Theme: Epidemiology & Public Health Research Year: 2025
Background:
The two-step procedure for HCV diagnosis (screening for antibodies and, if reactive, HCV-RNA testing)
as well as the time, cost and technical skills needed for HCV-RNA assessment represent a bottleneck
to the HCV cascade of care in the prison setting. HCV core antigen (HCVcAg) represents an alternative
marker for confirming HCV infection. The aim of this study is to evaluate the HCVcAg component of
Elecsys® HCV Duo assay for HCV screening, compared to the standard screening practice, in people
living in prison (PLIP).
Methods:
The study was conducted in the largest prison in Greece (Athens, March-June 2024). Following written
informed consent, participants were randomized into one of two screening groups. In Group 1 (standard testing), rapid anti-HCV testing was performed. If positive, blood sampling was performed for HCV-RNA determination. These participants were also tested with Elecsys® HCV Duo assay (antiHCV and HCVcAg). In Group 2 (HCV Duo), blood sampling and testing with Elecsys® HCV Duo assay were performed. If positive, HCV-RNA was performed. HCVcAg sensitivity and specificity were
evaluated using HCV-RNA as the reference method.
Results:
780 male inmates participated (Group 1: N = 507, Group 2: N = 273); 27.4% had history of injecting drug use. In total, 19.8% had reactive HCV antibodies; of those, 60.9% were HCV-RNA(+). HCVcAg sensitivity and specificity was 58% (95% CI: 46-69) and 96% (95% CI: 86-100), respectively. The mean (SD) log10 HCVRNA levels for the concordant [HCV-RNA(+)/HCVcAg(+)] and the discordant [HCVRNA(+)/HCVcAg(-)] samples were 6.4 (0.8) and 5.0 (1.1), respectively. In total, 45 of 47 HCVcAg(+) individuals were also HCV-RNA(+) (HCVcAg positive predictive value: 96%).
Conclusion:
The implementation of HCVcAg could facilitate one-step hepatitis C diagnosis in populations at increased risk, such as PLIP, with reduced sensitivity compared to HCV-RNA (in particular when HCVRNA levels are low) but high positive predictive value.
Disclosure of Interest Statement:
This study was supported through an Investigator Initiated Study grant from Roche Diagnostics International Ltd. The authors declare no other conflicts of interest related to this work.
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