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WHO Prequalifies First Self-Test for Hepatitis C

NEW YORK – The World Health Organization announced Wednesday that it has prequalified an at-home, over-the-counter assay manufactured by OraSure Technologies for hepatitis C virus.

The OraSure assay is the first self-test for HVC to be prequalified, WHO said in a statement. Prequalification ensures that medicines and diagnostics supplied by international procurement agencies meet standards of quality, safety, and efficacy, and a prequalified status enables test procurement in low- and middle-income countries.

The test is an extension of the OraQuick HCV Rapid Antibody Test which was initially prequalified by the WHO in 2017 for professional use, the organization said. OraSure's HIV self-test has also been previously prequalified.

"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," said Meg Doherty, WHO director of the Department of Global HIV, Hepatitis, and STI Programmes.

Spread by contact with blood from an infected person, HCV can lead to both acute and chronic liver illness. The WHO estimates that there are 1 million new HCV infections globally each year. The health agency also estimates that 50 million people live with chronic HCV infection and that approximately 242,000 people died from HCV-related causes such as cirrhosis and primary liver cancer in 2022.

Self-testing is recommended to complement existing testing services, based on evidence demonstrating that it increases both access to and uptake of services, particularly among people who may not otherwise test for the virus, the WHO said.

"The availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable self-testing options, which is essential to achieving the goal of 90 percent of all people with HCV to be diagnosed," Rogério Gaspar, WHO director for the Department of Regulation and Prequalification, said in the statement.

The WHO also said that it will continue to assess additional HCV self-tests.