5.2.18 Evaluation of diagnostic tests Estimated reading: 1 minute 128 views Authors 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 Analysis and validation - Previous 5.2.17 Verification of laboratory methods Next - 5.2 Analysis and validation 5.2.19 Software validation
