Quality control of recovered plasma for fractionation: an extensive Italian study

BACKGROUND: This study was aimed at obtaining significant information on the quality of whole-blood plasma (WBP) delivered to a private pharmaceutical company by the blood transfusion centers (BTCs) of 10 Italian regions. STUDY DESIGN AND METHODS: A statistical sampling plan of plasma units took into account the contribution each selected blood transfusion center, belonging to the 10 regions, made to the plasma pool annually delivered to the pharmaceutical company. A total of 1787 plasma units were selected for coagulation Factor VIII (FVIII:C) and Factor VIII antigen (FVIII:Ag) analysis. RESULTS: The FVIII:C mean value was 0.99 IU per mL; it was significantly lower in O units (0.86 IU/mL) than in non-O units (1.08 IU/mL). The mean value of FVIII:Ag was 0.90 IU per mL; it was significantly lower in O units (0.78 IU/mL) than in non-O units (0.99 IU/mL). In units with a FVIII:C level of less than 0.70 IU per mL, the FVIII:Ag mean value (0.62 IU/ mL) was higher in comparison to the FVIII:C mean value (0.57 IU/mL). Instead, in the units with a FVIII:C level of at least 0.70 IU per mL, the mean level of FVIII:C (1.08 IU/mL) was higher than that of FVIII:Ag (0.96 IU/mL). CONCLUSIONS: The mean value of FVIII:C (0.99 IU/mL) in whole-blood plasma produced by the 10 Italian regions is higher than that reported in other studies. A total of 83.1 percent of units have a FVIII:C level of at least 0.70 IU per mL. The mean level of FVIII:Ag is lower than that of FVIII:C. FVIII:Ag is higher in those units with a FVIII:C level of less than 0.70 IU per mL, while it gradually decreases as FVIII:C exceeds 0.70 IU per mL, thus showing a greater resistance to handling of plasma in the production steps mostly affecting FVIII:C stability.