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

ConditionsInfluenza Type A Influenza Type B COVID-19

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

700 Participants

are divided into 1 treatment group

Group A: Experimental: Experimental: Nasal sampling/Testing (Self-Test)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

5 months

Secondary outcomes

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

Time frame

5 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Rapid Dx

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: