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

NCT06127108 | Completed

• 1 other identifier: 2319801
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; Influenza A; Influenza B

Outcome Measures

Primary Outcomes (1)

• Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA

  1\. Primary Outcome: The primary objective of this study is to demonstrate 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, the 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. Samples may also be tested for viral culture.

  "up to 24 months"

Secondary Outcomes (1)

• Demonstrate the accuracy of the Panbio™ COVID-19/Flu A&B Panel in the hands of untrained users by a usability questionnaire.

  "Up to 24 months"

Study Arms (1)

Experimental: Nasal sampling/Testing (professional use)

EXPERIMENTAL

Operator or delegated study staff will collect one anterior nasal swab sample from both nostrils. The collected anterior nasal swab will the tested with the Panbio™ COVID-19/Flu A\&B Panel by the operator at the study site in a near patient testing setting (e.g. GP center or hospital clinic). After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2.

Diagnostic Test: Panbio™

Interventions

Panbio™ DIAGNOSTIC_TEST

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.

Also known as: Panbio™ COVID-19/Flu A&B Panel

Experimental: Nasal sampling/Testing (professional use)

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 suspected of acute viral respiratory infection by a healthcare professional, and
• Participant is age two (2) years or older, 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 enrollment
• 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 (1)

Advanced Pediatrics

Vienna, Virginia, 22180, 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

Model Details: Study staff will collect two (2) anterior nasal swabs from each Participant. One anterior nasal swab will be collected by a study staff member and tested immediately on the Panbio™ COVID-19/Flu A\&B Panel by an untrained test operator. The other anterior nasal swab will be eluted in VTM within 10 minutes of sample collection. The swab will be rotated vigorously in the VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary. VTM samples will be stored, handled and tested with comparator assays according to the manufacturers' product instructions. VTM specimens can be stored for up to 48 hours at 2-8°C. If delivery and processing of samples exceeds specified time periods, specimens should be transported in dry ice and once in laboratory frozen at -70°C or colder.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: November 14, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)