The World Health Organization (WHO) has qualified the first hepatitis C virus (HCV) self-test that can provide critical support to expand 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 default OraQuick® HCV Rapid Antibody test originally qualified by WHO in 2017 for professional use. The self-test version, specially designed for use by ordinary 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 countries. The recommendation was based on evidence of its ability to increase access and uptake of services, particularly among people who might not otherwise try.
National level HCVST implementation projects, largely supported by Unitaid, have shown high levels of acceptance and feasibility, as well as empowering people through personal choice, autonomy and access to stigma-free self-care services.
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% were on treatment by the end of 2022. Adding this product to the WHO default list provides a safe and effective way to expand testing HCV and treatment services, ensuring more people receive the diagnoses and treatment they need, and ultimately contributing to the global goal of eliminating HCV.”
Dr. Meg Doherty, WHO Director of the Division of Global Programs on HIV, Hepatitis and STDs
The WHO program of prequalification (PQ) for in vitro diagnostics (IVDs) evaluates a range of tests, including those used to detect antibodies to HCV. The program evaluates IVDs against quality, safety and performance standards. It is a cornerstone in supporting countries to achieve high quality follow-up diagnosis and treatment.
“The availability of a WHO default HCV self-test allows low- and middle-income countries to access safe and affordable self-testing options that are essential to achieving the goal of diagnosing 90% of all people with HCV,” he says. Dr Rogério Gaspar, WHO Director of the Department of Regulations and Defaults. “This achievement helps improve access to quality-assured health products for more people living in low-income countries.”
WHO will continue to evaluate additional HCV self-testing, support evidence-based implementation and work with communities to expand available options in all countries.
