BFTII Reference Guide 3.01

BFT* II Analyzer
Reference Guide 3.01

Not for use in the USA
This document is Siemens Healthcare Diagnostics Reference Guide

version number 3.01 for BFT* II Analyzer. From January 2010, this
document is the only relevant source for assay application information
on the BFT* II Analyzer.
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-01-01-3.01

BFT* II Analyzer
Trademarks
Actin, Ci-Trol, Dade, Innovin, ProC and Thromborel are trademarks of Siemens Healthcare Diagnostics.
* BCT, BFA, BFT, InnoCal, Multifibren, Pathromtin and Thromboclotin are trademarks of Siemens
Healthcare Diagnostics.
Sysmex is a registered trademark of SYSMEX CORPORATION.
Note
Siemens Healthcare Diagnostics has validated the provided instructions, reagents, instrument, 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-Straße 76
35041 Marburg
Germany
Reference Guide 3.01 - not for use in the USA - 2

BFT* II Analyzer
Revision History
Document Date Changes

Reference Guide 3.01 2010-01 New Application Sheets:
No new Application Sheet.
Deleted Application Sheets:

No Application Sheets deleted.
Revised Application Sheets:

General changes:
1. Disclaimer on product performance revised:
“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.”
2. Disclaimer for on-board stability added:
“The stability data presented here were established under controlled laboratory
conditions. Due to differences in laboratory environmental conditions and reagent
vial fill volumes performance may vary. Please contact your local service
representative to report any issues.”
Changes in detail:
No changes in detail
No new Application Sheets.


General changes:
- New layout for Application Sheets. Information within an Application Sheet may
be moved to other sections in order to be in a more appropriate position with
regards to content.
- Symbols used for reagent kit components instead of translated product names,
according to new labeling model
- Reference to guideline for reference intervals changed to CLSI document
C28-A3
- Parameter-Protocol: Non relevant parameter marked with * and corresponding
note “*This parameter does not have any function in this test.” added under
Remarks. (except: PT INR with Thromborel® S Dade® Innovin® (SW 2.01 and
SW 2.02) and with Dade® Thromboplastin C Plus)
Changes in detail:
PT sec with Thromborel® S and with Dade® Innovin® (SW 2.02)
Reference Interval: New data for reference interval.
® ® ®
PT % with Thromborel S and with Dade Innovin (SW 2.02)
Reference Interval: Data replaced by new data with PT-Multi Calibrator;
Test Protocol: PT-Multi Calibrator above the table deleted.
PT % with Dade® Innovin® (SW 2.01)
Test Protocol: PT-Multi Calibrator above the table deleted.
PT INR with Thromborel® S, Dade® Innovin® (SW 2.01 and 2.02) and with Dade®
Thromboplastin C Plus
Parameter-Protocol: Non relevant parameter marked with ** and corresponding

BFT* II Analyzer
note “**This parameter does not have any function in this test.” added under
Remarks.
Fibrinogen with Multifibren* U
Limitations: Note on HES interference revised: “… In a study with a HES solution
(130/0.4) no interference was observed up to 15 g HES per liter plasma.”;
Parameter-Protocol (page 4) - measurement - lot. no.: 5198xx replaced by xxxxxx


General changes:
Dade Behring Marburg GmbH changed to Siemens Healthcare Diagnostics
Products GmbH.
Dade Behring changed to Siemens Healthcare Diagnostics or Siemens.
Manufacturer and USA Distributor changed to Siemens.
Section Trademarks in Application Sheets deleted.
Trademark ° changed to * .
Test Protocol: “Dade Behring Preset No.” changed to “Preset No.”.
Changes in detail:
PT INR with Dade® Innovin® (SW 2.01 and SW 2.02)
Parameter Protocol – min./max. value: 150.0 % changed to 120.0 %.


Changes in detail:
Fibrinogen with Multifibren° U
Reference Interval: System specific values for Reference Interval added;
bibliographical reference 1,8-3,5 g/L deleted;
Bibliography: “Thomas, Lothar Clinical Laboratory Diagn. TH-Books
Verlagsgesellschaft mbH“ deleted.
Reference Guide 2.0 to - See respective Reference Guide
2.6
Reference Guide 1.0 - No Reference Guide 1.0 for BFT* II Analyzer

BFT* II Analyzer
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
07 PT seconds with Thromborel® S ..........................................................................................................7
09 PT % with Thromborel® S.....................................................................................................................10
08 PT INR with Thromborel® S .................................................................................................................14
08 PT INR calibrated with Thromborel® S.................................................................................................17
07 PT seconds (SW 2.01) with Dade® Innovin® ........................................................................................20
06 PT seconds (SW 2.02) with Dade® Innovin® ........................................................................................23
09 PT % (SW 2.01) with Dade® Innovin® ..................................................................................................26
07 PT % (SW 2.02) with Dade® Innovin® ..................................................................................................29
08 PT INR (SW 2.01) with Dade® Innovin® ...............................................................................................32
06 PT INR (SW 2.02) with Dade® Innovin® ...............................................................................................35
07 PT INR calibrated (SW 2.01) with Dade® Innovin®...............................................................................38
06 PT INR calibrated (SW 2.02) with Dade® Innovin®...............................................................................41
08 PT seconds with Dade® Thromboplastin C Plus ..................................................................................44
08 PT INR with Dade® Thromboplastin C Plus .........................................................................................47
08 PT INR calibrated with Dade® Thromboplastin C Plus.........................................................................50
APTT
08 APTT with Dade® Actin® Activated Cephaloplastin Reagent ...............................................................53
08 APTT with Dade® Actin® FS Activated PTT Reagent ..........................................................................56
09 APTT with Dade® Actin® FSL Activated PTT Reagent ........................................................................59
08 APTT with Pathromtin* SL ...................................................................................................................62
Fibrinogen
09 Fibrinogen with Multifibren* U ..............................................................................................................65
Thrombin Time / Batroxobin Time

08 Thrombin Time with Test Thrombin Reagent.......................................................................................69
08 Thrombin Time with Thromboclotin* ....................................................................................................72
08 Batroxobin Time with Batroxobin Reagent...........................................................................................76
Clotting Assays
07 Coagulation Factor II with Thromborel® S............................................................................................79
07 Coagulation Factor II with Dade® Innovin® ...........................................................................................83
07 Coagulation Factor V with Thromborel® S ..........................................................................................87
07 Coagulation Factor V with Dade® Innovin® ..........................................................................................91
07 Coagulation Factor VII with Thromborel® S .........................................................................................95
07 Coagulation Factor VII with Dade® Innovin® ........................................................................................99
07 Coagulation Factor X with Thromborel® S ...........................................................................................103
07 Coagulation Factor X with Dade® Innovin® ..........................................................................................107
07 Coagulation Factor VIII with Dade® Actin® Activated Cephaloplastin Reagent ...................................111
07 Coagulation Factor VIII with Pathromtin* SL .......................................................................................115

BFT* II Analyzer
07 Coagulation Factor IX with Dade® Actin® Activated Cephaloplastin Reagent .....................................119

07 Coagulation Factor IX with Pathromtin* SL..........................................................................................123
07 Coagulation Factor XI with Dade® Actin® Activated Cephaloplastin Reagent .....................................127
07 Coagulation Factor XI with Pathromtin* SL .........................................................................................131
07 Coagulation Factor XII with Dade® Actin® Activated Cephaloplastin Reagent ....................................135
07 Coagulation Factor XII with Pathromtin* SL.........................................................................................139
08 Lupus Anticoagulant with LA 1 Screening Reagent / LA 2 Confirmation Reagent..............................143
08 Protein C System with ProC® Global ...................................................................................................147
08 Factor V Leiden with ProC® Global / Factor V Deficient Plasma .........................................................151
08 Protein C with Protein C Reagent ........................................................................................................155

BFT* II Analyzer
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 Catalog # Size On-board position
®
Thromborel S Reagent Reagent positions 1 -OUHP
4 4/10 mL Reagent positions 1 - 4
Dade® Ci-Trol® 1 291070 1 mL Beside the BFT* II Analyzer
® ®
Dade Ci-Trol 2 291071 1 mL
Dade® Ci-Trol® 3 291072 1 mL
® ®
Dade Ci-Trol Coagulation Control Level 1 B4244-10 1 mL
Dade® Ci-Trol® Coagulation Control Level 2 B4244-20 1 mL
® ®
Control Plasma N ORKE 1 mL
Control Plasma P OUPZ 1 mL
BC Vial Kit see Additional Notes OVKE 5 mL see Additional Notes
Eppendorf ep T.I.P.S. — 003.0000.870 — —
Additional Notes
Appropriately sized aliquots may be prepared using vials from the BC Vial Kit. The aliquots are stable at 2-8 °C for up to 5 days. Before use
the reagent should be mixed carefully and brought to 37 °C. Each vial can be used once up to 2 hours on the BFT* II Analyzer. Discard the
vial after use.
Be sure to swirl the reagent bottle to assure that condensation on the bottle walls is re-mixed into the solution.
Keep cuvettes in the incubation block during the incubation. After incubation is complete place the cuvettes into the measuring channel.
Materials positioned beside the BFT* II Analyzer have to be kept at room temperature (+15 °C to +25 °C, RT).
On-board Stability
Material Time [h]
®
Thromborel S Reagent 2
The stability data presented here were established under controlled laboratory conditions. Due to differences in laboratory environmental
conditions and reagent vial fill volumes performance may vary. Please contact your local service representative to report any issues.
Interference Studies
No interferences up to ...
Triglycerides mg/dL 600
Hemoglobin mg/dL 1000
Bilirubin mg/dL 48
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 Reagent on BCT* System y = 1.06 x - 0.48 0.973
r = Correlation Coefficient

BFT* II Analyzer
PT seconds with
®
Thromborel S
Precision
Acceptable variability (imprecision) should be such that the total coefficient of variation (CV) of the analytical system on the same lot of
control plasma is less than 5 %.
Within Run Run to Run Total
% % %
Control Plasma N 1.3 2.1 2.4
Control Plasma P 2.3 2.5 3.3
Measuring Range
Refer to the Instructions for Use of the analyzer for additional information.
Reference Interval
In a study with ostensibly healthy subjects the following data were obtained:
Unit: sec
Comments n Median 2.5th - 97.5th Percentile
— 158 11.6 10.3 - 13.2
Reference intervals vary from laboratory to laboratory depending on the population served and the technique and reagent lot used.
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
Emil-von-Behring-Str. 76
35041 Marburg / Germany
USA Distributor
Siemens Healthcare Diagnostics Inc.
Newark, DE 19714 USA

BFT* II Analyzer
PT seconds with
®
Thromborel S
Test Protocol Parameter-Protocol

Method store 1 Method PT
Unit sec cuvette ON
Preset No. 1
1st convers none
Pipetting Scheme falling*
1. Sample 50 µL unit sec.*
decimal place xxx.x*
Incubation time 60 sec
min / max value 5.0 / 150.0% *
Start reagent
time interpolat. linear *
Thromborel® S Reagent 100 µL value interpolat. reciprocal *
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *
measurement lot. no.: xxxxxx

Start Reag. 100 µl
incubat (0 = off) 1st 0 s
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
min value 150 digits
adjust 1 s
learn 3 s
lag 1 s
Standard Curve Calibration

The assay is not calibrated.
Remarks
* This parameter does not have any function in this assay.

BFT* II Analyzer
PT % with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
® ®
® ®
® ®
PT-Multi Calibrator OPAT 6 x 1 mL
Additional Notes
vial after use.
On-board Stability
Material Time [h]
®
Bilirubin mg/dL 6

BFT* II Analyzer
PT % with
®
Thromborel S
Method Comparison
Test system for the method comparison:
1. Thromborel® S Reagent with Calibration Plasmas
2. Thromborel® S Reagent with PT-Multi Calibrator (comparison of calibrators)
®
1. Thromborel S Reagent on BCT* System y = 1.14 x - 2.37 0.986
2. Thromborel® S Reagent with Calibration Plasmas on BFT* // Analyzer y = 1.01 x - 0.59 0.998
Precision
The following studies have been calibrated with Calibration Plasmas.
% % %
Measuring Range
Reference Interval
Unit: % of norm
th th
Comments n Median 2.5 - 97.5 Percentile
— 158 99 78 - 124
are changed.
USA Distributor

BFT* II Analyzer
PT % with
®
Thromborel S

Unit % cuvette ON
Preset No. 1
1st convers reference curve
Pipetting Scheme falling
1. Sample 50 µL unit %
decimal place xxx.x
min / max value 5.0 / 150.0%
Start reagent
time interpolat. linear
Thromborel® S Reagent 100 µL value interpolat. reciprocal
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

The standard curve is measured in duplicate.
Remarks
Do not use the “Tables of values” for conversion of the seconds into percent as supplied with the reagent, as the data are only valid for the
old Fibrintimer, not the BFT* II Analyzer.
Do not use the “Quick with factor” method as the factor supplied with the “Tables of values” is only valid for the old Fibrintimer, not the BFT*
II Analyzer.

BFT* II Analyzer
PT % with
®
Thromborel S
Standard Curve (example only)

A new reference curve should be established with each change of reagent lot or with any deviation from controls or proficiency testing limits.
Do not use the calibration curve shown here or in the software, as it is an example only.
PT-Multi Calibrator
Calibrator % sec
Calibrator 1 116 10.6
Remarks
®
PT-Multi Calibrator level 6 is not applied to Thromborel S Reagent.

BFT* II Analyzer
PT INR with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
® ®
® ®
® ®
[1]
Standard Human Plasma ORKL 1 mL
Additional Notes
[1]
Optional; only if used to establish the MNPT.
vial after use.
On-board Stability
Material Time [h]
®
Bilirubin mg/dL 60

BFT* II Analyzer
PT INR with
®
Thromborel S
Method Comparison
®
Thromborel S Reagent on BCT* System y = 1.03 x - 0.01 0.984
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
PT INR with
®
Thromborel S

Unit INR cuvette ON
Preset No. 1
decimal place xxx.x
min / max value 5.0 / 150.0 %
Start reagent
Thromborel® S Reagent 100 µL value interpolat. reciprocal
Autostart yes
2nd convers INR
100.0% * xx.x s
factor --- **
ISI * x.xx

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks
*
System specific MNPT and ISI have to be used.
ISI values for prothrombin time assays must be entered directly as they appear on the current reagent labeling. Any changes of
reagent lot, software upgrades, major servicing, etc., require verification of the ISI value. Failure to enter the correct ISI value will
cause incorrect International Normalization Ratio (INR) results.
In order to report PT % and PT INR “1st conversion” in the BFT*II Analyzer Parameter-Protocol has to be set to “reference curve”. “2nd
conversion” has to be set to “INR”.
To obtain INR without PT %, set “1st conversion” to “none” and “2nd conversion” to “INR”.
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 “Table of Analytical Values” of the
respective Lot. No. of the plasma.
Do not use the “Tables of values” for conversion of the Prothrombin time into INR as the data are only valid for the Fibrintimer, not the BFT*
II Analyzer.
** This parameter does not have any function in this assay.

