENT FX FXaReag 8
SUBSTRATE HepSubs 8
Ci-Trol HEPARIN CONTROL 1 8
Ci-Trol HEPARIN CONTROL 2 8
No interferences up to ... LMW heparin UF heparin
Triglycerides mg/dL 192 222
Hemoglobin mg/dL 40 200
Bilirubin mg/dL 24 24

®
Heparin with
®
Berichrom Heparin
Method Comparison
Berichrom® Heparin on BCT® System y = 1.01 x + 0.04 0.987
Precision
CV (%) CV (%) CV (%)
0.2 IU/mL heparinized plasma 6.3 8.8 10.7
0.8 IU/mL heparinized plasma 2.1 2.7 3.3
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin with
®
Berichrom Heparin

Parameter BCHep Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL Parameter BCHep
Rinse None Unit U/mL
Diluent Vol. None 0 µL Calc. Method Lin-Lin Pt-Pt
Calibrator SHPHep
Rinse (Pre./Post.) None None Buffer SHPBuf
First Reagent AT3Reag 20 µL 20 sec
Push-out Solution No 0 µL For preparation of the Calibration Plasma 1 U/mL refer to the
Instructions for Use of Berichrom® Heparin.
Second Reagent FXaReag 170 µL 40 sec Repl.
Third Reagent HepSubs 40 µL 100 sec Calib. or Dil Ratio 3 1/2 2
Rinse (Pre./Post.) None x 0 Clean II x2 Calib. or Dil Ratio 5 1/10 2

- Select param. Param. BCHep - Replic. No. of Replicates 1
[Unit] U/mL
Detector Settings

BCHep
U/mL dOD
1.00 0.323
0.75 0.371
0.50 0.428
0.25 0.495
0.10 0.540
0.00 0.551

®
Heparin (LMW) with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
SUBSTRATE — 2 mL
Berichrom HEPARIN LMW CALIBRATOR OPCA rack position
Berichrom HEPARIN LMW CONTROL 1 OPCD 1 mL D1 - D14 or any position on sample rack
Berichrom HEPARIN LMW CONTROL 2 OPCB 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Standard Human Plasma without heparin has to be defined as buffer (SHP.DIL) for calibration purposes. On-board-position: Reagent holder
[1]
On-board Stability
SUBSTRATE HepSubs 8
Berichrom HEPARIN LMW CONTROL 1 8
Berichrom HEPARIN LMW CONTROL 2 8
Hemoglobin mg/dL 40
Bilirubin mg/dL 24

®
Heparin (LMW) with
®
Berichrom Heparin
Calibrator Comparison
The following study represents a functional correlation between standard curves of the 2nd WHO Standard for low molecular weight heparin
and the Berichrom® Heparin LMW Calibrator.
Berichrom® Heparin with WHO Standard y = 1.00 x + 0.04 0.999
Precision
The precision study was conducted using specimens collected in 3.2 % sodium citrate solution.
The standard deviation (SD) of the analytical system should be less than ± 0.05 IU/mL for a normal plasma and less than ± 0.15 IU/mL for a
sample of 1.0 IU/mL.
Mean Repeatability Within Device/Lab
(IU/mL) SD (IU/mL) SD (IU/mL)
Berichrom HEPARIN LMW CONTROL 1 0.37 ±0.03 ±0.05
Berichrom HEPARIN LMW CONTROL 2 0.81 ±0.03 ±0.05
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin (LMW) with
®
Berichrom Heparin

Parameter HepL Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL Parameter HepL
Rinse None Unit IU/mL
Calibrator LMW.CAL
Rinse (Pre./Post.) None None Buffer SHP.DIL
heparin concentration of Berichrom® Heparin LMW
Calibrator.
Second Reagent FXaReag 170 µL 40 sec
Push-out Solution No 0 µL Repl.
Sens/Wavelength Low Sens / 405 nm Inc Calib. or Dil Ratio 6 0/1 2

- Select param. Param. HepL - Replic. No. of Replicates 1
[Unit] IU/mL
Detector Settings

HepL
IU/mL dOD
1.49 0.273
1.19 0.308
0.89 0.353
0.60 0.415
0.30 0.476
0.00 0.528

®
Heparin (UF) with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
SUBSTRATE — 2 mL
Berichrom HEPARIN UF CALIBRATOR OPCC rack position
Berichrom HEPARIN UF CONTROL 1 OPBY 1 mL D1 - D14 or any position on sample rack
Berichrom HEPARIN UF CONTROL 2 OPBZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Standard Human Plasma without heparin has to be defined as buffer (SHP.DIL) for calibration purposes. On-board-position: Reagent holder
[1]
On-board Stability
SUBSTRATE HepSubs 8
Berichrom HEPARIN UF CONTROL 1 8
Berichrom HEPARIN UF CONTROL 2 8
Bilirubin mg/dL 24

®
Heparin (UF) with
®
Berichrom Heparin
Calibrator Comparison
The following study represents a functional correlation between standard curves of the 5th WHO Standard for unfractionated heparin and the
Berichrom® Heparin UF Calibrator.
Berichrom® Heparin with WHO Standard y = 1.01 x + 0.02 0.996
Precision
The precision study was conducted using specimens collected in 3.2 % sodium citrate solution.
The standard deviation (SD) of the analytical system should be less than ± 0.05 IU/mL for a normal plasma and less than ± 0.15 IU/mL for a
sample of 1.0 IU/mL.
Mean Repeatability Within Device/Lab
(IU/mL) SD (IU/mL) SD (IU/mL)
Berichrom HEPARIN UF CONTROL 1 0.25 ±0.02 ±0.03
Berichrom HEPARIN UF CONTROL 2 0.69 ±0.02 ±0.03
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin (UF) with
®
Berichrom Heparin

Parameter HepU Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL Parameter HepU
Rinse None Unit IU/mL
Calibrator UF.CAL
Rinse (Pre./Post.) None None Buffer SHP.DIL
heparin concentration of Berichrom® Heparin UF Calibrator.
Second Reagent FXaReag 170 µL 40 sec Repl.

