VoliroN SARS-CoV-2 Real-Time PCR Kit
Manufactured by Synbiotik Biotech, Turkey - https://synbiotiktr.com/
Device identification number
2966
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Microplate, Strip
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Voliron RT-qPCR kit is validated with Bio-Rad CFX96 Touch™,Applied Biosystem QuantStudio 1 Real-Time PCR System, Roche LightCycler ® 480 and Mic qPCR Cycler. The kit should be stored at -15℃ to -25℃. It is not recommended to freeze / thaw more than 5 times.". Performances: Alfa (100;98) Beta (100;98) Delta (100;100), Omicron (100;98)
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Subcategory
N.A.
Method
RT-PCR
Measurement
Quantitative
Time
59 minutes
LOD
41 cpm
Positive control
Plasmid
Negative control
nuclease-free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
98 %
Clinical Specificity
100 %
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