COVID-19 Antigen Test Cassette
Manufactured by Hangzhou Dian Biotechnology Co. Ltd., China
Device identification number
2629
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Antigen Test Cassette
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
96 %
False negatives
96 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97.6 %
Clinical Specificity
98.4 %
Type of antigen
Other
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements