Bio-Rad BioPlex 2200复合系统检测麻疹、腮腺炎、风疹和水痘带状疱疹抗体的性能评价

IF 1.6 Q4 INFECTIOUS DISEASES Journal of clinical virology plus Pub Date : 2023-02-01 DOI:10.1016/j.jcvp.2022.100131

Matthew A. Lafrenière , Eley Badr , John Beattie , Joseph Macri , Waliul I. Khan

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引用次数: 0

摘要

背景麻疹、腮腺炎、风疹和水痘-带状疱疹（MMRV）免疫测试在医护人员和高危人群的职业筛查中很重要。目的本研究的目的是比较Bio-Rad BioPlex 2200 MMRV多重荧光免疫测定（MFI）与两种酶免疫测定（EIA）方法的性能：Bio-Rad Evolis Twin Plus麻疹、腮腺炎和水痘带状疱疹（MMV）IgG测定和Abbott Architect Rubella IgG测定。研究设计使用Bio-Rad-BioPlex测定法获得并分析临床上未表征的血清样本，并与EIA方法进行比较。结果Bio-Rad-BioPlex对麻疹、腮腺炎、水痘-带状疱疹和风疹的总符合率分别为85.5%（95%置信区间，78.0至90.7%）、92.7%（95%可信区间，86.7至96.1%）、92.4%（95%置信间隔，86.9至95.7%）和98.8%（95%置信程度，93.7至99.8%）。此外，在13个合并样本中的10个样本中，精密度测试与制造商的包装插入物一致。结论这些数据表明，Bio-Rad-BioPlex具有与EIA方法相当的性能。

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Performance evaluation of the bio-rad BioPlex 2200 multiplex system in the detection of measles, mumps, rubella, and varicella-zoster antibodies

Background

Measles, mumps, rubella, and varicella-zoster (MMRV) immunity testing is important in occupational screening of healthcare workers and at-risk populations.

Objectives

The goal of this study was to compare the performance of the Bio-Rad BioPlex 2200 MMRV multiplex fluorescence immunoassay (MFI) against two enzyme immunoassay (EIA) methods: the Bio-Rad Evolis Twin Plus measles, mumps, and varicella-zoster (MMV) IgG assay and the Abbott Architect Rubella IgG assay.

Study Design

Clinically uncharacterized serum specimens were obtained and analyzed using the Bio-Rad BioPlex assay and compared against the EIA methods.

Results

The Bio-Rad BioPlex demonstrated total agreement of 85.5% (95% confidence interval (CI), 78.0 to 90.7%), 92.7% (95% confidence interval (CI), 86.7 to 96.1%), 92.4% (95% confidence interval (CI), 86.9 to 95.7%), and 98.8% (95% confidence interval (CI), 93.7 to 99.8%) for measles, mumps, varicella-zoster, and rubella, respectively, against the current EIA methods. Furthermore, precision testing agreed with the manufacturer's package insert in 10 of 13 pooled samples.