@article{6ce22d90d0704045939412dca7ac35fc,
title = "Head-to-head validation of six immunoassays for SARS-CoV-2 in hospitalized patients",
abstract = "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 (AllTest), 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 AllTest 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 AllTest, 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 AllTest 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 AllTest RIA that compares favorably with automated analyzer immunoassays.",
keywords = "COVID-19, ELISA, Immunoassay, SARS-CoV-2, Serology",
author = "Rens Zonneveld and Suzanne Jurriaans and {van Gool}, Tom and Hofstra, {Jorrit J.} and Hekker, {Thecla A. M.} and Pien Defoer and {Broekhuizen-van Haaften}, {Patricia E.} and Wentink-Bonnema, {Ellen M.} and Lynn Boonkamp and Teunissen, {Charlotte E.} and Heijboer, {Annemieke C.} and Frans Martens and {de Bree}, Godelieve and {van Vugt}, Michele and {van Houdt}, Robin and {van Agtmael}, M. and Algera, {A. G.} and {van Baarle}, F. and D. Bax and M. Beudel and Bogaard, {H. J.} and M. Bomers and L. Bos and M. Botta and {de Brabander}, J. and Brouwer, {M. C.} and {de Bruin}, S. and M. Bugiani and E. Bulle and O. Chouchane and A. Cloherty and P. Elbers and L. Fleuren and S. Geerlings and B. Geerts and T. Geijtenbeek and A. Girbes and A. Goorhuis and Grobusch, {M. P.} and F. Hafkamp and L. Hagens and J. Hamann and V. Harris and R. Hemke and Hermans, {S. M.} and L. Heunks and Hollmann, {M. W.} and J. Horn and Hovius, {J. W.} and R. Koning and {van Mourik}, N. and J. Nellen and F. Paulus and E. Peters and {van der Poll}, T. and B. Preckel and Prins, {J. M.} and J. Raasveld and T. Reijnders and M. Schinkel and Schultz, {M. J.} and A. Schuurman and K. Sigaloff and M. Smit and Stijnis, {C. S.} and W. Stilma and P. Thoral and A. Tsonas and {van der Valk}, M. and D. Veelo and Vlaar, {A. P. J.} and {de Vries}, H. and Wiersinga, {W. J.} and D. Wouters and {Amsterdam UMC Covid-19 Biobank} and Zwinderman, {A. H.} and {van de Beek}, D.",
note = "Publisher Copyright: {\textcopyright} 2021 The Author(s) Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = jun,
day = "1",
doi = "10.1016/j.jcv.2021.104821",
language = "English",
volume = "139",
journal = "Journal of Clinical Virology",
issn = "1386-6532",
publisher = "Elsevier",
}