Premium
STANDARDIZATION OF VIII:C ASSAYS: A MANUFACTURER'S VIEW
Author(s) -
Mikaelsson Marianne,
Oswaldsson Ulla
Publication year - 1984
Publication title -
scandinavian journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0036-553X
DOI - 10.1111/j.1600-0609.1984.tb02769.x
Subject(s) - standardization , chromogenic , potency , chromatography , chemistry , substrate (aquarium) , statistics , mathematics , biochemistry , computer science , biology , in vitro , ecology , operating system
Despite the use of an International Standard to define the unitage of Factor VIII coagulant activity (VIII:C) discrepancies still exist with respect to labelled potencies. In order to examine possible causes of this disagreement concentrates of low, intermediate and high purity, normal plasma (NP) and the 1st International Reference Plasma (IRP) were assayed against the 3rd International Standard (IS) using one‐stage, two‐stage and chromogenic substrate assays. When different concentrates were estimated in relation to the 3rd IS, and NP in relation to the 1st IRP, there was good agreement between the potency estimates obtained by the different assay methods. Consistent results were obtained when VIII:C deficient plasma was used instead of buffer as prediluent. When NP and IRP were assayed against the 3rd IS marked differences between the assay methods were observed when buffer was used as prediluent. This effect was reduced when the 3rd IS was prediluted with VIII:C deficient plasma. Many factors influence the standardization of VIII:C assays, but good agreement between methods can be achieved provided that like preparations are compared under standardized conditions.