Geneva – Unitaid and the World Health Organization (WHO) announced today the publication of the 2017 HIV Rapid Diagnostic Tests for Self-Testing Landscape report. Released during the 9th IAS Conference on HIV Science in Paris, the third edition of the landscape report provides an updated analysis of the latest technologies and market trends in HIV self-testing (HIVST) in low- and-middle income countries (LMICs).
In comparison to the previous edition, this year’s report identifies a growing number of HIVST products entering the market along with an increase in the number of countries adopting HIV self-testing. A total of 40 countries have incorporated HIVST in their national policies, following the WHO’s recommendation in 2016 that HIV self-testing be offered as a complementary approach to existing HIV testing approaches. An additional 48 countries are currently developing national HIV self-testing policies. This is more than double the number reported a year ago, when only 16 countries had policies supporting self-testing.
“WHO applauds countries taking up innovative approaches, including HIV self-testing, as additional ways to reach people who are currently not accessing testing services and are at higher risk of HIV infection, such as key populations, young people, and men in many settings,” says Dr Gottfried Hirnschall, WHO’s Director of HIV Department and Global Hepatitis Programme. “WHO will continue working with countries and partners to further support the rapid scale-up of HIV testing, including self-testing.”
To date, four HIV rapid diagnostic tests have been approved for use by a founding member of the Global Harmonization Task Force, while only one HIV self-test has obtained the approval of the WHO Expert Review Panel for Diagnostics. All of these products are now included in the list of eligible products approved for procurement using Global Fund and Unitaid funds. In addition, several other HIVST products are nationally registered in Brazil, China, Kenya, and Nigeria.
According to the report, pricing of HIV self-test kits continues to vary widely both across and within countries. In high income countries, prices range from US$ 22-48 in the private sector to US$ 7.50-15 per test kit in the public sector. While in emerging countries, prices vary from US$ 3-6 per test in the public sector to US$ 8-16 in the private sector. However, HIVST pricing in LMICs may begin to decrease, in part due to the Bill & Melinda Gates Foundation’s recent agreement to support the affordable sale of OraSure Technologies’ OraQuick® Self-Tests, in an effort to accelerate scale-up. As a result, public and non-profit buyers in 50 LMICs and high HIV burden countries will be able to purchase OraSure tests at the price of US$ 2 per kit.
At least four million HIV self-test kits are expected to be procured by donor-funded programmes between July 2017 and end of 2018, mainly the Unitaid-funded HIV Self-Testing Africa (STAR) Initiative, followed by programmes funded respectively by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR).
“Unitaid is at the forefront of global efforts to expand access to HIV self-testing in lower- and middle-income countries,” said Unitaid Executive Director Lelio Marmora. “The findings of this report show that our investments, and those of our partners, are helping countries to move forward in pursuit of the global goal of having 90 per cent of people living with HIV aware of their status by 2020.”
The STAR initiative and other efforts also provided the global community with a range of HIVST distribution models and systems to support linkage to care, promote products, and educate end users, all of which can inform HIVST programming in other regions.
“We’ve seen the effectiveness of HIV self-testing first hand through STAR,” states Dr. Karin Hatzold, Project Director STAR. “The successful scale-up of HIVST in initial STAR countries and its rapid introduction in new countries under the Initiative will provide a model for adoption in other regions.”
Despite these positive developments, successful implementation of HIV self-testing faces several challenges, including the level of government and donor support, uncertain and non-transparent regulatory pathways at the country-level, the need for product innovation, and low and unpredictable demand. Country governments, manufacturers, and partners, must continue to work together to address these challenges and support the development of an HIV self-test market. Doing so could expand HIV testing coverage and help countries meet key global targets, namely diagnosing 90 per cent of all people with HIV by 2020.
Read the full report: “Landscape for HIV rapid diagnostic tests for HIV self-testing – 3rd edition” – July 2016.
For more information, please contact:
Andrew Hurst, Unitaid, +41795616807, firstname.lastname@example.org
Tunga Namjilsuren, WHO, +41 79 203 31 76, email@example.com
Sandy Garçon, Population Services International (PSI), +1- 202.790.3162, firstname.lastname@example.org
Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps sets the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund. Learn more at www.unitaid.org.
About the World Health Organization
The World Health Organization (WHO) is the United Nations specialized agency for global health. WHO’s Department of HIV works to provide leading normative and technical guidance and support to the Member States to accelerate their responses to HIV towards achieving the universal coverage of prevention, treatment, care and support of services for every person in need.
About Population Services International
PSI is a leading global health organization working in HIV, reproductive health, child survival, non-communicable diseases and sanitation. Partnering with the public sector and harnessing the power of markets, PSI provides lifesaving products, services and communications that empower vulnerable populations to lead healthier lives. Learn more at staging.psi-2017.flywheelsites.com.