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UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations V1

REF 165A50

Description

The UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations V1 (RUO) is a RT-PCR Assay (nucleic acid technique (NAT)) intended to screen the emergence of SARS-CoV-2 genomic variations on the Spike (S) gene.

Application (RUO)

For Research Use Only (RUO). Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.

The UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations V1 is intended to screen the emergence of SARS-CoV-2 genome harboring the mutations L452R, E484K and E484Q on the Spike (S) gene.

This nucleic amplification test is indicated for use on previously diagnosed COVID-19 patients ONLY. This test is NOT intended to be used as a screening or confirmation test for the detection, confirmation or quantification in upper respiratory specimens of SARS-CoV-2.

Methodology

The Assay is a multiplex test  targeting the S region of SARS-CoV-2 patients’ extracted RNA in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens, and nasopharyngeal wash/aspirate or nasal aspirate specimens) from individuals already tested positive to SARS-CoV-2.

Intended user

The UltraGene SARS-CoV-2 SARS-CoV-2 452R & 484K & 484Q Mutations V1 (RUO) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR. The current laboratory biosafety guidance for the 2019 novel coronavirus (SARS-CoV-2) shall be followed.

More information on the UltraGene SARS-CoV-2 SARS-CoV-2 452R & 484K & 484Q Mutations V1 – Click here

Characteristics and performances

Features

real time RT-PCR
targeting specific mutations L452R, E484K and E484Q on the Spike (S) gene

RNA extraction and purification of clinical specimen

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).

PCR

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.

Format / Models

- 50 tests/kit (165A50)

Content

- 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

Hands-on-time

0h15

Estimated turnaround time

~1h45

Ordering information

Product

Reference

GTIN

UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations V1 (50 tests) (RUO)

165A50

Request of Documentation (IFU, MSDS, CoA, ...)

Email address
Assay Serial Number

APPLICATION – FOR RESEARCH USE ONLY (RUO)

Except for certain territories (EEA) – For Research Use Only (RUO). Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.