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LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study.
Handley, Becca Louise; González-Beiras, Camila; Tchatchouang, Serges; Basing, Laud Antony; Hugues, Kouadio Aboh; Bakheit, Mohammed; Becherer, Lisa; Ries, Christina; Njih Tabah, Earnest; Crucitti, Tania; Borst, Nadine; Lüert, Simone; Frischmann, Sieghard; Haerpfer, Tamara; Landmann, Emelie; Amanor, Ivy; Sylla, Aboubacar; Kouamé-Sina, Mireille S; Ndzomo-Ngono, Jean P; Tano, Adingra; Arhinful, Daniel; Awondo, Patrick; Ngazoa Kakou, Solange; Eyangoh, Sara; Addo, Kennedy Kwasi; Harding-Esch, Emma Michele; Knauf, Sascha; Mitjà, Oriol; Marks, Michael.
Afiliación
  • Handley BL; Clinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK rebecca.handley1@lshtm.ac.uk.
  • González-Beiras C; Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
  • Tchatchouang S; Centre Pasteur du Cameroun, Yaounde, Cameroon.
  • Basing LA; University of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, Ghana.
  • Hugues KA; National Program of African Trypanosomiasis Elimination, Abidjan, Côte d'Ivoire.
  • Bakheit M; Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire.
  • Becherer L; Mast Diagnostica GmbH, Reinfeld, Germany.
  • Ries C; IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany.
  • Njih Tabah E; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany.
  • Crucitti T; National Buruli Ulcer, Leprosy, Yaws and Leishmaniasis Control Program, Ministry of Public Health, Yaounde, Centre Region, Cameroon.
  • Borst N; Public Health & Epidemiology, University of Dschang, Yaounde, West Region, Cameroon.
  • Lüert S; Experimental Bacteriology Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.
  • Frischmann S; IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany.
  • Haerpfer T; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany.
  • Landmann E; Mast Diagnostica GmbH, Reinfeld, Germany.
  • Amanor I; IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany.
  • Sylla A; Mast Diagnostica GmbH, Reinfeld, Germany.
  • Kouamé-Sina MS; University of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, Ghana.
  • Ndzomo-Ngono JP; Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire.
  • Tano A; Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire.
  • Arhinful D; Centre Pasteur du Cameroun, Yaounde, Cameroon.
  • Awondo P; Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire.
  • Ngazoa Kakou S; University of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, Ghana.
  • Eyangoh S; Centre Pasteur du Cameroun, Yaounde, Cameroon.
  • Addo KK; Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire.
  • Harding-Esch EM; Centre Pasteur du Cameroun, Yaounde, Cameroon.
  • Knauf S; Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana.
  • Mitjà O; Clinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK.
  • Marks M; Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany.
BMJ Open ; 12(3): e058605, 2022 03 29.
Article en En | MEDLINE | ID: mdl-35351731
ABSTRACT

INTRODUCTION:

Yaws, caused by the bacterium Treponema pallidum subsp. pertenue, is a neglected tropical disease targeted for eradication by 2030. Improved diagnostics will be essential to meet this goal. Diagnosis of yaws has relied heavily on clinical and serological tools. However, the presence of coendemic cutaneous skin ulcer diseases, such as lesions caused by Haemophilus ducreyi (HD), means these techniques do not provide a reliable diagnosis. Thus, new diagnostic tools are needed. Molecular tools such as PCR are ideal, but often expensive as they require trained technicians and laboratory facilities, which are often not available to national yaws programmes. METHODS AND

ANALYSIS:

The LAMP4yaws project is a cross-sectional, observational, diagnostic accuracy study of a combined Treponema pallidum (TP) and HD loop mediated isothermal amplification (TPHD-LAMP) test performed under real world conditions in three endemic countries in West Africa. Individuals with serologically confirmed yaws will be recruited in Cameroon, Côte d'Ivoire and Ghana. Each participant will provide paired swabs, one of which will be sent to the respective national reference laboratory for yaws quantitative PCR and the other will be tested for both TP and HD using the TPHD-LAMP test at local district laboratories. Sensitivity and specificity of the TPHD-LAMP test will be calculated against the reference standard qPCR. We will also assess the acceptability, feasibility and cost-effectiveness of the test. We anticipate that results from this study will support the adoption of the TPHD-LAMP test for use in global yaws eradication efforts. ETHICS AND DISSEMINATION We have received ethical approval from all relevant institutional and national ethical committees. All participants, or their parents or guardians, must provide written informed consent prior to study enrolment. Study results will be published in an open access journal and disseminated with partners and the World Health Organization. TRIAL REGISTRATION NUMBER NCT04753788.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Úlcera Cutánea / Buba / Haemophilus ducreyi Tipo de estudio: Diagnostic_studies / Guideline / Observational_studies / Prevalence_studies / Risk_factors_studies País/Región como asunto: Africa Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Úlcera Cutánea / Buba / Haemophilus ducreyi Tipo de estudio: Diagnostic_studies / Guideline / Observational_studies / Prevalence_studies / Risk_factors_studies País/Región como asunto: Africa Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article