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# CBER Guidance on Hep B Testing for Cell/Tissue Donors
- URL: https://www.fdaweb.com/cber-guidance-on-hep-b-testing-for-cell-tissue-donors/
- Published: 2016-01-07T12:00:00.000Z
- Updated: 2026-09-15T02:26:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134367

> CBER has posted a draft guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based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.” The [document](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM480606.pdf?ref=fdaweb.com) is intended to help establishments that make eligibility determinations for donors of human cells, tissues , and cellular- and tissue-based products, with recommendations on using FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) DNA. “We consider the use of FDA-licensed HBV NAT in testing HCT/Ps donors to be necessary to adequately and appropriately reduce the risk of transmission of HBV,” the guidance says. Such tests can detect viral infection at an earlier stage than a hepatitis B surface antigen and total antibody to hepatitis B core antigen test, it notes.