Symphony IL-6 Reference Range Study

Recruiting

• Conditions: Sepsis

• Registration Number: NCT05048888
• Lead Sponsor: Bluejay Diagnostics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States