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FDA 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


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
In this guidance document FDA provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for HIV-1/HCV NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV-1 RNA and HCV RNA. This document contains recommendations regarding product disposition (§ 610.40(h)), and donor management (§ 610.41 and § 630.6) 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 component donations.

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