FDA revises Guideline on HIV and HCV Testing for the Assessment of Blood Donors

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In December 2017, the Food and Drug Administration's Center for Biologics Evaluation and Research published an updated version of their "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" for immediate implementation. This update of the original guideline published in 2010 includes the following revisions:

• Revised recommendations for reentry of donors deferred because of reactive HCV test results in Section V.B. The recommendations have been revised because of the discontinuation of the CHIRON® RIBA® HCV 3.0 SIA (RIBA), that was intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed anti-HCV screening test.
• Updated the definition of “Discriminatory NAT” in Section II. and made corresponding editorial revisions to recommendations in Section IV.C. and Sections V.A and V.B. to reflect approval of multiplex NAT assays that directly detect HIV-1 RNA and HCV RNA and simultaneously detect and discriminate HIV RNA and HCV RNA..
• Updated regulation citations for consistency with the current Code of Federal Regulations.
• Updated the Background and Discussion in Section III. to include the current estimates of HIV-1 and HCV in blood donations and the donor screening tests licensed since publication of the May 2010 guidance.

With this update, the FDA supplies new recommendations for blood and plasma establishments, fractionators and test laboratories for the testing of individual and pool donations regarding HIV-1 and HCV. It is part of FDA's activity to strengthen the overlapping safeguards that protect patients from unsuitable blood and blood products and should support the establishments in questions of testing, product disposition, donor deferral, donor notification, donor reentry and lookback.

Further details can be found directly in the revised guideline "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".