- Select param. Param. HepU - Replic. No. of Replicates 1
[Unit] IU/mL
Detector Settings

HepU
IU/mL dOD
1.28 0.147
1.02 0.189
0.77 0.246
0.51 0.327
0.26 0.440
0.00 0.521

®
Protein C with
®
Berichrom Protein C
analytical values.
and other findings.
Materials Required
Berichrom PROTEIN C OUVV Kit —
ACTIVATOR DILUENT — 30 mL
ACTIVATOR C1 - C10 — 5/10 mL C1 - C10
SUBSTRATE B1 - B10 — 3 mL B1 - B10
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
[1]
On-board Stability
ACTIVATOR BCPCAct 48
SUBSTRATE BCPCSub 48
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 24

®
Protein C with
®
Berichrom Protein C
Method Comparison
Berichrom® Protein C on BCT® System y = 1.09 x - 3.44 0.991
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.3 2.7 4.2
CONTROL P 7.4 2.2 7.3
Measuring Range
Expected Values
USA Distributor

®
Protein C with
®
Berichrom Protein C

Parameter BCPC Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 15 µL Parameter BCPC
Rinse None Unit %
Calibrator SHP
First Reagent BCPCAct 150 µL 40 sec
calibrator value.
Second Reagent BCPCSub 30 µL 340 sec Repl.
Third Reagent BCPCSub 4 µL 360 sec Calib. or Dil Ratio 3 1/2 2
Detector Chromogenic for PC Calib. or Dil Ratio 6 0/1 2

- Select param. Param. BCPC - Replic. No. of Replicates 1
[Unit] %
Detector Settings

BCPC
% dOD
0.0 0.005
11.6 0.013
23.2 0.028
46.5 0.051
93.0 0.090
139.5 0.128

®
α2-Antiplasmin with
®
Berichrom α2-Antiplasmin
analytical values.
and other findings.
Materials Required
Berichrom ANTIPLASMIN OUBU Kit —
REAGENT P DILUENT — 15 mL
REAGENT P — 5 mL B1 - B10
PLASMIN SUBSTRATE — 2 mL
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
[1]
On-board Stability
REAGENT P AplReag 8
PLASMIN SUBSTRATE PlSubs 8
CONTROL N 8
CONTROL P 8
Hemoglobin mg/dL 14
Bilirubin mg/dL 31

®
®
Method Comparison
® ®
Berichrom α2-Antiplasmin on Sysmex CA-6000 System y = 1.11 x - 16.41 0.990
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.6 3.1 3.9
CONTROL P 4.9 12.3 13.2
Measuring Range
Expected Values
USA Distributor

®
®

Parameter BCApl Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 112 µL Parameter BCApl
Rinse None Unit %
Factor Plasma None 0 µL Calibration Mode Auto Dilution
Calibrator SHP
Buffer OVB
First Reagent AplReag 175 µL 40 sec
Refer to the Table of Analytical Values for the lot specific
calibrator value.
Second Reagent PlSubs 35 µL 100 sec Repl.
Detector Chromogenic for APL Calib. or Dil Ratio 6 0/1 2

- Select param. Param. BCApl - Replic. No. of Replicates 1
[Unit] %
Detector Settings

BCApl
% dOD
135.0 0.055
90.0 0.086
45.0 0.121
22.5 0.141
11.2 0.151
0.0 0.157

®
Plasminogen with
®
Berichrom Plasminogen
analytical values.
and other findings.
Materials Required
Berichrom PLASMINOGEN — OUCA Kit —
REAGENT STR — 5 mL B1 - B10
PLASMIN SUBSTRATE — 2 mL
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
[1]
On-board Stability
REAGENT STR Streptok 24
PLASMIN SUBSTRATE PlSubs 24
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 60

®
Plasminogen with
®
Method Comparison
Berichrom® Plasminogen on BCT® System y = 0.93 x + 1.50 0.990
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.8 1.5 2.3
CONTROL P 3.4 5.2 6.2
Measuring Range
Expected Values
USA Distributor

®
Plasminogen with
®

Parameter BCPlg Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 112 µL Parameter BCPlg %
Rinse None Unit %
Calibrator SHP
First Reagent Streptok 175 µL 40 sec
calibrator value.
Second Reagent PlSubs 35 µL 340 sec Repl.
Detector Chromogenic for Plg Calib. or Dil Ratio 6 0/1 2

- Select param. Param. BCPlg % - Replic. No. of Replicates 1
[Unit] %
Detector Settings

