Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry

Issue Date: May 1, 2010
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood Products
Status: Final

Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry

We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion, with recommendations for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) were falsely positive and that there is no evidence of infection with hepatitis B virus (HBV). Currently, donors who are repeatedly reactive on more than one occasion for anti-HBc (samples from more than one collection from the same donor are repeatedly reactive for anti-HBc) must be indefinitely deferred in accordance with Title 21 Code of Federal Regulations, section 610.41(a) (21 CFR 610.41(a)).

Download the Guidance Document