HQ Team
July 10, 2024: OraSure Technologies’ hepatitis C virus self-test has been prequalified by the World Health Organization in a global bid to eliminate the disease.
The product, called the OraQuick HCV self-test, is an extension of the pre-qualified, OraQuick HCV Rapid Antibody Test which was initially prequalified by WHO in 2017 for professional use, according to a WHO statement.
The self-test is specifically designed for use by lay users and provides individuals with a single kit containing the components that are needed to perform the self-test.
The WHO recommended HCV self-testing (HCVST) 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 test otherwise.
50 million people
National-level HCVST implementation projects, largely supported by UNITAID, have shown high levels of acceptability and feasibility, as well as allowing people through personal choice, autonomy and access to stigma-free self-care services.
“Every day 3,500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36% had been diagnosed, and 20% have received curative treatment by the end of 2022,” says 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 diagnoses and treatment they need, and ultimately contributing to the global goal of HCV elimination.”
WHO’s prequalification programme for in vitro diagnostics evaluates a range of tests, including those used for the detection of antibodies to HCV.
The programme assesses IVDs against quality, safety and performance standards.
‘Safe, affordable’
“The availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable self-testing options which is essential to achieving the goal of 90% of all people with HCV being diagnosed,” says Dr Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification.
“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries.”
WHO will continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries, according to the statement.
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness to a serious, lifelong illness including liver cirrhosis and cancer.
The hepatitis C virus is a bloodborne virus and most infections occur through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use and sexual practices that lead to exposure to blood.
