A Serological Diagnostic Immunoassay Test Strip for Leishmaniasis

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DESCRIPTION (provided by applicant): Leishmaniasis is a disease endemic to India, Africa, Mediterranean nations, South American countries, and southern Texas. Americans visiting Latin American nations as tourists, and soldiers serving in Iraq and Afghanistan, have contracted the disease. Polymerase chain reaction (PCR) and enzyme immunosorbent assays (ELISA) are commonly used to diagnose this disease. The current methods are laboratory based, require special equipment, involve complex procedures, and are labor intensive and time-consuming. ELISA tests for leishmaniasis are not highly specific and sensitive, so there is an important need to develop easy-to- use and highly sensitive diagnostic tests for leishmaniasis. In this project, Intelligent Optical Systems, in collaboration with Professor Diane McMahon-Pratt of the Yale University School of Medicine, proposes to develop an easy-to-use and highly sensitive lateral flow immuno assay test strip for the accurate diagnosis of leishmaniasis. The conventional approach for developing immunoassays for leishmaniasis involves the use of total Leishmania promastigotes as antigens. Using these antigens in the assay reduces the sensitivity, and also causes a cross reactivity problem with related diseases, such as Chagas disease. This project involves the development of a more sensitive and specific lateral flow immunoassay that will utilize highly specific heat shock proteins as antigens. These antigens will be used, in conjunction with quantum dots labels, to achieve high sensitivity. In Phase I, IOS will demonstrate the superior performance of this assay over the ELISA kits currently used for cutaneous leishmaniasis diagnosis. The use of quantum dots as labels will allow additional antigens to be incorporated, in the future, to develop a multiplexed lateral flow immunoassay. PUBLIC HEALTH RELEVANCE: Leishmaniasis affects millions of people and causes thousands of deaths annually. Unfortunately, current methods of diagnosis involve labor intensive laboratory based procedures, and are not sufficiently sensitive or specific. This application describes a novel method to develop a simple, field-usable, sensitive, and highly specific test kit for leishmaniasis diagnosis.