WHO prequalifies first at-home self-test for Hepatitis C virus

Individuals will soon be able to self-test for Hepatitis C at home, following the World Health Organization’s (WHO) prequalification of the first self-test for the Hepatitis C Virus (HCV).

This move aims to improve access to testing and diagnosis, potentially transforming public health. The newly-introduced OraQuick HCV self-test, developed by OraSure Technologies, is designed for home use and expands on the 2017 WHO-prequalified OraQuick Hepatitis C Virus Rapid Antibody Test, originally intended for professional settings.

With Hepatitis C infections remaining a significant health concern, this self-test offers a personal and private alternative for individuals. WHO recommended Hepatitis C virus self-testing (HCVST) in 2021, predicting it would complement existing testing services and enhance overall uptake of HCV diagnostics.

“Every day, 3,500 lives are lost to Viral Hepatitis. Of the 50 million people living with Hepatitis C, only 36% had been diagnosed, and 20% had received curative treatment by the end of 2022,” emphasised Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis, and Sexually Transmitted Infections Programmes. This new prequalification provides an essential tool, aiding the global effort to eliminate Hepatitis C by broadening diagnosis and treatment access.

National implementation of Hepatitis C virus self-testing projects, supported by Unitaid, has shown significant acceptance, empowering individuals with autonomy and stigma-free self-care options. WHO’s in vitro diagnostics (IVDs) prequalification program, which assesses tests’ quality, safety, and performance, ensures that the OraQuick Hepatitis C virus self-test meets high standards. 

Dr Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification, noted, “The availability of a WHO prequalified Hepatitis C Virus self-test allows low- and middle-income countries’ access to safe and affordable self-testing options, essential for achieving the goal of diagnosing 90% of people with Hepatitis C.”

India, grappling with an estimated 40 million chronic HCV cases per WHO, might see a positive impact from the availability of such self-tests. While regulatory approval in India is still necessary, the prequalification of OraQuick in July 2024 could pave the way for these self-tests to become available in the country, marking a potential advance in India’s public health landscape.

“In India, where Hepatitis C prevalence is high, this accessible test can improve detection rates, especially in rural areas. Given Hepatitis C is a notifiable disease, a streamlined notification process is essential for effective management,” said Dr Ajay Phadke, Director, Strategy, Agilus Diagnostics Ltd.

“Patients should get tested if they have been exposed to risk factors such as sharing needles, receiving unscreened blood transfusions, or having unprotected intercourse with an infected person,” he said. 

Doctors say HCV can lead to serious liver complications. While new infection data may be limited, studies indicate a higher prevalence among high-risk groups such as those receiving blood transfusions or with HIV. This chronic liver disease, often called a ‘silent killer’, can progress to severe hepatic complications, including cirrhosis and liver cancer, if left untreated.

Currently, the most reliable way to get tested for HCV in India is through healthcare providers administering blood tests in clinical settings. However, with the global push for self-testing, India may soon catch up, not just for HCV but also for other conditions like diabetes and cholesterol.

“Hepatitis C is one of the most underdiagnosed infections, with many individuals in India remaining unaware of their status. It is concerning that a significant number of patients are never screened for Hepatitis C during their lifetime, even in critical situations like pre-surgery or pregnancy. Self-testing presents a valuable opportunity to address this issue. However, self-testing for Hepatitis C in India has yet to gain widespread popularity, unlike Covid-19 self-tests,” said Dr Nilesh Shah, President of Internal Assurance and Advisor to CEO of Metropolis Healthcare Limited.

While the need for self-testing exists, its adoption, Shah said, may take considerable time due to several challenges. “Firstly, there are concerns about the sensitivity of self-tests. Patients in the window period or with early infections may be missing, and results can sometimes be unclear, falling into a borderline stage that is neither definitively positive nor negative. Secondly, the concept of purchasing self-test kits from medical stores is not yet prevalent in India, or in many other countries,” said Shah