UltraGene® Assay SARS-CoV-2 452R & 484K & 484Q Mutations

▪ 50 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 (L452R, E484K and E484Q) from S gene
▪ Positive Control
▪ Negative Control
▪ 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).

▪ MagNa Pure 24 instrument (Roche; Catalog #07290519001B) with the MagNA Pure 24 Total NA Isolation Kit (Roche, Catalog #07658036001)

Note: Any laboratory validated instrument for RNA extraction and purification using magnetic-bead technology shall work with the test (i.e. bioMérieux EMAG®, Perkin Elmer ChemagicTM 360, ThermoFisher Scientific MagMAX Viral/Pathogen Nucleic Acid Isolation Kit, Qiagen QIAamp Viral RNA Mini Kit, Biopur® Mini Spin Plus Kit and Magtivio MagSi-NA Pathogens)

▪ ThermoFisher Scientific ProFlex™ PCR System (model 3 x 32-well (Catalog #4484073) or 96-well (Catalog #4484075) and associated specific material.

Note: Any laboratory validated thermal cycler with enough ramp rate of ≥ 1°C/s shall be sufficient.

▪ 0h15

~1h45