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

T2 Biosystems

Status: Terminated

Conditions: Lyme Disease

Treatments: Device: T2Lyme Panel testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03581279

PRO-000879

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 2 patient groups

EM present

Active Comparator group

Description:

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

Treatment:

Device: T2Lyme Panel testing

No EM present

Active Comparator group

Description:

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

Treatment:

Device: T2Lyme Panel testing