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NCT05048888 Clinical Trial

Symphony IL-6 Reference Range Study

Sepsis Clinical Trial

Official title:
Symphony IL-6 Reference Range Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05048888
Other study ID # CES-0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 31, 2021
Est. completion date March 30, 2024

Study information
Verified date August 2023
Source Bluejay Diagnostics, Inc.
Contact Jason Cook, PhD
Phone 844-327-7078
Email jason.cook@bluejaydx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Bluejay Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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