Early Economic Modeling to Inform a Target Product Profile: A Case Study of a Novel Rapid Test for Infection.

Unlabelled: Target product profiles (TPPs) specify the essential properties tests must have to be able to address an unmet clinical need. To explore how early economic modeling can help to define TPP specifications based on cost-effectiveness considerations using the example of a new rapid diagnostic for infection (CDI), a contagious health care-associated infection causing potentially fatal diarrhea. A resource-constrained simulation model was developed to compare a hypothetical test for CDI with current practice (i.