Faculty of medicine and life sciences, Hasselt University, Hasselt, Belgium.
Department of gastroenterology, Ziekenhuis Oost-Limburg, Genk, Belgium.
J Viral Hepat. 2020 Jul;27(7):709-714. doi: 10.1111/jvh.13284. Epub 2020 Mar 13.
To achieve the ambitious goals of the WHO to eliminate hepatitis C virus (HCV) infection as a public health threat by 2030, innovative approaches are needed to improve the uptake for screening and treatment in people who inject drugs (PWID). Important barriers to care are difficult venous access and the two-step approach in current point-of-care tests, using an HCV antibody screening test followed by a confirmatory HCV RNA test. In this study, we aimed to validate the new GenXpert instrument to diagnose HCV RNA by finger prick. This prospective study was conducted in a cohort of PWID in 6 alcohol/drug clinic sites and 1 outreach project in Belgium between January 2018 and March 2019. Plasma and capillary whole-blood samples were collected by venepuncture and finger prick, respectively. Sensitivity and specificity of the GenXpert system were compared to the gold standard Artus HCV RNA kit. Of 153 participants enrolled, 147 (96.1%) had results of both the GenXpert system and Artus HCV RNA kit available. HCV RNA was detected in 35 of 147 (23.8%) by the Artus HCV RNA kit and in 36 of 147 (24.8%) by the GenXpert. Median quantitative HCV RNA viral load on finger prick was 28 700 IU/mL (IQR 4070-65 875) vs 1 900 000IU/mL (IQR 416,466-2,265,510) on plasma. The GenXpert instrument had a sensitivity of 100% (95% CI 90%-100%) and a specificity of 99.1% (95.1%-99.9%). The overall diagnostic accuracy was 99.3% (96.3%-99.9%). This study validates the excellent performance of the GenXpert instrument to assess HCV RNA in capillary whole blood by finger prick in a PWID cohort.
为实现世界卫生组织（WHO）到 2030 年消除丙型肝炎病毒（HCV）感染这一公共卫生威胁的宏伟目标，需要采取创新方法来提高注射吸毒者（PWID）的筛查和治疗参与度。目前，在护理方面存在重要障碍，包括静脉穿刺困难和当前即时检测两步法，即先用 HCV 抗体筛查检测，再用 HCV RNA 确认检测。在这项研究中，我们旨在通过指尖采血验证新型 GeneXpert 仪器诊断 HCV RNA 的性能。这是一项前瞻性研究，于 2018 年 1 月至 2019 年 3 月在比利时的 6 个酒精/药物诊所和 1 个外展项目中，对一组 PWID 进行。通过静脉穿刺和指尖采血分别采集血浆和毛细血管全血样本。将 GeneXpert 系统的敏感性和特异性与金标准 Artus HCV RNA 试剂盒进行比较。共纳入 153 名参与者，其中 147 名（96.1%）的参与者同时获得了 GeneXpert 系统和 Artus HCV RNA 试剂盒的结果。Artus HCV RNA 试剂盒在 147 名参与者中检测到 35 名（23.8%）的 HCV RNA，而 GeneXpert 在 147 名参与者中检测到 36 名（24.8%）的 HCV RNA。指尖采血定量 HCV RNA 病毒载量中位数为 28700IU/ml（四分位距 4070-65875），血浆为 1900000IU/ml（四分位距 416466-2265510）。GeneXpert 仪器的敏感性为 100%（95%CI 90%-100%），特异性为 99.1%（95.1%-99.9%）。总体诊断准确性为 99.3%（96.3%-99.9%）。本研究验证了 GeneXpert 仪器在 PWID 队列中通过指尖采血评估毛细血管全血中 HCV RNA 的优异性能。
