Symphony IL-6 Reference Range Study

Bluejay Diagnostics

Status: Enrolling

Conditions: Sepsis

Study type: Observational

Funder types: Industry

Identifiers

NCT05048888

CES-0001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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