COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)
Manufactured by Jiangsu Diagnostics Biotechnology Co. Ltd., China - http://www.diagnostics-bio.com
Device identification number
1920
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
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), Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
Information on antigen epitope targeted by the antibodies used in the design of the device
Clone 1 binding site ：INTNSSP（74-80），Clone 2 binding site ：GTRNPANN（147-154）。
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Sample preparation
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
500 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
7 AU
False negatives
0 %
Precision
Evaluated
Accuracy
98.87 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.31 %
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