Our IVD Evaluation Process

About us

Developing and evaluating in vitro diagnostic product ideas and innovations

For a new in vitro diagnostic (IVD) test to be adopted and used by the NHS, there needs to be evidence that it offers a benefit over the test/s currently used.  

We act as a bridge between our network of academics, healthcare professionals, commercial companies, and local infrastructure to support developers of new IVDs in generating this evidence. 

After gaining insight into your current stage of development, we will help you identify the gaps and design the studies required to achieve the vision for your product. 

An example of the seven-stage evaluation process is described below: 

Discovery – what do we need and why?

  • Identifying an unmet diagnostic need or an idea for an innovation that addresses an unmet diagnostic need.


Selection, modelling and prioritisation – does the test meet the need?

  • Selection of proposals against clinical priorities.
  • Rapid evaluation for quality against pre-defined criteria, such as relevance to NHS priorities, potential economic benefit, and impact on NHS care pathways.
  • Pathways modelling to identify clinical decision outputs.


Qualification of analytical validity – is it measuring what we think it’s measuring?

  • Verification of technical performance to qualify analytical sensitivity, specificity, precision, parallelism, recovery, selectivity, limit of quantitation, and vulnerability to interferences.
  • Qualification of pre-analytical and biological source of variance.


Qualification of clinical validity – how accurate is it at detecting the condition of interest?

  • Review, verification, and establishment of clinical performance (e.g. sensitivity, specificity, predictive values) using samples from our NHS sites and biobanks.


Evaluation of clinical utility and cost effectiveness – how does it work in practice to change health outcomes?

  • Updating of pathway model developed in Stage 1, with data from Stage 2 and Stage 3, pathway outcomes from linked NHS data sets, and re-estimation of uncertainties and value information.
  • Where needed, methodologists will make research design recommendations and Leeds Clinical Trials Research Unit expertise will facilitate IVD trial delivery.


Dissemination of outputs: communicating our findings 

  • Dissemination throughout partners to maximise impact, and acceleration adoption in the NHS.


Adoption: getting into NHS use 

  • This process will ensure you have developed a product that is ideally placed for adoption within the NHS.