COVID-19 Antigen Rapid Detection Kit(Colloidal Gold)
Manufactured by Zhejiang Jiankang Biotech Co. Ltd., China
Device identification number
2675
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no
Assay Type
Immuno-Antigen
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.6 % (98.40%)
False negatives
1.89 % (98.11%)
Precision
Evaluated
Accuracy
98.31 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.07 %
Clinical Specificity
99.74 %
Type of antigen
Membrane 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