CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT
Manufactured by CORMAY, Poland - cormay.pl/index.php?lang=_en
Device identification number
1810
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Fully functional kit contains: cassettes, swabs, extraction buffers, extraction tubes, nozzles with filters and clear IFU.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
1.25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
-
False negatives
-
Precision
Evaluated
Accuracy
96 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
Clinical Specificity
98 %
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