The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
Lancet Gastroenterol Hepatol. 2017 Jul;2(7):514-520. doi: 10.1016/S2468-1253(17)30075-4. Epub 2017 Apr 22.
Point-of-care hepatitis C virus (HCV) RNA testing offers an advantage over antibody testing (which only indicates previous exposure), enabling diagnosis of active infection in a single visit. In this study, we evaluated the performance of the Xpert HCV Viral Load assay with venepuncture and finger-stick capillary whole-blood samples.
Plasma and finger-stick capillary whole-blood samples were collected from participants in an observational cohort enrolled at five sites in Australia (three drug and alcohol clinics, one homelessness service, and one needle and syringe programme). We compared the sensitivity and specificity of the Xpert HCV Viral Load test for HCV RNA detection by venepuncture and finger-stick collection with the Abbott RealTime HCV Viral Load assay (gold standard).
Of 210 participants enrolled between Feb 8, 2016, and July 27, 2016, 150 participants had viral load testing results for the three assays tested. HCV RNA was detected in 45 (30% [95% CI 23-38]) of 150 participants based on Abbott RealTime. Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in plasma collected by venepuncture was 100·0% (95% CI 92·0-100·0) and specificity was 99·1% (95% CI 94·9-100·0). Sensitivity of the Xpert HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick was 95·5% (95% CI 84·5-99·4) and specificity was 98·1% (95% CI 93·4-99·8). No adverse events caused by the index test or the reference standard were observed.
The Xpert HCV Viral Load test can detect active infection from a finger-stick sample, which represents an advance over antibody-based tests that only indicate past or previous exposure.
National Health and Medical Research Council (Australia), Cepheid, South Eastern Sydney Local Health District (Australia), and Merck Sharp & Dohme (Australia).
即时护理点（point-of-care）丙型肝炎病毒（HCV）RNA 检测比抗体检测具有优势（抗体检测仅表明曾有过暴露），能在单次就诊时诊断出活动性感染。本研究评估了 Xpert HCV 病毒载量检测在静脉穿刺和手指针刺毛细血管全血样本中的性能。
本研究从澳大利亚五个地点（三个药物和酒精诊所、一个无家可归者服务中心和一个针具交换项目）入组的观察性队列参与者中采集血浆和手指针刺毛细血管全血样本。我们将 Xpert HCV 病毒载量检测通过静脉穿刺和手指针刺采集对 HCV RNA 检测的灵敏度和特异性与 Abbott RealTime HCV 病毒载量检测（金标准）进行了比较。
在 2016 年 2 月 8 日至 7 月 27 日期间入组的 210 名参与者中，有 150 名参与者的三种检测方法均进行了病毒载量检测。根据 Abbott RealTime，有 45 名（30%[95%CI 23-38]）参与者的 HCV RNA 检测呈阳性。Xpert HCV 病毒载量检测对静脉穿刺采集的血浆中 HCV RNA 的检测灵敏度为 100·0%（95%CI 92·0-100·0），特异性为 99·1%（95%CI 94·9-100·0）。Xpert HCV 病毒载量检测对手指针刺采集的样本中 HCV RNA 的检测灵敏度为 95·5%（95%CI 84·5-99·4），特异性为 98·1%（95%CI 93·4-99·8）。未观察到由参比检测或金标准引起的不良事件。
Xpert HCV 病毒载量检测可从手指针刺样本中检测到活动性感染，这比仅表明过去或既往暴露的抗体检测有了进步。
澳大利亚国家卫生与医学研究理事会、Cepheid、澳大利亚南东部悉尼地方卫生区和默克 Sharp & Dohme（澳大利亚）。
