Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use

NCT06124638 | Completed

• 1 other identifier: 2324101
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen.

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

  The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the Panbio™ COVID-19/Flu A\&B Panel Self Test against the comparator Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236), in symptomatic patients suspected of respiratory viral infection, when nasal swabs are self-collected by the patient/lay user. The patient/lay user will perform the test, read and interpret the test result.

  6 months

Study Arms (1)

Self-Testing Group

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. Participants will be asked to document their result interpretation and will pass the test to site staff, who will document their interpretation of the result. In addition, a second swab will be collected by study staff and eluted in Viral Transport Medium (VTM).

Diagnostic Test: Panbio™ COVID-19/Flu A&B Panel

Interventions

Panbio™ COVID-19/Flu A&B Panel DIAGNOSTIC_TEST

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.

Self-Testing Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is at least two (2) years of age, and
• Participant is suspected of acute viral respiratory infection by a healthcare professional, and
• Participant is within seven (7) days of symptom onset, and
• Participant is experiencing two or more of the following symptoms
• Fever of \>100.0°F/ 37.8°C
• Cough
• Fatigue
• New loss of taste or smell
• Congestion or runny nose
• Shortness of breath or difficulty breathing
• Sore throat
• Muscle or body aches
• Headache
• Nausea or vomiting
• Diarrhea

You may not qualify if:

• Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
• Participants with an active nosebleed
• Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
• Participant has received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
• Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
• Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days
• Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals, convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (2)

Cahaba Research Inc

Pelham, Alabama, 35124, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, 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 8, 2023
• First Posted: November 9, 2023
• Study Start: December 4, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)