Sysmex CA-500 - 600 Series System Reference Guide 3.05

Sysmex CA-500/CA-600 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-500/CA-600 System. From December
2014, this document is the only relevant source for assay application
information on the Sysmex® CA-500/CA-600 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-31-01-3.05

Sysmex® CA-500/CA-600 System
Trademarks
Actin, BCT, Berichrom, Ci-Trol, Dade, Data-Fi, INNOVANCE, Innovin, Multifibren, Pathromtin and
Thromborel are trademarks of Siemens Healthcare Diagnostics.
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 2014-12 New Application Sheets
3.05 None
Deleted Application Sheet

None
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.
Additional information on CA CLEAN II (new: addition of 45 mL-product variant)

and Dade® CA System Buffer are summarized in the Appendix I.
Implementation of an Appendix II “Symbol names of required Materials”.
Changes in detail
None
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
®
12 PT seconds with Thromborel S ............................................................................................................................7
®
14 PT % with Thromborel S.....................................................................................................................................10
®
12 PT INR with Thromborel S..................................................................................................................................14
12 PT INR calibrated with Thromborel® S .................................................................................................................17
®
14 Derived Fibrinogen with Thromborel S ...............................................................................................................21
® ®
12 PT seconds with Dade Innovin .........................................................................................................................24
® ®
13 PT % with Dade Innovin ...................................................................................................................................27
14 PT INR with Dade Innovin® ................................................................................................................................31
®
® ®
11 PT INR calibrated with Dade Innovin ................................................................................................................34
15 Derived Fibrinogen with Dade® Innovin® ..............................................................................................................38
APTT
13 APTT with Dade® Actin® Activated Cephaloplastin Reagent ................................................................................41
® ®
13 APTT with Dade Actin FS Activated PTT Reagent ...........................................................................................44
13 APTT with Dade® Actin® FSL Activated PTT Reagent .........................................................................................47
®
13 APTT with Pathromtin SL ...................................................................................................................................50
Fibrinogen
®
14 Fibrinogen with Multifibren U ..............................................................................................................................53
15 Fibrinogen with Dade® Thrombin Reagent ...........................................................................................................56
Thrombin Time / Batroxobin Time

11 Thrombin Time with Test Thrombin Reagent .......................................................................................................61
11 Thrombin Time with Thromboclotin® ....................................................................................................................64
10 Batroxobin Time with Batroxobin Reagent ...........................................................................................................67
Clotting Assays
®
10 Coagulation Factor VII with Thromborel S ..........................................................................................................70
11 Coagulation Factor VII with Dade® Innovin® .........................................................................................................73
® ®
11 Coagulation Factor VIII with Dade Actin Activated Cephaloplastin Reagent.....................................................76
11 Coagulation Factor VIII with Dade Actin® FSL Activated PTT Reagent ..............................................................80
®
®
12 Coagulation Factor VIII with Pathromtin SL ........................................................................................................84
11 Lupus Anticoagulant with LA 1 Screening Reagent / LA 2 Confirmation Reagent................................................88
14 Protein C with Protein C Reagent ........................................................................................................................92
Chromogenic Assays
®
06 Antithrombin with INNOVANCE Antithrombin .....................................................................................................95
®
13 Antithrombin III with Berichrom Antithrombin III (A) ............................................................................................98
®
12 Heparin with Berichrom Heparin .......................................................................................................................101
06 Heparin (LMW) with Berichrom® Heparin ...........................................................................................................104
®
06 Heparin (UF) with Berichrom Heparin...............................................................................................................107
®
13 Protein C with Berichrom Protein C ..................................................................................................................110

Immunoassays
13 D-Dimer with D-Dimer PLUS ..............................................................................................................................113
13 D-Dimer with Advanced D-Dimer .......................................................................................................................117
10 D-Dimer with INNOVANCE® D-Dimer ................................................................................................................121
11 von Willebrand Factor with vWF Ag ...................................................................................................................126
Others
®
04 von Willebrand Factor with INNOVANCE VWF Ac ...........................................................................................131
Appendix I
Information on CA CLEAN I, CA CLEAN II and Dade® CA System Buffer .........................................................136
Appendix II
Symbol names of required Materials ..................................................................................................................137

®
Sysmex CA-500/CA-600 System
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
® [1]
Thromborel S OUHP
Reagent holder position 1 4/10 mL Reagent holder position 1 [1]
Ci-Trol CONTROL 1 B4244-10 1 mL 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
CA CLEAN I Rinse position 11
964-0631-3 50 mL Rinse position 11
BC Vial Kit — OVKE 5 mL —
Additional Notes
If reagents, rinse solutions or buffers are not supplied in exactly fitting vials it is necessary to transfer them into appropiate vials.
The required controls have to be transferred into appropriate sample cups.
[1]
Alternatively, any other cooled reagent position can be used.
Please note: If reagents recommended for cooling are stored on a non-cooled position, a reduced on-board stability has to be anticipated.
On-board Stability
Material Name in Test Protocol Time [h]
Thromborel® S PT THS 24
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 378
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 Sysmex® CA-6000 System y = 1.00 x - 0.50 0.999
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 (%)
Ci-Trol CONTROL 3/ Dade® Ci-Trol® 3 1,1 1,0 1,5
CONTROL N 0.7 0.7 0.9
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
— 158 10.2 9.3 - 11.6
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

Special Menu - Settings - Analysis Settings - Test Protocol The assay is not calibrated.
Test Protocol Name PT STD-Link No
[1]
Manage. ID 5000, 5010
Detector for PT THS
End Point 50 %
Maximum Time 100 sec
Sensitivity Low Gain
Sample Vol 50 µL
Dil.Vol ******* 0 µL
Pre. Rinse ******* x0
Post. Rinse ******* x0
2nd Dil
D.Samp Vol 0 µL
Reagent 1 180 sec
Reag. Vol PT THS 100 µL
Post. Rinse Clean I x1
Reagent 2 0 sec
Reag. Vol ******* 0 µL
Reagent 3 0 sec
[1]
The Management ID only applies to the CA-600 System.
Data Check Number of Replicates

Special Menu - Settings - Data Check Special Menu - Settings - Analysis Settings
- Mark Limits Select Param. PT - Set Replication Replicates 1

®
PT % with
®
Thromborel S
analytical values.
and other findings.
Materials Required
® [1]
Thromborel S OUHP
PT-Multi CALIBRATOR Sample rack OPAT
position 1 - 5 6 x 1 mL Sample rack position 1 - 5
® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Rinse position 11 50 mL Rinse position 11
Additional Notes
The required controls and calibrators have to be transferred into appropriate sample cups.
®
PT-Multi Calibrator Level 6 is not used in combination with Thromborel S.
[1]
On-board Stability
Bilirubin mg/dL 6

®
PT % with
®
Thromborel S
Method Comparison
Calibration with FNP pool using Thromborel® S on Sysmex® CA-500 series System y = 1.02 x + 0.54 0.999
Precision
CV (%) CV (%) CV (%)
Ci-Trol CONTROL 2/ Dade® Ci-Trol® 2 2.6 2.7 3.7
CONTROL N 2.2 1.7 2.6
Measuring Range
The measuring range is defined by the concentration of the calibrators used.
Expected Values
Unit: % of norm
th th
Comments n Median 2.5 - 97.5 Percentile
— 158 102 79 - 122
Reference intervals may vary from laboratory to laboratory. Therefore, each laboratory should establish its own reference intervals.
USA Distributor

®
PT % with
®
Thromborel S

Special Menu - Settings - Analysis Settings - Test Protocol Calibration Parameter 1
Test Protocol Name PT STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 5000, 5010 Param. PT%
Detector for PT THS Units %
End Point 50 % Number Format XXX.X
Maximum Time 100 sec Curve Fit Log Curve
Sensitivity Low Gain Standard Curve - Standard Analysis
Select Dilution Set M
Sample Vol 50 µL
Calibrator PT-Multi CALIBRATOR
Pre. Rinse ******* x0 Refer to the Table of Analytical Values for the lot specific
Post. Rinse ******* x0 calibrator value.
2nd Dil Repl.
D.Samp Vol 0 µL Calib. or Dil.Ratio 1 Calibrator 1 2
Dil.Vol ******* 0 µL Calib. or Dil.Ratio 2 Calibrator 2 2
Pre. Rinse ******* x0 Calib. or Dil.Ratio 3 Calibrator 3 2
Post. Rinse ******* x0 Calib. or Dil.Ratio 4 Calibrator 4 2
Reagent 1 180 sec Calib. or Dil.Ratio 5 Calibrator 5 2
Reag. Vol PT THS 100 µL Calib. or Dil.Ratio 6 — —
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. PT% - Set Replication Replicates 1
- Report Limits lower (<) 5.0 %
upper (>) 130.0 %
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
117.0 10.0
66.0 14.2
42.0 19.6
22.0 36.9
13.0 68.1

®
PT % with
®
Thromborel S
Remarks
If the Derived Fibrinogen method is also used on the instrument, the Derived Fibrinogen method has to be disabled during the calibration
with PT-Multi Calibrator to avoid overwriting the Derived Fibrinogen master curve.
- Press [Standard Curve] - [Select Param.], disable the parameter No. 4 “dFbg”
- Perform calibration with PT-Multi Calibrator according to the Application Sheet
- Press [Standard Curve] - [Select Param.], enable the parameter No. 4 “dFbg”
Nevertheless, please check all calibration curve data afterwards.

