The World Health Organization has prequalified the first hepatitis C virus self-test, which 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 pre-qualified OraQuick® HCV Rapid Antibody Test, which was initially prequalified by WHO in 2017 for professional use.
The UN agency disclosed this in a press statement on Wednesday, noting that 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 in 2021 to complement existing HCV testing services in countries.
The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not test.
The 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, autonomy, and access to stigma-free self-care services.
Dr. Meg Doherty, the WHO Director for the Department of Global HIV, Hepatitis, and STI Programs, stated, “Every day 3,500 lives are lost to viral hepatitis, of the 50 million people living with hepatitis C, only 36 percent have been diagnosed, and 20 percent have received curative treatment by the end of 2022.” She added, “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.”
WHO’s prequalification program for in vitro diagnostics evaluates a range of tests, including those used for the detection of antibodies to HCV.
The program assesses IVDs against quality, safety, and performance standards. It is a cornerstone in supporting countries in achieving high-quality diagnosis and treatment monitoring.
Dr. Rogério Gaspar, the WHO Director for the Department of Regulation and Prequalification, said, “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 are essential to achieving the goal of diagnosing 90% of all people with HCV.”
Finally, the global health body pledged to continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries.
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