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Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience

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 Sen...

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Autores principales: Bonifacio, Maria Addolorata, Genchi, Chiara, Lagioia, Antonella, Talamo, Vincenza, Volpe, Anna, Mariggiò, Maria Addolorata
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8911269/
https://www.ncbi.nlm.nih.gov/pubmed/35269868
http://dx.doi.org/10.3390/ijms23052727
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author Bonifacio, Maria Addolorata
Genchi, Chiara
Lagioia, Antonella
Talamo, Vincenza
Volpe, Anna
Mariggiò, Maria Addolorata
author_facet Bonifacio, Maria Addolorata
Genchi, Chiara
Lagioia, Antonella
Talamo, Vincenza
Volpe, Anna
Mariggiò, Maria Addolorata
author_sort Bonifacio, Maria Addolorata
collection PubMed
description 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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spelling pubmed-89112692022-03-11 Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience Bonifacio, Maria Addolorata Genchi, Chiara Lagioia, Antonella Talamo, Vincenza Volpe, Anna Mariggiò, Maria Addolorata Int J Mol Sci Article 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. MDPI 2022-03-01 /pmc/articles/PMC8911269/ /pubmed/35269868 http://dx.doi.org/10.3390/ijms23052727 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bonifacio, Maria Addolorata
Genchi, Chiara
Lagioia, Antonella
Talamo, Vincenza
Volpe, Anna
Mariggiò, Maria Addolorata
Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title_full Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title_fullStr Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title_full_unstemmed Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title_short Analytical Assessment of the Vela Diagnostics NGS Assay for HIV Genotyping and Resistance Testing: The Apulian Experience
title_sort analytical assessment of the vela diagnostics ngs assay for hiv genotyping and resistance testing: the apulian experience
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8911269/
https://www.ncbi.nlm.nih.gov/pubmed/35269868
http://dx.doi.org/10.3390/ijms23052727
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