Reference information for the clinical laboratory

Background

Accurate reference intervals established in healthy subjects are essential for appropriate interpretation of laboratory test results and to assist clinicians in diagnosis, monitoring, and treatment of disease. To facilitate interpretation of laboratory tests, reference intervals must be appropriately stratified based on key covariates, including age, sex, and ethnicity, which may alter “normal” analyte concentrations. When establishing or implementing reference intervals, it is important to consider the effect of these covariates as well as methodologic and regional variances. Notably, reference intervals may also be method and population dependent; thus reference intervals and clinical decision limits may vary across clinical laboratories. Reference intervals from one laboratory should not be adopted by another laboratory without first ensuring that proper transference and verification protocols have been completed.