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

NCT06928129 | Not Yet Recruiting

• 1 other identifier: 2506401
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza Type A; Influenza Type B; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in patient/lay user

  5 months

Study Arms (1)

Experimental: Experimental: Nasal sampling/Testing (Self-Test)

EXPERIMENTAL

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

Interventions

BinaxNOW™ COVID-19/Flu A&B Combo Self-Test DIAGNOSTIC_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.

Experimental: Experimental: Nasal sampling/Testing (Self-Test)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 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.

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 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)

Sponsors & Collaborators

• Abbott Rapid Dx: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Samantha Parsons, Manager of Clinical Operations

CONTACT

000-000-0000; samantha.parsons@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study staff will collect two (2) anterior nasal swabs from each Participant. 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. Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab up to 1 inch into one of the anterior naris. Staff will rotate the swab against the nasal mucosa five (5) times to obtain sample and withdraw. Staff will repeat with the other anterior naris using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM)/Universal Transport Media (UTM) immediately (within 5 minutes) of sample collection. The swab should be rotated vigorously in the VTM/UTM liquid for 10 seconds. The swab head will be left in the VTM/UTM, by snapping the shaft or clipping the base of the swab if necessary

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 15, 2025
• Study Start: June 30, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share