Introducing Anti-HBc Screening in Germany – Possible Implications for the Blood Donation Service

Abstract

The German National Advisory Committee ‘Blood’ (Arbeitskreis Blut), recently recommended testing of blood and plasma donations for antibodies against the hepatitis B core antigen (anti-HBc). We assessed possible effects of this intended measure on donor deferral rate and look back procedures. Study Design and Methods: 3,964 consecutive blood donors were tested for anti-HBc for the first time. Anti-HBc-positive samples were further investigated employing an alternative anti-HBc test, quantitative determination of anti-HBs and HBV nucleic acid testing. Results: 46 (1.16%) of the samples were tested specifically anti-HBc-positive. Following the recommendations of the Arbeitskreis Blut, 9 (0.23% of all) donors had to be permanently deferred. Eight of these were repeat donors and had already donated 353 blood components which had been transfused to 285 recipients during the past 17 years. Conclusions: Implementation of anti-HBc testing in Germany will result in an acceptable loss of blood donors. However, the realization of look-back procedures is problematic due to the huge number of transfused blood components, the long period of time those donors gave blood, and particularly the impossibility to precisely determine the time of seroconversion. Therefore, when introducing anti-HBc testing, regulatory authorities should consider the described implications for look-back procedures.

Efficacy of individual nucleic acid amplification testing in reducing the risk of transfusion‐transmitted hepatitis B virus infection in Switzerland, a low‐endemic region

“…It has been long debated whether antibody to hepatitis B core antigen (anti‐HBc) and/or HBV nucleic acid testing (NAT) should be considered as additional screening candidates for further reduction of the residual risk of HBV infections 4‐12 . Recently anti‐HBc testing was introduced in Germany, combined with screening of HBV DNA in large minipools (MPs) of 48 to 96 donations 13 . However, studies determining the efficacy of this approach in preventing HBV transmission are lacking.…”

Recent insights in testing for transfusion transmissible viral infections

“…Nevertheless, as anti‐HBc‐positive blood is known to be infectious some of the time (<10%) if anti‐HBs is not detectable [10,11] anti‐HBc screening has been introduced in a number of countries with a low HBV prevalence, well before NAT was introduced. More recently, a few European countries have introduced anti‐HBc testing after MP‐NAT had already been introduced [12], when it became clear that HBV transmission cases by blood from donors with occult HBV infection (OBI) could still occur [13]. HBV‐DNA levels in donors with OBI are generally low and can fluctuate around the detection limit of the NAT systems in use.…”