RT Journal Article SR Electronic T1 FDA Approved, Non-waived Laboratory Tests: Method Validation, Performance Standards & Biological Variations JF American Society for Clinical Laboratory Science JO Clin Lab Sci FD American Society of Chemistry and Laboratory Science SP ascls.118.000281 DO 10.29074/ascls.118.000281 A1 Hassan, Wael A1 Khatri, Ravina A1 Mehta, Shashi YR 2018 UL http://hwmaint.clsjournal.ascls.org/content/early/2018/03/01/ascls.118.000281.abstract AB 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 patient condition or disease, monitor a patientÂ’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.