Nucleic Acid Test Guidance

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 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.