The World Health Organization (WHO) has achieved a significant milestone in global health by prequalifying the first hepatitis C virus (HCV) self-test. This development marks a crucial step forward in expanding access to testing and diagnosis, accelerating efforts to eliminate hepatitis C worldwide.
The OraQuick HCV Self-Test
The prequalified product, known as the OraQuick HCV self-test, is manufactured by OraSure Technologies. It builds upon the prequalified OraQuick® HCV Rapid Antibody Test, which WHO initially approved in 2017 for professional use. The self-test version is designed specifically for lay users, providing a single kit containing all necessary components to perform the test accurately and reliably.
WHO’s Recommendation and Impact
In 2021, WHO recommended HCV self-testing (HCVST) as a complement to existing testing services. This recommendation was based on compelling evidence demonstrating the effectiveness of self-testing in increasing access and uptake of HCV testing services, particularly among populations who may not otherwise seek testing. Implementation projects at the national level, supported significantly by Unitaid, have shown high levels of acceptability and feasibility among users.
Advantages and Empowerment
The introduction of HCV self-testing empowers individuals by offering them personal choice, autonomy, and access to stigma-free self-care services. This approach is crucial in addressing barriers to traditional testing methods, such as stigma, inconvenience, and lack of access to healthcare facilities. By enabling self-testing, WHO aims to reach more individuals, diagnose more cases of hepatitis C, and ensure that those diagnosed can access timely treatment.
Global Health Impact and Goals
Dr. Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis, and STI Programmes, highlighted the impact of hepatitis C on global health, with approximately 3,500 lives lost daily to viral hepatitis. Despite this burden, a significant portion of those affected remain undiagnosed or untreated. The addition of the OraQuick HCV self-test to WHO’s prequalification list is expected to expand HCV testing and treatment services, contributing directly to the global goal of eliminating hepatitis C.
WHO Prequalification Program
WHO’s prequalification program for in vitro diagnostics (IVDs) ensures that tests, including those for detecting antibodies to HCV, meet rigorous standards of quality, safety, and performance. This program supports countries in adopting high-quality diagnostic tools and monitoring treatments effectively. Dr. Rogério Gaspar, WHO Director for the Department of Regulation and Prequalification, emphasized that the availability of WHO prequalified HCV self-tests will enhance access to safe and affordable testing options, particularly in low- and middle-income countries where resources may be limited.
Future Directions and Commitment
Looking ahead, WHO remains committed to assessing additional HCV self-tests, supporting evidence-based implementation strategies, and collaborating with communities to expand access to reliable testing options globally. The ongoing efforts aim to ensure that all countries can benefit from high-quality, WHO-prequalified health products, ultimately advancing the goal of diagnosing and treating 90% of all people with hepatitis C.
The prequalification of the OraQuick HCV self-test by WHO represents a pivotal achievement in the fight against hepatitis C. By leveraging innovative testing technologies and promoting self-testing options, WHO and its partners are poised to make significant strides towards eliminating hepatitis C as a public health threat. This milestone underscores the importance of global cooperation, evidence-based strategies, and equitable access to healthcare innovations in achieving health for all.
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