The aim of this study is to report on the specificity in the low-positive range of the Liaison CMV IgG II assay for determination of cytomegalovirus immune status in pregnancy. Sera with test results between 12.0 and 40.0 U/mL were retested with the Enzygnost Anti-CMV/IgG assay. Enzygnost-negative samples were analyzed by the Serion ELISA classic Cytomegalovirus IgG assay and, if positive or equivocal, also with the Mikrogen recomLine CMV IgG assay. A total of 12,117 sera were tested with the Liaison assay. Sixty sera were equivocal (12.0-13.9 U/mL), and 400 of 4295 positive sera were low-positive (14.0-40.0 U/mL). Based on consensus, at least 14% of the low-positives and 1.3% of all Liaison-positives can be considered as misclassified. The proportion of misclassified sera increased with lower Liaison IgG results. We suggest that the range for equivocal results in the Liaison assay should be revised.

中文翻译：

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联络人CMV IgG II分析中的低水平阳性结果可能将孕妇分类为免疫性。

这项研究的目的是报告在确定孕妇巨细胞病毒免疫状态的联络CMV IgG II分析的低阳性范围内的特异性。用Enzygnost Anti-CMV / IgG分析法重新检测测试结果在12.0和40.0 U / mL之间的血清。通过Serion ELISA经典的巨细胞病毒IgG分析对酶促阴性样品进行分析，如果阳性或含糊不清，还可以通过Mikrogen recomLine CMV IgG分析进​​行分析。用联络分析法测试了总共12,117份血清。60个血清含糊（12.0-13.9 U / mL），4295个阳性血清中有400个呈低阳性（14.0-40.0 U / mL）。根据共识，至少14％的低积极性和1.3％的所有联络积极性可以被视为错误分类。血清分类错误的比例随着联络IgG结果的降低而增加。