Evaluation Guidelines for Clinical Laboratory Tests
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*Martin Kroll, Quest Diagnostics 


The CLSI documents offer important guidelines for the planning, design, execution and interpretation of study for the evaluation of clinical laboratory tests as pertain to documenting efficacy and for FDA submissions. EP05-A2 provides guidelines in the evaluation of precision, while EP09-A2 provides information on accuracy of testing methods as regards comparison studies and the quantification of bias. EP21-A provides an assessment of the total analytical error. EP06-A provides a framework for making linearity claims; EP07-A2 discusses the evaluation for interference; while EP14-A2 presents a design for evaluating matrix effects. All of these guidelines are useful for evaluating analytical quality of tests. EP24-A2 concentration of the diagnostic efficacy of laboratory testing through the use of ROC curves.