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First CE-Marked Next-Generation Sequencing-based <i>in vitro</i> Diagnostics Test for HCV Genotyping
EP26399
Poster Title: First CE-Marked Next-Generation Sequencing-based in vitro Diagnostics Test for HCV Genotyping
Submitted on 11 Sep 2017
Author(s): Elian Rakhmanaliev, Alex Yeo, Yin Kum Ng, Pramila Ariyaratne, Wen Huang, Gerd Michel, Charlie Lee
Affiliations: Vela Diagnostics Pte. Ltd.
This poster was presented at The Singapore Hepatitis Conference. Singapore. 2–3 June 2017.
Poster Views: 1,110
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Poster Information
Abstract: Accurate determination of HCV genotypes (GTs) and detection of resistance-associated mutations (RAVs) is essential for treatment. Next Generation Sequencing (NGS) technology is increasingly used for genotyping and drug resistance testing in research field. The objective was to develop and evaluate an automated NGS-based workflow for HCV genotyping for in vitro diagnostics. The novel Sentosa HCV genotyping workflow comprised of 1) a robotic liquid handling system for RNA extraction and NGS library preparation (Sentosa SX101); 2) Ion Torrent NGS platform; 3) kits for RNA extraction, HCV NGS library preparation (Sentosa SQ HCV Genotyping Assay) and deep sequencing, and 4) data analysis and reporting software. The data reports on GTs 1a and 1b include 136 known RAVs in the NS3, NS5A and NS5B genes. However, the system does not make direct treatment recommendations, which are left to the investigator. The Sentosa HCV NGS workflow is highly automated and required <3hrs. hands-on time with total turn around time about 26hrs. The assay is able to process up to 15 clinical samples simultaneously. The analytical sensitivity was determined to be 1000IU/mL for GTs 1-4, and 2000IU/mL for GTs 5 and 6; reproducibility was 98.9%. For clinical evaluation we used a line probe-based test (VERSANT HCV Genotype 2.0 LiPA) in conjunction with the AutoBlot 3000H platform. Sanger sequencing was used as a reference method for discordant samples. Clinical study was conducted on 346 clinical samples across all 6 HCV GTs. Clinical sensitivity and genotyping correctness aggregated were 86.4% (95%CI:82.4-89.6%) and 93.7% (95%CI:90.3-95.9%) for VERSANT and 100% (95%CI:98.9-100%) and 100% (95%CI:98.7-100%) for Sentosa HCV, respectively. Considering the crucial role of drug resistance monitoring in HCV treatment management, the Sentosa HCV NGS workflow appears as a highly reliable tool for differentiating HCV GTs and RAVs, which can help to prevent diagnostic errors potentially leading to suboptimal treatment.Summary: First CE-Marked Next-Generation Sequencing-based In Vitro Diagnostics Test for HCV Genotyping.Report abuse »
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