Comparison of the Clinical Performances of the Abbott Alinity IgG, Abbott Architect IgM, and Roche Elecsys Total SARS-CoV-2 Antibody Assays.

Journal of Clinical Microbiology
Kellisha Harley, Ian L Gunsolus

Abstract

Critical evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays is needed to guide clinical decision-making and ensure that these assays provide optimal benefit to patients and the public. Here, three commercially available assays with widespread distribution capabilities are compared. A total of 667 specimens, 103 from patients with confirmed SARS-CoV-2 infections and 564 collected prior to the emergence of SARS-CoV-2, were analyzed in parallel using the Roche Elecsys SARS-CoV-2 total antibody and Abbott Alinity SARS-CoV-2 IgG assays; a subset of 55 samples from patients with confirmed SARS-CoV-2 infections was additionally evaluated using the Abbott Architect SARS-CoV-2 IgM assay. Qualitative agreement between the Abbott IgG and Roche total antibody assays was 98.7% (658/667), with Cohen's kappa value of 0.919 (95% confidence interval [CI], 0.867 to 0.972). Qualitative agreements with the Abbott IgM assay were 92.7% (51/55, Abbott IgG) and 85.5% (47/55, Roche total antibody). Diagnostic specificities determined using pre-COVID-19 samples for the Abbott IgG and Roche total antibody assays were 99.65% (95% CI, 98.72 to 99.90%) and 100.00% (95% CI, 99.32 to 100.00%), respectively, spanning cl...Continue Reading

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Citations

Mar 8, 2021·Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi·Yi-Chun LinPo-Ren Hsueh
Mar 13, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Mario PoljakKatja Seme
Apr 4, 2021·Microorganisms·Kirsten Alexandra EberhardtVeronica Di Cristanziano
Apr 11, 2021·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·Mario PoljakTatjana Avšič Županc
Apr 18, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Katarina Resman RusMario Poljak
Jun 20, 2021·The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation·Saima AslamMandeep R Mehra
Mar 25, 2021·Clinical Chemistry·Y Victoria ZhangUNKNOWN AACC COVID 19 Serologic Testing Task Force

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