Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal)
Manufactured by Changzhou Biowin Pharmaceutical Co. Ltd., China - www.czbiowin.cn
Device identification number
2766
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Store extraction buffer at 2-30°C; Store the test cartridge at 2-30°C; After the aluminum foil bag is opened, it should be used within 15 minutes. Reagents and devices must be at room temperature (15–30 °C) when used for testing。
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
30 minutes
Detection Principle
Colloidal gold
LOD
170 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.97 %
False negatives
4.35 %
Precision
Evaluated
Accuracy
98.41 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.65 % (Antigen)
Clinical Specificity
99.03 % (Antigen)
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