Test of source plasma for HCV, HBV and HIV-1 using PCR technique

摘要

Virus safety of blood products greatly relies on donor selection and screening, plasma testing, and virus inactivation during production. The introduction of highly sensitive and specific third-generation of Enzyme Linked ImmunoSorbent As-say(ELISA) for antibodies of hepatitis C virus (Anti-HCV) , HIV-Ⅰ /Ⅱ antibodies and hepatitis B surface antigen(Hb-sAg) significantly reduces virus contamination of source plasma, however, the risk still exists due to the "window period" during which an acutely infected donor may harbour large amounts of high infectious viruses without developing symptoms or detectable antigen and antibody concentration. Nucleic Acid Amplification Technique (NAT) has been proved to be an approach to shorten "window period" . Residual risk of HCV, HBV and HIV is believed to be reduced by 42%-72% with Polymerase Chain Reaction (PCR) testing. In Europe, it is required by CPMP and Eu.Ph. (2000) that plasma pool be tested for HCV RNA using validated NAT assay since July 1, 1999. Many blood products companies in US and Europe use NAT to test plasma mini-pool for HCV RNA, HIV RNA, HBV RNA, even for parvo virus B-19. Although NAT testing for plasma pool is not required by the Chinese regulatory authorities, we have long been working on to establish a PCR-screening procedure at Shanghai RAAS. Our main goal in implementing PCR test is to further guarantee virus safety of the products.