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重评估 VIDAS(®) 巨细胞病毒 (CMV) IgG 亲和性检测法:基于 CMV-IgG 成熟动力学研究确定新的临界值。

Re-evaluation of the VIDAS(®) cytomegalovirus (CMV) IgG avidity assay: determination of new cut-off values based on the study of kinetics of CMV-IgG maturation.

机构信息

INSERM U764, Université Paris Sud, AP-HP, Microbiology Department, Hôpital Antoine Béclère, Clamart, France.

出版信息

J Clin Virol. 2013 Feb;56(2):118-23. doi: 10.1016/j.jcv.2012.10.017. Epub 2012 Nov 22.

Abstract

BACKGROUND

In case of cytomegalovirus (CMV) infection, differentiation between primary and non-primary CMV infection can be of major importance for the correct management of pregnant women or immunocompromised patients. Besides CMV-IgM and IgG, CMV-IgG avidity measurement is now commonly used to distinguish primary from non-primary infection.

OBJECTIVE

To re-evaluate the performance of the VIDAS CMV-IgG avidity assay in comparison with 2 other techniques (Architect Abbott and Liaison DiaSorin) and to study the kinetics of CMV-IgG avidity maturation.

STUDY DESIGN

A panel of 135 sequential samples collected from 31 patients with a proven primary infection (attested by very recent CMV-IgG seroconversion) was tested with VIDAS, Liaison and Architect CMV-IgG avidity assays. Moreover, 235 routinely collected samples, CMV-IgG and CMV-IgM positive, were analyzed with Liaison, VIDAS and an in-house CMV-IgG avidity assay.

RESULTS AND CONCLUSIONS

The analysis of all the data allowed suggesting new VIDAS cut-off values of 0.40 for low avidity and 0.65 for high avidity, which significantly increase the test performance and enable better patient managements. Using these VIDAS new cut-off values, all of the 31 primary infections were correctly dated. Comparatively, 25 out of 31 were correctly dated with the Architect assay and 29 out of 31 with the Liaison assay. We also demonstrated that the VIDAS CMV-IgG avidity assay allows observing correctly the maturation of CMV-IgG avidity, which could be useful as an additional parameter for diagnosis of a recent CMV infection.

摘要

背景

在巨细胞病毒(CMV)感染的情况下,区分原发性和非原发性 CMV 感染对于孕妇或免疫功能低下患者的正确管理至关重要。除了 CMV-IgM 和 IgG 外,CMV-IgG 亲和性测定现在常用于区分原发性和非原发性感染。

目的

重新评估 VIDAS CMV-IgG 亲和性测定与另外两种技术(Architect Abbott 和 Liaison DiaSorin)的性能,并研究 CMV-IgG 亲和性成熟的动力学。

研究设计

一组 135 个来自 31 名确诊原发性感染患者(通过最近的 CMV-IgG 血清转换证明)的连续样本,用 VIDAS、Liaison 和 Architect CMV-IgG 亲和性测定进行了检测。此外,对 235 个常规收集的 CMV-IgG 和 CMV-IgM 阳性样本,用 Liaison、VIDAS 和内部 CMV-IgG 亲和性测定进行了分析。

结果与结论

对所有数据的分析表明,VIDAS 低亲和性的新临界值为 0.40,高亲和性的新临界值为 0.65,这显著提高了测试性能,使患者管理得到改善。使用这些 VIDAS 新的临界值,31 例原发性感染中的所有感染都被正确地确定了日期。相比之下,用 Architect 测定法可以正确确定 25/31 例感染日期,用 Liaison 测定法可以正确确定 29/31 例感染日期。我们还证明,VIDAS CMV-IgG 亲和性测定法可以正确观察 CMV-IgG 亲和性的成熟,这可能作为近期 CMV 感染诊断的附加参数有用。

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