CE mark for COVID-19 rapid antibody test welcomed

BBI Solutions has welcomed the UK-Rapid Test Consortium’s (UK-RTC) announcement that their COVID-19 lateral flow antibody test, designed for people to use within their own homes, has received approval to go to market for professional use.

The AbC-19 Rapid Test has been recognised with a CE mark for professional use, after meeting the technical performance for a rapid test as stipulated by the MHRA. This means that the test is now available for commercial distribution for use by professionals.

Dr Mario Gualano, chief executive of BBI Group, said: “We are incredibly pleased that the AbC-19 Rapid test has achieved CE mark for professional use, following the high specificity and sensitivity attained in trial results.

“We remain on track to deliver a test to the UK population that will make a significant difference to the approach needed to manage COVID-19 infections.

“The achievement represents another key milestone for the UK-Rapid Test Consortium, and we are proud to be an integral part of this vital project.”

Three production scale batches of the product have undergone validation and verification, with the devices showing sensitivity of 98.03% (95% confidence interval 95.03% to 99.46%) to test performance and specificity of 99.56% (95% confidence interval 98.40% to 99.95%).

These figures have been calculated following analysis of a total of 450 samples taken from individuals pre-September 2019 (negatives) and 203 patients who had symptoms of COVID-19, or tested positive for COVID-19, and tested positive by a commercially available Antibody ELISA test (EuroImmun). Results are from analyses performed at the Ulster University and Abingdon Health laboratories.

If the population is assumed to have a 10% incidence of COVID19, the AbC-19 Rapid test shows a 99.40% accuracy and is ready for high volume manufacture by the UK-RTC. 

As part of its role within the consortium, Crumlin-based BBI Solutions’ patented smart based reader technology will guide users at home through performing a test before securely sharing the results directly with the NHS.

The process will help ensure that people who have never performed a test like this before get the right result and feel confident in understanding it, while making sure that the NHS receives all data from each test to help plan and manage the disease’s progression.

Following the CE mark accreditation, the next steps for the test include further independent evaluation and to seek performance study approval from the MHRA to facilitate the self-test usability studies to be performed with Ulster University, using around 2000 volunteers. The conclusion of this study will allow UK-RTC to seek allowance (derogation) for self-testing via the MHRA, which is expected in the coming months. 

This complex project has been completed in a very short time period compared to a normal test development programme. The UK-RTC, of which BBI Solutions is a member, 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.