WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold)
Manufactured by Beijing Wantai Biological Pharmacy Enterprise Co. Ltd., China - www.ystwt.cn
Device identification number
1485
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We removed saliva from the specimen types.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
137 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.04 % (1.04/100)
False negatives
6.78 % (6.78/100)
Precision
Evaluated
Accuracy
97.06 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.22 %
Clinical Specificity
98.96 %
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