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# Guidance on Nucleic Acid Tests for Hepatitis
- URL: https://www.fdaweb.com/guidance-on-nucleic-acid-tests-for-hepatitis/
- Published: 2016-08-17T12:00:00.000Z
- Updated: 2026-09-14T21:25:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136544

*Federal Register* Notice: FDA is making available a guidance for industry entitled: *Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.* It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests in donor testing for hepatitis B virus deoxyribonucleic acid. The guidance finalizes the draft guidance of the same title from January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products dated 8/2007\. To download this guidance, click [here. ](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM516650.pdf?ref=fdaweb.com)To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19588.pdf?ref=fdaweb.com)