Alphadia
Manufactured by Alphadia, Belgium - www.alphadia.be
Device identification number
1803
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Dotblot
Target type
IgG
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Semiquantitative
Time
65 minutes
Subclass
Microarray
LOD
5 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
0 AU
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 % IgG
Clinical Specificity
99 % IgG
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