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NCT06124638 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
A NA study, sponsored by Abbott Rapid Dx.
- Completed
- Registry status
- NA
- Development phase
- 624
- Enrollment target
NCT06124638: Completed NA study, sponsored by Abbott Rapid Dx.
NCT06124638 is a NA study that has completed, run by Abbott Rapid Dx. The registered enrollment target is 624 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
NCT06124638, a NA study, has completed, sponsored by Abbott Rapid Dx.
- COMPLETED
- Registry status
- NA
- Development phase
- 624 participants
- Enrollment target
Study Summary
This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen.
Primary Outcome
The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the Panbio™ COVID-19/Flu A\&B Panel Self Test against the comparator Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236), in symptomatic patients suspected of respiratory viral infection, when nasal swabs are self-collected by the patient/lay user. The patient/lay user will perform the test, read and interpret the test result.
Interventions
- DIAGNOSTIC_TEST Panbio™ COVID-19/Flu A&B Panel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2024-04-03 |
| Phase | NA |
What the finished NCT06124638 record still lists
NCT06124638 is an interventional study that assigns participants to a tested intervention. The registered 624 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 Panbio™ COVID-19/Flu A&B Panel is the first listed.
NCT06124638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06124638 about?
NCT06124638 is a clinical study titled "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use". This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, r...
What is the current status of trial NCT06124638?
This trial is currently completed. It is a NA study. The enrollment target is 624 participants. The study started on 2023-12-04. Estimated completion is 2024-04-03.
What interventions are being tested in trial NCT06124638?
The interventions under investigation include: Panbio™ COVID-19/Flu A&B Panel (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06124638?
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 NCT06124638's enrollment target sits among peer trials
624 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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