FORA COVID-19 Antigen Rapid Test
Manufactured by TaiDoc Technology Corp., Taiwan ROC - https://taidoc.com/
Device identification number
1192
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://www.foracare.ch/covid-19-Antigen-rapid-test/; https://www.foracare.ch/wp-content/uploads/2020/11/20201104_FORA_TD-4531_Covid-19_quick-user-guide_EN_V3.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Magnetic Electrochemical
LOD
126 TCID50/ml
Clinical Sensitivity
91.3 % ((CT<30))
Clinical Specificity
98.6 %
Type of antigen
nucleocapsid recombinant Antigen
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