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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

KNAX-SMART SARS-CoV-2 Ag

Manufactured by Asan Pharmaceutical Co., Ltd., South Korea - http://www.asapharm.com 

Device identification number
2535
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-03 01:15:45 CET
Comments
.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
590 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
2.29 % (8/350)
Fn
5.33 % (8/150)
Precision
Evaluated
Accuracy
96.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.7 %
Clinical Specificity
97.7 %
Type of antigen
Nucleocapsid protein

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