WHO to evaluate first self-test for hepatitis C virus

The World Health Organization (WHO) has prequalified the drug.the first self-test for hepatitis C virus (HCV)which can provide critical support in expanding access to testing and diagnostics, accelerating global efforts to eliminate hepatitis C, a disease that kills an estimated 3,500 people every day.

The product is called “OraQuick HCV Self-Test”manufactured by OraSure Technologies, is an extension of the prequalified rapid HCV antibody test OraQuick, which was initially evaluated by WHO in 2017 for professional use. The self-test version, designed specifically for use by non-professional usersprovides people 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 research showing its potential 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.

This is stated by the Director of the Department of Global HIV, Hepatitis and STI Programmes at WHO, Dr. Meg Doherty. “Adding this product to the WHO prequalification list provides a safe and effective way to scale up HCV screening and treatment services. ensure that more people receive the diagnosis and treatment they need and ultimately contribute to achieving the global goal of HCV elimination.”

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 performance. This is a critical element in helping countries achieve high-quality diagnosis and treatment monitoring.