CLSI - GP10-A
Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
|Publication Date:||1 December 1995|
This guideline outlines the steps and principles for designing a prospective study to evaluate the intrinsic diagnostic accuracy of a clinical laboratory test, i.e., its fundamental ability to discriminate correctly among alternative states of health expressed in terms of sensitivity and specificity. Each of the steps is discussed in detail, along with its rationale and suggestions for its execution. These same concepts can be used in critical evaluations of data already generated.