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 10 minutes as accurately as laboratory testing.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Breen, Joseph J
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Immuno Technologies, Inc.
United States
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