The World Health Organization (WHO) has prequalified the first self-test for hepatitis C virus (HCV), a significant step towards expanding access to testing and diagnosis and accelerating global efforts to eliminate hepatitis C.
Called OraQuick HCV and manufactured by OraSure Technologies, the self-test is a spin-off of the OraQuick® HCV rapid antibody test, which was initially prequalified by WHO in 2017 for professional use. The self-test version, specially designed for non-professional users, is presented in a single kit containing all necessary components.
WHO recommended HCV self-testing in 2021 as a complement to existing screening services in countries. This recommendation was based on evidence that self-screening can expand access and increase uptake of services, particularly among people who might otherwise not get tested.
National HCV self-testing implementation projects, largely supported by Unitaid, have proven to be highly acceptable and feasible, empowering people to make informed choices regarding their health and take self-care without facing stigma.
“Every day, 3,500 people die from viral hepatitis. By the end of 2022, only 36% of the 50 million people living with hepatitis C had been diagnosed with the disease, and 20% had received curative treatment,” said Dr Meg Doherty, Director of the WHO Department of Global HIV, Hepatitis and STI Programmes. “Adding this product to the WHO prequalification list is a safe and effective way to expand hepatitis C testing and treatment services, bring diagnosis and treatment to more people who need it, and ultimately contribute to the global goal of eliminating hepatitis C.”
The WHO prequalification programme for in vitro diagnostics evaluates a range of tests, including HCV antibody tests. In vitro diagnostics are assessed based on quality, safety and performance criteria. The programme is a key element in supporting countries to ensure high-quality diagnostic and therapeutic monitoring.
“WHO prequalification of a self-test for HCV provides low- and middle-income countries with safe and affordable self-testing solutions, which are essential to achieving the goal of diagnosing 90% of hepatitis C cases,” said Dr Rogério Gaspar, Director of the WHO Department of Regulation and Prequalification. “This advancement helps make quality-assured health products accessible to more people in low-income countries.”
WHO will continue to evaluate additional HCV self-tests, support their evidence-based implementation, and work with communities to scale up solutions that can be used by all countries.
WHO Prequalifies First Self-Test for Hepatitis C Virus
A Major Step Towards Eliminating Hepatitis C
The World Health Organization (WHO) has taken a significant step towards expanding access to hepatitis C virus (HCV) testing and diagnosis by prequalifying the first self-test for the disease. This breakthrough, marked by the approval of OraQuick HCV, a self-test developed by OraSure Technologies, holds the potential to accelerate global efforts to eliminate hepatitis C.
Self-Testing: A Game Changer in HCV Management
The OraQuick HCV self-test, a spin-off of the professionally-used OraQuick® HCV rapid antibody test, is presented in a single kit containing all necessary components for self-administration. This readily accessible format empowers individuals to take control of their health by initiating testing without the need for healthcare professionals.
Importance of Self-Testing in Combating Hepatitis C
- Expanded Access: Self-testing eliminates barriers to testing, such as access to healthcare facilities, cost, and stigma, particularly for individuals who might otherwise avoid traditional testing methods.
- Increased Uptake: Studies have demonstrated that self-screening can lead to higher rates of testing, as individuals are more likely to test themselves than to visit a clinic.
- Empowerment: Self-testing allows individuals to take charge of their health, promoting self-care and reducing the stigma associated with hepatitis C.
WHO’s Recommendation and Support for Self-Testing
In 2021, WHO recommended HCV self-testing as a crucial complement to existing screening services in countries. This recommendation was informed by the growing body of evidence highlighting the significant benefits of self-testing, particularly in expanding access and increasing uptake, especially among those who are hesitant to undergo traditional testing.
National Implementation and Impact of Self-Testing
National HCV self-testing implementation projects, primarily funded by Unitaid, have proven to be highly acceptable and feasible. These projects have underscored the effectiveness of self-testing in:
- Empowering individuals: Encouraging people to make proactive choices regarding their health.
- Reducing stigma: Allowing individuals to test themselves without facing societal judgment.
Importance of Prequalified HCV Self-Tests
The WHO prequalification programme for in vitro diagnostics rigorously evaluates a range of tests, including HCV antibody tests, based on criteria like quality, safety, and performance.
Significance of WHO Prequalification for HCV Self-Tests
- Quality assurance: Ensuring that only safe and effective self-tests are made available to countries, contributing to a higher standard of testing and diagnosis.
- Affordable access: Supporting low- and middle-income countries in securing affordable and high-quality self-testing solutions, essential for achieving the goal of diagnosing 90% of hepatitis C cases.
Looking Forward: Expanding HCV Self-Testing Globally
WHO is dedicated to continuing its evaluation of additional HCV self-tests, supporting their evidence-based implementation, and collaborating with communities to expand access to these solutions across all countries. This commitment reflects the global determination to eliminate hepatitis C and ensure that everyone has access to timely and accurate testing.
Key Benefits of Prequalified HCV Self-Tests
- Increased Diagnosis: Prequalified self-tests offer a reliable and convenient way to detect HCV, increasing the likelihood of timely diagnosis.
- Early Treatment: Early diagnosis enables early treatment, leading to better treatment outcomes and reducing the risk of complications.
- Prevent Transmission: Early diagnosis and treatment can effectively prevent further transmission of the virus.
Contributing to the Global Goal of Eliminating Hepatitis C
The prequalification of OraQuick HCV represents a significant step towards achieving the global goal of eliminating hepatitis C. By making self-testing accessible, WHO is empowering individuals to take control of their health and contributing to a future free from hepatitis C.
Call to Action: Utilizing Prequalified HCV Self-Tests
Individuals at risk for HCV should consider utilizing prequalified self-tests as a convenient and confidential way to get tested. By making informed choices regarding their health, individuals can play an active role in achieving the goal of hepatitis C elimination.
