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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Performance of a novel diagnostic assay for rapid SARS-CoV-2 antigen detection in nasopharynx samples

Detection Principle
ImmunoAssay-Antigen
Target
not specified
Testing Method Category
 
Testing Method
kit
Testing Method - Additional Info
STANDARD F COVID-19 Ag fluorescent immunoassay (FIA) (SD Biosensor, Suwon, South Korea)
Reported Performance
PPA: 47.1% (vs RT-PCR); NPA: 98.4% (vs RT-PCR); LOD: 2 × 10^6 RNA copies/mL
Sample Size
359 samples
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