BBI Solutions OEM Limited of Crumlin at MEDICA 2020 in Düsseldorf -- COMPAMED Trade Fair
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BBI Solutions OEM Limited

Unit 2, Parkway, Pen-y-fan Industrial Estate, NP11 3EF Crumlin
United Kingdom of Great Britain and Northern Ireland
Telephone +44 1495 363000
Fax +44 2920 747242
info@bbisolutions.com

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Contact

Claudio Simone

Group Marketing Manager

David Fraser

Group Product Manager

Neil Polwart

Group Head of Mobile

Patrick McHenry

Sales Director - US

Tyler Ye

Sales Director - APAC

Dominic Hussey

Sales Director - EMEA

Katharina Bonfig

Head of Sales and Marketing - Diarect

Visit us

Unsettled / NN

16.11.2020

Topic

08:00 - 18:00

Meet The Team

The BBI Solutions EMEA, APAC and US teams will be attending virtual.MEDICA this year.

We are looking forward to meeting exhibitors and visitors from across the globe. 

At the BBI Solutions booth, you will be able to view presentations and digital collateral, highlighting our diverse product and services portfolio, including:

+ Custom antibody development
+ Antibodies, antigens and enzymes
+ Gold nanoparticles 
+ Lateral flow assay development 
+ Lateral flow test manufacture
+ Novarum™ Smartphone Diagnostic Platform 
+ Coronavirus Reagents
+ Our extended range of autoimmune, allergy and specific infectious disease products

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17.11.2020

Topic

08:00

Arrange a one to one meeting - Connect with the BBI Solutions Global Teams via the Matchmaking App

Partner with BBI to achieve your assay goals

Our unique combination of custom antibody development, lateral flow assay development & manufacturing services, alongside our patented smartphone reader technology, is shaping the future of lateral flow.

Our comprehensive approach means you need only partner with one company from concept to commercialisation.

Talk to our team today to learn more

Arrange a meeting with a member of our EMEA, US or APAC Teams (listed below) via the MEDICA matchmaking app to learn about

  • Our comprehensive suite of reagents with custom development options
  • Lateral flow development
  • Contract Manufacturing services
  • Smartphone Reader technologies
  • Antibody Development Services
  • Our enhanced range of autoimmune, allergy and specific infectious disease antigen products.
EMEA Team (find us via the Matchmaking app)

Dr Anona Bamford – Lateral Flow Services, Novarum TM Mobile Diagnostic Platform
Regions covered – Scotland, Ireland and Central Europe

Christopher Bauer – Regaents
Regions covered - France and Western Europe

Dr Michael Heimann -Reagents
Regions covered  - DACH Region and Eastern Europe

Ryan Lewis – Reagents
Regions covered – UK and Ireland

Ines Maria Nielsen – Reagents
Regions covered - Northern and Eastern Europe

Dr Lisa Mansell - Lateral Flow Services, Novarum TM Mobile Diagnostic Platform Dr 
Regions covered – Wales, England, Nordics and Southern Europe

US Team

Patrick McHenry – Head of Sales US

Abby Culberson – Monoclonal and Polyclonal Antibodies, Custom Antibody Services

Gerardo Gonzalez – Lateral Flow Services, Contract Manufacturing, NOVARUM TM Mobile Diagnostic Platform

Charles Lee – Reagents

Dan Myhaver - Monoclonal and Polyclonal Antibodies, Custom Antibody Services

Analeany Barrera – Reagents

APAC Team

Tyler Ye - Sales Director

Wing Chung - Business Development

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Our range of products

Product categories

  • 03  Diagnostic tests
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.01  Immuno assay testing
  • 03  Diagnostic tests
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.02  Diagnostic rapid tests
  • 03  Diagnostic tests
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.03  Diagnostic tests for cancer

Diagnostic tests for cancer

  • 07  Medical services and publications
  • 07.16  Certification and testing of medical devices, quality assurance

Our products

Product category: Diagnostic rapid tests, Immuno assay testing

Introducing BBI Solutions -Serving the Science of Diagnostics

BBI Solutions overview

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Product category: Immuno assay testing, Diagnostic rapid tests

BBI Solutions Products and Services

BBI Solutions is serving the life sciences industry through connected core competencies that include a comprehensive suite of reagents with custom development options, lateral flow development, diagnostic manufacturing services and smartphone reader technologies. Leveraging our decades of experience in all stages of diagnostic development for the right solutions, the first time.

