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Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied....

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Autores principales: Andrey, Diego O., Cohen, Patrick, Meyer, Benjamin, Torriani, Giulia, Yerly, Sabine, Mazza, Lena, Calame, Adrien, Arm-Vernez, Isabelle, Guessous, Idris, Stringhini, Silvia, Roux-Lombard, Pascale, Fontao, Lionel, Agoritsas, Thomas, Stirnemann, Jerôme, Reny, Jean-Luc, Siegrist, Claire-Anne, Eckerle, Isabella, Kaiser, Laurent, Vuilleumier, Nicolas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463984/
https://www.ncbi.nlm.nih.gov/pubmed/32722191
http://dx.doi.org/10.3390/jcm9082369
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author Andrey, Diego O.
Cohen, Patrick
Meyer, Benjamin
Torriani, Giulia
Yerly, Sabine
Mazza, Lena
Calame, Adrien
Arm-Vernez, Isabelle
Guessous, Idris
Stringhini, Silvia
Roux-Lombard, Pascale
Fontao, Lionel
Agoritsas, Thomas
Stirnemann, Jerôme
Reny, Jean-Luc
Siegrist, Claire-Anne
Eckerle, Isabella
Kaiser, Laurent
Vuilleumier, Nicolas
author_facet Andrey, Diego O.
Cohen, Patrick
Meyer, Benjamin
Torriani, Giulia
Yerly, Sabine
Mazza, Lena
Calame, Adrien
Arm-Vernez, Isabelle
Guessous, Idris
Stringhini, Silvia
Roux-Lombard, Pascale
Fontao, Lionel
Agoritsas, Thomas
Stirnemann, Jerôme
Reny, Jean-Luc
Siegrist, Claire-Anne
Eckerle, Isabella
Kaiser, Laurent
Vuilleumier, Nicolas
author_sort Andrey, Diego O.
collection PubMed
description Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
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spelling pubmed-74639842020-09-04 Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests Andrey, Diego O. Cohen, Patrick Meyer, Benjamin Torriani, Giulia Yerly, Sabine Mazza, Lena Calame, Adrien Arm-Vernez, Isabelle Guessous, Idris Stringhini, Silvia Roux-Lombard, Pascale Fontao, Lionel Agoritsas, Thomas Stirnemann, Jerôme Reny, Jean-Luc Siegrist, Claire-Anne Eckerle, Isabella Kaiser, Laurent Vuilleumier, Nicolas J Clin Med Article Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities. MDPI 2020-07-24 /pmc/articles/PMC7463984/ /pubmed/32722191 http://dx.doi.org/10.3390/jcm9082369 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Andrey, Diego O.
Cohen, Patrick
Meyer, Benjamin
Torriani, Giulia
Yerly, Sabine
Mazza, Lena
Calame, Adrien
Arm-Vernez, Isabelle
Guessous, Idris
Stringhini, Silvia
Roux-Lombard, Pascale
Fontao, Lionel
Agoritsas, Thomas
Stirnemann, Jerôme
Reny, Jean-Luc
Siegrist, Claire-Anne
Eckerle, Isabella
Kaiser, Laurent
Vuilleumier, Nicolas
Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title_full Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title_fullStr Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title_full_unstemmed Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title_short Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
title_sort head-to-head accuracy comparison of three commercial covid-19 igm/igg serology rapid tests
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463984/
https://www.ncbi.nlm.nih.gov/pubmed/32722191
http://dx.doi.org/10.3390/jcm9082369
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