OraQuick hepatitis C virus self-test: A new frontier in hepatitis C screening.

Abstract

According to the World Health Organization, an estimated 58 million people worldwide are chronically infected with hepatitis C virus (HCV), yet only about 20% have been formally diagnosed. Traditional laboratory-based antibody and RNA assays require infrastructure and trained personnel, limiting their uptake in resource-limited and hard-to-reach settings. The OraQuick HCV self-test (HCVST) is the first World Health Organization-prequalified HCVST, which delivers results in 20-40 min via an easy-to-use gum-swab format. Field evaluations report a sensitivity of about 97%-98% and a specificity of about 99%-100% that are comparable with those of blood-based lateral-flow assays (e.g., Alere Truline, SD Bioline). Usability studies demonstrated an acceptability rate of over 90% and a correct self-test completion rate of over 85% in key populations. HCVST with the OraQuick HCVST kit provides a practical, evidence-based approach to closing diagnostic gaps, particularly among underserved or stigmatized populations. To maximize the public health impact, programs should integrate self-testing into national screening algorithms, ensure linkage to RNA confirmation and treatment, and consider economic and operational contexts.