On Jul. 10, 2024, The World Health Organization (WHO) announced it had 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.

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.

National-level HCVST implementation projects, largely supported by Unitaid, have shown high levels of acceptability and feasibility, as well as empowering people through personal choice, autonomy and access to stigma-free self-care services.

WHO’s prequalification (PQ) programme for in vitro diagnostics (IVDs) 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. It is a cornerstone in supporting countries in achieving high-quality diagnosis and treatment monitoring.