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NCT05630365 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product Using Mid-Turbinate Nasal Swabs
A NA study, sponsored by Abbott Rapid Dx.
- Completed
- Registry status
- NA
- Development phase
- 1,129
- Enrollment target
NCT05630365: Completed NA study, sponsored by Abbott Rapid Dx.
NCT05630365 is a NA study that has completed, run by Abbott Rapid Dx. The registered enrollment target is 1,129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630365, a NA study, has completed, sponsored by Abbott Rapid Dx.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,129 participants
- Enrollment target
Study Summary
This study is designed as an international, prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. This study is part of the performance evaluation to support the CE conformity assessment procedures.
Primary Outcome
Evaluate 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 m
Interventions
- DIAGNOSTIC_TEST Panbio™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,129 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2023-03-31 |
| Phase | NA |
What the finished NCT05630365 record still lists
NCT05630365 is an interventional study that assigns participants to a tested intervention. Its 1,129 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Panbio™ is the first listed.
NCT05630365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05630365 about?
NCT05630365 is a clinical study titled "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product Using Mid-Turbinate Nasal Swabs". This study is designed as an international, prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collect...
What is the current status of trial NCT05630365?
This trial is currently completed. It is a NA study. The enrollment target is 1,129 participants. The study started on 2022-12-15. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT05630365?
The interventions under investigation include: Panbio™ (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05630365?
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 NCT05630365's enrollment target sits among peer trials
1,129 93rd of 2000 higher than 1,908 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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