World Health Organization prequalifies hepatitis C virus's OraQuick HCV self-test

The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, enhancing testing access and global hepatitis C elimination efforts. The OraQuick HCV self-test, made by OraSure Technologies, is a consumer version of the professional-use OraQuick HCV Rapid Antibody Test, prequalified by WHO in 2017. This self-test kit includes all components for individual use.

WHO recommended HCV self-testing (HCVST) in 2021 to complement existing services, citing evidence that it increases access and uptake, especially among those unlikely to test otherwise. National HCVST projects, mainly supported by Unitaid, have shown high acceptability and feasibility, empowering individuals through autonomy and stigma-free self-care.

The WHO's prequalification (PQ) program for in vitro diagnostics (IVDs) assesses tests, including HCV antibody detection, against quality, safety, and performance standards, aiding countries in high-quality diagnosis and treatment monitoring. WHO will continue to evaluate HCV self-tests and support their implementation globally.