DeepChek®-HCV NS5A DR Assay

K-16-NS5ADR

Description

The DeepChek®-HCV NS5A DR Assay (K-16-NS5ADR) is intended to be used for HCV drug resistance assessment. It provides drug susceptibility information for viral NS5A inhibitors. It combines target-specific PCR reagents with in vitro diagnostic software both compatible with either Sanger or Next Generation Sequencing platforms.

Assay should be used for patients with documented HCV genotype 1 to 6 (pan-genotypic assay).

For genotype 2 samples, in case of failure, please use the K-17-NS5ADR-GT2 Assay.

Methodology

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

Clinical Significance

EASL Recommendations on Treatment of Hepatitis C 2016: “Physicians who have easy access to a reliable test assessing HCV resistance to NS5A inhibitors (spanning amino acids 24 to 93) can use these results to guide their decisions, as specified in these recommendations. The test should be based on population sequencing (reporting RASs as “present” or “absent”) or deep sequencing with a cut-off of 15% (only RASs that are present in more than 15% of the sequences generated must be considered)”.

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

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 & Nested-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)

Covered positions

NS5A: codons 1 to 222

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

Genotyping/Subtyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, NGS run quality report, clinical genotyping report...

Drug resistance

Flexible, through up to 3 different up-to-date guidelines including geno2pheno...

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 SANGER sequencing

For NGS sequencing

Ordering information

Product

Reference

DeepChek®-HCV NS5A DR Assay

K-16-NS5ADR

Downloads

General documentation

  • Protocol

    EN

    Contact us

  • Installation check list

    EN

    Contact us

  • Q&A

    EN

MSDS

  • International

    EN

Posters

  • Retreatment with Direct Active Antivirals of Genotype 1, 3 and 4 Chronic Hepatitis C Patients who Previously Failed an Anti-NS5A-Containing Regimen in Real World

    EN