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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Absoludy COVID-19 Ag

Manufactured by Absology Co., Ltd., South Korea - www.absology.co.kr 

Device identification number
1982
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Lateral flow, Latex
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-16 09:52:57 CET
Comments
Absoludy COVID-19 Ag for use in conjunction with ABSOL instrument, is an in vitro diagnostic medical device based on microfluidic fluorescent immunoassay (FIA) for measurement of SARS-CoV-2 antigen.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
5 minutes
Detection Principle
Fluorescence
LOD
1.25 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.63 % ((3/184))
Fn
3 % ((3/100))
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 %
Clinical Specificity
98.37 %
Type of antigen
Nucleoprotein
Notes
Microfluidic

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