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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

COVID 19 diagnostic multiplicity and its role in community surveillance and control

Detection Principle
Others
Target
N gene, E gene, S gene, RdRP, ORF1
Testing Method Category
Mixed
Testing Method
review of clinical and radiological, molecular based (laboratory based and point-of-care), Immunoassay based (ELISA, rapid antigen and antibody detection tests) and digital diagnostics (artificial intelligence based algorithms): Altona Diagnostics; BGI Health (HK) Co. Ltd; Boditech Med. Inc; DAAN Gene Co. Ltd; GeneFirst Limited; KH Medical Co. Ltd; SD Biosensor Inc.; Tip Molbiol.
Reported Performance
Altona Diagnostics: E and S genes: sensitivity 92%, specificity 100%; BGI Health (HK) Co. Ltd: ORF1 gene, N gene: sensitivity 100% both, specificity 99% and 100% respectively; Boditech Med. Inc: E gene, RdRP: sensitivity 100 % and 90% respectively, specificity 100 % both; DAAN Gene Co. Ltd: ORF1 gene, N gene: sensitivity 100% both, specificity 96% and 96% respectively; GeneFirst Limited: ORF1 gene, N gene: sensitivity 100 % and 98% respectively, specificity 99% and 100% respectively; KH Medical Co. Ltd: S gene, RdRP gene: sensitivity 100% both, specificity 100% both; SD Biosensor Inc.: E gene, ORF1 gene: sensitivity 100% both, specificity 97% and 99% respectively; Tip Molbiol: E gene: sensitivity 100%, specificity 100%.
Sample Size
/
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