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Purpose

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 in a near patient setting. 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 and/or influenza infection.

Condition

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Whole-blood specimen collected in EDTA anticoagulant tube - Subject is 22+ years of age - A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing - Subjects who have concurrently received CRP test results - Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.

Exclusion Criteria

  • Subject is receiving an anti-IL-6 treatment - Hemolyzed specimens

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

University of Michigan Medical Center
Ann Arbor, Michigan 48109
Contact:
Tina McCarthy
clinical@bluejaydx.com

More Details

NCT ID
NCT05665153
Status
Unknown status
Sponsor
Bluejay Diagnostics, Inc.

Study Contact

Jason Cook, Ph.D.
9787935876
clinical@bluejaydx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.