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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Variable Performance in 6 Commercial SARS-CoV-2 Antibody Assays May Affect Convalescent Plasma and Seroprevalence Screening.

Detection Principle
IgG (Beckman); Total Ab (Roche, Siemens); IgA, IgG (Euroimmun)
Testing Method Category
Testing Method
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)

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements