WHO Approves First Hepatitis C Self-Test Kit To Boost Global Diagnosis Efforts
The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, marking a significant step in enhancing access to testing and diagnosis. This development aims to accelerate global efforts to eliminate hepatitis C.
Named OraQuick HCV self-test, this product is manufactured by OraSure Technologies. It extends the pre-qualified OraQuick HCV Rapid Antibody Test, initially prequalified by WHO in 2017 for professional use. The self-test version is designed for lay users, providing a single kit with all necessary components for self-testing.
In 2021, WHO recommended HCV self-testing (HCVST) to complement existing HCV testing services. This recommendation was based on evidence showing its potential to increase access and uptake of services, especially among those who might not otherwise test.
National-level HCVST implementation projects, mainly supported by Unitaid, have demonstrated high levels of acceptability and feasibility. These projects empower individuals 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% have received curative treatment by the end of 2022," says 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 various tests used for detecting antibodies to HCV. This programme assesses IVDs against quality, safety, and performance standards. It plays a crucial role in helping countries achieve high-quality diagnosis and treatment monitoring.
"The availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable self-testing options which is essential to achieving the goal of 90% of all people with HCV to be diagnosed," says 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 evaluating additional HCV self-tests while supporting evidence-based implementation. They will also work with communities globally to expand available options.
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