WHO prequalifies first self-test kit for hepatitis C virus — Global Issues

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The OraQuick HCV self-test “can be 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 approved for professional use by WHO in 2017.

Pre-selection by the UN health agency ensures that medicines supplied by international purchasing organisations 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 get the diagnoses and treatments they need, and ultimately contributing to the global goal of HCV elimination” said Dr. Meg Doherty, director of the Division of Global HIV, Hepatitis and STI Programs.

Blood-borne virus

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

It is spread through contact with infected blood, such as sharing needles or syringes, uncontrolled blood transfusions, and sexual practices involving contact with blood.

About 50 million people have a chronic infection with the hepatitis C viruswith about a million new infections per year, According to WHO.

The UN agency estimates that about 242,000 people will have died from hepatitis C in 2022, mainly from cirrhosis and hepatocellular carcinoma, or primary liver cancer.

In 2021, WHO recommended self-testing as a complement to existing testing services. Research has shown that self-testing increases access to and use of services, particularly among people who would not otherwise seek testing for the virus.

Expansion of testing and treatments

According to Dr. Doherty, 3,500 people die every day from viral hepatitis.

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

Dr Rogério Gaspar, Director of the WHO Department of Regulation and Prequalification, added that “the availability of a WHO pre-qualified HCV self-test ensures that low- and middle-income countries have access to safe and affordable self-testing options, which is essential to achieve the target of 90 per cent of all people diagnosed with HCV.”

WHO has indicated that it will continue to assess additional HCV self-testing options, among other things, and will work with other communities to expand the available options to all countries.

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