Drug Regulators, FDA, Publish Guidance on Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc).
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The FDA, are issuing this guidance to provide, 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)). Although it may seem unlikely that two anti-HBc tests would be falsely positive, such situations have occurred with some frequency because of the relative non-specificity of these tests. The result is that many otherwise suitable donors are indefinitely deferred because of their anti-HBc test results, even though medical follow-up of such donors indicates that they are not infected with HBV. The availability of FDA-licensed hepatitis B virus nucleic acid tests (HBV NAT), which are particularly sensitive when single samples are tested, provides an additional, powerful method of determining whether a donor who has been deferred because of anti-HBc reactivity is truly infected with HBV. Due to the availability of FDA-licensed HBV NAT and the improved specificity of anti-HBc assays, we are recommending in this guidance a reentry algorithm for donors deferred due to falsely positive repeatedly reactive tests for anti-HBc. This guidance finalizes the draft guidance of the same title dated May 2008.
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