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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lyme Disease

Intervention / Treatment
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* Device: T2Lyme Panel testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EM present<br>All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. | Device: T2Lyme Panel testing<br>* 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.<br>|
| Active Comparator: No EM present<br>All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. | Device: T2Lyme Panel testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents. | 1 day |