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

Author:

Harritshøj Lene H.1ORCID,Gybel-Brask Mikkel1ORCID,Afzal Shoaib23,Kamstrup Pia R.2,Jørgensen Charlotte S.4,Thomsen Marianne Kragh5,Hilsted Linda6,Friis-Hansen Lennart7,Szecsi Pal B.8,Pedersen Lise8,Nielsen Lene9,Hansen Cecilie B.10,Garred Peter1011,Korsholm Trine-Line12,Mikkelsen Susan12,Nielsen Kirstine O.12,Møller Bjarne K.12,Hansen Anne T.1,Iversen Kasper K.1314,Nielsen Pernille B.1314,Hasselbalch Rasmus B.1314,Fogh Kamille1314,Norsk Jakob B.1314,Kristensen Jonas Henrik1314,Schønning Kristian15ORCID,Kirkby Nikolai S.15,Nielsen Alex C. Y.15,Landsy Lone H.16,Loftager Mette16,Holm Dorte K.17,Nilsson Anna C.17,Sækmose Susanne G.18,Grum-Schwensen Birgitte18,Aagaard Bitten19,Jensen Thøger G.2021,Nielsen Dorte M.22,Ullum Henrik11123,Dessau Ram B.22ORCID

Affiliation:

1. Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

2. Department of Clinical Biochemistry, Copenhagen University Hospital, Herlev and Gentofte Hospital, Herlev, Denmark

3. Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

4. Department of Virus & Microbiological Special Diagnostics, Statens Serum Institut, Copenhagen, Denmark

5. Department of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark

6. Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

7. Department of Clinical Biochemistry, Copenhagen University Hospital, Bispebjerg, and Frederiksberg Hospital, Copenhagen, Denmark

8. Department of Clinical Biochemistry, Holbæk Hospital, Holbæk, Denmark

9. Department of Clinical Microbiology, Copenhagen University Hospital, Herlev and Gentofte Hospital, Copenhagen, Denmark

10. Laboratory of Molecular Medicine, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

11. Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark

12. Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark

13. Department of Cardiology, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark

14. Department of Emergency Medicine, Herlev og Gentofte Hospital, University of Copenhagen, Herlev, Denmark

15. Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

16. Department of Nonclinical and Clinical Assay Sciences in Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark

17. Department of Clinical Immunology, Odense University Hospital, Odense, Denmark

18. Department of Clinical Immunology, Zealand University Hospital, Næstved Hospital, Næstved, Denmark

19. Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark

20. Department of Clinical Microbiology, Odense University Hospital, Odense, Denmark

21. Research Unit for Clinical Microbiology, Odense University Hospital, University of Southern Denmark, Odense, Denmark

22. Department of Clinical Microbiology, Zealand University Hospital, Slagelse Hospital, Slagelse, Denmark

23. Statens Serum Institut, Copenhagen, Denmark

Abstract

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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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