Abingdon Health is delighted to announce the UK-RTC has reached design freeze for the AbC-19TM lateral flow test for IgG antibodies to the SARS-COV-2 virus (COVID-19). Achievement of this major milestone led by Abingdon Health’s R&D department means the test meets the required performance characteristics and the production specifications of the assay have now been set. The next stage will see the scale-up of processes in July in readiness for manufacture.
With regards to the test performance, an evaluation of pilot batch products showed a test sensitivity of 100% (95% confidence interval 92.6% to 100%) and specificity of 98.4% (95% confidence interval 95.4% to 99.7%). These figures have been calculated following analysis of a total of 186 samples taken from individuals pre-September 2019 (negatives) and 48 patients who had symptoms of COVID-19, a positive PCR result for the virus or both. Results are from analyses performed at the University of Ulster and Abingdon Health laboratories and follow an earlier analysis at Imperial College, London of 188 positive samples using pre-design freeze devices which showed a 95.7% sensitivity.
If the population is assumed to have a 10% incidence of COVID-19, the AbC-19 pilot batch test shows a 98.6% accuracy.
Additional independent testing of positive and negative samples along with other analytical studies will allow CE marking of the product by Abingdon Health. Work is continuing in parallel with the regulatory authorities to ensure approval of the test as quickly as possible.
This is a major step forward in an extremely complex project that has been completed in a very short time period compared to a normal test development programme. The UK-RTC has been committed to delivering this vital test to the UK public, to assist in the management of COVID-19 infections and aid further understanding of the disease.
Abingdon Health’s CEO, Chris Yates, commented:
“This has been a tremendous company-wide effort at Abingdon Health working with our partners at UK-RTC. Our R&D team have led the process working long hours to achieve this magnificent milestone. I am very proud of their commitment and the team-work across all functions of the company. We will now move the product through to production in July and liaise with our consortium partners for roll out of manufacturing across the UK-RTC.”
Abingdon Health is a technology-enabled lateral flow diagnostics company providing innovative rapid testing solutions to a multi-industry, global client base. Located across 3 UK sites, Abingdon Health provides specialist assay development and Smartphone reader division alongside Europe’s largest lateral flow test manufacturing capacity. By combining a multi-disciplinary approach with precision automation Abingdon Health assures product consistency and security of supply for the most complex of assays and markets. Abingdon Health takes projects from initial concept through scale-up and into high-volume manufacturing in addition to accommodating clients looking to transfer their rapid test from third-party developers or manufacturers.
Abingdon Health is headquartered in York, United Kingdom. Visit www.abingdonhealth.com.