Assessment of validation studies from a fractionator's point of view

NAT testing has become an integral part in the safety programs of both plas ma fractionators and transfusion services. NAT testing for HCV RNA is now m andatory for plasma fractionators in Europe and for transfusion services in Germany and Austria. Before NAT testing of plasma could become mandatory, a defined environment had to be created to allow comparison of different NA T procedures. To create such an environment, international virus standards, as well as guidelines for validation, assessment of robustness, and qualit y assurance of NAT have been released. This paper is a critical review of c urrently available standards and national reference preparations, detection limits, and national regulations of NAT in view of the specific nature of NAT. (C) 1999 The International Association for Biologicals.