KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2
Manufactured by NATRIX S.R.L., Italy - https://www.natrixlab.it/
Device identification number
2349
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
KIT REVOLUTION COVID-19 RAPID SALIVARY TEST FOR SARS-COV-2 cat 10400000 Italian Ministry of Health registration number 2002448 LOD is 7.05×102 TCID50/mL
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
25 minutes
Subclass
Sandwich
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
False positives
0 %
False negatives
8 %
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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