This study will address the following question: What are the diagnostic/clinical sensitivity and specificity of ML-RPA assay toward detection of leprosy using a mobile suitcase laboratory platform?
Evaluation of Mycobacterium leprae specific RPA assay incorporated in mobile suitcase lab for rapid diagnosis of clinical and sub-clinical leprosy in Bangladesh
Project coordination
Partners
- Damien Foundation, Bangladesh
- University of Leipzig
- Kumasi centre for Collaborative Research in Tropical Medicine
- Dept. of Pharmacology, Institute of Post Graduate Medical Education and Research, India
- Bankura Sammilani Medical College And Hospital
Project summary
Leprosy is a debilitating and contagious disease, caused by an obligate intracellular bacterium Mycobacterium leprae (M. leprae) and is the leading cause of disabilities and deformities among all the communicable diseases. The global leprosy elimination target has been achieved in 2000, however, the transmission of this primeval disease still continues and annually 220,000-250,000 cases are detected in 127 affected countries. Deformities, along with low literacy level of the leprosy afflicted population also give rises to the perpetual social stigma toward the affected persons in the community. Therefore, leprosy remains a major incapacitating disease contributing to significant disability-adjusted life years and social stigma resulting in adverse psycho-social apprehension, even in this modern era.
Early diagnosis is crucial for effective treatment of leprosy cases and to protect the family members/ household contacts of the leprosy patients, who are most susceptible to getting the infection. Therefore, a rapid and confirmatory diagnostic method is crucial for accurate diagnosis of M.Leprae for early management of the patients and limiting the spread of the disease in the community. To address this problem, the research team intends to introduce an isothermal amplification assay- the “Recombinant polymerase amplification assay” in a suitcase lab that is simple, easy to perform, field-friendly, and a cost-effective molecular diagnostic system. The aims of the study are as follows :
1. Develop a test that can accurately detect leprosy patients.
2. Evaluate the test to correctly identify M.Leprae infected patients with visible signs and symptoms.
3. Evaluate the test in the household contacts of leprosy patients who are infected but have not developed the signs and symptoms yet, who are most at risk of developing the disease.
The research group has already developed the ML-RPA test which has shown to be highly accurate with cultured DNA from M.leprae in the laboratory. However, its efficacy to diagnose actual leprosy cases and their contacts remains unknown. Therefore, in this study, it is planned to investigate the diagnostic efficacy of the test in Bangladesh with actual leprosy cases and their household contacts. Samples from leprosy-affected individuals and their household contacts will be taken and tested with ML-RPA assay as well as real-time PCR (another molecular test with high accuracy in detecting leprosy). Results between tests will be compared to decide if the developed ML-RPA assay retains similar efficacy as the real-time PCR. If it proves to be similar to or even better than the real-time PCR, it will be recommended to apply the assay for diagnosis of the leprosy patients in the field, where the patients require the service most.
Co-financer: Turing Foundation