UNITAID and WHO on Tuesday released a Landscape report that gives projections of the demand for and supply of HIV rapid diagnostic tests for self-testing and summarizes the emerging market landscape for this approach with the World AIDS Day slated on Wednesday.
The World AIDS Day is meant to unite people around the world in the fight against HIV/AIDS. A Recent UN report said India, China and Pakistan are among the 10 countries in the Asia-Pacific region that account for 98% youngsters aged 10 to 19 afflicted with HIV. The Report said the region is facing a “hidden epidemic” of HIV among adolescents who numbered 220,000 in 2014.
The Landscape report encompasses HIV rapid diagnostic tests used for professional-use and for self-testing, including estimates of demand and supply, pricing and the approval pathways.
The report presents the potential for HIV self-testing to achieve global 90–90–90 targets for treatment access by 2020, provides projections of the demand for and supply of HIV rapid diagnostic tests (RDTs) and summarizes the emerging market landscape for self-testing.
■ Demand for HIV self-testing is unknown yet, based on limited knowledge about uptake and use of HIV self-testing, with an estimated minimum of 4.8 million HIV RDTs in 2018. Many possible scenarios exist, with variable uptake of self-testing by populations not currently testing for HIV, possible replacement of standard testing with self-testing (0–30%) (10–70%) and different possibilities for frequency of HIV testing by self-testing (once or twice per year), leading to very broad estimates. The
potential global demand for HIV self-testing will have to be confirmed and informed by populationlevel estimates of the current uptake of HIV testing services.
■ While many HIV RDTs that are used for professional use could be adapted for self-testing, there are some characteristics that could be challenging for users. Changes, such as reducing the number of steps, simplifying specimen collection and transfer, simplifying incubation periods and result windows, and optimizing packaging and instructions for use, among others, could improve test performance. Such modifications may not just benefit individuals who self-test, but also health
workers and lay providers who often perform HIV RDTs in settings with poor visibility, inadequate Landscape for HIV rapid diagnostic tests for HIV self-testing lighting and limited time and supplies. This is particularly relevant as there has been a number of reports of poor quality HIV testing and misdiagnosis in some facility and community-based settings.
■ Based on reviewed reports, we identified 52 HIV RDTs available for professional use. Several commercially available tests are also approved by a stringent regulatory authority. However, only 12 are WHO prequalified and 11 are undergoing the WHO prequalification process. The majority of available HIV RDTs use fingerstick/whole blood specimens and only four RDTs use oral fluid specimens. Only one HIV RDT using oral fluid is listed as eligible for WHO procurement based on a transition criteria and none is WHO prequalified. In addition, three HIV RDTs for professional use using oral fluid are undergoing the WHO prequalification process.
■ Between 2012 and 2014, a total of 243 million HIV RDTs for professional use were reportedly procured by the Global Fund, SCMS, the United Nations Children’s Fund (UNICEF) and WHO, averaging about 81 million HIV RDTs per year. In total more than 242.2 million HIV RDTs using fingerstick/whole blood were procured, averaging about 80.7 million annually. During this same period, nearly 750 000 HIV RDTs using oral fluid were procured, averaging about 250 000 annually.
The market is likely to be much larger, as these estimates reflect what is reported by donor agencies and do not include HIV RDTs procured directly from manufacturers nor HIV testing services that take place in the private and/or informal sector.
■ In 2014, the cost of HIV RDTs for professional use ranged from US$ 0.95 to US$ 1.08, using volumeweighted average prices per smallest unit per year across the Global Fund, SCMS, UNICEF and WHO. However, the cost per HIV RDT for professional use procured in resource-limited settings by the Global Fund excluding any distributor markups and assuming ex-works, ranged from about US$ 0.50 per test to about US$ 11.00 per test. The cost of HIV RDTs using fingerstick/whole blood ranged from US$ 0.50 per test to about US$ 3.30 per test, whereas the cost of HIV RDTs using oral fluid ranged
from US$ 4.00 to US$ 11.00.
■ There are three HIV RDTs for self-testing that are formally available and approved by a stringent regulatory authority. All three countries where there is a regulated HIV RDT for self-testing are high income settings: France; United Kingdom; United States. No RDTs for HIV self-testing are WHO prequalified. In resource-limited settings, HIV self-testing is available for research purposes only or through informal sale.
■ Based on landscaping as of October 2015, 15 manufactures have been identified as interested or engaged in the HIV self-testing market. Of these, 10 are using fingerstick/whole blood-based HIV RDTs and 5 are using oral fluid-based HIV RDTs.
■ The cost of regulated HIV RDTs for self-testing direct to consumers in high-income settings ranges from about US$ 31 to US$ 40 per test. The cost of HIV RDTs for self-testing in the context of research or informal sales varies considerably, as costs will vary substantially based on packaging used, volumes procured, country policies and regulations, importation taxes and fees, among other factors.