Vibamat
Manufactured by Michael Bubolz GmbH, Germany - www.vibamat.de
Device identification number
4148
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Card
Target type
Antigen
Antibody type
Monoclonal
Targets
spike protein
Specimen
Other (Breathing Air)
Cross-reactivity (pathogens tested)
SARS-CoV-2
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Spike protein
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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
2022-12-07 08:48:05 CET
Comments
Many thanks for the implementation of the indicated changes!
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Quantitative
Time
1 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Immunofluorescence
LOD
100 %
Calibration
Evaluated
Analytical Sensitivity
99 %
Analytical Specificity
99 %
Analysis of cross reactivity
Evaluated
False positives
1 % IgG
False negatives
1 % IgG
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 %
Clinical Specificity
99 %
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