COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Manufactured by Xiamen Hopegen Medical Technology Co. Ltd., China
Device identification number
1996
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
none
Assay Type
Immuno-Antigen
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colloidal gold
LOD
170 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6.8 %
False negatives
0.45 %
Precision
Evaluated
Accuracy
97.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.2 %
Clinical Specificity
99.55 %
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