FDA-approved, Nonwaived Laboratory Tests: Method Validation, Performance Standards, and Biological Variations

ABSTRACT Laboratory Medicine is described as the use of clinical laboratory tests to make diagnostic decisions. Laboratory tests are used to diagnose or confirm a specific condition or disease, monitor a patient’s condition or response to treatment, and to aid in the early detection and determine the prognosis of disease. During the earliest years of laboratory medicine, clinical pathologists manually performed, interpreted, and communicated test results to physicians. However, the continuous advancement of medicine has demanded advanced methodologies and laboratory testing to be researched, developed, clinically evaluated, and ultimately performed by laboratory professionals. This article describes the process and guidelines for implementing new laboratory tests into clinical laboratories.