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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
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Anterior nasal swab
Commercial Status
Commercialised
Last Update
2021-11-09 08:49:53 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
170 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % No false positives were found in 899 samples tested.
Fn
1.63 %
Precision
Evaluated
Accuracy
98.37 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.91 %
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