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

NAT testing has become an integral part in the safety programs of both plasma fractionators and transfusion services. NAT testing for HCV RNA is now mandatory 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 NAT procedures. To create such an environment, international virus standards, as well as guidelines for validation, assessment of robustness, and quality assurance of NAT have been released. This paper is a critical review of currently available standards and national reference preparations, detection limits, and national regulations of NAT in view of the specific nature of NAT.