The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, marking a significant advancement in expanding access to testing and diagnosis and accelerating global efforts to eliminate hepatitis C.
The OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the prequalified OraQuick® HCV Rapid Antibody Test, initially approved by WHO in 2017 for professional use.
The self-test version is specifically designed for lay users and provides a single kit containing all necessary components to perform the test.
In 2021, WHO recommended HCV self-testing (HCVST) to complement existing HCV testing services.
This recommendation was based on evidence demonstrating the ability of self-testing to increase access and uptake of services, particularly among individuals who might not otherwise get tested.
National-level HCVST implementation projects, largely supported by Unitaid, have shown high levels of acceptability and feasibility.
These projects empower individuals through personal choice, autonomy, and access to stigma-free self-care services.
“Every day, 3,500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36 per cent had been diagnosed, and 20 per cent had received curative treatment by the end of 2022,” said Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis, and STI Programmes.
“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, ultimately contributing to the global goal of HCV elimination.”
WHO’s prequalification (PQ) program for in vitro diagnostics (IVDs) evaluates a range of tests, including those for detecting antibodies to HCV.
The program assesses IVDs against quality, safety, and performance standards and supports countries in achieving high-quality diagnosis and treatment monitoring.
“The availability of a WHO prequalified HCV self-test enables low- and middle-income countries to access safe and affordable self-testing options, essential for achieving the goal of diagnosing 90% of all people with HCV,” said Dr. Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification.
“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries.”
WHO will continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries.
