ABSTRACT
BACKGROUND: The aim of present study was to assess the effect of different freezing time after phlebotomy on the activity of coagulation factors in frozen plasma and to evaluate which source plasma for clotting factor fractionation is appropriate for use. METHODS: Blood plasma units rejected due to a high level of ALT were divided into four groups depending on freezing time after phlebotomy, and each unit of the four groups was assayed for six different clotting factors and blood type. SAS 9.2 was used for statistical analysis of data. RESULTS: A decrease was observed in the activities of FVIII of the plasmas, in the following order: PL-A>FFP>FP(8-24)approximatelyFP(24-72). Results of the assay also showed that the levels of FVIII were significantly higher in the AB type plasmas than in the O type plasmas. PL-A and FFP units met the current quality requirements of the Korean Red Cross, in which the FVIII activity should have more than 0.7 IU/mL in more than 75% of the source plasma, as 85.0% and 82.5%, respectively. On the other hand, FP24 met the Canadian (Quebec) requirements for the source plasma, in which the FVIII activity should have more than 0.52 IU/mL in more than 75% of the source plasma, as 82.6%. CONCLUSION: For use of plasma frozen within 24 hours after phlebotomy (FP24) and plasma of specific blood type, European Pharmacopeia and WHO guidelines on quality control should be adopted for production of plasma-derived coagulation factors in Korea.