Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel
Research type
Research Study
Full title
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device.
IRAS ID
318413
Contact name
Nathanael Wright
Contact email
Sponsor organisation
Abbott Rapid Dx International Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Influenza (flu) and COVID-19 are both contagious respiratory illnesses, but they are caused by different viruses. COVID-19 is caused by infection with a coronavirus first identified in 2019, and flu is caused by infection with influenza viruses. Compared to flu, COVID-19 can cause more serious illnesses in some people. COVID-19 can also take longer before people show symptoms and people can be contagious for longer. Because some of the symptoms of flu and COVID-19 are similar, the difference between them cannot be made based on symptoms alone. Testing is needed to tell what the illness is and to confirm a diagnosis.
The Panbio™ COVID-19 / Flu A&B Rapid Panel is a rapid test device that is used for detection of SARS-CoV-2 and influenza antigen (Ag) in human tissue fluids obtained from nasal swabs. This is a test that can be run in 15-20 minutes to obtain a quick result. This may enable healthcare professionals to identify infected patients early and to limit the spread of the virus.
This study will evaluate the accuracy of 2 devices in parallel; the COVID-19/Flu A&B Rapid Panel Professional Use (PU) device by a healthcare professional, and the Self-Test (ST) device performed by a lay person, both using nasal swab samples by comparing the test result to Flu A, Flu B and SARS-CoV-2 RT PCR testing using nasopharyngeal (NP) swab samples.
In total, globally, 1531 participants will participate in the study. The participants will provide a nasal sample and 2 NP samples in addition to basic medical demographic information. The usability of the device will be assessed by asking each lay user and healthcare professional to complete a user questionnaire. The participants will comprise of a minimum of 120 Flu A, 120 Flu B, 300 SARS-CoV-2 participants, 991 negative participants and a minimum of 100 lay users will also be asked to interpret randomly assigned mock devices.
The study is funded by Abbott Rapid Diagnostics International Unlimited Company.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0240
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion