Human African trypanosomiasis (HAT) is a neglected tropical disease caused by infection with the trypanosome parasite that is spread through the bite of the tsetse fly. HAT, commonly known as sleeping sickness, is a deadly disease found in sub-Saharan Africa, where over 70 million people are at risk of infection. It is almost invariably fatal if patients do not receive treatment. HAT is a focal disease that can be prevented with targeted control measures, but instability and neglect of control efforts have resulted in epidemics. Recently, the number of new cases has declined dramatically. In 2014, 3,796 cases were reported—the lowest number in 75 years.

The World Health Organization (WHO) has targeted HAT for elimination as a public health problem in at least 90 percent of foci by the year 2020. However, current diagnostic tools for HAT may not be sufficient to support elimination. The London Declaration on Neglected Tropical Diseases (NTDs) identified a need to develop and incorporate new diagnostic tools into ongoing elimination efforts in order to achieve the WHO target.

In support of the London Declaration goals, PATH aims to catalyze engagement of the diagnostics industry and product development efforts. As part of this work, PATH conducted a diagnostic landscape analysis to identify gaps and evaluated current and nascent HAT diagnostics that may provide solutions. We conducted literature reviews and interviews with key stakeholders to identify use cases for HAT diagnostics, understand current practices, and analyze progress toward more robust diagnostics across different biomarkers. The decline in prevalence, alongside persistent challenges with disease confirmation and treatment, will have significant implications for development of new diagnostic tools and methods to support elimination goals. Current work to improve screening methods and make available better tools for confirming and managing HAT cases will be instrumental in addressing current diagnostic gaps. Based on the findings of this analysis, PATH developed the following recommendations:

1. Support strategies to ensure sustainability of HAT surveillance. Given the declining prevalence, future diagnostic tools should be designed to be appropriate for passive surveillance and used in primary care settings. Research is needed on how best to integrate new tools into policy and practice.
2. Support development of improved tools for disease confirmation. Current parasitology methods are limited by sensitivity and reproducibility, and the lumbar puncture method is invasive and discourages patients from seeking or continuing treatment for HAT. Field-friendly, low-cost, sensitive diagnostics that are acceptable to patients are needed.
3. Support development of tools and other interventions that will reduce barriers to disease staging and treatment monitoring. New tools and methods are needed to guide treatment in order to achieve improved case management, reduce mortality, and support elimination goals.