Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories.
Сравнительное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Harritshøj Lene H, Gybel-Brask Mikkel, Afzal Shoaib, Kamstrup Pia R, Jørgensen Charlotte S, Thomsen Marianne Kragh, Hilsted Linda, Friis-Hansen Lennart, Szecsi Pal B, Pedersen Lise, Nielsen Lene, Hansen Cecilie B, Garred Peter, Korsholm Trine-Line, Mikkelsen Susan, Nielsen Kirstine O, Møller Bjarne K, Hansen Anne T, Iversen Kasper K, Nielsen Pernille B, Hasselbalch Rasmus B, Fogh Kamille, Norsk Jakob B, Kristensen Jonas Henrik, Schønning Kristian, Kirkby Nikolai S, Nielsen Alex C Y, Landsy Lone H, Loftager Mette, Holm Dorte K, Nilsson Anna C, Sækmose Susanne G, Grum-Schwensen Birgitte, Aagaard Bitten, Jensen Thøger G, Nielsen Dorte M, Ullum Henrik, Dessau Ram B
Аннотация
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.