Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran; Middle East Liver Diseases (MELD) Center, Tehran, Iran.
Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
J Clin Virol. 2019 Apr;113:20-23. doi: 10.1016/j.jcv.2019.02.005. Epub 2019 Feb 25.
Hepatitis C virus (HCV) point-of-care testing using rapid diagnostic test (RDT) is the solution for large-scale, feasible, fast and reliable screening of HCV infection.
The aim of this study was to evaluate the diagnostic performance of HCV RDT for screening of HCV infection in a real-life prison setting.
This study was conducted on individuals admitted and incarcerated in the Central Prison of Karaj, 2017-2018. For all inmates, anti-HCV testing using a RDT on finger-stick blood in the prison and ELISA at the laboratory were performed. For evaluation of reproducibility, more than 1000 cases were recruited for re-evaluation of the HCV RDT using anticoagulated blood in the laboratory.
Among 1788 participants, 76 (4.25%) and 106 (5.93%) were positive for anti-HCV using RDT and ELISA, respectively. Among 34 cases with discordant results using the RDT and ELISA, 17 were the result of testing error in prison, 7 false positive of ELISA and 10 false negative of RDT in individuals with HCV spontaneous clearance. The sensitivity of the RDT with inclusion of testing error in prison for detection of anti-HCV was 75%. However, with exclusion of testing error in prison and considering HCV RNA as the reference method for diagnosis of current HCV infection the sensitivity reached 100%. The RDT was 100% reproducible using both evaluations in prison and the laboratory.
The RDT is a reliable and feasible method for screening of anti-HCV in settings such as a prison. However, the testing should be performed in a standard procedure to have the optimal diagnostic performance.
使用即时诊断检测（RDT）的丙型肝炎病毒（HCV）即时检测是大规模、可行、快速和可靠筛查 HCV 感染的解决方案。
本研究旨在评估 HCV RDT 在真实监狱环境中筛查 HCV 感染的诊断性能。
该研究于 2017-2018 年在卡拉季中央监狱接受和监禁的个体中进行。对所有囚犯，在监狱中使用手指刺血进行 HCV RDT 检测，在实验室中使用 ELISA 检测抗-HCV。为了评估重现性，招募了 1000 多例个体，使用实验室中的抗凝血液重新评估 HCV RDT。
在 1788 名参与者中，76 名（4.25%）和 106 名（5.93%）使用 RDT 和 ELISA 检测抗-HCV 呈阳性。在 34 例 RDT 和 ELISA 检测结果不一致的病例中，17 例是监狱检测错误的结果，7 例是 ELISA 假阳性，10 例是 HCV 自发清除的 RDT 假阴性。将监狱检测错误纳入检测的 RDT 检测抗-HCV 的敏感性为 75%。然而，排除监狱检测错误，并将 HCV RNA 作为当前 HCV 感染诊断的参考方法，敏感性达到 100%。使用监狱和实验室的两种评估方法，RDT 的重现性为 100%。
RDT 是一种可靠且可行的筛查监狱环境中抗-HCV 的方法。然而，为了获得最佳的诊断性能，检测应该按照标准程序进行。