®
PT INR with
®
Thromborel S
analytical values.
and other findings.
Materials Required
® [1]
Thromborel S OUHP
STANDARD PLASMA [2] Sample rack ORKL
position 1 1 mL Sample rack position 1
® ®
® ®
® ®
CONTROL N ORKE 1 mL
Additional Notes
[1]
[2]
Optional; only required to establish the MNPT.
On-board Stability
Bilirubin mg/dL 36

®
PT INR with
®
Thromborel S
Method Comparison
Thromborel® S on Sysmex® CA-6000 System y = 0.89 x + 0.11 0.999
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.6 0.6 0.8
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
PT INR with
®
Thromborel S

[1]
Manage. ID 5010 Param. PT-INR
Detector for PT THS Units —
End Point 50 % Number Format XX.XX
Maximum Time 100 sec Curve Fit ISI Input
Sensitivity Low Gain Standard Curve - Manual Entry
Enter the Normal seconds = MNPT and the ISI.
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 180 sec
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. PT-INR - Set Replication Replicates 1
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
® [1]
Thromborel S OUHP
® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Additional Notes
®
PT-Multi Calibrator Level 6 is not used in combination with Thromborel S.
[1]
On-board Stability
Bilirubin mg/dL 12

®
®
Thromborel S
Method Comparison
Calibration with MNPT and ISI using Thromborel® S on Sysmex® CA-500 series System y = 0.85 x + 0.16 1.000
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.9 1.1 1.4
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
®
Thromborel S

[1]
Detector for PT THS Units —
Maximum Time 100 sec Curve Fit Calibration
Sample Vol 50 µL
2nd Dil Repl.
Reag. Vol PT THS 100 µL Calib. or Dil.Ratio 6 — —
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Report Limits lower (<) 0.80
upper (>) 6.00

PT-INR
— s
0.98 10.6
1.22 13.5
1.54 18.0
2.47 30.5
4.40 55.6

®
®
Thromborel S
Remarks

®
Derived Fibrinogen with
®
Thromborel S
analytical values.
and other findings.
Materials Required
® [1]
Thromborel S OUHP
® ®
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
Triglycerides mg/dL ---*
Bilirubin mg/dL 36
* 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 6 g HES per liter plasma.

®
®
Thromborel S
Method Comparison
Dade® Thrombin Reagent on Sysmex® CA-500 System y = 1.00 x - 0.10 0.870
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 2.7 1.6 1.9
Measuring Range
Expected Values
Unit: g/L
Comments n Mean Median 2.5th - 97.5th Percentile
— 124 2.8 2.7 1.9 - 4.0
USA Distributor

®
®
Thromborel S

Special Menu - Settings - Analysis Settings - Test Protocol Important Note:
Test Protocol Name PT STD-Link No The recommendation for the Number Format in Calibration
[1]
5000, 5010 Parameter differs from the information that is given in the
Manage. ID
Detector for PT THS Instructions for Use of the analyzer. Please check your Host
System for correct interpretation of transmitted results
End Point 50 %
whenever the Number Format will be changed.
Calibration Parameter 4
Sensitivity Low Gain Standard Curve - Select Param.
Param. dFbg
Sample Vol 50 µL
Units g/L or mg/dL
Number Format XXX.X or XXXX
Curve Fit —
2nd Dil Standard Curve - Manual Entry - Next (if applicable)
D.Samp Vol 0 µL Enter the Derived Fibrinogen g/L or mg/dL concentrations
Dil.Vol ******* 0 µL and the dH of the Master Curve specified in the “Table of
Pre. Rinse ******* x0 Assigned Values” of the specific Lot No. of the reagent used
Post. Rinse ******* x0 for the analyzer.
Reagent 1 180 sec
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. dFbg - Set Replication Replicates 1

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 dH
1.9 62
4.0 144

®
PT seconds with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin position 1 4/10/20 mL Reagent holder position 1 [1]
B4212
Reagent holder [1]

® ®
® ®
CONTROL N ORKE 1 mL
Additional Notes
[1]
On-board Stability
Dade® Innovin® PT INN 24
Bilirubin mg/dL 48

®
PT seconds with
® ®
Dade Innovin
Method Comparison
Dade® Innovin® on Sysmex® CA-6000 System y = 1.03 x - 0.26 0.999
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.2 0.4
Measuring Range
Expected Values
Unit: s
th th
Comments n Mean Median 2.5 - 97.5 Percentile
— 158 10.2 9.3 - 11.4
USA Distributor

®
PT seconds with
® ®
Dade Innovin

Test Protocol Name PT STD-Link No
[1]
Manage. ID 5100, 5110
Detector for PT INN
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 180 sec
Reag. Vol PT INN 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. PT - Set Replication Replicates 1
Remarks
As an alternative protocol it is admitted to extend the Maximum Time to 300 seconds if long coagulation times are expected.

®
PT % with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212
Reagent holder [1]

® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
Bilirubin mg/dL 24

®
PT % with
® ®
Dade Innovin
Method Comparison
Calibration with FNP pool and Dade® Innovin® on Sysmex® CA-500 series System y = 1.09 x - 0.57 1.000
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.3 2.4 3.2
Measuring Range
Expected Values
Unit: % of norm
th th
Comments n 2.5 - 97.5 Percentile
— 158 99 76 - 122
USA Distributor

®
PT % with
® ®
Dade Innovin

[1]
Manage. ID 5100, 5110 Param. PT%
Detector for PT INN Units %
Sample Vol 50 µL
2nd Dil Repl.
Reag. Vol PT INN 100 µL Calib. or Dil.Ratio 6 Calibrator 6 2
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. PT% - Set Replication Replicates 1
upper (>) 130.0 %

PT%
% s
105.0 10.5
67.0 12.5
44.0 15.6
23.0 25.8
13.0 42.3
10.0 49.6

®
PT % with
® ®
Dade Innovin
Remarks

®
PT INR with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212
Reagent holder [1]
STANDARD PLASMA [2] Sample rack ORKL

® ®
® ®
® ®
CONTROL N ORKE 1 mL
Additional Notes
[1]
[2]
Optional; only required to establish the MNPT.
On-board Stability
Bilirubin mg/dL 60

®
PT INR with
® ®
Dade Innovin
Method Comparison
Dade® Innovin® on Sysmex® CA-6000 System y = 1.08 x - 0.09 0.999
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.2 0.4
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
PT INR with
® ®
Dade Innovin

[1]
Detector for PT INN Units —
Maximum Time 100 sec Curve Fit ISI Input
Sensitivity Low Gain Standard Curve - Manual Entry
Enter the Normal seconds = MNPT and the ISI.
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 180 sec
Reagent 2 0 sec
Reagent 3 0 sec
[1]

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
® ®
B4212
Reagent holder [1]

® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
Bilirubin mg/dL 36

®
® ®
Dade Innovin
Method Comparison
Calibration with MNPT and ISI using Dade® Innovin® on Sysmex® CA-500 series System y = 1.07 x - 0.11 1.000
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.0 1.1 1.5
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
® ®
Dade Innovin

[1]
Detector for PT INN Units —
Maximum Time 100 sec Curve Fit Calibration
Sample Vol 50 µL
2nd Dil Repl.
Reag. Vol PT INN 100 µL Calib. or Dil.Ratio 6 Calibrator 6 2
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Report Limits lower (<) 0.80
upper (>) 6.00

PT-INR
— s
0.99 10.4
1.19 12.6
1.43 15.2
2.14 22.8
3.64 38.5
4.77 50.3

®
® ®
Dade Innovin
Remarks

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212
Reagent holder [1]

® ®
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
Bilirubin mg/dL 36
* 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-500 System y = 1.25 x - 0.58 0.857
Precision

(g/L) CV (%) CV (%)
Measuring Range
Expected Values
Unit: g/L
— 123 2.9 2.8 2.0 - 4.2
USA Distributor

®
® ®
Dade Innovin

Test Protocol Name PT STD-Link No The recommendation for the Number Format in Calibration
[1]
5100, 5110 Parameter differs from the information that is given in the
Manage. ID
Detector for PT INN Instructions for Use of the analyzer. Please check your Host
End Point 50 %
Param. dFbg
Sample Vol 50 µL
Units g/L or mg/dL
Curve Fit —
2nd Dil Standard Curve - Manual Entry - Next (if applicable)
D.Samp Vol 0 µL Enter the Derived Fibrinogen g/L or mg/dL concentrations
Dil.Vol ******* 0 µL and the dH of the Master Curve specified in the “Table of
Pre. Rinse ******* x0 Assigned Values” of the specific Lot No. of the reagent used
Post. Rinse ******* x0 for the analyzer.
Reagent 1 180 sec
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. dFbg - Set Replication Replicates 1

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 dH
2.0 43
4.2 84

®
APTT with
® ®
Dade Actin Activated Cephaloplastin Reagent
analytical values.
and other findings.
Materials Required
[1]
ACTIN B4218-1/-2
® ®
CONTROL N ORKE 1 mL
[2]
CaCl2 SOLUTION ORHO
Reagent holder position 7 15 mL Reagent holder position 7 [2]
CA CLEAN I Rinse position
964-0631-3
11 50 mL Rinse position 11
Additional Notes
[1]
[2]
Alternatively, any other non-cooled reagent position (positions 5 to 10) can be used.
On-board Stability
Dade® Actin® Reagent (cooled pos.) PTT ACT 48
® ®
Dade Actin Reagent (non-cooled pos.) 24
CaCl2 SOLUTION CaCl2 48
Hemoglobin mg/dL 40
Bilirubin mg/dL 12

®
APTT with
® ®
Method Comparison
Dade® Actin® Activated Cephaloplastin Reagent on Sysmex® CA-6000 System y = 1.00 x - 0.20 0.982
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.0 3.4 3.5
Measuring Range
Expected Values
Unit: s
th th
Comments n Mean Median 5 - 95 Percentile
— 111 25.7 25.6 21.4 - 30.6
USA Distributor

®
APTT with
® ®

Test Protocol Name APTT STD-Link No
[1]
Manage. ID 5200
Detector for PTT ACT
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol PTT ACT 50 µL
Reagent 2 240 sec
Reag. Vol CaCl2 50 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. APTT - Set Replication Replicates 1

®
APTT with
® ®
Dade Actin FS Activated PTT Reagent
analytical values.
and other findings.
Materials Required
[1]
ACTIN FS ReagentB4218-20/-100
holder position 2 2/10 mL Reagent holder position 2 [1]
® ®
CONTROL N ORKE 1 mL
[2]
CaCl2 SOLUTION ORHO
964-0631-3
Additional Notes
[1]
[2]
On-board Stability
Dade® Actin® FS Reagent (cooled pos.) PTT FS 48
® ®
Dade Actin FS Reagent (non-cooled pos.) 24
Bilirubin mg/dL 6

®
APTT with
® ®
Method Comparison
Dade® Actin® FS Activated PTT Reagent on Sysmex® CA-6000 System y = 1.00 x + 0.10 0.983
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.5 0.2 0.5
Measuring Range
Expected Values
Unit: s
th th
— 111 24.8 24.6 21.8 - 28.0
USA Distributor

