Market and Technology Landscape: HIV Rapid Diagnostic Tests for Self-Testing, 3rd Edition

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This third edition of the Unitaid/WHO market and technology landscape: HIV rapid diagnostic tests for self-testing report summarizes the current HIV testing gap; the challenges facing e orts to scale up; and the potential role HIV self-testing (HIVST) could play to achieve the United Nation’s 90-90-90 targets. In particular, the report synthesises the existing and emerging market demand and supply of kits. The information in this report is intended for manufacturers, donors, national programmes, researchers and other global health stakeholders who are exploring the potential role of HIVST.

An individual’s knowledge of their and their partner’s HIV status is essential to the HIV response. Despite the many benefits of HIV testing, in 2016, approximately 30 per cent of people with HIV remained unaware of their status. Some of the largest gaps in testing, prevention and treatment coverage are among men, young people and key populations who are o en reluctant or unable to access existing services. Recognizing this, the World Health Organization (WHO) recommended that HIVST be o ered as an approach to complement existing HIV testing approaches. Since then, HIVST has been scaling up rapidly.

As of July 2017, there is one WHO prequalified HIV self-test. In addition, there are an increasing number of HIVST products on the market (using oral fluid and whole-blood specimens) that are registered and approved by a founding member of the Global Harmonization Task Force (GHTF), have been submitted to WHO prequalification, or have been recommended for donor procurement by the Unitaid/Global Fund Expert Review Panel four Diagnostics (ERPD) upon programmes’ requests. In addition, four countries: Brazil, China, Kenya and Nigeria, each have one HIVST product manufactured and registered for use in-country.

Retail prices of available products in high-income countries range from US$ 22–48 per test in the private sector and from US$ 7.50–15.00 per test in the public sector. In low and middle-income countries (LMICs), public-sector pricing for HIVSTs has ranged from US$ 3-6 per test in the public sector to US$ 8-16 in the private sector.

The HIVST market is still nascent and many products are under development. To date, all HIVST products are serology assays, the majority of which are second-generation rapid diagnostic tests (RDTs) that require five to seven steps and include a time to result of between 1 and 45 minutes. Despite the growing market and introduction of new products, significant innovations and modifications of RDTs are needed to improve ease-of-use and interpretation, instructions for use, packaging, robustness and durability.

HIV policies and pathways are becoming increasingly clear. As of July 2017, 40 countries had adopted policies enabling HIVST implementation, with 13 reporting ongoing implementation, and another 48 with policies under development. Such increases have begun to stimulate demand. Between 2012 and 2017, approximately 2.5 million HIVST kits were sold worldwide. While HIVST use is growing in high-income markets, HIVST use in LMICs is only now beginning to appear outside of research and pilot programmes. However, with an HIVST product now prequalified by WHO, implementation is only expected to increase.