America’s Blood Centers, AABB, and the American Red Cross submitted this comment letter to the FDA regarding proposed changes to hepatitis B testing requirements for blood donations in response to draft FDA guidance that would eliminate the need to test blood donations for hepatitis B surface antigen (HBsAg) when nucleic acid testing (NAT) for HBV DNA and antibody testing for hepatitis B core antigen (anti-HBc) are performed.
While supportive of this change for whole blood donations, the organizations argue that HBsAg testing should also be eliminated for Source Plasma donations used in manufacturing plasma-derived medicinal products. They make clear that HBV NAT testing combined with viral inactivation/removal steps in the manufacturing process is sufficient to ensure safety without HBsAg testing. The letter requests that the FDA recognize this for all plasma used in manufacturing, not just recovered plasma, to create regulatory consistency and facilitate international harmonization of testing requirements.