Browse the attached Products and Services brochure for an overview of BBI Solutions comprehensive product and service offering including

  • Human Antigens
  • Enzymes
  • Serum & Plasma
  • Antibodies
  • Antibody Development
  • Nanoparticles
  • Gold Conjugates
  • Lateral Flow Assay
  • Development &
  • Manufacture
  • Novarum TM   Smartphone Diagnostic Platform

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Product category: Certification and testing of medical devices, quality assurance

Gold Nanoparticles

With over 25 years’ experience of manufacturing high-quality gold nanoparticles, BBI Solutions is the trusted partner for thousands of researchers, testers and manufacturers worldwide.

Every year, our colloidal gold nanoparticles are used in over 400 million assays and are renowned for offering exceptional levels of assay consistency. This is controlled through tight quality control release specifications in relation to gold nanoparticle size, optical properties, morphology and stability.

In summary, we are known for delivering reliable results, batch after batch.

Our specialist gold nanoparticles range in size from 5nm to 250nm, ensuring that you will always have the highest quality of components you need, regardless of the size or nature of your study. These specialist products have been used by our customers in numerous applications, including:

  • Lateral flow assays
  • SEM, TEM, light and dark field microscopy
  • Catalysts
  • Flow cytometry
  • Biosensors
  • Microarrays
  • SERRS applications

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Product category: Certification and testing of medical devices, quality assurance

Hemoglobin A1C HbA1C

Glycosylated hemoglobin A1c (HbA1c) levels are used as an indicator of blood glucose in diabetic patients. It is formed by the conjugation of a hexose sugar to the beta-chain of hemoglobin A. HbA1c builds up in red blood cells throughout their lifetime and its levels therefore represent a record of blood glucose levels over the previous 8 weeks or so. The hemoglobin A1c subunit has a molecular weight of 18kDa.

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Product category: Certification and testing of medical devices, quality assurance

Alpha 1 anti chymotrypsin

Human α1-Anti Chymotrypsin is a chronic acute phase marker and serine protease inhibitor of 68 kDa and pI between 3.75 and 4.0. ACT can complex with PSA to form the PSA-ACT complex, which is used as an indicator of tumor mass and clinical stage analysis of prostate cancer.

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Product category: Certification and testing of medical devices, quality assurance

Beta-2 Microglobulin (B2M)

Beta 2 Microglobulin is a protein of 12kDa and pI of 5.6. B2M levels can rise either because its rate of synthesis has increased (e.g. in AIDS, malignant monoclonal plasma cell dyspraxia, solid tumors and autoimmune disease) or because of impaired renal filtration (e.g. due to renal insufficiency, graft rejection or nephrotoxicity induced by post-transplantation immunosuppressive therapy).

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Product category: Diagnostic rapid tests

Novarum™ Smartphone Diagnostic Platform

BBI Solutions patented Novarum™ technology transforms a smartphone into a diagnostic test reader, empowering users to read and share the results of rapid tests from the point of care.

Our pioneering technology can be used by anyone, anywhere, with minimal training: connecting patients and doctors, field workers, lab researchers and primary care clinicians to specialist practices as part of a mobile eco-system.

The platform has applications across multiple sectors including human clinical, industrial, food safety, toxicology and veterinary diagnostics.

Novarum holds patents in Europe, the US, China, Japan and Russia and we are also ISO 13485:2016 certified for Medical Device Quality Management Systems.

For more information about our credentials or how we are revolutionising point of care testing please view the video below and dedicated Novarum™ brochure below.

