Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Viral Antigen Test Kit

Manufactured by Camtech, Singapore - covid19-test.com/ 

Device identification number
1237
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
Additional info available only upon request https://covid19-test.com/assets/Camtech_Covid19AntigenTestKit.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Fluorescence
LOD
ng/mL 100 ng/ml
Accuracy
82.4 %
Clinical Sensitivity
88.66 %
Clinical Specificity
94.55 %
Notes
Rapid diagnostic test cassette Fluorescence

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