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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Ksmart® SARS-COV2 Antigen Rapid Test

Manufactured by AVALUN SAS, France - avalun.com/ 

Device identification number
1800
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Semi-automated
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:12:25 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
30 U/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.68 % (The specificity was tested using 441 negative specimens.3 False positives results vs the PCR assay)
Fn
6.81 % (The sensitivity was tested using 176 positive specimens.12 False negatives results vs the PCR assay.)
Precision
Evaluated
Accuracy
97.57 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.18 %
Clinical Specificity
99.32 %

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