Performance of a rapid diagnostic test for screening of hepatitis C in a real-life prison setting

Abstract Background 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. Objectives 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. Study design 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. Results 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. Conclusions 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.