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NCT03422341 · ClinicalTrials.gov registry record · NA
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
A NA study, sponsored by Meridian Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 497
- Enrollment target
NCT03422341: Completed NA study, sponsored by Meridian Bioscience.
NCT03422341 is a NA study that has completed, run by Meridian Bioscience. The registered enrollment target is 497 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03422341, a NA study, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 497 participants
- Enrollment target
Study Summary
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
Primary Outcome
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the
Interventions
- DEVICE Comparison between GenePOC CR and Reference Method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2018-07-11 |
| Phase | NA |
What the finished NCT03422341 record still lists
NCT03422341 is an interventional study that assigns participants to a tested intervention. The registered 497 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 (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Comparison between GenePOC CR and Reference Method is the first listed.
NCT03422341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03422341 about?
NCT03422341 is a clinical study titled "Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.". The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic S...
What is the current status of trial NCT03422341?
This trial is currently completed. It is a NA study. The enrollment target is 497 participants. The study started on 2018-02-14. Estimated completion is 2018-07-11.
What interventions are being tested in trial NCT03422341?
The interventions under investigation include: Comparison between GenePOC CR and Reference Method (DEVICE).
Who is sponsoring clinical trial NCT03422341?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03422341's enrollment target sits among peer trials
497 213th of 2000 higher than 1,788 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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