IMMUNO TECHNOLOGIES INC — Department of Health and Human Services SBIR Phase II: R

Description

DESCRIPTION Caused by Borrelia burgdorferi Lyme disease LD can affect the skin heart joints or nervous system leading to an array of largely non specific symptoms that overlap with those of other debilitating illnesses Disease progression can lead to development of conditions with unfavorable prognosis such as antibiotic refractory arthritis or Post Treatment Lyme disease Syndrome PTLDS Early diagnosis and treatment is key to improving disease outcomes Current assays do not discriminate between early and late stages of the disease and cannot predict prognosis We propose to use ultrasensitive microfluidics technology to develop the first quantitative rapid lab on a chip point of care POC assay for the serodiagnosis of Lyme disease The proposed POC test will provide sensitive and definitive detection and differentiation of early and late stage Lyme disease in a single test It is a versatile and informative first tier assay which can evolve to replace the current bi serologic two tier standard of care PUBLIC HEALTH RELEVANCE Lyme disease the most common vector borne infectious disease in the United States affects multiple organ systems Disease progression can lead to development of conditions with unfavorable prognosis such as antibiotic refractory arthritis or Post Treatment Lyme disease Syndrome PTLDS Prompt diagnosis and treatment prevents or limits serious injury to the systems affected Our objective is to develop the first quantitative testing device that enables simultaneous detection of antibodies to multiple Borrelia burgdorferi antigens at the point of care It is a rapid assay for serodiagnosis of Lyme disease that has the additional benefit of distinguishing between the stages of the disease This low cost portable device requires just one small finger pricked volume of blood and performs diagnostic testing in about minutes as accurately as laboratory testing