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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers.

Detection Principle
IgG, IgM, IgA
Testing Method Category
Testing Method
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and University of Maryland Medical Center Enzyme Linked Immunosorbant Assay (UMMC ELISA)
Testing Method - Additional Info
evaluation of serological tests using RT-PCR tested samples
Reported Performance
Sensitivity: 100% (VITROS), 97.6% (ELISA) ; Specificity: 99.3% (VITROS), 100% (ELISA); PPA: 82.2% (VITROS), 100% (ELISA), 100% (combined) ; NPA: 100% (VITROS), 99.9% (ELISA), 100% (combined) ; Concordance: 98.8%
Sample Size
288 samples

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