KNAX-SMART SARS-CoV-2 IgM/IgG (N)
Manufactured by Asan Pharmaceutical Co. Ltd., South Korea - http://www.asapharm.com
Device identification number
2571
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 AU
False negatives
15 AU
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
100 % IgM
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
88.7 %
Clinical Specificity
98.1 %
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