BFT* II Analyzer
PT INR calibrated with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
® ®
® ®
® ®
Additional Notes
vial after use.
On-board Stability
Material Time [h]
®
Bilirubin mg/dL 6

BFT* II Analyzer
®
Thromborel S
Method Comparison
®
PT INR calibrated with Thromborel S Reagent on BFT* // Analyzer and PT INR using the y = 1.04 x - 0.15 0.997
ISI value with Thromborel® S Reagent on BFT* // Analyzer.
Precision
% % %
Measuring Range
The measuring range is defined by the concentration of the calibrators used.
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
®
Thromborel S

Unit INR cuvette ON
Preset No. 1
Pipetting Scheme rising
1. Sample 50 µL unit INR
decimal place xx.xx
min / max value 0.10 / 10.00 INR
Start reagent
time interpolat. logarithmic
Thromborel® S Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator INR sec
Calibrator 1 0.93 10.6
Remarks
PT-Multi Calibrator level 6 is not applied to Thromborel® S Reagent.

BFT* II Analyzer
PT seconds (SW 2.01) with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Dade Innovin Reagent Reagent positions 1 -B4212
4 4/10/20 mL Reagent positions 1 - 4
® ®
® ®
® ®
Additional Notes
vial after use.
On-board Stability
Material Time [h]
® ®
Dade Innovin Reagent 2
Bilirubin mg/dL 60
Method Comparison
® ® ®
Dade Innovin Reagent on Sysmex CA-6000 System y = 1.04 x - 1.79 0.979

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
Reference Interval
Unit: sec
Comments n Mean Median 5th - 95th Percentile
— 60 9.0 8.9 8.1 - 10.1
are changed.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit sec cuvette ON
Preset No. 1
1st convers none
Pipetting Scheme falling *
1. Sample 50 µL unit sec. *
decimal place xxx.x *
min / max value 5.0 / 150.0% *
Start reagent
Dade® Innovin® Reagent 100 µL value interpolat. reciprocal *
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
Additional Notes
vial after use.
On-board Stability
Material Time [h]
® ®
Bilirubin mg/dL 60
Method Comparison
®
Dade Innovin Reagent on BCT* System y = 1.06 x - 0.41 0.999

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
Reference Interval
Unit: sec
Comments n Median 2.5th - 97.5th Percentile
— 156 8.8 7.9 - 10.2
are changed.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Method store 9 Method PT-Innovin
Unit sec cuvette ON
Preset No. 9
1st convers none
1. Sample 50 µL unit sec.*
min / max value 5.0 / 150.0% *
Start reagent
Dade® Innovin® Reagent 100 µL value interpolat. reciprocal *
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 3 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
PT % (SW 2.01) with
® ®
Dade Innovin
analytical values. 2.01)
and other findings.
Materials Required
® ®
® ®
® ®
® ®
Additional Notes
vial after use.
Limitations
Lipemic specimens may affect the results.
On-board Stability
Material Time [h]
® ®
Triglycerides mg/dL <200
Bilirubin mg/dL 2.4

BFT* II Analyzer
PT % (SW 2.01) with
® ®
Dade Innovin
Method Comparison
Test system for the method comparison:
1. Dade® Innovin® Reagent with InnoCal* Set
2. Dade® Innovin® Reagent with PT-Multi Calibrator (comparison of calibrators)
® ® ®
1. Dade Innovin Reagent on Sysmex CA-6000 System y = 0.92 x + 3.25 0.979
2. Dade® Innovin® Reagent with InnoCal* Set on BFT* // Analyzer y = 0.92 x + 1.03 0.999
Precision
The following studies have been calibrated with InnoCal* Set.
% % %
Measuring Range
Reference Interval
Unit: %
— 60 109.6 110.3 86.6 - 133.6
Data were generated using InnoCal* Set.
Reference intervals vary from laboratory to laboratory depending on e.g. the technique used; therefore, each laboratory should establish its
own reference interval.
USA Distributor

BFT* II Analyzer
PT % (SW 2.01) with
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 1
decimal place xxx.x
min / max value 5.0 / 120.0%
Start reagent
Dade® Innovin® Reagent 100 µL value interpolat. reciprocal
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator % sec
Calibrator 6 8 59.8
Remarks

BFT* II Analyzer
PT % (SW 2.02) with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
Additional Notes
vial after use.
Limitations
Lipemic specimens may affect the results.
On-board Stability
Material Time [h]
® ®
Triglycerides mg/dL <200
Bilirubin mg/dL 60

BFT* II Analyzer
PT % (SW 2.02) with
® ®
Dade Innovin
Method Comparison
Data were generated using InnoCal* Set.
Dade Innovin® Reagent on BCT* System y = 0.90 x + 6.98 0.974
Precision
The following studies have been calibrated with InnoCal* Set.
% % %
Measuring Range
Reference Interval
Unit: % of norm
th th
Comments n Median 2.5 - 97.5 Percentile
— 156 98 75 - 121
USA Distributor

BFT* II Analyzer
PT % (SW 2.02) with
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 9
decimal place xxx.x
min / max value 5.0 / 120.0%
Start reagent
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 3 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator % sec
Remarks

BFT* II Analyzer
PT INR (SW 2.01) with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
[1]
Additional Notes
[1]
vial after use.
On-board Stability
Material Time [h]
® ®
Bilirubin mg/dL 6

BFT* II Analyzer
® ®
Dade Innovin
Method Comparison
® ® ®
Dade Innovin Reagent on Sysmex CA-6000 System y = 0.91 x - 0.20 0.951
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit INR cuvette ON
Preset No. 1
decimal place xxx.x
min / max value 5.0 / 120.0 %
Start reagent
Autostart yes
2nd convers INR
100.0% * xx.x s
factor --- **
ISI * x.xx

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks
*

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
[1]
Additional Notes
[1]
vial after use.
On-board Stability
Material Time [h]
® ®
Bilirubin mg/dL 60

BFT* II Analyzer
® ®
Dade Innovin
Method Comparison
®
Dade Innovin Reagent on BCT* System y = 1.06 x - 0.03 0.999
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit INR cuvette ON
Preset No. 9
decimal place xxx.x
min / max value 5.0 / 120.0 %
Start reagent
Autostart yes
2nd convers INR
100.0% * xx.x s
factor --- **
ISI * x.xx

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 3 s
learn 3 s
lag 1 s

Remarks
*

BFT* II Analyzer
PT INR calibrated (SW 2.01) with
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
Additional Notes
vial after use.
On-board Stability
Material Time [h]
® ®
Bilirubin mg/dL 12

BFT* II Analyzer
® ®
Dade Innovin
Method Comparison
® ®
PT INR calibrated with Dade Innovin Reagent on BFT* // Analyzer and PT INR using the y = 1.00 x + 0.01 0.999
ISI value with Dade® Innovin® Reagent on BFT* // Analyzer.
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit INR cuvette ON
Preset No. 1
decimal place xx.xx
Start reagent
Dade® Innovin® Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator INR sec
Remarks

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
® ®
® ®
® ®
Additional Notes
vial after use.
On-board Stability
Material Time [h]
® ®
Bilirubin mg/dL 60

BFT* II Analyzer
® ®
Dade Innovin
Method Comparison
® ®
PT INR calibrated with Dade Innovin Reagent on BFT* // Analyzer and PT INR using the y = 1.00 x + 0.01 1.000
ISI value with Dade® Innovin® Reagent on BFT* // Analyzer.
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit INR cuvette ON
Preset No. 9
decimal place xx.xx
Start reagent
Dade® Innovin® Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 30 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 3 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator INR sec
Remarks

