The World Health Organization (WHO) has prequalified the first self-test for hepatitis C virus (HCV), which could significantly expand access to testing and diagnosis and accelerate global action to eliminate hepatitis C.
This self-test is called OraQuick HCV and is manufactured by OraSure Technologies, Inc. It is a by-product of the OraQuick® Rapid Hepatitis C Antibody Test, which was prequalified by the World Health Organization in 2017 for the detection of hepatitis C virus (HCV) antibodies. Professional useThe self-test version, designed specifically for non-professional users, is presented in a single kit containing the components necessary to create it.
WHO recommended self-testing for hepatitis C virus (HCV) in 2021, to complement existing testing services in countries. The recommendation was based on evidence that self-testing can expand access and increase service utilization, especially among people who would not otherwise be tested.
National hepatitis C self-testing projects, widely supported by the International Development Assistance Facility, have been shown to be highly acceptable and feasible, helping to empower people to make their own choices and take care of themselves without stigmatizing themselves.
“Every day, 3,500 people die from viral hepatitis. At the end of 2022, only 36% of the 50 million people living with hepatitis C had been diagnosed with the disease, and 20% of them received curative treatment.Dr Meg Doherty, Director of the WHO Global Programme Management for HIV, Hepatitis and Sexually Transmitted Infections. “Adding this product to the WHO prequalification list is a safe and effective way to expand hepatitis C testing and treatment services, provide diagnosis and treatment to more people in need and ultimately contribute to the global goal of eliminating hepatitis C.”
The WHO prequalification programme for in vitro diagnostic products involves the evaluation of a range of tests, including hepatitis C antibody tests. In vitro diagnostic products are evaluated on the basis of quality, safety and performance criteria. This programme is a key component of support for countries wishing to ensure high-quality diagnostics and treatment monitoring.
“WHO prequalification of the hepatitis C self-test provides low- and middle-income countries with safe and affordable self-testing solutions, which are essential to achieving the goal of diagnosing 90% of hepatitis C cases,” said Dr.s Rogerio Gaspar, Director of the Department of Regulation and Prequalification at WHO. “This progress helps make quality-assured health products accessible to more people in low-income countries.”
WHO will continue to evaluate other hepatitis C self-tests, help ensure they are evidence-based, and work with communities to scale up solutions that can be used by all countries.
