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WHO prequalifies first self-test for hepatitis C virus


By: Henrietta Afful

The World Health Organization (WHO), has approved the first self-test for hepatitis C virus (HCV), marking a pivotal moment in the effort to increase access to testing and diagnosis. This development is expected to boost global initiatives aimed at eliminating hepatitis C.

The latest product from OraSure Technologies, the OraQuick HCV Self-Test, is an extension of the OraQuick® HCV Rapid Antibody Test, which was prequalified by the World Health Organization for professional use in 2017. This new version is intended for lay users and comes with a single kit containing the components needed to perform the self-test.

This was contained in a Press Release issued on Wednesday, July 10, 2024 by the World Health Organisation.

The world health governing body recommended HCV Self-Test (HCVST) in 2021 to complement existing HCV testing services in countries. The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.

The statement said national-level HCV self-testing (HCVST) implementation projects, primarily funded by Unitaid, have demonstrated high acceptability and feasibility. These projects have empowered individuals by offering 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 ”Dr Meg Doherty added.

WHO’s PQ Programme For In Vitro Diagnostics

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. It 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 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,” WHO Director for the Department of Regulation and Prequalification, Dr Rogério Gaspar said.

“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries” he said.

About Hepatitis C

Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness to a serious, lifelong illness including liver cirrhosis and cancer.

The hepatitis C virus is a bloodborne virus and most infection occur through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use and sexual practices that lead to exposure to blood.

The World Health Organization indicates that globally, an estimated 50 million people have chronic hepatitis C virus infection, with about 1.0 million new infections occurring per year.

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