Multiplex serodiagnostic test for Chagas disease

Tarleton, Rick

Abstract

The diagnosis of Trypanosoma cruzi infection (the cause of human Chagas disease) is difficult and the ability to assess treatment efficacy is almost nonexistent. A screen of >400 T. cruzi proteins resulted in the identification of a set that was able to efficiently detect both serologically confirmed as well as non-confirmed, human cases of T. cruzi infection, and to detect changes in immune status following drug treatment. This application seeks to exploit these findings for use in a low resource environment by transferring this T. cruzi serological test to a novel and low cost multiplex platform. For this purpose, a partnership involving Parallel Synthesis Technologies, an established biotech development firm with unique multiplex bead and reader technologies, PATH, an international nonprofit organization focused on designing and implementing health technologies for low-resource environments, and the University of Georgia, developer and patent holder of the initial T. cruzi multiplex serology technology, has been established. We propose to transfer the Luminex- based assay to the Parallume bead system developed by Parallel Synthesis, to validate this new platform and test with an extended set of well-characterized sera and improve upon this test by expanding the antigen panel. Firm performance characteristics will be determined and the ability of the test to assess treatment efficacy in chronically infected subjects will be determined. The development of an affordable multiplex diagnostic platform will not only be an important tool for the diagnosis and treatment of Chagas disease, but will open up possibilities for the diagnosis of other infections or multiple infections in a single test.

Public Health Relevance

Chagas disease (American trypanosomiasis) is the highest impact infectious disease in Latin America and is a growing threat in the United States. The goal of this project is to develop and field test a serodiagnostic test to detect infection by T. cruzi, the causative agent of Chagas Disease. This test will have a multiplex format and will be designed for use in low resource environments where Chagas disease is endemic.