By Joshua Isaac
The World Health Organization (WHO) has approved the first-ever self-test for the detection of Hepatitis C Virus (HCV), marking a significant step towards expanding access to testing and diagnosis worldwide.
The pre-qualification of this self-test is poised to accelerate global efforts towards eliminating Hepatitis C by providing individuals with a user-friendly kit for self-testing.
Hepatitis C disease is an inflammation of the liver caused by the hepatitis C virus. The virus can be transmitted through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use, and sexual practices, causing lifelong illnesses, including liver cirrhosis and cancer.
Globally, an estimated 50 million people have chronic hepatitis C virus infection, with about one million new infections occurring per year, according to the premier world health body.
“Every day, 3500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36% have been diagnosed, and 20% have received curative treatment by the end of 2022. 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 diagnosis and treatment they need, and ultimately contributing to the global goal of HCV elimination,” says Dr. Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes.
Specifically designed for lay users, the self-test version provides individuals with a single kit containing all the necessary components to perform the test in the comfort of their own homes. This innovation will enable individuals to take control of their health and well-being by allowing them to screen for the virus easily and conveniently.
The WHO’s rigorous pre-qualification process ensures the quality, safety, and performance of in vitro diagnostics, such as the hepatitis c self-test, supporting countries in achieving high-quality diagnosis and treatment monitoring.
Before approval, these diagnostic tools are evaluated against stringent quality, safety, and performance standards to ensure that countries can access reliable and accurate testing methods for Hepatitis C detection, diagnosis, and treatment.
The WHO’s pre-qualification program is a cornerstone of its support for countries aiming to achieve high-quality diagnosis and treatment monitoring for diseases, including Hepatitis C.
“The availability of a WHO prequalified HCV self-test enables low- and middle-income countries to access safe and affordable self-testing options, which is essential to achieving the goal of 90% of all people with HCV to be diagnosed. This achievement improves access to quality-assured health products for more people in low-income countries,” says Dr Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification.
In reaffirming its commitment to combating Hepatitis C, WHO will continue to offer additional self-tests for the virus, support evidence-based implementation of testing strategies, and collaborate with communities to expand access to testing options in all countries.
The health organization is crucial in ensuring the accuracy and reliability of testing methods used in healthcare settings worldwide by setting rigorous standards and guidelines for in vitro diagnostics.
