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NCT06191393 · ClinicalTrials.gov registry record · NA
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
A NA study, sponsored by Aptitude Medical Systems.
- Completed
- Registry status
- NA
- Development phase
- 614
- Enrollment target
NCT06191393: Completed NA study, sponsored by Aptitude Medical Systems.
NCT06191393 is a NA study that has completed, run by Aptitude Medical Systems. The registered enrollment target is 614 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191393, a NA study, has completed, sponsored by Aptitude Medical Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 614 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison
Interventions
- DIAGNOSTIC_TEST Aptitude Medical Systems Metrix COVID/Flu Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2025-03-11 |
| Phase | NA |
What the finished NCT06191393 record still lists
NCT06191393 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which Aptitude Medical Systems Metrix COVID/Flu Test is the first listed.
NCT06191393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06191393 about?
NCT06191393 is a clinical study titled "SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings". 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 (...
What is the current status of trial NCT06191393?
This trial is currently completed. It is a NA study. The enrollment target is 614 participants. The study started on 2023-11-20. Estimated completion is 2025-03-11.
What interventions are being tested in trial NCT06191393?
The interventions under investigation include: Aptitude Medical Systems Metrix COVID/Flu Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06191393?
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 NCT06191393's enrollment target sits among peer trials
614 161st of 2000 higher than 1,840 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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