Panbio™ COVID-19 Antigen Self-Test study [COVID-19]
Research type
Research Study
Full title
Clinical Evaluation of the Panbio™ COVID-19 Antigen Self-Test Device as an Over-The-Counter (OTC) self-test
IRAS ID
296441
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
Abbott Rapid Diagnostics Jena GmbH
ISRCTN Number
ISRCTN38930336
Clinicaltrials.gov Identifier
Protocol Number, CLDG-1001
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Research Summary
What is the clinical performance of the Panbio™ COVID-19 Antigen Self-Test Device, when performed and interpreted by lay users?
Coronavirus disease (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is spread by human-to-human transmission via droplets or direct contact. If someone gets infected with SARS-CoV-2, antigens to SARS-CoV-2 are presented in his/her tissue fluids. Hence nasal or nasopharyngeal swab tests can be used to indicate if someone has been infected with SARS-CoV-2. COVID-19 antigen tests may enable healthcare professionals to identify infected patients early and to limit the spread of the virus.
The Panbio™ COVID-19 Ag Self Test is a rapid test device that is used for qualitative detection of SARS-CoV-2 antigen (Ag) in human tissue fluids obtained from nasal or nasopharyngeal swabs.
The Panbio™ COVID-19 Ag test is approved in the UK for use by health care professionals with nasopharyngeal samples. This study will evaluate the performance of the Panbio™ COVID-19 Antigen Self-Test, as performed by self-testers (lay users) using nasal self-collected samples. Each self-test result will be compared with a Panbio™ COVID-19 Antigen Professional Use test result from the same participant. The Professional Use test will performed by a study staff member using a nasopharyngeal sample. In total, study participants will provide one nasal and one nasopharyngeal swab sample, and basic medical information. The study will also investigate lay user acceptability and feasibility in performing the test and self collecting their own nasal sample.
This study will enrol at least 150 subjects with a positive and 250 subjects with a negative COVID-19 reference test result. All participants will receive £30 compensation for their time and effort in the study.
The study will recruit participants in a study secondary / tertiary setting and is funded by Abbott Rapid Diagnostics.Summary of Results
The study was designed to demonstrate ≥80.0% sensitivity and ≥95.0% specificity of the Panbio™ COVID-19 Antigen Self-Test. This means that 80% or more of the true positive results should be identified as positive by the Panbio™ COVID-19 Antigen Self-Test and 95% or more of the true negative results should be identified as negative by the Panbio™ COVID-19 Antigen Self-Test. In the study, the test was performed by self-testers (lay users), to evaluate whether the test can be used by a lay person at home. For the testing, the lay users used nasal self-collected samples. The results that they obtained using the self-test was compared with the Panbio™ COVID-19 Antigen Professional Use test. This professional use test was performed by health care professionals using nasopharyngeal samples collected from the same participant. Information was also be collected and evaluated about the lay user acceptability and feasibility of collecting a nasal swab sample, performing the Panbio COVID-19 Antigen Self Test and interpreting the Panbio COVID-19.
Three hundred ten participants signed informed consent for the study, and, 300 evaluable participants were available for the method comparison analysis. The Panbio™ COVID-19 Antigen Self-Test performed better than required in the protocol. 85.5% of the lay users considered the test easy to conduct overall and 11.9% considered the test neither easy nor difficult to conduct.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0081
Date of REC Opinion
24 Mar 2021
REC opinion
Further Information Favourable Opinion