WHO Prequalifies First Self-Test for Hepatitis C Virus

The World Health Organization (WHO) has prequalified the first self-test for hepatitis C virus (HCV), improving testing access and bolstering global efforts to eliminate the disease. The OraQuick HCV self-test is designed for lay users and provides a complete kit for self-testing.

This self-test is based on the OraQuick HCV Rapid Antibody Test, which was prequalified by WHO in 2017 for professional use and is produced by OraSure Technologies. In 2021, WHO endorsed HCV self-testing (HCVST) to enhance existing services, highlighting its effectiveness in increasing access, especially for those who might not otherwise get tested.¹

HCV has been called the silent killer because many people who have the disease often are not aware they have it, and it can quietly linger in the body for years and lead to serious consequences including liver disease, cancer, and death. Tracy Gowan, MSN, APRN, FNP-C from the Hep C Center at the University of Louisville Hospital, emphasizes, “Most of the time people don't even realize they have hepatitis C because they present asymptomatic. A lot of times this is found through incidental lab work or during an ER visit.”²

With an estimated global impact of 58 million individuals, HCV infection typically arises from exposure to blood, commonly due to unsafe injection practices, inadequate healthcare, unscreened blood transfusions, injection drug use, and risky sexual behaviors involving blood exposure. The World Health Organization advises testing individuals at heightened risk of infection to facilitate early detection, which can prevent health complications and transmission. Some advocates suggest universal birth cohort screening to detect asymptomatic individuals unaware of their HCV status, although the cost-effectiveness of this approach remains uncertain and hinges on population prevalence.³

“Every day 3500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36% had been diagnosed, and 20% have received curative treatment by the end of 2022,” says Meg Doherty, MD, PhD, AME, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes. “The addition of this product to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services, ensuring more people receive the diagnoses and treatment they need, and ultimately contributing to the global goal of HCV elimination.”¹

National-level HCV self-testing projects, backed by Unitaid, have demonstrated strong acceptability and feasibility, empowering individuals with choice and access to stigma-free care. The WHO’s prequalification program assesses in vitro diagnostics (IVDs) for quality, safety, and performance, helping countries achieve reliable diagnosis and treatment monitoring. Additionally, WHO intends to evaluate more HCV self-tests and broaden its implementation efforts worldwide.

The WHO's prequalification of the OraQuick HCV self-test represents a key step in HCV testing, improving access and supporting global elimination efforts. This initiative provides individuals with the ability to test themselves, facilitating awareness and early detection of the disease.

References

1. WHO. WHO prequalifies the first self-test for hepatitis C virus. Published July 10, 2024. Accessed July 17, 2024. https://www.who.int/news/item/10-07-2024-who-prequalifies-the-first-self-test-for-hepatitis-c-virus

2. Parkinson J. The Means for Curative Hepatitis C Care are Available, But Many Still Don’t Utilize. Contagion. May 22, 2024. Accessed July 17, 2024. https://www.contagionlive.com/view/the-means-for-curative-hepatitis-c-care-are-available-but-many-still-don-t-utilize

3. Abene, S. Stagnant Progress in Assessing and Addressing HCV Prevalence. Contagion. Published July 9, 2024. Accessed July 17, 2024. https://www.contagionlive.com/view/stagnant-progress-in-assessing-and-addressing-hcv-prevalence