Daiminger A, Bäder U, Eggers M, Lazzarotto T, Enders G
Med.-diagn. Gemeinschaftslabor Prof. Enders und Partner & Institut für Virologie, Infektiologie und Epidemiologie e.V., Stuttgart, Germany.
J Clin Virol. 1999 Aug;13(3):161-71. doi: 10.1016/s1386-6532(99)00028-1.
Two novel enzyme linked immunosorbent assays (ELISA) (Abbott IMx CMV IgM 2.0, and Cobas Core CMV IgM EIA recomb, research version) which use recombinant antigens to detect cytomegalovirus (CMV)-specific IgM antibodies were evaluated.
A new ELISA is normally evaluated against a gold standard commercial kit, which in this case does not exist. We therefore evaluated the two novel recombinant ELISA against four conventional ELISAs and a recently developed CMV IgM immunoblot containing four purified viral and four recombinant proteins.
A total of 280 sera from pregnant women and 42 potentially cross-reactive sera were investigated using the six ELISAs, including 101 sera which were also tested using the new IgM immunoblot.
Relative sensitivity, relative specificity and overall agreement differed according to the reference assay. The Cobas Core CMV EIA recomb showed much higher agreement with the ELISA consensus, and the IMx CMV IgM 2.0 with the immunoblot.
The evaluation of these new IgM assays in terms of their agreement with either commercial ELISA kits or the IgM immunoblot demonstrates that the question 'which reference method?' is still open. However the recombinant IgM assays may improve the diagnosis of CMV infection in pregnancy since the recombinant technology offers helpful tools for identifying diagnostically relevant proteins and allows the use of standardized pure preparations of antigens. For serological diagnosis of CMV infection in pregnancy two IgM assays that can be relied upon should be performed. IgM positive sera should be tested with supplementary assays to differentiate primary from non-primary infection.
对两种新型酶联免疫吸附测定法（ELISA）（雅培IMx巨细胞病毒IgM 2.0和科宝核心巨细胞病毒IgM EIA重组体，研究版本）进行了评估，这两种方法使用重组抗原检测巨细胞病毒（CMV）特异性IgM抗体。
新的ELISA通常是与金标准商业试剂盒进行对比评估，但在这种情况下不存在这样的试剂盒。因此，我们将这两种新型重组ELISA与四种传统ELISA以及一种最近开发的包含四种纯化病毒蛋白和四种重组蛋白的CMV IgM免疫印迹法进行了对比评估。
使用这六种ELISA对总共280份孕妇血清和42份可能存在交叉反应的血清进行了研究，其中101份血清也使用新的IgM免疫印迹法进行了检测。
相对灵敏度、相对特异性和总体一致性因参考检测方法而异。科宝核心CMV EIA重组体与ELISA共识的一致性更高，而IMx CMV IgM 2.0与免疫印迹法的一致性更高。
对这些新型IgM检测方法与商业ELISA试剂盒或IgM免疫印迹法的一致性评估表明，“哪种参考方法？”这个问题仍然没有答案。然而，重组IgM检测方法可能会改善孕期CMV感染的诊断，因为重组技术为鉴定诊断相关蛋白提供了有用的工具，并允许使用标准化的纯抗原制剂。对于孕期CMV感染的血清学诊断，应进行两种可靠的IgM检测。IgM阳性血清应使用补充检测方法进行检测，以区分原发性感染和非原发性感染。