BFT* II Analyzer
PT seconds with
®
Dade Thromboplastin C Plus
analytical values.
and other findings.
Materials Required
®
Dade Thromboplastin C Plus Reagent Reagent position 1 B4216 4/10 mL Reagent position 1
Dade® Ci-Trol® Coagulation Control Level 1 B4244-10 1 mL Beside the BFT* II Analyzer
® ®
Magnetic stir bar — 718.88131 10 —
Additional Notes
Be sure to place a magnetic stir bar in the reagent bottle. Magnetic stir bars can be ordered as spare part (part no. 718.88131) at Siemens
Service.
Before use the reagent should be mixed carefully and brought to 37°C.
On-board Stability
Material Time [h]
Dade® Thromboplastin C Plus Reagent 4
Bilirubin mg/dL 60
Method Comparison
® ®
Dade Thromboplastin C Plus Reagent on Sysmex CA-6000 System y = 1.04 x - 2.05 0.956

BFT* II Analyzer
PT seconds with
®
Precision
% % %
Measuring Range
Reference Interval
Unit: sec
— 60 9.8 9.8 9.2 - 10.6
are changed.
USA Distributor

BFT* II Analyzer
PT seconds with
®

Unit sec cuvette ON
Preset No. 1
1st convers none
1. Sample 50 µL unit sec. *
min / max value 5.0 / 150.0% *
Start reagent
Dade® Thromboplastin C Plus Reagent 100 µL value interpolat. reciprocal *
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
PT INR with
®
analytical values.
and other findings.
Materials Required
®
® ®
Additional Notes
Service.
On-board Stability
Material Time [h]
Dade® Thromboplastin C Plus Reagent 4
Bilirubin mg/dL 6
Method Comparison
® ®
Dade Thromboplastin C Plus Reagent on Sysmex CA-6000 System y = 0.98 x - 0.00 0.876

BFT* II Analyzer
PT INR with
®
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
PT INR with
®

Unit INR cuvette ON
Preset No. 1
1st convers none
Pipetting Scheme falling **
1. Sample 50 µL unit % **
decimal place xxx.x **
min / max value 5.0 / 150.0 % **
Start reagent
time interpolat. linear **
Dade® Thromboplastin C Plus Reagent 100 µL value interpolat. reciprocal **
Autostart yes
2nd convers INR
100.0% * xx.x s
factor --- **
ISI * x.xx

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks
*
“1st conversion” in the BFT* II Analyzer Parameter-Protocol has to be set to “none” and “2nd conversion” to “INR”.

BFT* II Analyzer
®
analytical values.
and other findings.
Materials Required
®
® ®
Additional Notes
Service.
On-board Stability
Material Time [h]
®
Dade Thromboplastin C Plus Reagent 4
Bilirubin mg/dL 6
Method Comparison
®
PT INR using the ISI value with Dade Thromboplastin C Plus Reagent on BFT* // Analyzer y = 1.24 x - 0.43 0.999

BFT* II Analyzer
®
Precision
% % %
Measuring Range
Reference Interval
Not applicable.
USA Distributor

BFT* II Analyzer
®

Unit INR cuvette ON
Preset No. 1
decimal place xx.xx
Start reagent
Dade® Thromboplastin C Plus Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 11.0 s *
factor --- *
ISI 1.14 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


PT-Multi Calibrator
Calibrator INR sec
Remarks

BFT* II Analyzer
APTT with
® ®
Dade Actin Activated Cephaloplastin Reagent
analytical values.
and other findings.
Materials Required
® ®
Dade Actin Activated Cephaloplastin Reagent B4218-1/-2 2/10 mL Beside the BFT* II Analyzer [1]
® ®
® ®
® ®
Calcium Chloride Solution Reagent positions 1 -ORHO
4 15 mL Reagent positions 1 - 4
Additional Notes
[1]
Do not place on a reagent position of the BFT* II Analyzer, since all reagent positions of the BFT* II Analyzer are at 37 °C. These reagents
have to be placed beside the BFT*II Analyzer for use.
Before use the reagent has to be mixed carefully.
On-board Stability
Material Time [h]
Calcium Chloride Solution 24
® ®
Dade Actin Reagent (RT) 24
Bilirubin mg/dL 60

BFT* II Analyzer
APTT with
® ®
Method Comparison
Pathromtin* SL Reagent on BCT* System y = 0.73 x + 3.33 0.900
Precision
% % %
Measuring Range
Reference Interval
Unit: s
th th
Comments n Mean Median 5 - 95 Percentile
— 110 25.6 25.5 22.2 - 29.8
are changed.
USA Distributor

BFT* II Analyzer
APTT with
® ®

Method store 2 Method aPTT
Unit sec cuvette ON
Preset No. 2
1st convers none
1. Sample 50 µL unit sec *
® ® decimal place xxx.x *
2. Dade Actin Activated Cephaloplastin Reagent 50 µL
min / max value 0.0 / 0.0 *
Incubation time 180 sec time interpolat. linear *
Start reagent value interpolat. linear *
Calcium Chloride Solution 50 µL
2nd convers none
Autostart yes
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks

BFT* II Analyzer
APTT with
® ®
Dade Actin FS Activated PTT Reagent
analytical values.
and other findings.
Materials Required
® ®
Dade Actin FS Activated PTT Reagent B4218-20/-100 2/10 mL Beside the BFT* II Analyzer [1]
® ®
® ®
® ®
Additional Notes
[1]
On-board Stability
Material Time [h]
® ®
Dade Actin FS Reagent (RT) 24
Bilirubin mg/dL 60

BFT* II Analyzer
APTT with
® ®
Method Comparison
Pathromtin* SL Reagent on BCT* System y = 1.01 x - 2.18 0.941
Precision
% % %
Measuring Range
Reference Interval
Unit: sec
th th
— 110 26.2 26.2 22.4 - 29.3
are changed.
USA Distributor

BFT* II Analyzer
APTT with
® ®

Unit sec cuvette ON
Preset No. 2
1st convers none
2. Dade Actin FS Activated PTT Reagent 50 µL
2nd convers none
Autostart yes
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks

BFT* II Analyzer
APTT with
® ®
Dade Actin FSL Activated PTT Reagent
analytical values.
and other findings.
Materials Required
® ®
Dade Actin FSL Activated PTT Reagent B4219 2/10 mL Beside the BFT* II Analyzer [1]
® ®
® ®
® ®
Additional Notes
[1]
On-board Stability
Material Time [h]
® ®
Dade Actin FSL Reagent (RT) 24
Bilirubin mg/dL 60

BFT* II Analyzer
APTT with
® ®
Method Comparison
Precision
% % %
Dade® Ci-Trol® 3 1.4 1.1 1.7
Measuring Range
Reference Interval
Unit: sec
th th
— 110 27.8 27.8 24.0 - 32.6
are changed.
USA Distributor

BFT* II Analyzer
APTT with
® ®

Unit sec cuvette ON
Preset No. 2
1st convers none
2. Dade Actin FSL Activated PTT Reagent 50 µL
2nd convers none
Autostart yes
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks

BFT* II Analyzer
APTT with
Pathromtin* SL
analytical values.
and other findings.
Materials Required
Pathromtin* SL Reagent OQGS 5 mL Beside the BFT* II Analyzer [1]
® ®
® ®
® ®
® ®
® ®
® ®
Additional Notes
[1]
On-board Stability
Material Time [h]
Pathromtin* SL Reagent (RT) 24
Bilirubin mg/dL 60

