DeepChek® Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance (CE-IVD)

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...

DeepChek®Assay -HIV Assay Protease / Reverse Transcriptase Genotyping and Drug Resistance (CE-IVD)

121A24