BCPlg %
% dOD
0.0 0.001
12.2 0.007
24.5 0.020
49.0 0.045
98.0 0.103
147.0 0.151

®
Factor VIII Chromogenic Assay
analytical values.
and other findings.
Materials Required
FACTOR VIII CHROMOGENIC B4238 Kit —
SUBSTRATE BUFFER — 10 mL
REAGENT FIX — 3 mL * B1 - B10
REAGENT FX — 3 mL *
SUBSTRATE see “Additional—
Notes” 1 mL see “Additional Notes”
CONTROL P OUPZ 1 mL
CA CLEAN I A2 964-0631-3 50 mL A2
Additional Notes
Reconstitute 1 bottle of SUBSTRATE with 1 mL distilled or deionized water and equilibrate for 30 minutes at 15 °C to 25 °C. Mix 1
mL of SUBSTRATE with 7 mL SUBSTRATE BUFFER yielding 8 mL of ready for use Substrate Reagent and put on reagent rack
postion C1 - C10.
SUBSTRATE / SUBSTRATE BUFFER has to be transferred into a 15 mL vial.
* Although stated otherwise in the Instructions for Use make sure to reconstitute REAGENT FX and REAGENT FIX with 3 mL
distilled or deionized water.
[1]
On-board Stability
REAGENT FIX FIXaReag 24
REAGENT FX FX Reag 24
SUBSTRATE SubReag 24
CONTROL N 8
CONTROL P 8
Bilirubin mg/dL 36

®
Method Comparison
Factor VIII Chromogenic Assay on Sysmex® CA-6000 System y = 0.99 x + 0.99 0.989
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.2 4.6 5.1
CONTROL P 3.1 10.3 10.8
Measuring Range
Expected Values
USA Distributor

®

Parameter VIIICH Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 90 µL Parameter VIIICH
Rinse None Unit %
Diluent Vol. OVB 30 µL Calc. Method Lin-Lin Linear Regression
Calibrator SHP
First Reagent FX Reag 40 µL 30 sec
calibrator value.
Second Reagent FIXaReag 40 µL 60 sec Repl.
Third Reagent SubReag 120 µL 200 sec Calib. or Dil Ratio 3 1/2 2

- Select param. Param. VIIICH - Replic. No. of Replicates 1
[Unit] %
Detector Settings

VIIICH
% dOD
0.0 0.012
5.4 0.027
10.8 0.044
43.0 0.146
86.0 0.265
129.0 0.378

®
D-Dimer with
®
INNOVANCE D-Dimer
analytical values.
and other findings.
Materials Required
®
INNOVANCE D-Dimer — OPBP Kit —
REAGENT — 4 mL B1 - B10 or C1 - C10
BUFFER — 5 mL
SUPPLEMENT — 2.6 mL
DILUENT D2, D4, D6, D8,—D10, D12, D145 mL D2, D4, D6, D8, D10, D12, D14
CALIBRATOR — rack position
®
INNOVANCE D-Dimer CONTROLS — OPDY Kit —
CONTROL 1 — 1 mL D1 - D14 or any position on sample rack
CONTROL 2 — 1 mL
INNOVANCE® D-Dimer DILUENT OPBR
D2, D4, D6, D8, D10, D12, D145 mL D2, D4, D6, D8, D10, D12, D14
CA CLEAN I E3 964-0631-3 50 mL E3
Sample Cup Conical 4 mL — 424-1160-8 4 mL —
Additional Notes
The required controls and calibrators have to be transferred into 4 mL Conical Cups.
Plasma samples should not be stored frozen for more than 4 weeks. If frozen samples are stored longer than 4 weeks, they should be
measured in “Batch Mode“. Controls should be measured pre- and post-run.
Set up the worklist in “Normal Mode” for INNOVANCE® D-Dimer. Be aware that the automatic redilution of samples is not available in the
“Micro Mode”.
The units for INNOVANCE® D-Dimer assay are mg/L FEU. The software of the instruments uses only mg/L for technical reasons.
For patient results which are measured with a 1/8 redilution only and result in <3.65 mg/L FEU, measure the sample without dilution to verify
the result. Testing using the 2/1 dilution has not been validated for use with INNOVANCE® D-Dimer.
INNOVANCE® D-Dimer BUFFER must be defined as reagent and INNOVANCE® D-Dimer DILUENT must be defined as buffer.

®
D-Dimer with
®
INNOVANCE D-Dimer
On-board Stability
REAGENT DDi.REA 24
REAGENT (Conical Cup) DDi.REA 8
BUFFER DDi.BUF 24
BUFFER (Conical Cup) DDi.BUF 8
SUPPLEMENT DDi.SUP 24
SUPPLEMENT (Conical Cup) DDi.SUP 8
DILUENT DDi.DIL 24
DILUENT (Conical Cup) DDi.DIL 8
CONTROL 1 8
CONTROL 2 8
In original vials, the reagents may be left on board the instrument continuously for 24 hours or stored on and off the instrument for intervals of
1 hour x 10 or 2 hours x 5 over a maximum period of 14 days.
Storage and stability are described in the Instructions for Use. INNOVANCE® D-Dimer controls need to validate each new test run.
Bilirubin mg/dL 15
Limitations
Higher levels of lipids or turbid samples can lead to falsely elevated or decreased values. It is therefore recommended to perform an
additional centrifugation step of the plasma (10 minutes at approx. 15.000 x g) before analyzing lipemic patient specimens.
Method Comparison
INNOVANCE® D-Dimer on BCS® System y = 1.06 x - 0.04 0.997
Precision
(mg/L FEU) CV (%) CV (%)
INNOVANCE® D-Dimer CONTROL 1 0.29 2.2 2.5
INNOVANCE® D-Dimer CONTROL 2 2.50 3.6 4.9
Measuring Range
The total measuring range for INNOVANCE® D-Dimer is defined by the concentration of the calibrator used and is approximately 0.19 to 4.40
mg/L FEU. The measuring range can be extended to approximately 35.20 mg/L FEU by automatic redilution of samples above 4.40 mg/L
FEU. Samples with concentrations above 35.20 mg/L FEU can be further diluted manually with INNOVANCE® D-Dimer DILUENT.

