The World Health Organization (WHO) in a significant step forward in the fight against hepatitis C, has prequalified the first hepatitis C virus (HCV) self-test, OraQuick HCV self-test. This innovative product has the potential to revolutionize access to testing and diagnosis, accelerating global efforts to eliminate hepatitis C.
The self-test version of the OraQuick HCV Rapid Antibody Test, initially prequalified by WHO in 2017 for professional use, is specifically designed for lay users. It provides individuals with a single kit containing all the necessary components to perform the self-test.
WHO recommended HCV self-testing (HCVST) in 2021 to complement existing HCV testing services in countries. National-level HCVST implementation projects have shown high levels of acceptability and feasibility, empowering people through personal choice, autonomy, and access to stigma-free self-care services.
According to Dr. Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis, and STI Programmes, “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% have received curative treatment by the end of 2022. 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.”
The WHO prequalification programme for in vitro diagnostics (IVDs) evaluates tests against quality, safety, and performance standards. The availability of a WHO prequalified HCV self-test enables low- and middle-income countries to access safe and affordable self-testing options, essential to achieving the goal of 90% of all people with HCV to be diagnosed.
WHO will continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries. This breakthrough has the potential to transform the lives of millions of people worldwide, bringing us closer to eliminating hepatitis C.
WHO/Ruth Abla ADJORLOLO
