Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
This study is testing a new COVID-19 diagnostic test called the Aptitude Medical Systems Metrix COVID Test. This test is designed to detect the virus that causes COVID-19 using a special reader. Researchers want to see how well this test works compared to other FDA-approved COVID-19 tests. They are looking for about 1000 people aged 2 years and older who are currently experiencing a fever or other symptoms of a respiratory infection, like a cough or shortness of breath. The goal is to see if the Metrix COVID Test can accurately identify positive and negative COVID-19 cases in about 25 minutes. The study is currently unclear on its recruitment status.
- Study design
- This interventional study plans to enroll about 1000 participants. It will take place in simulated home environments set up near clinics.
- What's involved
- You would provide an anterior nasal (AN) swab sample for testing with the Metrix COVID Test. Comparator testing will also be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 25 minutes.
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Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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What this trial measures
- Qualitative detection of RNA from SARS-CoV-2 and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test25 minutes
Qualitative detection of RNA from SARS-CoV-2 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 COVID/Flu Test for the qualitative detection of SARS-CoV-2 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.