UltraGene® Assay SARS-CoV-2 VOC Screening & Determination

SARS-CoV-2 qPCR Assay to screen the distribution and to determine all currently designated variants of concern (VOCs)

Description

The UltraGene Assay SARS CoV 2 VOC Screening and Determination V1 (CE IVD) is a rtRT PCR Assay (nucleic acid technique ( intended for the qualitative
detection of SARS CoV 2 mutations L452R, K417N or K417T, E484A or E484K or E484Q, and the deletion 69 70 on the Spike gene.
The test is targeting the S and N regions of SARS CoV 2 patients’ extracted RNA and already diagnosed PCR positive to SARS CoV 2

Features

▪ 50 or 1000 tests per kit

▪ Multiplex format in 2 wells per sample

▪ Master Mix 2X, RT Mix, Enzyme Mix and Magnesium Sulfate
▪ Specific Primers & Probes for each mutation (del 69-70, K417N, K417T, L452R, E484K, E484A) from S gene
▪ Positive control
▪ Negative control
▪ Internal control (N-gene)
▪ PCR grade nuclease-free water

Upper respiratory specimens (nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate and bronchoalveolar lavage (BAL) fluid specimens (already tested SARS-CoV-2 positive).

▪ Magnetic beads

▪ Any qPCR instrument compatible with the FAM, HEX, ROX and Cy5 channels.
▪ Validated for use with C1000 Dx Thermal Cycler (Bio-Rad, Catalog # 1841000-IVD with CFX96-Dx ORM software          version 3.1) (C1000 CFX96)

▪ Less than 20 minutes for up to 48 samples
▪ Less than 40 minutes for up to 96 samples
▪ Automation capacity (liquid handling robots available upon request)

Workflow

Ordering Information

Product Reference
UltraGene® Assay SARS-CoV-2 VOC Screening and Determination (V1.x) (50 tests) (CE-IVD)
176A100
UltraGene® Assay SARS-CoV-2 VOC Screening & Determination (V1.x) (1000 tests) (CE-IVD)
176A1000

Downloads

Leaflet