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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Test Kit (colloidal gold method)

Manufactured by Guangdong Hecin Scientific Inc., China - https://www.hecin-scientific.cn/ 

Device identification number
1747
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
other pathogens tested for cross-reactivity: Influenza A H7N9,Rhinovirus C, Adenovirus(type 1,2, 4, 5, 55), Measles virus, Rotavirus, Norovirus, Haemophiluspamsuis
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
175 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
0.22 %
False negatives
2.91 %
Precision
Evaluated
Accuracy
98.28 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.09 %
Clinical Specificity
99.78 %
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