CAT
Manufactured by Oncosem Onkolojik Sistemler San. ve Tic. A.S., Turkey - www.oncosem.com
Device identification number
1199
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://oncosem.com/cat/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0.01 AU
False positives
6.25 % (out of 32 confirmed positive people 2 of them were diagnosed as negative 30 of them succesful)
False negatives
1.96 % (out of 204 confirmed negative people 4 of them were diagnesed as positive 200 of them succesful)
Accuracy
97.46 %
Clinical Sensitivity
93.75 %
Clinical Specificity
98.04 %
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