COVID-19 Antigen Test Cassette
Manufactured by Hangzhou Testsea Biotechnology Co. Ltd., China - www.testsealabs.com/
Device identification number
1392
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0.1 AU
Calibration
Not evaluated
False positives
2 AU
False negatives
8 AU
Accuracy
96.5 %
Clinical Sensitivity
92.1 %
Clinical Specificity
98.1 %
Type of antigen
nucleoprotein
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