Specificity of serological screening tests and reference laboratory tests to diagnose gambiense human African trypanosomiasis: a prospective clinical performance study  

作　　者：Martial Kassi N'Djetchil Oumou Camara Mathurin Koffi Mamadou Camara Dramane Kaba Jacques Kabore Alkali Tall Brice Rotureau Lucy Glover Melika Barkissa Traorel Minayegninrin Kone Bamoro Coulibaly Guy Pacome Adingra Aissata Soumah Mohamed Gassama Abdoulaye Dansy Camara Charlie Franck Alfred Compaore Aissata Camara Salimatou Boiro Elena Perez Anton Paul Bessell Nick Van Reet Bruno Bucheton Vincent Jamonneau Jean-Mathieu Bart Philippe Solano Sylvain Bieler Veerle Lejon 

机构地区：[1]Laboratory of Biodiversity and Ecosystem Management,Jean Lorougnon Guede University,Daloa,Cote d'ivoire [2]National Program for Neglected Tropical Disease Control,Patient Management,Ministry of Health,Conakry,Guinea [3]Trypanosomosis Research Unit,Pierre Richet Institute,Bouake,Cote d'ivoire [4]International Research and Development Centre on Livestock in Subhumid Zones,Bobo-Dioulasso,Burkina Faso [5]National Program for Malaria Control,Conakry,Guinea [6]Parasitology Unit,Institut Pasteur de Guinee,Conakry,Guinea [7]Trypanosome Molecular Biology Unit,Department of Parasites and Insect Vectors,Pasteur Institute,Paris Cite University,Paris,France [8]Intertryp,IRD-CIRAD-University of Montpellier,Montpellier,France [9]Independent Consultant,Edinburgh,Uk [10]Department of Biomedical Sciences,Institute of Tropical Medicine,Antwerp,Belgium [11]Foundation for Innovative New Diagnostics,Geneva,Switzerland

出　　处：《Infectious Diseases of Poverty》2024年第4期48-63,共16页贫困所致传染病（英文）

基　　金：This work was supported by the Swiss Agency for Development and Cooperation(grant nr.81071426,7F-08866.03.01);the Bill and Melinda Gates Foundation(www.gatesfoundation.org)through the Trypa-NO!Project(grants number INV-001785,OPP1033712,OPP1154033);the'Development and integration of serological and molecular diagnostics in view of interruption of transmission of gambiense-HAT'project(grant number INV-031353).

摘　　要：Background Serological screening tests play a crucial role to diagnose gambiense human African trypanosomiasis (gHAT). Presently, they preselect individuals for microscopic confirmation, but in future "screen and treat" strategies they will identify individuals for treatment. Variability in reported specificities, the development of new rapid diagnostic tests (RDT) and the hypothesis that malaria infection may decrease RDT specificity led us to evaluate the specificity of 5 gHAT screening tests.Methods During active screening, venous blood samples from 1095 individuals from Cote d’Ivoire and Guinea were tested consecutively with commercial (CATT, HAT Sero-K-SeT, Abbott Bioline HAT 2.0) and prototype (DCN HAT RDT, HAT Sero-K-SeT 2.0) gHAT screening tests and with a malaria RDT. Individuals with ≥ 1 positive gHAT screening test underwent microscopy and further immunological (trypanolysis withT.b. gambiense LiTat 1.3, 1.5 and 1.6;indirect ELISA/T.b. gambiense;T.b. gambiense inhibition ELISA withT.b. gambiense LiTat 1.3 and 1.5 VSG) and molecular reference laboratory tests (PCR TBRN3, 18S and TgsGP;SHERLOCK 18S Tids, 7SLZoon, and TgsGP;Trypanozoon S2-RT-qPCR 18S2, 177T, GPI-PLC and TgsGP in multiplex;RT-qPCR DT8, DT9 and TgsGP in multiplex). Microscopic trypanosome detection confirmed gHAT, while other individuals were considered gHAT free. Differences in fractions between groups were assessed by Chi square and differences in specificity between 2 tests on the same individuals by McNemar.Results One gHAT case was diagnosed. Overall test specificities (n = 1094) were: CATT 98.9% (95%CI: 98.1–99.4%);HAT Sero-K-SeT 86.7% (95%CI: 84.5–88.5%);Bioline HAT 2.0 82.1% (95%CI: 79.7–84.2%);DCN HAT RDT 78.2% (95%CI: 75.7–80.6%);and HAT Sero-K-SeT 2.0 78.4% (95%CI: 75.9–80.8%). In malaria positives, gHAT screening tests appeared less specific, but the difference was significant only in Guinea for Abbott Bioline HAT 2.0 (P = 0.03) and HAT Sero-K-Set 2.0 (P = 0.0006). The specificities of immunological and molecular l

关 键 词：Human African trypanosomiasis Trypanosoma brucei gambiense Diagnosis SPECIFICITY Rapid diagnostic test Immunological test Molecular test 

分 类 号：R531.9[医药卫生—内科学]