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DeepChek®Assay-HBV RT Genotyping and Drug Resistance V1 (RUO)

Ref: 113A24

Description

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.

Methodology

DNA Sequencing • Polymerase Chain Reaction (PCR)

More information on the DeepChek® Assays – Click here
More information on the DeepChek® Software – Click here
More information on the SeqHepB® Software – Click here

CHARACTERISTICS AND PERFORMANCES

Features

Compatibility with Capillary Electrophoresis (SANGER) platforms

Any

Compatibility with Next Generation Sequencing platforms

Any

Intended use

RUO – ISO-9001 manufacturing

Types of samples

Serum, plasma, DBS

Format

24 samples/kit

Content

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

Sensitivity

1000 UI/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 UI/mL) available

Specificity

Validated on all genotypes (pan-genotypic)

Reproducibility

>99%

Workflow

From sample to result in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)

Covered positions

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)

Available analyses

Genotyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, vaccine escape assessment, NGS run quality report, clinical genotyping report...

Drug resistance

Flexible, through up to 3 different up-to-date guidelines including SeqHepB

Included services

Unlimited updates & upgrades of the software, support, training...

Options

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

 

SeqHepB Report

 

Ordering information

Product

Reference

DeepChek®Assay-HBV RT Genotyping and Drug Resistance V1 (RUO)

113A24