Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use

Completed · Not applicable

Conditions studied: COVID-19, Influenza A, Influenza Type B

In brief

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.

Key facts

Study ID

NCT06124638

Run by

Abbott Rapid Dx

People needed

624

Starts

2023-12-04

Expected to finish

2024-04-03

Last updated by the study team

2024-08-19

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is at least two (2) years of age, and
• Participant is suspected of acute viral respiratory infection by a healthcare professional, and
• Participant is within seven (7) days of symptom onset, and
• 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

You may not qualify if…

• Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
• Participants with an active nosebleed
• Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
• Participant has received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
• Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
• Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days
• Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals, convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)

Where it is running

• Cahaba Research Inc — Pelham, Alabama, United States
• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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