Boditech Quick™ COIVD-19 Ag
Manufactured by Boditech Med Inc., South Korea - www.boditech.co.kr/en
Device identification number
2413
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge
Target
Antigen
Specimen
Saliva
Pathogens detected
Adenovirus 3, Influenza A, Influenza B, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Commercial Status
Commercialised
Last Update
2021-07-12 09:37:33 CET
Comments
Boditech Quick™ COVID-19 Ag is a chromatographic Immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human saliva. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of 'Novel Coronavirus' infection. For in vitro diagnostic use only.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
177 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
20 %
Precision
Evaluated
Accuracy
91.2 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
80 %
Clinical Specificity
100 %
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