A loop-mediated isothermal amplification test for yaws : a multi-country diagnostic accuracy evaluation
Handley, Becca L. (London School of Hygiene and Tropical Medicine (Regne Unit))
González-Beiras, Camila (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Tchatchouang, Serges (Centre Pasteur du Cameroun (Àfrica Central))
Hugues, Kouadio Aboh (Institut Pasteur de Côte d'Ivoire (Àfrica))
Basing, Laud Antony (University of Ghana (Àfrica))
Sylla, Aboubacar (Institut Pasteur de Côte d'Ivoire (Àfrica))
Kouamé-Sina, Mireille S. (Institut Pasteur de Côte d'Ivoire (Àfrica))
Amanor, Ivy (University of Ghana (Àfrica))
Ndzomo, Philippe (Centre Pasteur du Cameroun (Àfrica Central))
Aloumba, Axel (Université Marien Ngouabi (República del Congo, Àfrica))
Bakheit, Mohammed (Mast Diagnostica (Alemanya))
Müller, Claudia (Federal Research Institute for Animal Health)
Borst, Nadine (Hahn-Schickard)
Landmann, E. (Mast Diagnostica)
Gmoser, H. (University of Freiburg)
Härpfer, T. (University of Freiburg)
Becherer, L. (University of Freiburg)
Lüert, S. (Federal Research Institute for Animal Health)
Frischmann, S. (Mast Diagnostica)
Burl, S. (London School of Hygiene and Tropical Medicine)
Tabah, E.N. (Leprosy and Buruli Ulcer Control Programme. Ministry of Public Health)
Crucitti, Tania (Institut Pasteur de Madagascar)
Kouadio, A.T. (Centre Pasteur du Cameroun)
Arhinful, D.K. (University of Ghana)
Awondo, P. (Centre Pasteur du Cameroun)
Kakou, S.N. (Institut Pasteur de Côte d'Ivoire)
Eyangoh, S. (Institut Pasteur de Côte d'Ivoire)
Addo, Kennedy Kwasi (University of Ghana)
Knauf, S. (Justus Liebig University)
Mitjà, Oriol (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Harding-Esch, E.M. (London School of Hygiene and Tropical Medicine)
Marks, M. (Division of Infection and Immunity. University College London)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Adolescent ; Adult ; Cameroon ; Child ; Congo ; Cote d'Ivoire ; Female ; Ghana ; Humans ; LAMP assay ; Male ; Molecular Diagnostic Techniques ; Nucleic Acid Amplification Techniques ; Prospective Studies ; Sensitivity and Specificity ; Treponema pallidum ; Yaws ; Young Adult
Publicat a:	The Lancet. Global health, Vol. 12 Núm. 11 (november 2024) , p. e1891-e1898, ISSN 2214-109X

DOI: 10.1016/S2214-109X(24)00324-3
PMID: 39424576

8 p, 7.4 MB

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