Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442021000100420 |
Resumo: | 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. |
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Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassayscoronavirus infectionsserologyantibodiespoint of care testingimmunoassaybetacoronavirusABSTRACT 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.Sociedade Brasileira de Patologia Clínica2021-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442021000100420Jornal Brasileiro de Patologia e Medicina Laboratorial v.57 2021reponame:Jornal Brasileiro de Patologia e Medicina Laboratorial (Online)instname:Sociedade Brasileira de Patologia (SBP)instacron:SBP10.5935/1676-2444.20210040info:eu-repo/semantics/openAccessCastejon,Márcia J.Yamashiro,RosemeireOliveira,Elaine L.Silveira,Edilene R. P.Hong,Marisa A.Oliveira,Carmem Aparecida F.Silva,Valéria O.Ahagon,Cintia M.Lima,Ana Késia S.Lindoso,José Angelo L.Brígido,Luís Fernando M.eng2021-11-25T00:00:00Zoai:scielo:S1676-24442021000100420Revistahttp://www.scielo.br/jbpmlhttps://old.scielo.br/oai/scielo-oai.php||jbpml@sbpc.org.br1678-47741676-2444opendoar:2021-11-25T00:00Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) - Sociedade Brasileira de Patologia (SBP)false |
dc.title.none.fl_str_mv |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
title |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
spellingShingle |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays Castejon,Márcia J. coronavirus infections serology antibodies point of care testing immunoassay betacoronavirus |
title_short |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
title_full |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
title_fullStr |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
title_full_unstemmed |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
title_sort |
Performance evaluation of a Sars-CoV-2 rapid test and two automated immunoassays |
author |
Castejon,Márcia J. |
author_facet |
Castejon,Márcia J. Yamashiro,Rosemeire Oliveira,Elaine L. Silveira,Edilene R. P. Hong,Marisa A. Oliveira,Carmem Aparecida F. Silva,Valéria O. Ahagon,Cintia M. Lima,Ana Késia S. Lindoso,José Angelo L. Brígido,Luís Fernando M. |
author_role |
author |
author2 |
Yamashiro,Rosemeire Oliveira,Elaine L. Silveira,Edilene R. P. Hong,Marisa A. Oliveira,Carmem Aparecida F. Silva,Valéria O. Ahagon,Cintia M. Lima,Ana Késia S. Lindoso,José Angelo L. Brígido,Luís Fernando M. |
author2_role |
author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Castejon,Márcia J. Yamashiro,Rosemeire Oliveira,Elaine L. Silveira,Edilene R. P. Hong,Marisa A. Oliveira,Carmem Aparecida F. Silva,Valéria O. Ahagon,Cintia M. Lima,Ana Késia S. Lindoso,José Angelo L. Brígido,Luís Fernando M. |
dc.subject.por.fl_str_mv |
coronavirus infections serology antibodies point of care testing immunoassay betacoronavirus |
topic |
coronavirus infections serology antibodies point of care testing immunoassay betacoronavirus |
description |
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. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442021000100420 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442021000100420 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.5935/1676-2444.20210040 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Patologia Clínica |
publisher.none.fl_str_mv |
Sociedade Brasileira de Patologia Clínica |
dc.source.none.fl_str_mv |
Jornal Brasileiro de Patologia e Medicina Laboratorial v.57 2021 reponame:Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) instname:Sociedade Brasileira de Patologia (SBP) instacron:SBP |
instname_str |
Sociedade Brasileira de Patologia (SBP) |
instacron_str |
SBP |
institution |
SBP |
reponame_str |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
collection |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) |
repository.name.fl_str_mv |
Jornal Brasileiro de Patologia e Medicina Laboratorial (Online) - Sociedade Brasileira de Patologia (SBP) |
repository.mail.fl_str_mv |
||jbpml@sbpc.org.br |
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1752122297870712832 |