Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test
This study is testing a new at-home diagnostic test called the Metrix Respiratory Panel Test. This test is designed to detect common respiratory viruses like COVID-19, Influenza A and B, and RSV (Respiratory Syncytial Virus) from a nasal swab. Researchers want to see how well this test works in a home setting compared to current FDA-approved tests. You might be able to join if you are currently experiencing symptoms of a respiratory infection like fever, cough, or sore throat. The goal is to confirm the test accurately identifies these viruses within 25 minutes. The study plans to enroll 2000 participants.
- Study design
- This is an interventional study designed to evaluate the Metrix Respiratory Panel Test in simulated home environments. It aims to enroll 2000 participants across multiple sites in the United States.
- What's involved
- You would provide a nasal swab sample for testing with the Metrix Respiratory Panel Test. Comparator testing will also be performed to determine your infection status.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 25 minutes after testing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Brad W Killingsworth, M.A. · PRINCIPAL_INVESTIGATOR · Aptitude Medical Systems, Inc
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus, and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test25 minutes
Qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus in unprocessed AN swab samples. Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the Metrix Respiratory Panel Test for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus viral RNA using AN swab samples. Comparator testing will be performed to determine the status of each sample for comparison to results produced by the candidate test. 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 that detects SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.