ViroReal SARS-CoV-2 Assay

ViroReal SARS-CoV-2 Assay

Product Description

Intended use

ViroReal® SARS-CoV-2 Assay is a test, based on one-step reverse transcription real-time PCR, for the specific detection of the RdRp gene of SARS-CoV-2 (for research use only). ViroReal® Kit SARS-CoV-2 & SARS is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR, for the detection of the N gene of SARS-CoV-2 and SARS-CoV. The use of both test in a multiplex approach allows the rapid and sensitive detection and differentiation of RNA of SARS-CoV-2 and SARS-CoV in samples purified from nasopharyngeal and oropharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates, sputa and BAL.

Product description

ViroReal® SARS-CoV-2 Assay detect the RNA dependent RNA polymerase gene (RdRp) of SARS-CoV-2 in VIC channel. ViroReal® Kit SARS-CoV-2 & SARS detects the nucleocapsid protein gene (N gene) of SARS-CoV-2 as well as SARS-CoV and SARS-related coronavirus in FAM channel. Other beta coronaviruses are not detected with this kit.

The primer and probe design chosen for both tests is not identical with the WHO design. For ViroReal® SARS-CoV-2, a highly specific region in the RdRp gene of SARS-CoV-2 was chosen as target region, which allows specific detection of SARS-CoV-2.

Both tests should be combined in a multiplex one-step reverse transcription real-time PCR approach. A probe-specific amplification curve at 530 nm (FAM channel) indicates the amplification of RNA of SARS-CoV-2 as well as SARS-CoV and SARS-related coronavirus. A probe-specific amplification curve at 554 nm (VIC channel) indicates the specific amplification of RNA of SARS-CoV-2. An internal RNA positive control (RNA IPC) is detected in Cy5 channel and is used as RNA extraction as well as RT-PCR inhibition control. The target for the RNA IPC is extracted with the sample.

The test is based on one-step reverse transcription real-time PCR (RT-PCR). A specific RNA sequence of the pathogen genome is transcribed into cDNA and amplified in a one-step PCR. The generated PCR-product is detected by an oligonucleotide-probe labelled with a fluorescent dye. This technology allows a sequence-specific detection of PCR amplificates.

This test has been developed for use with the Applied Biosystems® (ABI) 7500 instrument (Thermo Fisher Scientific), LightCycler® 480 II (Roche), cobas Z 480 Analyzer (Roche) and Mx3005P® (Agilent), but is also compatible with other real-time PCR instruments which detect and differentiate fluorescence in FAM,VIC and Cy5 channel. When using PCR-platforms not tested by ingenetix, an evaluation of the multiplex-PCR is recommended. Keep in mind that some PCR-platforms first have to be calibrated with the corresponding dye before performing multiplex-PCR.

Ingenetix BactoReal®, ViroReal®, MycoReal, PanReal, ParoReal and SeptiReal Kits have been optimized to run under the same thermal cycling conditions. DNA and RNA material can be analysed in one run.