Lyme Disease Diagnostic Assay - Collection of Whole Blood
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sick Cohort 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
Serological and immunoresponse assay
|
| Apparently Healthy Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease |
Outcome Measures
Primary Outcome Measures
- Clinical Performance - Sensitivity [Through study completion, an average of 1 year]
Diagnostic Sensitivity
Secondary Outcome Measures
- Clinical Performance - Specificity [Through study completion, an average of 1 year]
Diagnostic Specificity
Eligibility Criteria
Criteria
Subjects with Established Lyme disease diagnosis
Inclusion Criteria:
-
Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation.
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The EM rash has been present < 6 weeks and the clinical diagnosis has been confirmed by the practitioner.
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Detailed description of the EM rash with consent for photographic documentation will be requested.
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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
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Absence of EM rash.
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Diagnostic test result(s) for Lyme disease available (Practitioner diagnosis is based on the data from standard clinical practice).
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Ability to provide the minimum sample volume required.
Exclusion Criteria:
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Subjects unable to provide informed consent.
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Subjects without clinical information and/or not meeting inclusion criteria.
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Subjects having started antibiotic treatment > 7 days before inclusion.
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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.
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Ability to provide the minimum sample volume required.
Exclusion Criteria:
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Subjects unable to provide informed consent.
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Subjects without clinical information and/or not meeting inclusion criteria.
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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.
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Uncontrolled HIV-infection, if known.
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Active syphilis or leptospirosis, if known.
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Active infection with Epstein Barr Virus (mononucleosis), if known.
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Active infection with Cytomegalovirus (CMV), if known.
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Subjects with autoimmune diseases, either confirmed rheumatoid arthritis or other autoimmune disorders diagnosed according to the leading guidelines.
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Current immunomodulation mediation including >7.5 mg prednisone daily, methotrexate, biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable.
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Immunodeficiency, hematologic malignancies in the medical history.
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Chemotherapy during the past year.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DiaSorin Inc. | Stillwater | Minnesota | United States | 55082 |
Sponsors and Collaborators
- DiaSorin Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PROT.648.00024.A