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.
DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
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.
Characteristics and performances
Compatibility with Capillary Electrophoresis (SANGER) platforms
Compatibility with Next Generation Sequencing platforms
CE-IVD – ISO-9001 manufacturing
Types of samples
Serum, plasma, pro-viral DNA, DBS
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
1000 cp/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 cp/mL) available
Validated on most of the subtypes and CRF strains
From sample to result in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)
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)
Subtyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, NGS run quality report, GSS, clinical genotyping report...
Flexible, through up to 7 different up-to-date guidelines including HIVdb/Stanford, ANRS, geno2pheno, Rega,...
Unlimited updates & upgrades of the software, support, training...
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
DeepChek®-HIV INT Genotyping and Drug Resistance Assay V1 (CE-IVD)
EC Declaration of Conformity (122A24)
Installation check list