Improving the development and deployment of rapid diagnostic tests in low- and middle-income countries 07 / 02 / 2017

Marilia Costa is a Society Champion and final-year PhD student based at the University of Dundee. She recently attended a one-day workshop on ‘Improving the development and deployment of rapid diagnostic tests in low- and middle-income countries’. The workshop was hosted and run by the Academy of Medical Science in London.

Rapid diagnostic tests (RDTs) are revolutionising how disease is diagnosed and treated, and are helping to deliver higher standards of healthcare and greater efficiency across public and private healthcare sectors, as well as at the community level. This is what Marilia took from the workshop.

What is the actual context of RDTs?

Although the increase in human mobility supports the economy and development of countries, from the view of public health, such globalisation is a perfect formula for the fast transmission of diseases. The lessons learned from previous outbreaks are clear: we need to be prepared, and the development of rapid diagnostic tests is essential in making progress by avoiding misdiagnosis and unpredictable transmissions. 

The need for reliable, accurate and sensitive tests for rapid diagnostics increases during outbreaks, such as during the emergence of Ebola and Zika in recent years. These tests also need to be at low cost, be easy to use (limited training required) and be able to deliver a fast result, in order to be used in rural and remote areas. The challenge lies in combining all these characteristics in an RDT. 

Professor Rosanna Peeling opened the workshop by setting the scene about RDTs and highlighting several important factors, such as the lack of investment, regulatory oversight and international standards necessary for more advances in the field of diagnostic tests. 

 Examples of successful RDTs were mentioned, such as the HIV and syphilis rapid tests. However, an important fact is that even when a test presents 99% accuracy, it means that over a million of patients worldwide will be misdiagnosed as part of the 1% inaccuracy window. In addition, Professor Lisa Hall mentioned an example – rapid glucose tests are very successful in sales (top 50) although they are not cheap. She also discussed RDT as an add-on to mobile phones.
 

What are the major challenges in developing RDTs? 

In fact, RDT development has to face several barriers involving much more than the science and technology behind them. The lack of funding and clear regulatory policies, and the challenge in lowering product cost and in implementing them in healthcare systems, are just a few to be considered. RDTs were pointed to be less regulated than medicines, which led to some non-reliable tests being placed on the market. Since countries have different policies, professionals from various sectors would like clear international standards regarding RDTs. 

How can researchers contribute to advances in RDTs?

As a group of researchers, we discussed this matter and found out that scientists are isolated from the business of RDTs. We proposed a more collaborative environment as researchers might hold important discoveries that support the development of new technologies. Improving connections between researchers/academics, health staff, health systems, the NHS and biotech companies is essential for advances. Agreements among collaborators could solve the barrier involving intellectual property and patents. Moreover, a world bank of serum and cells, composed of several positive and negative samples, could be used as a starting point for testing any new RDT. Thus, it could diminish discrepancies in some RDTs after being used on specific populations. 

An example of the difficulties in establishing collaboration is the fact that technologies could be combined for a multiple diagnosis in a single RDT. However, there is little interest from a business perspective, as it involves collaboration between companies.

Marilia Costa

University of Dundee