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

NCT05163730 | Completed FDA Device

• 1 other identifier: SDRD-G-026-P
• Study Type: interventional
• Target: 2,472
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a 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 (H1N1 and H3N2), and Influenza B antigen in human nasal swabs. 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

  Sensitivity of 70% is the target at the lower bound of the 95% confidence interval for SARS-CoV-2 and 70% for each Flu. The target specificity is 95% at the lower bound of the 95% confidence interval for each test line.

  8 months

Secondary Outcomes (1)

• Usability

  8 months

Study Arms (1)

Panbio™ COVID-19/ Flu A&B Rapid Panel

OTHER

One nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A\&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP centre or hospital clinic). Each Panbio™ COVID-19/ Flu A\&B Rapid Panel result will be photographed by the observer at the time of test interpretation. Nasopharyngeal samples will be collected and used for RT-PCR testing as per local procedures. Nasal samples must always be collected prior to the Nasopharyngeal sampling.

Device: COVID-19/ Flu A&B Rapid Panel

Interventions

COVID-19/ Flu A&B Rapid Panel DEVICE

Rapid Diagnostic Device

Panbio™ COVID-19/ Flu A&B Rapid Panel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• 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 seven days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme 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 nasopharyngeal swab taken within the last 4 hours.
• Subject has active nose bleeds or acute facial injuries/trauma
• Subject has received a nasal vaccine (i.e., FluMist®) within the previous five (5) days.
• Subject is currently taking or has taken an antiviral medication-i.e., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza 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 (Research Ethics Committee).

Sponsors & Collaborators

• Abbott Rapid Diagnostics Jena GmbH: lead

Study Sites (1)

Urgent Care

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: November 6, 2021
• First Posted: December 20, 2021
• Study Start: November 1, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)