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FebriDx® Method Comparison Study Protocol

NCT06746259 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-09-09

No results posted yet for this study

Summary

The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is:

• Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.

Conditions

  • Acute Respiratory Infections (ARIs)

Interventions

DIAGNOSTIC_TEST

Rapid point of care test to detect host immune response in ARI

FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood to aid in the differentiation of bacterial from non-bacterial acute respiratory infections.

Sponsors & Collaborators

Eligibility

Min Age
12 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2025-08-15
Completion
2025-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746259 on ClinicalTrials.gov