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

The product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick HCV Rapid Antibody Test which was initially prequalified by WHO in 2017 for professional use.

The self-test version, specifically designed for use by lay users, provides individuals with a single kit containing the components that are needed to perform the self-test.

WHO recommended HCV self-testing (HCVST) in 2021, to complement existing HCV testing services in countries.  The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.

National-level HCVST implementation projects, largely supported by Unitaid, have shown high levels of acceptability and feasibility, as well as empowering people through personal choice, autonomy and access to stigma-free self-care services.

“Every day 3500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36% had been diagnosed, and 20% have received curative treatment by the end of 2022,” says Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes.