NCT06746259

FebriDx® Method Comparison Study Protocol

CLP-0019- FebriDx® Method Comparison Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Lumos Diagnostics · Industry
• Sex: All
• Age: 12 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test. The study aims to: * Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result. * As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

Conditions

• Acute Respiratory Infections (ARIs)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-08-15
• Completion: 2025-08-31
• First posted: 2024-12-24
• Last updated: 2025-09-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study