ViroTrack Sero COVID-19 IgA+IgM/IgG Ab
Manufactured by BluSense Diagnostics ApS, Denmark - https://www.blusense-diagnostics.com/
Device identification number
103
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Physical Support
Card, Cartridge
Target type
Antibody, IgA, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Last Update
2022-08-24 09:08:01 CET
Comments
Patented IMA technology
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
13 minutes
Subclass
Other ()
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.15 % (1 false positive in a cohort of 87 negative samples)
False negatives
17.14 % (6 false negatives in a cohort of 35 positive samples)
Precision
Evaluated
Accuracy
93.4 % (IgA+IgM)
Accuracy
93.4 % IgG
Accuracy
93.4 % (IgA+IgM/IgG)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
80 % (IgA+IgM)
Clinical Sensitivity
77.1 % IgG
Clinical Sensitivity
82.9 % (IgA+IgM/IgG)
Notes
Patented IMA technology
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