Detection of hepatitis C virus RNA in alpha interferon derived from in vitro culture of leukocytes of human origin

In order to assure the virological safety of blood products, in addition to serological testing of individual donations and virus inactivation steps u ndertaken during manufacture, routine PCR testing for HCV RNA of starting m aterials (plasma, cells), intermediates or final product is necessary. The aim of this study was to determine the rate of HCV RNA positive batches of human native leukocyte interferon during large-scale production. Our findin gs indicate the presence of HCV RNA in 6.1% batches despite acidification o f intermediates in order to inactivate Sendai virus. (C) 2001 The Internati onal Association for Biologicals.