Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays

Q4 Medicine

Jornal Brasileiro de Patologia e Medicina Laboratorial Pub Date : 2021-01-01 DOI:10.5935/1676-2444.20210040

M. Castejon, Rosemeire Yamashiro, E. L. Oliveira, E. Silveira, M. Hong, Carmem Aparecida F. Oliveira, V. O. Silva, C. Ahagon, A. K. Lima, J. Lindoso, L. Brigido

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引用次数: 0

Abstract

Due to urgency and demand of a response to the Covid-19 pandemic, numerous Sars-CoV-2 immunoassays have been rapidly developed. Objective: This study aimed at assessing the performance of rapid Sars-CoV-2 antibody test in comparison to high-throughput serological assays. Methods: A total of 86 serum samples were evaluated in the three assays: a lateral flow immunoassay - Wondfo Sars-CoV-2 Antibody Test (WRT) - and two chemiluminescence immunoassays: Elecsys Anti-Sars-CoV-2 (ECLIA), and Sars-CoV-2 IgG (CMIA-IgG). Results: The estimated diagnostic sensitivities of serological tests in the evaluation of serum samples from the epidemiological survey were: WRT 59% [95% confidence interval (CI) 43.4%-72.9%], ECLIA 66.7% (51%-79.4%), and CMIA-IgG 61.5% (47.1%-73%). Meanwhile, the estimated diagnostic specificity was for WRT 78.7% (95% CI 65.1%-88%), ECLIA 72.3% (58.2%-83.1%), and CMIA-IgG 76.6% (74%-95.5%). The sensitivity and specificity values were lower than manufacturers' claimed. Although 16.2% (14/86) of serological results were discordant among the three Sars-CoV-2 serological assays, the degree of agreement by the kappa index was adequate: WRT/CMIA-IgG [0.757 (95% CI 0.615-0.899)], WRT/ECLIA [0.715 (0.565-0.864)], and ECLIA/CMIA-IgG [0.858 (0.748-0.968)]. Conclusion: The serological testing may be a useful diagnostic tool, which reinforces its careful evaluation, and, as well as the correct time to use it. © 2021 Sociedade Brasileira de Pneumologia e Tisiologia. All rights reserved.

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Sars-CoV-2快速检测和两种自动免疫分析的性能评估

由于应对Covid-19大流行的紧迫性和需求，迅速开发了许多Sars-CoV-2免疫测定方法。目的:比较快速Sars-CoV-2抗体检测与高通量血清学检测的性能。方法:采用横向流动免疫分析法- Wondfo Sars-CoV-2抗体试验(WRT)和两种化学发光免疫分析法:Elecsys Anti-Sars-CoV-2 (ECLIA)和Sars-CoV-2 IgG (cia -IgG)对86份血清样本进行评估。结果:在流行病学调查血清样本评估中，血清学检测的诊断敏感性估计为:WRT 59%[95%可信区间(CI) 43.4% ~ 72.9%]， ECLIA 66.7% (51% ~ 79.4%)， CMIA-IgG 61.5%(47.1% ~ 73%)。同时，估计诊断特异性WRT为78.7% (95% CI 65.1%-88%)， ECLIA为72.3% (58.2%-83.1%)，CMIA-IgG为76.6%(74%-95.5%)。灵敏度和特异性值低于制造商声称的。虽然三种Sars-CoV-2血清学检测结果有16.2%(14/86)不一致，但kappa指数的一致程度是足够的:WRT/CMIA-IgG [0.757 (95% CI 0.615-0.899)]， WRT/ECLIA [0.715 (0.565-0.864)]， ECLIA/CMIA-IgG[0.858(0.748-0.968)]。结论:血清学检测可作为一种有用的诊断工具，但应加强对血清学检测的谨慎评估，并在正确的时间使用血清学检测。©2021巴西肺病学会。版权所有。

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来源期刊

Jornal Brasileiro de Patologia e Medicina Laboratorial Health Professions-Medical Laboratory Technology

CiteScore

1.30

自引率

0.00%

发文量

审稿时长

20 weeks

期刊介绍： The Jornal Brasileiro de Patologia e Medicina Laboratorial (Brazilian Journal of Pathology and Laboratory Medicine), a continuation of Jornal Brasileiro de Patologia (Brazilian Journal of Pathology), and published quarterly (March, June, September and December) is directed towards the publication of scientific articles that contribute to the development of the area of Laboratory Medicine (Clinical Pathology, Pathology, Cytopathology). It accepts the following categories of articles: original articles, review articles, case reports, short communications, updating articles, letters to editors and reviews.