Metrix Respiratory Panel Test for COVID-19 and Flu

BW
TC
Overseen ByTyler Chozinski, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home test kit designed to detect common respiratory viruses like COVID-19, flu, and RSV using a simple nose swab. The goal is to evaluate the test's effectiveness outside a lab, in real-life settings like homes. People with symptoms of a respiratory infection, such as a cough, fever, or sore throat, who have not received treatment for these conditions in the past 30 days, might be suitable candidates. Participants will collect their own samples, which researchers will compare to results from standard lab tests. As an unphased trial, this study offers participants the chance to contribute to developing accessible testing solutions for respiratory illnesses.

Will I have to stop taking my current medications?

If you are currently taking or have recently taken medications for COVID-19, flu, or RSV, you may not be eligible to participate in the trial. The trial excludes those who have used certain antiviral treatments or vaccines within the past 30 days.

What prior data suggests that the Metrix Respiratory Panel Test is safe for home use?

Research has shown that the Metrix Respiratory Panel Test is approved for home use without a prescription for individuals aged 14 and older. This approval indicates that the test has undergone some safety evaluation. The test uses a nasal swab to detect viruses such as COVID-19 and the flu. Currently, it is available under an Emergency Use Authorization (EUA) by the FDA, which deems it safe enough for use during health emergencies.

Although the test has not yet received full FDA approval, its availability under EUA is a positive indication. This suggests that, based on current data, it is considered reasonably safe and effective for its intended purpose. However, it is important to note that this is still a trial use, and participants in the study will contribute to confirming its safety and effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about the Metrix Respiratory Panel Test because it offers a quick and user-friendly way to detect both COVID-19 and flu at home. Unlike standard diagnostic tests that often require a trip to a healthcare facility and professional sample collection, this test allows individuals to collect samples themselves in a comfortable, simulated home setting. This convenience could lead to faster diagnosis and treatment, helping to curb the spread of these respiratory illnesses. Moreover, maintaining confidentiality through coded samples ensures privacy, which is an added benefit for users.

What evidence suggests that the Metrix Respiratory Panel Test is effective for detecting respiratory viruses?

Research shows that the Metrix Respiratory Panel Test, studied in this trial, is a high-quality test capable of identifying various viruses, including COVID-19, flu (Influenza A and B), and RSV (Respiratory syncytial virus). Studies have found that it can deliver results in about 20 minutes. This trial compares the test's accuracy with an FDA-approved test. Early findings suggest that the Metrix test effectively detects these viruses at home. Although not yet FDA-approved, it aims to provide reliable results for home testing.24567

Who Is on the Research Team?

BW

Brad W Killingsworth, M.A.

Principal Investigator

Aptitude Medical Systems, Inc

Are You a Good Fit for This Trial?

This trial is for individuals who may have respiratory illnesses like COVID-19, flu, or common cold. Participants will use the Metrix Respiratory Panel Test at home to see if it accurately detects these viruses. The test environment will mimic a home setting but be near clinical facilities.

Inclusion Criteria

Participant or guardian agrees to read, and is able to read with understanding, the Quick Reference Instructions (QRI) prior to beginning the execution of each of the tests
Participant is willing to provide all samples and run tests for the specified investigational devices
I understand the study and agree to participate.
See 2 more

Exclusion Criteria

Participant or guardian is not able to comply with nasal swab collection requirements following the Quick Reference Instructions (QRI)
Participant has previously participated in the study
Participant is not able to tolerate specimen collection
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Testing

Participants self-collect AN swab samples for testing with the Metrix Respiratory Panel Test. Comparator samples are collected by healthcare practitioners.

1 day
1 visit (in-person)

Comparator Testing

Comparator NP swab samples are tested with an FDA-cleared assay to determine infection status.

1 day

Follow-up

Participants are monitored for any adverse events and the performance of the test is evaluated.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aptitude Medical Systems Metrix Respiratory Panel Test
Trial Overview The study tests the Aptitude Medical Systems Respiratory Panel Test's ability to identify various respiratory viruses from nose swabs in non-laboratory settings. It compares results with FDA-cleared assays to validate its accuracy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: OTC StudyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aptitude Medical Systems

Lead Sponsor

Trials
2
Recruited
2,000+

Citations

Clinical Validation of the Aptitude Medical Systems Metrix ...Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence ...
Metrix COVID/Flu Test - Healthcare Provider Fact SheetThe Metrix COVID/Flu Test can be used for the detection and differentiation of SARS-CoV-2, influenza A, and/or influenza B in individuals aged.
Metrix® COVID/Flu TestMetrix COVID/Flu test is a lab-quality molecular test for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, and influenza B nucleic ...
Clinical Validation of the Aptitude Medical Systems Metrix ...The Metrix COVID/Flu Test is intended for 510(k)/De Novo submission. FOR INVESTIGATIONAL USE ONLY and has not been FDA cleared/market authorized.
FDA Authorizes Aptitude Metrix COVID/Flu Multiplex ...The Metrix COVID/Flu molecular test detects and differentiates SARS-CoV-2, influenza A, and influenza B in approximately 20 minutes.
Metrix COVID/Flu Test Letter of AuthorizationThis test is authorized for non-prescription home use with anterior nasal (AN) swab specimens from individuals aged 14 years or older (self- ...
Aptitude Metrix COVID/Flu TestThe Metrix COVID/Flu Test is only for use under the Food and Drug Administration's Emergency Authorization.
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