The World Health Organization (WHO) has prequalified the first Hepatitis C Virus (HCV) self-test, marking a significant step toward expanding access to testing and diagnosis, and advancing global efforts to eliminate the virus.
The health body in a statement published on its website on Wednesday noted 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,” It said.
“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.”
According to the statement, the WHO recommended HCV self-testing in 2021, to complement existing HCV testing services in countries.
The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.
It 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.
The 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 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.”
Pre qualification programme
The health body noted that its prequalification (PQ) programme for in-vitro diagnostics (IVDs) entails a comprehensive evaluation of various tests, including those employed for the detection of antibodies to the hepatitis C virus (HCV).
It said 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.
WHO’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.
“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.”
WHO said it will continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries.