UltraGene Assay NS5B / 5’UTR V1 (RUO)

REF 111A24

Description

Application

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 NS5B / 5’UTR V1 is intended to be used for Viral Hepatitis C (HCV) viral load measurement above 20 UI/mL through qPCR.

When results are positive, it can also be used for genotyping and provides antiviral susceptibility information for 5’UTR.

It includes target-specific qPCR reagents compatible with either Sanger or Next Generation Sequencing platforms.

Use by laboratory personnel specifically instructed and trained in the techniques of qPCR and next generation sequencing (NGS) workflow.

Methodology

DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

More information on the UltraGene Assays – Click here
More information on the DeepChek® Software – Click here

Characteristics and performances

Features

Compatibility with qPCR platforms

Many

Compatibility with Next Generation Sequencing platforms

Any

Intended use

RUO – ISO 13485 manufacturing

Types of samples

Serum, plasma, DBS

Format

48 samples/kit or 96 samples/kit

Content

RT-qPCR reagents (enzymes, master mixes, primers, dNTPs...), SANGER sequencing primers, protocols for SANGER and NGS sequencing

Sensitivity

20 UI/mL for 400 µL plasma/serum

Specificity

Validated on all genotypes

Reproducibility

>99%

Workflow

From sample to result in less than 2 hours. Genotyping performed in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)

Amplicon length

5'UTR: X bp

Compatible extraction methods

Automatic (MagNA Pure Compact Nucleic Acid Isolation Kit I - Roche, Promega - Abbott), Manual (Manual extractions using QIAamp® Viral RNA - Qiagen)...

Data analysis and interpretation software

Not included

Examples of reports

Viral Load Detection

 

 

Ordering information

Product

Reference

UltraGene-HCV Assay

Available on request - R&D project