Predictive value

Predictive values combine test performance with how common the condition is in the tested population. An IVD's predictive values hold for a defined population and do not carry over to a different one without adjustment.

‘predictive value’ means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition;

IVDR, Article 2(51)