UNITAID and the Global Fund expert panel approves the first HIV self-testing product
2 March 2017 – Today marks a significant development in responding to the HIV testing gap with the approval of the first product for HIV self-testing (HIVST) by the UNITAID-funded Expert Review Panel for Diagnostics (ERPD), hosted by the Global Fund to Fight AIDS, Tuberculosis and Malaria. The ERPD outcome is a time-limited, risk-based recommendation on eligibility for procurement in anticipation of a review by WHO prequalification or a national regulatory authority. The approval is particularly timely as many countries are submitting their funding requests to the Global Fund, as well as other donors.
"The expert panel approval of an HIV self-testing product is a critical development, enabling countries to operationalize WHO guidelines and encouraging more people get tested," said Dr Gottfried Hirnschall, Director of WHO's Department of HIV.
On World AIDS Day 2016, the World Health Organization released the first guidelines on HIVST, recommending countries to offer HIVST as an additional HIV testing approach. It is estimated that 40% of all people with HIV or over 14 million people remain unaware of their HIV infection status. Many of these are people at higher risk of HIV infection who often find it difficult to access existing testing services.
The Global Fund and UNITAID are inviting manufacturers of rapid diagnostic tests for HIV self-testing to submit an expression of interest to have their products evaluated by the ERPD by 30 April 2017. Once all expressions of interest have been received, the ERPD will determine which products they will wish to evaluate. The ERPD is funded by UNITAID and the Global Fund.
About HIV self-testing
HIV self-testing means people can use oral fluid or blood- finger-pricks to discover their status in a private and convenient setting. Results are ready within 20 minutes or less. Those with positive results are advised to seek confirmatory tests at health clinics. WHO recommends they receive information and links to counselling as well as rapid referral to prevention, treatment and care services.
HIV self-testing is a way to reach more people with undiagnosed HIV and represents a step forward to empower individuals, diagnose people earlier before they become sick, bring services closer to where people live, and create demand for HIV testing. This is particularly important for those people facing barriers to accessing existing services.
About the Global Fund and UNITAID
The Global Fund is a partnership between governments, civil society, the private sector and people affected by diseases. The partnership organization is designed to finance programs aimed at accelerating the end of HIV/AIDS, tuberculosis and malaria as epidemics.
UNITAID is engaged in finding new ways to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria more quickly, more cheaply and more effectively. It takes game-changing ideas and turns them into practical solutions that can help accelerate the end of the three diseases. Established in 2006 by Brazil, Chile, France, Norway and the United Kingdom to provide an innovative approach to global health, UNITAID plays an important part in the global effort to defeat HIV/AIDS, tuberculosis and malaria, by facilitating and speeding up the availability of improved health tools, including medicines and diagnostics.