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 (RAT)
×No
Format
Lab-based, Manual, Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal 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
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
Analysis of cross reactivity
Evaluated
False positives
3 % (3/100)
False negatives
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