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UltraGene Assay Duplex SARS-CoV-2 (N/ORF1ab) V1.X

REF 169A50 // 169A1000

Description

The UltraGene Assay Duplex SARS-CoV-2 (N/ORF1ab) V1.X (CE-IVD) is a RT-PCR Assay (nucleic acid technique (NAT)) intended for the qualitative detection of RNA from the SARS-CoV-2.

Application (CEIVD)

The UltraGene Assay Duplex SARS-CoV-2 (N/ORF1ab) V1.X is intended for the qualitative detection of RNA from the SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

Methodology

The UltraGene Assay Duplex SARS-CoV-2 (N / ORF1ab) V1.X  includes two primer and probe sets designed to detect RNA fromthe SARS-CoV-2 nucleocapsid (N) gene and ORF1ab region (RNA-dependent RNA Polymerase (RdRp) gene) in upper respiratory specimens.

Intended user

The UltraGene Assay Duplex SARS-CoV-2 (N / ORF1ab) V1.X  is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The current laboratory biosafety guidance for the 2019 novel coronavirus (SARS-CoV-2) shall be followed.

More information on the UltraGene Duplex SARS-CoV-2 (N / ORF1ab) V1.X – Click here

Characteristics and performances

Features

Real time RT-PCR
Targeting N gene and ORF1ab region

RNA extraction and purification of clinical specimen

- Validated on magnetic-beads based system (PurePrep 96 Nucleic Acid Purification Instrument)
- 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

- Validated on UltraGene qPCR 96 (Advanced Biological Laboratories (ABL)) & C1000 Dx Thermal Cycler (Bio-Rad) (CFX96)
-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)
- 1000 tests/kit (169A1000)

Content

- Master Mix, Enzyme Mix and Magnesium Sulfate (MgSO4)
- Specific CoV ORF1ab/N/RNase P Primer and Probe Mix
- Positive Control
- Negative Control
- PCR grade nuclease-free Water

Hands-on-time

0h20

Estimated turnaround time

~1h30

Limit of detection (LOD)

0.115 TCID50/mL (through C1000 CFX96 Dx Thermal Cycler and the UltraGene qPCR 96 instrument).

In-silico specificity

The assay is expected to amplify and detect both genes in all current variants of the virus.

Cross-reactivity testing (wet and in-silico)

The assay did not react (i.e., tested positive) when tested with the microorganisms that are commonly found in upper respiratory specimens.

Clinical agreement study with CE-IVD test

Positive Percent Agreement = 100% (95% C.I. = 88.65% - 100%)
Negative Percent Agreement = 100% (95% C.I. = 88.65% - 100%)

Clinical accuracy

93%

Ordering information

Product

Reference

GTIN

UltraGene Assay Duplex SARS-CoV-2 (N/ORF1ab) V1.X (50 tests) (CEIVD)

169A50

05407007960323

UltraGene Assay Duplex SARS-CoV-2 (N/ORF1ab) V1.X (1000 tests) (CEIVD)

169A1000

05407007960330

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

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Assay Serial Number