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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-11-03 10:43:54 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
Crossreactivity
Evaluated
Fp
1.04 % (1.04/100)
Fn
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