Metrix Test for COVID-19 and Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.
Will I have to stop taking my current medications?
If you are currently taking antiviral medications or treatments for COVID-19, you will need to stop these before participating in the trial. The trial excludes participants who are undergoing antiviral treatment or have taken certain COVID-19 medications in the past 30 days.
How does the Metrix Test for COVID-19 and Flu differ from other treatments?
The Metrix Test for COVID-19 and Flu is unique because it likely involves a point-of-care testing approach, which provides rapid results directly at the site of patient care, unlike traditional lab-based tests that require more time and resources. This can be particularly beneficial in remote or low-resourced settings where quick decision-making is crucial.12345
What data supports the effectiveness of the Metrix COVID/Flu Test treatment?
The research on point-of-care tests like the Abbott ID NOW and Lucira Check-It shows that these tests can quickly and accurately diagnose infections like flu and COVID-19, helping manage patient flow and reduce resource use in hospitals. This suggests that the Metrix COVID/Flu Test, which is also a point-of-care test, could be effective in providing timely and reliable results for COVID-19 and flu.46789
Who Is on the Research Team?
Qin Yang, PhD
Principal Investigator
Aptitude Medical Systems
Are You a Good Fit for This Trial?
This trial is for individuals who can participate in a study to test the Metrix COVID/Flu Test, which detects SARS-CoV-2 and Influenza A/B. Participants will use the test in simulated home environments within or near clinical settings like urgent care facilities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection and Testing
Participants self-collect samples (saliva or AN swab) for testing with the Metrix COVID/Flu Test. Comparator samples are collected by healthcare practitioners.
Comparator Testing
Comparator testing is performed to determine the infection status of each sample for comparison to results generated by the candidate test.
Follow-up
Participants are monitored for any adverse events and data is collected for analysis.
What Are the Treatments Tested in This Trial?
Interventions
- Aptitude Medical Systems Metrix COVID/Flu Test
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aptitude Medical Systems
Lead Sponsor
Biomedical Advanced Research and Development Authority
Collaborator