The yield of universal antibody to hepatitis B core antigen donor screening in the Netherlands, a hepatitis B virus low-endemic country.

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. [ABSTRACT FROM AUTHOR]