The World Health Organization (WHO) has approved the first self-test for hepatitis C (HCV), aiming to make testing and diagnosis more accessible and help eliminate the disease.

3,500 people die from viral hepatitis every day. Of the 50 million people with hepatitis C, only 36% had been diagnosed, and 20% had received treatment by the end of 2022.

The new self-test, called the OraQuick HCV Self-Test, is created by OraSure Technologies and is pre-qualified.

The OraQuick HCV Test was previously approved by the U.S. Food and Drug Administration (FDA) to detect HCV antibodies in fingerstick and venipuncture (blood from a vein) whole blood.

According to the OraSure Technologies website, “Our simple platform enables healthcare providers to deliver an accurate diagnosis in as little as 20 minutes.”

The product is based on the OraQuick HCV Rapid Antibody Test, which has been used by healthcare professionals since 2017. This self-test is designed for individuals to use on their own and includes everything needed to perform the test.

In 2021, the World Health Organization recommended hepatitis C self-testing (HCVST) as a complement to existing testing services.

This was based on evidence that self-testing increases access to services, particularly for people who might not otherwise want to get tested.

National projects supported by Unitaid have shown that self-testing is well-received, practical, and empowers people by giving them greater control and access to care without stigma.

“Inclusion of this product on WHO’s prequalification list will provide a safe and effective way to expand HCV testing and treatment, ensuring more people can receive the diagnosis and treatment they need, helping us move towards ending HCV,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programme Department.

WHO’s pre-qualification (PQ) programme for in vitro diagnostics (IVD) evaluates all tests, including HCV antibody, based on quality, safety, and performance parameters.

The programme helps countries access high-quality diagnosis and treatment.

“The availability of a WHO prequalified HCV self-test provides low- and middle-income countries with access to safe and affordable self-testing options, which are crucial for diagnosing the 90% of people with HCV,” said Dr. Rogério Gaspar, Director of the WHO Department of Regulation and Prequalification.

The World Health Organization (WHO) will continue to evaluate HCV self-tests in greater numbers, support evidence-based implementation, and work with communities to ensure these options are available globally.

Prequalification of medicines is a service provided by the World Health Organization to assess the quality, safety and efficacy of medicinal products.