In its effort to eliminate hepatitis C virus (HCV) by 2030, the World Health Organization (WHO) has prequalified the first HCV self-test.
On Wednesday, the WHO made this known on its website, stating that HCV self-testing is critical to expanding access to testing and diagnosis, “accelerating efforts to eliminate hepatitis C globally.”
The global health body explained that the product (OraQuick HCV self-diagnostic test) is an easy-to-use version of the professionally used rapid antibody test.
“The product, called the OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the prequalified OraQuick® HCV rapid antibody test, which was initially prequalified by WHO in 2017 for professional use. The self-test version, designed specifically for use by non-professional users, provides individuals with a single kit containing the components necessary to perform the test,” it said.
Eliminating HCV
According to WHO, hepatitis C is a liver disease caused by HCV that is transmitted through the bloodstream and can cause acute and chronic liver disease, including cirrhosis and liver cancer.
In 2016, WHO set a goal of eliminating HCV as a major public health problem by 2030, in response to the significant global health burden of the disease and in pursuit of a world in which HCV no longer poses a significant threat to public health.
However, current statistics indicate that in 2019, 58 million people worldwide were living with chronic HCV infection, and 75 percent remained undiagnosed.
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To achieve the elimination goal, the world body said innovative strategies are essential. “Self-diagnosis emerges as a vital component in this effort, allowing people to take the first step towards diagnosis and treatment.”
By expanding access to self-testing, WHO aims to reduce the diagnostic gap and accelerate progress towards a world free of HCV.
HCV Self-Test Passed
WHO stated that in 2021 it endorsed HCV self-testing (HCVST) as a strategy to improve existing HCV testing services in countries, noting that the recommendation was based on strong evidence showing the effectiveness of HCVST in expanding access and uptake of services, particularly among marginalized populations.
The organisation said Unitaid-supported HCVST projects have proven successful, showing high acceptability “and empowering people through autonomy, personal choice and stigma-free access to self-care”.
WHO Director of Global Programmes on HIV, Hepatitis and STIs Meg Doherty said around 3,500 lives are lost every day to viral hepatitis.
According to her, “3,500 lives are lost every day due to viral hepatitis. Of the 50 million people living with hepatitis C, by the end of 2022 only 36% had been diagnosed and 20% had received curative treatment.”
“The addition of this product to the WHO prequalification list provides a safe and effective way to scale up HCV testing and treatment services, ensuring that more people receive the diagnosis and treatment they need and ultimately contributing to the global goal of HCV elimination.”
WHO prequalification programme
WHO noted that its prequalification (PQ) programme for in vitro diagnostics (IVD) includes a comprehensive evaluation of a range of tests, including those used for the detection of antibodies against hepatitis C virus (HCV).
He added that the programme rigorously evaluates in vitro diagnostics against strict standards of quality, safety and performance, and serves as a cornerstone to support countries in their efforts to achieve high-calibre diagnostics and treatment monitoring.
Rogerio Gasper, director of the organization's Regulatory and Prequalification Department, said the HCV self-test PQ allows low- and middle-income countries to access safe and affordable tests, crucial to achieving a 90 percent 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 percent of all people with HCV being diagnosed.
“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries.”