IVD Evaluation Process

The evaluation of new and existing diagnostic tests will take a phased approach. The diagram below shows the whole process from start to finish, but proposals for the NIHR Leeds In Vitro Diagnostics Co-operative evaluations can be entered at any stage along the pipeline.

Stage 1: Selection, modelling and prioritisation

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

Stage 2: Qualify analytical validity

Verification of technical performance to qualify analytical sensitivity, specificity, precision, parallelism, recovery, selectivity, limit of quantitation and vulnerability to interferences. Pre-analytical and biological source of variance will also be qualified.

Stage 3: Qualify clinical validity

Clinical performance (e.g. sensitivity, specificity, predictive values) reviewed, verified or established using samples from our networks of NHS sites and biobanks.

Stage 4: Evaluations of clinical utility and cost effectiveness

Update pathway model developed in stage 1 with data from stages 2 & 3, pathway outcomes from linked NHS data sets and re-estimation of uncertainties and value information. Where needed Methodologists will make recommendations on research designs and utilise the expertise of the Leeds Clinical Trials Research Unit for running trials of IVDs.

Stage 5: Dissemination of outputs

Dissemination throughout partners to maximise impact and acceleration adoption into the NHS.