TGS COVID-19 IgG
Manufactured by TECHNOGENETICS, Italy - www.technogenetics.it
Device identification number
2770
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Cartridge
Target type
IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The value that is need to change is related the mesurement
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
CLIA
Measurement
Quantitative
Time
25 minutes
Subclass
Sandwich
LOD
1.7 AU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.52 % (1/192)
False negatives
2.52 % (3/119)
Precision
Evaluated
Accuracy
98.7 % IgG
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
62.9 % IgG (< 10 days)
Clinical Sensitivity
92.3 % IgG (11-20 days)
Clinical Sensitivity
100 % IgG (> 21 day)
Clinical Specificity
99.4 % 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