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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

Manufactured by Xiamen AmonMed Biotechnology Co. Ltd., China - www.amonmed.com 

Device identification number
1763
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, 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
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
500 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.45 %
False negatives
1.98 %
Accuracy
99.07 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.02 %
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