Anti-HBc screening - is it worth the effort? Results of a 10-year surveillance programme covering more than 30 million donations in Germany

Background and Objectives Antibodies to hepatitis B core antigen (anti-HBc) testing were added to hepatitis surface antigen (HBsAg) screening in Germany in 2006 to prevent hepatitis B virus (HBV) transmissions by chronically infected donors. We report the results of a national surveillance of anti-HBc-reactive and HBsAg-negative donations and assess the resulting gain in blood safety and the donor loss. Materials and Methods Donations were tested for anti-HBc, and if reactive, by sensitive individual donation nucleic acid testing (ID-NAT) and for antibodies to HBsAg (anti-HBs). Data from the national anti-HBc surveillance from 2006 to 2015 determined the proportion of anti-HBc-reactive donations stratified for donor type, sex, anti-HBs concentration and NAT-positivity. Donor loss due to anti-HBc-reactive results was quantified. Results Of 31 562 556 donations screened, 70 671 were anti-HBc reactive but HBsAg negative (0.22%). The proportion of repeat donors with these test results decreased significantly from 0.25% in 2007 to 0.08% in 2015. In the entire study period, 82 HBV-NAT-positive donations were identified. Of these, 47 donations were only identified by ID-NAT. A total of 54 203 anti-HBc-reactive units were discarded either due to possible infectiousness (NAT positive or anti-HBs concentration IU/l) or because no further testing was performed. Conclusion Anti-HBc screening has improved blood safety in Germany. HBV-NAT-positive donations were identified after ID-NAT was triggered by the initial reactive anti-HBc result. The observed loss of donations was sustainable for maintaining an adequate blood supply in Germany.