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
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.56 % (Nasal swab)
False positives
0.56 % (Oropharyngeal swab)
False negatives
6.02 % (Nasal swab)
False negatives
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