Roth W Kurt
GFE Blut mbH, Frankfurt/M., Germany.
Transfus Med Hemother. 2010 Jun;37(3):118-122. doi: 10.1159/000314710. Epub 2010 May 25.
Upon the introduction of mandatory nucleic acid amplification technology (NAT) testing in Germany for HCV, quarantining of fresh frozen plasma (FFP) was reduced in 2002 from 6 to 4 months. In 2004 HIV-1 NAT and in 2005 anti-HBc testing were introduced to further reduce the residual transmission risks for transfusion relevant viruses. After testing more than 40 million donations by HCV NAT it became obvious that NAT testing has a very significant impact on viral blood safety by reducing the residual risk by a factor of 10. Only one documented HCV transmission occurred during more than 10 years of NAT testing in Germany, indicating that the remaining risk is marginal. Similar data were obtained for HIV-1. The question arises whether we could discontinue quarantining of FFP or further reduce the quarantining interval for retesting of the donor. This could facilitate logistics and reduce losses as quarantine FFP can be released earlier after donation and at regular donation intervals. Essential parameters for estimating the remaining infectious risks are the minimal infectious dose and replication kinetics of the viruses involved, the detection limits of the NAT tests applied, and the volume of plasma transfused. In essence it can be assumed that discontinuation of quarantining would only marginally increase the residual risk and that the reduction of the quarantine period to only 4 weeks would add an additional benefit to the viral safety of quarantine FFP.
在德国将丙型肝炎病毒(HCV)的核酸扩增技术(NAT)检测强制推行后,新鲜冰冻血浆(FFP)的检疫期在2002年从6个月缩短至4个月。2004年引入了HIV-1核酸检测,2005年引入了抗-HBc检测,以进一步降低与输血相关病毒的残余传播风险。在通过HCV核酸检测对超过4000万份献血进行检测后,很明显核酸检测对病毒血液安全性具有非常显著的影响,将残余风险降低了10倍。在德国进行核酸检测的10多年间,仅记录到1例HCV传播,这表明剩余风险微乎其微。对于HIV-1也获得了类似的数据。问题在于我们是否可以停止对FFP的检疫,或者进一步缩短对献血者重新检测的检疫间隔。这将有助于物流并减少损失,因为检疫后的FFP可以在献血后更早且按常规献血间隔放行。估计剩余感染风险的关键参数包括所涉病毒的最小感染剂量和复制动力学、所应用核酸检测的检测限以及输注的血浆量。从本质上讲,可以假定停止检疫只会略微增加残余风险,而将检疫期缩短至仅4周将为检疫FFP的病毒安全性带来额外益处。