Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms
Point-of-care serological tests for SARS-CoV-2 have been used for COVID-19 diagnosis. However, their accuracy over time regarding the onset of symptoms is not fully understood. We aimed to assess the accuracy of a point-of-care lateral flow immunoassay (LFI). Subjects, aged over 18 years, presenting clinical symptoms suggestive of acute SARS-CoV-2 infection were tested once by both nasopharyngeal and oropharyngeal RT-PCR and LFI. The accuracy of LFI was assessed in periodic intervals of three days in relation to the onset of symptoms. The optimal cut-off point was defined as the number of days required to achieve the best sensitivity and specificity. This cut-off point was also used to compare LFI accuracy according to participants’ status: outpatient or hospitalized. In total, 959 patients were included, 379 (39.52%) tested positive for SARS-CoV-2 with RT-PCR, and 272 (28.36%) tested positive with LFI. LFI best performance was achieved after 10 days of the onset of symptoms, with sensitivity and specificity of 84.9% (95%CI: 79.8-89.1) and 94.4% (95%CI: 91.0-96.8), respectively. Although the specificity was similar (94.6% vs. 88.9%, p = 0.051), the sensitivity was higher in hospitalized patients than in outpatients (91.7% vs. 82.1%, p = 0.032) after 10 days of the onset of symptoms. Best sensitivity of point-of-care LFI was found 10 days after the onset of symptoms which may limit its use in acute care. Specificity remained high regardless of the number of days since the onset of symptoms.
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Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz
2022
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oai:scielo:S0102-311X20220001050072022-01-10Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptomsDavid,Caroline Nespolo deVarela,Fernanda HammesSartor,Ivaine Tais SauthierPolese-Bonatto,MárciaFernandes,Ingrid RodriguesZavaglia,Gabriela OliveiraKern,Luciane BeatrizFerreira,Charles FranciscoBastos,Gisele Alsina NaderPitrez,Paulo MárcioAlmeida,Walquiria Aparecida Ferreira dePorto,Victor Bertollo GomesZavascki,Alexandre PrehnStein,Renato TetelbomScotta,Marcelo Comerlato SARS-CoV-2 COVID-19 Testing Point-of-Care Testing Immunoassay Sensitivity and Specificity Point-of-care serological tests for SARS-CoV-2 have been used for COVID-19 diagnosis. However, their accuracy over time regarding the onset of symptoms is not fully understood. We aimed to assess the accuracy of a point-of-care lateral flow immunoassay (LFI). Subjects, aged over 18 years, presenting clinical symptoms suggestive of acute SARS-CoV-2 infection were tested once by both nasopharyngeal and oropharyngeal RT-PCR and LFI. The accuracy of LFI was assessed in periodic intervals of three days in relation to the onset of symptoms. The optimal cut-off point was defined as the number of days required to achieve the best sensitivity and specificity. This cut-off point was also used to compare LFI accuracy according to participants’ status: outpatient or hospitalized. In total, 959 patients were included, 379 (39.52%) tested positive for SARS-CoV-2 with RT-PCR, and 272 (28.36%) tested positive with LFI. LFI best performance was achieved after 10 days of the onset of symptoms, with sensitivity and specificity of 84.9% (95%CI: 79.8-89.1) and 94.4% (95%CI: 91.0-96.8), respectively. Although the specificity was similar (94.6% vs. 88.9%, p = 0.051), the sensitivity was higher in hospitalized patients than in outpatients (91.7% vs. 82.1%, p = 0.032) after 10 days of the onset of symptoms. Best sensitivity of point-of-care LFI was found 10 days after the onset of symptoms which may limit its use in acute care. Specificity remained high regardless of the number of days since the onset of symptoms.info:eu-repo/semantics/openAccessEscola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo CruzCadernos de Saúde Pública v.38 n.1 20222022-01-01info:eu-repo/semantics/articletext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2022000105007en10.1590/0102-311x00069921 |
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David,Caroline Nespolo de Varela,Fernanda Hammes Sartor,Ivaine Tais Sauthier Polese-Bonatto,Márcia Fernandes,Ingrid Rodrigues Zavaglia,Gabriela Oliveira Kern,Luciane Beatriz Ferreira,Charles Francisco Bastos,Gisele Alsina Nader Pitrez,Paulo Márcio Almeida,Walquiria Aparecida Ferreira de Porto,Victor Bertollo Gomes Zavascki,Alexandre Prehn Stein,Renato Tetelbom Scotta,Marcelo Comerlato |
spellingShingle |
David,Caroline Nespolo de Varela,Fernanda Hammes Sartor,Ivaine Tais Sauthier Polese-Bonatto,Márcia Fernandes,Ingrid Rodrigues Zavaglia,Gabriela Oliveira Kern,Luciane Beatriz Ferreira,Charles Francisco Bastos,Gisele Alsina Nader Pitrez,Paulo Márcio Almeida,Walquiria Aparecida Ferreira de Porto,Victor Bertollo Gomes Zavascki,Alexandre Prehn Stein,Renato Tetelbom Scotta,Marcelo Comerlato Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
author_facet |
David,Caroline Nespolo de Varela,Fernanda Hammes Sartor,Ivaine Tais Sauthier Polese-Bonatto,Márcia Fernandes,Ingrid Rodrigues Zavaglia,Gabriela Oliveira Kern,Luciane Beatriz Ferreira,Charles Francisco Bastos,Gisele Alsina Nader Pitrez,Paulo Márcio Almeida,Walquiria Aparecida Ferreira de Porto,Victor Bertollo Gomes Zavascki,Alexandre Prehn Stein,Renato Tetelbom Scotta,Marcelo Comerlato |
author_sort |
David,Caroline Nespolo de |
title |
Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
title_short |
Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
title_full |
Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
title_fullStr |
Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
title_full_unstemmed |
Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
title_sort |
diagnostic accuracy of a sars-cov-2 rapid test and optimal time for seropositivity according to the onset of symptoms |
description |
Point-of-care serological tests for SARS-CoV-2 have been used for COVID-19 diagnosis. However, their accuracy over time regarding the onset of symptoms is not fully understood. We aimed to assess the accuracy of a point-of-care lateral flow immunoassay (LFI). Subjects, aged over 18 years, presenting clinical symptoms suggestive of acute SARS-CoV-2 infection were tested once by both nasopharyngeal and oropharyngeal RT-PCR and LFI. The accuracy of LFI was assessed in periodic intervals of three days in relation to the onset of symptoms. The optimal cut-off point was defined as the number of days required to achieve the best sensitivity and specificity. This cut-off point was also used to compare LFI accuracy according to participants’ status: outpatient or hospitalized. In total, 959 patients were included, 379 (39.52%) tested positive for SARS-CoV-2 with RT-PCR, and 272 (28.36%) tested positive with LFI. LFI best performance was achieved after 10 days of the onset of symptoms, with sensitivity and specificity of 84.9% (95%CI: 79.8-89.1) and 94.4% (95%CI: 91.0-96.8), respectively. Although the specificity was similar (94.6% vs. 88.9%, p = 0.051), the sensitivity was higher in hospitalized patients than in outpatients (91.7% vs. 82.1%, p = 0.032) after 10 days of the onset of symptoms. Best sensitivity of point-of-care LFI was found 10 days after the onset of symptoms which may limit its use in acute care. Specificity remained high regardless of the number of days since the onset of symptoms. |
publisher |
Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz |
publishDate |
2022 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2022000105007 |
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