Acute Respiratory Infections (ARIs)NCT06746259
FebriDx® Method Comparison Study Protocol
An observational study of Acute Respiratory Infections (ARIs), run by Lumos Diagnostics at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- Acute Respiratory Infections (ARIs)
- What is being tested?
- Rapid point of care test to detect host immune response in ARI
- How many people
- 800 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Dec 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Hometown Urgent Care and Research
Beavercreek, Ohio, 45430
HMG Clinical Research/Herrera Medical Group
Bedford, Texas, 76021
Ascada Health
Fullerton, California, 92835
Ascada Health
Katy, Texas, 77494
L&C
Miami, Florida, 33144
Trujillo Medical Center
Miramar, Florida, 33027
Hillcrest Medical Research, LLC
Orange City, Florida, 32763
Exer Urgent Care
Pasadena, California, 91105
About this study
Official title: CLP-0019- FebriDx® Method Comparison Study Protocol
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.
Read the 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)
- Being tested
- Rapid point of care test to detect host immune response in ARI
- Keywords
- Point of care diagnostics, CRP (C- Reactive Protein), MxA (Myxovirus resistance protein A)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid point of care test to detect host immune response in ARIDiagnostic test
Also called Fingerstick 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Diagnostic Test: Rapid point of care test to detect host immune response in ARI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (1)
Usability
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start20 Dec 2024
- Primary completion15 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Infections (ARIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746259
- Sponsor's protocol ID
- CLP-0019
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLP-0019- FebriDx® Method Comparison Study Protocol
- ClinicalTrials.gov ID
- NCT06746259
- Acronym / sponsor ID
- CLP-0019
- Conditions
- Acute Respiratory Infections (ARIs)
- Keywords
- Point of care diagnostics, CRP (C- Reactive Protein), MxA (Myxovirus resistance protein A)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Untrained Operator | – | Diagnostic Test: Rapid point of care test to detect host immune response in ARIUntrained 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). |
| Trained Operator | – | Diagnostic Test: Rapid point of care test to detect host immune response in ARITrained 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 |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid point of care test to detect host immune response in ARIAlso: Fingerstick testFebriDx 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. | Diagnostic test | Trained Operator, Untrained Operator |
Primary outcome
Performance
Time frame: Day 1
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).
1 secondary outcome
Usability
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infections (ARIs), run by Lumos Diagnostics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.