REGULATORY UPDATE: Blood Community Sends Joint Letter to FDA on HBsAg Testing Requirements

June 22, 2022

AABB, America’s Blood Centers and the American Red Cross recently sent a joint letter to Nicole Verdun, MD, director of the Office of Blood Research and Review at FDA’s Center for Biologics Evaluation and Research, requesting an update on the current testing recommendations for hepatitis B virus (HBV) and asking the agency to consider discontinuation of the testing requirement for hepatitis B surface antigen (HBsAg) in blood donations of whole blood and blood components intended for transfusion. 

The organizations believe the 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. AABB, ABC and ARC believe that the test does not increase transfusion safety, is outdated and is overly burdensome because other required testing methods have proven to be highly effective in identifying HBV risk in donors.

AABB’s Transfusion Transmitted Diseases Committee initially developed the letter for a statement during the April 2020 Blood Products Advisory Committee (BPAC) meeting, which was canceled due to concerns associated with the COVID-19 pandemic. The BPAC had been scheduled to discuss “whether testing for HBsAg can be discontinued considering the sensitivity of hepatitis B virus nucleic acid testing and hepatitis B anti-core testing of blood donations in the U.S.”

Member centers may contact with questions.