MedTrace Logo

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

NCT03581279 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-02-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Lyme Disease

Interventions

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.

Sponsors & Collaborators

  • T2 Biosystems

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03581279 on ClinicalTrials.gov