Detecting HIV Drug Resistance Mutations (DRMs) with the Sentosa® SQ HIV-1 Genotyping Assay

Learn more about Vela Diagnostics' solutions for HIV drug resistance.

 

 

 

Available as US-IVD, CE-IVD, AU-TGA, RUO.

Robert Shafer - Stanford University

"We identified cryopreserved samples that had previously undergone standard genotypic resistance testing (SGRT), and were found to have HIV drug resistance mutations (DRMs), for a blinded comparison with the Vela Diagnostics Sentosa® SQ HIV-1 Genotyping NGS Assay [...] The more sensitive detection of low-level variants by NGS resulted in a higher predicted level of drug resistance” 

-  Robert W. Shafer, Professor of Medicine and Pathology, Stanford University

DETECTING HIV DRUG RESISTANCE MUTATIONS (DRMS) WITH VELA DIAGNOSTICS' SENTOSA® SQ HIV-1 GENOTYPING ASSAY

Resistance of HIV to antiretroviral drugs is the most common cause of therapeutic failure in patients infected with HIV. Detection and reporting of drug resistance mutations (DRMs) is critical for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimen and can prevent or minimize the development of resistance to antiviral drugs. 

Using next generation sequencing (NGS) technology, the Sentosa® SQ HIV-1 Genotyping Assay developed by Vela Diagnostics detects DRMs with high sensitivity and reproducibility in 3 major antiretroviral drug targeted regions of the Pol gene – Protease (PR), Reverse Transcriptase (RT) and Integrase (IN), in HIV-1 Group M strains. The assay is performed on the automated VELA NGS Workflow, which has one of the shortest turnaround time and hands-on time available in the market for HIV-1 genotyping.

The Sentosa® SQ HIV-1 Genotyping Assay has been granted marketing authorization by the US FDA and HSA (Singapore), and an earlier version has also been CE-IVD, TGA, Thai FDA approved. Read the press releases on the FDA and Vela Diagnostics websites.

 THE SENTOSA® SQ HIV-1 GENOTYPING ASSAY DETECTS DRMS AMONG HIV-1 GROUP M STRAINS

 

The Sentosa® SQ HIV-1 Genotyping Assay detects mutations in 3 major antiretroviral drug targeted regions of the Pol gene:

Protease (PR), Reverse Transcriptase (RT), and Integrase (IN)

The assay detects and calls all drug resistance mutations (DRMs) in these target regions simultaneously from one plasma sample

  • Limit of Detection (LoD)1000 copies/mL
  • Specificity: 99.94%
  • Assay reproducibility: 98.89%
Drug resistance mutations in the protease, reverse transcriptase of HIV-1 and integrase genes

The Sentosa® SQ HIV-1 Genotyping Assay detects DRMs in the protease (PR)reverse transcriptase (RT) and integrase (IN) regions of the pol gene.  

 

 

 

AUTOMATED NGS SAMPLE-TO-RESULT WORKFLOW:
FROM SAMPLE TO RESULT IN 2 DAYS
 
 
The Sentosa® SQ HIV-1 Genotyping Assay is used on the automated VELA NGS Workflow. The Sentosa® NGS Workflow is highly sensitive and delivers clinically relevant results with reduced hands-on (< 2 hours) and turnaround time (~2 days) compared to Sanger and other non-automated NGS alternatives. From sample-to-result, the workflow delivers comprehensive, clinically relevant information for optimal selection of HIV treatment regimens out of the box.
 
Interpretation report generated by Sentosa® SQ Reporter is based on the Stanford HIV drug resistance database

From sample extraction to result interpretation, the Sentosa® SQ HIV-1 Genotyping Assay is performed on the automated Sentosa® NGS workflow.  

The Sentosa® SQ HIV-1 Genotyping Assay detects DRMs at a greater sensitivity than Sanger sequencing

MAYO CLINIC AND CLEVELAND CLINIC

 

In collaboration with the Mayo Clinic and the Cleveland Clinic, Vela Diagnostics conducted a multi-center US FDA registration clinical trial study to evaluate the performance of the Sentosa® SQ HIV-1 Genotyping Assay

The clinical trial found that:

  • At 1,000 copies/mL, the Sentosa® SQ HIV-1 Genotyping Assay detected DRMs at a frequency of ≥20% in ≥90% of replicates
  • Analytical reproducibility tests (10 runs performed at each of 3 laboratory sites) showed 100% sample detection, with DRM detection rates of 99.6%, 98.1%, and 97.9% among the 3 sites (96.0% κ-coefficient).
  • 98.2% to 100% of expected DRMs were detected among 20 clinical reproducibility specimens at each of the 3 laboratory sites.

 

Watch the video here

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STANFORD UNIVERSITY
 
 
Stanford University conducted a Blinded Comparison of the Sentosa® SQ HIV-1 Genotyping Assay with Sanger Sequencing for HIV-1 using cryopreserved samples that were found to have HIV DRMs .
 
We determined the extent of concordance between Sanger sequencing and NGS for the identification of DRMs and predicted levels of reduced susceptibility to the most commonly used antiretroviral (ARV) drugs.
 
The more sensitive detection of low-level variants by NGS resulted in a higher predicted level of drug resistance in 9 (18.4%) of 49 samples and in 18 (3.8%) of 490 drug resistance interpretations. Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) was the most commonly affected antiretroviral class.” 
 
 
 
 
 
INSTITUTE OF VIROLOGY, UNIVERSITY HOSPITAL OF COLOGNE
 
 
“We analysed 122 plasma samples with a viral load of more than 1000 copies/mL of therapy-naive and therapy-experienced patients with 3 different HIV genotyping methods. 109 samples could be successfully analysed with VELA, Sanger and in-house methods.
 
We saw a concordance of 98.2% within PR-RT and 99.1% within IN for subtype prediction between the Sentosa® SQ HIV-1 Genotyping Assay versus COMET HIV-1 subtyping based on Sanger sequencing.
 
For therapy-experienced patients (13%), we demonstrated that the Sentosa® SQ HIV-1 Genotyping Assay detects all mutations which were found by Sanger sequencing. The assay also reported additional mutations (>3.4% minorities) - 5 for NRTI, 3 for NNRTI and 2 for PI."
 
 
 
 
 
UNIVERSITY OF TOULOUSE
 
 
The University of Toulouse conducted a study to evaluate the diagnostic performance of the Sentosa® SQ HIV-1 Genotyping Assay on the VELA NGS Workflow for sequencing and genotyping HIV-1 samples.
 
They concluded that:
 
The Sentosa® SQ HIV-1 Genotyping Assay and VELA NGS Workflow identified the same resistance-associated mutations found by direct sequencing. 
 
 
 

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