America’s Blood Centers (ABC) submitted this letter to the Food and Drug Administration (FDA) in response to a draft guidance on testing blood donations for Hepatitis B Surface Antigen (HBsAg). ABC, representing a significant portion of the U.S. and Canadian blood supply, strongly supports the FDA’s proposal to remove the HBsAg testing requirement for whole blood and blood components. We argue that nucleic acid tests (NAT) and hepatitis B core antigen (anti-HBc) testing are sufficient to reduce the risk of hepatitis B virus (HBV) transmission.
Additionally, ABC urges the FDA to consider removing the HBsAg testing requirement for Recovered Plasma and to update current testing requirements for human T-lymphotropic virus types I and II (HTLV-I/II). We propose a one-time donor testing for HTLV-I/II antibodies coupled with effective leukoreduction for donors of whole blood and blood components intended for transfusion. ABC supports these changes based on declining prevalence of infections, low incidence among repeat donors, and the effectiveness of current prevention methods. ABC views these updates as crucial steps in maintaining a safe and available blood supply while ensuring that testing requirements are evidence-based and justified.