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Panbio Test for Flu and COVID-19

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 experiencing two or more of the following symptoms: Fever of >100.0°F/ 37.8°C, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache, Nausea or vomiting, Diarrhea

Participant is suspected of acute viral respiratory infection by a healthcare professional

Timeline

Screening 3 weeks

Treatment Varies

Follow Up "up to 24 months"

Awards & highlights

Study Summary

This trial tests a new test for respiratory viruses that compares to other existing tests.

Who is the study for?

This trial is for people aged 2 or older with symptoms like fever, cough, fatigue, or loss of taste/smell. They must be within a week of symptom onset and suspected by a doctor to have a respiratory viral infection. Those who've had certain nasal procedures, nosebleeds, antiviral treatments for flu or COVID-19 recently can't join.Check my eligibility

What is being tested?

The Panbio™ COVID-19/Flu A&B Panel is being tested to see how well it identifies infections compared to established tests (Roche cobas® & Quidel Lyra®). It's used on nasal swabs from symptomatic patients to detect the presence of respiratory viruses.See study design

What are the potential side effects?

Since this trial involves diagnostic testing rather than medication administration, there are no direct side effects from the intervention itself. However, discomfort or minor bleeding from the nasal swab could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am experiencing two or more symptoms like fever, cough, or fatigue.

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A doctor thinks I might have a viral respiratory infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ "up to 24 months"

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~"up to 24 months"

This trial's timeline: 3 weeks for screening, Varies for treatment, and "up to 24 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

Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA

Secondary outcome measures

Demonstrate the accuracy of the Panbio™ COVID-19/Flu A&B Panel in the hands of untrained users by a usability questionnaire.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Nasal sampling/Testing (professional use)Experimental Treatment1 Intervention

Operator or delegated study staff will collect one anterior nasal swab sample from both nostrils. The collected anterior nasal swab will the tested with the Panbio™ COVID-19/Flu A&B Panel by the operator at the study site in a near patient testing setting (e.g. GP center or hospital clinic). After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panbio™

2023

N/A

~2040

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Rapid DxLead Sponsor

5 Previous Clinical Trials

5,731 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies available for participants in this experiment?

"This trial, which was initially shared on November 14th 2023, is actively in pursuit of participants. The information has been revised as recently as November 17th 2023 and can be accessed via clinicaltrials.gov."

Answered by AI

What is the upper limit to the amount of individuals participating in this study?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research project is actively searching for participants, with an original posting date of November 14th 2023 and the most recent edit taking place on November 17th 2023. 2000 volunteers are sought after from one site in particular."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel

2023. "Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127108.

All > Covid 19