Lyme Disease
Conditions
Brief 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.
Interventions
DEVICET2Lyme 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
T2 Biosystems
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
All patients are assigned a unique study ID number to de-identify them.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | 1 day | Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EM Present All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.
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. | 18 |
| No EM Present All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
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. | 0 |
| Total | 18 |
Baseline characteristics
| Characteristic | No EM Present | EM Present | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 10 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 8 Participants | 8 Participants |
| Age, Continuous | — | 66 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 18 Participants | 18 Participants |
| Race (NIH/OMB) White | — | 0 Participants | 0 Participants |
| Region of Enrollment United States | — | 18 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 0 |
| other Total, other adverse events | 0 / 18 | 0 / 0 |
| serious Total, serious adverse events | 0 / 18 | 0 / 0 |
Outcome results
Primary
Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents.
Time frame: 1 day
Population: The No EM present arm of the study was never initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EM Present | Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | 18 Participants |
| No EM Present | Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | 0 Participants |