Standardization of Protein C in Plasma: Establishment of an International Standard

Abstract

SummaryAn international collaborative study, involving 18 laboratories, was carried out to establish an international standard for protein C in plasma. The proposed standard, which consisted of a freeze-dried ampouled plasma preparation coded 86/622, was assayed against fresh normal plasma and the participants’ local standards. Protein C activity assays were placed in four groups, depending on the method of activation and detection of protein C. The combined potencies (units per ampoule) for the proposed international standard were: thrombin activation/clottirg assays, 0.86; thrombin activation/chromogenic assays, 0.81; snake venom activation/clotting assays, 0.81 and snake venom activation/chromogenic assays, 0.82. Measurement of protein C antigen gave potency estimates of 0.81 and 0.82 units per ampoule for the Laurell electroimmunoassay and ELISA techniques, respectively. The good agreement in potency estimates between the different methods indicates that the overall combined figure (226 assays) for the international standard of 0.82 international units per ampoule should serve for all methods. Accelerated degradation studies have indicated that the standard should be suitably stable when stored at −20° C.The freeze-dried plasma 86/622 has been established by the WHO Expert Committee on Biological Standardization as the 1st International Standard for Protein C in Plasma, with an assigned unitage of 0.82 international units per ampoule.