The DeepChek®-HIV V3 Loop/Tropism Assay (K-17-H2-V3) is intended to be used for determining eligibility for CCR5 antagonist treatment in patients infected with human immunodeficiency virus 1 (HIV-1). 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)
Characteristics and performances
Compatibility with Capillary Electrophoresis (SANGER) platforms
Compatibility with Next Generation Sequencing platforms
Validated on MiSeq, MiniSeq, Ion PGM, Ion S5
RUO – 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)
Codons 1-35 of the V3 loop
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)
Amino-acid mutations detection, nucleotide changes detection, Tropism assessment, CCR5 antagonist susceptibility, NGS run quality report, clinical genotyping report...
Flexible, through several virtual-phenotypic guidelines (Pyrovir, geno2pheno)
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
DeepChek®-HIV V3 Loop/Tropism Assay
Installation check list