NCT03581279

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: T2 Biosystems · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Lyme Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2018-05-08
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2018-07-10
• Last updated: 2022-02-04
• Results posted: 2022-01-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study