Drug Regulators, FDA, Publish 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.
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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 The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2005.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 results, HIV–1 p24 antigen test results, and anti-HCV test results that were provided in the FDA memoranda entitled ‘‘Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV–1) Transmission by Blood and Blood Products,’’ April 23, 1992; ‘‘Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),’’ August 5, 1993; ‘‘Recommendations for Donor Screening with a Licensed Test for HIV–1 Antigen,’’ August 8, 1995.
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