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NCT07217639 · ClinicalTrials.gov registry record · NA
Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings
A NA study, sponsored by Aptitude Medical Systems.
- Not yet
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
NCT07217639: Clinical Trial NA study, sponsored by Aptitude Medical Systems.
NCT07217639 is a NA study that has not yet begun recruiting, run by Aptitude Medical Systems. The registered enrollment target is 2,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217639, a NA study, has not yet begun recruiting, sponsored by Aptitude Medical Systems.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
Study Summary
The Metrix Respiratory Panel Test will be evaluated for use in 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 Respiratory Panel Test for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in anterior nares (AN) swab 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. 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, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.
Primary Outcome
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
Interventions
- DIAGNOSTIC_TEST Aptitude Medical Systems Respiratory Panel Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
What is known before NCT07217639 opens enrollment
NCT07217639 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 1 intervention - of which Aptitude Medical Systems Respiratory Panel Test is the first listed.
NCT07217639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07217639 about?
NCT07217639 is a clinical study titled "Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings". The Metrix Respiratory Panel Test will be evaluated for use in 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., urge...
What is the current status of trial NCT07217639?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 2,000 participants. The study started on 2025-11-01. Estimated completion is 2026-09-01.
What interventions are being tested in trial NCT07217639?
The interventions under investigation include: Aptitude Medical Systems Respiratory Panel Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07217639?
This trial is sponsored by Aptitude Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07217639's enrollment target sits among peer trials
2,000 52nd of 2000 higher than 1,947 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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