Symphony IL-6 Reference Range Study

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jason Cook, PhD; Phone Number: 844-327-7078; Email: jason.cook@bluejaydx.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Madhusudhanan Narasimhan, PhD, MSHA; Phone Number: 214-645-5142; Email: madhusudhanan.narasimhan@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will enroll approximately 120 apparently healthy individuals, split approximately between males and females, and covering an age range from approximately 18 to 85 years of age at the University of Texas Southwestern Medical Center, or from satellite facilities associated with the medical center. Subjects must meet all eligibility criteria to be in enrolled in the study. Whole blood specimens will be prospectively collected and tested using the Symphony IL-6 system.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6 Reference Range Study	Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals.	Specimen is tested within 12 hours from collection

Collaborators and Investigators

• Sponsor: Bluejay Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CES-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No