Leprosy Diagnostic Working Group develops 2 target product profiles
19 July, 2021 | Global Partnership for Zero Leprosy
Despite available treatment, over 200,000 individuals were diagnosed with leprosy across more than 120 countries in 2019. Early detection of the disease can help prevent disability and the spread of infection. Detection rates could be improved with a tool that’s easy to use to accurately and efficiently diagnose leprosy.
The development of this tool is one of the priorities of the Zero Leprosy Research Agenda. In 2020, the Global Partnership for Zero Leprosy convened the Leprosy Diagnostic Working Group to approach this challenge.
The working group, led by Dr. Sundeep Chaitanya and Dr. Petra Kukkaro, set out to foster the development of a target product profile (TPP) for a leprosy diagnostic. In an early phase of product development, a target product profile outlines the characteristics of the desired product. By bringing together experts in laboratory science, experts in the clinical aspects of leprosy, and representatives from stakeholder groups in the leprosy community, GPZL’s working group developed two TPPs for consideration.
The first TPP describes a diagnostic test used to confirm the diagnosis of leprosy in individuals with clinical signs and symptoms. The second TPP details a diagnostic test to detect Mycobacterium leprae infection among asymptomatic household or familial contacts of leprosy patients to treat them with appropriate prophylactic interventions, like a single dose of the antibiotic rifampicin, and prevent the transmission of leprosy.
Last month the Leprosy Diagnostic Working Group submitted the two TPPs to the WHO Diagnostics Technical Advisory Group (DTAG) for review. The WHO DTAG was formed in advance of the launch of the WHO Roadmap for Neglected Tropical Diseases 2021 – 2030 to facilitate the collaborative development of new diagnostic tools for multiple NTD programmes, including leprosy. Diagnostics is one of four priority areas of the 2030 Roadmap.
Following the completion of this internal review by WHO DTAG, the leprosy diagnostic TPPs will be made available online for public comment. GPZL is proud to have been a part of this collaborative and forward-looking effort and will continue to work with the leprosy- and broader NTD community to promote the development of a leprosy diagnostic tool.