Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays
| Autor: | M A Hong, Ana Kesia de Souza Lima, Luís Fernando de Macedo Brígido, Cintia Mayumi Ahagon, Elaine L. Oliveira, Rosemeire Yamashiro, Edilene R. P. Silveira, Valeria Oliveira Silva, Márcia Jorge Castejon, José Angelo Lauletta Lindoso, Carmem Aparecida de Freitas Oliveira |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical Biochemistry serology Diagnostic Specificity Gastroenterology Pathology and Forensic Medicine Serology Kappa index coronavirus infections Internal medicine Pathology medicine RB1-214 antibodies immunoassay point of care testing business.industry Serum samples betacoronavirus Confidence interval Medical Laboratory Technology business Lateral flow immunoassay |
| Zdroj: | Jornal Brasileiro de Patologia e Medicina Laboratorial v.57 2021 Jornal Brasileiro de Patologia e Medicina Laboratorial Sociedade Brasileira de Patologia (SBP) instacron:SBP Jornal Brasileiro de Patologia e Medicina Laboratorial, Vol 57 (2021) |
| ISSN: | 1676-2444 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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