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

Rens Zonneveld,Charlotte E Teunissen,Suzanne Jurriaans,Patricia E Broekhuizen-Van Haaften,Lynn Boonkamp,Pien Defoer,Janke Schinkel,Robin Van Houdt,Menno D De Jong,Jorrit J Hofstra,Annemieke C Heijboer,Tom Van Gool,Bart F Geerts ,Anissa M Tsonas ,Harm Jan Bogaard ,Joppe W Hovius ,Lucas M Fleuren ,Osoul Chouchane ,Patrick Thoral ,Suzanne E Geerlings ,Marianna Bugiani ,Janneke Horn ,Anne Geke Algera ,T.b.h Geijtenbeek ,Esther Bulle ,Marije K Bomers ,Heder De Vries ,Frederique Paulus ,Justin De Brabander ,Alex Cloherty ,Paul Elbers ,Martin P Grobusch ,Laura A Hagens ,Marc Van Der Valk ,Niels Van Mourik ,Sabine Hermans ,Frank Van Baarle ,Benedikt Preckel ,Michela Botta ,Kim C.e Sigaloff ,Marcus J Schultz ,T A M Hekker ,Matthijs C Brouwer ,Sanne De Bruin ,Rosaline De Koning ,A H Zwinderman ,Jörg Hamann ,Jan M Prins ,Martijn Beudel ,Robert Hemke ,Dorien Wouters ,Vanessa Harris ,Abraham Goorhuis ,W Joost Wiersinga ,Michiel Schinkel ,Alex R Schuurman ,Markus W Hollmann ,Marry R Smit ,Michèle Van Vugt ,Jorinde Raasveld ,Michiel A Van Agtmael ,Denise P Veelo ,Tom D Y Reijnders ,Willemke Stilma ,Leo Heunks ,Godelieve De Bree ,Florianne Hafkamp ,Edgar J.g Peters ,Frans Martens ,Tom Van Der Poll ,Diane Bax ,Jeaninne Nellen ,Cornelis Stijnis ,Armand R.j Girbes ,Alexander P.j Vlaar ,Lieuwe D J Bos ,Ellen Wentink-Bonnema ,Diederik Van De Beek

doi:10.1016/j.jcv.2021.104821

Rens Zonneveld, Charlotte E Teunissen + Show 76 more

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https://doi.org/10.1016/j.jcv.2021.104821

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Abstract

BackgroundDetecting 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.MethodsWe 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.ResultsOverall 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.ConclusionWe 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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