WHO pre-qualifies first self-test for Hepatitis C

In its effort to eliminate Hepatitis C virus (HCV) by 2030, the World Health Organisation (WHO) has pre-qualified the first HCV self-test.

On Wednesday, WHO made this known on its website stating that the HCV self-test is critical in expanding access to testing and diagnosis, “accelerating efforts to eliminate hepatitis C globally.”

The global health body explained that the product (OraQuick HCV self-test) is a user-friendly version of the professionally used rapid antibody test.

“The product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick® HCV Rapid Antibody Test which was initially prequalified by WHO in 2017 for professional use. The self-test version, specifically designed for use by lay users, provides individuals with a single kit containing the components that are needed to perform the self-test,” it said.

Eliminating HCV

According to WHO, Hepatitis C is a liver disease caused by the HCV which is transmitted through the bloodstream and can lead to acute and chronic liver disease, including cirrhosis and liver cancer.

In 2016, WHO established a target to eliminate HCV as a major public health concern by 2030, in response to the disease’s significant global health burden and in pursuit of a world where HCV no longer poses a significant threat to public health.

However, current statistics indicate that 58 million people worldwide were living with chronic HCV infection in 2019, with 75 per cent remaining undiagnosed.

To achieve the elimination target, the global body said innovative strategies are essential. “Self-testing emerges as a vital component in this effort, enabling individuals to take the first step toward diagnosis and treatment.”

By expanding access to self-testing, WHO aims to bridge the diagnosis gap and accelerate progress towards a world free of HCV.

Endorsement of HCV self-testing

WHO stated that in 2021, it endorsed HCV self-testing (HCVST) as a strategy to enhance existing HCV testing services in countries noting that the recommendation was grounded in robust evidence, showcasing the effectiveness of HCVST in expanding access and uptake of services, particularly among marginalised populations.

The organisation said Unitaid-supported HCVST projects have proven successful, showing high acceptability “and empowering individuals through autonomy, personal choice, and stigma-free access to self-care.”

WHO’s Director for the Department of Global HIV, Hepatitis and STI Programmes, Meg Doherty, said about 3,500 lives are lost daily to viral hepatitis.

She said: “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.

“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.”

WHO’s prequalification programme

WHO noted that its prequalification (PQ) programme for in-vitro diagnostics (IVDs) encompasses a comprehensive evaluation of various tests, including those employed for the detection of antibodies to the hepatitis C virus (HCV).

Also, it added that the programme rigorously assesses IVDs against stringent standards for quality, safety, and performance, serving as a cornerstone in supporting countries in their endeavour to achieve high-calibre diagnosis and treatment monitoring.

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The organisation’s Director for the Department of Regulation and Prequalification, Rogerio Gasper, said the PQ of HCV self-test enables low- and middle-income countries to access safe, affordable testing, crucial for achieving a 90 per cent diagnosis rate.

She said: “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 per cent of all people with HCV to be diagnosed.

“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries.”