FebriDx® Method Comparison Study Protocol

NCT06746259 | Completed DMC FDA Device

• 1 other identifier: CLP-0019
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Respiratory Infections (ARIs)

Keywords

Point of care diagnostics; CRP (C- Reactive Protein); MxA (Myxovirus resistance protein A)

Outcome Measures

Primary Outcomes (1)

• Performance

  Positive Percent Agreement (PPA), Negative Percent Agreement (NPA) and 95% confidence intervals will be calculated for each untrained operator and compared to performance in trained operators (truth).

  Day 1

Secondary Outcomes (1)

• Usability

  Day 1

Study Arms (2)

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).

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

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

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

Interventions

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

Also known as: Fingerstick test

Trained Operator; Untrained Operator

Eligibility Criteria

• Age: 12 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients presenting to outpatient settings (e.g., physician offices, clinics, urgent care centers) with recent fever (reported within the last 72h) and recent symptoms of acute respiratory infection (symptoms reported to have started ≤ 7 days prior to study visit).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumos Diagnostics: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (8)

Ascada Health

Fullerton, California, 92835, United States

Location

Exer Urgent Care

Pasadena, California, 91105, United States

Location

L&C

Miami, Florida, 33144, United States

Location

Trujillo Medical Center

Miramar, Florida, 33027, United States

Location

Hillcrest Medical Research, LLC

Orange City, Florida, 32763, United States

Location

Hometown Urgent Care and Research

Beavercreek, Ohio, 45430, United States

Location

HMG Clinical Research/Herrera Medical Group

Bedford, Texas, 76021, United States

Location

Ascada Health

Katy, Texas, 77494, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: December 20, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-03

Locations

US (8)