SARS-CoV-2 Antigen Rapid Test
Manufactured by Xiamen Wiz Biotech Co. Ltd., China - www.wizbiotech.com
Device identification number
1456
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
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
2022-10-17 01:04:39 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
170 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0.89 %
Precision
Evaluated
Accuracy
99.11 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
100 %
Type of antigen
nucleoprotein
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