The DeepChek®-HCV NS5B DR Assay (K-16-NS5BDR) 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 NS5B DR Assay
Installation check list