Call for public consultation  ̶  Target Product Profiles (TPP) for dermal leishmaniasis diagnostics

Deadline: 24 December 2021

23 November 2021
Call for consultation

Dermal leishmaniases

Localized cutaneous leishmaniasis and its evolving forms diffuse cutaneous leishmaniasis, mucosal leishmaniasis and cutaneous leishmaniasis recidivans, together with the visceral leishmaniasis sequela post-kala-azar dermal leishmaniasis, account for about one million dermal leishmaniases cases per year worldwide. Although not lethal, the dermal leishmaniases cause chronic and disfiguring skin lesions, which are an important cause of morbidity and stigma.

Microscopy remains the reference test for diagnosis of dermal leishmaniases; however, it has low and variable sensitivity and requires well-trained personnel. The technical complexity and cost of the more sensitive molecular techniques (e.g. PCR) limits their application in routine diagnosis in endemic areas. As a result, a high number of patients are put on treatment without laboratory confirmation, exposing a variable number of them to unnecessary toxic treatment.

Thus, there is a great need for point-of-care (POC) tests for early diagnosis of dermal leishmaniases, in order to benefit both patients and communities by early identification of those that need treatment, reducing the risk of both sequelae and ongoing Leishmania transmission.

The World Health Organization (WHO) is seeking feedback on the TPP from experts in the industry, product developers, the scientific community, NTD programme personnel and clinicians currently involved in the management and control of dermal leishmaniases.

Details of the TPP may be found in the linked documents.

Proposed revisions arising from the public consultation will be considered by the TPP working group before it is finalized. The final TPPs will be used for the development of diagnostics to the treatment of dermal leishmaniases. 

If you have any comments, please submit them to Dr. Kingsley Bampoe Asiedu (asieduk@who.int).

Media Contacts

Ashok Moloo

Information Officer
WHO/UCN/NTD

Telephone: +41 22 791 16 37

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