Dejavu COVİD-19 Antigen Rapit test (nazofaringeal/ orafaringel swap)
Manufactured by Dejavu Medikal San. Tic.Ldt.Åžti, Turkey - www.dejavumedikal.com
Device identification number
2453
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is used for in vitro diagnostic test for the qualitative detection of the antigen of SARS-CoV-2 (novel coronavirus) in human nasopharyngeal and/or oropharyngeal swabs. This instruction for use (IFU) must be read and followed carefully prior to use. The reliability of assay results cannot be guaranteed in case of any discrepancies from the instructions for use.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
30 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
99.54 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
99.01 %
Clinical Specificity
99.57 %
Type of antigen
Nucleoprotein
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