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 (RAT)
✓Yes
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Lateral flow, Latex
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Semiquantitative
Time
5 minutes
Detection Principle
Fluorescence
LOD
1.25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.63 % ((3/184))
False negatives
3 % ((3/100))
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 %
Clinical Specificity
98.37 %
Type of antigen
Nucleocapsid protein
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