Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies

Autores
Jacobsen, Dario Gustavo; Gonzalez, D.; Jamardo, J.; Ibar, C.; Pugliese, L.; Fortuna, F.; Carrizo, E.; Caro, E. M.; Perazzi, Beatriz Elizabeth; Repetto, Esteban Martín; Reboredo, G.; Fabre, B.
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Evaluating the clinical performance of available methods to detect antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has become a primordial issue in clinical laboratories. The aim of this study was to evaluate the clinical performance of two methods for SARS-CoV-2 antibodies detection, an automated Chemiluminescent Immunoassay (CLIA) and an immunochromatographic Lateral-Flow Assay (LFA) in patients with positive reverse transcription polymerase chain reaction (RT-PCR). Performance for CLIA method was Positive Agreement (PA) 56.6% and Negative Agreement (NA) 96,6% for IgM and PA 85.8%/NA 90,2% for IgG. Performance for LFA method was PA 56.2% and NA 100% for IgM and PA 95.5% and NA 100 % for IgG. LFA general agreement IgG was better than CLIA. In both methods, significant differences in Kappa index are observed when IgG and IgM are compared. When evaluating the data from a clinical perspective, we found that both method performance for IgM detection may not meet the expected requirements for their clinical utility and could lead to an inappropriate medical decision. The findings of this study show that both immunoassay methods might be reliable for assessing immunological response in COVID-19 patients. Our results also confirm that IgG measurement could be helpful, especially for epidemiological studies in our population. These results provide evidence to justify epidemiological studies in our population.
Fil: Jacobsen, Dario Gustavo. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Gonzalez, D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Jamardo, J.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Ibar, C.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Pugliese, L.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Fortuna, F.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Carrizo, E.. Coordinadora de Salud Misionar; Argentina
Fil: Caro, E. M.. Laboratorio Biogenar; Argentina
Fil: Perazzi, Beatriz Elizabeth. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Repetto, Esteban Martín. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Reboredo, G.. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina
Fil: Fabre, B.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Materia
Clinical Performance
SARS-CoV-2
COVID-19
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/149842
Acceder
id CONICETDig_bbabad6a759b6fd5329c45051180b30c
oai_identifier_str oai:ri.conicet.gov.ar:11336/149842
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 AntibodiesJacobsen, Dario GustavoGonzalez, D.Jamardo, J.Ibar, C.Pugliese, L.Fortuna, F.Carrizo, E.Caro, E. M.Perazzi, Beatriz ElizabethRepetto, Esteban MartínReboredo, G.Fabre, B.Clinical PerformanceSARS-CoV-2COVID-19https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Evaluating the clinical performance of available methods to detect antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has become a primordial issue in clinical laboratories. The aim of this study was to evaluate the clinical performance of two methods for SARS-CoV-2 antibodies detection, an automated Chemiluminescent Immunoassay (CLIA) and an immunochromatographic Lateral-Flow Assay (LFA) in patients with positive reverse transcription polymerase chain reaction (RT-PCR). Performance for CLIA method was Positive Agreement (PA) 56.6% and Negative Agreement (NA) 96,6% for IgM and PA 85.8%/NA 90,2% for IgG. Performance for LFA method was PA 56.2% and NA 100% for IgM and PA 95.5% and NA 100 % for IgG. LFA general agreement IgG was better than CLIA. In both methods, significant differences in Kappa index are observed when IgG and IgM are compared. When evaluating the data from a clinical perspective, we found that both method performance for IgM detection may not meet the expected requirements for their clinical utility and could lead to an inappropriate medical decision. The findings of this study show that both immunoassay methods might be reliable for assessing immunological response in COVID-19 patients. Our results also confirm that IgG measurement could be helpful, especially for epidemiological studies in our population. These results provide evidence to justify epidemiological studies in our population.Fil: Jacobsen, Dario Gustavo. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; ArgentinaFil: Gonzalez, D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; ArgentinaFil: Jamardo, J.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; ArgentinaFil: Ibar, C.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; ArgentinaFil: Pugliese, L.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; ArgentinaFil: Fortuna, F.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; ArgentinaFil: Carrizo, E.. Coordinadora de Salud Misionar; ArgentinaFil: Caro, E. M.. Laboratorio Biogenar; ArgentinaFil: Perazzi, Beatriz Elizabeth. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; ArgentinaFil: Repetto, Esteban Martín. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Reboredo, G.. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; ArgentinaFil: Fabre, B.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; ArgentinaAustin Publishing Group2021-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/149842Jacobsen, Dario Gustavo; Gonzalez, D.; Jamardo, J.; Ibar, C.; Pugliese, L.; et al.; Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies; Austin Publishing Group; Journal of Immune Research; 7; 2; 5-2021; 1-32471-0261CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://austinpublishinggroup.com/immune-research/fulltext/immunes-v7-id1040.phpinfo:eu-repo/semantics/altIdentifier/doi/10.26420/jimmunres.2021.1040info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T15:08:31Zoai:ri.conicet.gov.ar:11336/149842instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 15:08:31.639CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
title Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
spellingShingle Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
Jacobsen, Dario Gustavo
Clinical Performance
SARS-CoV-2
COVID-19
title_short Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
title_full Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
title_fullStr Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
title_full_unstemmed Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
title_sort Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies
dc.creator.none.fl_str_mv Jacobsen, Dario Gustavo
Gonzalez, D.
