Analysis of a number of parameters of a lyophilized donor plasma reference sample to be used for the assessment of the prothrombin complex factors has shown the stability of this sample over the course of 14 months (a follow-up period). The sample may be used as a reference one in estimation of plasma prothrombin complex factor activities, and of PPSB activity. The reference sample activity should be estimated from the fresh donor plasma native pool, whose procoagulant activity is conventionally estimated as 100% or 1 U/ml. Use of a lyophilized reference sample helps obtain objective results compatible within this country, particularly so if all biologic reagents included in the test systems are standardized.
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