합성기질 및 응고시간을 이용한 혈액응고 제8인자 역가측정법

Potency Assay of Factor VIII : C Concentrates using the Chromogenic and Clotting Assay

The clotting assay was replaced by the chromogenic substrate assay which is recommended by the European Pharmacopoeia (EP) and the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis based on the reliability convenience and simplicity of the chromogenic assay: A correlation study was carried out with a one-stage factor VIII : C clotting assay and the perfonnance of the chromogenic assay was evaluated using two test kits that fulfilled the requirements of EP for factor VIII concentrates test. Although chromogenic assay has partly differences in measurement principle and standardization, this assay has a high correlation with clotting assay in various types of factor VIII concentrates and factor Vlll standard. We conclude that the chromogenic assay for factor VIII : C con- centrates correlates well with the clotting assay and shows good analytical performance.