CLSI EP49
Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods
CLSI EP49 provides a framework for establishing evidence of a medical laboratory test method’s clinical validity, with a focus on designing clinical performance studies and key measures of clinical performance.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI EP49, Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods provides test developers (both manufacturers and laboratories that create laboratory-developed tests) with a framework for establishing evidence of clinical validity for a medical laboratory test method. Clinical validation is defined and discussed in the context of clinical utility and analytical validation during the establishment of a test method. CLSI EP49 focuses on evaluating clinical validity through a clinical performance study, comparing a candidate test method with a comparator for assessing a target condition based on the test method’s intended use. Purposes and categories of tests are described along with measures of a test method’s clinical performance. Considerations are outlined for components of a study protocol and clinical performance study report, as well as for monitoring clinical validity postlaunch.
Additional topics discussed in CLSI EP49 include obtaining samples for clinical performance studies, use of real-world data, potential biases in subject selection, and ethical considerations.
CLSI EP49, Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods provides test developers (both manufacturers and laboratories that create laboratory-developed tests) with a framework for establishing evidence of clinical validity for a medical laboratory test method. Clinical validation is defined and discussed in the context of clinical utility and analytical validation during the establishment of a test method. CLSI EP49 focuses on evaluating clinical validity through a clinical performance study, comparing a candidate test method with a comparator for assessing a target condition based on the test method’s intended use. Purposes and categories of tests are described along with measures of a test method’s clinical performance. Considerations are outlined for components of a study protocol and clinical performance study report, as well as for monitoring clinical validity postlaunch.
Additional topics discussed in CLSI EP49 include obtaining samples for clinical performance studies, use of real-world data, potential biases in subject selection, and ethical considerations.