VTRUST COVID-19 Antigen Rapid Test TD-4531
Manufactured by TaiDoc Technology Corp., Taiwan ROC - https://taidoc.com/
Device identification number
1096
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://taidoc.com/covid-19-Antigen-rapid-test-td-4531/; https://taidoc.com/wp-content/uploads/2020/08/Covid-19-Antigen-rapid-test.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
126 TCID50/ml
Analysis of cross reactivity
0% for virus, microorganisms and negatives matrices tested; Evaluated
Clinical Sensitivity
93.1 %
Clinical Specificity
99.6 %
Type of antigen
nucleocapsid recombinant Antigen (NP)
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