HIV Diagnostics: The Development of a $1 HIV Viral Load Test
Organized by: Theoren Loo
Event Name: CGI U Commitments Challenge 2016
Nearly 39 million people in the world today are infected with HIV. The majority of those infected live in low-income communities and 70% live in Sub-Saharan Africa. A crucial part of effective HIV management strongly recommended by the World Health Organization (WHO) is regular testing of viral load (the amount of virus in a person's blood). A sudden increase in viral load gives an early indicator of failure of a patient's treatment (anti-retroviral therapy or ART) which can then be reversed by changing treatments. However, only 25% of individuals living in low-resource settings currently have access to suitable viral load testing. The main barriers to viral load testing are the associated financial burdens (on average $24-44 per test) and a lack of facilities equipped with the complex equipment required (which can cost hundreds of thousands of dollars, require expensive maintenance, as well as access to steady electricity). Millions of people are thus unable to monitor the potential progression of HIV into AIDS, contributing to the loss of hundreds of thousands of lives each year. Ribosense Diagnostics aims to field test and then commercialize an HIV viral load diagnostic device that allows for the total materials/consumables cost of a viral load test to be reduced to less than $1, while requiring no expensive or complex equipment, being easy to use, and still delivering gold-standard readings. By engaging communities in Uganda (where only 10% of patients are actively receiving viral load testing), starting with the Joint Clinical Research Center in Kampala, Ribosense Diagnostics hopes to bring accessible viral load testing to places with no current infrastructure in a point-of-care fashion using our easily deployable system. In addition this venture hopes to lower the costs of viral load testing in clinics that do currently perform viral load testing to further improve treatment accessibility to Ugandans living with HIV.
Our theory of change
Current efforts to expand access to viral load testing in Uganda have been met with difficulty. A UNAIDS-supported effort to scale up viral load testing resulted in an increase in the percent of HIV patients having received one or more viral load tests from 5% to only 10% from 2014-2015. Difficulties cited during the effort included insufficient funding to support increased viral load testing, issues with equipment maintenance, and a lack of trained personnel. Ribosense Diagnostics aims to implement a diagnostic device that will specifically address each of these issues. The main advantage of the device being developed will be the extremely low cost of implementation. With cheap components and reagents costing, the total materials cost per test will be reduced from the $6 optimized by team allies professor David Beebe and Dr. Scott Berry to less than $1, for a total cost per test of $2-3. In addition, equipment will be changed from a thermocycler (which can cost upwards of $50,000) to a DIY incubator and an in-house developed imaging system (total cost less than $1000). Reducing equipment and materials costs will greatly help facilitate increased viral load testing in situations where funding is scarce. The reduced per-test cost from $8 to $2-3 is particularly relevant in a nation where the poverty line is $1.25/day. In terms of improving equipment maintenance issues, the simplicity of the equipment required to use Ribosense Diagnostic's device will mean that it is also more robust and will require less maintenance than other more complex platforms. The simplicity also means that many fixes will be doable by locals rather than requiring a member of the company to perform repairs. Lastly, the lack of trained personnel will be addressed by the device's ability to perform testing in high-throughput format. Being able to carry out up to 200 tests at once will mean that a single staff member can carry out work that would typically require many more staff members. In general, the team aims to have the testing require the operation of just one staff member from sample preparation to detection and imaging.
Once validated, the diagnostic device developed by Ribosense Diagnostics has the potential to provide low-cost HIV viral load testing for communities that do not have the necessary healthcare infrastructure needed for measuring HIV viral load. This is due to the following factors that facilitate diagnostic testing for healthcare workers: 1. The device requires no complex laboratory machinery, meaning that clinics lacking reliable electricity can use the device. When combined with the Beebe lab's cheap sample purification system, point-of-care testing at local clinics will be achievable at a very low cost. 2. The per-test cost is <$2-3 compared to >$20 for existing assays, a price which will encourage patients receiving ART to seek VL testing. If successful, implementing this device will assist healthcare professionals working in HIV-prevalent communities as well as greatly improve accessibility and monitoring of HIV for people living in low-resource communities and HIV-positive couples trying for HIV-negative babies.