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NCT05715515 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
A NA study, sponsored by Abbott Rapid Dx.
- Completed
- Registry status
- NA
- Development phase
- 903
- Enrollment target
NCT05715515: Completed NA study, sponsored by Abbott Rapid Dx.
NCT05715515 is a NA study that has completed, run by Abbott Rapid Dx. The registered enrollment target is 903 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05715515, a NA study, has completed, sponsored by Abbott Rapid Dx.
- COMPLETED
- Registry status
- NA
- Development phase
- 903 participants
- Enrollment target
Study Summary
This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively. This study is part of the performance evaluation to support the CE conformity assessment procedures.
Primary Outcome
To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID-19/Flu A\&B Rapid Panel in fresh collected mid-turbinate nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms in a Near Patient Testing setting, compared to Flu and SARS-CoV-2 RT-PCR tested using NP swab samples. Concordance analyisis of investigational device and reference
Interventions
- DIAGNOSTIC_TEST Panbio™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 903 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2023-05-29 |
| Phase | NA |
What the finished NCT05715515 record still lists
NCT05715515 is an interventional study that assigns participants to a tested intervention. The registered 903 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 (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Panbio™ is the first listed.
NCT05715515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05715515 about?
NCT05715515 is a clinical study titled "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device". This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza ...
What is the current status of trial NCT05715515?
This trial is currently completed. It is a NA study. The enrollment target is 903 participants. The study started on 2023-01-06. Estimated completion is 2023-05-29.
What interventions are being tested in trial NCT05715515?
The interventions under investigation include: Panbio™ (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05715515?
This trial is sponsored by Abbott Rapid Dx, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05715515's enrollment target sits among peer trials
903 124th of 2000 higher than 1,877 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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