2019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing)
Manufactured by Guangdong Hecin Scientific Inc., China - https://www.hecin-scientific.cn/
Device identification number
4088
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-09-20 05:22:27 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Immunofluorescence
LOD
175 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.22 % ( (1 false positive out of 263 PCR negative samples.))
False negatives
2.91 % ((9 false negative results out of 101 PCR positive samples for Ct<=30.))
Precision
Evaluated
Accuracy
99.28 %
Robustness
Evaluated
Clinical Sensitivity
97.09 %
Clinical Specificity
99.78 %
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