AI Article Synopsis

  • Drug-resistance monitoring is crucial for effective HIV management, and next-generation sequencing (NGS) technologies improve the detection and treatment of drug resistance.
  • The Vela Diagnostics Sentosa SQ HIV Genotyping Assay, recently approved for diagnostics use, was evaluated in Italy using 420 HIV-1 clinical samples, showing a 97.2% concordance with traditional Sanger sequencing.
  • The assay demonstrated an 87% success rate in clinical applications, with high accuracy and reproducibility, though technical optimizations and cost-speed balance improvements are needed for future implementation.

Article Abstract

Drug-resistance monitoring is one of the hardest challenges in HIV management. Next-generation sequencing (NGS) technologies speed up the detection of drug resistance, allowing the adjustment of antiretroviral therapy and enhancing the quality of life of people living with HIV. Recently, the NGS Sentosa SQ HIV Genotyping Assay (Vela Diagnostics) received approval for in vitro diagnostics use. This work is the first Italian evaluation of the performance of the Vela Diagnostics NGS platform, assessed with 420 HIV-1 clinical samples. A comparison with Sanger sequencing performance is also reported, highlighting the advantages and disadvantages of the Sentosa NGS assay. The precision of the technology was studied with reference specimens, while intra- and inter-assay reproducibility were evaluated for selected clinical samples. Vela Diagnostics' NGS assay reached an 87% success rate through 30 runs of analysis in a real-world clinical context. The concordance with Sanger sequencing outcomes was equal to 97.2%. Several detected mismatches were due to NGS's superior sensitivity to low-frequency variants. A high accuracy was observed in testing reference samples. Repeatability and reproducibility assays highlighted the good performance of the NGS platform. Beyond a few technical issues that call for further optimization, the key improvement will be a better balance between costs and processing speed. Once these issues have been solved, the Sentosa SQ HIV Genotyping Assay will be the way forward for HIV resistance testing.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8911269PMC
http://dx.doi.org/10.3390/ijms23052727DOI Listing

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