A new partnership announced today between the Clinton Health Access Initiative (CHAI), MedAccess, and Wondfo Biotech Company will make an HIV self-test available for US$ 1 to the public sector in low- and middle-income countries, marking it as lowest ever priced WHO prequalified HIV self-test.
Despite the availability of affordable diagnostics and treatment, globally there are an estimated 5.9 million people with HIV who remain unaware of their status. Key populations (including sex workers, men who have sex with men, transgender people,people who inject drugs, and people in prisons and other closed settings) and their partners account for the majority of new HIV infections, and adolescent girls and young women are 3 times as likely to acquire HIV than their male peers. Many, including people from key populations and young people, find HIV self-testing to be a convenient and confidential option for HIV testing(1).
"The announcement of the new pricing is an important step toward making HIV testing for diagnosis and prevention monitoring accessible worldwide," said Dr Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes. "It will help programmes deliver HIV self-testing in public, community and private sector service delivery channels."
WHO recommends HIV self-testing as a safe, accurate and effective way to reach people who may not test otherwise, and to date, has prequalified 6 HIV self-tests both oral fluid and blood-based products, assuring the quality and usability of these products. "Quality-assured diagnostic tests are critical for effective healthcare systems. The addition of a new self-test to the list of prequalified In Vitro Diagnostics contributes to ensuring access to safe, appropriate and affordable tests of good quality" said Rogério Gaspar, Director of the Regulation and Prequalification Department at WHO.
Globally, many countries have developed national policies that support HIV self-testing, and implementation is growing rapidly. As of June 2022, 98 countries - 52% of reporting countries - have a policy on HIV self-testing, but implementation is lagging behind, with only 52 countries routinely implementing globally (2). WHO estimates that major donors and governments procured more than 10 million HIV self-tests in low- and middle-income countries in the year 2021. While the future forecast looks promising, the availability of low-cost quality products for self-testing is critical to address the large need for HIV self-testing.
During COVID-19, many countries moved to accelerate HIV testing approaches that included HIV self-testing. The newly negotiated price reduction is an opportunity for more programmes to adopt and deliver HIV self-testing and to bring testing, treatment and prevention services to those who need them most. This is timely, as WHO has issued new guidance on differentiated service delivery for pre-exposure prophylaxis (PrEP), which includes provisions to use HIV self-tests to increase access and avert new infections.
1. Examining the effects of HIV self-testing compared to standard HIV testing services in the general population: A systematic review and meta-analysis - eClinicalMedicine, The Lancet, July 2021