Health
About the first WHO-approved Hepatitis C self-test
The World Health Organization (WHO) has approved the first self-test for Hepatitis C (HCV), aiming to make testing and diagnosis more accessible and contribute to the elimination of the disease.
every day, 3,500 deaths from viral hepatitisOf the 50 million people living 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, was created and pre-certified by OraSure Technologies.
The OraQuick HCV test was previously approved by the U.S. Food and Drug Administration (FDA) for the detection of 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 make an accurate diagnosis in under 20 minutes.”
The product is based on the OraQuick HCV Rapid Antibody Test, which has been used by medical professionals since 2017. The self-test is designed for individuals to use on their own and includes everything needed to run the test.
In 2021, WHO recommended Hepatitis C self-testing (HCVST) to complement existing testing services.
This is based on evidence that self-testing improves access to services, particularly for people who might not otherwise seek testing.
National projects supported by Unitaid have shown that self-testing is well-received, practical and empowers people by giving them control over and access to healthcare without stigma.
“Adding this product to the WHO prequalification list provides a safe and effective way to scale up HCV testing and treatment, helping more people get the diagnosis and treatment they need and making progress towards HCV elimination,” said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and Sexually Transmitted Diseases Programme.
The WHO Prequalification (PQ) Programme for In Vitro Diagnostics (IVDs) evaluates tests and Quality, safety and performance standards, including HCV antibodies.
The program helps countries achieve quality diagnosis and treatment.
“The availability of a WHO prequalified HCV self-test will ensure that low- and middle-income countries have a safe and affordable self-testing option, which is essential to diagnose the 90% of people living with HCV,” said Dr Rogerio Gaspar, Director of WHO's Regulatory and Prequalification Department.
WHO will continue to evaluate more HCV self-tests, support evidence-based implementation, and work with communities to make these options available worldwide.
Prequalification of medicines is a service provided by WHO to assess the quality, safety and effectiveness of medicines.
Sources 2/ https://www.indiatoday.in/health/story/all-about-the-first-self-test-for-hepatitis-c-virus-approved-by-who-2568679-2024-07-18 The mention sources can contact us to remove/changing this article |
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