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Download All Description: ViroReal® Kit SARS-CoV-2 Multiplex (Version 2.0) is a non-automated IVD test, based on one-step reverse transcription real-time PCR (RT-PCR), for the qualitative detection of RNA of the N gene of SARS-CoV-2, SARS-CoV and SARS-related coronavirus (Sarbecovirus) and of the RdRp gene of SARS-CoV-2. Proper specimens are RNA extracts of samples from the human respiratory tract (throat rinsing fluid, nasopharyngeal and oropharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates). This test is suitable for patients of all ages with or without a suspected SARS-CoV infection and is intended as an aid in the diagnosis of SARS-CoV infection in combination with patient history and additional clinical information. The test is for professional use only and the use is limited to qualified personnel instructed in real-time PCR and in vitro diagnostic procedures. A probe-specific amplification-curve in the FAM channel (530 nm) indicates the amplification of the N gene specific RNA. A probe-specific amplification-curve in the VIC channel (554 nm) indicates the amplification of RdRp gene specific RNA. 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 (artificial target RNA) is added during extraction of the sample. The multiplex approach allows universal detection of all so far known SARS coronavirus strains (Sarbecovirus) including SARS-CoV-2, and the discrimination between SARS-CoV-2 and the other Sarbecovirus strains. The chosen design for the N gene includes a highly conserved region in all SARS coronavirus clusters of the N gene, which allows the universal detection of previously known Sarbecoviruses including SARS-CoV-2. Due to its universal character, it takes into account possible future mutations in the SARS-CoV-2 virus sequence. Because of its design, the test has the potential to detect new SARS corona viruses in the future. For the RdRp gene, a sequence range highly specific for SARS-CoV-2 was chosen, which allows the specific detection of SARS-CoV-2. The primer and probe designs chosen are not identical with designs published by the WHO.
| Order Number | Reactions | Channel Pathogen | Channel IPC | Target |
|---|---|---|---|---|
| DHUV02413 | 100 | FAM, VIC | Cy5 | N gene & RdRp |
| DHUV02413x5 | 500 | FAM, VIC | Cy5 | N gene & RdRp |