Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

Lene H Harritshøj, Mikkel Gybel-Brask, Shoaib Afzal, Pia R Kamstrup, Charlotte S Jørgensen, Marianne Kragh Thomsen, Linda Hilsted, Lennart Friis-Hansen, Pal B Szecsi, Lise Pedersen, Lene Nielsen, Cecilie B Hansen, Peter Garred, Trine-Line Korsholm, Susan Mikkelsen, Kirstine O Nielsen, Bjarne K Møller, Anne T Hansen, Kasper K Iversen, Pernille B NielsenRasmus B Hasselbalch, Kamille Fogh, Jakob B Norsk, Jonas Henrik Kristensen, Kristian Schønning, Nikolai S Kirkby, Alex C Y Nielsen, Lone H Landsy, Mette Loftager, Dorte K Holm, Anna C Nilsson, Susanne G Sækmose, Birgitte Grum-Schwensen, Bitten Aagaard, Thøger G Jensen, Dorte M Nielsen, Henrik Ullum, Ram B C Dessau

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Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

TidsskriftJournal of Clinical Microbiology
Udgave nummer5
Tidlig onlinedato11 feb. 2021
StatusUdgivet - 20 apr. 2021


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