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

Completed · Not applicable

Conditions studied: COVID-19, Influenza A, Influenza B

In brief

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.

Key facts

Study ID

NCT06127108

Run by

Abbott Rapid Dx

People needed

447

Starts

2023-11-14

Expected to finish

2024-02-02

Last updated by the study team

2024-04-25

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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