Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel

Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel

The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.

The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval.

The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.

Inclusion Criteria:

• Presence of erythematous skin lesion, consistent with erythema migrans (EM).
• Age 18 or older.
• Ability to read, comprehend, and sign the informed consent form.
• Two (2) or more signs/symptoms of Lyme Disease

Exclusion Criteria:

• Subject has medically diagnosed bleeding disorder.
• Having had taken antibiotics in the past 30 days.
• EM located on face or neck.
• Unable to provide consent.