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Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device

NCT05715515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 903

Last updated 2023-11-09

No results posted yet for this study

Summary

This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively.

This study is part of the performance evaluation to support the CE conformity assessment procedures.

Conditions

Interventions

DIAGNOSTIC_TEST

Panbio™

The Panbio™ COVID-19/Flu A\&B Rapid Panel Professional use device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in nasopharyngeal swabs, collected by a trained health worker. The Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in self-collected mid-turbinate nasal swabs. The test is designed to be used by lay users

Sponsors & Collaborators

  • Abbott Rapid Dx

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2023-05-29
Completion
2023-05-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT05715515 on ClinicalTrials.gov