®
D-Dimer with
®
INNOVANCE D-Dimer
Expected Values
Unit: mg/L FEU
Comments n Mean Median 90th Percentile
— 150 --- --- 0.55
USA Distributor

®
D-Dimer with
®
INNOVANCE D-Dimer

Parameter DDi Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. DDi.DIL 13 µL Parameter DDi
Rinse None Unit mg/L
Calibrator DDi.CAL
Rinse (Pre./Post.) None None Buffer DDi.DIL
First Reagent DDi.SUP 17 µL 20 sec
Push-out Solution No 0 µL Refer to the Table of Analytical Values for the lot specific D-
Dimer concentration of INNOVANCE® D-Dimer
CALIBRATOR.
Second Reagent DDi.BUF 61 µL 40 sec
Third Reagent DDi.REA 56 µL 180 sec Calib. or Dil Ratio 2 1/2 2
Detector Immuno for IMMUNO1 Calib. or Dil Ratio 5 1/16 2
Sens/Wavelength Low Sens / 800 nm Inc Calib. or Dil Ratio 6 1/32 2
200 sec

- Select param. Param. DDi - Replic. No. of Replicates 1
[Unit] mg/L
- Report Limit lower (<) 0.19 mg/L Detector Settings
upper (>) 35.20 mg/L Settings - Analysis Settings
- Redil. Limits ON / OFF ON - Detector Settings Analysis Range [s] - (VLinIntegral)
lower (-) 0.00 mg/L
upper (+) 4.40 mg/L
- Replic. Limits Difference Limit 20 %
Remarks
Important!
The parameters given in the Application Sheet have to be entered into the software carefully. Additionally, there are parameters which have
to be entered by the service only. Please contact your local service.

®
D-Dimer with
®
INNOVANCE D-Dimer

DDi
mg/L dOD
5.30 0.1467
2.65 0.1101
1.32 0.0614
0.66 0.0236
0.33 0.0098
0.17 0.0043

®
Free Protein S with
®
INNOVANCE Free PS Ag
analytical values.
and other findings.
Materials Required
®
INNOVANCE Free PS Ag — OPGL Kit —
REAGENT — 3.4 mL B1 - B10 or C1 - C10
BUFFER — 3.0 mL
D1 - D14 or sample 1 [2]
1 mL D1 - D14 or sample rack position 1 [2]
CONTROL N ORKE 1 mL D1 - D14 or any position on sample rack [2]
CONTROL P OUPZ 1 mL
Sample Cup Conical 4 mL — 424-1160-8 4 mL —
Additional Notes
INNOVANCE® Free PS Ag BUFFER has to be defined as reagent.
[1]
[2]
The required controls and calibrators have to be transferred into Sample Cups conical 4 mL.
On-board Stability
REAGENT FPS.REA 48
BUFFER FPS.BUF 48
CONTROL N 8
CONTROL P 8
CA SYSTEM BUFFER (GW15) OVB 48
OV BUFFER (GW15) OVB 48
In original vials, the reagent may be left on board the instrument continuously for 48 hours or stored on and off the instrument for intervals of
6 x 8 hours over a maximum period of 8 weeks.
Bilirubin mg/dL 60
Limitations
Higher levels of lipids or turbid samples can lead to falsely elevated or decreased values. It is therefore recommended to perform an
additional centrifugation step of the plasma (10 minutes at approx. 15.000 x g) before analyzing lipemic patient specimens.

®
Free Protein S with
®
Method Comparison
INNOVANCE® Free PS Ag on BCS® XP System y = 0.99 x - 3.91 0.995
Precision

CONTROL N 80.4 1.8 1.8
CONTROL P 27.2 1.7 1.9
Measuring Range
TThe total measuring range of INNOVANCE® Free PS Ag is 10 % of norm to 150 % of norm. Samples with concentrations above 150 % of
norm can be further diluted manually by mixing one part of the sample with one part of Dade® CA System Buffer (OVB).
Expected Values
Unit: % of norm
Comments n Median 2.5th - 97.5th Percentile
Males 133 96.8 67.3 - 129.8
Females [1] 125 83.2 61.5 - 114.8
[1]
Females without oral contraception, hormone replacement therapy or pregnancy.
USA Distributor

®
Free Protein S with
®

Parameter FPS Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 100 µL Parameter FPS%
Rinse None Unit %
Diluent Vol. OVB 10 µL Calc. Method Lin-Lin Pt-Pt
Calibrator SHP
First Reagent FPS.BUF 60 µL 20 sec
calibrator value.
Second Reagent FPS.REA 80 µL 140 sec Repl.
Detector Immuno for IMMUNO1 Calib. or Dil Ratio 6 1/10 2

- Select param. Param. FPS% - Replic. No. of Replicates 1
[Unit] %
- Replic. Limits Difference Limit 10 % - Detector Settings Analysis Range [s] - (VLinIntegral)

