WHO Prequalifies First Self Test for Hepatitis C

July 10, 2024
Self testing for hepatitis C is hoped to increase the rate of patients with the disease that have been officially diagnosed. The agency's goal is to increase the number of people with the disease who have a diagnosis from 36% to 90%.

WHO has prequalified the first hepatitis C self-test, providing “critical support in expanding access to testing and diagnosis” and “accelerating global efforts to eliminate hepatitis C.” Their website has the news.

The product is called OraQuick HCV self-test, manufactured by OraSure Technologies. It is an extension of an HCV rapid antibody test prequalified by WHO in 2017 for professional use, but this new product is “specifically designed for use by lay users.” WHO recommended HCV self-testing in 2021.

National-level HCV self-testing implementation projects have shown “high levels of acceptability and feasibility.” As of the end of 2022, only 36% of the 50 million people living with hepatitis C had been diagnosed and only 20% “have received curative treatment.” This product will hopefully “provide a safe and effective way to expand HCV testing and treatment services.”

The product went through WHO’s prequalification (PQ) program for in vitro diagnostics (IVDs) to ensure it met quality, safety, and performance standards. Dr. Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification, says that the agency’s goal is for “90% of all people with HCV to be diagnosed.”

About the Author

Matt MacKenzie | Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.