Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lyme Disease
- Sponsor
- DiaSorin Inc.
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Clinical Performance - Sensitivity
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease.
In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Detailed Description
Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signs and symptoms of acute Lyme disease which include at least one of the following:
- •Recent onset of fatigue
- •Skin rash
- •Muscle aches
- •Neck pain
- •Joint pain or lymphadenopathy
- •Subgroup Borreliosis Subjects- restricted signs and symptoms of acute Lyme including EM Rash
- •Under physician or medical evaluation for acute on-set of Lyme Disease presenting with EM Rash
- •Detailed description of the EM rash (e.g. Itchy, painful, hot, vesicular, raised) with consent for photographic documentation is required including additional picture with ruler placing to confirming size.
- •EM rash with the following attributes:
Exclusion Criteria
- •Subjects unable to provide informed consent.
- •Subjects without clinical information and/or not meeting inclusion criteria.
- •Subjects having started antibiotic treatment \> 5 days before inclusion.
- •Healthy Subjects
- •Inclusion Criteria:
- •Apparently healthy subjects with no present fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes, e.g. flu-like symptoms.
- •Ability to provide the minimum sample volume required.
- •Exclusion Criteria:
- •● Subjects unable to provide informed consent
- •Subjects without clinical information and/or not meeting inclusion criteria
Outcomes
Primary Outcomes
Clinical Performance - Sensitivity
Time Frame: Through study completion, an average of 1 year
Diagnostic Sensitivity
Secondary Outcomes
- Clinical Performance - Specificity(Through study completion, an average of 1 year)