KNAX-SMART SARS-CoV2 Influenza A&B Ag combo
Manufactured by Asan Pharmaceutical Co. Ltd., South Korea - http://www.asapharm.com
Device identification number
2536
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1230 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
-
False negatives
-
Precision
Evaluated
Accuracy
-
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.7 %
Clinical Specificity
97.4 %
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