DeepChek®-HCV NS5B + 5’UTR Genotyping Assay

K-16-NS5B5UTR

Description

The DeepChek®-HCV NS5B + 5’UTR Genotyping Assay (K-16-NS5B5UTR) is intended to be used for Viral Hepatitis C (HCV) genotyping and subtyping. It combines target-specific PCR reagents with in vitro diagnostic software both compatible with either Sanger or Next Generation Sequencing platforms.

Methodology

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

EASL Recommendations on Treatment of Hepatitis C 2016

“The HCV genotype, including genotype 1 subtype (1a or 1b), should be assessed prior to treatment initiation. Genotyping/subtyping should be performed with an assay that accurately discriminates subtype 1a from 1b, i.e. an assay using the sequence of the 50 untranslated region plus a portion of another genomic region, generally the core-coding or the NS5B-coding regions …”

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Characteristics and performances

Features

Compatibility with Capillary Electrophoresis (SANGER) platforms

Any

Compatibility with Next Generation Sequencing platforms

Validated on MiSeq, MiniSeq, Ion PGM, Ion S5

Intended use

RUO – ISO-9001 manufacturing

Types of samples

Serum, plasma, DBS

Format

24 samples/kit

Content

RT-PCR reagents (enzymes, master mixes, primers, dNTPs...), SANGER sequencing primers, protocols for SANGER and NGS sequencing, SANGER or NGS software analyses for 24 samples through a Cloud access

Sensitivity

1000 UI/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 UI/mL) available

Specificity

Validated on all genotypes (pan-genotypic)

Reproducibility

>99%

Workflow

From sample to result in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)

Amplicon length

5'UTR: 244 bp, NS5B: 420 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

Included (DeepChek-HCV / CE-IVD)

Available analyses

Subtyping, genotyping, NGS run quality report, clinical genotyping report...

Included services

Unlimited updates & upgrades of the software, support, training...

Options

Local servers, historical data import, integration with LIS and HIS, integration with sequencers, automation of the IT workflow, customization...

Examples of reports

 

For NGS sequencing

Ordering information

Product

Reference

DeepChek®-HCV NS5B + 5’UTR Genotyping Assay

K-16-NS5B5UTR

Downloads

General documentation

  • Protocol

    EN

    Contact us

  • Installation check list

    EN

    Contact us

  • Q&A

    EN

MSDS

  • International

    EN

Publications

  • Evaluation of a sequence-based method for hepatitis C genotyping (DeepChek® SingleRound PCR and NS5B/5'UTR sequencing) ...

    EN

    1.0