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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 Rapid

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

Device identification number
1981
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-16 09:57:22 CET
Comments
Absoludy COVID-19 Ag Rapid is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal and Oropharyngeal swab specimen.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
125 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
12 % ((12/100))
Precision
Evaluated
Accuracy
95.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
88 % ((100/100))
Clinical Specificity
100 % ((184/184))
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