The DeepChek®-HCV NS5B + 5’UTR Genotyping Assay (K-16-NS5B5UTR) is intended to be used for Viral Hepatitis C (HCV) genotyping and subtyping. 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)
EASL Recommendations on Treatment of Hepatitis C 2016
“The HCV genotype, including genotype 1 subtype (1a or 1b), should be assessed prior to treatment initiation. Genotyping/subtyping should be performed with an assay that accurately discriminates subtype 1a from 1b, i.e. an assay using the sequence of the 50 untranslated region plus a portion of another genomic region, generally the core-coding or the NS5B-coding regions …”
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, DBS
RT-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 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)
5'UTR: 244 bp, NS5B: 420 bp
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)
Subtyping, genotyping, NGS run quality report, clinical genotyping report...
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 NGS sequencing
DeepChek®-HCV NS5B + 5’UTR Genotyping Assay
Installation check list
Evaluation of a sequence-based method for hepatitis C genotyping (DeepChek® SingleRound PCR and NS5B/5'UTR sequencing) ...