DECLARATION OF TRACEABILITY AND UNCERTAINTY

STA UNICALIBRATOR ®

Parameter Reference Determination International Relative

Method Standard Uncertainty *
PT
Clotting Against fresh normal plasmas pools. NA ± 4.3 %
(STA Neoplastine CI Plus)

PT (STA Hepato - Quick) Clotting Against fresh normal plasmas pools. NA ± 4.1 %

Fibrinogen Clotting Against I.M calibrated against I.S. 3rd I.S : 09/264 ± 3.1 %

Antithrombin Chromogenic Against I.M calibrated against I.S. 3rd I.S : 08/258 ± 5.2 %

Protein C Chromogenic Against I.M calibrated against I.S. 2nd I.S : 02/342 ± 3.9 %

Protein C Clotting Against I.M calibrated against I.S. 2nd I.S : 02/342 ± 6.3 %

Protein S Clotting Against I.M calibrated against I.S. 2nd I.S : 03/228 ± 4.9 %

Antiplasmin Chromogenic Against I.M calibrated against fresh normal plasmas pools. NA ± 5.8 %

Plasminogen Chromogenic Against I.M calibrated against fresh normal plasmas pools. NA ± 4.3 %

Version 5 1/2 August 2014

 DECLARATION OF TRACEABILITY AND UNCERTAINTY
STA UNICALIBRATOR ®

Parameter Reference Determination International Relative Uncertainty *

Method Standard

Factor II Clotting Against I.M calibrated against I.S. 4th I.S : 09/172 ± 4.3 %

Factor V Clotting Against I.M calibrated against against I.S. 1st I.S : 03/116 ± 4.9 %

Factor VII Clotting Against I.M calibrated against I.S. 4th I.S : 09/172 ± 4.5 %

Factor X Clotting Against I.M calibrated against I.S. 4th I.S : 09/172 ± 4.4 %

Factor VIII Clotting Against I.M calibrated against I.S. 6th I.S : 07/316 ± 7.7 %

Factor IX Clotting Against I.M calibrated against I.S. 4th I.S : 09/172 ± 5.7 %

st
Factor XI Clotting Against I.M calibrated against I.S. 1 I.S : 04/102 ± 6.0 %

Factor XII Clotting Against I.M calibrated against fresh normal plasmas pools. NA ± 6.1 %

I. M : Internal MasterLot. I.S : International Standard NA : Not Applicable

* The Uncertainty (expanded relative uncertainty, 95 % two-sided confidence interval) was calculated in accordance with:
- ISO 5725-2," Accuracy (trueness and precision) of measurement methods and results"- Part 2: "Basic method for the determination of repeatability and reproducibility of a standard
measurement method",
- GUM (NF ENV 13005) "Guide to the expression of Uncertainty in Measurement".
The uncertainties include the contribution of: internal master lot determination (including I. S) or pools estimated uncertainty, round rate, calibration curve and intermediate precision of the
method.

Version 5 2/2 August 2014