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Product category: Immuno assay testing, Certification and testing of medical devices, quality assurance

Point of Care Testing Capabilities

 BBI Solutions can support your lateral flow development from concept to commercialisation

Our partnership approach allows you to work with one company to reach your assay goals and bring your concept to reality.

Faster Lateral Flow Development

We understand that getting results quickly is critical for both you and your customers. We have a wealth of expertise in the development of highly responsive point-of-care lateral flow assays, with over 250 successful projects to date.

Whether you are looking to develop a new point-of-care assay or improve an existing diagnostic test, we offer end-to-end services to deliver robust and reproducible tests ready for the global market.

Using high-quality raw materials, we’ll rapidly take your assay from concept to creation, supporting you through development and manufacturing.

Our highly skilled and knowledgeable team has many years of experience developing novel immunoassays that comply with the highest quality and regulatory standards. This lateral flow expertise can be paired with our market-leading gold nanoparticle technology (or your nanoparticle of choice) to deliver the very best outcome for your assay, resulting in a product that will give you a competitive edge.

Expertise:

As part of our full service solution, we have expertise in:

  • Sample preparation – including blood separation and experience in using analytes at various concentration
  • Antibody/antigen selection
  • Detector label selection – including gold, latex, paramagnetic and fluorescent particles
  • Numerous conjugation techniques – such as sandwich, competitive and inhibition assays
  • Nitrocellulose membrane selection
  • Test strip architecture and chemistry
  • Reader solutions
Whether you require a complete outsourced service or just an initial feasibility evaluation, we can provide consultation and customised lateral development packages to accommodate most sample matrices, applications and budgets.

Our modular approach means you can select the level of development that suits your needs. For customers looking for a complete ‘turnkey’ assay development, an indicative timeline for a project will take from 12 to 15 months and follows our robust approach.

We’re certified to ISO 13485, and have vast experience of working on lateral flow assay development projects that require FDA approval. A dedicated team of scientists work exclusively on your assay to ensure rapid progress. At the end of the development cycle, we will hand over the design history file, so that you fully own your test.

Talk to us today to learn how we are shaping the future of lateral flow assay development.

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Product category: Immuno assay testing

Lateral Flow Services

For over 25 years BBI Solutions has been a trusted OEM partner for the development and manufacture of lateral flow assays.

The core mission of BBI Solutions is to deliver exceptional service and technologies to improve the quality of life for all people.

With that core value in mind, we have continuously expanded our portfolio of OEM services and brought first to market innovations such as our Novarum mobile diagnostic platform.

The acquisition of Maine Biotechnology Services (MBS) brings to BBI Solutions a technical team with broad
expertise and experience in collaborative project planning ready to create goal-driven development of
antibodies for any application.

Why BBI?

Whether you require the complete outsourced service or just one of our services, we offer a partnership approach which allows you to work with one company to reach your assay goals. We can provide a customised package accommodating most applications or budget, creating a robust and reproducible test ready for the global market. Using high-quality raw materials, we’ll rapidly take your assay from concept to creation, supporting you through every step of development and manufacture.

Our highly skilled and knowledgeable team has many years of experience developing novel immunoassays that comply with the highest quality and regulatory standards. This lateral flow expertise can be paired with our market-leading gold nanoparticle technology (or detector label of your choice) to deliver the very best outcome for your assay, resulting in a product that will give you a competitive edge.

At BBI Solutions, we offer robust and flexible manufacturing options. We cater to routine manufacturing production at a range of production batch sizes and for spiked demand or supply as part of a disaster recovery program. Browse our catalogue for a detailed overview of our suite of OEM services for IVD development.

Our unique combination of custom antibody development, lateral flow development and manufacturing services, signal enhancement technology and our mobile diagnostic platform are shaping the future of lateral flow. Our partnership approach allows you to work with one company to reach your assay goals.

Lateral Flow services include:
  • Antibody Development
  • Lateral Flow Assay
  • Development & Manufacture
  • Reader Technology
  • Mobile Diagnostic Platform
Please see the attached Lateral Flow Services Brochure to find out more.

