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

• Published in: Vox sanguinis Vol. 114; no. 5; pp. 459 - 466
• Main Authors: Houareau, Claudia, Offergeld, Ruth
• Format: Journal Article
• Language: English
• Published: England S. Karger AG 01.07.2019
• Subjects: Antibodies; Antigens; anti‐HBc; Blood; Core protein; HBV‐DNA; Hepatitis; Hepatitis B; Hepatitis B core antigen; Hepatitis B surface antigen; Safety; Screening; Surveillance; transfusion‐transmissible infections; Viruses; Germany; anti-HBc; hepatitis B; transfusion-transmissible infections; HBV-DNA
• ISSN: 0042-9007; 1423-0410
• DOI: 10.1111/vox.12781

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 <100 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.