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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 (FIA)

Manufactured by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, China - www.ystwt.cn 

Device identification number
1484
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Lab-based, Manual, Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-11-03 10:50:06 CET
Comments
ID 1484 was deleted from RAT database, we now submit an application with new data again.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Other
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Fluorescence
LOD
60 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3 % (3/100)
Fn
7 % (7/100)
Precision
Evaluated
Accuracy
96 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
97 %
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