WHO prequalifies the first self-test for hepatitis C virus

WHO
Jul 10, 2024

WHO prequalifies the first self-test for hepatitis C virus


The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test which can provide a critical support in expanding access to testing and diagnosis, accelerating global efforts to eliminate hepatitis C.

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. 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.

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 otherwise test.