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用于麻疹实验室确诊的 6 种免疫球蛋白 M 酶联免疫吸附测定的性能特征。

Performance Characteristics of Six Immunoglobulin M Enzyme-Linked Immunosorbent Assays Used for Laboratory Confirmation of Measles.

机构信息

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Preventiongrid.416738.f, Atlanta, Georgia, USA.

出版信息

J Clin Microbiol. 2022 Dec 21;60(12):e0122722. doi: 10.1128/jcm.01227-22. Epub 2022 Nov 21.

Abstract

Laboratory confirmation of infection is an essential component of measles surveillance. Detection of measles-specific IgM in serum by enzyme-linked immunosorbent assay (ELISA) is the most common method used to confirm measles infection. ELISA formats vary, as does the sensitivity and specificity of each assay. Specimens collected within 3 days of rash onset can yield a false-negative result, which can delay confirmation of measles cases. Interfering substances can yield a false-positive result, leading to unnecessary public health interventions. The IgM capture assay developed at the Centers for Disease Control (CDC) was compared against five commercially available ELISA kits for the ability to detect measles virus-specific IgM in a panel of 90 well-characterized specimens. Serum samples were tested in triplicate using each commercial kit as recommended by the manufacturer. Using the CDC measles IgM capture assay as the reference test; the sensitivity and specificity for each commercial kit ranged from 50 to 83% and 86.9 to 98%, respectively. Discrepant results were observed for samples tested with all five commercial kits and ranged from 13.8 to 28.8% of the specimens tested. False-positive results occurred in 2.0 to 13.1% of sera, while negative results were observed in 16.7 to 50% of sera that were positive by the CDC measles IgM capture assay. Evaluation and interpretation of measles IgM serologic results can be complex, particularly in measles elimination settings. The performance characteristics of a measles IgM assay should be carefully considered when selecting an assay to achieve high-quality measles surveillance.

摘要

实验室确证感染是麻疹监测的一个重要组成部分。通过酶联免疫吸附试验(ELISA)检测血清中麻疹特异性 IgM 是最常用的确认麻疹感染的方法。ELISA 格式不同,每种检测方法的灵敏度和特异性也不同。发病后 3 天内采集的标本可能产生假阴性结果,从而延迟麻疹病例的确认。干扰物质可能产生假阳性结果,导致不必要的公共卫生干预。疾病预防控制中心(CDC)开发的 IgM 捕获检测与五种市售 ELISA 试剂盒进行了比较,以评估它们在 90 个特征明确的标本组成的检测面板中检测麻疹病毒特异性 IgM 的能力。血清样本使用每种商业试剂盒按照制造商建议进行了三次重复测试。以 CDC 麻疹 IgM 捕获检测为参考检测,每种商业试剂盒的灵敏度和特异性范围分别为 50%至 83%和 86.9%至 98%。使用所有五种商业试剂盒测试的样本均观察到不一致的结果,占测试样本的 13.8%至 28.8%。假阳性结果发生在 2.0%至 13.1%的血清中,而在 CDC 麻疹 IgM 捕获检测呈阳性的血清中,阴性结果则分别为 16.7%至 50%。在消除麻疹的环境中,麻疹 IgM 血清学结果的评估和解释可能很复杂。在选择用于实现高质量麻疹监测的检测方法时,应仔细考虑麻疹 IgM 检测的性能特征。

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J Infect Dis. 2004 May 1;189 Suppl 1:S1-3. doi: 10.1086/377693.

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