Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Nasal swab
Manufactured by Nanjing Vazyme Medical Technology Co. Ltd., China - www.vazyme.com
Device identification number
3107
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein, spike protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A
Pathogens detected
SARS-CoV
Type of Antigen (in case of Antigen-based)
Other
Lineages detected
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.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-05 09:31:40 CET
Comments
The product has entered the recommended list of antigen kit in German, Switzerland, French, Belgium. and have been registered in Russia, Ukraine, Indonesia, India, the Philippines, Columbia, Peru. The product has also obtained the CE 1434 certificate issued by the notified body, and has entered the recommended list of self-test antigen kit in French , Switzerland ,Belgium,Spain.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
10000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
6 %
Precision
Evaluated
Accuracy
98.15 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 %
Clinical Specificity
100 %
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