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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to

Detection Principle
IgA, IgG vs N
Testing Method Category
Other Immuno assay
Testing Method
kit (Elecsys)
Testing Method - Additional Info
Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics, electrochemiluminescence), evaluated vs pseudoneutralization
Reported Performance
Sensitivity: 99.5% (>14 days post positive PCR), 85.3% (7-13 days post positive PCR), 60.2% (0-6 days post positive PCR); Specificity: 99.8% (overall), 99.81% (diagnostic samples), 99.78% (blood donor samples), 99.5% (overall in cross reactvity samples); PPA: 86.4%; NPA: 100%; overall agreement: 87.0%
Sample Size
496 samples (sensitivity), 10453 samples (specificity), 792 samples (cross reactivity)

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