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# Nucleic Acid Test Guidance
- URL: https://www.fdaweb.com/nucleic-acid-test-guidance/
- Published: 2016-08-17T12:00:00.000Z
- Updated: 2026-09-14T21:25:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136536

FDA has published a guidance, *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*, to make recommendations to establishments that make donor eligibility determinations on using FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). “We consider the use of FDA-licensed HBV NAT in testing HCT/P donors to be necessary to adequately and appropriately reduce the risk of transmission of HBV,” the [guidance](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM516650.pdf?ref=fdaweb.com) says. “The FDA-licensed HBV NAT can detect evidence of the viral infection at an earlier stage than the hepatitis B surface antigen and total antibody to hepatitis B core antigen tests.”

The guidance finalizes a January draft and supplements previous recommendations from FDA to HCT/P establishments concerning donor testing.