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Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product Using Mid-Turbinate Nasal Swabs

NCT05630365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1129

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 of the Panbio™ COVID-19/Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. 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 device, hereafter referred to as the Panbio™ Rapid Panel, is a visual lateral flow assay for the rapid immuno-chromatographic qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in mid-turbinate nasal swabs

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
2022-12-15
Primary Completion
2023-03-31
Completion
2023-03-31

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 NCT05630365 on ClinicalTrials.gov