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

Description

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

Conditions

Severe Sepsis

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Severe Sepsis
Intervention / Treatment

-

Contacts and Locations

Acton

Tina McCarthy, Acton, Texas, United States, 01720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Whole blood specimen collected in EDTA anticoagulant tubes
  • * Subject is considered to have severe or critical illness per below:
  • 1. SpO2 \< 94% on room air at sea level;
  • 2. Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \< 300 mmHg;
  • 3. Respiratory frequency \> 30 breaths/min;
  • 4. Or lung infiltrates \>50% Critical Illness
  • * Subject confirmed to be COVID-19 positive by an EUA RT-PCR test
  • * Subject is 18+ years of age
  • * Minimum volume of 100µL for Symphony IL-6 testing
  • * Specimen is available for testing within 12 hours from collection
  • * Subject is receiving an anti-IL-6 treatment
  • * Subject is receiving corticosteroids
  • * Hemolyzed specimens

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bluejay Diagnostics, Inc.,

Study Record Dates

2024-12-31