WHO prequalifies first HCV self-test

The World Health Organization (WHO) has prequalified the first self-test for hepatitis C virus (HCV) that could provide critical support in expanding access to testing and diagnostics. accelerating global efforts to eliminate hepatitis C.

The product, called the OraQuick HCV Self-Test, manufactured by OraSure Technologies, is an extension of the prequalified rapid HCV antibody test, OraQuick, which was initially 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 recommends home testing for HCV in 2021 in addition to existing HCV testing services in countries. The recommendation was based on research showing its ability to increase access to and uptake 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 self-care services without stigma.

Director of the Department of Global HIV, Hepatitis and STI Programmes, WHO, Dr. Meg Doherty it is said that “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 against HCV. The programme assesses in vitro diagnostics against standards of quality, safety and efficacy. It is a fundamental element in helping countries achieve high-quality diagnostics and treatment monitoring.