The World Health Organization (WHO) has prequalified the first self-test for hepatitis C virus, which could provide critical support in expanding access to testing and diagnosis, accelerating global efforts to eliminate the disease.
The product, called OraQuick HCV Self-Test and manufactured by OraSure Technologies, is an extension of the OraQuick HCV Rapid Antibody Test, which was prequalified for professional use by WHO in 2017.
“The self-test version, designed specifically for use by lay people, is a single kit containing the components needed to perform a self-test,” WHO explained in a statement.
The organization recommended that self-testing be implemented in 2021 in addition to existing testing methods, based on data demonstrating the potential to increase access and use of services, particularly among people who would otherwise not be able to get tested.
The option for users to take the test confidentially and “stigma-free” was also considered.
“Viral hepatitis claims 3,500 lives every day. Of the 50 million people living with hepatitis C, only 36% will be diagnosed and 20% treated by the end of 2022,” said Meg Doherty, WHO’s Director of Health, Department of Global HIV, Hepatitis and STD (Sexually Transmitted Diseases) Programmes, in a statement.
WHO believes that the availability of this product will help expand testing and treatment options in a “safe and effective” way.
The self-testing will allow less developed countries to access “safe and affordable” options, which is seen as necessary to reach the target of 90% of diagnoses in people with the virus.