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iSpot LymeTM: A New Generation of Lyme Disease Testing

Chenggang Jin, PhD, MDa,b, Deanna J. Fall, BAc, Diana Roen BS,a and Gottfried Kellermann, PhDc

Abstract
Lyme disease is the most reported vectorborne illness in the United States. The incidence may be vastly under-reported due to limitations of current testing methodologies; the need for more sensitive and specific tests is apparent. The iSpot LymeTM assay is a new generation of in vitro diagnostic test for the detection of antigen-specific effector/memory T cells that respond to stimulation by Borrelia burgdorferi antigens. The highly sensitive T cell-based enzyme-linked immunospot (ELISPOT) methodology enumerates the Borrelia burgdorferi activated effector/memory T cells. This assay is intended for clinical use as a laboratory aid in the diagnosis of B. burgdorferi infection. The iSpot LymeTM test represents a breakthrough in diagnostic accuracy with improved sensitivity and specificity over current Lyme disease testing methodologies, and can increase the speed of diagnosis and treatment.

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