TY - JOUR
T1 - Comparison of sixteen serological SARS-CoV-2 immunoassays in sixteen clinical laboratories
AU - Harritshøj, Lene H
AU - Gybel-Brask, Mikkel
AU - Afzal, Shoaib
AU - Kamstrup, Pia R
AU - Jørgensen, Charlotte S
AU - Thomsen, Marianne Kragh
AU - Hilsted, Linda
AU - Friis-Hansen, Lennart
AU - Szecsi, Pal B
AU - Pedersen, Lise
AU - Nielsen, Lene
AU - Hansen, Cecilie B
AU - Garred, Peter
AU - Korsholm, Trine-Line
AU - Mikkelsen, Susan
AU - Nielsen, Kirstine O
AU - Møller, Bjarne K
AU - Hansen, Anne T
AU - Iversen, Kasper K
AU - Nielsen, Pernille B
AU - Hasselbalch, Rasmus B
AU - Fogh, Kamille
AU - Norsk, Jakob B
AU - Kristensen, Jonas Henrik
AU - Schønning, Kristian
AU - Kirkby, Nikolai S
AU - Nielsen, Alex C Y
AU - Landsy, Lone H
AU - Loftager, Mette
AU - Holm, Dorte K
AU - Nilsson, Anna C
AU - Sækmose, Susanne G
AU - Grum-Schwensen, Birgitte
AU - Aagaard, Bitten
AU - Jensen, Thøger G
AU - Nielsen, Dorte M
AU - Ullum, Henrik
AU - Dessau, Ram B C
N1 - Copyright © 2021 American Society for Microbiology.
PY - 2021/2/11
Y1 - 2021/2/11
N2 - 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.
AB - 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.
U2 - 10.1128/JCM.02596-20
DO - 10.1128/JCM.02596-20
M3 - Journal article
C2 - 33574119
VL - 59
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
SN - 0095-1137
IS - 5
M1 - e02596-20
ER -