Evaluation of a COVID-19 antibody test: What is the performance of the Panbio™ COVID-19 IgG/IgM rapid test device in fingerstick blood, venous whole blood, serum and plasma in adult participants?

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.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

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 had an immune response to SARS-CoV-2. Antibody tests are important to confirm prior infection, including in individuals with few or no symptoms.
The Panbio™ COVID-19 IgG/IgM Rapid Test is a rapid test that uses a small drop of blood for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and capillary whole blood. The test is interpreted 10-20 minutes after sample application.
This study will evaluate the performance of the Panbio COVID-19 IgG/IgM test.

Who can participate?
Adults over 18 years who are known to have been infected with SARS-CoV-2, and participants who have not been infected with SARS-CoV-2.

What does the study involve?
Participants will have several different blood tests performed.

What are the possible benefits and risks of participating?
It is possible that the collection of blood through venipuncture and capillary finger-stick could cause discomfort. However, as these are routine medical procedures and the samples will be obtained by trained medical personnel, the discomfort is likely to be minimized.
COVID-19 transmission is a risk to the participants. However, convalescent patients are not expected to be transmitting virus. There is a risk, albeit low, that a symptomatic 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?
The Royal London Hospital (UK)

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

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

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Abbott (Germany)
Industry

Abbott Rapid Diagnostics Jena GmbH
Orlaweg 1
Jena
07743
Germany

Phone	+44 7792902244
Email	camilla.forssten@abbott.com
Website	http://www.abbott.com/
"ROR"	https://ror.org/02x2gk324

Funders

Funder type

Not defined

Results and Publications

Study outputs

Editorial Notes

28/01/2022: Publication reference added.
06/08/2020: The intention to publish date was changed from 17/07/2020 to 28/08/2020.
22/06/2020: Trial’s existence confirmed by HRA.