TGS COVID-19 IgM
Manufactured by TECHNOGENETICS, Italy - www.technogenetics.it
Device identification number
2771
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Cartridge
Target type
IgM
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
the only value is related the measurement
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
CLIA
Measurement
Quantitative
Time
30 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
50 % (19/38)
False negatives
0.31 % (1/320)
Precision
Evaluated
Accuracy
94.7 % IgM
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
78.6 % IgM (<7 dd)
Clinical Sensitivity
82 % IgM (8-14 dd)
Clinical Sensitivity
96.6 % IgM (15-30dd)
Clinical Specificity
99.2 % IgM
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