ADDIS ABABA — The World Health Organization (WHO) announced it has prequalified the first self-test for the hepatitis C virus (HCV), marking a significant step towards the elimination of the viral infection. The OraQuick HCV self-tests can play a critical role in expanding access to testing and diagnosis, according to WHO.
According to Ethiopian News Agency, the kit is manufactured by OraSure Technologies and is an extension of the OraQuick HCV Rapid Antibody Test, which was initially prequalified by WHO in 2017 for professional use. Prequalification by the UN’s health agency ensures that medicines and medical devices supplied by international procurement agencies meet acceptable standards of quality, safety, and efficacy.
“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,” said Dr. Meg Doherty, Director of the Department of Global HIV, Hepatitis and STI Programmes.
Hepatitis C attacks the liver and can cause both acute and chronic illness, which can be life-threatening. It spreads through contact with infected blood, including through sharing needles or syringes, unscreened blood transfusions, and certain sexual practices. Approximately 50 million people have chronic hepatitis C virus infection, with about a million new infections occurring each year, according to WHO. The UN agency estimated that around 242,000 people died from hepatitis C in 2022, mainly from cirrhosis and hepatocellular carcinoma, or primary liver cancer.
WHO recommended self-testing in 2021 to complement existing testing services, based on evidence that it increases both access to and uptake of services, particularly among people who may not otherwise test for the virus. Dr. Doherty highlighted that 3,500 lives are lost each day to viral hepatitis and noted that “of the 50 million people living with hepatitis C, only 36 percent had been diagnosed, and 20 percent have received curative treatment by the end of 2022.”
WHO Director for the Department of Regulation and Prequalification, Dr. Rogério Gaspar, added, “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 90 percent of all people with HCV to be diagnosed.”
WHO will continue to assess additional HCV self-tests and expand available options to all countries in collaboration with communities and stakeholders.