2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)
Manufactured by Guangdong Hecin Scientific Inc., China - https://www.hecin-scientific.cn/
Device identification number
1809
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
2 AU
Precision
Evaluated
Accuracy
98.51 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.23 %
Clinical Specificity
99.07 %
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