Lagrou K, Bodeus M, Van Ranst M, Goubau P
Department of Medical Diagnostic Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.
J Clin Microbiol. 2009 Jun;47(6):1695-9. doi: 10.1128/JCM.02172-08. Epub 2009 Apr 1.
A panel of new cytomegalovirus (CMV) assays for use on the Architect instrument has been developed, including a CMV avidity assay based on a new technology. The purpose of this study was to compare the performance characteristics of the fully automated CMV immunoglobulin M (IgM), IgG, and IgG avidity tests on the Architect instrument with those of other available assays. A total of 503 consecutive fresh patient serum specimens (routine serum specimens) and 96 serum specimens from 33 pregnant women with a recent CMV primary infection (seroconversion serum specimens) were tested for CMV IgM and IgG by the Architect (Abbott), Vidas (BioMérieux), and Enzygnost (Siemens) assays. The seroconversion sera and 100 preselected serum specimens IgM negative and IgG positive by the AxSYM assay were also tested by the IgG avidity tests on the Architect and Vidas instruments. The relative agreements for CMV IgM determination with routine sera between the Architect assay and the Vidas, Enzygnost, and AxSYM assays were 97%, 94%, and 93%, respectively, for the CMV IgM tests and 99%, 98%, and 98%, respectively, for the CMV IgG tests. The specificities of the CMV IgG avidity test were 98% for the Architect assay and 76% for the Vidas assay. No high CMV IgG avidity test results were found within the first 3 months after seroconversion by either of those assays. The correlation between the results of the newly developed CMV IgM and IgG tests on the Architect instrument with the Vidas and Enzygnost assays was excellent (> or = 94%). The CMV IgG avidity test reliably excluded patients with recent infections and showed an excellent specificity (98%).
已开发出一组用于Architect仪器的新型巨细胞病毒（CMV）检测方法，包括基于一项新技术的CMV亲和力检测。本研究的目的是比较Architect仪器上全自动CMV免疫球蛋白M（IgM）、IgG和IgG亲和力检测与其他现有检测方法的性能特征。通过Architect（雅培）、Vidas（生物梅里埃）和Enzygnost（西门子）检测方法，对总共503份连续的新鲜患者血清标本（常规血清标本）以及来自33名近期发生CMV原发性感染的孕妇的96份血清标本（血清转化血清标本）进行了CMV IgM和IgG检测。血清转化血清以及通过AxSYM检测方法筛选出的100份IgM阴性且IgG阳性的预选血清标本，也通过Architect和Vidas仪器上的IgG亲和力检测进行了检测。对于CMV IgM检测，Architect检测方法与Vidas、Enzygnost和AxSYM检测方法在常规血清CMV IgM测定方面的相对一致性分别为97%、94%和93%，对于CMV IgG检测分别为99%、98%和98%。CMV IgG亲和力检测的特异性，Architect检测方法为98%，Vidas检测方法为76%。在血清转化后的前3个月内，这两种检测方法均未发现高CMV IgG亲和力检测结果。Architect仪器上新开发的CMV IgM和IgG检测结果与Vidas和Enzygnost检测方法之间的相关性极佳（≥94%）。CMV IgG亲和力检测可靠地排除了近期感染患者，特异性极佳（98%）。
