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Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel

NCT06127108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2024-04-25

No results posted yet for this study

Summary

The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.

Conditions

Interventions

DIAGNOSTIC_TEST

Panbio™

The Panbio™ COVID-19/Flu A\&B Panel is a visual lateral flow in vitro immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B in anterior nasal swab samples from individuals with symptoms and suspected of COVID-19 or Flu infection by their healthcare provider.

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
2023-11-14
Primary Completion
2024-02-02
Completion
2024-02-02

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 NCT06127108 on ClinicalTrials.gov