Blood donor screening in the Netherlands: Universal anti‐HBc screening in combination with HBV nucleic acid amplification testing may allow discontinuation of hepatitis B virus antigen testing

Abstract Background In the Netherlands, blood donor screening for hepatitis B virus (HBV) consists of HBsAg screening since the 1970s, HBV DNA minipool testing (MP‐NAT) since 2008, and anti‐HBc screening since 2011. Anti‐HBc reactivity causes deferral only if anti‐HBs titers are <200 IU/mL, or when anti‐HBc was acquired during follow‐up. Study design and methods Over 5.5 million donations from 582,459 Dutch donors were screened for HBV DNA, HBsAg, anti‐HBc, and, if anti‐HBc positive, also for anti‐HBs. The added value, expressed as the yield of (potentially) infectious and/or recent HBV infections versus unnecessary donor loss, was evaluated for each of the three HBV screening tests. Results HBV donor screening identified 89 HBV‐infected donors with at least two reactive HBV markers (MP‐NAT, HBsAg and/or anti‐HBc). Single HBV‐marker yield was: 5 MP‐NAT‐only, 0 HBsAg‐only, and 20 anti‐HBc‐only donors. In addition, anti‐HBc screening yielded 1,067 potentially infectious donors at risk for occult HBV infection (OBI). In total, 4,126 (0.71%) donors were anti‐HBc‐reactive at first‐time screening, and 1,098 (0.19%) seroconverted during follow‐up. Anti‐HBc‐related donor loss was limited to 2,627 (0.45%) donors using anti‐HBs titers and two‐strike programs. Donor loss due to MP‐NAT and HBsAg screening was extremely low: 0 and 128 donors, respectively. Conclusion HBV donor screening could be limited to MP‐NAT and anti‐HBc screening. MP‐NAT and anti‐HBc improved blood safety by intercepting infectious donations from donors with recent infection or OBI, while HBsAg did not. Unnecessary donor loss related to anti‐HBc screening is substantial but does not endanger the continuity of the blood supply.