TGS Velox Ag COVID-19 POCT SALIVA (25 test)
Manufactured by Technogenetics SRL, Italy - www.technogenetics.it
Device identification number
2274
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The TGS Velox Ag COVID-19 POCT SALIVA (25 test) kit for qualitative determination of antigens and/or virus particles (virions) SARS-CoV-2 in oral swab samples is based on the Localized Surface Plasmon Resonance (LSPR), that consists of coherent and non-propagating oscillations of free electrons in metal nanoparticles arising when they interact with an electromagnetic wave whose frequency resonates with the plasmonic one. Colorimetric detection based on gold nanoparticles (AuNPs) takes advantage of the color change occurring in a colloidal suspension from red to blue as a result of LSPR coupling among the functionalized nanoparticles (f-AuNPs) with antibodies targeting three surface proteins of SARS-CoV-2 Spike, Envelope and Membrane (S, E and M respectively) around the antigens or the virus particles.
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
13 minutes
Subclass
Other ()
LOD
30 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.05 % (2/190 (Specificity 98.9%))
False negatives
5.69 % (7/123 (Sensitivity 94.3%))
Precision
Evaluated
Accuracy
97.1 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.3 % ( (Antigen))
Clinical Specificity
98.9 % ( (Antigen))
Type of antigen
Other
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