Quality Requirements for Reference Intervals and Decision Limits in Clinical Laboratory
10.3969/j.issn.1671-7414.2017.05.040
- VernacularTitle:临床检验参考区间和决定限的质量要求
- Author:
Min DUAN
1
;
jian Hai ZHAO
;
Wei WANG
;
guo Zhi WANG
Author Information
1. 北京医院卫生部临床检验中心北京市临床检验工程技术研究中心
- Keywords:
reference intervals;
decision limits;
quality requirements
- From:
Journal of Modern Laboratory Medicine
2017;32(5):148-151
- CountryChina
- Language:Chinese
-
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 indicators:① 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 measurands:ALP,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.
