The DeepChek®Assay-HBV RT Genotyping and Drug Resistance V1 (RUO) is intended to be used for HBV genotyping, drug resistance and vaccine escape assessment. It provides drug susceptibility information for viral HBV Polymerase inhibitors. It combines target-specific PCR reagents with in vitro diagnostic software both compatible with either Sanger or Next Generation Sequencing platforms.
DNA Sequencing • Polymerase Chain Reaction (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
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)
Polymerase: codons 1 to 344, HBsAg: 1-226
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-HBV / CE-IVD + SeqHepB)
Genotyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, vaccine escape assessment, NGS run quality report, clinical genotyping report...
Flexible, through up to 3 different up-to-date guidelines including SeqHepB
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
DeepChek®Assay-HBV RT Genotyping and Drug Resistance V1 (RUO)