Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada
Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
J Clin Microbiol. 2021 May 19;59(6). doi: 10.1128/JCM.03161-20.
The World Health Organization (WHO) has targeted measles for global eradication through mass immunization. For effective monitoring of eradication targets, high-quality surveillance is needed. The detection of IgM antibodies, specific to the measles virus, with the use of commercial enzyme-linked immunosorbent assays (ELISA or EIA) is broadly used within the WHO global measles and rubella laboratory network for laboratory confirmation, and in particular, ELISA kits manufactured by Siemens (Enzygnost kits) have been primarily used. Spurred by the discontinuation of these kits, this study aims to report on the clinical sensitivity and specificity of comparable commercial ELISA kits and one automated chemiluminescent immunoassay (CLIA) method. A panel of 239 serum samples was assembled that included sera from confirmed measles cases ( = 50) and probable post-MMR vaccine response ( = 2). Measles-negative sera ( = 187) were collected from individuals presenting with other fever and rash illnesses. A total of 7 ELISA kits (Euroimmun native antigens and recombinant nucleoprotein, IBL, Clin-Tech Microimmune, NovaTec NovaLisa, Serion, and Siemens Enzygnost) and one CLIA method (DiaSorin LIAISON XL) were evaluated. The ELISA kits included two IgM capture methods and five indirect methods. Calculated sensitivities and specificities ranged from 75.0% to 98.1% and 86.6% to 99.5%, respectively. The parvovirus B19 IgM positive sera were noted to cause false-positive results, particularly for the ELISA kits from Serion and NovaLisa; specificities for this subset of samples ranged from 51.4% to 100.0%. The capture IgM ELISA methods provided the best combination of sensitivity and specificity.
世界卫生组织（WHO）通过大规模免疫接种，将麻疹作为全球消除目标。为了有效监测消除目标，需要高质量的监测。使用商业酶联免疫吸附测定（ELISA 或 EIA）检测针对麻疹病毒的 IgM 抗体，广泛用于 WHO 全球麻疹和风疹实验室网络进行实验室确认，特别是西门子（Enzygnost 试剂盒）生产的 ELISA 试剂盒被主要使用。由于这些试剂盒的停产，本研究旨在报告可比商业 ELISA 试剂盒和一种自动化化学发光免疫分析（CLIA）方法的临床灵敏度和特异性。本研究汇集了 239 份血清样本，其中包括确诊麻疹病例（ = 50）和疑似 MMR 疫苗反应（ = 2）的血清，以及麻疹阴性血清（ = 187）来自出现其他发热和皮疹疾病的个体。共评估了 7 种 ELISA 试剂盒（Euroimmun 天然抗原和重组核蛋白、IBL、Clin-Tech Microimmune、NovaTec NovaLisa、Serion 和 Siemens Enzygnost）和一种 CLIA 方法（DiaSorin LIAISON XL）。ELISA 试剂盒包括两种 IgM 捕获方法和五种间接方法。计算得出的灵敏度和特异性分别为 75.0%至 98.1%和 86.6%至 99.5%。细小病毒 B19 IgM 阳性血清被发现会导致假阳性结果，特别是对 Serion 和 NovaLisa 的 ELISA 试剂盒；对于这部分样本，特异性范围为 51.4%至 100.0%。捕获 IgM ELISA 方法提供了最佳的灵敏度和特异性组合。
