Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Asan Easy Test COVID-19 Ag

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

Device identification number
2251
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is CE marked, evaluated and approved by the Paul-Ehrlich-Institute in Germany.
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
Analysis of cross reactivity
Evaluated
False positives
2.29 % ( (8/350))
False negatives
5.33 % ( (8/150))
Precision
Evaluated
Accuracy
96.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.7 %
Clinical Specificity
97.7 %
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