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 (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
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