The first hepatitis C virus (HCV) self-test has been prequalified by the World Health Organisation (WHO), which is a major step in the global campaign to eradicate hepatitis C.
The OraQuick HCV self-test, produced by OraSure Technologies, is an extension of the OraQuick HCV Rapid Antibody Test, which was pre-qualified for use in healthcare settings by the WHO in 2017. This self-test version, which is specifically designed to be used 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 as a supplement to existing HCV testing programmes, noting that HCVST promotes access to and adoption of testing.
The Unitaid-funded national-level HCVST implementation studies have shown high levels of acceptance and feasibility, empowering individuals via personal choice, autonomy, and stigma-free self-care options.
“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% had received curative treatment by the end of 2022,” says WHO Director for the Department of Global HIV, Hepatitis, and STI Programmes, Dr. Meg Doherty.
“The addition of this product to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services, ensuring more people receive the diagnoses and treatment they need and ultimately contributing to the global goal of HCV elimination,” she added.
Also, the WHO Director for the Department of Regulation and Prequalification, Dr. Rogério Gaspar, said that “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, which is essential to achieving the goal of 90% of all people with HCV to be diagnosed.”
He further said that this achievement contributes to improving access to quality-assured health products for more people living in low-income countries.
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