5.2.18 Evaluation of diagnostic tests Estimated reading: 1 minute 1783 views Purpose and goal The quality characteristics of diagnostic tests (e.g. accuracy, repeatability, sensitivity, specificity) should be determined. Application Description of the process Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2.18 Evaluation of diagnostic tests - Previous 5.2.17 Verification of laboratory methods Next - 5.2.18 Evaluation of diagnostic tests 5.2.19 Software validation