Importance of a quality assurance scheme for factor VIII assays in quality monitoring of human plasma destined for fractionation into factor VIII concentrate.

A national quality assurance scheme has been established to monitor the validity of factor VIII assays performed by the various laboratories of the Scottish National Blood Transfusion Service engaged in collection and processing of donor plasma destined for fractionation. The results over the first 3-year period show that comparable assay values can be obtained by participating centres using a common standard, despite differences in equipment, methods or substrate chosen for the one-stage assay. The results also showed that chromogenic factor VIII assays correlated well with the one-stage method. Random factor VIII assays performed on plasma, harvested and frozen within 18 h from collection, were analysed to validate recently proposed Scottish specifications which stipulate that 70% of plasma donations destined for fractionation should contain at least 0.7 IU/ml. Plasma harvested and frozen between 8 and 18 h from collection did not meet the specified level in any of the regional centres. This nationally specified level was also not met by plasma harvested and frozen within 8 h from collection in spite of being achieved individually by three regional centres. Assays performed on large plasma pools at the Fractionation Centre suggested loss of some factor VIII during storage, transportation and thawing of plasma prior to bulk processing.