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四种 IgM 抗体检测试剂盒在麻疹病毒初次感染和血清学特征提示再感染病例诊断中的性能比较。

Performance of Four IgM Antibody Assays in the Diagnosis of Measles Virus Primary Infection and Cases with a Serological Profile Indicating Reinfection.

机构信息

Center for Virology, Medical University of Vienna, Vienna, Austria.

Department of Surveillance and Infectious Disease Epidemiology, Austrian Agency for Health and Food Safety, Vienna, Austria.

出版信息

J Clin Microbiol. 2021 Apr 20;59(5). doi: 10.1128/JCM.02047-20.

Abstract

The object of this study was to determine the diagnostic performance of four commercially available IgM tests in the diagnosis of measles virus (MeV) primary infection and cases with a serological profile indicating reinfection. Sera from 187 patients with MeV primary infection, 30 patients with suspected reinfection (after vaccine failure), and 153 patients with rash-like symptoms after exclusion of MeV infection were retested with four IgM tests. MeV infection was verified by reverse transcriptase PCR (RT-PCR), and primary and suspected reinfections were differentiated by IgG avidity and neutralization assays. All IgM assays displayed significant agreement (Cohen's κ, ≥0.604; all  < 0.001) and a higher diagnostic accuracy in primary infection than in suspected reinfection (indicated by high IgG avidity and significantly higher anti-MeV-IgG and neutralizing titers). In the overall cohort, the areas under the curve (AUC) were comparable among all tests, ranging from 0.875 to 0.931, with ranges increasing to 0.911 to 0.930 in the primary infection and decreasing to 0.765 to 0.940 in the setting of high anti-MeV-IgG avidity, and all tests displayed high specificity (81.1 to 92.2%). Of note, IgM tests with the highest diagnostic accuracy had discriminatory abilities not significantly different than PCR from serum. Although reinfections pose a challenge for IgM testing, IgM assays remain a cornerstone in the diagnosis of MeV infections. Especially in samples with a serological profile indicating reinfections, IgM tests displayed an equal or even superior diagnostic ability compared to PCR from serum.

摘要

本研究旨在评估四种市售 IgM 检测试剂在麻疹病毒(MeV)原发感染和血清学特征提示再感染病例中的诊断性能。对 187 例 MeV 原发感染患者、30 例疑似再感染患者(疫苗接种失败后)和 153 例皮疹样症状排除 MeV 感染患者的血清标本,用四种 IgM 检测试剂进行了复测。通过逆转录 PCR(RT-PCR)验证了 MeV 感染,通过 IgG 亲和性和中和试验区分了原发感染和疑似再感染。所有 IgM 检测试剂均显示出显著的一致性(Cohen's κ,≥0.604;均 < 0.001),并且在原发感染中的诊断准确性高于疑似再感染(表现为高 IgG 亲和性,且抗-MeV-IgG 和中和滴度显著升高)。在总队列中,所有检测试剂的曲线下面积(AUC)相当,范围为 0.875 至 0.931,在原发感染中范围增加至 0.911 至 0.930,在高抗-MeV-IgG 亲和性时范围降低至 0.765 至 0.940,所有检测试剂均具有较高的特异性(81.1 至 92.2%)。值得注意的是,具有最高诊断准确性的 IgM 检测试剂与血清 PCR 相比具有相似的鉴别能力。虽然再感染给 IgM 检测带来了挑战,但 IgM 检测仍然是 MeV 感染诊断的基石。特别是在血清学特征提示再感染的标本中,IgM 检测的诊断能力与血清 PCR 相当甚至更优。

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