Sepsis
Conditions
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.
Interventions
None listed
Sponsors
Bluejay Diagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJason Cook, PhD
Outcome results
None listed