Establishing a reference range for IL-6 levels in healthy individuals
Symphony IL-6 Reference Range Study
This study is trying to find out what normal IL-6 levels are in healthy people to help with diagnosing and managing illnesses like sepsis later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Bluejay Diagnostics, Inc. Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05048888 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a reference range for IL-6 levels using the Symphony IL-6 device, which quantifies IL-6 from whole blood without the need for plasma separation. Participants will provide whole blood specimens, which will be analyzed using the Symphony Fluorescence Immunoanalyzer and IL-6 Cartridge. The study focuses on healthy individuals to determine baseline IL-6 concentrations, which could aid in the diagnosis and management of conditions like sepsis in the future.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals over 18 years of age who can provide informed consent.
Not a fit: Patients presenting with fever or diagnosed with COVID-19 or other respiratory illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable reference range for IL-6 levels, improving the diagnosis and treatment of sepsis.
How similar studies have performed: While the approach of using point-of-care devices for biomarker quantification is gaining traction, establishing a reference range for IL-6 specifically with this device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is willing and able to provide informed consent * \> 18 years of age * Whole blood specimen collected in EDTA anticoagulant tubes * Minimum volume of 100µL for Symphony IL-6 testing * Specimen is available for testing within 12 hours from collection * C-Reactive Protein (CRP) \< 10 mg/L Exclusion Criteria: * Subjects presenting with a fever * Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection * Subjects otherwise self-reported as unhealthy * Hemolyzed specimens
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jason Cook, PhD
- Email: jason.cook@bluejaydx.com
- Phone: 844-327-7078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.