FDA Approves New Hepatitis C, HIV Screening Test for Blood Plasma Donations
The FDA on Friday announced the approval of the first nucleic acid test (NAT) systems for screening blood plasma donations for hepatitis C and HIV infections, according to an agency release. The new test systems, developed by the Los Angeles-based National Genetics Institute, can detect minute amounts of viral genetic material in pooled plasma samples by amplifying gene fragments of HIV-1 and hepatitis C virus. If a pool tests positive for either virus, the individual sample can be detected and removed from further processing, and the donor can be deferred and notified. Although current plasma donations go through a process of viral inactivation and are tested for HIV and hepatitis C antibodies and HIV-1 antigen, the NAT systems will reduce even further the number of donations that make it through this screening process. The current screening process allows for a "window period" during which infected samples can go undetected. The NAT systems will reduce the "window period" for HCV from 82 days to 25 days and for HIV-1 from 22 days with the antibody test and 16 days with the antigen test to 12 days (FDA release, 9/21).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.