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Background
In the Netherlands, universal antibody to hepatitis B core antigen (anti‐HBc) donor screening was introduced in July 2011 to intercept potentially infectious donations slipping through hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA minipool screening (HBV DNA MP6).
Study Design and Methods
The yield and donor loss were evaluated after the first 2 years of universal anti‐HBc donor screening. A total of 382,173 donors were tested for anti‐HBc and, if positive, for antibody to HBsAg (anti‐HBs). Anti‐HBc–reactive donors with anti‐HBs of less than 200 IU/L were deferred, but repeat donors were allowed retesting after 6 months if anti‐HBs was less than 10 IU/mL. Anti‐HBc false positivity was estimated using the crude anti‐HBc signal, family name–based ethnicity scoring, and donor follow‐up.
Results
Anti‐HBc screening identified 13 confirmed or potential HBsAg‐ and HBV DNA MP6–negative recent HBV infections. In addition, 820 anti‐HBc–reactive donors with low anti‐HBs titers (<200 IU/mL), potentially harboring occult HBV infection (OBI), were identified and deferred. Overall, 1583 (0.41%) donors were deferred: 1178 (0.31%) during first‐time anti‐HBc screening, 361 (0.09%) anti‐HBc seroconverters, and 44 (0.01%) donors with waning anti‐HBs titers. Only 188 of 1583 (12%) deferred donors could be reentered upon retesting. Estimated anti‐HBc false positivity was 16%, but varied greatly among anti‐HBc–reactive donors with and without anti‐HBs (8% vs. 62%).
Conclusion
Anti‐HBc testing has improved the safety of the Dutch blood supply but its exact yield remains difficult to determine, due to the complexity of confirming anti‐HBc reactivity and OBI. In a low‐endemic country, donor loss associated with anti‐HBc screening is sustainable, but adds to the already considerable list of donor exclusions.