Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere

Launched by ABBOTT RAPID DX · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new test called the BinaxNOW™ COVID-19/Flu A&B Combo. The goal is to see how well this test works in identifying COVID-19 and influenza (the flu) when patients collect their own nasal swabs. The researchers will compare the results from this test to results from a more sensitive method called PCR. They want to find out how accurately the BinaxNOW test can detect these viruses in people who have symptoms of a respiratory infection.

To participate in this study, individuals must be at least 2 years old and show signs of a viral infection, like fever, cough, or loss of taste or smell, within five days of feeling unwell. However, certain people cannot join, such as those currently taking part in another study, those with a recent positive COVID-19 test, or those who have had certain treatments or vaccines in the last month. Participants will be asked to provide consent and will have the opportunity to learn more about the study and what to expect. This trial is currently not recruiting participants yet, but it is an important step in understanding how to better diagnose respiratory infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 five (5) days of symptom onset, AND
• Participant is experiencing two or more of the following symptoms:
• • Fever of \>100.0°F/ 37.8°C or chills, 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
• • -The Participant and/or legally authorized representative is willing to undergo the informed consent/Assent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.
• Exclusion Criteria:
• • 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 tested positive for COVID-19 within the last 45 days
• • Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.
• • 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 (such as Paxlovid), convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
• • Participant is unable to meet all inclusion criteria as listed above