BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 30/04/2010

Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry" dated May 2010. The guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV-1 ribonucleic acid (RNA) and HCV RNA. This guidance also contains recommendations regarding product disposition and donor management based on the results of NAT and serologic testing for markers of HIV-1 and HCV infection on samples, collected at the time of donation, from donors of human blood and blood components. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV-1 test

Source: Federal Register — Health and Human ServicesOpen original release →