LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study
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...
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2022-03-01
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| author | Michael Marks Tania Crucitti Emma Michele Harding-Esch Daniel Arhinful Earnest Njih Tabah Serges Tchatchouang Oriol Mitja Becca Louise Handley Camila González-Beiras Laud Antony Basing Kouadio Aboh Hugues Mohammed Bakheit Lisa Becherer Christina Ries Nadine Borst Simone Lüert Sieghard Frischmann Tamara Haerpfer Emelie Landmann Ivy Amanor Aboubacar Sylla Mireille S Kouamé-Sina Jean P Ndzomo-Ngono Adingra Tano Patrick Awondo Solange Ngazoa Kakou Sara Eyangoh Kennedy Kwasi Addo Sascha Knauf |
| author_facet | Michael Marks Tania Crucitti Emma Michele Harding-Esch Daniel Arhinful Earnest Njih Tabah Serges Tchatchouang Oriol Mitja Becca Louise Handley Camila González-Beiras Laud Antony Basing Kouadio Aboh Hugues Mohammed Bakheit Lisa Becherer Christina Ries Nadine Borst Simone Lüert Sieghard Frischmann Tamara Haerpfer Emelie Landmann Ivy Amanor Aboubacar Sylla Mireille S Kouamé-Sina Jean P Ndzomo-Ngono Adingra Tano Patrick Awondo Solange Ngazoa Kakou Sara Eyangoh Kennedy Kwasi Addo Sascha Knauf |
| author_sort | Michael Marks |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-61bbd23db90d43ea9fe47ffb71d78869 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-03-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-61bbd23db90d43ea9fe47ffb71d788692025-08-20T02:17:39ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-058605LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy studyMichael Marks0Tania Crucitti1Emma Michele Harding-Esch2Daniel Arhinful3Earnest Njih Tabah4Serges Tchatchouang5Oriol Mitja6Becca Louise Handley7Camila González-Beiras8Laud Antony Basing9Kouadio Aboh Hugues10Mohammed Bakheit11Lisa Becherer12Christina Ries13Nadine Borst14Simone Lüert15Sieghard Frischmann16Tamara Haerpfer17Emelie Landmann18Ivy Amanor19Aboubacar Sylla20Mireille S Kouamé-Sina21Jean P Ndzomo-Ngono22Adingra Tano23Patrick Awondo24Solange Ngazoa Kakou25Sara Eyangoh26Kennedy Kwasi Addo27Sascha Knauf281 Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK4 Institute of Tropical Medicine, Antwerp, BelgiumClinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK1 Department of Epidemiology, University of Ghana, Noguchi Memorial Institute for Medical Research, Accra, GhanaNational Buruli Ulcer, Leprosy, Yaws and Leishmaniasis Control Program, Ministry of Public Health, Yaounde, CameroonCentre Pasteur du Cameroun, Yaounde, CameroonUniversity of Barcelona, Barcelona, SpainClinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UKDepartment of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, SpainUniversity of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, GhanaNational Program of African Trypanosomiasis Elimination, Abidjan, Côte d`IvoireMast Diagnostica GmbH, Reinfeld, GermanyIMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, GermanyInstitute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, GermanyIMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, GermanyInstitute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, GermanyMast Diagnostica GmbH, Reinfeld, GermanyIMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, GermanyMast Diagnostica GmbH, Reinfeld, GermanyUniversity of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, GhanaInstitut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`IvoireInstitut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`IvoireCentre Pasteur du Cameroun, Yaounde, CameroonInstitut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`IvoireCentre Pasteur du Cameroun, Yaounde, CameroonInstitut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`IvoireCentre Pasteur du Cameroun, Yaounde, CameroonNoguchi Memorial Institute for Medical Research, University of Ghana, Legon, GhanaInstitute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, GermanyIntroduction 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.https://bmjopen.bmj.com/content/12/3/e058605.full |
| spellingShingle | Michael Marks Tania Crucitti Emma Michele Harding-Esch Daniel Arhinful Earnest Njih Tabah Serges Tchatchouang Oriol Mitja Becca Louise Handley Camila González-Beiras Laud Antony Basing Kouadio Aboh Hugues Mohammed Bakheit Lisa Becherer Christina Ries Nadine Borst Simone Lüert Sieghard Frischmann Tamara Haerpfer Emelie Landmann Ivy Amanor Aboubacar Sylla Mireille S Kouamé-Sina Jean P Ndzomo-Ngono Adingra Tano Patrick Awondo Solange Ngazoa Kakou Sara Eyangoh Kennedy Kwasi Addo Sascha Knauf LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study BMJ Open |
| title | LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study |
| title_full | LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study |
| title_fullStr | LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study |
| title_full_unstemmed | LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study |
| title_short | LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study |
| title_sort | lamp4yaws treponema pallidum haemophilus ducreyi loop mediated isothermal amplification protocol for a cross sectional observational diagnostic accuracy study |
| url | https://bmjopen.bmj.com/content/12/3/e058605.full |
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