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HAT

NEW PRODUCT ! HAT – Rapid Detection Test for Sleeping Sickness

Human African trypanosomiasis

Human African trypanosomiasis (HAT), or sleeping sickness, is a life-threatening neglected tropical infection affecting rural populations in sub-Saharan Africa. In West and Central Africa, chronic trypanosomiasis is caused by Trypanosoma brucei gambiense infection.(1) Control of the disease has been facilitated by the use of the card agglutination test for trypanosomiasis, which is particularly suited for large-scale screening of the populations at risk.(2) With the steadily decreasing prevalence of trypanosomiasis, individual rapid diagnostic tests that can be used in primary health centers, that are stable at ambient temperatures, and that are highly specific have become a research priority.(1)

We developed two rapid diagnostic tests for trypanosomiasis caused by T. brucei gambienseinfection. The HAT Sero-Strip and HAT Sero-K-SeT tests detect trypanosome-specific antibodies and are, respectively, a dipstick and a lateral-flow device for testing blood (30 μl) or plasma (15 μl); both tests provide results in 15 minutes. The tests contain variant surface glycoproteins of the T. brucei gambiense variable antigen types LiTat 1.3 and LiTat 1.5.(3)

More information about HAT product

Evaluation of the test

The tests were evaluated with the use of plasma from 198 patients with trypanosomiasis that was confirmed on parasitologic analysis and from 99 local controls with neither clinical nor serologic evidence of the disease. The specimens were collected in the Democratic Republic of Congo (4) and obtained from the World Health Organization HAT Specimen Bank (www.who.int/trypanosomiasis_african/research/en). All specimens were tested with the use of immune trypanolysis, the reference test for detecting specific antibodies against T. brucei gambiense variable antigen types LiTat 1.3 and LiTat 1.5.(5) To evaluate the applicability of these tests when blood was used, samples of reconstituted blood were prepared by adding plasma from patients with trypanosomiasis or from local controls to sedimented blood cells from a healthy donor.

Results are summarized in Table 1. As compared with the immune trypanolysis test, the HAT Sero-Strip showed excellent sensitivity, with specificity being slightly lower when plasma was tested (P=0.05). When reconstituted blood was tested, the sensitivity and specificity of the HAT Sero-Strip did not differ significantly from the sensitivity and specificity of immune trypanolysis (P>0.05 for both comparisons); for the HAT Sero-K-SeT, the sensitivity was lower than that of immune trypanolysis (P=0.01), but the specificity was not significantly different (P=0.32).

If further evaluation in the field confirms their diagnostic accuracy, we believe that the HAT Sero-K-SeT and the HAT Sero-Strip, with an estimated price of less than $2.50 each, may become valuable tools in the control of trypanosomiasis.


Büscher P.
(Institute of Tropical Medecine), Gilleman Q. (Coris BioConcept), Lejon V. (Institute of Tropical Medecine)


References
:

1. Simarro PP, Jannin J, Cattand P. Eliminating human African trypanosomiasis: where do we stand and what comes next? PLoS Med 2008;5(2):e55.

2. Magnus E, Vervoort T, Van Meirvenne N. A card-agglutination test with stained trypanosomes (C.A.T.T.) for the serological diagnosis of T.b. gambiense trypanosomiasis. Ann Soc Belg Med Trop 1978;58:169-76.

3. Büscher P, Draelants E, Magnus E, Vervoort T, Van Meirvenne N. An experimental latex agglutination test for antibody detection in human African trypanosomiasis. Ann Soc Belg Med Trop 1991;71:267-73.

4. Amin DN, Rottenberg ME, Thomsen AR, et al. Expression and role of CXCL10 during the encephalitic stage of experimental and clinical African trypanosomiasis. J Infect Dis 2009;200: 1556-65.

5. Van Meirvenne N, Magnus E, Büscher P. Evaluation of variant specific trypanolysis tests for serodiagnosis of human infections with Trypanosoma brucei gambiense. Acta Trop 1995;60:189-99.

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