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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 - www.asanpharm.com 

Device identification number
1654
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The Asan Easy Test® COVID-19 Ag is an in vitro diagnostic medical device that diagnoses COVID-19 by qualitatively testing SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab by immunochromatographic assay (ICA).
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
590 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
97.6 %
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