Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorAbbott Rapid Dx
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BinaxNOW™ COVID-19/Flu A&B Combo Self-Test
Treatment groups
700 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov