COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Manufactured by AmonMed Xiamen Biotechnology Co., Ltd., China - www.amonmed.com
Device identification number
1763
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Throat swab
Commercial Status
Commercialised
Last Update
04/16/2021 12:08
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
170 U/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.45 %
Fn
6.8 %
Accuracy
97.52 %
Reproducibility
Not evaluated
Robustness
Not 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