SaliVIR COVID 19 Rapid Multiplex qRT-PCR Kit
Manufactured by Chronomics Limited, United Kingdom - www.chronomics.com/
Device identification number
1181
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
End-to-end CE marked IVD for the detection of SARS-CoV-2 viral RNA from saliva and nasopharyngeal swabs.Saliva collection can be performed with or without the supervision of a healthcare professional. Product includes saliva collection devices (if required), reagents (RNA extraction and qRT-PCR kits) and software (sampling and reporting modules via online platform). The SaliVIR COVID19 Rapid Multiplex qRT-PCR Kit comprises only primers and probes designed by the CDC from the CDC 2019-Novel Coronavirus (2019-CoV) Real-Time RT-PCR Diagnostic Panel (assays N1 and RP) and by Cortman et al. from the Charité Berlin WHO protocol (assay E) without any changes. Analytical specificity (cross-reactivity) of these diagnostic panels has been previously established. https://www.chronomics.com/lab-products/end-to-end-product; https://content.chronomics.com/hubfs/COVID/SaliVIR%20COVID19%20Rapid%20Multiplex%20qRT-PCR%20Protocol%20v1.0.1.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
750 copies/ml
Positive control
2019-nCoV nucleocapsid gene and 2019-nCoV envelope gene
Negative control
Human RPP30 gene
Analytical Sensitivity
100 %
Notes
information provided by the manufacturer + website: multiplex of primer / probe assays which target the nucleocapsid gene (assay N1) and the envelope gene (assay E) of SARS-CoV-2; and the human RPP30 gene (assay RP) used as internal RNA extraction control. Two plasmid controls are also included in the kit to confirm functionality of the assays and the qRT-PCR reaction: the RPP30 Negative Control and the combined 2019-nCoV nucleocapsid gene and 2019-nCoV envelope gene Positive Control. The kit also contains ROX reference dye at 10x concentration for use with real-time quantitative PCR (qPCR) instruments that require it.
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