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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2

Detection Principle
ImmunoAssay-Antigen
Target
nucleoprotein
Testing Method Category
 
Testing Method
kit
Testing Method - Additional Info
STANDARD Q COVID-19 Ag (SD-Biosensor, RELAB, I)
Reported Performance
Sensitivity: 70.6% (vs RT-PCR), 72.1% (diagnostic samples), 40% (screening samples); specificity: 100%; NPV: 87.4% (Vs RT-PCR); PPV: 100% (vs RT-PCR); concordance with RT-PCR: 90.3%
Sample Size
330 patients
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