Roback John D, Drew W Lawrence, Laycock Megan E, Todd Deborah, Hillyer Christopher D, Busch Michael P
Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia 30322, USA.
Transfusion. 2003 Mar;43(3):314-21. doi: 10.1046/j.1537-2995.2003.00312.x.
Although serologic screening or WBC reduction of blood components can reduce the incidence of transfusion-transmitted CMV (TT-CMV) infection, 'breakthrough' cases of TT-CMV still occur and may produce serious sequelae. NAT of blood components for CMV DNA has been proposed to further reduce the risks of TT-CMV. However, large-scale studies to determine the utility of validated CMV NAT assays for donor screening have not been reported.
Coded whole-blood samples (n=1000) were tested for the presence of CMV DNA using two CMV PCR assays previously validated in a multicenter trial (a nested PCR assay directed at the CMV UL93 open-reading frame and the Roche Monitor assay). Corresponding plasma samples were tested in parallel for the presence of anti-CMV using other assays (Abbott CMV EIA and Fujirebio/Olympus CMV particle agglutination assays).
In total 416 and 514 of the samples tested as CMV-seropositive and -seronegative, respectively, by both antibody assays. The remaining 70 samples had discrepant serology results. Only 2 of the 1000 samples (both seropositive) had reproducibly detectable CMV DNA (positive in at least three of four replicates). CMV DNA was not reproducibly detected in seronegative samples or in samples with discrepant serology results.
Although previous investigations showed frequent detection of CMV DNA in healthy CMV-seropositive (and some seronegative) blood donors, these studies were relatively small and the performance characteristics of their assays were difficult to evaluate. In contrast, the present large cross-sectional study of US donors utilized two previously validated PCR assays and demonstrated that CMV DNA is only rarely detectable in seropositive donors. Thus, the use of CMV PCR assays with optimal performance characteristics did not increase the detection of potentially infectious blood components beyond that provided by current serologic screening assays.
尽管对血液成分进行血清学筛查或白细胞去除可以降低输血传播巨细胞病毒（TT-CMV）感染的发生率，但TT-CMV的“突破性”病例仍会出现，并可能产生严重的后遗症。有人提出对血液成分进行CMV DNA核酸扩增检测（NAT）以进一步降低TT-CMV的风险。然而，尚未有大规模研究来确定经过验证的CMV NAT检测用于供体筛查的效用。
使用两种先前在多中心试验中经过验证的CMV PCR检测方法（一种针对CMV UL93开放阅读框的巢式PCR检测方法和罗氏监测检测方法）对编码全血样本（n = 1000）进行CMV DNA检测。使用其他检测方法（雅培CMV酶免疫分析和富士瑞必欧/奥林巴斯CMV颗粒凝集试验）对相应的血浆样本同时进行抗CMV检测。
两种抗体检测方法分别检测出416份样本CMV血清学阳性和514份样本CMV血清学阴性。其余70份样本的血清学结果不一致。1000份样本中只有2份（均为血清学阳性）可重复检测到CMV DNA（在四次重复检测中至少三次呈阳性）。在血清学阴性样本或血清学结果不一致的样本中未重复检测到CMV DNA。
尽管先前的研究表明在健康的CMV血清学阳性（以及一些血清学阴性）献血者中经常检测到CMV DNA，但这些研究规模相对较小，其检测方法的性能特征难以评估。相比之下，目前对美国献血者进行的这项大型横断面研究使用了两种先前经过验证的PCR检测方法，并表明在血清学阳性的献血者中很少能检测到CMV DNA。因此，使用具有最佳性能特征的CMV PCR检测方法，在检测潜在感染性血液成分方面，并没有比目前的血清学筛查检测方法有更多的发现。
