Overview
Safety Data Sheet
Description
Description
This product is CE Marked with limited regional availability. Check with your local sales office.
Contact a Specialist The Reliance SARS-CoV-2 RT-PCR CE-IVD Kit provides real-time PCR detection of multiple RNA targets from the SARS-CoV-2 virus with great sensitivity and speed. It is designed to detect nucleic acid from SARS-CoV-2 in nasopharyngeal swabs specimen from individuals suspected of COVID-19 by their healthcare provider.
We have performed a variant analysis of our SARS-CoV-2 assay in this kit, and the performance is unlikely to be affected by the variants of concern, as of February 2021. See the IFU for details.
Two primer/probe sets are the sequences reported by the Center for Disease Control and Prevention (CDC) for detection of SARS-CoV-2, selected from regions of the virus nucleocapsid (N1 and N2) genes. An additional primer/probe set to detect the human RNase P (RP) gene is also included in the panel as an internal control. RNA that is isolated and purified from control samples and clinical specimens is added to the master mix, which is composed of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad Reliance One-Step Multiplex RT-qPCR Supermix.
The kit contains all materials necessary for the efficient detection of SARS-CoV-2, including independently developed Exact Diagnostics positive and negative molecular controls.
For use in European Union only with CE-IVD marked In Vitro Diagnostics Medical Devices.
The Reliance SARS-CoV-2 RT-PCR CE-IVD has been validated for use with the Bio-Rad CFX96 Dx and the Thermo Fisher ABI 7500 Fast real-time PCR systems.
Customers using research instruments can also self-validate the kit. For information on how to validate the kit with your instrument, please contact technical support.
Kit Components
The kit contains all the required reagents for 200 reactions. The kit should be stored at –20 °C.
- SARS-CoV-2 RT-PCR Oligos
- Reliance One-Step Multiplex RT-qPCR Supermix
- Exact Diagnostics SARS-CoV-2 Standard
- Exact Diagnostics SARS-CoV-2 Negative