CLSI Publishes Revised Guideline: Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves

Wayne, Pennsylvania, USA-December 2011-The Clinical and Laboratory Standards Institute (CLSI) recently published an updated guideline entitled Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline-Second Edition (EP24-A2). This document provides a protocol for evaluating the accuracy of a test to discriminate between two subclasses of subjects when there is some clinically relevant reason to separate them. In addition to the use of receiver operating characteristic (ROC) curves and the comparison of two curves, the document emphasizes the importance of defining the question, selecting the sample group, and determining the "true" clinical state.

"This guideline explains how to evaluate the usefulness of clinical laboratory tests using ROC curves. In the current resource-constrained environment, laboratories will need to use robust tools to assess the usefulness of tests, whether they are performed in-house or sent out to a reference laboratory," explains Martin H. Kroll, MD, Chief, Department of Laboratory Medicine, Boston Medical Center, Boston, Massachusetts, USA, and Chairholder of the document development committee. "EP24 describes how to select the data, create ROC curves, and interpret the results. This version of the guideline explains both qualitative and quantitative interpretations of ROC curves and provides an in-depth discussion of the quantitative calculations."

This guideline will be of value to a wide variety of possible users, including:

  • Investigators who are developing new tests for specific applications
  • Manufacturers of reagents and devices for performing tests who are interested in assessing or validating test performance in terms of diagnostic accuracy
  • Regulatory agencies interested in establishing requirements for claims related to diagnostic accuracy
  • Clinical laboratorians who are reviewing data or the literature, and/or generating their own data, to make decisions about which tests to employ in their laboratories
  • Health care or scientific workers interested in critical evaluation of data being presented on clinical test performance

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information, visit the CLSI website at  or call 610.688.0100.

Amanda Holm
Senior Marketing Manager
610.688.0100 ext. 5935
[email protected]