TY - JOUR
T1 - Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 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 - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
KW - SARS-CoV-2 antibody test
KW - anti-SARS-CoV-2 serology assay
KW - evaluation
KW - Evaluation
KW - Anti-SARS-CoV-2 serology assay
UR - http://www.scopus.com/inward/record.url?scp=85105112647&partnerID=8YFLogxK
U2 - 10.1128/JCM.02596-20
DO - 10.1128/JCM.02596-20
M3 - Journal article
C2 - 33574119
SN - 0095-1137
VL - 59
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 5
M1 - e02596-20
ER -