2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25
Manufactured by Huachenyang (Shenzhen) Technology Co. Ltd., China - https://www.chenyanglobal.com
Device identification number
1748
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
50 U/ml
Analysis of cross reactivity
Evaluated
False positives
6.6 % (4 false positives out of 61 tests)
False negatives
0.22 % (1 false negatives out of 449 tests)
Precision
Evaluated
Accuracy
99.02 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.67 %
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