2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25
Manufactured by Huachenyang (Shenzhen) Technology Co., Ltd., China - www.chenyanglobal.com
Device identification number
1748
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Other
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
50 U/ml
Crossreactivity
Evaluated
Fp
6.6 % (4 false positives out of 61 tests)
Fn
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