WHO approves OraQuick HCV self-test for Hepatitis C

SWITZERLAND—The World Health Organization (WHO) has authorized OraQuick HCV self-test, created by OraSure Technologies, which is intended to help improve access to testing and diagnosis, thereby furthering worldwide efforts to eradicate hepatitis C.

This follows the FDA’s approval of Cepheid’s Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test designed for use in certified point-of-care settings for those at risk of hepatitis C.

The OraQuick HCV self-test is an extension of the WHO-prequalified OraQuick HCV Rapid Antibody Test, which was authorized for professional use in 2017.

  The self-test version is specifically designed for lay people and includes a single kit with all of the components needed to execute the test yourself.

HCV self-testing (HCVST) was proposed by WHO in 2021 to supplement nations’ existing HCV testing capabilities.

This suggestion was based on research demonstrating its ability to promote access to and use of services, particularly among persons who would not otherwise be tested.

HCVST implementation projects at the national level have demonstrated high levels of acceptability and practicality, with Unitaid providing significant support.

Individuals have been empowered by these programmes’ emphasis on personal choice, autonomy, and access to stigma-free self-care.

Commenting on this development, Dr. Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis, and STI Programmes, noted that every day, 3,500 lives are lost to viral hepatitis.

Among the approximately 50 million people living with hepatitis C, only 36% had been diagnosed, and just 20% had received curative treatment by the end of 2022.

Dr. Doherty emphasized that adding the OraQuick HCV self-test to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services.

This ensures that more people receive the diagnoses and treatments they need, ultimately contributing to the global goal of HCV elimination.

For his part, Dr. Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification, noted that the availability of a WHO-prequalified HCV self-test enables low—and middle-income countries to access safe and affordable self-testing options.

This accessibility is essential for achieving the goal of diagnosing 90% of all people with HCV.

 Dr. Gaspar highlighted that this achievement improves access to quality-assured health products for more people in low-income countries.

WHO’s prequalification (PQ) programme for in vitro diagnostics (IVDs) evaluates a range of tests, including those used to detect antibodies to HCV.

The programme assesses IVDs against quality, safety, and performance standards, which is a cornerstone of supporting countries in achieving high-quality diagnosis and treatment monitoring.

Moving forward, WHO will continue to assess additional HCV self-tests, support evidence-based implementation, and work with communities to expand available options to all countries.

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