Blood coagulation disorders
The WHO International Standards (IS) for the measurement of blood coagulation factors and inhibitors in plasma are used by manufacturers and reference laboratories to calibrate their secondary standards. This assures a correct diagnosis of clotting factor deficiencies and monitoring of treatment with certain plasma products such as in patients with haemophilia.
The unitage assignment of clotting factors and inhibitors takes into account an external reference point, namely the concentration in 1 ml of "average fresh human normal plasma". In the preparation of "average fresh human normal plasma" it is necessary to adhere to defined conditions for blood collection and to take care that the composition of the plasma pool (e.g. distribution of age, sex, blood groups, use of drugs etc.) is representative of the normal population.
The quality of the collaborative study to assign the unitage and the reproducibility of assay methods can be found in the respective Reports of the WHO Collaborative Studies.
Reference preparations are established for:
Blood coagulation factors:
-
Blood coagulation factor V Leiden, human gDNA. 1st International Genetic Reference Panel (ECBS 2004) (WHO/BS/04.1997)
pdf, 102kb -
Instructions for use
pdf, 53kb -
Press release
pdf, 21kb -
Blood coagulation factor XIII (FXIII), plasma, human (02/206). Activity potency 0,91IU / ampoule. 1st International Standard (ECBS 2004) (WHO/BS/04.1994 Rev.1)
pdf, 187kb -
Instructions for use
pdf, 58kb -
Blood coagulation factor VIII and von Willebrand factor, plasma, human (02/150). 5th International Standard (ECBS 2003). Lyophilized. 0.68 IU / ampoule Factor VIII:C; 0.94 IU/ampoule factor VIII. Antigen; 0.91 IU/ampoule VWF:antigen; 0.78 IU/ampoule VWF:ristocetin cofactor; 0.94 IU/ampoule VWF:collagen binding. (WHO/BS/03.1972)
pdf, 1.41Mb -
Instructions for use
pdf, 58kb -
Blood coagulation factors II, VII, IX, X, plasma, human, Lyophilized. 0.91 IU (factor II), 1.00 IU (factor VII), 0.86 IU (factor IX), 0.93 IU (factor X) / ampoule. 3rd International Standard (ECBS 2001) (WHO/BS/01.1946)
pdf, 8.05Mb -
Instructions for use
pdf, 57kb
Inhibitors:
-
Protein C, plasma, human, Lyophilized. 0.82 IU / ampoule. (WHO/BS/87.1561)
pdf, 671kb -
Instructions for use
pdf, 50kb -
Protein S, plasma, human, Lyophilized. 0.90 IU / ampoule. (WHO/BS/95.1804)
pdf, 4.72Mb -
Instructions for use
pdf, 121kb
-------------------------------------------------------------------------
OTHER WHO INTERNATIONAL REFERENCE MATERIALS
The characteristics of all reference preparations as well as the information regarding establishment can be found in the WHO Reference Material section.