Balancing Efficiency and Accuracy in Hepatitis C Rapid Antibody Testing: Insights From a Cluster Randomised Crossover Trial

Abstract

Hepatitis C remains a significant global health problem, particularly among people who inject drugs. To achieve Australia's 2030 elimination targets, efficient testing strategies are needed. The OraQuick rapid antibody test provides results in 20 min, but many non-viraemic individuals with resolved infections test positive, potentially leading to unnecessary confirmatory RNA testing. Reducing the read time to five minutes has been proposed to reduce false positives and improve efficiency, but its impact on viremia detection is unclear. This study utilised data from the QuickStart study, a randomised controlled trial investigating different rapid testing pathways and a same-day test-and-treat model. Participants underwent OraQuick rapid antibody testing with results read at both five and 20 min, followed by confirmatory RNA testing. Among 298 participants with OraQuick and RNA test results, the 20-min OraQuick test was positive for all 79 viraemic individuals and 156 non-viraemic individuals. At five minutes, positive results decreased to 77 (97.5%) of viraemic and 135 (87%) non-viraemic individuals with positive 20-min results. Using a five-minute result to trigger RNA testing would have reduced unnecessary RNA testing by 13% in our cohort at the cost of missing 2.5% of viraemic individuals. A five-minute read time could improve efficiency by reducing unnecessary RNA testing, but confirmatory RNA testing remains essential to distinguish active from resolved infections. The balance between efficiency and accuracy may vary contextually, reflecting differing rates of resolved infections. This approach may be beneficial in resource-limited settings, but the potential for missed viremia must be considered. Trial Registration: ClinicalTrials.gov number; NCT05016609.

Keywords: diagnostic accuracy; hepatitis C; people who inject drugs; point‐of‐care; rapid antibody test.