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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 NAb & TAb

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

Device identification number
1984
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Serum
Commercial Status
In development
Last Update
2021-05-10 01:04:00 CET
Comments
Absoludy COVID-19 NAb & TAb is a single-use only, fluorescent nanoparticle immunoassay designed for in vitro measurement of COVID-19 neutralizing antibody and COVID-19 total antibody. Human serum can be used as specimen for the test. Absoludy COVID-19 NAb & TAb is intended to be used by a healthcare professional who is sufficiently trained in clinical skills like specimen handling and medical instrument usage. Absoludy COVID-19 NAb & TAb is designed for use only with the ABSOL(ABSOL-001), fluorescent immunoassay reading instrument manufactured by Absology Co., Ltd.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Fluorescence
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Evaluation ongoing
Fn
Evaluation ongoing
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
98 %
Type of antigen
Other

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