Description
The DeepChek® Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance 
is intended to be used for HIV-1 genotyping and provides antiretroviral susceptibility information for protease inhibitors (PI) and reverse transcriptase inhibitors (NRTI, NNRTI). It combines target-specific PCR reagents with in vitro diagnostic software both compatible with either Sanger or Next Generation Sequencing platforms.
Methodology
DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
More information on the DeepChek® Assays – Click here
More information on the DeepChek® Software – Click here
This test is not available for sale in the U.S. – CE marking only valid for EEA and territories recognizing it – Otherwise For Research Use Only (RUO). Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease. See product REF 101B24.
Characteristics and performances
Features
Compatibility with Capillary Electrophoresis (SANGER) platforms
Any
Compatibility with Next Generation Sequencing platforms
Any
Intended use
CE-IVD – ISO-9001 manufacturing
Types of samples
Serum, plasma, pro-viral DNA, DBS
Format
24 samples/kit
Content
RT-PCR & Nested-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 cp/mL for 400 µL plasma/serum. Protocols for low viral loads (>200 - 300 cp/mL) available
Specificity
Validated on most of the subtypes and CRF strains
Reproducibility
>99%
Workflow
From sample to result in ~15 hours for SANGER and ~30 hours for NGS (depending on the platform)
Covered positions
PR: codons 1 to 99, RT: codons 1 to 320
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-HIV / CE-IVD)
Available analyses
Subtyping, amino-acid mutations detection, nucleotide changes detection, drug resistance, NGS run quality report, GSS, clinical genotyping report...
Drug resistance
Flexible, through up to 7 different up-to-date guidelines including HIVdb/Stanford, ANRS, geno2pheno, Rega,...
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
For NGS sequencing
Ordering information
Product
Reference
DeepChek®Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance (CE-IVD)
121A24
Downloads
General documentation
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Protocol
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Installation check list
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EC Declaration of Conformity (121A24)
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Q&A
MSDS
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International
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