BFT* II Analyzer
APTT with
Pathromtin* SL
Method Comparison
Precision
% % %
Measuring Range
Reference Interval
Unit: sec
th th
— 110 32.0 31.7 27.1 - 38.8
are changed.
USA Distributor

BFT* II Analyzer
APTT with
Pathromtin* SL

Unit sec cuvette ON
Preset No. 2
1st convers none
2. Pathromtin* SL Reagent 50 µL
2nd convers none
Autostart yes
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks

BFT* II Analyzer
Fibrinogen with
Multifibren* U
analytical values.
and other findings.
Materials Required
Multifibren* U Reagent Reagent position 1 OWZG 2/5 mL Reagent position 1
Kaolin Suspension for Fibrintimer OQAB 50 mL Beside the BFT* II Analyzer
Fibrinogen Calibrator Kit OQVK 6 x 1 mL
Additional Notes
Before use the Kaolin Suspension has to be mixed well to get a homogeneous suspension.
Reconstitute Multifibren* U Reagent with an equal volume of Kaolin Suspension for Fibrintimer.
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 15 g HES per liter plasma.
On-board Stability
Material Time [h]
Multifibren* U Reagent 4
Bilirubin mg/dL 60
Method Comparison
Multifibren* U Reagent on BCT* System y = 1.00 x + 0.03 0.968

BFT* II Analyzer
Fibrinogen with
Multifibren* U
Precision
% % %
Measuring Range
Reference Interval
Unit: g/L
— 149 2.8 2.7 2.0 - 4.0
are changed.
USA Distributor

BFT* II Analyzer
Fibrinogen with
Multifibren* U

Method store 5 Method Fib. g/L
Unit g/L cuvette ON
Preset No. 5
1. Sample 50 µL unit g/L
decimal place xx.xx
min / max value 0.20 / 10.00 g/L
Start reagent
Multifibren* U Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 40 s
1 500 rpm
2 200 rpm
adjust 1 s
learn 3 s
lag 1 s


Fibrinogen Calibrator Kit
Calibrator g/L sec
Fibrinogen Calibrator 1 0.63 133.0
Remarks
Do not use calibration values as supplied in the “Table for the evaluation of Fibrinogen determination with Multifibren* U Reagent” for BFT*
II Analyzer, since these values are only for the old Behring Fibrintimer.

BFT* II Analyzer
Fibrinogen with
Multifibren* U
Test Protocol for mg/dL:

Method store 6 Method Fib. mg/dL
Unit mg/dL cuvette ON
Preset No. 6
falling
Pipetting Scheme
unit mg/dL
1. Sample 50 µL
decimal place xxxx.
min / max value 20 / 1000 mg/dL
Start reagent time interpolat. logarithmic
Multifibren* U Reagent 100 µL value interpolat. logarithmic
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 40 s
1 500 rpm
2 200 rpm
adjust 1 s
learn 3 s
lag 1 s

See previous page.
Remarks

BFT* II Analyzer
Thrombin Time with
Test Thrombin Reagent
analytical values.
and other findings.
Materials Required
Test Thrombin Reagent — OWHM Kit —
REAGENT DILUENT — — 50 mL —
TEST THROMBIN REAGENT Reagent positions 1 - 4 — 5 mL Reagent positions 1 - 4
® ®
Dade Ci-Trol 1 291070
Beside the BFT* II Analyzer 1 mL Beside the BFT* II Analyzer
Additional Notes
On-board Stability
Material Time [h]
Test Thrombin Reagent 6
Bilirubin mg/dL 36
Method Comparison
Test Thrombin Reagent on BFA* System y = 0.98 x -6.17 0.950
Precision
% % %
Measuring Range

BFT* II Analyzer
Thrombin Time with
Reference Interval
Unit: sec
th th
— 76 12.3 11.7 10.4 - 16.1
are changed.
USA Distributor

BFT* II Analyzer
Thrombin Time with

Method store 3 Method Thrombin Time
Unit sec cuvette ON
Preset No. 3
1st convers none
Start reagent
Test Thrombin Reagent 100 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
Thrombin Time with
Thromboclotin*
analytical values.
and other findings.
Materials Required
Thromboclotin* Reagent Reagent positions 1 -281007
Dade® Ci-Trol® 1 291070
Additional Notes
If expected heparin concentration of the sample is low, the method TT Thromboclotin has to be used.
If expected heparin concentration of the sample is high, the method TT Thromboclotin Hep. high has to be used.
On-board Stability
Material Time [h]
Thromboclotin* Reagent 1
Triglycerides mg/dL 300 300*
Hemoglobin mg/dL 600 1000*
Bilirubin mg/dL 60 60*
* Values for TT Thromboclotin / TT Thromboclotin Hep. high
Precision
% % %
For TT Thromboclotin: Control Plasma N 3.8 1.7 3.9
For TT Thromboclotin Hep.high: Control Plasma N 5.9 2.5 6.0
Measuring Range

BFT* II Analyzer
Thrombin Time with
Thromboclotin*
Method Comparison
®
For TT Thromboclotin with Thromboclotin* Reagent on Sysmex CA-6000 System y = 1.42 x - 8.91 0.849
For TT Thromboclotin Hep.high with Thromboclotin* Reagent on Sysmex® CA-6000 y = 0.90 x - 3.13 0.941
System
Reference Interval
Unit: sec
th th
for TT Thromboclotin 76 12.7 13.0 10.3 - 15.0
For TT Thromboclotin Hep.high 76 11.4 11.0 9.3 - 14.2
are changed.
USA Distributor

BFT* II Analyzer
Thrombin Time with
Thromboclotin*
TT Thromboclotin:

Unit sec cuvette ON
Preset No. 3
1st convers none
falling *
Pipetting Scheme
unit sec *
1. Sample 100 µL
Start reagent time interpolat. linear *
Thromboclotin* Reagent 100 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0 s*
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
Thrombin Time with
Thromboclotin*
TT Thromboclotin Hep. high:

Unit sec cuvette ON
Preset No. 3
1st convers none
falling *
Pipetting Scheme
unit sec *
1. Sample 80 µL
Start reagent time interpolat. linear *
Thromboclotin* Reagent 140 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 140 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
Batroxobin Time with
Batroxobin Reagent
analytical values.
and other findings.
Materials Required
Batroxobin Reagent Reagent positions 1 -OUOV
Dade® Ci-Trol® 1 291070
Additional Notes
On-board Stability
Material Time [h]
Batroxobin Reagent 8
Bilirubin mg/dL 60
Method Comparison
Batroxobin Reagent on BCT* System y = 0.98 x - 2.26 0.961
Precision
% % %
Dade® Ci-Trol® 1 2.4 2.1 3.1
Measuring Range

BFT* II Analyzer
Batroxobin Reagent
Reference Interval
Unit: sec
th th
— 69 12.9 12.8 11.9 - 14.1
are changed.
USA Distributor

BFT* II Analyzer
Batroxobin Reagent

Method store 4 Method Batroxobin Time
Unit sec cuvette ON
Preset No. 4
1st convers none
Start reagent
Batroxobin Reagent 100 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

Remarks

BFT* II Analyzer
Coagulation Factor II with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Coagulation Factor II Deficient Plasma OSGR 1 mL Beside the BFT* II Analyzer [1]
Imidazole Buffer Solution OQAA 15 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
Thromborel® S Reagent 8
FII Deficient Plasma (RT) 8
Imidazole Buffer Solution (RT) 8
Bilirubin mg/dL 60
Method Comparison
Thromborel® S Reagent on BCT* System y = 1.19 x - 2.39 0.977

