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Projects

LAMP4Yaws - Clinical evaluation of a Loop-mediated isothermal amplification test for Treponema pallidum pertenue: A Diagnostic tool to support Yaws Eradication

Projektbild

Project description

Yaws, caused by the bacterium Treponema pallidum subsp. pertenue (T. pallidum), is a neglected tropical disease affecting millions of individuals in poor rural communities in Africa, Asia, and the Pacific Islands. It mostly affects children and manifests as lesions of the skin, bone, and cartilage. It can progress into severe bodily destruction if untreated. In 2012, WHO developed the Morges strategy for the eradication of yaws based on mass treatment with single-dose azithromycin. A reliable diagnosis represents an essential part in the eradication of yaws. However, commonly used serological tests cannot differentiate current yaws from previous infection, nor differentiate yaws from other causes of similar skin lesions, such as Haemophilus ducreyi (H. ducreyi). Nucleic acid amplification tests (NAATs), like PCR, overcome the limitation of serological testing and enable the specific detection of the causative pathogen, the detection of early yaws infections, and the detection of azithromycin resistance mutations. PCR requires sophisticated thermal management and is thus restricted to central laboratories, distant from endemic settings. Consequently, there is the urgent need of an accurate point-of-care NAAT to enable early diagnosis of yaws. Within the project LAMP4Yaws a rapid isothermal NAAT based on loop-mediated isothermal amplification (LAMP) for the simultaneous detection of T. pallidum and H. ducreyi is evaluated. The overarching aim of this study is to validate the LAMP test for yaws diagnosis with patient samples in endemic countries. The performance of this LAMP test conducted at the district level will be compared with the gold standard qPCR, performed at a national reference laboratory. This study is a multi-country clinical evaluation trial with sites in Ghana, Cote d’Ivoire and Cameroon.

Start/End of project

01.01.2020 until 31.12.2022

Project manager

Lisa Becherer (Prof. Dr. R. Zengerle)

Contact person

Lisa Becherer
Phone:+49 761 203-73227

Partners

1. London School of Hygiene and Tropical Medicine (LSHTM), United Kingdom 2. Centre Pasteur du Cameroun, Cameroon 3. Fundación Privada de Lucha contra el sida (FLS), Spain 4. Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts, Germany 5. Institut Pasteur de Cote D’Ivoire, Cote d'Ivoire 6. Mast Diagnostica GmbH, Germany 7. University of Ghana, Noguchi Memorial Institute for Medical Research (NMIMR), Ghana

Funding

EDCTP2 (Second European and Developing Countries Clinical Trials Partnership Programme)

Keywords

Bioanalytik, Biosensoren, bioanalysis, biosensors
Benutzerspezifische Werkzeuge