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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2019-10-31

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.

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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.

Conditions

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Lyme Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

All patients are assigned a unique study ID number to de-identify them.

Study Groups

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EM present

All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.

Group Type ACTIVE_COMPARATOR

T2Lyme Panel testing

Intervention Type DEVICE

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.

No EM present

All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.

Group Type ACTIVE_COMPARATOR

T2Lyme Panel testing

Intervention Type DEVICE

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.

Interventions

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T2Lyme Panel testing

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No