BFT* II Analyzer
®
Thromborel S
Precision
% % %
Measuring Range
The measuring range is defined by the concentration of the calibrators used. Refer to the Instructions for Use of the analyzer for additional
information.
Reference Interval
70 - 120 % [2]
[2]
Thomas, Lothar, “Clinical Laboratory Diagnostics”, TH-Books Emil-von-Behring-Str. 76
Verlagsgesellschaft mbH, Frankfurt/Main, Germany, 1998: 607. 35041 Marburg / Germany
USA Distributor

BFT* II Analyzer
®
Thromborel S

Method store 7 Method Extr. Factor
Unit % cuvette ON
Preset No. 7
Predilution 1:20 falling
Sample 10 µL unit %
Imidazole Buffer Solution 190 µL decimal place xxx.x
min / max value 0.5 / 200.0 %
Pipetting Scheme time interpolat. logarithmic
1. Prediluted sample 50 µL value interpolat. logarithmic
2. Coagulation Factor II Deficient Plasma 50 µL 2nd convers none
Incubation time 60 sec 100.0% 0.0 s *
Start reagent factor --- *
Thromborel® S Reagent 100 µL ISI 0.00 *
Autostart yes measurement lot. no.: xxxxxx
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

The results are evaluated using a reference curve established with Standard Human Plasma. The standard curve is measured in duplicate.
Standard Human Prediluted Standard

Factor [1] Dilution Plasma Human Plasma 1:25 Imidazole Buffer
µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Factor: Multiply the analytical value of the calibrator by the specified factors.
The analytical value is lot specific, refer to the table of analytical values.
Remarks

BFT* II Analyzer
®
Thromborel S

Standard Human Plasma
% sec
145.5 18.8
97.0 21.9
72.8 25.2
48.5 30.0
32.0 36.1
24.3 42.2
12.1 59.7

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor II Deficient Plasma OSGR 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
Dade® Innovin® Reagent 3
FII Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison
Thromborel® S Reagent on BCT* System y = 1.06 x + 0.11 0.985

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor II Deficient Plasma 50 µL 2nd convers none
Dade® Innovin® Reagent 100 µL ISI 0.00 *
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
® ®
Dade Innovin

% sec
145.5 17.3
97.0 21.3
72.8 24.8
48.5 30.1
32.0 37.3
24.3 45.7
12.1 74.7

BFT* II Analyzer
Coagulation Factor V with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Coagulation Factor V Deficient Plasma ORSM 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
FV Deficient Plasma (RT) 8
Bilirubin mg/dL 24
Method Comparison

BFT* II Analyzer
®
Thromborel S
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
®
Thromborel S

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor V Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
®
Thromborel S

% sec
138.0 21.2
92.0 23.6
69.0 25.6
46.0 28.8
30.4 32.5
23.0 36.1
11.5 43.7

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor V Deficient Plasma ORSM 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
Bilirubin mg/dL 6
Method Comparison

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor V Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
® ®
Dade Innovin

% sec
138.0 15.9
92.0 17.5
69.0 19.0
46.0 21.2
30.4 23.9
23.0 25.7
11.5 31.4

BFT* II Analyzer
Coagulation Factor VII with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Coagulation Factor VII Deficient Plasma OTXV 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
FVII Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
®
Thromborel S
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
®
Thromborel S

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor VII Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
®
Thromborel S

% sec
139.5 23.2
93.0 26.1
69.8 28.5
46.5 32.3
30.7 36.6
23.3 40.3
11.6 50.2

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor VII Deficient Plasma OTXV 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
FVII Deficient Plasma (RT) 8
Bilirubin mg/dL 48
Method Comparison

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor VII Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
® ®
Dade Innovin

% sec
139.5 19.5
93.0 22.3
69.8 25.1
46.5 29.9
30.7 34.9
23.3 40.2
11.6 54.2

BFT* II Analyzer
Coagulation Factor X with
®
Thromborel S
analytical values.
and other findings.
Materials Required
®
Coagulation Factor X Deficient Plasma OTXY 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
FX Deficient Plasma (RT) 8
Bilirubin mg/dL 48
Method Comparison

BFT* II Analyzer
®
Thromborel S
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
®
Thromborel S

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor X Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
®
Thromborel S

% sec
148.5 22.9
99.0 26.8
74.3 30.3
49.5 35.7
32.7 41.7
24.8 48.6
12.4 68.5

BFT* II Analyzer
® ®
Dade Innovin
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor X Deficient Plasma OTXY 1 mL Beside the BFT* II Analyzer [1]
Additional Notes
[1]
On-board Stability
Material Time [h]
FX Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
® ®
Dade Innovin
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®
Dade Innovin

Unit % cuvette ON
Preset No. 7
min / max value 0.5 / 200.0 %
2. Coagulation Factor X Deficient Plasma 50 µL 2nd convers none
Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s


µL µL µL —
1.25 1:16 10 --- 150 ---
1.0 1:20 10 --- 190 ---
0.8 1:25 20 --- 480 ---
0.6 1:33.3 --- 150 50 ---
0.4 1:50 --- 100 100 ---
0.15 1:133.3 --- 30 130 ---
[1]
Remarks

BFT* II Analyzer
® ®
Dade Innovin

% sec
148.5 18.6
99.0 22.1
74.3 24.6
49.5 28.5
32.7 32.9
24.8 38.6
12.4 53.1

BFT* II Analyzer
Coagulation Factor VIII with
® ®
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor VIII Deficient Plasma OTXW 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FVIII Deficient Plasma (RT) 8
® ®
Dade Actin Reagent (RT) 8
Bilirubin mg/dL 60
Method Comparison
Pathromtin* SL Reagent on BCT* System y = 0.97 x 5.43 0.946

BFT* II Analyzer
® ®
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 150 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®
The measurement has to be started manually by pressing the start button with the pipetting of Calcium Chloride since the autostart does not
work with this assay.

Method store 8 Method Intr. Factor
Unit % cuvette ON
Preset No. 8 1st convers reference curve
unit %
Sample 40 µL
decimal place xxx.x
Imidazole Buffer Solution 160 µL
min / max value 0.5 / 200.0 %
2. Coagulation Factor VIII Deficient Plasma 50 µL 2nd convers none
3. Dade® Actin® Activated Cephaloplastin Reagent 50 µL 100.0% 0.0 s *
Incubation time 120 sec factor --- *
Start reagent ISI 0.00 *
Calcium Chloride Solution 50 µL measurement lot. no.: xxxxxx
Autostart no Start Reag. 50 µl
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.05 1:100 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
® ®

% sec
136.5 42.4
91.0 48.4
68.3 52.4
45.5 59.8
30.0 66.4
22.8 69.2
11.4 78.2

BFT* II Analyzer
Pathromtin* SL
analytical values.
and other findings.
Materials Required
Coagulation Factor VIII Deficient Plasma OTXW 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FVIII Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
Pathromtin* SL
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 150 % [2]
[2]
USA Distributor

BFT* II Analyzer
Pathromtin* SL

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor VIII Deficient Plasma 50 µL 2nd convers none
3. Pathromtin* SL Reagent 50 µL 100.0% 0.0 s *
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.05 1:100 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
Pathromtin* SL

% sec
136.5 41.4
91.0 45.4
68.3 47.7
45.5 52.3
30.0 57.6
22.8 60.7
11.4 69.6

BFT* II Analyzer
Coagulation Factor IX with
® ®
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor IX Deficient Plasma OTXX 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
Dade® Actin® Reagent (RT) 8
FIX Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
® ®
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor IX Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
® ®

% sec
150.0 38.5
100.0 43.2
75.0 46.8
50.0 51.7
33.0 57.7
25.0 61.5
12.5 70.3

BFT* II Analyzer
Pathromtin* SL
analytical values.
and other findings.
Materials Required
Coagulation Factor IX Deficient Plasma OTXX 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FIX Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
Pathromtin* SL
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
Pathromtin* SL

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor IX Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
Pathromtin* SL

% sec
150.0 38.1
100.0 42.0
75.0 45.1
50.0 50.1
33.0 55.0
25.0 59.9
12.5 69.7

BFT* II Analyzer
Coagulation Factor XI with
® ®
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor XI Deficient Plasma OSDF 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FXI Deficient Plasma (RT) 6
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
® ®
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor XI Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
® ®

% sec
139.5 41.7
93.0 47.2
69.8 51.2
46.5 57.3
30.7 64.1
23.3 69.4
11.6 79.4

BFT* II Analyzer
Pathromtin* SL
analytical values.
and other findings.
Materials Required
Coagulation Factor XI Deficient Plasma OSDF 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FXI Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
Pathromtin* SL
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
Pathromtin* SL

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor XI Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
Pathromtin* SL

% sec
139.5 40.7
93.0 45.0
69.8 48.9
46.5 54.7
30.7 60.0
23.3 64.1
11.6 74.6

BFT* II Analyzer
Coagulation Factor XII with
® ®
analytical values.
and other findings.
Materials Required
® ®
Coagulation Factor XII Deficient Plasma OSDG 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FXII Deficient Plasma (RT) 4
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
® ®
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 120 % [2]
[2]
USA Distributor

BFT* II Analyzer
® ®

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor XII Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
® ®

% sec
142.5 37.7
95.0 41.5
71.3 45.3
47.5 50.5
31.4 57.4
23.8 62.9
11.9 77.6

BFT* II Analyzer
Pathromtin* SL
analytical values.
and other findings.
Materials Required
Coagulation Factor XII Deficient Plasma OSDG 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
FXII Deficient Plasma (RT) 8
Bilirubin mg/dL 60
Method Comparison

BFT* II Analyzer
Pathromtin* SL
Precision
% % %
Measuring Range
information.
Reference Interval
70 - 150 % [2]
[2]
USA Distributor

BFT* II Analyzer
Pathromtin* SL

Unit % cuvette ON
unit %
Sample 40 µL
decimal place xxx.x
min / max value 0.5 / 200.0 %
2. Coagulation Factor XII Deficient Plasma 50 µL 2nd convers none
2nd 120 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 15 s


µL µL µL —
1.25 1:4 30 --- 90 ---
1.0 1:5 30 --- 120 ---
0.75 1:6.7 30 --- 170 ---
0.5 1:10 20 --- 180 ---
0.25 1:20 10 --- 190 ---
0.10 1:50 --- 30 120 ---
[1]
Remarks

BFT* II Analyzer
Pathromtin* SL

% sec
142.5 37.3
95.0 41.7
71.3 44.4
47.5 49.4
31.4 54.8
23.8 57.4
11.9 69.8

BFT* II Analyzer
Lupus Anticoagulant with
LA 1 Screening Reagent / LA 2 Confirmation Reagent
analytical values.
and other findings.
Materials Required
LA 1 Screening Reagent OQGP 2 mL Reagent positions 1 - 4
LA 2 Confirmation Reagent OQGR 1 mL
Control Plasma N ORKE 1 mL Beside the BFT* II Analyzer
LA Control High OQWD 1 mL
LA Control Low OQWE 1 mL
Additional Notes
On-board Stability
Material Time [h]
LA 1 Screening Reagent 4
LA 2 Confirmation Reagent 4
Bilirubin mg/dL 60
Method Comparison
LA 1 Screening Reagent on BCT* System y = 1.03 x - 1.38 0.990
LA 1 Screening Reagent / LA 2 Confirmation Reagent on BCT* System y = 0.99 x - 0.01 0.984

BFT* II Analyzer
Precision
% % %
LA 1: Control Plasma N 2.2 1.0 2.3
LA 1: LA Control Low 1.3 2.1 2.4
LA 1: LA Control High 1.6 1.3 2.0
LA 2: Control Plasma N 1.8 0.4 1.8
LA 2: LA Control Low 1.2 0.8 1.4
LA 2: LA Control High 1.3 1.2 1.7
LA 1 / LA 2 Ratio: Control Plasma N 2.7 0.8 2.6
LA 1 / LA 2 Ratio: LA Control Low 1.1 2.0 2.3
LA 1 / LA 2 Ratio: LA Control High 1.7 0.5 1.7
Measuring Range
Reference Interval
Unit: sec
th th
LA 1 Screening Reagent 75 31.1 30.5 27.8 - 35.1
LA 2 Confirmation Reagent 75 31.2 31.2 29.0 - 34.3
LA 1 / LA 2 Ratio (no unit) 75 0.99 0.99 0.91 - 1.11
are changed.
USA Distributor

BFT* II Analyzer

Method store 14 Method LA 1
Unit sec cuvette ON
Preset No. 14
1st convers none
Start reagent
LA 1 Screening Reagent 100 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks
Refer to the Instructions for Use for information regarding result evaluation.
All parameters have to be entered manually.

BFT* II Analyzer

Method store 15 Method LA 2
Unit sec cuvette ON
Preset No. 15
1st convers none
Start reagent
LA 2 Confirmation Reagent 100 µL value interpolat. linear *
Autostart yes
2nd convers none
100.0% 0.0 s *
factor --- *
ISI 0.00 *

Start Reag. 100 µl
2nd 60 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Remarks

BFT* II Analyzer
Protein C System with
®
ProC Global
analytical values.
and other findings.
Materials Required
®
ProC Global Assay — OQLS Kit —
REAGENT APTT — 5 mL Beside the BFT* II Analyzer [1]
ACTIVATOR — 2 mL
BUFFER — 2 mL
®
ProC Control Plasma OQKE 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
REAGENT APTT (RT) 24
ACTIVATOR (RT) 24
BUFFER (RT) 24
Bilirubin mg/dL 60
Method Comparison
ProC® Global Assay on BFA* System y = 0.91 x + 0.01 0.945

BFT* II Analyzer
®
ProC Global
Precision
% % %
ProC® Control Plasma 4.3 0.9 4.1
Measuring Range
Reference Interval
Unit: NR
— 65 1.05 1.01 0.78 - 1.40
USA Distributor

BFT* II Analyzer
®
ProC Global

Method store 10 Method PCAT
Unit sec cuvette ON
Preset No. 10
1st convers none
2. ACTIVATOR 50 µL
3. REAGENT APTT 50 µL time interpolat. linear *
Incubation time 180 sec value interpolat. linear *
Start reagent
2nd convers none
100.0% 0.0 s *
Autostart no
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

Refer to the Instructions for Use regarding calibration. The calibration factor must be determined every month for each analyzer and lot of
reagent.
Remarks
To assure inter-laboratory comparability of the results, it is recommended that the Normalized Ratio (NR) of each sample should be
calculated. Refer to Instruction for Use for further information regarding result evaluation.

