PT  - JOURNAL ARTICLE
AU  - Hassan, Wael
AU  - Khatri, Ravina
AU  - Mehta, Shashi
TI  - FDA-approved, Nonwaived Laboratory Tests: Method Validation, Performance Standards, and Biological Variations
AID  - 10.29074/ascls.2018000281
DP  - 2018 Jan 01
TA  - American Society for Clinical Laboratory Science
PG  - 29--31
VI  - 31
IP  - 1
4099  - http://hwmaint.clsjournal.ascls.org/content/31/1/29.short
4100  - http://hwmaint.clsjournal.ascls.org/content/31/1/29.full
SO  - Clin Lab Sci2018 Jan 01; 31
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.