Please use this identifier to cite or link to this item:http://hdl.handle.net/20.500.12105/16325
Target product profile for a diagnostic test to detect Mycobacterium leprae infection among asymptomatic household and familial contacts of leprosy patients
Target product profile for a diagnostic test to detect Mycobacterium leprae infection among asymptomatic household and familial contacts of leprosy patients. Geneva: World Health Organization; 2023
Leprosy remains a significant health problem in endemic tropical countries where about 200,000 new cases are reported annually from more than 155 WHO Member States and territories. The stable incidence rates during the past 15 years and the occurrence of about 10% of paediatric cases among newly detected leprosy cases annually indicate ongoing transmission of the disease in endemic countries. Leprosy is caused by an obligate intracellular bacilli, Mycobacterium leprae and, in some cases, by Mycobacterium lepromatosis. Transmission of leprosy bacilli is poorly understood, and existing evidence suggests that inhalation of aerosols containing M. leprae is the main route of transmission. In some circumstances, skin-to-skin contact has also been implicated in transmission. To date, there is no conclusive evidence that the shedding of bacteria into the environment by an active case can lead to subsequent infection of individuals. Owing to the chronicity of M. leprae infection, individuals in close contact with leprosy cases may harbour infection before clinical signs appear. During this latent period, infection without any clinical signs can eventually progress towards manifesting overt clinical signs and symptoms of leprosy. Limited evidence suggests that subclinically infected individuals may transmit M. leprae to other individuals in close physical contact. Those at highest risk are household and family contacts. Hence it is vital to detect M. leprae infection primarily in the household and among familial contacts of leprosy cases in order to determine individuals who require an enhanced regimen of post-exposure prophylaxis (PEP) and to prevent M. leprae transmission. In the new WHO road map for neglected tropical diseases 2021−2030 (“the road map”), leprosy is targeted for elimination (interruption of M. leprae transmission). Guidelines for contact tracing and interrupting transmission with appropriate prophylactic interventions have also been developed. However, the precise mechanisms of action of these interventions have not yet been studied, and the long-term consequences of the interventions are not known.
Table of contents
1. Epidemiology. 2. Public health response. 3. Available diagnostic tools. 4. WHO Diagnostic Technical Advisory Group for Neglected Tropical Diseases. 5. WHO Technical Advisory Group on Leprosy. 6. Purpose of the Target product profile (TPP). 7. Audiences engaged and external consultations to develop the TPP
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