SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method
Manufactured by Sichuan Xincheng Biological Co. Ltd., China - www.xinchengbio.com/en/
Device identification number
1660
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Latex
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
500 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.95 %
False negatives
5.7 %
Precision
Evaluated
Accuracy
96.9 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.2 % ((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