Comparison of sixteen serological SARS-CoV-2 immunoassays in sixteen clinical laboratories

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  • Lene H Harritshøj, Københavns Universitet
  • ,
  • Mikkel Gybel-Brask, Københavns Universitet
  • ,
  • Shoaib Afzal, Københavns Universitet
  • ,
  • Pia R Kamstrup, Københavns Universitet
  • ,
  • Charlotte S Jørgensen, Statens Serum Inst, Statens Serum Institut, Dept Sexually Transmitted Dis
  • ,
  • Marianne Kragh Thomsen
  • Linda Hilsted, Københavns Universitet
  • ,
  • Lennart Friis-Hansen, Københavns Universitet
  • ,
  • Pal B Szecsi, Holbaek Hospital, Holbaek, Denmark.
  • ,
  • Lise Pedersen
  • ,
  • Lene Nielsen, Københavns Universitet
  • ,
  • Cecilie B Hansen, Københavns Universitet
  • ,
  • Peter Garred, Københavns Universitet
  • ,
  • Trine-Line Korsholm
  • Susan Mikkelsen
  • Kirstine O Nielsen
  • Bjarne K Møller
  • Anne T Hansen, Københavns Universitet
  • ,
  • Kasper K Iversen, Københavns Universitet
  • ,
  • Pernille B Nielsen, Københavns Universitet
  • ,
  • Rasmus B Hasselbalch, Københavns Universitet
  • ,
  • Kamille Fogh, Københavns Universitet
  • ,
  • Jakob B Norsk, Københavns Universitet
  • ,
  • Jonas Henrik Kristensen, Københavns Universitet
  • ,
  • Kristian Schønning, Københavns Universitet
  • ,
  • Nikolai S Kirkby, Københavns Universitet
  • ,
  • Alex C Y Nielsen, Københavns Universitet
  • ,
  • Lone H Landsy, Novo Nordisk A/S
  • ,
  • Mette Loftager, Novo Nordisk A/S
  • ,
  • Dorte K Holm, Syddansk Universitet
  • ,
  • Anna C Nilsson, Syddansk Universitet
  • ,
  • Susanne G Sækmose, Københavns Universitet
  • ,
  • Birgitte Grum-Schwensen, Innovational Counsil, Zealand University Hospital, Region Zealand
  • ,
  • Bitten Aagaard, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Thøger G Jensen, Syddansk Universitet
  • ,
  • Dorte M Nielsen, Innovational Counsil, Zealand University Hospital, Region Zealand
  • ,
  • Henrik Ullum, Københavns Universitet, Statens Serum Institut
  • ,
  • Ram B C Dessau, Innovational Counsil, Zealand University Hospital, Region Zealand

Serological SARS-CoV-2 assays are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (total-Ab) and immunoglobulin (Ig) G and M 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 fifteen commercial and one in-house anti-SARS-CoV-2 assays in sixteen 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), collected 13-73 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/LiaisonXL-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/LiaisonXL-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/ELISA-IgM showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Microbiology
Vol/bind59
Nummer5
Antal sider11
ISSN0095-1137
DOI
StatusUdgivet - apr. 2021

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