The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, OraQuick HCV self-test, manufactured by OraSure Technologies. This self-test, an extension of the professional-use OraQuick® HCV Rapid Antibody Test, is designed for lay users and includes all necessary components to perform the test. HCV self-testing, recommended by WHO since 2021, has proven effective in increasing testing uptake, particularly among underserved populations. National implementation projects, supported by Unitaid, have shown high acceptability, feasibility, and the potential to empower individuals with stigma-free, self-directed care options.

With only 36% of the estimated 50 million people living with HCV diagnosed and just 20% receiving curative treatment by the end of 2022, WHO emphasizes the critical role of HCV self-tests in expanding access to care. This milestone enables low- and middle-income countries to access affordable testing options, contributing to the global goal of diagnosing 90% of people with HCV and advancing efforts toward HCV elimination. WHO will continue to assess additional self-tests, promote evidence-based implementation, and collaborate with communities to ensure broader access worldwide.

Reference: Who Media Team. WHO prequalifies the first self-test for hepatitis C virus. World Health Organization. Published July 10, 2024. Accessed December 17, 2024. https://www.who.int/news/item/10-07-2024-who-prequalifies-the-first-self-test-for-hepatitis-c-virus