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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection.

Detection Principle
Testing Method Category
Other Immuno assay
Testing Method
Biotical SARS-CoV-2 Ag card (Biotical Health, Madrid, Spain), Panbio™ COVID-19 Ag Rapid Test Device (Abbott, Chicago, IL, USA), Coronavirus Ag Rapid Test Cassette (Healgen Scientific, Houston, TX, USA), Roche SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics, Basel, Switzerland) and VITROS Immunodiagnostic Products SARS-CoV-2 Antigen test (Ortho Clinical Diagnostics, Raritan, NJ, USA)
Testing Method - Additional Info
comparison of 5 antigen tests against LightMix® (Roche Diagnostics®) Modular SARS-CoV E-gene test results
Reported Performance
Sensitivity: 66.7% (Biotical), 67.7% (Panbio), 72.9% (Healgen), 69.8% (Roche), 83.3% (Ortho) ; Specificity: 83.1% (Ortho), 91.5% (Roche), 87.7% (Healgen), 91.5% (Panbio, Biotical) ; PPV: 87.3% (Biotical), 96.6% (Panbio), 84.2% (Healgen), 96.7% (Roche), 100% (Ortho) ; NPV: 92.4% (Biotical), 93.7% (Panbio), 96.2% (Healgen), 94.4% (Roche), 100% (Ortho) ; Accuracy: 91.3% (Biotical), 94.3% (Panbio), 93% (Healgen), 94.9% (Roche), 100% (Ortho) ; Remarks: more values are available for sensitivity and specificity at different Ct values and reading times considered. More PPV, NPV and accuracy values are available at different disease prevalence %.
Sample Size
188 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