Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03581279
Study type Interventional
Source T2 Biosystems
Contact
Status Terminated
Phase N/A
Start date May 8, 2018
Completion date October 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT01207739 - Persistent Lyme Empiric Antibiotic Study Europe Phase 4
Terminated NCT04577053 - PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics N/A
Completed NCT04867473 - Feasibility of Teleyoga for Treatment of Lyme Disease N/A
Recruiting NCT04038346 - Symptomatic Management of Lyme Arthritis Phase 3
Completed NCT01143558 - Searching for Persistence of Infection in Lyme Disease Early Phase 1
Withdrawn NCT04318925 - Evaluation and Follow-up of People With Tick-borne Diseases
Enrolling by invitation NCT05041595 - Lyme Disease Diagnostic Assay - Collection of Whole Blood
Recruiting NCT03981874 - Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children N/A
Recruiting NCT03963635 - Novel Diagnostics for Early Lyme Disease
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT04835792 - Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Recruiting NCT06397794 - Navigating Pregnancy and Parenthood With Lyme Disease
Recruiting NCT04148222 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Terminated NCT03201042 - Lyme Test Indication Combinations (LyTIC) Study
Completed NCT01368341 - Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice Phase 4
Terminated NCT00958139 - Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes Phase 3
Recruiting NCT00001539 - A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Recruiting NCT03501407 - Understanding Tick-borne Diseases
Completed NCT04422314 - ImmuneSense Lyme Study
Recruiting NCT04719962 - Direct Diagnosis of Disseminated Lyme Borreliosis. N/A