Offergeld R, Faensen D, Ritter S, Hamouda O
Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
Euro Surveill. 2005 Feb;10(2):8-11.
Blood and plasma donations in Germany are collected by several institutions, namely the German Red Cross, community and hospital-based blood services, private blood centres, commercial plasma donation sites and transfusion services of the army. All blood donation centres are required to report quarterly data on infection markers to the Robert Koch Institute, thus providing current and accurate epidemiological data. The prevalence and incidence of relevant viral infections are low in the blood donor population in Germany, with a decreasing trend for hepatitis C infections in new and repeat donors since 1997. The implementation of mandatory nucleic acid amplification technique (NAT) testing for hepatitis C virus (HCV) in 1999 has markedly improved transfusion safety. HIV-NAT became mandatory in 2004 but was done voluntarily by the majority of the blood donation services before then. The potential benefit of hepatitis B virus (HBV) minipool NAT is not as clear because chronic HBV carriers with very low virus levels might donate unidentified. The residual risk of an infectious window period donation inadvertently entering the blood supply can be estimated using a mathematic model which multiplies the incidence rate by the number of days during which an infection may be present but not detectable, i.e. the length of the window period. The risk of an undetected infection without NAT testing was estimated to be 1 in 2,770,000 for HIV, 1 in 670,000 for HCV and 1 in 230,000 for HBV in 2001/2002. This contrasts with 1 in 5,540,000 for HIV, 1 in 4,400,000 for HCV and 1 in 620,000 for HBV with minipool NAT testing. This demonstrates that NAT testing can further reduce the already very small risk of infectious donations entering the blood supply.
在德国，血液和血浆捐赠由多个机构负责采集，即德国红十字会、社区及医院血站、私人血液中心、商业血浆采集点以及军队输血服务机构。所有献血中心都必须每季度向罗伯特·科赫研究所报告感染标志物数据，从而提供最新且准确的流行病学数据。德国献血人群中相关病毒感染的患病率和发病率较低，自1997年以来，新献血者和重复献血者中丙型肝炎感染呈下降趋势。1999年实施丙型肝炎病毒（HCV）强制核酸扩增技术（NAT）检测显著提高了输血安全性。HIV - NAT检测在2004年成为强制性要求，但在此之前大多数献血服务机构已自愿开展。乙肝病毒（HBV）混合样本NAT检测的潜在益处尚不明确，因为病毒水平极低的慢性HBV携带者可能未被检测出来而进行了献血。对于无意中进入供血系统的处于感染窗口期的献血，其残余风险可通过数学模型进行估算，该模型用发病率乘以感染可能存在但无法检测到的天数，即窗口期的时长。在2001/2002年，未经NAT检测而未被发现感染的风险估计为HIV每277万次献血中有1例，HCV每67万次献血中有1例，HBV每23万次献血中有1例。相比之下，采用混合样本NAT检测时，HIV为每554万次献血中有1例，HCV为每440万次献血中有1例，HBV为每62万次献血中有1例。这表明NAT检测可进一步降低本就极小的感染性献血进入供血系统的风险。
