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Home-use Nasal Swab Test for COVID-19 and Flu

N/A
Recruiting
Research Sponsored by Abbott Rapid Dx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is at least two (2) years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial tests a home-use nasal swab test for COVID-19, Flu A&B. Subjects self-collect and interpret results to detect viral respiratory infection.

Who is the study for?
This trial is for people suspected of having a viral respiratory infection by a healthcare professional, within seven days of symptom onset, and experiencing symptoms like fever, cough, or loss of taste/smell. It's open to individuals aged two years and above. Those who've had certain flu treatments or vaccines recently, nasal procedures on the day of enrollment, COVID-19 treatment in the last 45 days, or are in another drug study can't join.Check my eligibility
What is being tested?
The Panbio™ COVID-19/Flu A&B Panel Self Test is being evaluated. Participants will self-collect nasal swabs and use this home test kit to check for qualitative detection of COVID-19 and Influenza A & B antigens.See study design
What are the potential side effects?
Since this trial involves a diagnostic test rather than medication or vaccine administration, typical side effects associated with drugs are not expected. However, discomfort from nasal swabbing may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 2 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device

Trial Design

1Treatment groups
Experimental Treatment
Group I: Self-Testing GroupExperimental Treatment1 Intervention
Lay users (self-tester or caregiver) will be provided with a Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test kit. Each lay user will collect one mid-turbinate nasal swab from both nostrils, perform and interpret the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test. All procedures for testing and result interpretation, including sample collection and extraction will be conducted by the lay user following the Instructions for Use provided in the kit. Participants will be asked to document their result interpretation and will pass the test to site staff, who will document their interpretation of the result. In addition, a second swab will be collected by study staff and eluted in Viral Transport Medium (VTM).

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Who is running the clinical trial?

Abbott Rapid DxLead Sponsor
5 Previous Clinical Trials
4,178 Total Patients Enrolled
4 Trials studying COVID-19
3,155 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recruiting opportunities associated with this clinical trial?

"As advertised on clinicaltrials.gov, the enrolment period for this study is currently active and began on November 30th 2023 with a most recent update taking place just 10 days later."

Answered by AI

How many participants are involved in this clinical experiment?

"Affirmative. As noted on clinicaltrials.gov, this study is actively seeking participants and was initially posted on November 30th 2023 with a recent update issued on the 10th of November, 2023. 2000 individuals from two different medical centres are needed for enrolment in the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Cahaba Research Inc
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Hoping this will help me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
2023. "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06124638.
All > Covid 19
~0 spots leftby Apr 2024
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