FDA: 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

We, FDA, are providing you, 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 (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (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 FDA-licensed HBV NAT can detect evidence of the viral infection at an earlier stage than the hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc tests).

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