Singapore (August 21, 2017) – Vela Diagnostics announced today that the Next Generation Sequencing (NGS)-based Sentosa® SQ HIV Genotyping Assay is now CE-IVD marked for in-vitro diagnostics use. The Sentosa® SQ HIV Genotyping Assay is intended for the detection of HIV-1 Group M genomic mutations in Protease, Reverse Transcriptase and Integrase regions from plasma in patients diagnosed with HIV infection.
The Sentosa® SQ HIV Genotyping Assay is validated on the highly automated Sentosa® NGS workflow which enables automated RNA extraction, library construction, template preparation, sequencing, data analysis and generation of both Pathology report and Quality Control report. The Sentosa® NGS workflow also allows clear sample traceability, with seamless LIS integration and connectivity.
The Sentosa® SQ HIV Genotyping Assay on Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands on - and turn around time in comparison to Sanger and other non automated NGS alternatives. The automated workflow is validated to process clinical samples with as low as 1,000 copies/mL of HIV viral load. This highly sensitive assay is also able to detect as low as 5% variant frequency at 4000 copies/mL viral load, and has demonstrated 98.50% clinical sensitivity in all three target regions, 99.82% variant detection correctness, with 100% reproducibility.
To learn more about Sentosa® NGS workflow and test menu, visit http://www.veladx.com/products.html#ngs