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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Comparison of diagnostic accuracies of rapid serological tests and ELISA to molecular diagnostics in patients with suspected coronavirus disease 2019 presenting to the hospital

Detection Principle
Testing Method Category
Testing Method
LFAs (Boson Biotech, Cellex, Dynamiker Biotechnology, Orient Gene Biotech, Prometheus Bio and Wantai Rapid Test), ELISA (Wantai SARS-CoV-2 Ab ELISA kit), RT-PCR (CE-IVD kit GeneFinderâ„¢ COVID-19 Plus RealAmp Kit and WHO-5)
Testing Method - Additional Info
assessment of diagnostic performance of rapid LFAs compared with an ELISA and NATs in individuals with suspected COVID-19
Reported Performance
sensitivity: 43% (Orient Gene Biotech LFA), 62% (Wantai ELISA) ; specificity: 98% (both kits) ; remarks: more detailed performance data for each kits available in tables
Sample Size
228 patients

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