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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Analytical and Clinical Evaluation of the Automated Elecsys Anti-SARS-CoV-2 Antibody Assay on the Roche cobas e602 Analyzer

DOI
10.1093/ajcp/aqaa155 
Detection Principle
ImmunoAssay-Antibody
Target
IgA/IgG
Testing Method Category
 
Testing Method
Kit
Testing Method - Additional Info
Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) vs Euroimmun IgA/IgG
Reported Performance
Sensitivity: 95% (>14 days post positive PCR), 77.5% (0-13 days post positive PCR); specificity: 100%; Concordance with ELISA: 100%; PPV: 100%; NPV: 98.83%; accuracy: 98.88 (0-13 days post positive PCR), 99.74% (>14 days post positive PCR)
Sample Size
66 samples (method comparison) & 77 samples (cross reactivity) & 78 samples (clinical performance)
Peer-reviewed
yes

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