Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients
Background: Commercial availability of serological tests to evaluate immunoglobulins (Ig) targeting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has grown exponentially since the start of the coronavirus disease 2019 (COVID-19) outbreak. Thorough validation of these tests is importan...
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Elsevier
2021-03-01
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Series: | International Journal of Infectious Diseases |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221000497 |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
C. Serre-Miranda C. Nobrega S. Roque J. Canto-Gomes C.S. Silva N. Vieira P. Barreira-Silva P. Alves-Peixoto J. Cotter A. Reis M. Formigo H. Sarmento O. Pires A. Carvalho D.Y. Petrovykh L. Diéguez J.C. Sousa N. Sousa C. Capela J.A. Palha P.G. Cunha M. Correia-Neves |
spellingShingle |
C. Serre-Miranda C. Nobrega S. Roque J. Canto-Gomes C.S. Silva N. Vieira P. Barreira-Silva P. Alves-Peixoto J. Cotter A. Reis M. Formigo H. Sarmento O. Pires A. Carvalho D.Y. Petrovykh L. Diéguez J.C. Sousa N. Sousa C. Capela J.A. Palha P.G. Cunha M. Correia-Neves Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients International Journal of Infectious Diseases COVID-19 Serological tests Qualitative and semiquantitative tests Sensitivity Specificity Clinical presentation |
author_facet |
C. Serre-Miranda C. Nobrega S. Roque J. Canto-Gomes C.S. Silva N. Vieira P. Barreira-Silva P. Alves-Peixoto J. Cotter A. Reis M. Formigo H. Sarmento O. Pires A. Carvalho D.Y. Petrovykh L. Diéguez J.C. Sousa N. Sousa C. Capela J.A. Palha P.G. Cunha M. Correia-Neves |
author_sort |
C. Serre-Miranda |
title |
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients |
title_short |
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients |
title_full |
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients |
title_fullStr |
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients |
title_full_unstemmed |
Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients |
title_sort |
performance assessment of 11 commercial serological tests for sars-cov-2 on hospitalised covid-19 patients |
publisher |
Elsevier |
series |
International Journal of Infectious Diseases |
issn |
1201-9712 |
publishDate |
2021-03-01 |
description |
Background: Commercial availability of serological tests to evaluate immunoglobulins (Ig) targeting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has grown exponentially since the start of the coronavirus disease 2019 (COVID-19) outbreak. Thorough validation of these tests is important before use as epidemiological tools to infer seroprevalence in specific populations and as diagnostic tools to complement molecular approaches (e.g., quantitative reverse transcription-polymerase chain reaction). Methods: Commercial serological tests from 11 suppliers were assayed side-by-side using 126 samples from SARS-CoV-2-infected inpatients and 36 from healthy and HIV-infected individuals. Results: The majority of the tests assayed have >95% specificity. For the sensitivity calculation, samples were stratified by days since symptoms onset; sensitivity peaks at 16–21 days for IgM and IgA (maximum 91.2%, Euroimmun) and, dependant on the test, at 16–21 or >21 days for IgG (maximum 94.1%, Snibe). Data from semiquantitative tests show that patients with a severe clinical presentation have lower levels of Ig targeting SARS-CoV-2 at <10 days since symptoms onset and higher levels at >21 days, compared to patients with a non-severe presentation. Conclusions: This study highlights the heterogeneity of sensitivity and generally high specificity of the serological tests and establishes a basis for their usefulness to complement diagnostic techniques and population seroprevalence studies. |
topic |
COVID-19 Serological tests Qualitative and semiquantitative tests Sensitivity Specificity Clinical presentation |
url |
http://www.sciencedirect.com/science/article/pii/S1201971221000497 |
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doaj-373e59ce2e3d40daafceae1ffd0a5bf52021-03-27T04:26:00ZengElsevierInternational Journal of Infectious Diseases1201-97122021-03-01104661669Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patientsC. Serre-Miranda0C. Nobrega1S. Roque2J. Canto-Gomes3C.S. Silva4N. Vieira5P. Barreira-Silva6P. Alves-Peixoto7J. Cotter8A. Reis9M. Formigo10H. Sarmento11O. Pires12A. Carvalho13D.Y. Petrovykh14L. Diéguez15J.C. Sousa16N. Sousa17C. Capela18J.A. Palha19P.G. Cunha20M. Correia-Neves21Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Center for the Research and Treatment of Arterial Hypertension and Cardiovascular Risk, Internal Medicine Department, Senhora da Oliveira Hospital, Guimarães, PortugalCenter for the Research and Treatment of Arterial Hypertension and Cardiovascular Risk, Internal Medicine Department, Senhora da Oliveira Hospital, Guimarães, PortugalCenter for the Research and Treatment of Arterial Hypertension and Cardiovascular Risk, Internal Medicine Department, Senhora da Oliveira Hospital, Guimarães, PortugalCenter for the Research and Treatment of Arterial Hypertension and Cardiovascular Risk, Internal Medicine Department, Senhora da Oliveira Hospital, Guimarães, PortugalHospital of Braga, Braga, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Hospital of Braga, Braga, PortugalInternational Iberian Nanotechnology Laboratory (INL), Braga, PortugalInternational Iberian Nanotechnology Laboratory (INL), Braga, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Clinical Academic Center, Braga, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Hospital of Braga, Braga, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Clinical Academic Center, Braga, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Center for the Research and Treatment of Arterial Hypertension and Cardiovascular Risk, Internal Medicine Department, Senhora da Oliveira Hospital, Guimarães, PortugalLife and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; ICVS/3B’s-PT Government Associate Laboratory, Braga/Guimarães, Portugal; Clinical Academic Center, Braga, Portugal; Corresponding author at: Life and Health Sciences Research Institute, School of Medicine, University of Minho, Campus de Gualtar, 4710-057 Braga, Portugal.Background: Commercial availability of serological tests to evaluate immunoglobulins (Ig) targeting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has grown exponentially since the start of the coronavirus disease 2019 (COVID-19) outbreak. Thorough validation of these tests is important before use as epidemiological tools to infer seroprevalence in specific populations and as diagnostic tools to complement molecular approaches (e.g., quantitative reverse transcription-polymerase chain reaction). Methods: Commercial serological tests from 11 suppliers were assayed side-by-side using 126 samples from SARS-CoV-2-infected inpatients and 36 from healthy and HIV-infected individuals. Results: The majority of the tests assayed have >95% specificity. For the sensitivity calculation, samples were stratified by days since symptoms onset; sensitivity peaks at 16–21 days for IgM and IgA (maximum 91.2%, Euroimmun) and, dependant on the test, at 16–21 or >21 days for IgG (maximum 94.1%, Snibe). Data from semiquantitative tests show that patients with a severe clinical presentation have lower levels of Ig targeting SARS-CoV-2 at <10 days since symptoms onset and higher levels at >21 days, compared to patients with a non-severe presentation. Conclusions: This study highlights the heterogeneity of sensitivity and generally high specificity of the serological tests and establishes a basis for their usefulness to complement diagnostic techniques and population seroprevalence studies.http://www.sciencedirect.com/science/article/pii/S1201971221000497COVID-19Serological testsQualitative and semiquantitative testsSensitivitySpecificityClinical presentation |