Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; Department of Health and Nutrition, Chia Nan University of Pharmacy and Science, Tainan, Taiwan; School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Department of Laboratory Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.
J Formos Med Assoc. 2021 May;120(5):1237-1241. doi: 10.1016/j.jfma.2020.09.013. Epub 2020 Sep 30.
BACKGROUND/PURPOSE: The HCV core antigen (HCV Ag) assay displays high sensitivity and strong correlation with HCV RNA. However, the feasibility of anti-HCV reflex HCV Ag screening in a community-wide setting is rarely discussed.
We performed a two-phase community-based hepatitis C screen in an HCV-prone area of central Taiwan. During the training phase, all participants were test for anti-HCV, HCV Ag and HCV RNA to validate sensitivity, specificity, and accuracy of HCV Ag. During the validation phase, an anti-HCV reflex HCV Ag screen was conducted based on the results of training phase. Outcomes of the study were presented as positive and negative predictive values (PPV and NPV).
Of 935 training phase participants, the rate of positive anti-HCV and HCV Ag were 175 (18.7%) and 78 (8.3%), respectively. Test sensitivity, specificity, and accuracy of HCV Ag were 97.1%, 98.6%, and 97.8%, respectively. During validation phase, only anti-HCV-positive serum samples were tested for HCV Ag. Of 1932 participant, 285 (14.8%) were anti-HCV-positive. 133 (46.7%) of the 285 anti-HCV-positive samples were HCV Ag-positive. PPV and NPV were 98.4% and 99.3%, respectively. Across the entire participant sample, a significant linear correlation between HCV Ag and HCV RNA concentration was noted (r = 0.93, p-value<0.001) following log-log transformation.
Anti-HCV reflex HCV Ag screening is a feasible strategy for aiding HCV-prone communities.
背景/目的：丙型肝炎病毒核心抗原（HCV Ag）检测具有很高的灵敏度，与 HCV RNA 具有很强的相关性。然而，在社区范围内进行抗-HCV 反射性 HCV Ag 筛查的可行性很少被讨论。
我们在台湾中部一个丙型肝炎高发地区进行了两阶段基于社区的丙型肝炎筛查。在培训阶段，所有参与者都接受了抗-HCV、HCV Ag 和 HCV RNA 检测，以验证 HCV Ag 的灵敏度、特异性和准确性。在验证阶段，根据培训阶段的结果进行了抗-HCV 反射性 HCV Ag 筛查。研究结果表示为阳性和阴性预测值（PPV 和 NPV）。
在 935 名培训阶段参与者中，抗-HCV 阳性和 HCV Ag 阳性的比例分别为 175（18.7%）和 78（8.3%）。HCV Ag 的检测灵敏度、特异性和准确性分别为 97.1%、98.6%和 97.8%。在验证阶段，仅对抗-HCV 阳性血清样本进行 HCV Ag 检测。在 1932 名参与者中，有 285 名（14.8%）抗-HCV 阳性。在 285 名抗-HCV 阳性样本中，有 133 名（46.7%）HCV Ag 阳性。PPV 和 NPV 分别为 98.4%和 99.3%。在整个参与者样本中，HCV Ag 和 HCV RNA 浓度之间存在显著的线性相关性（r=0.93，p 值<0.001），经过对数-对数转换。
抗-HCV 反射性 HCV Ag 筛查是丙型肝炎高发社区的一种可行策略。
