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Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

Severe Sepsis Clinical Trial

Official title:
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

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. This study is to validate an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05048927
Study type Observational
Source Bluejay Diagnostics, Inc.
Contact Jason Cook, PhD
Phone 8657429127
Email jason.cook@bluejaydx.com
Status Recruiting
Phase
Start date August 31, 2021
Completion date December 31, 2024
View Details
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