The DeepChek®-HCV Assay NS5B Drug Resistance V4 (RUO) Drug Resistance Assay is intended to be used for HCV drug resistance assessment. It provides drug susceptibility information for viral NS5B 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).
DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Characteristics and performances
Compatibility with Capillary Electrophoresis (SANGER) platforms
Compatibility with Next Generation Sequencing platforms
RUO – ISO-9001 manufacturing
Types of samples
Serum, plasma, DBS
RT-PCR reagents for 2 fragments (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 UI/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 UI/mL) available
Validated on all genotypes (pan-genotypic)
From sample to result in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)
NS5B: codons 1 to 579
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)
Genotyping/Subtyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, NGS run quality report, clinical genotyping report...
Flexible, through up to 3 different up-to-date guidelines including 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®-HCV Assay NS5B Drug Resistance V4 (RUO)
Installation check list