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Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients

BACKGROUND: Detecting SARS-CoV-2 antibodies may help to diagnose COVID-19. Head-to-head validation of different types of immunoassays in well-characterized cohorts of hospitalized patients remains needed. METHODS: We validated three chemiluminescence immunoassays (CLIAs) (Liaison, Elecsys, and Abbot...

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Autores principales: Zonneveld, Rens, Jurriaans, Suzanne, van Gool, Tom, Hofstra, Jorrit J., Hekker, Thecla A.M., Defoer, Pien, Broekhuizen-van Haaften, Patricia E., Wentink-Bonnema, Ellen M., Boonkamp, Lynn, Teunissen, Charlotte E., Heijboer, Annemieke C., Martens, Frans, de Bree, Godelieve, van Vugt, Michele, van Houdt, Robin, Schinkel, Janke, de Jong, Menno D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Author(s). Published by Elsevier B.V. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053367/
https://www.ncbi.nlm.nih.gov/pubmed/33882373
http://dx.doi.org/10.1016/j.jcv.2021.104821
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author Zonneveld, Rens
Jurriaans, Suzanne
van Gool, Tom
Hofstra, Jorrit J.
Hekker, Thecla A.M.
Defoer, Pien
Broekhuizen-van Haaften, Patricia E.
Wentink-Bonnema, Ellen M.
Boonkamp, Lynn
Teunissen, Charlotte E.
Heijboer, Annemieke C.
Martens, Frans
de Bree, Godelieve
van Vugt, Michele
van Houdt, Robin
Schinkel, Janke
de Jong, Menno D.
author_facet Zonneveld, Rens
Jurriaans, Suzanne
van Gool, Tom
Hofstra, Jorrit J.
Hekker, Thecla A.M.
Defoer, Pien
Broekhuizen-van Haaften, Patricia E.
Wentink-Bonnema, Ellen M.
Boonkamp, Lynn
Teunissen, Charlotte E.
Heijboer, Annemieke C.
Martens, Frans
de Bree, Godelieve
van Vugt, Michele
van Houdt, Robin
Schinkel, Janke
de Jong, Menno D.
author_sort Zonneveld, Rens
collection PubMed
description BACKGROUND: Detecting SARS-CoV-2 antibodies may help to diagnose COVID-19. Head-to-head validation of different types of immunoassays in well-characterized cohorts of hospitalized patients remains needed. METHODS: We validated three chemiluminescence immunoassays (CLIAs) (Liaison, Elecsys, and Abbott) and one single molecule array assay (SIMOA) (Quanterix) for automated analyzers, one rapid immunoassay RIA (Biozek), and one ELISA (Wantai) in parallel in first samples from 126 PCR confirmed COVID-19 hospitalized patients and 158 pre-COVID-19 patients. Specificity of the Biozek was also tested in 106 patients with confirmed parasitic and dengue virus infections. Specificity of the Wantai assay was not tested due to limitations in sample volumes. RESULTS: Overall sensitivity in first samples was 70.6 % for the Liaison, 71.4 % for the Elecsys, 75.4 % for the Abbott, 70.6 % for the Quanterix, 77.8 % for the Biozek, and 88.9 % for the Wantai assay, respectively. Sensitivity was between 77.4 % (Liaison) and 94.0 % (Wantai) after 10 dpso. No false positive results were observed for the Elecsys and Abbott assays. Specificity was 91.1 % for the Quanterix, 96.2 % for the Liaison, and 98.1 % for the Biozek assay, respectively. CONCLUSION: We conclude that low sensitivity of all immunoassays limits their use early after onset of illness in diagnosing COVID-19 in hospitalized patients. After 10 dpso, the Wantai ELISA has a relatively high sensitivity, followed by the point-of-care Biozek RIA that compares favorably with automated analyzer immunoassays.
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spelling pubmed-80533672021-04-19 Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients Zonneveld, Rens Jurriaans, Suzanne van Gool, Tom Hofstra, Jorrit J. Hekker, Thecla A.M. Defoer, Pien Broekhuizen-van Haaften, Patricia E. Wentink-Bonnema, Ellen M. Boonkamp, Lynn Teunissen, Charlotte E. Heijboer, Annemieke C. Martens, Frans de Bree, Godelieve van Vugt, Michele van Houdt, Robin Schinkel, Janke de Jong, Menno D. J Clin Virol Article BACKGROUND: Detecting SARS-CoV-2 antibodies may help to diagnose COVID-19. Head-to-head validation of different types of immunoassays in well-characterized cohorts of hospitalized patients remains needed. METHODS: We validated three chemiluminescence immunoassays (CLIAs) (Liaison, Elecsys, and Abbott) and one single molecule array assay (SIMOA) (Quanterix) for automated analyzers, one rapid immunoassay RIA (Biozek), and one ELISA (Wantai) in parallel in first samples from 126 PCR confirmed COVID-19 hospitalized patients and 158 pre-COVID-19 patients. Specificity of the Biozek was also tested in 106 patients with confirmed parasitic and dengue virus infections. Specificity of the Wantai assay was not tested due to limitations in sample volumes. RESULTS: Overall sensitivity in first samples was 70.6 % for the Liaison, 71.4 % for the Elecsys, 75.4 % for the Abbott, 70.6 % for the Quanterix, 77.8 % for the Biozek, and 88.9 % for the Wantai assay, respectively. Sensitivity was between 77.4 % (Liaison) and 94.0 % (Wantai) after 10 dpso. No false positive results were observed for the Elecsys and Abbott assays. Specificity was 91.1 % for the Quanterix, 96.2 % for the Liaison, and 98.1 % for the Biozek assay, respectively. CONCLUSION: We conclude that low sensitivity of all immunoassays limits their use early after onset of illness in diagnosing COVID-19 in hospitalized patients. After 10 dpso, the Wantai ELISA has a relatively high sensitivity, followed by the point-of-care Biozek RIA that compares favorably with automated analyzer immunoassays. The Author(s). Published by Elsevier B.V. 2021-06 2021-04-18 /pmc/articles/PMC8053367/ /pubmed/33882373 http://dx.doi.org/10.1016/j.jcv.2021.104821 Text en © 2021 The Author(s) Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Zonneveld, Rens
Jurriaans, Suzanne
van Gool, Tom
Hofstra, Jorrit J.
Hekker, Thecla A.M.
Defoer, Pien
Broekhuizen-van Haaften, Patricia E.
Wentink-Bonnema, Ellen M.
Boonkamp, Lynn
Teunissen, Charlotte E.
Heijboer, Annemieke C.
Martens, Frans
de Bree, Godelieve
van Vugt, Michele
van Houdt, Robin
Schinkel, Janke
de Jong, Menno D.
Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title_full Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title_fullStr Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title_full_unstemmed Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title_short Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients
title_sort head-to-head validation of six immunoassays for sars-cov-2 in hospitalized patients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053367/
https://www.ncbi.nlm.nih.gov/pubmed/33882373
http://dx.doi.org/10.1016/j.jcv.2021.104821
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