Hepatitis C RNA Point-of-Care Testing: Performance and Feasibility in a Community Setting

Oct 15, 2024

Photo Credit: jarun011

The following is a summary of “Feasibility and Performance of a Point-of-Care Hepatitis C RNA Assay in a Community Supervision Cohort,” published in the October 2024 issue of Infectious Disease by Harvey et al.

Efforts to eliminate the hepatitis C virus (HCV) in the United States have been slowed by the need for multistep diagnostic processes that delay treatment, especially in high-risk populations such as people who use drugs or those involved in the carceral system. Point-of-care (POC) HCV RNA testing has shown promise in increasing treatment uptake and speeding up time to treatment, but such tests have only recently been approved for clinical use in the U.S.

For a cross-sectional study, researchers evaluated the feasibility and clinical performance of a POC HCV RNA test (Xpert HCV Viral Load; Cepheid) in a nonclinical setting among individuals on community supervision (probation or parole). It was conducted among 203 participants enrolled in a larger HCV antibody testing program. Participants were aged 18 or older, English-speaking, and had unknown HCV status or had not received prior HCV treatment. Demographic data were self-reported, and POC HCV RNA testing was performed on-site.

Of the 203 participants tested, 94% (n=190) had valid results. The POC HCV RNA assay demonstrated a sensitivity of 96.8% and a specificity of 99.4% compared to laboratory-based testing. Discrepancies in results were found in two cases: one false-positive and one false-negative, which was attributed to acute HCV infection. Approximately 23% of participants with reactive HCV antibodies had no detectable HCV RNA, suggesting spontaneous clearance of the virus. One participant, with negative HCV antibodies but detectable HCV RNA, was identified as having an acute HCV infection.

Investigators concluded that POC HCV RNA testing was feasible and accurate in nonclinical, justice-related settings, allowing for immediate diagnosis and faster linkage to treatment.

The findings highlighted the potential of POC assays to reduce diagnostic delays and improve care for marginalized populations at high risk for HCV. Despite these benefits, the study noted limitations such as its single-site nature and the fact that the POC test had not yet been approved for clinical use during the study period.

Multistep diagnostic approaches currently hinder timely HCV diagnosis and treatment. Still, the approval of POC HCV RNA assays in the U.S. could help eliminate such barriers and bring the country closer to achieving its HCV elimination goals.

Source: doi.org/10.1001/jamanetworkopen.2024.38222

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