Lyme Disease Diagnostic Assay - Collection of Whole Blood

Study Overview
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Brief Summary
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The primary objective is to obtain whole blood from subjects with an established diagnosis of early Borrelisois expressing with EM rash. Whole blood will also be obtained from subjects without EM rash but with signs and symptoms consistent 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 apparently healthy subjects residing in areas non-endemic to Lyme disease.

Detailed Description
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Whole blood will be collection and 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 an investigational Lyme assay. This study will be coordinated by the Sponsor.

Official Title
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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.

Conditions
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Lyme Disease, Healthy

Intervention / Treatment
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* Diagnostic Test: Lyme diagnostic assay


Participation Criteria
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Eligibility Criteria
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Subjects with Established Lyme disease diagnosis Inclusion Criteria: Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation. The EM rash has been present < 6 weeks and the clinical diagnosis has been confirmed by the practitioner. Detailed description of the EM rash with consent for photographic documentation will be requested. Ability to provide the minimum sample volume required. Subjects with signs and symptoms consistent with suspicion of acute or recent Borreliosis, e.g. fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes Inclusion Criteria: Subjects with known or suspected tick bite within 8 weeks of medical examination Absence of EM rash. Diagnostic test result(s) for Lyme disease available (Practitioner diagnosis is based on the data from standard clinical practice). 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 > 7 days before inclusion. Subjects having ongoing signs or symptoms attributed to a previous episode of Lyme borreliosis. 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. Subjects with a past or recent diagnosis of Lyme disease, Anaplasmosis, Babesiosis, or history of known embedded tick bite which may have required 'manual extraction'. Subjects having started antibiotic treatment > 7 days before inclusion. Uncontrolled HIV-infection, if known. Active syphilis or leptospirosis, if known. Active infection with Epstein Barr Virus (mononucleosis), if known. Active infection with Cytomegalovirus (CMV), if known. Subjects with autoimmune diseases, either confirmed rheumatoid arthritis or other autoimmune disorders diagnosed according to the leading guidelines. Current immunomodulation mediation including >7.5 mg prednisone daily, methotrexate, biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable. Immunodeficiency, hematologic malignancies in the medical history. Chemotherapy during the past year.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sick Cohort<br>Borreliosis Subjects - established diagnosis of early Borreliosis expressing EM Rash Borreliosis Subjects - expressing signs and symtoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease | Diagnostic Test: Lyme diagnostic assay<br>* Serological and immunoresponse assay<br>|
| Apparently Healthy<br>Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance - Sensitivity | Diagnostic Sensitivity | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance - Specificity | Diagnostic Specificity | Through study completion, an average of 1 year |