Abingdon Healt. Regulatory News (ABDX)

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

York, U.K. 09 July 2021: Abingdon Health plc ("the Company"), a leading international developer and manufacturer of high quality and effective rapid tests, welcomes the recent 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:

· In the first study:

o Excellent laboratory validation performance metrics for the AbC-19™ rapid test for SARS-CoV-2 spike protein IgG antibody detection and semi-quantitative correlation with laboratory ELISA methods assaying IgG antibodies to the spike protein of the SARS-CoV-2 virus.

o AbC-19™ showed sensitivity of 97.58% and specificity of 99.59% when using evaluation methods as defined by the MHRA for Target Product Profile of an antibody test.

o In addition, the study notes that IgG antibodies to the SARS-CoV-2 virus were detected 10 months after infection. Understanding the longevity of COVID-19 antibodies is important both immunologically and in helping to guide pandemic exit protocols.

· Positive user experience score from 1,544 participants who used AbC-19™ as a 'self-test' in the second study.

Chris Yates, Chief Executive Officer of Abingdon Health commented: "We welcome the findings of these peer-reviewed studies which demonstrate that the AbC-19™ test is highly sensitive, specific, and user-friendly. As we move to the next stage of the pandemic with several vaccines now being administered, understanding and monitoring the response and longevity of antibodies can be a powerful tool for public health authorities, governments and individuals, enabling them to monitor immunity levels in surveillance studies, to efficiently deploy financial resources for ongoing vaccine programmes as well as potentially assess which individuals should be prioritized in vaccination or vaccine booster programmes. The use of semi-quantification of LFT results opens further possibilities."

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 1,544 participants of mixed age and gender in Northern Ireland in September 2020, 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

(published 29 June 2021)

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

(published 07 July 2021)

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About Abingdon Health

Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19. Abingdon is the partner of choice for a growing global customer base and takes projects from initial concept through to routine and large-scale manufacturing and has also developed and marketed its own labelled tests.

The Company offers product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing. Faster access to results allows for rapid decision making, targeted intervention and can support better outcomes. This ability has a significant role to play in improving life across the world. To support this aim Abingdon Health has also developed AppDx®, a customisable image capturing technology that transforms a smartphone into a self-sufficient, standalone lateral-flow reader.

Founded in 2008, Abingdon Health is headquartered in York, England.

https://www.abingdonhealth.com/