Quality Requirements for Reference Intervals and Decision Limits in Clinical Laboratory / 现代检验医学杂志

ABSTRACT

Reference intervals and decision limits are critical parts of the clinical laboratory report.The evaluation ot their correct use represents a tool to verify the post analytical quality.Four elements are identified as indicators① The use of decision limits for lipids and glycated hemoglobin.② The use of common reference values.③The presence of gender-related reference intervals for at least the following common serum measurands (besides obviously the fertility relate hormones)alkaline phosphatase (ALP),alanine aminotransferase (ALT),creatine kinase (CK),creatinine,gamma-glutamyl transferase (GGT),IgM,ferritin,iron,transferrin,urate,red blood cells (RBC),hemoglobin (Hb) and hematocrit (HCT).④) The presence of age-related reference intervals.The problem of specific reference intervals for elderly people is discussed,but their use is not recommended.On the contrary it is necessary the presence of pediatric age-related reference intervals at least for the following common serum measurandsALP,amylase,creatinine,inorganic phosphate,lactate dehydrogenase,aspartate aminotransferase,urate,insulin like growth factor 1,white blood cells,RBC,Hb,HCT,alfafetoprotein and fertility related hormones.The lack of such reference intervals may imply significant risks for the patients.