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June 28, 2022

Blood Community Sends Joint Letter to FDA for Update on HBV Testing Recommendations

By America's Blood Centers

America’s Blood Centers, the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross submitted a joint letter to the U.S. Food and Drug Administration (FDA) this week to “request an update on the current testing recommendations for hepatitis B virus (HBV).” The letter recognizes recent efforts by the agency to make “evidence-based changes to regulatory requirements
and recommendations” citing guidances for variant Creutzfeldt-Jakob Disease (vCJD) and CJD, donor blood pressure and pulse, and donation suitability, donor eligibility and source plasma quarantine hold requirements.

The blood community stated that “[c]onsistent with CBER’s evidence-based updates to donor eligibility, we believe the hepatitis B surface antigen (HBsAg) testing requirement for whole blood and blood components intended for transfusion should be removed because HBsAg testing, is one of three tests currently required for HBV, and (1) does not increase transfusion safety; (2) is outdated, and (3) is overly burdensome because other required testing methods have proven to be highly effective
in identifying HBV risk in donors for years.”

Thus, the organizations requested that the FDA “consider the following information supporting the removal of the current HBsAg testing requirement. Currently, in the United States (U.S.) the risk of HBV transfusion transmission is reduced by testing all blood donations for three FDA-required markers: HBsAg (since 1971), antibody to hepatitis B core antigen (anti-HBc, since 1986), and HBV DNA by minipool
nucleic acid testing (NAT, since 2006-2009). As judged by the absence of reported confirmed cases of HBV transfusion transmission, the policy has been successful.”

View Letter.
Posted in Letters and Comments
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