Summary
Health Innovation Oxford and Thames Valley (HIOTV) performed a feasibility study of InfectiClear Rapid, a rapid molecular diagnostic designed to support early rule out of infection in emergency and acute care settings, developed by Presymptom Health. Using HIOTV’s Lean Assessment Process (LAP) methodology, semi-structured interviews were conducted with clinicians across nine NHS trusts to explore unmet needs, perceived usefulness, barriers to adoption, and practical pathway fit.
The interviews captured clinicians’ perspectives on where a rapid diagnostic could add value within complex decision-making pathways, and explored current sources of diagnostic uncertainty, antibiotic prescribing challenges, and discharge processes. They also identified practical considerations relevant to future development and NHS adoption, including evidence requirements, workflow integration, and usability needs.
What is the challenge?
Suspected infection is a frequent reason for emergency attendance, yet existing diagnostics often leave clinicians uncertain. Blood cultures can take days, while biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) lack specificity, contributing to non-targeted or unnecessary antibiotic use, which increases antimicrobial resistance and exposes patients to avoidable treatment risks, as well as potentially avoidable hospital admissions. These patterns drive considerable cost through longer hospital stays, repeated assessments, and unnecessary testing and treatment. InfectiClear Rapid aims to provide a faster result, helping to confirm or rule out infection earlier in the pathway, thereby reducing avoidable admissions and associated healthcare costs, and decreasing reliance on empirical antibiotic treatment in the absence of definitive diagnostic evidence.
What did we do?
HIOTV carried out the feasibility study using its LAP methodology to understand the unmet needs and barriers to adoption in acute and emergency care settings. This included designing interview materials, engaging stakeholders across nine NHS organisations and analysing feedback from clinicians working in urgent infection pathways. The outputs shaped an evidence-informed view of pathway fit, clinical priorities and areas where the test may add greatest value. Patient and public involvement activity has been included as part of the wider InfectiClear programme. Discussions with individuals who have lived experience of infection and sepsis were used to understand patient perspectives and ensure that user needs inform ongoing development.
Impacts
The findings showed strong clinical interest in the innovation. Clinicians felt that an accurate, rapid local laboratory infection rule-out test could help reduce diagnostic uncertainty, guide decisions around antibiotics and admission, and improve patient flow. They also described potential operational benefits, noting that earlier clarity could reduce repeated reviews, support appropriate and targeted use of antibiotics, and help staff prioritise higher-risk cases. This feasibility work enabled InfectiClear to refine its positioning and focus on priority pathway applications for future research.
Health and care system success
If accuracy and performance are confirmed, InfectiClear Rapid could help improve the infection and sepsis pathway by enabling earlier and more consistent decision-making. Clinicians suggested that this could reduce unnecessary admissions, shorten stays and support safer discharge, helping to relieve pressure on emergency services and enhance patient experience.
Economic success
While this phase did not include economic modelling, clinicians recognised the potential for system efficiencies through fewer avoidable hospital admissions, more appropriate antibiotic use and more efficient use of clinician time. Future economic analysis may help quantify these gains and support commissioning decisions.
Lessons learned
The feasibility work highlighted several conditions important for NHS adoption. Turnaround time was seen as critical, with most clinicians expecting results within 30–60 minutes to influence real-time decisions. Integration with existing workflows and digital systems will be essential to avoid increasing the burden on clinical teams. Clinicians also emphasised the need for strong diagnostic accuracy to build confidence and support widespread uptake.
In addition, several stakeholders noted that demonstrating cost-effectiveness will be an important factor for future commissioning decisions, particularly in showing value relative to existing diagnostic processes and hospital resource use. These lessons will guide future research, accuracy testing and commercial planning.
Next steps
The feasibility evaluation provides a strong foundation for InfectiClear’s next phase of evidence generation. Stakeholders recommended progressing to multi-centre diagnostic accuracy trials to determine real-world performance, followed by a full economic evaluation to support future business cases. As development continues, the company will also need to explore workflow integration, usability and the potential for point-of-care deployment. The insights gathered through the feasibility study position InfectiClear well for these next steps and strengthen its readiness for further clinical validation.
What they said
“Working with the HIOTV team on this feasibility study has been an extremely positive experience. Their responsiveness, clarity and willingness to engage deeply with the technical and clinical questions we faced made the collaboration both efficient and genuinely constructive. The study has provided us with valuable insights that directly support our decision-making around assay optimisation, platform transfer and early clinical deployment.”
“The feasibility work has already helped shape our development roadmap and strengthened our strategic planning for point-of-care integration. The expertise and partnership approach from HIOTV ensured we were able to interrogate key assumptions early, identify technical risks and build confidence in the direction of travel for InfectiClear.”
Nadia Whittley, CEO – Presymptom Health