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 using nasal swab specimens
IRAS ID
304692
Contact name
Raza Mohammad
Contact email
Sponsor organisation
Abbott Rapid Diagnostics Jena GmbH
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
, SDRD-G-026-P
Duration of Study in the UK
0 years, 7 months, 18 days
Research summary
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 the COVID-19 / Flu A&B Rapid Panel test using nasal swab samples, by comparing the test result to Flu A, Flu B and SARS-CoV-2 RT-PCR using nasopharyngeal swab samples.
In total, study participants will provide one nasal and one nasopharyngeal swab sample, and basic medical information. The study will also investigate the usability of this test device using a questionnaire.
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. All participants will be compensated for their time and effort in the study, as well as their travel expenses.
The study is funded by Abbott Rapid Diagnostics.Lay summary of study results
During the interim analysis it was observed that the investigational product was not meeting the product’s predicted performance goals, Abbott therefore decided to terminate the study early.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/HRA/3835
Date of REC Opinion
29 Nov 2021
REC opinion
Further Information Favourable Opinion