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Company news

Date

Topic

Download

Oct 10, 2020

Iceni Diagnostics appoint BBI to produce their Covid-19/Influenza test

Original article published on 10/10/2020

Iceni Diagnostics has appointed BBI Solutions to generate clinical trial batches for their new, rapid SARS-COV-2/Influenza virus detection test. The test exploits the diagnostic company’s unique, proprietary HPGR™ (Host-Pathogen Glycan Recognition)  technology to detect the presence of live virus in non-invasive samples within 15 minutes.

The agreement between Iceni Diagnostics and BBI will transfer protocols to standard lateral flow equipment. This work will enable the generation of devices for clinical trials, with the expectation of moving to assay scale-up and manufacturing transfer.

BBI is an ISO 13485 accredited manufacturer and will work with Iceni Diagnostics to deliver the necessary information required for CE marking of the final product. In parallel, similar studies will be undertaken in the US through a comparable program with a US manufacturer.

Professor Rob Field (pictured), CEO of Iceni Diagnostics said: “We are delighted to be working with BBI on our rapid SARS-COV-2/Influenza diagnostic. BBI has a clear understanding of our unique HPGR™ technology, and we are confident they can help us meet our ambitious targets to get product to market as quickly as possible.

“We are excited about the potential of this test.  Our proprietary technology identifies intact virus, unlike most existing tests that identify viral genetic material.  This crucial difference means that a positive result is a key indicator that live, active virus is present, giving a clear signal of current infection, whether the patient has started to show symptoms or not. Significantly, the test may also identify asymptomatic carriers and thus limit virus spread. It will similarly give rapid clearance to those who need to return home or to their school or workplace but who may still be carrying inactive virus particles following infection.

“We are manufacturing a duplex test that differentiates between SARS-COV-2 and Influenza from one sample.  Covid-19 and human flu have similar symptoms so our test will be vital in supporting lockdown decisions during the winter flu season.

“The test is housed in a lateral flow device, with results available within 15 minutes. This makes it ideal to use as a rapid triage option to complement laboratory testing. 

“Much interest is being generated worldwide and Iceni Diagnostics is heavily involved in generating the required investment to rapidly accelerate validation, manufacture and distribution to the global market.”

Dr. Mario Gualano, Chief Executive of BBI Group, said “BBI is delighted to extend our lateral flow development expertise to assist Iceni in translating their HPGR™ technology to market readiness for SARS-Cov2 and Influenza testing.

With BBI’s extensive experience in the In Vitro Diagnostics arena, we are confident that the Iceni Diagnostics technology offers significant potential benefits in pathogen detection while maintaining compatibility with an established, scalable and trusted lateral flow diagnostic platform.

We look forward to working together in further addressing the global challenges presented by COVID-19.”

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Oct 7, 2020

BBI Solutions Confirms UK Government contract for UK-Rapid Test Consortium

Successful independent evaluation from PHE for COVID-19 lateral flow antibody test

CRUMLIN-BASED BBI Solutions, a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market, notes the press release issued by the UK Rapid Test Consortium (“UK-RTC”), of which BBI Solutions is a partner, on the UK Government’s first order for one million COVID-19 lateral flow antibody tests (the “AbC-19™ Rapid test”).

This first order is part of the UK Government’s plans to roll-out COVID-19 surveillance studies to help build a picture of how the virus has spread across the country.

The AbC-19™ Rapid test uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need for a patient sample to be sent to a laboratory.

The test is currently CE-Marked for professional use, and can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. The UK-RTC are seeking approval from the MHRA for self-test use.

The consortium will draw on BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

BBI Solutions is also working closely with healthcare providers to optimise its smartphone diagnostic reader to be used in conjunction with the test. BBI’s patented Novarum technology will guide users at home through performing a test before securely providing the results with their healthcare provider.

The UK-RTC is reproduced in full at the end of this statement.

Dr Mario Gualano, CEO, BBI Solutions, said: “I am delighted that the UK-RTC has now received its first contract from the UK Government for our COVID-19 lateral flow antibody test.

