Neglected tropical diseases (NTD) affect the poorest populations. Several NTDs including schistosomiasis are controlled by preventive chemotherapy in the form of periodic mass drug administration (MDA). In areas with insufficient sanitation, schistosomes and soil-transmitted helminth are transmitted by eggs excreted in human stool and/or urine that contaminates the environment. Around 200 million individuals are infected with schistosomiasis, resulting in an estimated 1.7 to 4.5 million disability-adjusted life years (DALYs) lost, and 14,000 to 280,000 deaths per year.

Control programs based on MDA have four designated stages: mapping disease distribution, impact

monitoring of MDA interventions, stopping decisions for MDA, and post-elimination surveillance. Current diagnostic tools including the Kato-Katz technique are thought to be sufficient for mapping disease distribution (see Appendix A: Common diagnostic tools). As the most commonly used method for schistosomiasis detection, its main strength is its extensive validation and familiarity all over the world. Requiring nothing more than a microscope and a good light source or power, the simplistic technology allows easier use at lower infrastructure levels. However, the major limitations of the Kato-Katz technique are its need for a trained microscopist and low sensitivity for detecting light intensity infections, which diminish its utility in later disease control stages. To support schistosomiasis control programs to continue to move toward elimination, a more sensitive, field-deployable diagnostic is needed.

This report proposes a target product profile (TPP) for the development of a new diagnostic technology that facilitates an accurate stopping decision for MDA. Each attribute has an “acceptable” standard that must be met and an “ideal” standard that if met would maximize the target product’s value. This TPP focuses on the development of a lateral flow rapid diagnostic test that detects a Schistosoma-specific antigen.