WHO prequalifies 1st home test for hepatitis C
Expanded testing access marks step toward virus elimination
The World Health Organization (WHO) has prequalified the first self-test kit to detect the hepatitis C virus (HCV) in a home setting, marking a step toward expanding access to testing and diagnosis across the world and moving toward the common goal of eliminating infection.
OraQuick HCV, the self-test kit developed by OraSure Technologies, is an extension of the OraQuick HCV Rapid Antibody Test, which was prequalified by WHO in 2017 for professional use. Prequalification means the diagnostics meet acceptable standards of quality, safety, and efficacy.
“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,” Meg Doherty, MD, PhD, director of the WHO’s Department of Global HIV, Hepatitis and STI Programmes, said in a WHO press release.
The WHO recommended self-testing in 2021 as a complement to existing testing services, based on evidence that it makes it easier for more people to get tested, especially those who are less likely to have access to existing diagnosis and treatment services.
“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% of all people with HCV to be diagnosed,” said Rogério Gaspar, PhD, director of the WHO Department of Regulation and Prequalification. Widespread availability of a self-test kit “contributes to improving access to quality-assured health products for more people living in low-income countries,” Gaspar said.
Expanding testing, treatment
“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,” Doherty said.
Cepheid in June received approval from the U.S. Food and Drug Administration (FDA) to market its Xpert HCV test, a finger-stick test that runs on the company’s Genexpert Xpress System, delivering results at the point of care in about an hour using a few drops of blood from the fingertip.
Hepatitis C is a viral infection that causes liver inflammation and damage. Most people infected with the virus don’t develop overt symptoms until the disease has already progressed to cirrhosis, when permanent scarring interferes with liver functioning.
“Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a June press release announcing marketing authorization of the Cepheid test.
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