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

NCT05630365 | Completed

• 1 other identifier: SDRD-H-027-P
• Study Type: interventional
• Target: 1,129
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; Influenza A; Influenza Type B

Outcome Measures

Primary Outcomes (1)

• Primary Outcome:

  Evaluate the clinical performance (sensitivity/specificity) of the Panbio™ COVID-19/Flu A\&B Rapid Panel in fresh collected mid-turbinate nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms in a Near Patient Testing setting, compared to Flu and SARS-CoV-2 RT-PCR tested using NP swab samples. Concordance analyisis of investigational device and reference method. Acceptance criterion: Sensitivity \>80%, Specificity \>95%

  immediate

Secondary Outcomes (1)

• Secondary Outcome:

  immediate

Study Arms (1)

Nasal sampling/Testing (Professional Use)

EXPERIMENTAL

operators will collect one mid-turbinate nasal swab sample from both nostrils from each subject. The collected mid-turbinate nasal swab will be tested with the Panbio™ Rapid Panel by an operator at the study site in a Near Patient Testing setting (e.g. GP centre or hospital clinic). After the mid-turbinate nasal sampling, the operators will collect one NP swab sample from one nostril of each subject.UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, as per the laboratory manual

Diagnostic Test: Panbio™

Interventions

Panbio™ DIAGNOSTIC_TEST

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

Also known as: Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product

Nasal sampling/Testing (Professional Use)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects from all age groups, able and willing to provide written informed consent or assent, suspected of having a respiratory viral infection consistent with COVID-19 and or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.

You may not qualify if:

• Subject has had a nasal or a NP swab taken within the last 4 hours and is not available for further testing after 4 hours has elapsed.
• Subject has active nose bleeds or acute facial injuries/trauma.
• Subject has received a nasal vaccine (i.e., FluMist®) within the previous fourteen (14) days.
• Subject is currently taking or has taken an antiviral medication-e.g., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza or COVID-19 within the previous thirty (30) days.
• Subject is currently enrolled in a study to evaluate an investigational drug.
• Subject is unwilling or unable to provide informed consent.
• Vulnerable populations as deemed inappropriate for study by the site's PI and/or reviewing REC.

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

UCCT @ Complete Health Partners- Nashville

Nashville, Tennessee, 37209, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: November 29, 2022
• Study Start: December 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)