A loop-mediated isothermal amplification test for yaws: a multi-country diagnostic accuracy evaluation.

Autor:	Handley BL; Faculty of Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: rebecca.handley1@lshtm.ac.uk., González-Beiras C; STI and Skin NTDs Unit, Department of Infectious Diseases and Fight AIDS Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain., Tchatchouang S; Centre Pasteur du Cameroun, Yaoundé, Cameroon., Hugues KA; National Program of African Trypanosomiasis Elimination, Abidjan, Côte d'Ivoire; Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire., Basing LA; Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana., Sylla A; Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire., Kouamé-Sina MS; Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire., Amanor I; Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana., Ndzomo P; Centre Pasteur du Cameroun, Yaoundé, Cameroon., Aloumba A; Department of Infectious Diseases, Université Marien Ngouabi, Brazzaville, Republic of the Congo., Bakheit M; Mast Diagnostica, Reinfeld, Germany., Müller C; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald-Insel Riems, Germany., Borst N; Laboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Baden-Württemberg, Germany; Hahn-Schickard, Freiburg, Germany., Landmann E; Mast Diagnostica, Reinfeld, Germany., Gmoser H; Laboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Baden-Württemberg, Germany., Härpfer T; Laboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Baden-Württemberg, Germany., Becherer L; Laboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Baden-Württemberg, Germany., Lüert S; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald-Insel Riems, Germany., Frischmann S; Mast Diagnostica, Reinfeld, Germany., Burl S; Faculty of Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK., Tabah EN; Department of Public Health, Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Dschang, Cameroon; National Yaws, Leishmaniasis, Leprosy and Buruli Ulcer Control Programme, Ministry of Public Health, Yaoundé, Cameroon., Crucitti T; Institut Pasteur de Madagascar, Antananarivo, Madagascar., Kouadio AT; Centre Pasteur du Cameroun, Yaoundé, Cameroon., Arhinful DK; Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana., Awondo P; Centre Pasteur du Cameroun, Yaoundé, Cameroon., Kakou SN; Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire., Eyangoh S; Institut Pasteur de Côte d'Ivoire, Abidjan, Côte d'Ivoire., Addo KK; Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana., Knauf S; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald-Insel Riems, Germany; One Health/International Animal Health, Faculty of Veterinary Medicine, Justus Liebig University, Giessen, Germany., Mitjà O; STI and Skin NTDs Unit, Department of Infectious Diseases and Fight AIDS Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain., Harding-Esch EM; Faculty of Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK., Marks M; Faculty of Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK; Hospital for Tropical Diseases, London, UK; Division of Infection and Immunity, University College London, London, UK.
Jazyk:	angličtina
Zdroj:	The Lancet. Global health [Lancet Glob Health] 2024 Nov; Vol. 12 (11), pp. e1891-e1898.
DOI:	10.1016/S2214-109X(24)00324-3
Abstrakt:	Background: To meet the WHO target of eradicating yaws by 2030, highly sensitive and specific diagnostic tools are needed. A multiplex Treponema pallidum-Haemophilus ducreyi loop-mediated isothermal amplification (TPHD-LAMP) test holds promise as a near-patient diagnostic tool for yaws and H ducreyi. We conducted a prospective evaluation in Cameroon, Côte d'Ivoire, Ghana, and the Republic of the Congo to determine the diagnostic accuracy of the TPHD-LAMP test, as well as to assess its acceptability, feasibility, and cost. Methods: Active case searching within schools and communities was used to locate participants with clinically suspicious laws-like lesions. Individuals with serologically confirmed active yaws provided paired lesion swabs between March, 2021, and April, 2023. For each participant, one swab was tested with the TPHD-LAMP at a local district laboratory and the other with reference quantitative PCR (qPCR) tests conducted at national reference laboratories. The primary outcome was TPHD-LAMP test sensitivity and specificity compared with qPCR. Laboratory technicians were interviewed using a multiple-choice survey to gauge acceptability and feasibility of the TPHD-LAMP test. Costs of each test were calculated. Findings: Of 3085 individuals with at least one suspected yaws lesion, 531 (17%) were serologically confirmed. We enrolled 493 participants with seropositive yaws and a further 32 with negative serology. The sensitivity of the TPHD-LAMP test for detecting T pallidum was 63% (95% CI 56-70) and the specificity was 66% (95% CI 61-71). Sensitivity and specificity for T pallidum improved to 73% (63-82; p=0·0065) and 75% (68-80; p=0·0003), respectively, in H ducreyi-negative samples. Interviews highlighted challenges in user-friendliness and practicality of the TPHD-LAMP test. The cost of the test per sample was one third of that of qPCR, although the TPHD-LAMP test entailed higher costs to establish the assay. Interpretation: This was the first multi-country diagnostic evaluation of a molecular test for yaws. The TPHD-LAMP testing, in its current form, falls short of the WHO target product profile criteria for yaws diagnostics. These findings highlight the importance of assessing new diagnostics in real-world conditions to ensure their suitability for programmatic use. Funding: The EDCTP2 programme supported by the EU. Competing Interests: Declaration of interests SF, MB, and EL are employees of Mast Diagnostica, which produces and sells LAMP products. A patent covering the mediator displacement probe technique, a component of the TPHD-LAMP assay described in this study, has been applied for by the University of Freiburg and Hahn-Schickard. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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