COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd., China - https://en.konsung.com/
Device identification number
2066
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-20 09:46:02 CET
Comments
Additional information is available by H&W Biotech Oy, Finland. Email: kristiina.ylihonko€care4living.fi or li.ma@healthwing.fi
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.57 % (Compared with RT-PCR: 8/175)
False negatives
0.41 % (Compared with RT-PCR: 5/1208)
Precision
Evaluated
Accuracy
99 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % ((Antigen))
Clinical Specificity
99 % ((Antigen))
Type of antigen
Nucleoprotein
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