Diagnostic Evaluations

We hold a ready and reliable access to a consistent supply of clinical samples through strong working relationships with multiple clinics and clinical laboratories across the UK and internationally.

Our focus is on diagnostic tests offering one or more of the following characteristics:

  • Simple to use, affordable technology
  • Rapid and accurate reporting of results
  • Poly-microbial detection of pathogens
  • Antibiotic resistance/susceptibility profiling

Point-of-care (POC) implementation

Diagnostic evaluations are divided into three stages

1. Assay development & early-stage evaluations

Informing which specimen type(s) to use for the diagnostic test

  • Informing how to process the specimens
  • Determining cross-reactivity with other pathogens
  • Ensuring detection of pathogen sub-types
  • Informing selection and testing of cut-off values
2. Performance characteristics evaluations

The purpose of pre-clinical performance evaluations includes:

  • Pre-clinical determination of sensitivity, specificity, positive and negative predictive values
  • Assessment of clinical performance when used in the field
  • Informing regulatory approvals (e.g. CE-marking)
  • Informing NHS adoption
3. Operational characteristics evaluations
  • Time taken to perform the test in practice
  • Ease of use
  • Training requirements for tests
  • User acceptability
  • Stability of test under user conditions
  • Impact on care pathway

Please see Health Systems Research or contact us for more information

Visit our key publications page for examples of the work we have been involved with. Please contact us if you are interested in conducting a diagnostic evaluation with us or would like to know more.