FebriDx® Method Comparison Study Protocol

Lumos Diagnostics

Status: Completed

Conditions: Acute Respiratory Infections (ARIs)

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

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06746259

CLP-0019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 12 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Untrained Operator

Description:

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).

Treatment:

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

Trained Operator

Description:

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

Treatment:

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