Performance and self-test user experience evaluation

Peer reviewed performance evaluation and self-test user experience of AbC 19™

9th July 2021: The UK-RTC, a consortium of UK diagnostic companies including Abingdon Health, CIGA Healthcare, BBI Solutions and Omega Diagnostics, welcomes the publication of two peer-reviewed studies conducted by Ulster University and involving AbC-19™, a lateral flow test for the detection of neutralising IgG antibodies to the full trimeric spike protein of the SARS-CoV-2 virus.

Highlights from the studies include:

Professor Chris Molloy, Independent chairman of the UK Rapid Test Consortium said: “We are entering a phase of the pandemic where testing for immunity will become as or more important than testing for infection. Rapid, accurate immunity tests are therefore a critical tool for citizens and public health providers to embrace. Development of multiple antibody tests, and semi-quantitative approaches will enhance this portfolio and enable the most rapid global recovery.”

Details of both studies can be found below:

Study 1: The evaluation of IgG antibody response to SARS-CoV-2 infection and the performance of AbC-19™.

The evaluation, which took place between May 2020 and February 2021, tested blood plasma samples in more than 700 individuals aged 18-78 years to assess correlation between AbC-19™ Rapid Test and approved laboratory-based assays (Roche Elecsys Anti-SARS-CoV-2 IgG/IgA/IgM, Abbott SARS-CoV-2 IgG and EuroImmun IgG SARS-CoV-2 ELISA).

This study evaluated the dynamics and longevity of the humoral immune response to SARS-CoV-2 infection and assess the performance of AbC-19™ Rapid Test in detecting SARS-CoV-2 spike protein IgG antibodies, also known as neutralising antibodies. In addition to the evaluation of the AbC-19™ Rapid Test, following cross-sectional and longitudinal analysis using laboratory methods, the authors detected the presence of COVID-19 antibodies in patients’ blood 10 months after infection.

The ability to accurately detect SARS-CoV-2 specific antibodies, which develop after an immune response, can provide various benefits including building biobanks of convalescent sera for treatment, monitoring immune response to infection alongside surveillance studies and assessing responses to vaccination programmes.

Study 2: A review of the use of AbC-19™ as a self-test for detecting SARS-CoV-2 IgG antibodies.

This study, which was conducted on 1544 participants of mixed age and gender in Northern Ireland, evaluated the potential use of AbC-19™ as a self-test for detecting SARS-CoV-2 spike protein IgG antibodies. The participants self-administered the test in their own cars and were overseen by researchers.

The assessment gave a user experience score of 96.03% indicating ‘a good degree of user experience’ when using AbC‑19™ antibody test as a self-test. Overall, the participants “perceived the kit to be user-friendly”. Agreement on test results between the lay person performing the test in their own car and professional researchers was 95.85%. Participants outlined opportunities for improving sample collection and findings from the study have already been used to further simplify the AbC-19™ instructions for users to further enhance the user experience.

The full content of both studies can be found here:

1. Robertson LJ, Moore JS, Blighe K, et al Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months. BMJ Open 2021;11:e048142. doi: 10.1136/bmjopen-2020-048142 https://bmjopen.bmj.com/content/11/6/e048142.full
2. Jing M, Bond R, Louise J. Robertson et al, User experience analysis of AbC 19 Rapid Test via lateral flow immunoassays for self administrated SARS CoV 2 antibody testing. Nature Scientific Reports | (2021) 11:14026 | https://doi.org/10.1038/s41598-021-93262-0