Variable Performance in 6 Commercial SARS-CoV-2 Antibody Assays May Affect Convalescent Plasma and Seroprevalence Screening.
Detection Principle
ImmunoAssay-Antibody
Target
IgG (Beckman); Total Ab (Roche, Siemens); IgA, IgG (Euroimmun)
Testing Method Category
Mixed
Testing Method
kits
Testing Method - Additional Info
6 SARS-CoV-2 antibody assays: Beckman Coulter SARS-CoV-2 IgG (AU5800 analyzer; Beckman Coulter), Roche Elecsys Anti–SARS-CoV-2 Total (ecobas 400 analyzer; Roche), Siemens SARS-CoV-2 Total (Centaur XP analyzer; Siemens-C), and Siemens SARS-CoV-2 Total Antibody (Vista 1500 analyzer; Siemens-V), Euroimmun Anti–SARS-CoV-2 IgA and Euroimmun Anti–SARS-CoV-2 IgG.
Reported Performance
Specificity : >99% (Beckman Coulter, Roche, Siemens-C, and Siemens-V), 98.9% (Euroimmun IgG), 4.6% (Euroimmun IgA); Sensitivity at >21 dpo: 84% (Beckman Coulter), 95% (Centaur), 72% (Vista), 98% (Roche), 67% (Euroimmun IgA), 84% (Euroimmun IgG); Sensitivity compared with clinical status, >14 dpo: 86% (Beckman Coulter), 95% (Siemens-C), 78% (Siemens-V), 90% (Roche), 73% (Euroimmun IgA), 96% (Euroimmun IgG); concordance between assays: 97% (Beckman Coulter), 97% (Siemens-C), 86% (Siemens-V), 85% (Roche), 82% (Euroimmun IgA), 99% (Euroimmun IgG)
Sample Size
184 samples (specificity), 154 samples (sensitivity)
Peer-reviewed
yes
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