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 | Completed

• 1 other identifier: SDRD-H-029-P
• Study Type: interventional
• Target: 903
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; Influenza A; Influenza Type B

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device.

  To assess 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% To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID- 19/Flu A\&B Rapid Panel Self-Test device, as performed by lay users (self-testers or caregivers) using fresh collected mid-turbinate nasal self- collected samples, when compared to Flu and SARS-CoV-2 RT- PCR using NP swab samples.

  "up to 24 months"

Secondary Outcomes (3)

• Concordance of self-test and professional use device

  "up to 24 months"

• Usability of the professional use device

  "up to 24 months"

• Usability of the self test device

  "up to 24 months"

Study Arms (1)

Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use)

EXPERIMENTAL

Lay users (self-tester or caregiver) will be provided with a Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test kit. Each lay user will collect one mid-turbinate nasal swab from both nostrils, perform and interpret the Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test. All procedures for testing and result interpretation, including sample collection and extraction will be conducted by the lay user following the Instructions for Use provided in the kit. The first NP swab sample will be used to conduct a Panbio™ COVID- 19/FluA\&B Rapid Panel Professional Use test. The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual.

Diagnostic Test: Panbio™

Interventions

Panbio™ DIAGNOSTIC_TEST

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

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

Nasal sampling/Testing (Self-Test) + Nasopharyngeal 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.
• Self-tester or caregiver has prior medical or laboratory training.
• Self-tester or caregiver has a visual impairment that cannot be restored using glasses or contact lenses or lay user is unable to read the Instructions for Use.
• Subject has a condition deemed unfit to safely perform the test.
• Subject is unwilling or unable to provide informed consent.
• Vulnerable populations as deemed inappropriate for the study by the site's PI.

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

UCCT @ AFC Urgent Care- Easley

Easley, South Carolina, 29640, 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: January 9, 2023
• First Posted: February 8, 2023
• Study Start: January 6, 2023
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)