SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method
Manufactured by Sichuan Xincheng Biological Co. Ltd., China - www.xinchengbio.com/en/
Device identification number
1659
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
15 minutes
LOD
500 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 %
False negatives
3.8 %
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.2 %
Clinical Specificity
99.5 %
Type of antigen
Nucleocapsid protein
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