HCV has become an emerging global health problem, well known for its potential to cause chronic liver disease. It is actually a bloodborne, normally infecting the liver virus that may provoke disorders such as mild sickness and very serious damage to the liver.
The first hepatitis C virus (HVC) self-test has been prequalified by WHO to be used. This is a major move in expanding access to testing and diagnosis so that more people may know their status and seek urgent care, hence supporting global elimination of hepatitis C.
The OraQuick HCV self-test is innovated and marketed by the company OraSure Technologies. It is a derivative of the OraQuick<sup> </sup>HCV Rapid Antibody Test for professional use that was prequalified by WHO in 2017. The self-test version is adapted for lay users in a single kit.
In 2021, WHO recommended HCV self-testing in parallel to the established HCV testing services. The evidence base for this recommendation confirmed that HCVST expands access to and uptake of testing services, particularly among audiences who would not otherwise be reached for testing.
Country implementation projects on HCVST (to a significant extent funded by Unitaid) demonstrated high acceptability and feasibility. The HCVST implementation projects going on at the country level are driven by empowering people, chiefly by way of 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% had received curative treatment by the end of 2022,” said Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes. “Listing on the WHO Prequalification List contributes to a safe and effective way of expanding HCV testing and treatment services, so that more people get the diagnoses and the treatment they need toward the global goal of HCV elimination.”
WHO prequalification of in vitro diagnostics includes the assessment of HCV antibody detection tests. IVDs are assessed against the standards of quality, safety, and performance under which countries can reach the target of high-quality diagnosis and treatment monitoring.
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Source: WHO