BFT* II Analyzer
®
ProC Global

Method store 11 Method PCAT/ 0
Unit sec cuvette ON
Preset No. 11
1st convers none
1. Sample 50 µL unit sec*
decimal place xxx.x*
2. BUFFER 50 µL
3. REAGENT APTT 50 µL time interpolat. linear *
Incubation time 180 sec value interpolat. linear *
Start reagent
2nd convers none
100.0% 0.0 s *
Autostart no
factor --- *
ISI 0.00 *

Start Reag. 50 µl
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

reagent.
Remarks

BFT* II Analyzer
Factor V Leiden with
®
ProC Global / Factor V Deficient Plasma
analytical values.
and other findings.
Materials Required
®
ProC Global Assay — OQLS Kit —
REAGENT APTT — 5 mL Beside the BFT* II Analyzer [1]
ACTIVATOR — 2 mL
BUFFER — 2 mL
Coagulation Factor V Deficient Plasma ORSM 1 mL
®
ProC Control Plasma OQKE 1 mL
Additional Notes
[1]
On-board Stability
Material Time [h]
REAGENT APTT (RT) 24
ACTIVATOR (RT) 24
BUFFER (RT) 24
Bilirubin mg/dL 48

BFT* II Analyzer
®
Method Comparison
®
ProC Global / Factor V Assay on BCT* System y = 1.00 x - 0.02 0.978
Precision
% % %
ProC® Control Plasma 3.1 2.4 3.8
Measuring Range
Reference Interval
Unit: NR
th th
— 66 1.02 1.01 0.91 - 1.14
USA Distributor

BFT* II Analyzer
®

Method store 12 Method FV PCAT
Unit sec cuvette ON
Preset No. 12
1st convers none
Predilution 1:5 falling *
Sample 20 µL unit sec *
Coagulation Factor V Deficient 80 µL decimal place xxx.x *
Pipetting Scheme time interpolat. linear *
1. Prediluted sample 50 µL value interpolat. linear *
2. ACTIVATOR 50 µL 2nd convers none
3. REAGENT APTT 50 µL 100.0% 0.0 s *
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

reagent.
Remarks

BFT* II Analyzer
®

Method store 13 Method FV PCAT/ 0
Unit sec cuvette ON
Preset No. 13
1st convers none
Predilution 1:5 falling *
Sample 20 µL unit sec *
Coagulation Factor V Deficient 80 µL decimal place xxx.x *
Pipetting Scheme time interpolat. linear *
1. Prediluted sample 50 µL value interpolat. linear *
2. BUFFER 50 µL 2nd convers none
3. REAGENT APTT 50 µL 100.0% 0.0 s *
2nd 180 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 5 s
learn 3 s
lag 15 s

reagent.
Remarks

BFT* II Analyzer
Protein C with
Protein C Reagent
analytical values.
and other findings.
Materials Required
Protein C Reagent — OQYG Kit —
ACTIVATOR — 3 mL Beside the BFT* II Analyzer [1]
DEFICIENT — 1 mL
REAGENT APTT — 10 mL
Additional Notes
[1]
Limitations
Hemolyzed samples are not suitable for protein C determination.
On-board Stability
Material Time [h]
ACTIVATOR (RT) 8
DEFICIENT (RT) 4
REAGENT APTT (RT) 8
Bilirubin mg/dL 24

BFT* II Analyzer
Protein C with
Protein C Reagent
Method Comparison
Protein C Reagent, coagulometric on BCT* System y = 1.03 x + 1.99 0.986
Precision
% % %
Measuring Range
information.
Reference Interval
Refer to the Instructions for Use of the reagent.
USA Distributor

BFT* II Analyzer
Protein C with
Protein C Reagent

Method store 14 Method Protein C Clot
Unit % cuvette ON
Predilution 1:10 rising
unit %
Sample 20 µL
decimal place xxx.x
min / max value 10.0 / 150.0 %
2. DEFICIENT 50 µL 2nd convers none
3. ACTIVATOR 50 µL 100.0% 0.0 s *
4. REAGENT APTT 50 µL factor --- *
Incubation time 240 sec ISI 0.00 *
Start reagent measurement lot. no.: xxxxxx
Calcium Chloride Solution 50 µL Start Reag. 50 µl
Autostart no incubat (0 = off) 1st 0 s
2nd 240 s
mixer 1 -> 2 10 s
1 500 rpm
2 500 rpm
adjust 1 s
learn 3 s
lag 1 s

1. dilution step 2. dilution step
Standard Human
Factor [1] Dilution Plasma Deficient Plasma SHP dil. with Imidazole Buffer
µL µL deficient plasma µL µL
1.50 1:6.7 60 --- --- 340
1.00 1:10 50 --- --- 450
0.75 1:13.3 150 50 50 450
0.50 1:20 50 50 50 450
0.33 1:30 50 100 50 450
0.10 1:100 20 180 50 450
[1]
Remarks

BFT* II Analyzer
Protein C with
Protein C Reagent

% sec
148.5 102.7
99.0 85.8
74.3 72.3
49.5 58.2
32.7 50.3
10.0 38.5
Remarks
Calibrators are measured in duplicate using 50 µl of the respective final calibrator dilution.

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BFT* II Analyzer

Reference Guide 3.01

This document is Siemens Healthcare Diagnostics Reference Guide

Document ID: RG-01-01-3.01

Sysmex is a registered trademark of SYSMEX CORPORATION.

Siemens Healthcare Diagnostics Products GmbH

Reference Guide 3.01 - not for use in the USA - 2

Document Date Changes

Deleted Application Sheets:

Revised Application Sheets:

Deleted Application Sheets:

Revised Application Sheets:

Reference Guide 3.01 - not for use in the USA - 3

Deleted Application Sheets:

Revised Application Sheets:

Deleted Application Sheets:

Revised Application Sheets:

Reference Guide 3.01 - not for use in the USA - 4

Version Application Sheet Page

Thrombin Time / Batroxobin Time

Reference Guide 3.01 - not for use in the USA - 5

07 Coagulation Factor IX with Dade® Actin® Activated Cephaloplastin Reagent .....................................119

Reference Guide 3.01 - not for use in the USA - 6

Reference Guide 3.01 - not for use in the USA - 7

Reference Guide 3.01 - not for use in the USA - 8

Test Protocol Parameter-Protocol

measurement lot. no.: xxxxxx

Standard Curve Calibration

Reference Guide 3.01 - not for use in the USA - 9

Reference Guide 3.01 - not for use in the USA - 10

Reference Guide 3.01 - not for use in the USA - 11

Test Protocol Parameter-Protocol

measurement lot. no.: xxxxxx

Standard Curve Calibration

Reference Guide 3.01 - not for use in the USA - 12

Standard Curve (example only)

Reference Guide 3.01 - not for use in the USA - 13

Reference Guide 3.01 - not for use in the USA - 14

Reference Guide 3.01 - not for use in the USA - 15

Test Protocol Parameter-Protocol

measurement lot. no.: xxxxxx

Standard Curve Calibration

Reference Guide 3.01 - not for use in the USA - 16

Reference Guide 3.01 - not for use in the USA - 17

Reference Guide 3.01 - not for use in the USA - 18

Test Protocol Parameter-Protocol

measurement lot. no.: xxxxxx

Standard Curve Calibration

Standard Curve (example only)

Reference Guide 3.01 - not for use in the USA - 19

Reference Guide 3.01 - not for use in the USA - 20

Reference Guide 3.01 - not for use in the USA - 21

Test Protocol Parameter-Protocol

measurement lot. no.: xxxxxx

Standard Curve Calibration

Reference Guide 3.01 - not for use in the USA - 22

Reference Guide 3.01 - not for use in the USA - 23

Reference Guide 3.01 - not for use in the USA - 24

Test Protocol Parameter-Protocol