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Comparative Study
. 2021 Apr 20;59(5):e02596-20.
doi: 10.1128/JCM.02596-20. Print 2021 Apr 20.

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

Affiliations
Comparative Study

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

Lene H Harritshøj et al. J Clin Microbiol. .

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. 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.

Keywords: SARS-CoV-2 antibody test; anti-SARS-CoV-2 serology assay; evaluation.

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Figures

FIG 1
FIG 1
Summary ROC plot of sensitivity and false-positive rate with elliptic 95% bivariate confidence regions corresponding to the data in Table 3 for assays with total Ig, IgG, and IgM, respectively. For the IgG assays where data were available from more than one laboratory, the median result was chosen for the COVID-19 cases, and for the prepandemic blood donors, the total of all the samples was used, as these were from different persons. The vertical broken line at a false-positive rate of 0.01 corresponds to a 99% specificity. The y axis for IgM has a different scale, from 20% sensitivity instead of 70%.
FIG 2
FIG 2
Antibody development for total-Ab (IgT), IgG, and IgM as a function of days from symptom onset in 3-week periods and severity of symptoms. Assays are color coded. Multiple lines with the same color appear if the same assay was performed in different laboratories, to show the (small) interlaboratory variation.

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