Clinical Trial

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

Not Yet Recruiting
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Record status
This record was last updated April 15, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06928129
Lead Sponsor Abbott Rapid Dx
Conditions Influenza Type A, Influenza Type B, COVID-19
Enrollment 700 participants
Start Date 2025-06-30
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-15