World Health Organisation prequalifies first self-test for hepatitis C virus

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In a first, the World Health Organisation (WHO) on Wednesday prequalified the hepatitis C virus (HCV) self-test that will help expand access to testing and diagnosis and accelerate global efforts to eliminate the disease.

Hepatitis is an inflammation of the liver caused by a variety of infectious viruses and non-infectious agents leading to a range of health problems.

An estimated 354 million people worldwide live with hepatitis B or C, and for most, testing and treatment remain beyond reach.

The new product, called OraQuick HCV self-test, manufactured by US-based OraSure Technologies is designed for use by anyone, without any expertise.

The WHO had, in 2021, recommended HCV self-testing (HCVST) to complement existing HCV testing services in countries, and may help increase access to and uptake of services, particularly among people who may not otherwise test.

"Every day 3,500 lives are lost to viral hepatitis. 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," said 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 diagnosis and treatment they need, and ultimately contributing to the global goal of HCV elimination," she added.

Importantly, the WHO prequalified HCV self-test will help "low- and middle-income countries have access to safe and affordable self-testing options -- essential to achieving the goal of 90 per cent of all people with HCV to be diagnosed", said Dr Rogerio Gaspar, WHO Director for the Department of Regulation and Prequalification.

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