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.
Highlights
More than 40 million people all over the world are currently living with human immunodeficiency virus (HIV), the retrovirus responsible for the HIV/AIDS pandemic [1]
The Sentosa® SQ HIV Genotyping Assay was performed to check for resistance-associated mutations (RAMs) upon treatment failure or before the start of Combined antiretroviral therapy (cART)
This study reports the analytical assessment of the Sentosa® SQ HIV Genotyping Assay in a real-world clinical context
Summary
More than 40 million people all over the world are currently living with HIV, the retrovirus responsible for the HIV/AIDS pandemic [1]. After almost 40 years from the isolation of HIV, this retrovirus is still a world health threat. In 2020, HIV claimed the life of 680,000 people [2]. Combined antiretroviral therapy (cART) suppresses HIV replication, preventing the development of AIDS syndrome and replacing it with a manageable chronic disease [3]. A cure with which to eradicate HIV is currently unavailable, partly because of the intrinsic genetic variability of this infectious agent [4]. CART triggers the emergence of HIV-resistant variants, selected under drug pressure [5]. Several studies have explored the impact of low-frequency resistance-associated mutations (RAMs) on virological failure [6,7]
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