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NCT02718157 · ClinicalTrials.gov registry record · NA
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
A NA study, sponsored by Meridian Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 771
- Enrollment target
NCT02718157: Completed NA study, sponsored by Meridian Bioscience.
NCT02718157 is a NA study that has completed, run by Meridian Bioscience. The registered enrollment target is 771 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02718157, a NA study, has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 771 participants
- Enrollment target
Study Summary
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women.
Primary Outcome
To establish the performance characteristics of the GenePOC GBS System for its use in determining the presence of GBS in vaginal/rectal swab, after Lim Broth enrichment, specimens from antepartum pregnant women. Sensitivity and specificity will be established in comparison to the Reference Method. Sensitivity performance results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Reference Method only. Sensi
Interventions
- DEVICE Comparison between GenePOC PCR and Reference Method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 771 participants |
| Start Date | 2016-08-10 |
| Est. Completion | 2017-02-07 |
| Phase | NA |
What the finished NCT02718157 record still lists
NCT02718157 is an interventional study that assigns participants to a tested intervention. The registered 771 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 (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Comparison between GenePOC PCR and Reference Method is the first listed.
NCT02718157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02718157 about?
NCT02718157 is a clinical study titled "Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains". The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from ant...
What is the current status of trial NCT02718157?
This trial is currently completed. It is a NA study. The enrollment target is 771 participants. The study started on 2016-08-10. Estimated completion is 2017-02-07.
What interventions are being tested in trial NCT02718157?
The interventions under investigation include: Comparison between GenePOC PCR and Reference Method (DEVICE).
Who is sponsoring clinical trial NCT02718157?
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 NCT02718157's enrollment target sits among peer trials
771 143rd of 2000 higher than 1,858 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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