FebriDx® Method Comparison Study Protocol

NCT ID: NCT06746259

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-08-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Untrained Operator

Untrained Operators have no training or hands-on experience in conducting laboratory testing (moderate or high complexity). Should not have previous training or experience with FebriDx but may have limited experience with other waived or home use tests.

Untrained operators will test patients with ARI with the FebriDx test after reviewing and familiarizing themselves with the study articles and the manufacturer's instructions (QRI and IFU).

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

Intervention Type: DIAGNOSTIC_TEST

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.

Trained Operator

Trained operators are qualified to perform moderate complexity testing and have previous training and/or experience with the FebriDx test.

Trained operators will test patients with ARI with the FebriDx test after completing a training seminar which includes review of the test procedure as described in the IFU/QRI, a competency test, interpretation of mock test results, as well as at least one (1) practice test

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Fingerstick test

Eligibility Criteria

Inclusion Criteria

• Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit
• Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath

Exclusion Criteria

• Subject is unable or unwilling to provide signed, Informed Consent
• Subject is less than 12 years old or over 64 years old
• Subject has a fever that started more than 3 days (> 72 hours) prior to enrollment
• Subject has symptoms of Acute Respiratory Infection that started > 7 days of enrollment
• Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
• Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
• Subject has taken antibiotics or antiviral therapy in the last 14 days
• Subject received a live viral immunization in the last 14 days
• Subject has significant trauma or burns (> 5% total body surface area or full thickness (3rd°)) in the last 30 days
• Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
• Subject has a history of a myocardial infarction or stroke in the last 30 days

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Lumos Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ascada Health

Fullerton, California, United States

Exer Urgent Care

Pasadena, California, United States

L&C

Miami, Florida, United States

Trujillo Medical Center

Miramar, Florida, United States

Hillcrest Medical Research, LLC

Orange City, Florida, United States

Hometown Urgent Care and Research

Beavercreek, Ohio, United States

HMG Clinical Research/Herrera Medical Group

Bedford, Texas, United States

Ascada Health

Katy, Texas, United States

Countries

United States

Other Identifiers

CLP-0019

Identifier Type: -

Identifier Source: org_study_id