Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)

Manufactured by Pro-med (Beijing) Technology Co., Ltd., China - www.pmdt.com.cn 

Device identification number
2482
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other
Detection Principle
Colloidal gold
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.56 % (Nasal swab)
Fp
0.56 % (Oropharyngeal swab)
Fn
6.02 % (Nasal swab)
Fn
5.26 % (Oropharyngeal swab)
Precision
Evaluated
Accuracy
97.12 % (Nasal swab)
Accuracy
97.44 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.98 % (Nasal swab)
Clinical Sensitivity
94.74 % (Oropharyngeal swab)
Clinical Specificity
99.44 % (Nasal swab)
Clinical Specificity
99.44 % (Oropharyngeal swab)
Type of antigen
Nucleocapsid protein

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