“We believe that the AbC-19™ Rapid test has the immediate opportunity to allow the UK to build a swift and clear picture of how the virus has spread throughout the population. It also has the potential to be deployed in conjunction with vaccine candidates to help assess initial immune responses.”

 
Press Release from the UK-RTC (issued on 6 October 2020):

UK-RTC AbC-19TM Rapid Test receives successful independent PHE evaluation

The UK Government has entered into a contract with Abingdon Health, on behalf of the UK-Rapid Test Consortium (“UK-RTC”), for the supply of the AbC-19TM Rapid Antibody tests. As part of the contract the UK Government has placed its first order for one million COVID-19 rapid antibody tests.

This follows an independent evaluation commissioned by the UK government of the AbC-19TM Rapid Antibody test, which will be published in full in due course by PHE, after peer review.   

The “AbC-19TM Rapid Test”, uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to go to a specialised laboratory. 

The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care.  It has already received the “CE mark”, which indicates health and safety conformity for goods sold in the UK and EU.     

The test will make it possible to build a swift and clear picture of how the virus has spread throughout the UK population. 

It will also be able to help establish the effectiveness of any vaccine which provides protection by creating new antibodies.  This information will be critical to managing current and future outbreaks of COVID-19.

Mass production is already under way. The antibody test will be rolled out under the government’s COVID-19 surveillance studies to help build a picture of how the virus has spread across the country. Surveillance studies are vital to develop our understanding of how antibodies work.

The UK Government helped to set up the UK Rapid Test Consortium and invested in the development of the tests.

Health Minister Lord Bethell said: “This home antibody test developed by our outstanding British scientists and researchers at the UK Rapid Test Consortium will provide critical insight into how the infection has spread, growing our understanding of coronavirus so that we can better respond to it.”

The test detects IgG antibodies to “full trimeric spike proteins” of the SARS-CoV-2 virus.  This means the test detects those antibodies which interfere with the virus’s ability to enter the human cells.

An extensive validation study performed by Ulster University involving over 1000 participant blood samples is currently under peer review for publication.

About the UK-RTC

The UK-Rapid Test Consortium was set up by Abingdon Health to bring together scientists and medical technology manufacturers to be able to deliver millions of test kits as quickly as possible.  By working together, some of the UK’s leading medical technology companies will deliver more volume more quickly to help fight Covid-19.

The UK Government supported the setup of the UK Rapid Testing Consortium and invested in the development of the rapid antibody tests.

The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics, BBI Solutions and CIGA Healthcare.

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Aug 20, 2020

BBI creates new jobs to support next phase in COVID-19 home test development

BBI Solutions is recruiting for roles to support its work as part of a UK Government consortium, tasked with developing and manufacturing a Covid-19 Point of Care antibody test to support the government strategy on COVID-19 testing.

Four months ago, UK Government established the UK-Rapid Test Consortium (UK-RTC), in which BBI Solutions is a partner, to develop a COVID-19 lateral flow antibody test that can be used by people in their homes to determine if they have an antibody response to COVID-19, which would confirm previous infection.

This test together with the Government’s overall strategy on testing and vaccination mark a move towards detecting and eradicating the virus.

The successful completion of the development of the assay means BBI and its UK-Rapid Test Consortium (UK-RTC) partners require more staff to meet production demands in advance of final approval of the test by regulatory authorities.

BBI is investing in multiple roles at its manufacturing headquarters in Crumlin, South Wales, and 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.  

This is a unique opportunity to join a progressive and growing organisation, which is contributing to South Wales and the UK’s resistance to the pandemic.

BBI Group Chief Executive Dr 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.

“This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme.

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

“We are proud to be an integral part of this project and are thrilled with the progress to date.”

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

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Aug 6, 2020

BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer

BBI Solutions is pleased to announce it has 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 (AIM: AVCT) in conjunction with Cytiva.

South Wales 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.

Dr. Mario Gualano, Chief Executive of BBI Group, 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 announced today 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 commented: “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.”

