WHO Prequalifies First Hepatitis C Self-Test to Boost Global Testing and Diagnosis Efforts

WHO’s prequalification (PQ) programme for in vitro diagnostics (IVDs) evaluates a range of tests, including those used for the detection of antibodies to HCV.

The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, marking a significant step in expanding access to testing and diagnosis and accelerating global efforts to eliminate hepatitis C.

The product, called OraQuick HCV self-test, is manufactured by OraSure Technologies. It is an extension of the prequalified OraQuick® HCV Rapid Antibody Test, which was initially prequalified by WHO in 2017 for professional use. The self-test version is specifically designed for lay users and provides individuals with a single kit containing all necessary components to perform the test.

WHO recommended HCV self-testing (HCVST) in 2021 to complement existing HCV testing services in countries. The recommendation was based on evidence demonstrating HCVST's ability to increase access to and uptake of services, particularly among people who may not otherwise test.

National-level HCVST implementation projects, largely supported by Unitaid, have shown high levels of acceptability and feasibility. These projects have empowered people 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% had been diagnosed, and 20% have 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, and ultimately contributing to the global goal of HCV elimination."

WHO's prequalification (PQ) programme for in vitro diagnostics (IVDs) evaluates a range of tests, including those used for the detection of antibodies to HCV. The programme assesses IVDs against quality, safety, and performance standards and is a cornerstone in supporting 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 have access to safe and affordable self-testing options, which is essential to 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.