COVID-19 Antigen Detection Kit
Manufactured by New Gene (Hangzhou) Bioengineering Co., Ltd, China - www.new-gene.net/
Device identification number
1501
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:23:34 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Chromatography
Time
30 minutes
LOD
0.05 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
2 %
Fn
0.9 %
Precision
evaluated
Accuracy
98.3 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
98 %
Type of antigen
nucleocapside
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