®
APTT with
® ®

[1]
Manage. ID 5210
Detector for PTT FS
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol PTT FS 50 µL
Reagent 2 240 sec
Reagent 3 0 sec
[1]


®
APTT with
® ®
Dade Actin FSL Activated PTT Reagent
analytical values.
and other findings.
Materials Required
[1]
ACTIN FSL B4219
® ®
CONTROL N ORKE 1 mL
[2]
CaCl2 SOLUTION ORHO
964-0631-3
Additional Notes
[1]
[2]
On-board Stability
Dade® Actin® FSL Reagent (cooled pos.) PTT FSL 48
® ®
Dade Actin FSL Reagent (non-cooled pos.) 24
Bilirubin mg/dL 12

®
APTT with
® ®
Method Comparison
Dade® Actin® FSL Activated PTT Reagent on Sysmex® CA-6000 System y = 1.00 x + 0.10 0.990
Precision
CV (%) CV (%) CV (%)
CONTROL N 0.4 0.2 0.4
Measuring Range
Expected Values
Unit: s
th th
— 111 27.9 27.7 24.5 - 32.8
USA Distributor

®
APTT with
® ®

[1]
Manage. ID 5220
Detector for PTT FSL
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol PTT FSL 50 µL
Reagent 2 240 sec
Reagent 3 0 sec
[1]

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
® [1]
Pathromtin SL OQGS
® ®
CONTROL N ORKE 1 mL
[2]
CaCl2 SOLUTION ORHO
964-0631-3
Additional Notes
The reagent must be gently inverted (5 to 8 times) to mix before first use.
[1]
[2]
On-board Stability
®
Pathromtin SL (cooled pos.) PTT PSL 48
Pathromtin® SL (non-cooled pos.) 24
Bilirubin mg/dL 2.4

®
APTT with
®
Pathromtin SL
Method Comparison
Pathromtin® SL on Sysmex® CA-6000 System y = 0.99 x - 1.10 0.968
Precision
CV (%) CV (%) CV (%)
Measuring Range
Expected Values
Unit: s
th th
— 110 34.1 33.8 29.0 - 40.2
USA Distributor

®
APTT with
®
Pathromtin SL

[1]
Manage. ID 5230
Detector for PTT PSL
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 30 sec
Reag. Vol PTT PSL 50 µL
Reagent 2 150 sec
Reagent 3 0 sec
[1]


®
Fibrinogen with
®
Multifibren U
analytical values.
and other findings.
Materials Required
® [1]
Multifibren U OWZG
FIBRINOGEN CALIBRATOR Sample rack OQVK
CONTROL N Any position ORKE
on sample rack 1 mL Any position on sample rack
964-0631-3
Additional Notes
CA CLEAN I has to be transferred into an appropriate vial.
[1]
On-board Stability
®
Multifibren U Fbg MFU 24
Bilirubin mg/dL 36
Limitations

®
Fibrinogen with
®
Multifibren U
Method Comparison
Multifibren® U on BCT® System y = 1.01 x - 0.28 0.973
Precision
CV (%) CV (%) CV (%)
CONTROL N 4.5 3.1 5.3
Pathological plasma pool 3.5 1.4 3.6
Measuring Range
Expected Values
Unit: g/L
th th
— 124 2.6 2.6 1.9 - 3.5
USA Distributor

®
Fibrinogen with
®
Multifibren U

Test Protocol Name Fbg STD-Link No The recommendation for the Number Format in Calibration
[1]
5360 Parameter differs from the information that is given in the
Manage. ID
Detector for Fbg Instructions for Use of the analyzer. Please check your Host
End Point 30 %
Param. Fbg.C
Sample Vol 100 µL
Units g/L or mg/dL
Curve Fit Log Curve
2nd Dil Standard Curve - Standard Analysis
D.Samp Vol 0 µL Select Dilution Set M
Dil.Vol ******* 0 µL Calibrator Fib. Calibrator Kit
Reagent 1 60 sec Repl.
Reag. Vol Fbg MFU 100 µL Calib. or Dil.Ratio 1 Calibrator 2 2
Calib. or Dil.Ratio 3 Calibrator 4 2
Reag. Vol ******* 0 µL Calib. or Dil.Ratio 5 Calibrator 6 2
Calib. or Dil.Ratio 6 — —
Reagent 3 0 sec
[1]

- Mark Limits Select Param. Fbg.C - Set Replication Replicates 1
- Report Limits lower (<) 1.1 g/L or 110 mg/dL
upper (>) 8.0 g/L or 800 mg/dL

Fbg.C
g/L s
8.0 7.3
5.4 8.5
3.5 11.4
2.4 14.4
1.1 25.6
Remarks
Fibrinogen Calibrator 1 is not used in this test.

®
Fibrinogen with
®
Dade Thrombin Reagent
analytical values.
and other findings.
Materials Required
FIBRINOGEN DETERMINATION — B4233-15SY Kit —
THROMBIN REAGENT Reagent holder—position 3 [1] 1 mL Reagent holder position 3 [1]
FIBRINOGEN STANDARD —
Sample rack position 1 1 mL Sample rack position 1
OV BUFFER (OVB) Buffer position —
12 15 mL Buffer position 12
THROMBIN REAGENT holder position 3 [1] 1/5 mL
Reagent B4233-25/-27 Reagent holder position 3 [1]
STANDARD PLASMA (SHP) Sample rack ORKL
CONTROL P OUPZ 1 mL
Data-Fi FIBRINOGEN CONTROL B4233-22 1 mL
CA SYSTEM BUFFER (OVB) —[2] — Buffer position 12
OV BUFFER (OVB) B4234-25 15 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
For additional information please refer to the Appendix I.
On-board Stability
THROMBIN REAGENT Fbg 24
CA SYSTEM BUFFER (in GW5 or SLD vials) OVB 8
OV BUFFER (in GW5 or SLD vials) 8

®
Fibrinogen with
®
Bilirubin mg/dL 48
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-1500 System y = 1.05 x + 0.04 0.974
Precision
CV (%) CV (%) CV (%)
Data-Fi FIBRINOGEN CONTROL 3.8 3.0 4.8
Measuring Range
Expected Values
Unit: g/L
Comments n Mean Median 5th - 95th Percentile
— 123 2.73 2.70 2.10 - 3.58
USA Distributor

®
Fibrinogen with
®

Test Protocol Name Fbg STD-Link Master The recommendation for the Number Format in Calibration
[1]
5300 Parameter differs from the information that is given in the
Manage. ID
Detector for Fbg Instructions for Use of the analyzer. Please check your Host
End Point 50 %
Sensitivity High Gain Standard Curve - Select Param.
Param. Fbg.C
Sample Vol 10 µL
Units g/L or mg/dL
Dil.Vol OVB 90 µL
Number Format XX.XX or XXXX
Curve Fit Log Curve
2nd Dil Standard Curve - Standard Analysis
D.Samp Vol 0 µL Select Dilution Set 9
Dil.Vol ******* 0 µL Calibrator SHP
Reagent 1 60 sec Repl.
Reag. Vol Fbg 50 µL Calib. or Dil.Ratio 1 2/1 2
Pre. Rinse ******* x0 Calib. or Dil.Ratio 2 3/2 2
Calib. or Dil.Ratio 3 1/1 2
Reagent 2 0 sec Calib. or Dil.Ratio 4 1/2 2
Reag. Vol ******* 0 µL Calib. or Dil.Ratio 5 1/3 2
Calib. or Dil.Ratio 6 0/1 0
Reagent 3 0 sec
[1]

All samples exceeding the mentioned report limits should be Special Menu - Settings - Analysis Settings
repeated using the appropriate +Fbg or -Fbg setting again. The Replicates 1
- Set Replication
redilution has to be requested manually.
Special Menu - Settings - Data Check
- Mark Limits Select Param. Fbg.C

Fbg.C
g/L s
5.20 5.5
3.90 6.7
2.60 9.6
1.30 19.2
0.87 34.1

®
Fibrinogen with
®

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve created with “Fbg” will be
Test Protocol Name +Fbg STD-Link Fbg used automatically. For more information refer to the
[1]
5310 Instructions for Use of the Analyzer.
Manage. ID
Detector for Fbg
End Point 50 %
Sensitivity High Gain
Sample Vol 5 µL
Dil.Vol OVB 95 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol Fbg 50 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. +Fbg - Set Replication Replicates 1
upper (>) 10.00 g/L or 1000 mg/dL

®
Fibrinogen with
®

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve created with “Fbg” will be
Test Protocol Name -Fbg STD-Link Fbg used automatically. For more information refer to the
[1]
5320 Instructions for Use of the Analyzer.
Manage. ID
Detector for Fbg
End Point 50 %
Sensitivity High Gain
Sample Vol 20 µL
Dil.Vol OVB 80 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol Fbg 50 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. -Fbg - Set Replication Replicates 1

®
Thrombin Time with
Test Thrombin Reagent
analytical values.
and other findings.
Materials Required
TEST THROMBIN — OWHM Kit —
REAGENT Reagent holder—position 2 [1] 5 mL Reagent holder position 2 [1]
REAGENT DILUENT — — 50 mL —
CONTROL N on sample rack 1 mL
Any position ORKE Any position on sample rack
CA CLEAN I 964-0631-3
Additional Notes
[1]
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
REAGENT TestThr 24
Hemoglobin mg/dL 20
Bilirubin mg/dL 24

®
Thrombin Time with
Method Comparison
Test Thrombin Reagent on BFA System y = 0.56 x + 5.69 0.946
Precision
CV (%) CV (%) CV (%)
CONTROL N 6.2 3.9 7.0
Measuring Range
Expected Values
Unit: s
— 180 17.8 17.9 16.1 - 19.5
USA Distributor

®
Thrombin Time with

Test Protocol Name TT STD-Link No
[1]
Manage. ID 5330
Detector for TT
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol TestThr 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. TT - Set Replication Replicates 1

®
Thrombin Time with
®
Thromboclotin
analytical values.
and other findings.
Materials Required
® [1]
Thromboclotin 281007
® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
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® Thrombo 48
Bilirubin mg/dL 12

