Evaluation of a COVID-19 antibody professional use test and a COVID-19 antibody self-test: What is the performance of the Panbio™ COVID-19 antibody self-test when performed by lay users? What is the performance of the Panbio™ COVID-19 antibody test when performed by healthcare professional users?

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system, and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Antibodies detected by blood tests indicate that a person has had an immune response to SARS-CoV-2 or a COVID-19 vaccination. Antibody tests can be used to confirm prior infection, including in individuals with few or no symptoms.

The Panbio™ COVID-19 IgG Rapid Test Device (professional use test) is a rapid, lateral flow test that uses a small drop of blood (20 µL) or a small drop of serum or plasma (10 µL) for the qualitative detection of antibodies (S-IgG) to SARS-CoV-2 in human plasma, serum, venous and capillary whole blood. The Panbio™ COVID-19 Antibody Self Test is a rapid lateral flow test that uses a small drop (20 µL) capillary whole blood for the qualitative detection of antibodies (S-IgG) to SARS-CoV-2. Both tests can be interpreted 10-20 minutes after sample application. Negative test results must be confirmed 20 minutes after sample application. The Panbio™ antibody tests (professional use and self-test) are intended to detect antibodies due to past SARS-CoV-2 infection or COVID-19 vaccination.

This study evaluates the clinical performance of the Panbio™ COVID-19 Antibody Self-Test and Panbio™ COVID-19 IgG Rapid Test Device (professional use test).

Who can participate?
Adults over 16 years (UK) or over 18 years (Spain) who are known to have been infected with SARS-CoV-2, and participants who have not been infected with SARS-CoV-2. In addition, the analyses will include participants enrolled under a separate, similar protocol in the US.

What does the study involve?
Participants will provide a fingerstick sample for testing with the Panbio™ professional use test as well as a venous sample which will be processed to plasma. The plasma will be used for testing of Panbio™ using plasma samples and for laboratory reference testing. Participants will also conduct a Panbio™ self-test (self-testers) and/or interpret a Panbio™ self-test result from someone else (test reader). Self-testers will also interpret the results of two mock devices with printed lines. All lay users will complete a usability questionnaire.

What are the possible benefits and risks of participating?
It is possible that the collection of blood through venipuncture (by a healthcare professional) and capillary finger-stick (by a healthcare professional or as a self-tester) could cause discomfort. However, as the collection of samples by a healthcare professional are routine medical procedures and the samples will be obtained by trained medical personnel, the discomfort is likely to be minimized. Other self-tests are available and approved for use in the EU and the UK. A study staff member will be present for all procedures, although will not assist the self-tester, except in a medical emergency.
COVID-19 transmission is a risk to the participants. However, convalescent patients are not expected to be transmitting the virus. There is a risk, albeit low, that asymptomatic patients in the control group will be carrying COVID-19. All operations will be conducted under strict social distancing to minimize the risk of transmission.

Where is the study run from?
Royal London Hospital (UK), Princess Alexandra Hospital (UK), Brockwood Medical Practice (UK), Bridgewater Surgeries (UK), Hampstead Group Practice (UK), Parliament Hill Practice (UK), Millway Medical Practice (UK), Medicus Health Partners (UK) and Hospital Infanta Leonor (Spain).

When is the study starting and how long is it expected to run for?
April 2020 to January 2022

Who is funding the study?
Abbott Rapid Diagnostics (Germany)

Who is the main contact?
Prof. Patrick T. Kennedy, p.kennedy@qmul.ac.uk

Contact information

Prof Patrick Kennedy
Principal Investigator

Barts Liver Centre
Immunobiology
Blizard Institute
Barts and The London SMD
QMUL
4 Newark Street
London
E1 2AT
United Kingdom

ORCID ID	0000-0001-9201-0094
Phone	+44 (0)207 882 6187
Email	p.kennedy@qmul.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Spain
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Industry

Results and Publications

Study outputs

Editorial Notes

08/01/2024: Publication reference added.
15/05/2023: The intention to publish date was changed from 31/08/2022 to 01/09/2023.
01/02/2022: Internal review.
26/01/2022: Trial's existence confirmed by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee.