Institute of Transfusion Medicine and Immunohematology, German Red Cross, Johann Wolfgang Goethe University, Frankfurt, Germany.
Int J Lab Hematol. 2009 Dec;31(6):649-56. doi: 10.1111/j.1751-553X.2008.01092.x. Epub 2008 Jul 31.
Compared to HIV and hepatitis C virus, the residual infectious risk of hepatitis B virus (HBV) posed by blood products is about 10 times higher. In addition to HBsAg testing, screening for anti-HBc was recommended by the German Advisory Committee Blood in March 2005. Prevalence of anti-HBc in German blood donors was investigated at five test sites located in different geographic regions. In total, 12,000 blood donors were screened for anti-HBc by PRISM HBcore, and a statistically representative number of these were tested with Abbott Murex anti-HBc total, bioMérieux Hepanostika anti-HBc uniform, Bio-Rad Monolisa anti-HBc PLUS and Dade Behring Enzygnost anti-HBc. Anti-HBc repeat reactive samples were tested for anti-HBs, anti-HBe and HBV DNA by individual donation NAT. The mean prevalence of anti-HBc was 1.75% in donors that had not been tested for anti-HBc in the past. The percentage of anti-HBs in anti-HBc repeat reactive donors was 93.7%. Samples that were additionally reactive for anti-HBe were anti-HBc reactive in all tested assays. The sample to cut-off (S/Co) values for anti-HBc were lower (competitive assays) in samples that were also positive for anti-HBe, when compared to samples that were only anti-HBc reactive. Most commercially available anti-HBc assays provide sufficient sensitivity for routine screening purposes, and lacking specificity is no longer a serious issue for most of them. Assay differences were recognized for samples that were anti-HBc only reactive. The overall loss of 1.75% of positive testing donors can be significantly reduced to 0.45% by implementation of re-entry procedures for donors with an anti-HBs titre of over 100 IU/l and negative by sensitive ID-NAT.
与 HIV 和丙型肝炎病毒相比，血液制品中乙型肝炎病毒（HBV）的残余传染性风险要高出约 10 倍。除 HBsAg 检测外，德国血液咨询委员会（German Advisory Committee Blood）于 2005 年 3 月建议对乙型肝炎核心抗体（抗-HBc）进行筛查。在德国五个不同地理位置的检测点对献血者的抗-HBc 流行率进行了调查。共有 12000 名献血者通过 PRISM HBcore 进行了抗-HBc 检测，其中有代表性数量的献血者用 Abbott Murex 抗-HBc 总抗体、bioMérieux Hepanostika 抗-HBc 均相、Bio-Rad Monolisa 抗-HBc PLUS 和 Dade Behring Enzygnost 抗-HBc 进行了检测。对抗-HBc 重复反应性样本进行了个体献血者 NAT 检测抗-HBs、抗-HBe 和 HBV DNA。过去未进行抗-HBc 检测的献血者抗-HBc 的平均流行率为 1.75%。在抗-HBc 重复反应性献血者中，抗-HBs 的比例为 93.7%。在所有检测方法中，抗-HBe 也呈反应性的样本在所有检测方法中均为抗-HBc 反应性。与仅抗-HBc 反应性的样本相比，抗-HBe 同时呈阳性的样本的抗-HBc 样本/临界值（S/Co）值较低（竞争检测法）。大多数市售的抗-HBc 检测法在常规筛查方面都具有足够的灵敏度，而且特异性缺乏不再是大多数检测法的严重问题。仅抗-HBc 反应性的样本存在检测方法差异。通过对 HBs 滴度超过 100 IU/l 且阴性的献血者实施再输入程序，可以将 1.75%的阳性检测献血者的总损失显著降低至 0.45%。
