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.

Crumlin based BBI Solutions is a leading global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics market with manufacturing sites in five different countries, spanning four continents.

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 (Medicines and Healthcare Products Regulatory Agency).

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 four hundred and fifty samples taken from individuals pre-September 2019 (negatives) and two hundred and three 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 Covid-19, the AbC-19 Rapid test shows a 99.4% accuracy and is ready for high volume manufacture by the UK-RTC.

As part of its role within the consortium, BBI Solutions’ patented smartphone 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, there was further independent evaluation and performance study approval from the MHRA to facilitate the self-test usability studies to be performed with Ulster University using around two thousand volunteers. Insider Media reports has been successfully concluded, which 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 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. The consortium is now ready to provide this test.

BBI Solutions has also been appointed to manufacture the saliva based rapid SARS-COV-2 antigen test that is being developed by Affimer biotherapeutics and reagents developer Avacta Group plc in conjunction with Cytiva.

Mario Gualano said “BBI are delighted to have been appointed to lead the manufacture of Avacta’s rapid coronavirus antigen test and to be able to further extend our lateral flow expertise to addressing the global challenges presented by COVID-19.

“Our ability to respond rapidly to Avacta’s needs is testament to our team’s diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility.”

The manufacturing agreement between BBI and Avacta comprises accelerated development and validation of a scaled up manufacturing process that has the potential to ramp up to a production capacity of millions of tests per month. Avacta, Cytiva and BBI are in the process of technology transfer of the prototype and related manufacturing procedures for the saliva based rapid Covid-19 antigen test from Cytiva to BBI.

Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK Government’s CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.

Dr Alastair Smith, Chief Executive of Avacta Group, said “I am delighted to be working with BBI to manufacture the rapid coronavirus antigen test. BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get product to market as quickly as possible.

“We anticipate very high demand for the COVID-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand. We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-COV-2 antigen testing in the next few years.

“As we set out in the use of proceeds at the recent fund raising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic Product Development Manager and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins the coronavirus tests and future diagnostic tests in the pipeline.

“The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.

“I am immensely proud of what has been achieved by Avacta’s diagnostics team. It would have been challenging under normal circumstances to have made such progress in just a few months, but with the additional restrictions imposed by COVID-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.

“I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch.”

BBI Solutions is recruiting for multiple roles at its manufacturing headquarters in Crumlin to support its work as part of UK-RTC. These roles will be based in manufacturing, quality control, compliance, technical operations and supply chain.

Given the scale of the potential demand for the test within the UK, the consortium will introduce a phased ramping up in capacity, but is making these key appointments in preparation for ensuring a smooth transition to high volume production at the manufacturing facilities by the end of the year.

Mario Gualano said “Given the difficult times we find ourselves in, we are delighted to announce vacancies. We have always valued our employees and they have been key to the speed at which our work with UK-RTC has progressed. We are pleased to be able to build on our team – these are exciting times for BBI and we envisage these key appointments playing their part in further developments with the Consortium.”

For further details on vacancies, please go to https://www.the-bbigroup.com/careers/our-vacancies/