DeepChek® Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance (CE-IVD)

121A24

Description

The DeepChek® Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance Afficher l’image source is intended to be used for HIV-1 genotyping and provides antiretroviral susceptibility information for protease inhibitors (PI) and reverse transcriptase inhibitors (NRTI, NNRTI). 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)

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

 

This test is not available for sale in the U.S. – CE marking only valid for EEA and territories recognizing it – Otherwise 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. See product REF 101B24.

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

PR: codons 1 to 99, RT: codons 1 to 320

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®Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance (CE-IVD)

121A24

Downloads

General documentation

  • Protocol

    EN

    Contact us

  • Installation check list

    EN

    Contact us

  • EC Declaration of Conformity (121A24)

    EN

  • Q&A

    EN

MSDS

  • International

    EN