CAP ’13 – THE Pathologists’ Meeting – October 13 – 16, 2013™
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ST109  How to Validate a New Test

Tuesday, October 15
10:30–11:30 AM

CAP SAMs Practice-Based Learning and Improvement Patient Care

Laboratories must validate the technical performance of tests before use on patient samples; but with laboratory testing conducted in a variety of clinical settings—from core laboratories to physician office and mobile vehicles—method validation can be challenging. Newer point-of-care devices and automated instrumentation are also challenging to validate, given the spectrum of different methodologies, device operation, and clinical applications of the test results. The presenter will review regulatory requirements for technical performance (precision, accuracy, reportable range, reference intervals, and other specifications) and offer practical suggestions to validate tests. Using real-world examples, faculty will highlight the importance of method validation to patient care and clinical consultation. Following this session, participants may complete a related online self-assessment module, available at through December 31, 2013.

You will learn to:

James H. Nichols, PhD, D(ABCC)





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