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Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19

Severe Sepsis Clinical Trial

Official title:
Symphony IL-6 Cutoff Establishment 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 establish 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 NCT05060250
Study type Observational
Source Bluejay Diagnostics, Inc.
Contact
Status Active, not recruiting
Phase
Start date August 31, 2021
Completion date December 31, 2024
View Details
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