MyBox Flurescence Immunoassay Analyzer
Manufactured by Mylab Discovery Solutions Pvt. Ltd., India - https://mylabdiscoverysolutions.com/
Device identification number
2423
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Chip
Target type
Antigen
Specimen
Mid-turbinates swab, Nasal aspiration, Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Fluorescence
LOD
32 AU
Calibration
Evaluated
Analysis of cross reactivity
Not evaluated
False positives
0 %
False negatives
5 %
Precision
Evaluated
Accuracy
100 ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ( (Antigen))
Clinical Specificity
100 % ( (Antigen))
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