The first hepatitis C virus (HCV) self-test has been pre-qualified by the World Health Organisation (WHO), providing critical support in expanding access to testing and diagnosis, and accelerating global efforts to eliminate the virus.
The OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick® HCV Rapid Antibody Test that was initially pre-qualified 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 needed to perform the self-test.
WHO recommended HCV self-testing (HCVST) in 2021, to complement existing HCV testing services in various 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 and access to stigma-free self-care services.
Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes, said that every day, 3 500 lives were lost to viral hepatitis.
“Of the 50m people with hepatitis C, only 36% had been diagnosed, and 20% had received curative treatment by the end of 2022.
“Adding this product to the WHO pre-qualification list will expand HCV testing and treatment services, contributing to the global goal of HCV elimination.”
WHO’s pre-qualification (PQ) programme for in vitro diagnostics (IVDs) evaluates a range of tests, including those used for the detection of antibodies to HCV. The programme assesses IVDs against quality, safety and performance standards. It is a cornerstone in supporting countries in achieving high-quality diagnosis and treatment monitoring.
“The availability of a WHO prequalified HCV self-test enables low- and middle-income countries to have access to safe and affordable self-testing options, essential to achieving the goal of 90% of all people with HCV to be diagnosed,” says Dr Rogério Gaspar, WHO Director for the Department of Regulation and Pre-qualification.
WHO article – WHO prequalifies the first self-test for hepatitis C virus (Open access)
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