Introduction of the gene amplification technique to decrease the risk of hepatitis C virus transmission by plasma products

The viral safety of plasma-derived products with respect to hepatitis C vir us (HCV) is assured by selection of donors, screening of individual donatio ns for antibodies to HCV and the incorporation of effective viral inactivat ion-removal steps into manufacturing processes. As antibody screening of si ngle donations is not sufficient to completely eliminate HCV RNA positive p lasmas from plasma pools, testing for HCV RNA by gene amplification techniq ues may be necessary to identify positive donations. Using modem molecular biology techniques, we developed a specific, sensitive and reproducible met hod for routine PCR screening for HCV RNA in plasma pools. (C) 1999 Elsevie r Science B.V. All rights reserved.