Wantai SARS-CoV-2 Ag Rapid Test (FIA)
Manufactured by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd - http://www.ystwt.cn/
Device identification number
1484
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
03/26/2021 08:37
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Fluorescence
LOD
5 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
96.9 % 629/649 (CI: 95.29%-98.00%)
Fn
96.6 % 168/174 (CI: 92.68%-98.41%)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Type of antigen
nucleoprotein
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