FPS%
% dOD
9.3 0.0068
34.9 0.0347
69.8 0.0710
102.3 0.0962
130.2 0.1158
174.4 0.1440

®
von Willebrand Factor with
vWF Ag
analytical values.
and other findings.
Materials Required
vWF Ag — OPAB Kit —
REAGENT (diluent added) — 2 + 4 mL B1 - B10 or C1 - C10
BUFFER (Glycine buffer) — 5 mL
CONTROL P OUPZ 1 mL
Additional Notes
[1]
On-board Stability
BUFFER vWFBuf 48
REAGENT vWFReag 48
CONTROL N 8
CONTROL P 8
CA SYSTEM BUFFER OVB 48
Bilirubin mg/dL 48

®
vWF Ag
Method Comparison
Commercially available von Willebrand Factor antigen assay on STA** System y = 0.95 x + 0.97 0.988
Precision
CV (%) CV (%) CV (%)
vWF.m CONTROL N 1.4 1.3 1.8
vWF.m CONTROL P 2.5 2.5 3.4
vWF.l pathological plasma pool I (low conc.) 2.0 11.9 12.1
vWF.l pathological plasma pool II (low conc.) 1.7 3.9 4.3
vWF.h pathological plasma pool I (high conc.) 1.9 4.0 4.4
vWF.h pathological plasma pool II (high conc.) 2.1 3.6 4.1
Measuring Range
Expected Values
Unit: %
th th
Total 185 98.1 94.2 57.3 - 153.3
Blood group 0 80 83.6 80.5 54.0 - 133.8
Other blood groups 105 109.2 106.1 68.5 - 159.4
USA Distributor

®
vWF Ag

Settings - Analysis Settings - Test Protocol Each Test Protocol has to be calibrated separately.
Parameter VWF.m Calculation Parameter Settings
Diluent Vol. OVB 15 µL - Calc. Para 1
Rinse None Parameter vWFm
Second Dilution 0 µL Unit %
Diluent Vol. None 0 µL Number Format XXX.X
Rinse None Calc. Method Lin-Lin Pt-Pt
Factor Plasma None 0 µL Standard Curve - Analysis Setting
Rinse (Pre./Post.) None None Calibrator SHP
First Reagent vWFBuf 60 µL 20 sec Buffer OVB
calibrator value.
Second Reagent vWFReag 90 µL 260 sec
Detector Immuno for vWF.Ag Calib. or Dil Ratio 5 1/10 2
Sens/Wavelength Low Sens / 575 nm Inc Calib. or Dil Ratio 6 --- ---

- Select param. Param. vWFm - Replic. No. of Replicates 1
[Unit] %
lower (-) 0.0 %
upper (+) 180.0 %

vWFm
% dOD
9.5 0.0041
38.0 0.0208
65.8 0.0386
114.0 0.0780
190.0 0.1313
Remarks
All samples with unknown vWF concentration should be measured with vWF.m setting first.
It is necessary to switch ON [Reflex] and to switch OFF [Micro] for the respective samples in the worklist to enable both, reflex and redilution
feature.
Based on the analysis results the system will automatically perform a redilution analysis if the vWF concentration exceedes the calibration
range or the system will automatically perform a reflex testing (vWF.l setting) if the vWF concentration is below the calibration range.

®
vWF Ag

Parameter VWF.l Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL Parameter vWFI
Rinse None Unit %
Calibrator SHP
First Reagent vWFBuf 60 µL 20 sec
calibrator value.
Second Reagent vWFReag 90 µL 260 sec Repl.
Detector Immuno for vWF.Ag Calib. or Dil Ratio 6 --- ---

- Select param. Param. vWFI - Replic. No. of Replicates 1
[Unit] %
Remarks
Settings/Data Check/Reflex Tests:
Choose an unused line, delete another if there is no line free and add Reflex test.
Select [Insert] to add the Reflex Test
Select Parameter: [Param.]/vWF.m/vWFm %
Select [<]
Select [Numeric Key] and enter 10
Select [THEN]
Select Parameter: [Param.]/vWF.l

®
vWF Ag

Parameter VWF.h Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. OVB 25 µL Parameter vWFh
Rinse None Unit %
Calibrator SHP
First Reagent vWFBuf 60 µL 20 sec
calibrator value.
Second Reagent vWFReag 90 µL 260 sec Repl.
Detector Immuno for vWF.Ag Calib. or Dil Ratio 6 --- ---

- Select param. Param. vWFh - Replic. No. of Replicates 1
[Unit] %
Remarks
The vWF.h setting can be used as an option in case of a known sample with high vWF concentration.

®
®
INNOVANCE VWF Ac
analytical values.
and other findings.
Materials Required
®
INNOVANCE VWF Ac — OPHL Kit —
REAGENT I — 2.0 mL B1 - B10 or C1 - C10
REAGENT II — 3.5 mL
REAGENT III — 2.5 mL
CONTROL P OUPZ 1 mL
CA SYSTEM BUFFER (OVB) —[1] — E1 - E2
Additional Notes
As a control in the low measurement range, Control Plasma P (OUPZ) diluted 1:3 with Dade® Owren’s Veronal Buffer or Dade® CA System
Buffer can be used. The assigned value is calculated by division of the concentration given in the Table of Assigned Values by the dilution
(divisor:3). The range of the diluted control is +/- 4.0 % of norm VWF.
[1]
On-board Stability
REAGENT I VWFAcI 16
REAGENT II VWFAcII 16
REAGENT III VWFAcIII 48
CONTROL N 4
CONTROL P 4
CONTROL P 1:3 diluted 4
If stored on and off the intrument, REAGENT I and II may be used for intervals of 4 x 4 hours over a maximum period of 4 weeks. If
REAGENT III is stored on and off the instrument, it may be used for intervals of 12 x 4 hours over a maximum period of 12 weeks.
No interferences up to ... VWFAc.m VWFAc.l
Triglycerides mg/dL 401 312
Hemoglobin mg/dL 1000 1000
Bilirubin mg/dL 60 60

