Historical
CLSI C28-P3
Defining , Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Proposed Guideline-Third Edition
Focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies to determine reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another. FDA
Clinical And Laboratory Standards Institute [clsi]