®
Thrombin Time with
®
Thromboclotin
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 1.2 3.1
Measuring Range
Expected Values
Refer to the Instructions for Use of the reagent.
USA Distributor

®
Thrombin Time with
®
Thromboclotin

Test Protocol Name TT STD-Link No
[1]
Manage. ID 5340
Detector for TT
End Point 50 %
Sample Vol 100 µL

2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol Thrombo 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. TT - Set Replication Replicates 1

®
Batroxobin Time with
Batroxobin Reagent
analytical values.
and other findings.
Materials Required
[1]
Batroxobin REAGENT OUOV
® ®
CONTROL N ORKE 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
Batroxobin REAGENT Batrox 48
Bilirubin mg/dL 12

®
Batroxobin Reagent
Method Comparison
Batroxobin Reagent on BCT® System y = 0.77 x + 5.66 0.984
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.0 1.2 1.5
Measuring Range
Expected Values
Unit: s
th th
— 66 17.6 17.6 16.7 - 18.9
USA Distributor

®
Batroxobin Reagent

Test Protocol Name BXT STD-Link No
[1]
Manage. ID 5350
Detector for BXT
End Point 50 %
Sample Vol 50 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol Batrox 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. BXT - Set Replication Replicates 1

®
Coagulation Factor VII with
®
Thromborel S
analytical values.
and other findings.
Materials Required
® [1]
Thromborel S OUHP
FACTOR VII DEFICIENT position 6 [2]
OTXV
Reagent holder 1 mL Reagent holder position 6 [2]
CONTROL N ORKE 1 mL Any position on sample rack
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
[3]
On-board Stability
FACTOR VII DEFICIENT VII 6
Bilirubin mg/dL 36

®
®
Thromborel S
Method Comparison
Thromborel® S on BCT® System y = 1.04 x + 3.44 0.979
Precision
CV (%) CV (%) CV (%)
CONTROL N 7.4 4.4 8.2
CONTROL P 4.1 7.7 8.6
Measuring Range
Expected Values
Refer to the Coagulation Factors II, VII and X Deficient Plasma Instructions for Use.
USA Distributor

®
®
Thromborel S

Test Protocol Name VII STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 5400 Param. VII%
Detector for F-Ext [2] Units %
Select Dilution Set 8
Sample Vol 5 µL
Calibrator SHP
Dil.Vol OVB 45 µL
2nd Dil Repl.
D.Samp Vol 0 µL Calib. or Dil.Ratio 1 3/2 2
Dil.Vol ******* 0 µL Calib. or Dil.Ratio 2 1/1 2
Post. Rinse ******* x0 Calib. or Dil.Ratio 4 1/4 2
Reag. Vol VII 50 µL Calib. or Dil.Ratio 6 0/1 0
Reagent 2 90 sec
Reagent 3 0 sec
[1]
[2]
For the CA-600 System, it is also possible to select the detector 'for
FExtTHS'.

- Mark Limits Select Param. VII% - Set Replication Replicates 1

VII%
% s
139.5 20.8
93.0 24.2
46.5 30.4
23.2 39.3
11.6 51.6
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.

®
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
B4212
Reagent holder [1]
FACTOR VII DEFICIENT position 6 [2]

OTXV
Reagent holder 1 mL Reagent holder position 6 [2]
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
[3]
On-board Stability
FACTOR VII DEFICIENT VII 8
Bilirubin mg/dL 36

®
® ®
Dade Innovin
Method Comparison
Thromborel® S on BCT® System y = 0.97 x - 1.55 0.976
Precision
CV (%) CV (%) CV (%)
CONTROL N 5.0 1.3 4.9
CONTROL P 3.9 1.8 4.1
Measuring Range
Expected Values
Refer to the Coagulation Factors II, VII and X Deficient Plasma Instructions for Use.
USA Distributor

®
® ®
Dade Innovin

Test Protocol Name VII STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 5410 Param. VII%
Detector for F-Ext [2] Units %
Sample Vol 5 µL
Calibrator SHP
Dil.Vol OVB 45 µL
2nd Dil Repl.
Reag. Vol VII 50 µL Calib. or Dil.Ratio 6 0/1 0
Reagent 2 90 sec
Reagent 3 0 sec
[1]
[2]
FExtINN'.

- Mark Limits Select Param. VII% - Set Replication Replicates 1

VII%
% s
139.5 17.0
93.0 20.1
46.5 26.7
23.3 36.9
11.6 54.4
Remarks
Important!

®
Coagulation Factor VIII with
® ®
analytical values.
and other findings.
Materials Required
[1]
ACTIN B4218-1/-2
FACTOR VIII DEFICIENT OTXW
Reagent holder position 8 [2] 1 mL Reagent holder position 8 [2]
CONTROL P OUPZ 1 mL
CaCl2 SOLUTION ORHO
[3]
CA SYSTEM BUFFER (OVB) — — Buffer position 12
CA CLEAN I 964-0631-3
BC Vial Kit — OVKE 5 / 15 mL —
Additional Notes
[1]
[2]
[3]
On-board Stability
ACTIN PTT ACT 48
FACTOR VIII DEFICIENT VIII 4
Bilirubin mg/dL 48

®
® ®
Method Comparison
Pathromtin® SL on BCT® System y = 1.05 x + 2.24 0.965
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 5.3 6.1
CONTROL P 4.6 6.2 7.6
Measuring Range
Expected Values
Refer to the Coagulation Factors VIII, IX, XI and XII Deficient Plasma Instructions for Use.
USA Distributor

®
® ®

Special Menu - Settings - Analysis Settings - Test Protocol For higher concentrations (approx. 150 - 12.5 %) select
Test Protocol Name VIII STD-Link No Dilution Set 8.
[1]
5420 Calibration Parameter 1
Manage. ID
Standard Curve - Select Param.
Detector for F-Int [2]
End Point 50 % Param. VIII%
Maximum Time 150 sec Units %
Sensitivity Low Gain Number Format XXX.X
Curve Fit Log Curve
Sample Vol 5 µL Standard Curve - Standard Analysis
Dil.Vol OVB 45 µL Select Dilution Set 8
Pre. Rinse ******* x0 Calibrator SHP
Refer to the Table of Analytical Values for the lot specific
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Dil.Vol ******* 0 µL Repl.
Reag. Vol VIII 50 µL Calib. or Dil.Ratio 4 1/4 2
Post. Rinse Clean I x1 Calib. or Dil.Ratio 6 0/1 0
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntACT'.

- Mark Limits Select Param. VIII% - Set Replication Replicates 1

VIII%
% s
129.0 55.5
86.0 60.1
43.0 68.5
21.5 79.0
10.7 88.4
Remarks
Important!

®
® ®

Special Menu - Settings - Analysis Settings - Test Protocol For lower concentrations (approx. 100 - 3.1 %) select
[1]
Manage. ID
Curve Fit Log Curve
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntACT'.


VIII%
% s
86.0 60.3
43.0 68.8
21.5 78.4
10.4 88.1
5.4 98.0
2.6 107.8

®
® ®
analytical values.
and other findings.
Materials Required
[1]
ACTIN FSL B4219
CONTROL P OUPZ 1 mL
CaCl2 SOLUTION ORHO
[3]
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
[3]
On-board Stability
ACTIN FSL PTT FSL 48
Hemoglobin mg/dL 40
Bilirubin mg/dL 24

®
® ®
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.5 3.2 4.0
CONTROL P 3.2 4.2 5.2
Measuring Range
Expected Values
USA Distributor

®
® ®

[1]
Manage. ID
Curve Fit Log Curve
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntACT'.


VIII%
% s
129.0 66.7
86.0 72.1
43.0 82.2
21.5 92.9
10.8 104.0
Remarks
Important!

®
® ®

[1]
Manage. ID
Curve Fit Log Curve
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntACT'.


VIII%
% s
86.0 70.2
43.0 79.9
21.5 89.7
10.8 100.3
5.4 110.2
2.7 118.7

®
®
Pathromtin SL
analytical values.
and other findings.
Materials Required
® [1]
Pathromtin SL OQGS
CONTROL P OUPZ 1 mL
CaCl2 SOLUTION ORHO
[3]
CA CLEAN I 964-0631-3
Additional Notes
The reagent must be gently inverted (5 to 8 times) to mix before first use.
[1]
[2]
[3]
On-board Stability
Pathromtin® SL PTT PSL 48
Bilirubin mg/dL 24

®
®
Pathromtin SL
Method Comparison
Precision
CV (%) CV (%) CV (%)
CONTROL N 3.1 3.2 4.3
CONTROL P 3.1 2.6 3.9
Measuring Range
Expected Values
USA Distributor

®
®
Pathromtin SL

[1]
Manage. ID
Curve Fit Log Curve
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntPSL'.


VIII%
% s
129.0 65.2
86.0 70.7
43.0 78.9
21.5 90.4
10.7 103.3
Remarks
Important!

®
®
Pathromtin SL

[1]
Manage. ID
Curve Fit Log Curve
2nd Dil
calibrator value.
D.Samp Vol 0 µL
Reagent 2 60 sec
Reagent 3 240 sec
[1]
[2]
FIntPSL'.


VIII%
% s
86.0 70.2
43.0 79.7
21.5 91.2
10.4 103.6
5.4 115.0
2.6 125.7

®
Lupus Anticoagulant with
LA 1 Screening Reagent / LA 2 Confirmation Reagent
analytical values.
and other findings.
Materials Required
[1]
LA 1 REAGENT OQGP
LA 2 REAGENT OQGR
LA CONTROL 1 OQWE 1 mL
LA CONTROL 2 OQWD 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
LA 1 REAGENT LA1 24
LA 2 REAGENT LA2 24
Bilirubin mg/dL 60

®
Method Comparison
LA 1 on BCT® System y = 1.26 x - 1.56 0.990
LA 1 / LA 2 Ratio on BCT® System y = 1.06 x + 0.03 0.993
Precision
CV (%) CV (%) CV (%)
LA 1: CONTROL N 0.8 2.0 2.2
LA 2: CONTROL N 0.5 0.8 1.0
LA 1 / LA 2 Ratio: CONTROL N 0.9 1.9 2.1
Measuring Range
Expected Values
Unit: s
Comments n Mean Median 5th - 95th Percentile
LA 1 128 41.0 40.6 35.8 - 47.8
LA 2 128 36.1 36.0 33.3 - 39.3
LA 1 / LA 2 Ratio (no unit) 128 1.14 1.12 1.01 - 1.26
USA Distributor

®

Test Protocol Name LA1 STD-Link No
[1]
Manage. ID 5600
Detector for LA1
End Point 50 %
Sample Vol 100 µL

2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol LA1 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. LA1 - Set Replication Replicates 2
- Replic. Limits Difference (%) 10

®

Test Protocol Name LA2 STD-Link No
[1]
Manage. ID 5610
Detector for LA2
End Point 50 %
Sample Vol 100 µL

2nd Dil
D.Samp Vol 0 µL
Reagent 1 60 sec
Reag. Vol LA2 100 µL
Reagent 2 0 sec
Reagent 3 0 sec
[1]

- Mark Limits Select Param. LA2 - Set Replication Replicates 2

®
Protein C with
Protein C Reagent
analytical values.
and other findings.
Materials Required
PROTEIN C COAG — OQYG Kit —
ACTIVATOR Reagent holder—position 1 [1] 3 mL Reagent holder position 1 [1]
REAGENT APTT Reagent holder—position 2 [1] 10 mL Reagent holder position 2 [1]
DEFICIENT Reagent holder—position 10 1 mL Reagent holder position 10
CONTROL P OUPZ 1 mL
CaCl2 SOLUTION ORHO
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
On-board Stability
ACTIVATOR PC.A.cl 24
REAGENT APTT PC.APTT 24
DEFICIENT PC.DefP 6
Bilirubin mg/dL 36
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, coagulometric on BCT® System y = 1.01 x + 3.60 0.989
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.9 4.3 4.7
CONTROL P 2.5 4.5 5.1
Measuring Range
Expected Values
USA Distributor

®
Protein C with
Protein C Reagent

Test Protocol Name PCcl STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 5500 Param. PC.cl%
Detector for PCc Units %
Maximum Time 300 sec Curve Fit Lin-Lin
Sample Vol 5 µL
Calibrator SHP
Dil.Vol PC.DefP 45 µL
2nd Dil Repl.
Reag. Vol PC.A.cl 50 µL Calib. or Dil.Ratio 6 0/1 2
Reagent 2 60 sec
Reag. Vol PC.APTT 50 µL
Reagent 3 300 sec
[1]

- Mark Limits Select Param. PC.cl% - Set Replication Replicates 1

PC.cl%
% s
148.5 115.5
99.0 91.7
49.5 66.8
24.8 50.0
12.4 41.3
0.0 34.3

®
Antithrombin with
®
INNOVANCE Antithrombin
analytical values.
and other findings.
Materials Required
®
INNOVANCE Antithrombin — OPFH Kit —
REAGENT Reagent holder—position 4 [1] 2.7 mL Reagent holder position 4 [1]
[2]
SUBSTRATE Reagent holder—position 6 2.7 mL Reagent holder position 6 [2]
BUFFER Reagent holder—position 10 5 mL Reagent holder position 10
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
[3]
On-board Stability
REAGENT ATReag 8
SUBSTRATE ATSub 8
BUFFER ATBuf 8
In order to achieve the maximum reagent stability over several days, we recommend the following procedure. Pour 0.9 mL INNOVANCE®
Antithrombin REAGENT, 0.9 mL INNOVANCE® Antithrombin SUBSTRATE, and 1.6 mL INNOVANCE® Antithrombin BUFFER from the
original vial into 3.5 mL sample cups, Catalog # 73-646. Place these cups on the system. Store the reagents in their closed original vials at
+2 °C to +8 °C. The same procedure can be followed again up to day 3. Under these conditions the stability data listed in the table above are
still valid. Please refer to the Instructions for Use “Once-opened stability” information regarding the stability for reagents stored in original
containers.

®
Antithrombin with
®
Bilirubin mg/dL 60
Method Comparison
® ®
Berichrom Antithrombin III (A) on Sysmex CA-500 series System y = 0.98 x + 0.87 0.973
Precision

(% of norm) CV (%) CV (%)
CONTROL N 89.5 2.5 4.3
CONTROL P 29.1 3.2 6.9
Measuring Range
Expected Values
Unit: % of norm
— 150 96.2 96.1 83 - 111
USA Distributor

®
Antithrombin with
®

Test Protocol Name AT STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6000 Param. AT%
Detector for BCAT3 Units %
Start Point 6 sec Number Format XXX.X
End Point 21 sec Curve Fit Log Curve
Wavelength 405 nm Inc
Sample Vol 10 µL
Calibrator SHP
Dil.Vol ATBuf 110 µL
2nd Dil Repl.
Reag. Vol ATReag 80 µL Calib. or Dil.Ratio 6 1/16 2
Reagent 2 210 sec
Reag. Vol ATSub 80 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. AT% - Set Replication Replicates 1

AT%
% dOD
135.0 0.299
90.0 0.524
45.0 0.889
22.5 1.137
11.3 1.295
5.6 1.377

®
Antithrombin III with
®
Berichrom Antithrombin III (A)
analytical values.
and other findings.
Materials Required
Berichrom AT III — OWWR15 Kit —
REAGENT THR Reagent holder—position 4 [1] 5/15 mL Reagent holder position 4 [1]
SUBSTRATE Reagent holder—position 6 [2] 3 mL Reagent holder position 6 [2]
REAGENT THR DILUENT — — 30/100 mL —
® ®
CONTROL N ORKE 1 mL
CONTROL P OUPZ 1 mL
[3]
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
[3]
On-board Stability
REAGENT THR AT3Thro 8
SUBSTRATE AT3Subs 8
CA SYSTEM BUFFER (in GW5 or SLD vials) OVB 8
OV BUFFER (in GW5 or SLD vials) 8
Bilirubin mg/dL 60

®
®
Method Comparison
Berichrom® Antithrombin III (A) on Sysmex® CA-6000 System y = 0.95 x + 4.50 0.972
Precision
CV (%) CV (%) CV (%)
CONTROL N 2.3 4.5 5.0
CONTROL P 2.9 9.5 9.9
Measuring Range
Expected Values
Unit: % of norm
th th
Comments n Mean Median 2.5 - 97.5 Percentile
— 285 96.1 96.5 79.1 - 114.1
USA Distributor

®
®

Test Protocol Name AT3 STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6010 Param. AT3%
Detector for BCAT3 Units %
End Point 40 sec Curve Fit Lin-Lin
Sample Vol 10 µL
Calibrator SHP
Dil.Vol OVB 83 µL
2nd Dil Repl.
Reag. Vol AT3Thro 125 µL Calib. or Dil.Ratio 6 0/1 2
Reagent 2 90 sec
Reag. Vol AT3Subs 33 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. AT3% - Set Replication Replicates 1

AT3%
% dOD
145.5 0.180
97.0 0.507
48.5 0.832
24.3 0.992
12.1 1.065
0.0 1.097

®
Heparin with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
Berichrom HEPARIN — OWLD Kit —
REAGENT AT Reagent holder—position 1 [1] 1 mL Reagent holder position 1 [1]
REAGENT FX Reagent holder—position 2 [1] 10 mL Reagent holder position 2 [1]
[1]
SUBSTRATE Reagent holder—position 3 2 mL Reagent holder position 3 [1]
REAGENT FX DILUENT — — 10 mL —
STANDARD PLASMA (SHP) Reagent holder position 9 or 101 mL
ORKL Reagent holder position 9 or 10
Ci-Trol HEPARIN CONTROL 1 B4224-50 1 mL Any position on sample rack
Ci-Trol HEPARIN CONTROL 2 B4224-60 1 mL
CONTROL N ORKE 1 mL
[2]
CA CLEAN I 964-0631-3
Additional Notes
For preparation of the Calibration Plasma (Standard Human Plasma with 1 U/mL Heparin) refer to the Instructions for Use. On-board
position: Sample rack position 1.
[1]
[2]
On-board Stability
REAGENT AT AT3Reag 4
REAGENT FX FXaReag 4
SUBSTRATE HepSubs 4
No interferences up to ... LMW heparin UF heparin
Triglycerides mg/dL 252 252
Hemoglobin mg/dL 100 400
Bilirubin mg/dL 36 60

®
Heparin with
®
Berichrom Heparin
Method Comparison
Berichrom® Heparin on BCT® System y = 0.92 x - 0.01 0.977
Precision
CV (%) CV (%) CV (%)
Ci-Trol HEPARIN CONTROL 1 5.6 4.7 7.1
Ci-Trol HEPARIN CONTROL 2 4.0 5.2 6.4
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin with
®
Berichrom Heparin

Test Protocol Name Hep STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6100 Param. Hep
Detector for BCHep Units U/mL
Start Point 11 sec Number Format XX.XX
End Point 40 sec Curve Fit Log Curve
Sample Vol 20 µL
Calibrator Calibration Plasma
Dil.Vol SHP 0 µL
Pre. Rinse ******* x0 For preparation of the Calibration Plasma 1 U/mL refer to the
Post. Rinse ******* x0 Instructions for Use of Berichrom® Heparin.
2nd Dil Repl.
Reag. Vol AT3Reag 20 µL Calib. or Dil.Ratio 6 1/32 0
Reagent 2 60 sec
Reag. Vol FXaReag 125 µL
Reagent 3 120 sec
Reag. Vol HepSubs 40 µL
[1]

- Mark Limits Select Param. Hep - Set Replication Replicates 1

Hep
U/mL dOD
1.00 0.171
0.50 0.317
0.25 0.463
0.13 0.600
0.06 0.655
Remarks
For calibration purposes it is necessary to define Standard Human Plasma (SHP) as diluent in the test protocol. The diluent volume has to be
set to 0 µL.