 This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).
Return to news
 BBI Solutions Partners with Avacta Group PLC as COVID-19 Rapid Antigen Test Manufacturer

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Jul 30, 2020

BBI Solutions welcomes consortium CE marking for professional use of its AbC-19™ Rapid Test

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-19TM 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 (The Medicines and Healthcare Products Regulatory Agency.) 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 COVID19, or tested positive for COVID-19, and tested positive by a commercially available Antibody ELISA test (EuroImmunTM). 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-19TM 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 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, 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. The Consortium is now ready to provide this test.

 


 

For further information, contact Lydia Lambert, Effective Communication via llambert@effcom.co.uk and 07890 953402  

Notes to editor:

Companies interested in distribution should register their interest at sales@uk-rtc.com
The “UK Rapid Test Consortium” (UK-RTC) comprises Oxford University, BBI Solutions, Abingdon Health, Omega Diagnostics and CIGA Healthcare.
The UK-RTC is utilising BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

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Apr 23, 2020

BBI Solutions partners with The Native Antigen Company to deliver Coronavirus specific antigens

Original article published on 23/04/2020

BBI Solutions is committed to enabling IVD companies worldwide to source critical reagents for the development of immunoassays.

In the midst of the Global Coronavirus Pandemic, BBI has partnered with The Native Antigen Company to deliver virus-specific antigens. These Coronavirus reagents are added to our complementary product portfolio, which includes enzymes, gold nanoparticles and secondary antibodies. This enhanced offering means that BBI can be your single source in the development of immunological Coronavirus diagnostic kits. BBI will have distribution rights to provide these products in China and will provide further antigen products as they are made available by NAC.

With immediate effect, BBI Solutions, is offering recombinant SARS-CoV Spike 1 and Spike 2 glycoproteins, and nucleoprotein for the 2019 Novel Coronavirus (SARS-CoV-2, Covid-19), and spike 1 glycoprotein for the related SARS-Coronavirus. The antigens are produced in Native Antigen Company’s proprietary expression systems, including their VirtuE (HEK293) expression system to ensure glycosylation and proper folding. All reagents are suitable to support vaccine R&D, diagnostic development, or basic research. 

The COVID-19 antigens and specific antibodies are critical tools for the development of rapid immunological testing kits alongside ancillary reagents and raw materials essential for the method development including secondary antibodies, enzymes and gold nanoparticles that enable Lateral flow-based methods.

Original article published on 23/04/2020

BBI’s global sales and supply chain capabilities will ensure secure distribution of these critical products worldwide, with a particular focus on supply to the Chinese market.

Dr Mario Gualano, BBI Group CEO, said “At this exceptional time when numerous countries are managing additional demands on their health systems, BBI is committed to ensuring products and services are rapidly and effectively available to diagnostic test manufacturers globally. We are delighted to work closely with The Native Antigen Company, to bring their critical immunoassay products to as wide a customer base as possible.”

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About us

Company details

BBI Solutions has been serving the global diagnostics industry for over 50 years, and is the the world’s largest independent producer of immuno-diagnostics reagents.

We develop and manufacture critical components for the diagnostic industry, but also apply our expertise by delivering solutions that bring critical components together in the development and manufacture of point of care and conventional tests.

Furthermore, our Novarum Mobile Diagnostic Platform complements across the diagnostics workflow to interpret and share assay results. This makes BBI unique among IVD suppliers. 

Our range of immuno-diagnostics reagents includes human antigens, antibodies, enzymes and serum & plasma products.

 With manufacturing sites spanning four continents, we produce world-renowned labels for lateral flow, ELISA assay and biosensors, including our high-quality gold nanoparticles and glucose oxidase.

 The acquisition of German-based DIARECT AG in June 2020 established BBI as the leading provider of antigens in the autoimmune and tick-borne IVD markets.

BBI Solutions is part of the BBI Group.
Website: www.bbisolutions.com
E-mail: info@bbisolutions.com
Tel: +44 (0) 1495 363 000

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Company data

Number of employees

100-499

Area of business
  • Electromedical equipment / Medical Technology
  • Diagnostics