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. Dessau

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

71 Citations (Scopus)


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-SARSCoV-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 73days 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.

Original languageEnglish
Article numbere02596-20
JournalJournal of Clinical Microbiology
Issue number5
Number of pages11
Publication statusPublished - May 2021

Bibliographical note

Copyright © 2021 American Society for Microbiology.


  • Anti-SARS-CoV-2 serology assay
  • Evaluation
  • SARS-CoV-2 antibody test


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