RT Journal Article
SR Electronic
T1 FDA-approved, Nonwaived Laboratory Tests: Method Validation, Performance Standards, and Biological Variations
JF American Society for Clinical Laboratory Science
JO Clin Lab Sci
FD American Society of Chemistry and Laboratory Science
SP 29
OP 31
DO 10.29074/ascls.2018000281
VO 31
IS 1
A1 Hassan, Wael
A1 Khatri, Ravina
A1 Mehta, Shashi
YR 2018
UL http://hwmaint.clsjournal.ascls.org/content/31/1/29.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 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.