®
Heparin (LMW) with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
[1]
Berichrom HEPARIN LMW CALIBRATOR Sample rack OPCA
Berichrom HEPARIN LMW CONTROL 1 OPCD 1 mL Any position on sample rack
Berichrom HEPARIN LMW CONTROL 2 OPCB 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
On-board Stability
SUBSTRATE HepSubs 4
Bilirubin mg/dL 36

®
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 0.998
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 0.38 ±0.01 ±0.02
Berichrom HEPARIN LMW CONTROL 2 0.81 ±0.02 ±0.02
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin (LMW) with
®
Berichrom Heparin

Test Protocol Name HepL STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6110 Param. HepL
Detector for BCHep Units IU/mL
End Point 40 sec Curve Fit Lin Pt-Pt
Sample Vol 20 µL
Calibrator Berichrom® Heparin LMW Cal.
Dil.Vol SHP 0 µL
Post. Rinse ******* x0 heparin concentration of Berichrom® Heparin LMW
2nd Dil Calibrator.
D.Samp Vol 0 µL Repl.
Reagent 2 60 sec
Reagent 3 120 sec
[1]

- Mark Limits Select Param. HepL - Set Replication Replicates 1

HepL
IU/mL dOD
1.49 0.221
1.19 0.260
0.89 0.338
0.60 0.421
0.30 0.551
0.00 0.653
Remarks
For calibration purposes it is necessary to define Standard Human Plasma (SHP) as diluent in the test protocol. The diluent volume in the
test protocol has to be set to 0 µL. Define and set Standard Human Plasma on Reagent holder position 9 or 10. Set Berichrom® Heparin
LMW Calibrator on Sample rack postion 1.

®
Heparin (UF) with
®
Berichrom Heparin
analytical values.
and other findings.
Materials Required
[1]
Berichrom HEPARIN UF CALIBRATOR Sample rack OPCC
Berichrom HEPARIN UF CONTROL 1 OPBY 1 mL Any position on sample rack
Berichrom HEPARIN UF CONTROL 2 OPBZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
On-board Stability
SUBSTRATE HepSubs 4
Bilirubin mg/dL 60

®
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 = 0.96 x + 0.01 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 UF CONTROL 1 0.27 ±0.01 ±0.01
Berichrom HEPARIN UF CONTROL 2 0.67 ±0.01 ±0.02
Measuring Range
Expected Values
Not applicable.
USA Distributor

®
Heparin (UF) with
®
Berichrom Heparin

Test Protocol Name HepU STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6120 Param. HepU
Detector for BCHep Units IU/mL
End Point 40 sec Curve Fit Lin Pt-Pt
Sample Vol 20 µL
Calibrator Berichrom® Heparin UF Cal.
Dil.Vol SHP 0 µL
Post. Rinse ******* x0 heparin concentration of Berichrom® Heparin UF Calibrator.
2nd Dil Repl.
Reagent 2 60 sec
Reagent 3 120 sec
[1]

- Mark Limits Select Param. HepU - Set Replication Replicates 1

HepU
IU/mL dOD
1.28 0.117
1.02 0.151
0.77 0.227
0.51 0.313
0.26 0.480
0.00 0.646
Remarks
For calibration purposes it is necessary to define Standard Human Plasma (SHP) as diluent in the test protocol. The diluent volume in the
test protocol has to be set to 0 µL. Define and set Standard Human Plasma on Reagent holder position 9 or 10. Set Berichrom® Heparin UF
Calibrator on Sample rack postion 1.

®
Protein C with
®
Berichrom Protein C
analytical values.
and other findings.
Materials Required
Berichrom PROTEIN C — OUVV15 Kit —
ACTIVATOR Reagent holder—position 1 [1] 5/10 mL Reagent holder position 1 [1]
SUBSTRATE Reagent holder—position 2 [1] 3 mL Reagent holder position 2 [1]
ACTIVATOR DILUENT — — 30 mL —
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
[2]
On-board Stability
ACTIVATOR BCPCAct 48
SUBSTRATE BCPCSub 48
Bilirubin mg/dL 36

®
Protein C with
®
Berichrom Protein C
Method Comparison
Berichrom® Protein C on BCT® System y = 1.05 x - 1.02 0.963
Precision
CV (%) CV (%) CV (%)
CONTROL N 1.6 1.0 1.8
CONTROL P 3.6 1.4 3.6
Measuring Range
Expected Values
USA Distributor

®
Protein C with
®
Berichrom Protein C

Test Protocol Name BCPC STD-Link No Standard Curve - Select Param.
[1]
Manage. ID 6200 Param. BCPC%
Detector for BCPC Units %
End Point 100 sec Curve Fit Lin-Lin
Sample Vol 20 µL
Calibrator SHP
2nd Dil Repl.
Reag. Vol BCPCAct 125 µL Calib. or Dil.Ratio 6 1/32 2
Reagent 2 540 sec
Reag. Vol BCPCSub 30 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. BCPC% - Set Replication Replicates 1

BCPC%
% dOD
97.0 0.148
48.5 0.080
24.3 0.039
12.1 0.019
6.1 0.009
3.0 0.004

®
D-Dimer with
D-Dimer PLUS
analytical values.
and other findings.
Materials Required
D-Dimer PLUS — OQWW Kit —
D-Dimer PLUS REAGENT Reagent holder—position 8 [2] 3 / 4 mL Reagent holder position 8 [2]
D-Dimer PLUS ACTIVATOR Reagent holder—position 4 [1] 3 / 5 mL Reagent holder position 4 [1]
D-Dimer PLUS REAGENT DILUENT — — 25 mL —
D-Dimer PLUS STANDARD Sample rack OQXA
position 1 6 x 1 mL Sample rack position 1
D-Dimer CONTROL 1 Any position OQKA
on sample rack 1 mL Any position on sample rack
[3]
Additional Notes
It is recommended to place the original reagent vials on the system. If cups are used instead, do not leave the reagents on the system for
longer than described in the table of on-board stabilities and use Sample Cup Conical 4.0 mL, REF 424-1160-8.
[1]
[2]
[3]
On-board Stability
D-Dimer PLUS REAGENT DD.Pl.R 48
D-Dimer PLUS REAGENT (Conical Cup) 8
D-Dimer PLUS ACTIVATOR DD.Pl.A 48
D-Dimer PLUS ACTIVATOR (Conical Cup) 8
Bilirubin mg/dL 60
* Turbid samples can lead to falsely elevated or decreased values even if triglyceride concentrations are within the normal range.

®
D-Dimer with
D-Dimer PLUS
Method Comparison
D-Dimer PLUS on Sysmex® CA-7000 System y = 1.01 x + 16.92 0.992
Precision
CV (%) CV (%) CV (%)
D-Dimer CONTROL 1 2.4 1.8 2.9
Measuring Range
The D-Dimer PLUS total measuring range on the Sysmex® CA-500/CA-600 System extends from 47 µg/L to 9999 µg/L. This total measuring
range is achieved by a manually requested redilution of the sample if the range of the standard curve (approximately 47 µg/L - 2332 µg/L) is
exceeded.
Expected Values
Unit: µg/L
th th
— 130 152 115 < 50 - 372
24 samples were below the limit of detection of 50 µg/L.
USA Distributor

®
D-Dimer with
D-Dimer PLUS

Test Protocol Name DDPl STD-Link Master Standard Curve - Select Param.
[1]
Manage. ID 6300 Param. DDPl
Detector for DDPLUS Units µg/L
Number Format XXXX
Curve Fit Lin Pt-Pt
Sample Vol 50 µL
Calibrator DD PLUS Standard Plasma
Pre. Rinse Clean I x1 Refer to the D-Dimer PLUS STANDARD Table of Analytical
Post. Rinse ******* x0 Values for the D-Dimer concentration of D-Dimer PLUS
STANDARD 2.
2nd Dil
Reag. Vol DD.Pl.A 25 µL Calib. or Dil.Ratio 5 1/38 3
Reagent 2 60 sec
Reag. Vol DD.Pl.R 150 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. DDPl - Set Replication Replicates 2
- Report Limits lower (<) 50 µg/L
upper (>) 2000 µg/L

DDPl
µg/L dOD
2332 0.4400
1166 0.2723
583 0.1270
233 0.0259
117 0.0145
47 0.0093

®
D-Dimer with
D-Dimer PLUS

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “DDPl” will be used
Test Protocol Name +DDP STD-Link DDPl automatically. For more information refer to the Instructions
[1]
6310 for Use of the analyzer.
Manage. ID
Detector for DDPLUS

Sample Vol 15 µL
Dil.Vol OVB 105 µL
Pre. Rinse Clean I x1
2nd Dil
D.Samp Vol 50 µL
Reagent 1 30 sec
Reag. Vol DD.Pl.A 25 µL
Reagent 2 60 sec
Reag. Vol DD.Pl.R 150 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. +DDP - Set Replication Replicates 2
- Report Limits lower (<) 2000 µg/L
upper (>) 9999 µg/L
Remarks
Both, DDPl and +DDP should be set in the test group setting to enable manual sample redilution if the standard curve range is exceeded.
All samples above the upper report limit should be repeated using the appropriate +DDP Setting again. The redilution has to be requested
manually.

