Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study

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Abstract

Background: We examined which clinical signs and symptoms are associated with human African trypanosomiasis (HAT), and assessed the performance of selected clinical presentations, of rapid diagnostic tests (RDT), and of reference laboratory tests on dried blood spots (DBS) for diagnosing HAT in Guinea.

Materials and methods: The study took place in 14 health facilities in Guinea, where 2345 clinical suspects were tested with RDTs (HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT). Seropositives underwent parasitological examination (reference test) to confirm HAT and their DBS were tested in indirect enzyme-linked immunoassay (ELISA)/Trypanosoma brucei gambiense, trypanolysis, Loopamp Trypanosoma brucei Detection kit (LAMP) and m18S quantitative PCR (qPCR). Multivariable regression analysis assessed association of clinical presentation with HAT.

Results: The HAT prevalence, as confirmed parasitologically, was 2.0% (48/2345, 95% CI: 1.5–2.7%). Odds ratios (OR) for HAT were increased for participants with swollen lymph nodes (OR=96.7, 95% CI: 20.7–452.0), important weight loss (OR=20.4, 95% CI: 7.05–58.9), severe itching (OR=45.9, 95% CI: 7.3–288.7) or motor disorders (OR=4.5, 95% CI: 0.89–22.5). HAT Sero-K-Set, rHAT Sero-Strip, and SD Bioline HAT were respectively 97.5% (95% CI: 96.8–98.1%), 99.4% (95% CI: 99.0–99.7%) and 97.9% (95% CI: 97.2–98.4%) specific, and 100% (95% CI: 92.5–100.0%), 59.6% (95% CI: 44.3–73.3%) and 93.8% (95% CI: 82.8–98.7%) sensitive for HAT. The RDT’s positive and negative predictive values ranged from 45.2–66.7% and 99.2–100% respectively.

Conclusion: Diagnostic performances of HAT Sero-K-Set and SD Bioline HAT are sufficient for referring positives to microscopy. Trypanolysis on DBS may discriminate HAT patients from false RDT positives.

This article is a translation of the article by Camara O, Camara M, Falzon LC, et al. Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study. Infect Dis Poverty. 2023;12(1):22. doi: 10.1186/s40249-023-01076-1

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About the authors

Oumou Camara

Programme National de Lutte contre la Trypanosomiase Humaine Africaine

Email: veerle.lejon@ird.fr
ORCID iD: 0009-0003-5016-9293

Dr. Sci. (Philosophy)

Guinea, Conakry

Camara Mamadou

Programme National de Lutte contre la Trypanosomiase Humaine Africaine

Email: mamadou.camara@iutv.univ-paris13.fr
ORCID iD: 0000-0001-7785-6649
Guinea, Conakry

Laura Cristina Falzon

International Livestock Research Institute; Institute of infection, veterinary and ecological sciences, University of Liverpool

Email: laura.falzon@liverpool.ac.uk
ORCID iD: 0000-0002-4043-1644

Dr. Sci. (Veterinary Medicine), PhD (Population Medicine)

Kenya, Nairobi; UK, Liverpool

Hamidou Ilboudo

Institute for Health Science Research

Email: hamidou_ilboudo@hotmail.com
ORCID iD: 0000-0003-3936-7718
Burkina Faso, Ouagadougou

Jacques Kaboré

International Research and Development Center on Livestock in Sub-Humid Areas; University of Nazi Boni

Email: jacqueskabore@yahoo.fr
ORCID iD: 0000-0003-0224-4458
Burkina Faso, Bobo-Dioulasso; Bobo-Dioulasso

Charlie Franck Alfred Compaoré

International Research and Development Center on Livestock in Sub-Humid Areas

Email: veerle.lejon@ird.fr
Burkina Faso, Bobo-Dioulasso

Eric Maurice Fèvre

International Livestock Research Institute; Institute of infection, veterinary and ecological sciences, University of Liverpool

Email: Eric.Fevre@liverpool.ac.uk
ORCID iD: 0000-0001-8931-4986
Kenya, Nairobi; UK, Liverpool

Philippe Büscher

Institute of Tropical Medicine

Email: pbuscher@itg.be
ORCID iD: 0000-0002-1926-7472
Belgium, Antwerp

Bruno Bucheton

Programme National de Lutte contre la Trypanosomiase Humaine Africaine; University of Montpellier

Email: bruno.bucheton@ird.fr
ORCID iD: 0000-0003-3804-5426
Guinea, Conakry; France, Montpellier

Veerle Lejon

University of Montpellier

Author for correspondence.
Email: veerle.lejon@ird.fr
ORCID iD: 0000-0002-6795-0962

PhD (Biochemistry)

France, Montpellier

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Supplementary files

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2. Fig. 1. DiTECT-HAT-WP2 study conduct and test results in Guinea. СМЖ — Cerebrospinal fluid, СПК — dried blood spot, АТЧ — Human African trypanosomiasis (HAT), mAECT-BC — mini anion exchange centrifugation on buffy coat, БДТ — rapid diagnostic test, ИФА — enzyme immunoassay (ELISA). * АТЧ confirmed by CSF examination. НП — not done. АТЧ⊕ — HAT positive. АТЧ⊘ — HAT free.

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3. Fig. 2. Frequency of 13 clinical symptoms and signs in human African trypanosomiasis (АТЧ) and non-АТЧ affected study participants. The figure contains data for 48 АТЧ and 2297 non-АТЧ participants with the exception of * only 19 АТЧ and 1294 non-HАТЧ female participants.

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4. Fig. 3. Individual rapid diagnostic tests (БДТ) results of human African trypanosomiasis (АТЧ) patients and АТЧ free participants. The Venn diagram shows results in the БДТ АТЧ Sero-K-Set, rАТЧ Sero-Strip and SD Bioline АТЧ of 48 АТЧ patients and 2297 АТЧ free participants. K° — АТЧ Sero-K-Set not performed, S° rАТЧ Sero-Strip not performed, B° SD Bioline АТЧ not performed, АТЧ⊕ — АТЧ patients, АТЧ⊘ — АТЧ free participants.

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5. Fig. 4. Reference laboratory test results on dried blood spots. The Venn diagram shows the results of trypanolysis, ELISA/T.b. gambiense, LAMP and m18S qПЦР on dried blood spot (СПК) from 34 АТЧ patients (АТЧ⊕) and 43 АТЧ negatives (АТЧ⊘) who all tested rapid diagnostic test positive. T° — trypanolysis not performed, L° — LAMP not performed,  died after the first parasitological examination at inclusion, * including 1 АТЧ negative person with 265 WBC/μl.

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Copyright (c) 2024 Camara O., Mamadou C., Falzon L.C., Ilboudo H., Kaboré J., Compaoré C.F., Fèvre E.M., Büscher P., Bucheton B., Lejon V.

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