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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VTRUST COVID-19 Antigen Rapid Test TD-4531

Manufactured by TaiDoc Technology Corp., Taiwan ROC - taidoc.com/ 

Device identification number
1096
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 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
Crossreactivity
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