Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.

NCT05354115 | Completed

• 1 other identifier: SDRD-H-002-P
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation 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 and nasopharyngeal swabs by the study sponsor, Abbott.

Conditions

COVID-19; Influenza A; Influenza Type B

Outcome Measures

Primary Outcomes (1)

• Nasal and Nasopharyngeal Sample Collection

  The objective of this study is to collect nasal and nasopharyngeal 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. The collected samples will be sent to the sponsor (Abbott) or central laboratory for reference testing, diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel some of which will be used to support product registrations.

  6 months

Study Arms (1)

Sampling

OTHER

Every second participant will be instructed to blow their nose. Study personnel will then collect one nasal swab from both nostrils and two NP swabs, one from each nostril from each participant. Nasal samples must always be collected prior to the Nasopharyngeal sampling. A minimum of 90 Flu A positive subjects, a minimum of 90 Flu B positive subjects and a minimum of 100 SARS-CoV-2 positive subjects will be enrolled. In addition, a minimum of 385 negative subjects will be enrolled.

Diagnostic Test: Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel

Interventions

Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel DIAGNOSTIC_TEST

Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. After the nasal sampling, the operators will collect two nasopharyngeal swab one from each nostril of each subject.

Sampling

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects \>14 years of age who are able and willing to provide written informed consent, and deemed suitable for nasopharyngeal sampling in accordance with local procedures, 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, 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.

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

Urgent Care Clinical Trials 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: April 6, 2022
• First Posted: April 29, 2022
• Study Start: March 14, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (1)