TaqPath™ Seq HIV-1 Genotyping Kit

The Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit is a Sanger sequencing-based in vitro diagnostic (IVD) assay that aids in the detection of genomic mutations in the protease, reverse transcriptase, and integrase regions of the pol gene in HIV-1 RNA extracted from EDTA plasma and dried blood spots, as an aid in the monitoring and treatment of HIV-1 infected individuals.

Features of the TaqPath Seq HIV-1 Genotyping assay include:
• Cost-effective, CE-IVDD-compliant test developed in collaboration with the U.S. CDC
• Designed for a wide range of group-M subtypes, addressing strains found predominantly in the regions with the greatest need
• From sample to result in ∼14 hours
• Covers the protease, reverse transcriptase, and integrase regions of the pol gene
• Scalable workflow
• Pre-mixed reagents to minimize pipetting steps
• Easy-to-read sequencing results
• First regulated Sanger sequencing product to address all three regions of the pol gene

The TaqPath Seq HIV-1 Genotyping Kit enables reliable genotyping of the genetically diverse HIV-1 virus to investigate drug resistance mutations (DRMs) to protease inhibitors (PI), nucleoside reverse-transcriptase inhibitors (NRTI), non-nucleoside reverse-transcriptase inhibitors (NNRTI), and integrase inhibitors (INSTI) from HIV-1 RNA extracted from EDTA plasma and dried blood spot samples. This product employs assays for HIV-1 genotyping licensed from the U.S. Centers for Disease Control and Prevention.

The TaqPath Seq HIV-1 Genotyping Kit contains amplification and sequencing reagents targeted to the protease, reverse transcriptase, and integrase regions of the HIV-1 pol gene. Specifically, the kit contains ready-to-use master mix, enzyme, and positive and negative controls to cover the three phases of the workflow: RT-PCR, nested PCR, and bidirectional cycle sequencing steps to process 48 test samples.

Starting with viral RNA extracted from an EDTA plasma or dried blood spot sample, RT-PCR is conducted to generate PR/RT and IN PCR products as DNA template. After confirming the band size of the PCR amplicons, the Cycle Sequencing module is used to sequence the DNA templates utilizing Sanger sequencing technology. The sequencing reactions are first purified, then sequenced using POP-7 on a designated capillary electrophoresis system. The sequencing traces are reviewed for quality, after which the user exports the AB1 file for use in downstream analysis and reporting.

The TaqPath Seq HIV-1 Genotyping Kit delivers gold-standard Sanger sequencing results for use in the identification of drug resistant mutations from the diverse and rapidly evolving HIV-1 virus.