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WHO prequalifies first self-test for hepatitis C virus
The World Health Organization (WHO) has requalified the first hepatitis C virus (HCV) self-test that can provide 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 previously qualified OraQuick® HCV rapid antibody test that was originally requalified by the WHO in 2017. professional use. The self-test version, specifically designed for lay use, provides individuals with a single kit containing the components necessary to perform the self-test.
WHO recommended HCV self-testing (HCVST) in 2021, as a complement to existing HCV testing services in countries. The recommendation was based on evidence showing its ability to increase access to and use of services, particularly among people who would not otherwise be tested.
National level HCVST implementation projects, largely supported by Unitaid, have demonstrated high levels of acceptability and feasibility, as well as empowering people through personal choice, autonomy and stigma-free access to self-care services.
“Every day, 3,500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36% were diagnosed and 20% received curative treatment by the end of 2022,” says Dr Meg Doherty, WHO Director of Global Programs on HIV, Hepatitis and STIs. “Adding 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 eliminating HCV.”
WHO Prequalification Program (PQ) for In Vitro Diagnostics (IVD) evaluates a range of tests, including those used to detect antibodies to HCV. The program evaluates IVD against standards of quality, safety and efficacy. It is a cornerstone in supporting countries to achieve high-quality diagnosis and follow-up treatment.
“The availability of pre-qualified WHO self-testing for HCV allows low- and middle-income countries to access safe and affordable self-testing options, which is critical to achieving the goal of diagnosing 90% of all people with HCV,” says Dr. Rogério Gaspar, WHO Director of the Department for Regulation and Retraining. “This achievement contributes to improving access to quality-assured health products for more people living in low-income countries.”
WHO will continue to evaluate additional HCV self-tests, support evidence-based implementation and work with communities to expand available options to all countries.
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Sources 2/ https://www.who.int/news/item/10-07-2024-who-prequalifies-the-first-self-test-for-hepatitis-c-virus The mention sources can contact us to remove/changing this article |
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