Panbio™ COVID-19 Antibody Self-Test Study
Research type
Research Study
Full title
Panbio™ COVID-19 Antibody Self-Test Study
IRAS ID
283060
Contact name
Patrick T. Kennedy
Contact email
Sponsor organisation
Abbott Rapid Diagnostics Jena GmbH
ISRCTN Number
ISRCTN10699017
Clinicaltrials.gov Identifier
Protocol number, 0502
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
Research Summary
What is the performance of the Panbio™ COVID-19 Antibody Self Test, when performed and interpreted by lay users, for detecting antibodies to COVID-19 in patients?
Coronavirus 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 Antibody Self Test is a rapid test that uses a fingerstick sample for the detection of IgG and IgM antibodies to SARS-CoV-2. The test is intended to be used by untrained lay users (self testing) to assist screening for past SARS-CoV-2 infection.
The professional use version of the test has been validated for use with venous plasma and is currently undergoing further validation, also with fingerstick whole blood. This study will evaluate the performance of the Panbio™ COVID-19 Antibody Self Test when performed by lay users, in comparison to a reference method using venous plasma. The lay user acceptability and feasibility of the sample collection and test procedures will also be evaluated. The study will investigate the prevalence of COVID- 19 antibodies in all participants.
Study participants will also provide a venous blood sample and basic medical information. All participants will have their antibody results made available to them, based on CE marked tests.
This study will enroll 107 participants who are known to have been infected with SARS-CoV-2, and 107 participants who have not been infected with SARS-CoV-2. Two hundred fourteen additional participants will be enrolled to read the test result, in order to keep the readers blinded to the expected test result.
The study will recruit participants in a study secondary / tertiary clinical setting and is funded by Abbott Rapid Diagnostics.Summary of Results
One main objective of the study was to evaluate the diagnostic sensitivity and specificity of the Panbio™ COVID-19 IgG Rapid Test Device using fingerstick capillary whole blood and venous plasma, when the test is performed by professional users. Another main objective of the study was to evaluate the diagnostic sensitivity and specificity of the Panbio™ COVID-19 Antibody Self-Test as performed by lay users using fingerstick samples. A total of 498 subjects who provided specimens were enrolled in the study, of whom 447 were evaluable and 51 were unevaluable. Participants were enrolled in the US, UK and Spain. In the UK, 213 evaluable participants were enrolled. The professional use test has been CE marked and the self-test results are being submitted for CE mark. The professional use test performance was evaluated against the Abbott Architect™ platforms (Europe) or on the equivalent Abbott Alinity™ platform (US).
For the professional use Panbio™ COVID-19 IgG Rapid Test used with fingerstick whole blood samples, the study data for unvaccinated participants demonstrates a sensitivity of 92.6% in participants with PCR confirmed infection and symptoms onset > 21 days ago, and a specificity of 97.0%. The sensitivity is the proportion of true positive participants who are positive by the investigational test and the specificity is the proportion of true negative participants who are negative by the investigational test. For the vaccinated participants, the fingerstick whole blood sensitivity was 98.4% and the specificity was 100%, based on one reference-negative participant.
Using venous plasma samples, the professional use Panbio™ COVID-19 IgG Rapid Test sensitivity was 90.0% in unvaccinated participants with PCR confirmed infection and symptoms onset 21 < days ≤ 180 days ago. The specificity was 96.3%. For vaccinated participants, the plasma sensitivity was 96.7% and the specificity was 100.0%, based on one reference-negative participant.
For the Panbio™ COVID-19 Antibody Self-Test, the sensitivity and specificity obtained was also very high, and the usability showed good results. 93.2% of the self-testers users felt that the device was very easy or fairly easy to execute and 95.7% felt confident that they performed the test correctly.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0155
Date of REC Opinion
4 May 2020
REC opinion
Further Information Favourable Opinion