|Research||Catalyse development||Guide use and policy||Accelerate Access|
|Technologies||Test for screening symptomatic patients||Test for case confirmation & cure at the district hospital level|
|Test for case confirmation at the microscopy laboratory level|
|Enabling Environment||TPPs & NTD need prioritization||Advocacy with community & health personnel|
Buruli ulcer (BU) is a disease caused by a toxin-producing bacteria,Mycobacterium ulcerans, which is endemic in 30 countries. The disease occurs largely in rural, swampy subtropical locations amongst children 5 – 15 years old. Central and West Africa have the largest number of cases, followed by Australia and Southeast Asia.
Infections normally begin with a painless growth under the skin on the arms or legs. This growth breaks down over weeks or months, forming an ulcer that destroys the skin, soft tissues, and sometimes bone. Early detection and treatment can prevent permanent disfigurement and disability. In the later stages, treatment is extremely difficult, costly and has poor outcomes.
Each year, more than 6000 cases of BU are reported. Approximately 25% of those are reported or treated too late to prevent disability. The epidemiology of BU is very poorly understood and there are no primary preventative measures for control of the disease. The current control strategy emphasizes early detection and prompt treatment.
Clinical diagnosis of BU at the community level lacks specificity as early signs of BU are similar to other skin conditions. Skin diseases are present in up to 15% of all attendees in peripheral health clinics in tropical countries. These population can be benefited from an accurate POC test able to rule-in or rule-out BU.
FIND is collaborating with the Swiss Tropical and Public Health Institute, Standard Diagnostics/Alere, Korea, and partners in BU-endemic countries in the development and evaluation of a point-of-care (POC) rapid test that detects a surface protein from Mycobacterium ulcerans for screening and diagnosis of BU at the community level.
Currently, the most accurate method for diagnosing BU is through detection of bacterial DNA from lesion specimens using polymerase chain reaction (PCR), an expensive technology with limited implementation because it can only be performed by experts in sophisticated laboratories. An alternative to PCR is loop-mediated isothermal amplification (LAMP) of DNA, a platform technology that has been successfully exploited by FIND and partners for diagnosis of several infectious diseases.
Under a partnership between FIND, the Noguchi Memorial Institute for Medical Research (Ghana) and other partners, we are carrying out studies to determine which set of the published primer sequences yields the best results when used in a LAMP assay to detect M. ulcerans. The data generated will be used to develop a LAMP kit based on dried down reagents, which can be used in decentralized laboratories without the need of cold chain.
Mycolactones are unique toxins produced by M. ulcerans, and these can destroy the skin and soft tissues, causing large ulcers. The toxins can be detected by fluorescence thin layer chromatography (f-TLC). During the BU experts meeting held in Geneva in late 2013 the f-TLC method, developed at Harvard University, was identified as the most advanced to date, and its evaluation at district level laboratories was recommended.
The WHO, FIND and Harvard University (USA) are now working with a number of laboratories in Ghana, Benin and the DRC, to evaluate the test. The evaluation study is also determining whether the test can be used to monitor the efficacy of treatment. If successful, the test could greatly improve diagnosis and treatment monitoring of BU in district hospitals.