Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)
Manufactured by Nanjing Vazyme Medical Technology Co. Ltd., China - www.vazyme.com
Device identification number
1849
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, Nasopharyngeal 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, Cytomegalovirus (CMV), 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-2
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
2022-09-21 08:27:37 CET
Comments
Vazyme has established independent process to ensure that variants are monitored in time. Each variant listed as “variant of concern” and “variant of interest” by World Health Organization (WHO) will be studied since the date of listing. And the study procedure is as follows:
Step one: In-silico analysis
Note: In in-silico analysis, the overlap of mutation site of new variant and the epitope of antibodies used in the test will be analyzed to identify potential impact on the performance of test kit.
Step two: Validation of Limit of Detection (LOD) in form of TCID50/mL, if necessary
Step three:Clinical performance validation of Positive Percent Agreement (PPA), if necessary
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
% 0.00% (Nasal Swab) 0.22% (Nasopharyngeal Swab)
False negatives
6 % (6.00% (Nasal Swab) 5.50% (Nasopharyngeal Swab))
Precision
Evaluated
Accuracy
98.15 % (98.15% (Nasal Swab) 98.15% (Nasopharyngeal Swab))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 % (94.00% (Nasal Swab) 94.50% (Nasopharyngeal Swab))
Clinical Specificity
100 % (100.00% (Nasal Swab) 99.78% (Nasopharyngeal Swab))
Type of antigen
Nucleocapsid protein; Spike 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