SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method
Manufactured by Sichuan Xincheng Biological Co., LTD - http://www.xinchengbio.com/en/
Device identification number
1659
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
03/25/2021 08:31
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Fluorescence
LOD
500 AU 500
Calibration
evaluated
Crossreactivity
evaluated
Fp
0.47 %
Fn
3.8 %
Precision
evaluated
Accuracy
98 % (Antigen)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96.2 % (Antigen)
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