Jamardo, J.
Ibar, C.
Pugliese, L.
Fortuna, F.
Carrizo, E.
Caro, E. M.
Perazzi, Beatriz Elizabeth
Repetto, Esteban Martín
Reboredo, G.
Fabre, B.
author Jacobsen, Dario Gustavo
author_facet Jacobsen, Dario Gustavo
Gonzalez, D.
Jamardo, J.
Ibar, C.
Pugliese, L.
Fortuna, F.
Carrizo, E.
Caro, E. M.
Perazzi, Beatriz Elizabeth
Repetto, Esteban Martín
Reboredo, G.
Fabre, B.
author_role author
author2 Gonzalez, D.
Jamardo, J.
Ibar, C.
Pugliese, L.
Fortuna, F.
Carrizo, E.
Caro, E. M.
Perazzi, Beatriz Elizabeth
Repetto, Esteban Martín
Reboredo, G.
Fabre, B.
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Clinical Performance
SARS-CoV-2
COVID-19
topic Clinical Performance
SARS-CoV-2
COVID-19
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Evaluating the clinical performance of available methods to detect antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has become a primordial issue in clinical laboratories. The aim of this study was to evaluate the clinical performance of two methods for SARS-CoV-2 antibodies detection, an automated Chemiluminescent Immunoassay (CLIA) and an immunochromatographic Lateral-Flow Assay (LFA) in patients with positive reverse transcription polymerase chain reaction (RT-PCR). Performance for CLIA method was Positive Agreement (PA) 56.6% and Negative Agreement (NA) 96,6% for IgM and PA 85.8%/NA 90,2% for IgG. Performance for LFA method was PA 56.2% and NA 100% for IgM and PA 95.5% and NA 100 % for IgG. LFA general agreement IgG was better than CLIA. In both methods, significant differences in Kappa index are observed when IgG and IgM are compared. When evaluating the data from a clinical perspective, we found that both method performance for IgM detection may not meet the expected requirements for their clinical utility and could lead to an inappropriate medical decision. The findings of this study show that both immunoassay methods might be reliable for assessing immunological response in COVID-19 patients. Our results also confirm that IgG measurement could be helpful, especially for epidemiological studies in our population. These results provide evidence to justify epidemiological studies in our population.
Fil: Jacobsen, Dario Gustavo. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Gonzalez, D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Jamardo, J.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Ibar, C.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Pugliese, L.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Fortuna, F.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina
Fil: Carrizo, E.. Coordinadora de Salud Misionar; Argentina
Fil: Caro, E. M.. Laboratorio Biogenar; Argentina
Fil: Perazzi, Beatriz Elizabeth. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Repetto, Esteban Martín. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Reboredo, G.. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina
Fil: Fabre, B.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Bioquímica Clínica; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
description Evaluating the clinical performance of available methods to detect antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has become a primordial issue in clinical laboratories. The aim of this study was to evaluate the clinical performance of two methods for SARS-CoV-2 antibodies detection, an automated Chemiluminescent Immunoassay (CLIA) and an immunochromatographic Lateral-Flow Assay (LFA) in patients with positive reverse transcription polymerase chain reaction (RT-PCR). Performance for CLIA method was Positive Agreement (PA) 56.6% and Negative Agreement (NA) 96,6% for IgM and PA 85.8%/NA 90,2% for IgG. Performance for LFA method was PA 56.2% and NA 100% for IgM and PA 95.5% and NA 100 % for IgG. LFA general agreement IgG was better than CLIA. In both methods, significant differences in Kappa index are observed when IgG and IgM are compared. When evaluating the data from a clinical perspective, we found that both method performance for IgM detection may not meet the expected requirements for their clinical utility and could lead to an inappropriate medical decision. The findings of this study show that both immunoassay methods might be reliable for assessing immunological response in COVID-19 patients. Our results also confirm that IgG measurement could be helpful, especially for epidemiological studies in our population. These results provide evidence to justify epidemiological studies in our population.
publishDate 2021
dc.date.none.fl_str_mv 2021-05
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/149842
Jacobsen, Dario Gustavo; Gonzalez, D.; Jamardo, J.; Ibar, C.; Pugliese, L.; et al.; Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies; Austin Publishing Group; Journal of Immune Research; 7; 2; 5-2021; 1-3
2471-0261
CONICET Digital
CONICET
url http://hdl.handle.net/11336/149842
identifier_str_mv Jacobsen, Dario Gustavo; Gonzalez, D.; Jamardo, J.; Ibar, C.; Pugliese, L.; et al.; Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies; Austin Publishing Group; Journal of Immune Research; 7; 2; 5-2021; 1-3
2471-0261
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://austinpublishinggroup.com/immune-research/fulltext/immunes-v7-id1040.php
info:eu-repo/semantics/altIdentifier/doi/10.26420/jimmunres.2021.1040
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Austin Publishing Group
publisher.none.fl_str_mv Austin Publishing Group
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.221938

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