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

NCT06928129 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-04-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Abbott Rapid Dx

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-11-01
Completion
2025-11-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06928129 on ClinicalTrials.gov