®
®
INNOVANCE VWF Ac
Method Comparison
INNOVANCE® VWF Ac on BCS® / BCS® XP System y = 1.03x + 0.01 0.991
Precision
Parameter Mean Repeatability Within-Device/Lab
CONTROL N VWFAc.m 86.7 1.6 1.7
CONTROL P VWFAc.m 32.3 3.1 3.5
Pathological plasma pool 1 VWFAc.m 17.7 4.8 5.8
Pathological plasma pool 2 VWFAc.l 9.0 5.9 6.6
Pathological plasma pool 3 448 2.1 2.6
Measuring Range
The INNOVANCE® VWF Ac total measuring range on the Sysmex® CA-1500 System extends from 4 % to 600 %. This total measuring
range is achieved by an automatic redilution of samples > 150 % or by reflex testing of samples < 15 %.
Expected Values
Unit: %
th th
Blood group independent 263 101.2 96.2 51.7 - 173.9
Blood group 0 129 86.3 83.3 47.8 - 140.3
Blood group non-0 134 115.6 118.2 66.3 - 184.4
USA Distributor

®
®
INNOVANCE VWF Ac

Settings - Analysis Settings - Test Protocol Each Test Protocol has to be calibrated separately.
Parameter VWFAc.m Calculation Parameter Settings
Diluent Vol. OVB 30 µL - Calc. Para 1
Rinse None Parameter VWFAcm
Second Dilution 0 µL Unit %
Diluent Vol. None 0 µL Number Format XXX.X
Rinse None Calc. Method Lin-Lin Pt-Pt
Factor Plasma None 0 µL Standard Curve - Analysis Setting
Rinse (Pre./Post.) None None Calibrator SHP
First Reagent VWFAcII 70 µL 20 sec Buffer OVB
calibrator value.
Second Reagent VWFAcIII 13 µL 40 sec
Third Reagent VWFAcI 40 µL 350 sec Calib. or Dil Ratio 2 4/3 2
Detector Immuno for IMMUNO 2 Calib. or Dil Ratio 5 1/2 2
Sens/Wavelength Low Sens 800 nm Inc Calib. or Dil Ratio 6 1/7 2

- Select param. Param. VWFAcm - Replic. No. of Replicates 1
[Unit] %
lower (-) 0.0 %
upper (+) 150.0 %

VWFAc.m
% dOD
14.1 0.0137
49.5 0.1252
74.2 0.1968
99.0 0.2728
132.0 0.3407
178.2 0.3946

®
®
INNOVANCE VWF Ac

Parameter VWFAc.l Settings - Analysis Settings - More - Parameter Settings
Diluent Vol. None 0 µL Parameter VWFAcl
Rinse None Unit %
Calibrator SHP
First Reagent VWFAcII 70 µL 20 sec
calibrator value.
Second Reagent VWFAcIII 13 µL 40 sec Repl.
Third Reagent VWFAcI 40 µL 350 sec Calib. or Dil Ratio 3 1/8 2
Detector Immuno for IMMUNO2 Calib. or Dil Ratio 6 --- ---
Sens/Wavelength Low Sens 800 nm Inc

- Select param. Param. VWFAcl - Replic. No. of Replicates 1
[Unit] %

VWFAc.l
% dOD
3.9 0.0183
8.2 0.0539
12.2 0.0971
16.3 0.1374
24.5 0.2120

®
®
INNOVANCE VWF Ac
Remarks
All samples with unknown VWF concentration should be measured with VWFAc.m setting first.
It is necessary to switch ON [Reflex] and to switch OFF [Micro] for the respective samples in the worklist to enable both, reflex and redilution
feature.
Based on the analysis results the system will automatically perform either a redilution analysis if the VWF concentration exceeds the
calibration range or the system will automatically perform a reflex testing (VWF low setting) if the VWF concentration is below the calibration
range.
Please make sure that the parameters for IMMUNO2 are entered correctly according to the Service Setting Guide.
In order to guarantee reliable results it is crucial to modify the analysis parameter for this assay.
Settings/Data Check/Reflex Tests:
Choose an unused line, delete another if there is no line free and add the Reflex test.
Select [Insert]
Select [Param.]: Parameter Selection [VWFAc.m]/[VWFAcm %]
Select [<]
Select [Numeric Key] and enter 15
Select [Then]
Select [Param.]: Parameter [VWFAc.l]
The necessary technical modification has to be done by a Siemens representative
The errors listed in the table below may appear if the sample measured contains a very low or undetectable level of VWF (e.g. Type 3 von
Willebrand disease). If not already done, the sample should be measured by using the VWF low setting and also by using other assays, e.g.
VWF Ag.
Result Raw value Error code
****** ----.-- Range Over
***** 0.0000 ERR 0
***** ****** Reaction Curve Err

®
Appendix I Page 1 of 1
General Information to the Applications
CA CLEAN II
Material 45 mL 500 mL 5L
® ®
Dade Innovin X X X X
Multifibren® U X X X X
LA 1 REAGENT X X X X
LA 2 REAGENT X X X X
ProC® Global X X X X
®
ProC Ac R X X X X
Berichrom HEPARIN X X X X
Factor V Leiden Assay X X X X
CA CLEAN II is available as 45 mL, 500 mL and 5 L product variants (REF 10708787, 964-0611, 974-0581-0). The table above lists under
“Material” all kits requiring CA CLEAN II in addition to the material provided with the kit.
If required CA CLEAN II has to be transferred into an appropriate vial.
On-board Stability
The on-board stability of CA CLEAN I and CA CLEAN II for all applications is 48 h (in GW50 or PV-10 vials).
®
Dade CA System Buffer
The REF for Dade® CA System Buffer is B4265. For positioning on the analyzer, the buffer has to be transferred into an appropriate vial.

Appendix II Page 1 of 3
Symbol names of required Materials
Symbol names are depicted onto the reagent labels and are not translatable. In the following table symbol
names and corresponding product names in the language of this Reference Guide are listed.
Symbol name Product name
1. Reagents / Supplementary Reagents
® ®
ACTIN Dade Actin Activated Cephaloplastin Reagent
® ®
ACTIN FS Dade Actin FS Activated PTT Reagent
® ®
ACTIN FSL Dade Actin FSL Activated PTT Reagent
Batroxobin REAGENT Batroxobin Reagent
LA 1 REAGENT LA 1 Screening Reagent
LA 2 REAGENT LA 2 Confirmation Reagent
FACTOR II DEFICIENT Coagulation Factor II Deficient Plasma
FACTOR V DEFICIENT Coagulation Factor V Deficient Plasma
FACTOR VII DEFICIENT Coagulation Factor VII Deficient Plasma
FACTOR VIII DEFICIENT Coagulation Factor VIII Deficient Plasma
FACTOR IX DEFICIENT Coagulation Factor IX Deficient Plasma
FACTOR X DEFICIENT Coagulation Factor X Deficient Plasma
FACTOR XI DEFICIENT Coagulation Factor XI Deficient Plasma
FACTOR XII DEFICIENT Coagulation Factor XII Deficient Plasma
®
THROMBIN REAGENT Dade Thrombin Reagent
® ®
INNOVANCE D-Dimer DILUENT INNOVANCE D-Dimer Sample Diluent
CaCl2 SOLUTION Calcium Chloride Solution
CA CLEAN I CA CLEAN I
CA CLEAN II CA CLEAN II
®
CA SYSTEM BUFFER Dade CA System Buffer
®
OV BUFFER Dade Owren’s Veronal Buffer
®
Berichrom ANTIPLASMIN Berichrom α2-Antiplasmin
REAGENT P Plasmin
PLASMIN SUBSTRATE Plasmin Substrate
REAGENT P DILUENT Buffer Solution
®
Berichrom AT III Berichrom Antithrombin III (A)
REAGENT THR Thrombin Reagent
SUBSTRATE Substrate Reagent
REAGENT THR DILUENT Buffer Solution
®
Berichrom HEPARIN Berichrom Heparin
REAGENT AT AT III Reagent
REAGENT FX Factor Xa Reagent
REAGENT FX DILUENT Dextran Sulfate Reagent
®
Berichrom PLASMINOGEN Berichrom Plasminogen
REAGENT STR Streptokinase Reagent
PLASMIN SUBSTRATE Plasmin Substrate
®
Berichrom PROTEIN C Berichrom Protein C
ACTIVATOR Protein C Activator
ACTIVATOR DILUENT Hepes Buffer Solution


® ®
INNOVANCE Antithrombin INNOVANCE Antithrombin
®
REAGENT INNOVANCE Antithrombin Reagent
®
SUBSTRATE INNOVANCE Antithrombin Substrate
®
BUFFER INNOVANCE Antithrombin Buffer
® ®
INNOVANCE D-Dimer INNOVANCE D-Dimer
®
REAGENT INNOVANCE D-Dimer Reagent
®
BUFFER INNOVANCE D-Dimer Buffer
®
SUPPLEMENT INNOVANCE D-Dimer Supplement
®
DILUENT INNOVANCE D-Dimer Diluent
®
CALIBRATOR INNOVANCE D-Dimer Calibrator
® ®
INNOVANCE Free PS Ag INNOVANCE Free PS Ag
®
REAGENT INNOVANCE Free PS Ag Reagent
®
BUFFER INNOVANCE Free PS Ag Buffer
® ®
INNOVANCE VWF Ac INNOVANCE VWF Ac
®
REAGENT I INNOVANCE VWF Ac reagent I
®
REAGENT II INNOVANCE VWF Ac reagent II
®
REAGENT III INNOVANCE VWF Ac reagent III
FACTOR VIII CHROMOGENIC Factor VIII Chromogenic Assay
REAGENT FIX Factor IXa Reagent
REAGENT FX Factor X Reagent
SUBSTRATE BUFFER Stopping Buffer
®
FIBRINOGEN DETERMINATION Dade Fibrinogen Determination Reagents
®
THROMBIN REAGENT Dade Thrombin Reagent
®
FIBRINOGEN STANDARD Dade Fibrinogen Standard
®
OV BUFFER Dade Owren’s Veronal Buffer
TEST THROMBIN Test Thrombin Reagent
REAGENT Test Thrombin Reagent
REAGENT DILUENT Buffer Solution
® ®
ProC Ac R ProC Ac R
REAGENT PR3V Reagent
ACTIVATOR Activator Reagent
® ®
ProC Global ProC Global
®
ACTIVATOR Activator Reagent for ProC Global
®
BUFFER Buffer for ProC Global
®
REAGENT APTT APTT reagent for ProC Global
PROTEIN C COAG Protein C Reagent
REAGENT APTT APTT Reagent for Protein C
ACTIVATOR Protein C Activator
DEFICIENT Protein C Deficient Plasma
Protein S Ac Protein S Ac
REAGENT APC Reagent
DEFICIENT Deficient Plasma
ACTIVATOR Starting Reagent


vWF Ag vWF Ag
REAGENT Latex Reagent
(REAGENT DILUENT) (Diluent for Latex Reagent)
BUFFER Buffer
2. Standards / Controls
®
Berichrom HEPARIN LMW CALIBRATOR Berichrom Heparin LMW Calibrator
®
Berichrom HEPARIN UF CALIBRATOR Berichrom Heparin UF Calibrator
FIBRINOGEN CALIBRATOR Fibrinogen Calibrator Kit
STANDARD PLASMA Standard Human Plasma
PT-Multi CALIBRATOR PT-Multi Calibrator
®
Berichrom HEPARIN LMW CONTROL 1 Berichrom Heparin LMW Control 1
®
Berichrom HEPARIN LMW CONTROL 2 Berichrom Heparin LMW Control 2
®
Berichrom HEPARIN UF CONTROL 1 Berichrom Heparin UF Control 1
®
Berichrom HEPARIN UF CONTROL 2 Berichrom Heparin UF Control 2
® ®
Ci-Trol CONTROL 1 Dade Ci-Trol Coagulation Control Level 1
® ®
® ®
® ®
Ci-Trol HEPARIN CONTROL 1 Dade Ci-Trol Heparin Control, Low
® ®
Ci-Trol HEPARIN CONTROL 2 Dade Ci-Trol Heparin Control, High
CONTROL N Control Plasma N
CONTROL P Control Plasma P
® ®
Data-Fi FIBRINOGEN CONTROL Dade Data-Fi Abnormal Fibrinogen Control
D-Dimer CONTROL 1 D-Dimer Control Plasma I
LA CONTROL 1 LA Control low
LA CONTROL 2 LA Control high
®
ProC CONTROL ProC Control Plasma
® ®
INNOVANCE D-Dimer CONTROLS INNOVANCE D-Dimer Controls
®
CONTROL 1 INNOVANCE D-Dimer Control 1
®
CONTROL 2 INNOVANCE D-Dimer Control 2

Sysmex CA-1500 System Reference Guide 3.05 DXDCM 0900ac6d8005f093-1421696006187

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Sysmex CA-1500 System Reference Guide 3.05 DXDCM 0900ac6d8005f093-1421696006187

Uploaded by

Copyright:

Available Formats

®

Sysmex CA-1500 System

Reference Guide 3.05

Not for use in the USA

This document is Siemens Healthcare Diagnostics Reference Guide

Document ID: RG-32-01-3.05

Siemens Healthcare Diagnostics Products GmbH

Reference Guide 3.05 - not for use in the USA - 2

Deleted Application Sheet

Revised Application Sheets

Implementation of an Appendix II “Symbol names of required Materials”.

Reference Guide 3.05 - not for use in the USA - 3

Reference Guide 3.05 - not for use in the USA - 4

Version Application Sheet Page

Thrombin Time / Batroxobin Time

Reference Guide 3.05 - not for use in the USA - 5

Reference Guide 3.05 - not for use in the USA - 6

Reference Guide 3.05 - not for use in the USA - 7

Reference Guide 3.05 - not for use in the USA - 8

Test Protocol Standard Curve Calibration

Rinse (Pre./Post.) None None

Data Check Number of Replicates

Reference Guide 3.05 - not for use in the USA - 9

Reference Guide 3.05 - not for use in the USA - 10

Reference Guide 3.05 - not for use in the USA - 11

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

Reference Guide 3.05 - not for use in the USA - 12

Reference Guide 3.05 - not for use in the USA - 13

Reference Guide 3.05 - not for use in the USA - 14

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Reference Guide 3.05 - not for use in the USA - 15

Reference Guide 3.05 - not for use in the USA - 16

Reference Guide 3.05 - not for use in the USA - 17

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

Reference Guide 3.05 - not for use in the USA - 18

Reference Guide 3.05 - not for use in the USA - 19

Mean Repeatability Within-Device/Lab

Reference Guide 3.05 - not for use in the USA - 20

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

Reference Guide 3.05 - not for use in the USA - 21

Reference Guide 3.05 - not for use in the USA - 22

Reference Guide 3.05 - not for use in the USA - 23

Test Protocol Standard Curve Calibration

Rinse (Pre./Post.) None None

Data Check Number of Replicates

Reference Guide 3.05 - not for use in the USA - 24

Reference Guide 3.05 - not for use in the USA - 25

Reference Guide 3.05 - not for use in the USA - 26

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

Reference Guide 3.05 - not for use in the USA - 27

Reference Guide 3.05 - not for use in the USA - 28

Reference Guide 3.05 - not for use in the USA - 29

Test Protocol Standard Curve Calibration

Data Check Number of Replicates