Department of Clinical Biochemistry (Clinical Laboratories), University Hospital Vall d'Hebron, Barcelona, Spain.
Clinical Biochemistry Research Group, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain.
J Clin Microbiol. 2019 Dec 23;58(1). doi: 10.1128/JCM.01815-19.
The remarkable effectivity of current antiviral therapies has led to consider the elimination of hepatitis C virus (HCV) infection. However, HCV infection is highly underdiagnosed; therefore, a global strategy for eliminating it requires improving the effectiveness of HCV diagnosis to identify hidden cases. In this study, we assessed the effectiveness of a protocol for HCV diagnosis based on viral load reflex testing of anti-HCV antibody-positive patients (known as one-step diagnosis) by analyzing all diagnostic tests performed by a central laboratory covering an area of 1.5 million inhabitants in Barcelona, Spain, before (83,786 cases) and after (45,935 cases) the implementation of the reflex testing protocol. After its implementation, the percentage of anti-HCV-positive patients with omitted HCV RNA determination remarkably decreased in most settings, particularly in drug treatment centers and primary care settings, where omitted HCV RNA analyses had absolute reductions of 76.4 and 20.2%, respectively. In these two settings, the percentage of HCV RNA-positive patients identified as a result of reflex testing accounted for 55 and 61% of all anti-HCV-positive patients. HCV RNA results were provided in a mean of 2 days. The presence of HCV RNA and age of ≥65 years were significantly associated with advanced fibrosis, assessed using the serological FIB-4 index (odds ratio [OR], 5.92; 95% confidence interval [CI], 3.4 to 10.4). The implementation of viral load reflex testing in a central laboratory is feasible and significantly increases the diagnostic effectiveness of HCV infections, while allowing the identification of underdiagnosed cases.
目前抗病毒疗法的显著疗效使得人们考虑消除丙型肝炎病毒 (HCV) 感染。然而，HCV 感染的诊断率非常低；因此，消除 HCV 的全球策略需要提高 HCV 诊断的有效性，以发现隐匿性病例。在这项研究中，我们通过分析西班牙巴塞罗那一个覆盖 150 万居民的中央实验室进行的所有诊断检测，评估了基于 HCV 抗体阳性患者病毒载量反射检测（称为一步诊断）的 HCV 诊断方案的有效性，该实验室在实施反射检测方案之前（83786 例）和之后（45935 例）进行了所有诊断检测。实施后，在大多数情况下，特别是在药物治疗中心和初级保健机构，抗-HCV 阳性患者中未进行 HCV RNA 检测的比例显著降低，在这些机构中，未进行 HCV RNA 分析的绝对比例分别降低了 76.4%和 20.2%。在这两个环境中，由于反射检测而确定的 HCV RNA 阳性患者比例分别占所有抗-HCV 阳性患者的 55%和 61%。HCV RNA 结果平均在 2 天内提供。HCV RNA 的存在和年龄≥65 岁与使用血清学 FIB-4 指数评估的晚期纤维化显著相关（比值比 [OR]，5.92；95%置信区间 [CI]，3.4 至 10.4）。在中央实验室实施病毒载量反射检测是可行的，并且可以显著提高 HCV 感染的诊断效果，同时还可以发现未被诊断的病例。
