VIDAS® ANTI-HEV IgM 和 IgG 检测法的性能特征。

Performance characteristics of the VIDAS® ANTI-HEV IgM and IgG assays.

机构信息

CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France.

Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.

出版信息

J Clin Virol. 2019 Mar;112:10-14. doi: 10.1016/j.jcv.2019.01.005. Epub 2019 Jan 11.

DOI:10.1016/j.jcv.2019.01.005

PMID:30658273

Abstract

BACKGROUND

Several unautomated anti-HEV diagnostic tests are presently available.

OBJECTIVE

We have evaluated the performance of the new automated VIDAS® ANTI-HEV IgM and IgG assays.

STUDY DESIGN

We assessed the reproducibility and cross-reactivity of both VIDAS assays and the analytical sensitivity and linearity of the VIDAS IgG assay. We also tested the VIDAS and comparator assays Wantai IgG and IgM on immunocompetent and immunocompromised patients. Data were analysed according to the infectious profile, with samples from viremic phase (HEV RNA/IgM positive) and post-viremic phase (HEV RNA negative, IgM positive) infections, and uninfected patients (HEV RNA/IgM negative).

RESULTS

Within-run reproducibility was <10% and between-run reproducibility was <12% for both assays. We found no cross-reactivity, except for the VIDAS IgG assay in some patients with HBV (1/10) or malaria (3/23) infections and for the VIDAS IgM assay in some HIV-infected patients (1/10). The VIDAS IgG assay was linear over 0.10-10.0 U/mL. Analytical sensitivity of the IgG assay was 0.71 IU/ml (probit analysis). The clinical sensitivity of the VIDAS IgM assay was 97.65% for viremic samples (83/85) and 59.15% (42/71) for post-viremic samples from immunocompetent patients. It was 78.95% (45/57) for acute phase samples and 77.78% (28/36) for post-viremic samples from immunocompromised patients. Specificity was excellent (>99%) in both populations.

CONCLUSION

The analytical and clinical performance of the new VIDAS® ANTI-HEV assays was excellent. These rapid, automated assays for detecting HEV antibodies will strengthen the arsenal for diagnosing HEV infections.

摘要

背景

目前有几种非自动化的抗 HEV 诊断检测方法。

目的

我们评估了新型全自动 VIDAS®抗 HEV IgM 和 IgG 检测方法的性能。

研究设计

我们评估了两种 VIDAS 检测方法的重现性和交叉反应性，以及 VIDAS IgG 检测方法的分析灵敏度和线性度。我们还在免疫功能正常和免疫功能低下的患者中测试了 VIDAS 和比较剂检测方法 Wantai IgG 和 IgM。根据感染情况分析数据，包括病毒血症期（HEV RNA/IgM 阳性）和病毒血症后期（HEV RNA 阴性，IgM 阳性）感染以及未感染患者（HEV RNA/IgM 阴性）的样本。

结果

两种检测方法的批内重复性均<10%，批间重复性均<12%。我们发现除了 VIDAS IgG 检测方法在一些 HBV（1/10）或疟疾（3/23）感染患者中以及 VIDAS IgM 检测方法在一些 HIV 感染患者中（1/10）存在交叉反应外，没有其他交叉反应。VIDAS IgG 检测方法在 0.10-10.0 U/mL 范围内具有线性关系。IgG 检测方法的分析灵敏度为 0.71 IU/ml（概率分析）。VIDAS IgM 检测方法对病毒血症样本的临床灵敏度为 97.65%（83/85），对免疫功能正常患者的病毒血症后样本的灵敏度为 59.15%（42/71）。对急性期样本的灵敏度为 78.95%（45/57），对免疫功能低下患者的病毒血症后样本的灵敏度为 77.78%（28/36）。在两种人群中的特异性均>99%。