Target product profiles: leprosy diagnostics

Bulletin of the World Health Organization, vol. 102, pp. 288–295

Abstract

The World Health Organization (WHO) aims to reduce new leprosy cases by 70% by 2030, necessitating advancements in leprosy diagnostics.Here we discuss the development of two WHO's target product profiles for such diagnostics.These profiles define criteria for product use, design, performance, configuration and distribution, with a focus on accessibility and affordability.The first target product profile outlines requirements for tests to confirm diagnosis of leprosy in individuals with clinical signs and symptoms, to guide multidrug treatment initiation.The second target product profile outlines requirements for tests to detect Mycobacterium leprae or M. lepromatosis infection among asymptomatic contacts of leprosy patients, aiding prophylactic interventions and prevention.Statistical modelling was used to assess sensitivity and specificity requirements for these diagnostic tests.The paper highlights challenges in achieving high specificity, given the varying endemicity of M. leprae, and identifying target analytes with robust performance across leprosy phenotypes.We conclude that diagnostics with appropriate product design and performance characteristics are crucial for early detection and preventive intervention, advocating for the transition from leprosy management to prevention.

Authors 15

1. Petra Kukkaro

   Novartis (Switzerland)

   Affiliation as printed

   Novartis Pharma AG, Basel, Switzerland

2. Sundeep Chaitanya Vedithi

   University of Cambridge

   Affiliation as printed

   Department of Biochemistry, University of Cambridge, Cambridge, England

3. David J. Blok

   Erasmus MC

   Affiliation as printed

   Department of Public Health, Erasmus University Medical Center, Rotterdam, Kingdom of the Netherlands

4. Wim H. van Brakel
   Affiliation as printed

   Until No Leprosy Remains, Amsterdam, Kingdom of the Netherlands

5. Annemieke Geluk Aachen Department of Infectious Diseases

   Leiden University Medical Center

   Affiliation as printed

   Department of Infectious Diseases, Leiden University Medical Center, Leiden, Kingdom of the Netherlands

6. Aparna Srikantam

   Lepra Society

   Affiliation as printed

   Clinical and Laboratory Research Division, Blue Peter Public Health and Research Centre-LEPRA Society, Hyderabad, India

7. David M. Scollard

   National Hansen's Disease Program

   Affiliation as printed

   National Hansen's Disease Program, Baton Rouge, United States of America (USA)

8. Linda B. Adams

   National Hansen's Disease Program

   Affiliation as printed

   National Hansen's Disease Program, Baton Rouge, United States of America (USA)

9. Mathias Duck

   The Leprosy Mission International

   Affiliation as printed

   The Leprosy Mission International, Brentford, England

10. Andie Tucker corresponding

    The Task Force for Global Health

    Affiliation as printed

    The Task Force for Global Health, Inc, Decatur, USA

11. Israel Cruz

    Instituto de Salud Carlos III · Escuela Nacional de Sanidad

    Affiliation as printed

    National School of Public Health, Instituto de Salud Carlos III, Madrid, Spain

12. VRR Pemmaraju

    World Health Organization Regional Office for South-East Asia · World Health Organization - India

    Affiliation as printed

    Global Leprosy Programme, WHO Regional Office for South-East Asia, New Delhi, India

13. Daniel Argaw Dagne

    World Health Organization

    Affiliation as printed

    Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland

14. Kingsley Bampoe Asiedu

    World Health Organization

    Affiliation as printed

    Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland

15. Christopher Hanna
    Affiliation as printed

    Global Project Partners, Oakland, USA