COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography)
Manufactured by Shenzhen Kingfocus Biomedical Engineering Co. Ltd., China - www.king-focus.com
Device identification number
2941
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated, Manual
Physical Support
Card
Target type
Antigen, IgG, IgM
Targets
nucleocapsid protein, ORF1ab polyprotein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
The kit adopts the principle of double antibody sandwich method with two highly specific and sensitive novel coronavirus (SARS-CoV-2) monoclonal antibodies, of which monoclonal antibody I is a Quantum Dots labeled antibody fixed on a binding pad for detecting antigen; monoclonal antibody II is a capture antibody encapsulated on a chromatography membrane to form a detection line (T line). To monitor the validity of the test paper, a quality control line (C line) is set. The quality control area is encapsulated with rabbit anti-mouse IgG, which can directly bind to the Quantum Dots-labeled monoclonal antibody I.
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Please be updated the Rapid antigen tests with CE Marking.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
Fluorescence
LOD
0.1 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (99.00%)
False negatives
6.67 % (93.33%)
Precision
Evaluated
Accuracy
95.38 %
Robustness
Evaluated
Clinical Sensitivity
90.83 %
Clinical Specificity
99.28 %
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