WHO prequalifies first self-test kit for Hepatitis C virus

The OraQuick HCV self-test “can provide a critical support in expanding access to testing and diagnosis,” WHO said in a press release.

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 helps to ensure that medicines 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.

Bloodborne virus

Hepatitis C attacks the liver and can cause both acute and chronic illness that can be life-threatening.

It is spread through contact with infected blood, including through sharing needles or syringes, unscreened blood transfusions, and sexual practices that lead to exposure to blood.

Some 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 approximately 242,000 people died from hepatitis C in 2022, mostly from cirrhosis and hepatocellular carcinoma, or primary liver cancer.

WHO recommended self-testing in 2021 to complement existing testing services, based on evidence demonstrating that it increases both access to and uptake of services, particularly among people who may not otherwise test for the virus.

Expanding testing and treatment

Dr. Doherty said 3,500 lives are lost each day to viral hepatitis.

Furthermore, “of the 50 million people living with hepatitis C, only 36 per cent had been diagnosed, and 20 per cent have received curative treatment by the end of 2022.”

Dr. Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification, added that “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 per cent of all people with HCV to be diagnosed.”

WHO said that it will continue to assess additional HCV self-tests, among other measures, that include working with communities to expand available options to all countries.