Assessing analytical validity
What is analytical validity?
This refers to the ability of a device to correctly detect or measure a particular chemical substance, also known as an analyte, in clinical samples taken from patients.
When should analytical validity studies be done?
Analytical validity studies should be carried out somewhere around Technology Readiness Level (TRL) 3 to 4. This is early in the development of the diagnostic. These studies should be conducted ahead of, or at the same time as, most other aspects of diagnostic evaluation.
What we do
We can help to:
- Design an appropriate analytical validity study
- Set up the analytical validity study
- Analyse and communicate the results from the analytical validity study
We can also introduce the developer to an appropriate laboratory in our network who can perform the study and has access to clinical samples. This includes the North East Innovation Lab.
Look at the impact and news posts below for examples of our analytical validity work.