Chembio Awarded NIH Grant for Leptospirosis Test

Chembio Diagnostics, of Medford, NY, has been awarded a $286,000 Small Business Innovative Research Phase I grant ffrom the National Institutes of Health to develop a rapid seriodiagnostic test for leptospirosis, an emerging infectious disease in the U.S.

The test — which will be developed in collaboration with Weill Medical College of Cornell University in New York and the Oswaldo Cruz Foundation in Brazil, the largest research institution in Latin America — will be based on Chembio’s Dual Path Platform (DPP) technology, for which it was awarded a U.S. patent in March.

DPP is a lateral flow technology that employs separate membrane strips for sample migration and test reagents. The design allows for complete control and management of the sample flow, and as a result, the immunological reaction is much more efficient than conventional single path lateral flow (SPLF) tests. These features enable improved detectability, sensitivity and specificity when compared with SPLF tests.
Leptospirosis, also known as Weil’s disease, is an emerging infectious disease caused by spirochetes of the genus Leptospira that affects humans and a wide range of animals, including mammals, birds, amphibians and reptiles. It is considered the most widespread zoonotic disease in the world; with few laboratories equipped to perform the antiquated microagglutination test upon which diagnosis now depends, it is well recognized that human leptospirosis is an under-recognized disorder. There are as many as 500,000 severe human cases worldwide each year.

Currently there is no effective prevention for leptospirosis, which can be treated with inexpensive antimicrobial agents. Timely treatment, however, is essential to prevent disease progression to renal or hepatic failure, and/or massive pulmonary hemorrhage. The major obstacle to successful treatment is the difficulty in making an early and accurate diagnosis. This NIH-funded project aims to develop a rapid point-of-care test that would enable antibiotic therapy to be initiated during the acute phase of the infection, when drug therapy is most effective.

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