Beschreibung:
<jats:sec><jats:title>Background and Objectives</jats:title><jats:p>Antibodies to hepatitis B core antigen (anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c) testing were added to hepatitis surface antigen (<jats:styled-content style="fixed-case">HB</jats:styled-content>sAg) screening in Germany in 2006 to prevent hepatitis B virus (<jats:styled-content style="fixed-case">HBV</jats:styled-content>) transmissions by chronically infected donors. We report the results of a national surveillance of anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c‐reactive and <jats:styled-content style="fixed-case">HB</jats:styled-content>sAg‐negative donations and assess the resulting gain in blood safety and the donor loss.</jats:p></jats:sec><jats:sec><jats:title>Materials and Methods</jats:title><jats:p>Donations were tested for anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c, and if reactive, by sensitive individual donation nucleic acid testing (<jats:styled-content style="fixed-case">ID</jats:styled-content>‐<jats:styled-content style="fixed-case">NAT</jats:styled-content>) and for antibodies to <jats:styled-content style="fixed-case">HB</jats:styled-content>sAg (anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>s). Data from the national anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c surveillance from 2006 to 2015 determined the proportion of anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c‐reactive donations stratified for donor type, sex, anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>s concentration and <jats:styled-content style="fixed-case">NAT</jats:styled-content>‐positivity. Donor loss due to anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c‐reactive results was quantified.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 31 562 556 donations screened, 70 671 were anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c reactive but <jats:styled-content style="fixed-case">HB</jats:styled-content>sAg 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 <jats:styled-content style="fixed-case">HBV</jats:styled-content>‐<jats:styled-content style="fixed-case">NAT</jats:styled-content>‐positive donations were identified. Of these, 47 donations were only identified by <jats:styled-content style="fixed-case">ID</jats:styled-content>‐<jats:styled-content style="fixed-case">NAT</jats:styled-content>. A total of 54 203 anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c‐reactive units were discarded either due to possible infectiousness (<jats:styled-content style="fixed-case">NAT</jats:styled-content> positive or anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>s concentration <100 <jats:styled-content style="fixed-case">IU</jats:styled-content>/l) or because no further testing was performed.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c screening has improved blood safety in Germany. <jats:styled-content style="fixed-case">HBV</jats:styled-content>‐<jats:styled-content style="fixed-case">NAT</jats:styled-content>‐positive donations were identified after <jats:styled-content style="fixed-case">ID</jats:styled-content>‐<jats:styled-content style="fixed-case">NAT</jats:styled-content> was triggered by the initial reactive anti‐<jats:styled-content style="fixed-case">HB</jats:styled-content>c result. The observed loss of donations was sustainable for maintaining an adequate blood supply in Germany.</jats:p></jats:sec>