An observational study in Sepsis, sponsored by Bluejay Diagnostics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Bluejay Diagnostics, Inc. · Observational
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 120 is below the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Bluejay Diagnostics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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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.
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Exclusion Criteria:
IL-6 Reference Range Study
Establishment of the interleukin-6 concentration in whole blood samples from healthy individuals.
Time frame: Specimen is tested within 12 hours from collection
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Bluejay Diagnostics, Inc.