Implementation of an in-house PCR assay validated for the detection of hepatitis C virus RNA

GONZALO RODRÍGUEZ-LOMBARDI

TRANSFUSION MEDICINE

WILEY-BLACKWELL PUBLISHING, INC

Año: 2008 vol. 18 p. 317 - 317

0958-7578

The manuscript has been seen and approved by allauthors, it is not under active consideration forpublication, has not been accepted for publication,nor has it been published, in full or in part (except inabstract form)?.Since 1 July 1999, the European Pharmacopeia monograph 0853 ?human plasma fractionation? has requiredthat the manufacturing plasma pools are tested forhepatitis C virus (HCV) RNA by validated nucleic acidtechnology (NAT). For this reason, manufacturers areencouraged to adopt strategies for minipool testing(between 100 and 520 donors/plasma pool) to avoid theloss of completely manufactured pools and to facilitatedonor tracing in the event of positive results (WorldFederation of Hemophilia, 2003). The Committee forProprietary Medicinal Products has introduced guidelines for testing and complete validation of the chosen?in-house? or commercial NAT method to guaranteea robusttechnique. The EuropeanMedicinal EvaluationAgency requests a minimal sensitivity of 100 IU mL21by N