REGULATORY UPDATE: New FDA Draft Guidance Outlines Recommendations for Testing Blood Donations for HBsAg

The Food and Drug Administration published a new draft guidance document today that provides blood establishments with the agency’s recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV). The recommendations apply to whole blood, blood components and source plasma. The draft guidance recommendations are consistent with the request outlined in the 2019 AABB joint letter to FDA on hepatitis B surface antigen testing requirements.

The draft guidance states that testing donations for HBsAg is not necessary to adequately and appropriately reduce the risk of transmission of HBV “when donations are tested for HBV deoxyribonucleic acid (DNA) by nucleic acid tests and for antibody to hepatitis B core antigen [anti-HBc] using screening tests that FDA has licensed, approved or cleared for such use, in accordance with the manufacturer's instructions.”

The draft guidance recommends the continued testing of source plasma donations for HBsAg, as source plasma donations are not tested for anti-HBc.

FDA intends for the guidance, when finalized, to supersede the recommendations described in an October 2012 guidance on NAT testing of blood and blood components for HBV and a December 1987 memorandum focusing on management of HBsAg -reactive donors and units. The agency announced plans to consolidate all HBV recommendations into a single guidance document and, except for conforming changes to reflect the new recommendations, noted it does not “intend to revise existing recommendations for HBV donation testing, quarantine and disposition of reactive units, donor deferral and requalification.”

FDA is accepting comments on the draft guidance through Oct. 14. AABB intends to submit comments on the draft guidance and encourages members to share their feedback via email at regulatory@aabb.org.