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

•Head-to-head validation of SARS-CoV-2 immunoassays remains needed.•Sensitivity of the Wantai ELISA was unparalleled by five other immunoassays.•A simple rapid immunoassay (Biozek) with off-laboratory applicability compared favorably to immunoassays for automated analyzers.•Immunoassays may help to...

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Veröffentlicht in:Journal of clinical virology 2021-06, Vol.139, p.104821-104821, Article 104821
Hauptverfasser: 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., van Agtmael, M., Algera, A.G., van Baarle, F., Bax, D., Beudel, M., Bogaard, H.J., Bomers, M., Bos, L., Botta, M., de Brabander, J., Brouwer, M.C., de Bruin, S., Bugiani, M., Bulle, E., Chouchane, O., Cloherty, A., Elbers, P., Fleuren, L., Geerlings, S., Geerts, B., Geijtenbeek, T., Girbes, A., Goorhuis, A., Grobusch, M.P., Hafkamp, F., Hagens, L., Hamann, J., Harris, V., Hemke, R., Hermans, S.M., Heunks, L., Hollmann, M.W., Horn, J., Hovius, J.W., Koning, R., van Mourik, N., Nellen, J., Paulus, F., Peters, E., van der Poll, T., Preckel, B., Prins, J.M., Raasveld, J., Reijnders, T., Schinkel, M., Schultz, M.J., Schuurman, A., Sigaloff, K., Smit, M., Stijnis, C.S., Stilma, W., Thoral, P., Tsonas, A., van der Valk, M., Veelo, D., Vlaar, A.P.J., de Vries, H., Wiersinga, W.J., Wouters, D., Zwinderman, A.H., van de Beek, D.
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Zusammenfassung:•Head-to-head validation of SARS-CoV-2 immunoassays remains needed.•Sensitivity of the Wantai ELISA was unparalleled by five other immunoassays.•A simple rapid immunoassay (Biozek) with off-laboratory applicability compared favorably to immunoassays for automated analyzers.•Immunoassays may help to diagnose COVID-19 in hospitalized patients after 10 days post symptom onset. 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. 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. 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. 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.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2021.104821