Diagnostic test for lymphatic filariasis to support decisions for stopping triple-therapy mass drug administration: target product profile

Overview

The WHO Department of Control of Neglected Tropical Diseases (NTD) manages a diverse portfolio of twenty diseases, each with its own unique epidemiological and diagnostic challenges. It was decided by the Strategic and Technical Advisory Group (STAG), the principal advisory group to WHO for the control of NTDs, that a single WHO working group would help ensure that a unified approach could be used to identify and prioritize diagnostic needs, and to inform WHO strategies and guidance on the subject.

A provisional strategy for monitoring and evaluating the impact of IDA was proposed after 2 annual IDA rounds, but the Guideline Development Group identified that current strategies for determining when to stop IDA may not be sufficient and further research was needed (3). As countries approach the 2nd IDA MDA round, programmes urgently need a new diagnostic with specific characteristics and a new survey methodology. The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for measuring when there is evidence to support stopping IDA MDA. The tools must be able to discriminate targeted prevalence threshold in the tested areas (<1% microfilaremia or <2% antigenemia).