The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen (HBsAg).” The draft guidance proposes removing the requirement for testing blood donations for HBsAg. The recommendation for removing the Hepatitis B surface antigen testing requirement is based on scientific evidence indicating that the risk of hepatitis B virus (HBV) transmission is appropriately reduced by the other two tests currently required for HBV.
This proposed change is a significant victory for community blood centers and aligns with America’s Blood Centers’ (ABC) long-standing advocacy efforts, most recently its inclusion in a letter to the U.S. Department of Health and Human Services (HHS) outlining opportunities to reduce burdens on blood centers while maintaining the highest standards of blood safety. The elimination of Hepatitis B surface antigen testing requirement could save blood centers an estimated $15 to $22.5 million annually, allowing community blood centers to operate more efficiently while maintaining the safety and availability of the nation’s blood supply.
The draft guidance states that, “when donations of blood and blood components are tested for HBV DNA and antibody to hepatitis B core antigen (anti-HBc) using screening tests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, FDA believes that testing of the donations for HBsAg is not necessary to comply with 21 CFR 610.40(b).” According to available scientific data, the risk of HBV transmission by blood and blood components is appropriately reduced by testing blood donations for HBV DNA and anti-HBc. This recommendation does not apply to source plasma, and centers must continue to follow their, “standard operating procedures for testing source plasma for HBV.”
Once this draft guidance is finalized, “blood establishments that discontinue testing donations for HBsAg should revise their Circular of Information to remove the statement that donations are nonreactive for HBsAg.” Additionally, this change is considered a minor change, meaning blood centers, “must report the change in [their] annual report.”
ABC Chief Executive Officer (CEO) Kate Fry, MBA, CAE explained in a statement, “ABC applauds the FDA for taking this evidence-based step towards streamlining blood donation testing requirements. We call upon FDA to continue to examine options to remove unnecessary, outdated, and burdensome requirements on blood centers, including other testing requirements that fail to increase the safety of the nation’s blood supply.”
ABC will continue to provide updates on its advocacy efforts as they become available.