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

The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Influenza Type B; Influenza Type A
• Intervention / Treatment: Diagnostic test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test

Detailed Description

Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza PCR negatives.

The total number of research-related anterior nasal swabs collected from each consented Participant is two (2). Participants ages two (2) years and older meeting eligibility criteria will be enrolled.

The order of nasal swab collection will be randomized according to the Participant ID as to which swab is used for BinaxNOW™ COVID-19/Flu A&B Combo and which is to be eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing.

For Participants with an odd numbered Participant ID, the first swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A&B Combo. The second swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The Participant will review the Instructions for Use, collect the nasal swab, and perform the BinaxNOW™ COVID-19/Flu A&B Combo, then interpret and record the result at the time specified in the product instructions.

For Participants with an even numbered Participant ID, the first swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The second swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A&B Combo. Once the healthcare provider collected the swab for the comparator test the Participant will review the Instructions for Use.

The VTM/UTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM/UTM specimens can be stored for up to 48 hours at 2-8°C. If delivery and processing of samples exceeds specified time periods, specimens should be transported in dry ice and once in laboratory frozen at -70°C or colder.

Each Participant's demographic data, inclusion/exclusion data, days of symptom onset, comparator results, Education level, occupation, and socioeconomic status and other data points will be documented on the data collection worksheets and EDC.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Parsons, Manager of Clinical Operations; Phone Number: 000-000-0000; Email: samantha.parsons@abbott.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Experimental: Nasal sampling/Testing (Self-Test); Each Participant will be provided a single-use test kit containing a BinaxNOW™ COVID-19/Flu A&B Combo, buffer and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19/Flu A&B Combo, then interpret and record the result. The testing will be completed in a home like setting. 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. The order of collections will be based off the subject number.

Diagnostic test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test; Diagnostic Test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test The BinaxNOW™ COVID-19/Flu A&B Combo Self-Test is a visually read lateral flow in vitro immunoassay for the qualitative detection and differentiation of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)	The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user. The patient/lay user will perform the test, read, and interpret the test result.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in patient/lay user	The secondary objective of this study is to demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in the hands of patients/lay users, which are "intended users" in a point of care (POC) Clinical Laboratory Improvement Amendments of 1988 (CLIA) moderate, high or waived complexity test environment	5 months

Collaborators and Investigators

• Sponsor: Abbott Rapid Dx

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Influenza, Human
• Other Study ID Numbers: 2506401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share as this is a feasibility trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No