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NCT06734741 · ClinicalTrials.gov registry record
Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use
A clinical trial, sponsored by InBios International.
- Completed
- Registry status
- 899
- Enrollment target
NCT06734741: Completed study, sponsored by InBios International.
NCT06734741 is a clinical trial that has completed, run by InBios International. The registered enrollment target is 899 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06734741 has completed, sponsored by InBios International.
- COMPLETED
- Registry status
- 899 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.
Primary Outcome
The primary objective of the study is to evaluate the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test for SARS-CoV-2, influenza A, and influenza B when used in a home-like setting by symptomatic lay users who are within five (5) days of symptoms onset compared to RT-PCR comparator tests for SARS-CoV-2, influenza A, and influenza B. The comparator tests will include an emergency use authorized (EUA) or FDA-cleared SARS-CoV-2 RT-PCR te
Interventions
- DIAGNOSTIC_TEST COVID/Flu Detect™ Rapid Self-Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 899 participants |
| Start Date | 2024-12-26 |
| Est. Completion | 2025-05-19 |
What the finished NCT06734741 record still lists
NCT06734741 is an observational study that tracks outcomes without assigning an intervention. The registered 899 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which COVID/Flu Detect™ Rapid Self-Test is the first listed.
NCT06734741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06734741 about?
NCT06734741 is a clinical study titled "Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use". The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and ...
What is the current status of trial NCT06734741?
This trial is currently completed. The enrollment target is 899 participants. The study started on 2024-12-26. Estimated completion is 2025-05-19.
What interventions are being tested in trial NCT06734741?
The interventions under investigation include: COVID/Flu Detect™ Rapid Self-Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06734741?
This trial is sponsored by InBios International, which has 5 total clinical trials registered on ClinicalTrials.gov.
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