Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays
Jornal Brasileiro de Patologia e Medicina Laboratorial
; 57, 2021.
Article
in English
| Scopus | ID: covidwho-1444466
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.
Full text:
Available
Collection:
Databases of international organizations
Database:
Scopus
Type of study:
Experimental Studies
Language:
English
Journal:
Jornal Brasileiro de Patologia e Medicina Laboratorial
Year:
2021
Document Type:
Article
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