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DeepChek®-HIV Assay INT Genotyping and Drug Resistance V1 (CE-IVD)

122A24

Description

The DeepChek®-HIV INT Genotyping and Drug Resistance Assay V1  (CE-IVD) is intended to be used for HIV-1 genotyping and provides antiretroviral susceptibility information for integrase inhibitors (II). 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)

Clinical Significance

The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on raltegravir in clinical trials. Twenty three percent of patients receiving raltegravir in a clinical trial experienced virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

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

Any

Intended use

CE-IVD – ISO-9001 manufacturing

Types of samples

Serum, plasma, pro-viral DNA, 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 cp/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 cp/mL) available

Specificity

Validated on most of the subtypes and CRF strains

Reproducibility

>99%

Workflow

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

Covered positions

INT: codons 20 to 280

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-HIV / CE-IVD)

Available analyses

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

Drug resistance

Flexible, through up to 7 different up-to-date guidelines including HIVdb/Stanford, ANRS, geno2pheno, Rega,...

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®-HIV INT Genotyping and Drug Resistance Assay V1 (CE-IVD)

122A24

General document

  • EC Declaration of Conformity (122A24)

    EN

Downloads

General documentation

  • Protocol

    EN

    Contact us

  • Installation check list

    EN

    Contact us

  • Q&A

    EN

MSDS

  • International

    EN