WHO prequalifies first self-test for hepatitis C virus

The availability of a WHO-prequalified HCV self-test allows low- and middle-income countries to have access to safe and affordable self-testing options.

WHO communiqué

Viral hepatitis kills 3,500 people every day. Of the 50 million people living with hepatitis C, only 36% have been diagnosed.

World Health Organization (WHO)) has been prequalified as the first HIV self-diagnosis test. hepatitis C (HCV), which can provide critical support in expanding access to testing and diagnostics, accelerating global efforts to eliminate hepatitis C.

The OraQuick HCV Self-Test product, manufactured by OraSure Technologies, is a follow-up to the prequalified OraQuick® HCV Rapid Antibody Test, which was originally prequalified by WHO in 2017 for professional use. The self-test version, designed specifically for non-professional users, provides users with a single kit containing the components needed to perform the test.

WHO recommended home-based HCV testing in 2021 as a complement to existing HCV testing services in countries. The recommendation was based on evidence demonstrating its potential to increase access to and use of services, particularly among people who would otherwise not be able to get tested.

National HCVST implementation projects, largely supported by Unitaid, have demonstrated high levels of acceptability and feasibility, as well as empowerment of people through personal choice, autonomy and access to safe self-care services.

“Every day 3,500 lives are lost because of viral hepatitisBy the end of 2022, of the 50 million people living with hepatitis C, only 36% had been diagnosed and 20% had received treatment,” the report says. Dr. Meg Doherty, Director of the Department of Global HIV, Hepatitis and STI Programmes, WHO.

“Adding this product to the WHO prequalification list provides a safe and effective way to scale up HCV screening and treatment services, ensuring that more people receive the diagnosis and treatment they need and ultimately contributing to the global goal of eliminating HCV.”

The WHO Prequalification Programme for In Vitro Diagnostics evaluates a range of tests, including those used to detect antibodies to HCV. The programme assesses in vitro diagnostics against quality, safety and efficacy standards. It is a key element in helping countries achieve high-quality diagnostics and treatment monitoring.

“Availability Self-testing for HCV “WHO prequalification enables low- and middle-income countries to have access to safe and affordable self-testing options, which is essential to achieving the target of 90% of all people with HCV being diagnosed,” said Dr Rogerio Gaspar, Director of the Department of Regulation and Prequalification at WHO. “This achievement will improve access to quality-assured medical products for more people living in low-income countries.”

WHO will continue to evaluate additional HCV self-testing tests, support evidence-based implementation, and work with communities to expand available options for all countries.

WHO communiqué