Asan Easy Test COVID-19 IgG/IgM
Manufactured by Asan Pharmaceutical Co. Ltd., South Korea - www.asanpharm.com
Device identification number
1760
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
IgG, IgM
Targets
nucleocapsid protein
Specimen
Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0.2 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
13 AU
False negatives
12 AU
Precision
Evaluated
Accuracy
95.38 %
Robustness
Not evaluated
Clinical Sensitivity
95 %
Type of antigen
Nucleoprotein
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