Evaluation of Diagnostic Accuracy of Laboratory Tests Using CLSI EP24-A2 Receiver Operating Characteristic Curves

This standard outlines the steps and principles of prospectively planned and retrospective studies to assess the intrinsic diagnostic accuracy of a clinical laboratory test, defined as the essential ability to accurately distinguish between alternative health conditions. It is not intended to help determine how best to use a diagnostic test in clinical practice, but rather to determine how accurate a laboratory test is in terms of diagnostic sensitivity and specificity.

The receiver operating characteristic (ROC) curve methodology emerged in the early 1950s in response to needs in electronic signal detection and problems with radar. It is derived from conditional probabilities as first formulated by Bayes. This standard aims to describe ROC curves and explain how to design, construct, interpret and apply information from ROC studies to evaluate diagnostic tests. For simplicity, only continuous scales diagnostic tests, such as those typical for in vitro, are discussed.

The clinical condition that the test is intended to detect must be verifiable by some means other than the test under investigation. In other words, there must be an independent clinical reference standard against which the test can be compared. By choosing thresholds between positive and negative diagnoses across the continuous scale of the test, the diagnostic results for these decision levels are compared to the actual clinical situation, which creates the ROC curve.

This standard will be valuable to a wide range of potential users, including:

• Researchers developing new tests for specific applications;
• Reagent and instrument manufacturers to perform tests interested in evaluating or verifying test performance for diagnostic accuracy;
• Regulatory bodies interested in establishing requirements for diagnostic accuracy claims;
• Clinical laboratory workers reviewing data or literature, or to create their own data, to decide which tests to use in their laboratories;
• Healthcare professionals or science professionals interested in the critical evaluation of submitted data on clinical test performance.

EUROLAB assists manufacturers with CLSI EP24-A2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.