Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)
Manufactured by Avioq Bio-Tech Co. Ltd., China - www.avioqbio.com
Device identification number
1972
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-09-20 02:57:20 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
300 TCID50/ml
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.44 %
False negatives
6.36 %
Precision
Evaluated
Accuracy
98.41 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.64 %
Clinical Specificity
99.56 %
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