Development and clinical validation of a 2nd generation rapid blood test with improved usability and performance for identification of stroke patients eligible for emergency thrombectomy treatment.

Background: Large Vessel Occlusion (LVO) stroke is a major cause of disability, mortality and care costs. Emergency time-critical thrombectomy significantly improves outcomes, but as many treatable patients require lengthy transfers from a local hospital to specialist regional centres, real world clinical and cost effectiveness is sub-optimal. This situation may be improved if ambulance staff could recognise LVO and directly admit patients to regional hospitals but currently there is no accurate assessment or test available for this purpose. Upfront Diagnostics have developed LVOne , a rapid portable blood test for early detection of LVO comprising two clinical-read lateral flow tests (LFT). Evaluation in a large multi-site hospital study has demonstrated potential for accurate LVO diagnosis, but before implementation in NHS ambulances the test requires further technological improvements to i) decrease user errors and ii) automatise results reading/interpretation. Aims and Objectives: This project aims to develop, clinically validate and bring to market a next generation LV2 test. Specific objectives are: (1) Develop an LV2 prototype with improved usability and performance; (2) Produce high-quality LV2 batches for clinical performance evaluation; (3) Evaluate clinical performance of LV2 in an appropriate target patient population in the NHS (4) Evaluate ambulance usability and implementation feasibility of LV2; (5) Prepare regulatory approval documentation; (6) Seek advice and feedback from patient and public involvement (PPI). Methods: The project will employ a multi-faceted approach through parallel work packages, encompassing: (1) Iterative LV2 prototype development comprising: Development of a unified, multiplex lateral flow test, leveraging a user-friendly market-approved all-in-one device (LV2-LFT); Development of a digital reader App for automatic AI-driven LFT interpretation (LV2-App); (2) Production of evaluation batches and analytical verification of the LV2 system according to international standard requirements; (3) A prospective clinical diagnostic accuracy study in six NHS hospitals will deploy LV2 on 485 patients with suspected stroke and analyse results against independently adjudicated reference standard. (4) A simulation exercise of LV2 use by ambulance personnel to collect views on usability and implementation barriers; (5) Preparation of regulatory documentation for UKCA/CE marking; (6) Regular patient and public involvement throughout the study including engagement with established public research panels and community groups. Timelines for delivery: M1-13: Iterative LV2 prototype development; M13-18 Production and verification of LV2; M11-36 Clinical diagnostic accuracy study (set up, enrolment, analysis); M21-26 Ambulance simulation exercise; M1-36 regulatory documentation preparation; M1-36 PPI. Anticipated Impact and Dissemination: This project is expected to deliver a clinically validated, ambulance-deployable LV2 test, with improved performance for LVO detection. This will facilitate direct admission of selected patients to thrombectomy hospitals which will result in: 6,000 patients being treated/having faster access to thrombectomy, improving outcomes £35 million/year saved in direct healthcare costs plus additional social care savings Fewer emergency ambulance transfers Equitable access to NICE-recommended thrombectomy Results will be disseminated through peer-reviewed publications, conference presentations, and reports to NHS Integrated Stroke Delivery Networks, and pre-hospital care guideline groups. Public awareness will be promoted through media outputs from stroke advocacy organisations.