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

Autor: Márcia J. Castejon, Rosemeire Yamashiro, Elaine L. Oliveira, Edilene R. P. Silveira, Marisa A. Hong, Carmem Aparecida F. Oliveira, Valéria O. Silva, Cintia M. Ahagon, Ana Késia S. Lima, José Angelo L. Lindoso, Luís Fernando M. Brígido
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Jornal Brasileiro de Patologia e Medicina Laboratorial, Vol 57 (2021)
Druh dokumentu: article
ISSN: 1678-4774
1676-2444
DOI: 10.5935/1676-2444.20210040
Popis: ABSTRACT Introduction: 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.
Databáze: Directory of Open Access Journals
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