This protocol is suggested by Diagnostica Stago to assist users who choose to utilize the above mentioned reagents and

instrument. Users assume total responsibility

for validation of test results obtained with this protocol so as to be in full compliance with current local regulations applicable to in vitro reagents.
Under no circumstances, shall Diagnostica Stago be held liable for any consequential damages resulting from the use of this protocol.

1101-V4 Page 1/3
APPLICATION
Theoretical suggested protocol
STACLOT

VIIa-rTF (REF 00281)

for NovoSeven application
on STA

- STA Compact

For research use only


REAGENTS / SAMPLE

Refer to the package insert sheet.


REAGENT REQUIRED BUT NOT PROVIDED

STA

- CaCl
2
0.025 M (REF 00367)
0,15 M NaCl
Stirring-bar (REF 27425)
Reductor ring DIN 14 (REF 26605)


CALIBRATOR

Calibrator (reagent 4) is not suited to this procedure.
Calibrator have to be prepared.

Normal Human Plasma Pool spiked with recombinant VIIa to obtain a final concentration at 30 U/ml.


QUALITY CONTROLS

Controls (reagents 5a and 5b) are not suited to this procedure.
Controls have to be prepared.

Normal Human Plasma Pool spiked with recombinant VIIa at 2 levels to obtain final concentrations of :
- level 1 : 5 U/ml
- level 2 : 20 U/ml


REAGENTS PREPARATION

Refer to the package insert sheet.

After reconstitution, prepare a Working reagent of Reagent 3 (Phospholipids-frTF) as following :
dilute 10 fold in 0.15 M NaCl (dilution must be made out in polypropylen tube). Transfer dilution in a
siliconized vial (DIN 14 type) or in a plastic container suitable for STA

or STA

Compact and place a
stirring-bar.

Place the reagents on board

:
- the vial of Reagent 2 (Factor VII deficient plasma) in R1 Area - Reagent drawer
- the Working reagent (diluted reagent 3) in R1 Area - Reagent drawer with magnetic stirring-motor and with
Reductor ring DIN 14
- the STA

- CaCl
2
0.025 M solution in R2 Area - Reagent drawer


This protocol is suggested by Diagnostica Stago to assist users who choose to utilize the above mentioned reagents and instrument. Users assume total responsibility
for validation of test results obtained with this protocol so as to be in full compliance with current local regulations applicable to in vitro reagents.
Under no circumstances, shall Diagnostica Stago be held liable for any consequential damages resulting from the use of this protocol.

1101-V4 Page 2/3
APPLICATION
Theoretical suggested protocol

PREPARATION OF STANDARDS

Using the recombinant VIIa standard, prepare a solution at 600 U/ml in the Staclot VIIa-rTF Buffer (reagent 1).
Then, spike a normal plasma pool at 30 U/ml of rVIIa (1:20 dilution). This pool represents the "calibrator".

Calibration is performed on the undiluted calibrator. Its level (30 U/ml) corresponds to the 1:10 dilution made
out by the device.


PREPARATION OF PATIENT'S SAMPLES AND CONTROLS

The samples and prepared controls are tested undiluted.



TEST SETUP

TEST SETUP - Page 1/3
Identification
Abbreviation Name Method Date
VIIa new Staclot VIIa monitoring chronomtrie
Sample Diluent
Volume Incu Dil. Id. Name Vial Stab. Min. Nolume
50 l 0 sec 1/10 TVIIa TAMPON VIIA 5 ml 24 h 1,00 ml
Reagents
ID Name Incub. Vol. Vial Stab. Min. Volume Washing
sec l ml h (ml) Before After
Ra DEFVII Def. plasma VII 0 50 1 4 0,50 no normal
Rb RSTFD Diluted rsTF-Phospho 240 50 2 4 0,60 no special
Rc
Rd 11851 CaCl2 0,025M 50 15 72 0,90 no normal
Analysis Result Validation (U/ml)
Min. Time 10 Primary Units U/ml Prefix Min. Max.
Max. Time 240 Corrector 1,000 STANDARD 0,50 50,00
Mean Time 80 Single/Duplicate duplic

Rd Heating yes Precision 5,00 %

Stirring yes Redil. Condition (U/ml)

Clot Type normal <


>


Washing Ra Rb Rc Rd
Before no no no
After normal special normal
Desorb 12227
Name STA - DESORB U
Vial ml 15 ml ml ml
Stability h 120 h h h
Min. Volume ml 0,90 ml ml ml


This protocol is suggested by Diagnostica Stago to assist users who choose to utilize the above mentioned reagents and instrument. Users assume total responsibility
for validation of test results obtained with this protocol so as to be in full compliance with current local regulations applicable to in vitro reagents.
Under no circumstances, shall Diagnostica Stago be held liable for any consequential damages resulting from the use of this protocol.

1101-V4 Page 3/3
APPLICATION
Theoretical suggested protocol

TEST SETUP - Page 2/3
CALIBRATION

Scale
MODE
Graph - Linear regression Measures Log
Concentrations Log
Calibrators Vial Stab. Min. Volume Single/Duplicate
ID Key Name Dil. ml h (ml) Duplicate
VIIa CAL2 Cal. VIIa monitoring 1/400 1 4 0,25 OffsetCorrector
VIIa CAL2 Cal. VIIa monitoring 1/100 1 4 0,25
Id.
VIIa CAL2 Cal. VIIa monitoring 1/30 1 4 0,25
Key
VIIa CAL2 Cal. VIIa monitoring 1/10 1 4 0,25
Name

Vial Stab. Min. Volume

ml h (ml)
Controls ID Key Name Vial Stab. Min. Volume

ml h (ml)
Level 1 VIIa C1-2 Ct VIIa monitoring- level 1 1 4 0,25
Level 2 VIIa C2-2 Ct VIIa monitoring- level 2 1 4 0,25




TEST SETUP - Page 2/3
Printout / Transmission Usual Values (U/ml)
Convers. Transmission Min. Max.
Unit Factor Print. Test Number STANDARD 0,50 50,00
Main U/ml yes 0
Aux. 1 sec yes 0
Aux. 2
Aux. 3
Printout Limits Min. 0,50 U/ml
Max. 50,00
Quality Control Period Vial Stab. Min. Volume
ID Key Name h ml h (ml)
Level 1
Level 2
Level 3





For further information, refer to the package insert sheet.