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Hepatitis B virus (HBV) is a DNA virus from the family Hepadnaviridae . It is transmitted parenterally, sexually, and perinatally. Every blood donation is tested for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and HBV nucleic acid testing (NAT). Donors may be permanently deferred if confirmed positive or temporarily deferred based on various testing scenarios.
Posttransfusion hepatitis due to HBV was a common consequence from 1940 to 1970, infecting as many as 25% of transfusion recipients. In 1970, the initial mitigation step was to eliminate high-risk donors (prisoners and paid donors) and move to an all-volunteer donor blood supply. This was followed by the introduction of HBsAg testing, decreasing transfusion transmission risk to 12%–13%. In 1982, with the addition of alanine transaminase (ALT) testing, a liver function test that is elevated in some cases of HBV infection, transmission decreased to 10%. Incidence continues to decrease because of increased HBsAg testing sensitivity, introduction of anti-HBc testing in 1987, and the recent addition of HBV NAT.
In the United States, the estimated risk of TT-HBV (transfusion-transmitted HBV) is 1:592,000 to 1:754,000. However, suspected cases of TT-HBV are infrequently confirmed: Of the 2790 cases of TT-HBV reported to CDC in 2014, only one was confirmed. Therefore, calculated residual risk may be overestimated secondary to overestimates of HBV incidence, overestimates of window period, overreporting, incomplete investigations of cases, and widespread use of the HBV vaccine.
The FDA and AABB Standards require testing allogeneic donors for evidence of infection with HBV NAT, HBsAg, and anti-HBc.
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