iSpot Lyme Test Page

This study is sponsored by Burgdorf Osceola, L.L.C., Teshome Gherezghiher, Ph.D. and Brandon Peacock B.S. are the principal investigators (throughout this document, the sponsor, the principal investigator, and the healthcare provider who gave you this form are collectively referred to as “we”). We are conducting the study with the assistance of multiple laboratories and investigators. The purpose of the study is to learn more about ways that Lyme disease can be identified in the laboratory by evaluating the iSpot LymeTM test – an investigational diagnostic test to detect the immune reaction to the organism that causes Lyme disease. The results of the iSpot LymeTM test will be compared to the results obtained using standard clinical laboratory tests. iSpot LymeTM is an in vitro test for the detection of effector T cells by capturing IFNg in the vicinity of T cells isolated from human whole blood collected in ACD tubes. The test detects effector T cells that respond to the B. burgdorferi sensu stricto specific antigens DbpA, OspC, VisE and p100. It is intended for use as an aid in the diagnosis of early B. burgdorferi infection (as characterized by Infectious Diseases Society of America 2006 guidelines) in adults residing in the United States or Canada and is used in conjunction with clinical assessment and other diagnostic evaluations.