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

Sponsor
Abbott Rapid Dx
Study ID
NCT06928129
Status
Not Yet Recruiting

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Conditions

  • COVID-19
  • Influenza Type A
  • Influenza Type B

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Apr 15, 2025
Start date
Jun 30, 2025
Status verified
Apr 2025
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
700 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) [ Time Frame: 5 months ]

Central Contacts

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