Healthy, Lyme Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTLyme diagnostic assay
Serological and immunoresponse assay
Sponsors
DiaSorin Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Subjects with under evaluation of Lyme Disease Inclusion Criteria: Signs and symptoms of acute Lyme disease which include at least one of the following: * Recent onset of fatigue * Skin rash * Fever * 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: * Size \> 5 cm in diameter * Appeared 3-30 days after bite or suspected bite * Specify Location (e.g. underarm or back of knee) * Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation * Signs and symptoms (e.g. Fever, Chills/Sweats, Headache, Fatigue/Tiredness, Myalgia/Sore muscles) * The EM rash has been present \<42 days * Clinical diagnosis of Lyme disease is suspected by the practitioner * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance - Sensitivity | Through study completion, an average of 1 year | Diagnostic Sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance - Specificity | Through study completion, an average of 1 year | Diagnostic Specificity |
Countries
United States
Outcome results
None listed