New Generation Graphene-Based PCT/CRP IVD Test to Give Results Within Minutes

The test will be the first in a pipeline of affordable, portable, easy-to-use, graphene-based IVD products, which will at least match the performance of the most advanced hospital laboratory, but at the point of care.

Paragraf (Cambridgeshire, UK) is collaborating with leading UK universities to develop a new generation of graphene-based, in-vitro diagnostic products that will give results within a few minutes. The company is starting a two-year program to develop a proof-of-concept combined PCT (procalcitonin) and CRP (C-reactive protein) test, on a single panel. A clinical study of the combined PCT/CRP test will be delivered at the Diagnostics and Technology Accelerator (DiTA) in mid-2023. DiTA aims to address unmet needs, transform patient care and improve efficiency within the UK NHS, by facilitating the rapid translation and adoption of new innovations into the health and care system. The project is expected to be completed by the end of May 2024.

“This graphene-based diagnostic test is expected to become the first test in the world to give clinicians the ability to identify patients who need an antibiotic treatment within the space of a regular 15-minute clinic appointment. It encourages antimicrobial stewardship by giving clinicians the insight into when not to prescribe antibiotics as the test result differentiates viral from bacterial infections,” said Malcolm Stewart, Paragraf Diagnostics Business Development Director. “Paragraf will go on to deliver a series of high sensitivity, rapid tests for disease biomarkers in areas including cardiovascular disease, oncology, and infectious diseases. The ambition is to develop a comprehensive suite of tests that could be used in almost any environment or healthcare setting. Our tests are designed to provide ultra-fast answers to diagnostic challenges and to reach beyond the concept of point of care testing to create a complete diagnostic toolkit at the point of need.”

“We expect to show that our proposed acute inflammatory marker test will have the capability to deliver accurate results for emergency patient care within a few minutes, from a small sample of blood,” said Paul Dark, Professor of Critical Care Medicine at The University of Manchester. “The accuracy of the test is envisaged to be at least comparable with hospital centralized lab-based immunoassay (antibody) tests which can take hours to provide results back to emergency services.”

“The main benefit of a single PCT and CRP test is that a combined test increases confidence in the accuracy of the result when discriminating between bacterial and other infections,” said Dr. Tim Felton, Director of DiTA. “An accurate test able to provide results that can guide antibiotic therapy in real time is becoming a critical tool in the fight against antibiotic resistance.”

“This technology reduces the time and complexity of sample preparation which, together with its rapid measurement speed, provides clinicians with accurate results in a timeframe that allows immediate decisions to be made on antimicrobial prescribing. This is especially important for the treatment of children and neonates,” added Professor Enitan Carrol, Professor of Paediatric Infectious Diseases at the University of Liverpool.

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