®
D-Dimer with
Advanced D-Dimer
analytical values.
and other findings.
Materials Required
Advanced D-Dimer — OQWM Kit —
REAGENT Reagent holder—position 8 [2] 3 / 4 mL Reagent holder position 8 [2]
ACTIVATOR Reagent holder—position 4 [1] 3 / 5 mL Reagent holder position 4 [1]
REAGENT DILUENT — — 25 mL —
Advanced D-Dimer STANDARD Sample rackOQWR
position 1 6 x 1 mL Sample rack position 1
Advanced D-Dimer CONTROL 1 OQWT 1 mL Any position on sample rack
Advanced D-Dimer CONTROL 2 OQWV 1 mL
Advanced D-Dimer REAGENT DILUENT — OQWP 25 mL —
Additional Notes
It is generally recommended to place the reagents on the system using original vials. If cups are used instead, do not leave the reagents on
the system for longer than described in the table of On-board Stability and use Sample Cup Conical 4.0 mL, REF B4267-4.
[1]
[2]
[3]
On-board Stability
REAGENT Ad.DD.R 48
REAGENT (Conical Cup) 8
ACTIVATOR Ad.DD.A 48
ACTIVATOR (Conical Cup) 8

®
D-Dimer with
Advanced D-Dimer
Bilirubin mg/dL 60
Method Comparison
Advanced D-Dimer on Sysmex® CA-7000 System y = 1.01 x + 0.14 0.992
Precision
CV (%) CV (%) CV (%)
Advanced D-Dimer CONTROL 1 2.4 1.8 2.9
Advanced D-Dimer CONTROL 2 1.6 1.4 2.0
Measuring Range
The Advanced D-Dimer total measuring range on the Sysmex® CA-500/CA-600 System extends from 0.43 to 99.99 mg/L (FEU). This total
measuring range is achieved by a manually requested redilution of the sample if the range of the standard curve (approximately 0.43 - 17.00
mg/L(FEU)) is exceeded.
Expected Values
Unit: mg/L (FEU)
th th
— 130 1.29 0.98 < 0.43 - 3.17
24 samples were below the limit of detection of 0.43 mg/L (FEU).
USA Distributor

®
D-Dimer with
Advanced D-Dimer

Test Protocol Name AdDD STD-Link Master Standard Curve - Select Param.
[1]
Manage. ID 6400 Param. Adv.DD
Detector for Adv. DD Units mg/L
Number Format XX.XX
Curve Fit Lin Pt-Pt
Sample Vol 50 µL
Calibrator Adv.DD Standard Plasma
Pre. Rinse Clean I x1 Refer to the Advanced D-Dimer STANDARD Table of
Post. Rinse ******* x0 Analytical Values for the D-Dimer concentration of Advanced
D-Dimer STANDARD 2.
2nd Dil
Reag. Vol Ad.DD.A 25 µL Calib. or Dil.Ratio 5 1/38 3
Reagent 2 60 sec
Reag. Vol Ad.DD.R 150 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. Adv.DD - Set Replication Replicates 2
- Report Limits lower (<) 0.43 mg/L
upper (>) 17.00 mg/L

Adv.DD
mg/L (FEU) dOD
17.84 0.4394
8.92 0.2741
4.46 0.1288
1.78 0.0243
0.89 0.0133
0.36 0.0083

®
D-Dimer with
Advanced D-Dimer

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve created with “AdDD” will be
Test Protocol Name +AdD STD-Link AdDD used automatically. For more information refer to the
[1]
6410 Instructions for Use of the analyzer.
Manage. ID
Detector for Adv. DD

Sample Vol 15 µL
Dil.Vol OVB 105 µL
Pre. Rinse Clean I x1
2nd Dil
D.Samp Vol 50 µL
Reagent 1 30 sec
Reag. Vol Ad.DD.A 25 µL
Reagent 2 60 sec
Reag. Vol Ad.DD.R 150 µL
Reagent 3 0 sec
[1]

- Mark Limits Select Param. +AdD - Set Replication Replicates 2
Remarks
Both, AdDD and +AdD should be set in the test group setting to enable manual sample redilution if the standard curve range is exceeded.
All samples above the upper report limit should be repeated using the appropriate +AdD setting again. The redilution has to be requested
manually.

®
D-Dimer with
®
INNOVANCE D-Dimer
analytical values.
and other findings.
Materials Required
®
INNOVANCE D-Dimer — OPBP Kit —
REAGENT Reagent holder—position 6 [2] 4 mL Reagent holder position 6 [2]
[1]
BUFFER Reagent holder—position 4 5 mL Reagent holder position 4 [1]
SUPPLEMENT Reagent holder—position 8 [2] 2.6 mL Reagent holder position 8 [2]
DILUENT Reagent holder—position 10 5 mL Reagent holder position 10
CALIBRATOR Sample rack position
— 1 1 mL Sample rack position 1
INNOVANCE® D-Dimer CONTROLS — OPDY Kit —
CONTROL 1 — 1 mL Any position on sample rack
CONTROL 2 — 1 mL
INNOVANCE® D-Dimer DILUENT Reagent holder
OPBR
position 10 5 mL Reagent holder position 10
[3]
Additional Notes
If reagents, rinse solutions or buffers are not supplied in vials, which fit on the instrument exactly it is necessary to transfer them into
appropiate vials.
The required controls and calibrators have to be transferred into 4 mL Conical Cups (catalog # 424-1160-8).
Push vials (Push Vial PV-10, catalog # 541-1352-1) and 5 mL vials from the BC Vial kit (catalog # OVKE) can be used as appropriate vials
for reagents, rinse solutions or buffers that are not supplied in vials that fit exactly on the instrument.
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.
[1]
[2]
[3]

®
D-Dimer with
®
INNOVANCE D-Dimer
On-board Stability
REAGENT DDi.REA 16
REAGENT (Conical Cup) 4
DILUENT DDi.DIL 16
DILUENT (Conical Cup) 4
BUFFER DDi.BUF 16
BUFFER (Conical Cup) 4
SUPPLEMENT DDi.SUP 16
SUPPLEMENT (Conical Cup) 4
OV BUFFER (in GW5 or SLD vials) OVB 48
CA SYSTEM BUFFER (in GW5 or SLD vials) 48
In original vials, the reagents may be left on board the instrument continuously for 16 hours or stored on and off the instrument for intervals of
7 x 1 hour 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 12
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 Sysmex® CA-1500 System y = 0.98 x + 0.03 0.998
Precision
(mg/L FEU) CV (%) CV (%)
INNOVANCE® D-Dimer CONTROL 1 0.30 5.3 6.7
INNOVANCE® D-Dimer CONTROL 2 2.69 3.9 5.2
Measuring Range
The INNOVANCE® D-Dimer total measuring range on the Sysmex® CA-500/CA-600 System extends from 0.19 to 35.20 mg/L FEU. This total
measuring range is achieved by a manually requested redilution of the sample if the redilution limits of 0.19 to 4.40 mg/L FEU are exceeded.
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

Test Protocol Name DDi STD-Link Master Standard Curve - Select Param.
[1]
Manage. ID 6500 Param. DDi
Detector Units mg/L
Number Format XX.XX
Curve Fit Log Curve
Sample Vol 8 µL
Calibrator DDi.CAL
Dil.Vol DDi.DIL 12 µL
Pre. Rinse OVB x1 Refer to the Table of Analytical Values for the lot specific D-
Post. Rinse ******* x0 Dimer concentration of INNOVANCE® D-Dimer
2nd Dil CALIBRATOR.
Reag. Vol DDi.SUP 16 µL Calib. or Dil.Ratio 5 1/16 2
Post. Rinse OVB x1
Reagent 2 60 sec
Reag. Vol DDi.BUF 80 µL
Post. Rinse OVB x1
Reagent 3 180 sec
Reag. Vol DDi.REA 44 µL
Pre. Rinse OVB x1
Post. Rinse OVB x1
[1]
[2]
For the CA-600 System, it is also possible to select the detector 'for DD
INN'.

- Replic. Limits Difference (%) 20 - Set Replication Replicates 1
upper (>) 4.40 mg/L

DDi
mg/L dOD
5.30 0.1896
2.65 0.1401
1.33 0.0768
0.66 0.0345
0.33 0.0143
0.17 0.0074

®
D-Dimer with
®
INNOVANCE D-Dimer

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “DDi” will be used
Test Protocol Name +DDi STD-Link DDi automatically. Ensure that the STD-Link in the test protocol
[1]
6510 is set to "DDi". For more information refer to Operator`s
Manage. ID
Detector Manual.

Sample Vol 10 µL
Pre. Rinse OVB x1
2nd Dil
D.Samp Vol 8 µL
Pre. Rinse OVB x1
Reagent 1 30 sec
Reag. Vol DDi.SUP 16 µL
Post. Rinse OVB x1
Reagent 2 60 sec
Reag. Vol DDi.BUF 80 µL
Post. Rinse OVB x1
Reagent 3 180 sec
Reag. Vol DDi.REA 44 µL
Pre. Rinse OVB x1
Post. Rinse OVB x1
[1]
[2]
For the CA-600 System, it is also possible to select the detector 'for DD
INN'.

- Replic. Limits Difference (%) 20 - Set Replication Replicates 1
Remarks
Both, DDi and +DDi should be set in the test group setting to enable manual sample redilution if the standard curve range is exceeded.
All samples above the upper report limit should be repeated using the appropriate +DDi setting again. The redilution has to be requested
manually.
The units of measure for INNOVANCE® D-Dimer assay are mg/L FEU. The software of the instruments uses only mg/L for technical reasons.
Important!

®
von Willebrand Factor with
vWF Ag
analytical values.
and other findings.
Materials Required
vWF Ag — OPAB Kit —
REAGENT (diluent added) Reagent holder—position 5 - 10
2 + 4 mL Reagent holder position 5 - 10
BUFFER (Glycine buffer) Reagent holder—position 5 - 10 5 mL Reagent holder position 5 - 10
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
[1]
On-board Stability
REAGENT vWFReag 8
BUFFER vWFBuf 8
CA SYSTEM BUFFER (OVB) OVB 8
Bilirubin mg/dL 36

®
vWF Ag
Method Comparison
vWF Ag on Sysmex® CA-1500 System y = 1.01 x + 1.33 0.995
Precision
CV (%) CV (%) CV (%)
CONTROL N (vWF) 1.3 1.1 1.6
CONTROL P (vWF) 1.7 1.9 2.5
Measuring Range
The vWF Ag total measuring range on the Sysmex® CA-500/CA-600 System extends from 6 % to 600 %. This total measuring range is
achieved by a manually requested redilution of the sample if the reportable range of the standard curve (12.5 % - 200 %) is fallen below or
exceeded.
Expected Values
Unit: %
th th
Total 204 105.3 99.1 61.7 - 178.1
Blood group 0 80 87.6 77.8 59.4 - 145.3
Other blood groups 124 116.7 114.2 70.6 - 183.7
USA Distributor

®
vWF Ag

Test Protocol Name vWF STD-Link Master Standard Curve - Select Param.
[1]
Manage. ID 6600 Param. vWF%
Detector Units %
Number Format XXX.X
Curve Fit Log Curve
Sample Vol 15 µL
Calibrator SHP
Dil.Vol OVB 15 µL
2nd Dil Repl.
Reag. Vol vWFBuf 60 µL Calib. or Dil.Ratio 6 0/1 0
Reagent 2 270 sec
Reag. Vol vWFReag 90 µL
Reagent 3 0 sec
[1]
[2]
For the CA-600 System, it is also possible to select the detector 'for vWF
Ag'.

