Almost half a million rapid diagnostic tests developed from research at the University of Dundee will be donated with the aim of helping eliminate the disease known as African sleeping sickness.
The Foundation for Innovative New Diagnostics (FIND) have announced that 450,000 rapid diagnostic tests (RDTs) will be donated by global healthcare company Abbott to scale up testing for sleeping sickness. Research in Dundee, in collaboration with the University of Cambridge, led to the development of the BIOLINE HAT 2.0 test, which will accelerate the efficiency of testing.
Sleeping sickness, or Human African Trypanosomiasis (HAT), is caused by parasites transmitted by tsetse flies in sub-Saharan Africa and is generally fatal if left untreated.
The BIOLINE HAT 2.0 test costs US $0.50 each and requires no specialised equipment to diagnose sleeping sickness from a pinprick of blood. This provides the same level of accuracy as the previous test in a more robust production format suitable for use even in remote, resource-poor settings.
The test originated from research performed in the laboratories of Professor Sir Mike Ferguson at Dundee in collaboration with Professor Mark Carrington at Cambridge. Efforts to control the disease rely on effective diagnosis to enable early treatment, prevention of further transmission and a reduction in the density of tsetse flies. The WHO has targeted HAT for elimination of community transmission by 2030.
Rapid diagnostic tests are critical for both quickly identifying infected individuals for treatment andfor active surveillance to take rapid action if any potential reemergence occurs in areas of previous disease elimination.
Professor Ferguson, Regius Professor of Life Sciences, said, “This is a potentially devastating disease mostly affecting rural populations. Early diagnosis is key to avoid the disease progressing to the second stage whereby the parasites cross the blood-brain barrier to infect the central nervous system.
“This research started by taking an unbiased approach to diagnostic antigen discovery. We asked the following questions: Which of about 7,000 proteins in the trypanosome elicit a robust antibody response in infected patients, and can we reliably detect those antibodies to make a diagnosis. To answer them, we isolated immunoglobulin G (IgG) antibodies from HAT infected and uninfected individuals in Africa and used quantitative proteomics, something we specialise in at the University of Dundee, to identify a handful trypanosome proteins that selectively bound to the infection IgGs. We then did a contest between then and found the best for diagnosis – a protein called Invariant Surface Glycoprotein 65 (ISG65) and made a prototype diagnostic device using recombinant ISG65 made in E. coli . In a subsequent study, recombinant ISG65 was found to be one of a pair of recombinant trypanosome proteins that gave the best diagnostic performance  and both are now built in to the BIOLINE HAT 2.0 test.
“We are so glad to see our original research adopted through partnership with FIND being distributed to those who need it most and making a real difference. Working with FIND to put this research into action is an excellent example of institutions working in collaboration to achieve great things.”
FIND will distribute 150,000 tests to start, primarily as part of the Trypa-NO! partnership (which includes FIND, the French National Research Institute for Sustainable Development and the Liverpool School of Tropical Medicine).
The partnership is supporting elimination programmes in five countries – Chad, Guinea, Ivory Coast, South Sudan and Uganda – in collaboration with national governments. Angola and the Democratic Republic of Congo (DRC)are expected to soon be included in the partnership. .
FIND’s roll-out of HAT rapid diagnostic tests in endemic countries has already resulted in excellent outcomes. In March 2021, Ivory Coast was the latest country to eliminate sleeping sickness as a public health problem.
For more information from FIND see their webpage.
Read the papers
 Sullivan, L., Wall, S., Carrington, M. and Ferguson, MAJ (2013) Proteomic selection of immunodiagnostic antigens for human African trypanosomiasis and generation of a prototype lateral flow immunodiagnostic device. PLoS Neglected Tropical Diseases 7, e2087
 Sternberg, J.M., Gierliński, M., Biéler, S., Ferguson, M.A.J. and Ndung’u, J.M. (2014) Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. PLoS Neglected Tropical Disease e3373.
21 June 2021