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Symphony IL-6 Reference Range Study

Symphony IL-6 Reference Range Study

Non Recruiting
18-85 years
All
Phase N/A

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Overview

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.

The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.

Eligibility

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

Study details
    Sepsis

NCT05048888

Bluejay Diagnostics, Inc.

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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