IMMUNO TECHNOLOGIES INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Leptospirosis is the most widespread neglected zoonotic disease in the worldIt affects vulnerable populations such as rural subsistence farmers and urban slum dwellersUrban epidemics are reported in cities in developing countries and will likely increase as the world s slum population doubles tobillion byAn unexpected outbreak was reported in New York City recently and climate change may account for its re emerging statusA recent review of published cases estimated that leptospirosis causesmillion cases a year resulting indeath rateThe gold standard for serodiagnosis of Leptospirosis is the MAT assaywhich isyears oldMAT cannot be used for rapid case identification since it requires analysis of paired serumacute and convalescentin a reference laboratory with highly trained personnel and expensive equipmentThusMAT is rarely performed routinely even by diagnostic laboratoriesCurrentlythere are no rapid quantitative assays on the market for serodiagnosis of LeptospirosisIn this Phase I SBIRwe propose two specific aims to develop a new diagnostic testing device for detection of antibodies against multiple Linterrogans antigens at the Point of CareThis low cost portable device is a quantitative rapid assay that can perform POC testing as accurately as a laboratory ELISAThe test will be inexpensiveaboutcents in materialand can be performed inminutesallowing for early diagnosis of Leptospirosis and treatment in the first visit to the doctor s officeThe technology can be adapted to a smartphone based reader in a subsequent Phase II application to allow for serodiagnosis in remote field locations Leptospirosis is the most widespread zoonotic disease in the worldIt is a burden on society dueto elevated morbidity in humansmillion cases a yearwith atomortality rateandextensive economic loss of animals of agricultural interestAlthough leptospirosis is more commonin regions with tempered climatean outbreak was reported in New York City recentlyFebruaryThe gold standard serologic MAT assay for this spirochetal disease is based onyearknow howThe goal of this project is to use ultrasensitive microfluidics technology to develop arapidpoint of care assay for serodiagnosis of Leptospira infection for the human and veterinarymarkets