Panbio™ COVID-19 IgG/IgM Rapid Test Matrix Equivalence Study [COVID-19]
Research type
Research Study
Full title
Panbio™ COVID-19 IgG/IgM Rapid Test Device Matrix Equivalence Study
IRAS ID
283040
Contact name
Patrick T. Kennedy
Contact email
Sponsor organisation
Alere International (Abbott Rapid Diagnostics)
ISRCTN Number
ISRCTN60400862
Duration of Study in the UK
0 years, 0 months, 26 days
Research summary
What is the performance of the Panbio™ COVID-19 IgG/IgM Rapid Test Device, when using venous and fingerstick whole blood as well as serum samples, for detecting antibodies to COVID-19 in patients who have had COVID-19?\n\nCoronavirus disease (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Antibodies detected by serology 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 20 μL (a small drop) 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.\nThe Panbio COVID-19 IgG/IgM test has been validated mostly for use with venous plasma. This study will evaluate the performance of the Panbio COVID-19 IgG/IgM test using fingerstick capillary and venous whole blood as well as serum, compared to the Panbio COVID-19 IgG/IgM test using venous plasma. The study will validate the test as performed and interpreted by professional users only. All Panbio COVID-19 IgG/IgM test results will also be evaluated against two ELISA reference methods using venous plasma in order to obtain additional clinical data for the product. Study participants will provide a fingerstick and a venous whole blood sample, and basic medical information. All participants will have their antibody results made available to them, based on CE marked tests. The study will also investigate the prevalence of COVID-19 IgG and IgM antibodies in all participants. \nThis study will enroll 103 participants who are known to have been infected with SARS-CoV-2, and 103 participants who have not been infected with SARS-CoV-2. \nThe study is funded by Abbott Rapid Diagnostics.\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0191
Date of REC Opinion
21 Apr 2020
REC opinion
Favourable Opinion