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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 Detection Kit (Colloidal Gold)

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

Device identification number
2636
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Influenza A H1N1, Mumps Virus (MuV), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Rhinovirus, Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.7 (Alpha), B.1.617.2 (Delta), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
-
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other
Detection Principle
Colloidal gold
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.56 %
Fn
6.02 %
Precision
Evaluated
Accuracy
97.12 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.98 %
Clinical Specificity
99.44 %
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