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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

Manufactured by Xiamen Wiz Biotech Co. Ltd., China - www.wizbiotech.com 

Device identification number
1884
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product received CE certification
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
170 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 out of 113
False negatives
0.43 % (2 out of 458)
Precision
Evaluated
Accuracy
99.65 %
Accuracy
%
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.26 %
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