- Mark Limits Select Param. vWF% - Set Replication Replicates 1
upper (>) 200.0 %

vWF%
% dOD
202.0 0.1447
101.0 0.0736
50.5 0.0321
25.3 0.0136
12.6 0.0055

®
vWF Ag

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “vWF” will be used
Test Protocol Name +vWF STD-Link vWF automatically.
[1]
Manage. ID 6610
Detector

Sample Vol 5 µL
Dil.Vol OVB 25 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 30 sec
Reag. Vol vWFBuf 60 µL
Reagent 2 270 sec
Reagent 3 0 sec
[1]
[2]
Ag'.

- Mark Limits Select Param. +vWF - Set Replication Replicates 1
upper (>) 600.0 %
Remarks
In order to guarantee reliable analysis results it is crucial to modify the analysis parameter for this assay. The necessary technical
modification has to be done by a Siemens representative.
All samples with unknown vWF antigen concentration should be measured with vWF setting first.
vWF should also be set as +vWF and -vWF in the test group setting to enable manual sample redilution if the standard curve range is fallen
below or exceeded.
All samples above the upper report limit should be repeated using the appropriate +vWF setting. The redilution has to be requested
manually.
All samples below the lower report limit should be repeated using the appropriate -vWF setting. The redilution has to be requested manually.

®
vWF Ag

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “vWF” will be used
Test Protocol Name -vWF STD-Link vWF automatically.
[1]
Manage. ID 6620
Detector

Sample Vol 30 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 30 sec
Reag. Vol vWFBuf 60 µL
Reagent 2 270 sec
Reagent 3 0 sec
[1]
[2]
Ag'.

- Mark Limits Select Param. -vWF - Set Replication Replicates 1
upper (>) 12.5 %
Remarks
Important!

®
®
INNOVANCE VWF Ac
analytical values.
and other findings.
Materials Required
®
INNOVANCE VWF Ac — OPHL Kit —
REAGENT I Reagent holder—position 1 - 4 2.0 mL Reagent holder position 1 - 4
REAGENT II — 3.5 mL Reagent holder position 5 - 10
REAGENT III — 2.5 mL
CONTROL P OUPZ 1 mL
CA CLEAN I 964-0631-3
Additional Notes
REAGENT I, II and III must not be used in Sysmex Sample Cups on the Reagent Holder Positions.
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 WFAcI 8
REAGENT II WFAcII 8
REAGENT III WFAcIII 24
CONTROL N 4
CONTROL P 4
CONTROL P 1:3 diluted 4
REAGENT I and II may be stored on and off the instrument for intervals of 2 x 4 hours over a maximum period of 2 weeks. REAGENT III may
be stored on and off the instrument for intervals of 6 x 4 hours over a maximum period of 6 weeks.

®
®
INNOVANCE VWF Ac
No interferences up to ... WFa/+WFa -WFa
Triglycerides mg/dL 416 ---*
Hemoglobin mg/dL 1000 200
Bilirubin mg/dL 60 48
Method Comparison
INNOVANCE® VWF Ac on BCS® / BCS® XP System y = 1.09x -0.98 0.994
Precision
Mean Repeatability Within Device
(% of norm) CV (%) CV (%)
CONTROL N WFa 91.7 1.5 1.9
CONTROL P WFa 33.5 3.0 3.4
Pathological plasma pool 2 - WFa 8.9 3.4 4.5
Pathological plasma pool 3 +WFa 435 3.1 4.0
Measuring Range
The INNOVANCE® VWF Ac total measuring range on the Sysmex® CA-500/CA-600 System extends from 6 % to 500 %. This total
measuring range is achieved by a manually requested redilution of the sample as +WFa or -WFa if the reportable range of the standard is >
125 % or < 25 %.
Expected Values
Unit: % of norm
Blood group independent 263 107.8 103.1 55.0 - 193.9
Blood group 0 129 92.5 89.3 50.6 - 147.4
Blood group non-0 134 122.6 120.0 72.7 - 208.2
USA Distributor

®
®
INNOVANCE VWF Ac

Test Protocol Name WFa STD-Link Master Standard Curve - Select Param.
[1]
Manage. ID 6700 Param. vWFAc%
Detector Units %
Number Format XXX.X
Curve Fit Lin Pt-Pt
Sample Vol 12 µL
Calibrator SHP
Dil.Vol OVB 48 µL
2nd Dil Repl.
Reag. Vol WFAcII 50 µL Calib. or Dil.Ratio 6 0/1 0
Reagent 2 60 sec
Reag. Vol WFAcIII 20 µL
Reagent 3 300 sec
Reag. Vol WFAcI 20 µL
[1]
[2]
Ac'.

- Mark Limits Select Param. WFa - Set Replication Replicates 1
upper (>) 125.0 %

WFa
% dOD
147.0 0.2250
98.0 0.1788
49.0 0.0835
24.5 0.0334
Remarks
All samples with unknown VWF activity concentration should be measured with WFa setting first.

®
®
INNOVANCE VWF Ac

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “WFa” will be used
Test Protocol Name +WFa STD-Link WFa automatically.
[1]
Manage. ID 6710
Detector

Sample Vol 20 µL
Dil.Vol OVB 60 µL
2nd Dil
D.Samp Vol 12 µL
Dil.Vol OVB 48 µL
Reagent 1 30 sec
Reag. Vol WFAcII 50 µL
Reagent 2 60 sec
Reagent 3 300 sec
[1]
[2]
Ac'.

- Mark Limits Select Param. +WFa - Set Replication Replicates 1
upper (>) 500.0 %
Remarks
VWF should also be set as +WFa and -WFa in the test group setting to enable manual sample redilution if the standard curve range is fallen
below or exceeded.
All samples above the upper report limit should be repeated using the appropriate +WFa setting. The redilution has to be requested
manually.
All samples below the lower report limit should be repeated using the appropriate -WFa setting. The redilution has to be requested manually.
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
*.**** *---.- Measurement Error
*.**** *---.- No Linearity
*.**** *---.- Reaction Curve Error
*.**** *---.- Range Over
*.**** *---.- Trans Light Low

®
®
INNOVANCE VWF Ac

Special Menu - Settings - Analysis Settings - Test Protocol Not applicable - Standard curve for “WFa” will be used
Test Protocol Name -WFa STD-Link WFa automatically.
[1]
Manage. ID 6720
Detector

Sample Vol 48 µL
Dil.Vol OVB 12 µL
2nd Dil
D.Samp Vol 0 µL
Reagent 1 30 sec
Reag. Vol WFAcII 50 µL
Reagent 2 60 sec
Reagent 3 300 sec
[1]
[2]
Ac'.

- Mark Limits Select Param. -WFa - Set Replication Replicates 1
upper (>) 30.0 %
Remarks
Important!

®
Appendix I Page 1 of 1
General Information to the Applications
CA CLEAN II
CA CLEAN II is available as 45 mL, 500 mL and 5 L product variants (REF 10708787, 964-0611, 974-0581-0).
If required CA CLEAN II has to be transferred into an appropriate vial.
On-board Stability
The on-board stability of CA CLEAN I for all applications is 24 h (in PV-10 or SLD vials).
The on-board stability of CA CLEAN II is 24 h (in 4 mL conical cup).
®
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 2
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 VII DEFICIENT Coagulation Factor VII Deficient Plasma
FACTOR VIII DEFICIENT Coagulation Factor VIII Deficient Plasma
®
THROMBIN REAGENT Dade Thrombin Reagent
Advanced D-Dimer REAGENT DILUENT Advanced D-Dimer Reconstitution Medium
® ®
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
Advanced D-Dimer Advanced D-Dimer
REAGENT Advanced D-Dimer Reagent
ACTIVATOR Advanced D-Dimer Activator
REAGENT DILUENT Advanced D-Dimer Reconstitution Medium
®
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 PROTEIN C Berichrom Protein C
ACTIVATOR Protein C Activator
ACTIVATOR DILUENT Hepes Buffer Solution
D-Dimer PLUS D-Dimer PLUS
D-Dimer PLUS REAGENT D-Dimer PLUS Reagent
D-Dimer PLUS ACTIVATOR D-Dimer PLUS Accelerator
D-Dimer PLUS REAGENT DILUENT D-Dimer PLUS Reconstitution Medium
® ®
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

Appendix II Page 2 of 2
Symbol names of required Materials
Symbol name Product name

® ®
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
®
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
PROTEIN C COAG Protein C Reagent
REAGENT APTT APTT Reagent for Protein C
ACTIVATOR Protein C Activator
DEFICIENT Protein C Deficient Plasma
2. Standards / Controls
Advanced D-Dimer STANDARD Advanced D-Dimer Standard Plasma
®
Berichrom HEPARIN LMW CALIBRATOR Berichrom Heparin LMW Calibrator
®
Berichrom HEPARIN UF CALIBRATOR Berichrom Heparin UF Calibrator
D-Dimer PLUS STANDARD D-Dimer PLUS Standard-Plasma
FIBRINOGEN CALIBRATOR Fibrinogen Calibrator Kit
STANDARD PLASMA Standard Human Plasma
PT-Multi CALIBRATOR PT Multi Calibrator
Advanced D-Dimer CONTROL 1 Advanced D-Dimer Control Plasma 1
Advanced D-Dimer CONTROL 2 Advanced D-Dimer Control Plasma 2
®
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
® ®
INNOVANCE D-Dimer CONTROLS INNOVANCE D-Dimer Controls
®
CONTROL 1 INNOVANCE D-Dimer Control 1
®
CONTROL 2 INNOVANCE D-Dimer Control 2

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Sysmex CA-500/CA-600 System

Reference Guide 3.05

Not for use in the USA

This document is Siemens Healthcare Diagnostics Reference Guide

Document ID: RG-31-01-3.05

Siemens Healthcare Diagnostics Products GmbH

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

Deleted Application Sheet

Revised Application Sheets

Additional information on CA CLEAN II (new: addition of 45 mL-product variant)

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

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

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

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

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

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

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

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

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

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

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

Mean Repeatability Within-Device/Lab

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

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

Standard Curve (example only)

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

Ci-Trol CONTROL 1 B4244-10 1 mL Any position on sample rack

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

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

Test Protocol Standard Curve Calibration

Data Check Number of Replicates

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

PT-Multi CALIBRATOR Sample rack OPAT