Product profile for a rapid test for diagnosis of Buruli ulcer at the primary health-care level

Diagnostics Technical Advisory Group (DTAG) World Health Organization WHO (2022) C_WHO
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified: a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and a screening test at the primary health care or community level for symptomatic patients with ulcer In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.