Analytical Performance Specifications for Routine Items of Biochemical Inspection Based on EQA and IQC Data in Clinical Laboratory
10.3969/j.issn.1671-7414.2024.04.037
- VernacularTitle:临床实验室基于EQA和IQC数据设定生物化学检验常规项目分析性能规范
- Author:
Feng WU
1
,
2
;
Lirui KONG
;
Yan ZHANG
;
Dahai HE
;
Ying HUANG
;
Chaoqiong ZHOU
;
Yanqun LIU
;
Lin YU
Author Information
1. 成都市郫都区中医医院检验科,成都 611730
2. 成都中医药大学附属第三医院检验科,成都 610031
- Keywords:
biological variation;
allowable total error;
allowable imprecision;
allowable bias;
analytical performance specifications;
biochemical inspection items
- From:
Journal of Modern Laboratory Medicine
2024;39(4):203-207,212
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the analytical performance specifications(APS)for routine items of biochemical inspection based on the external quality assessment(EQA)and internal quality control(IQC)data.Methods The EQA data and IQC data of routine items of biochemistry inspection in clinical laboratory center of national health commission from 2021 to 2023 were collected from the Department Clinical Laboratory of Traditional Chinese Medicine Hospital of Chengdu Pidu District.Comparing the percentage difference of the EQA data and the IQC in control imprecision[expressed as the coefficient of variation(CV)]data with the 3-level evaluation criteria derived based on biological variation(BV),the percentage pass rate of EQA data and the pass rate of CV under control were calculated,so as to achieve the quality target of APS with 80％or more as the quality control product of this level as the routine biochemical test items of the laboratory.For the inspection items that did not reach BV standard APS or were not applicable to meet the standard,the APS would be set to the WS/T 403-2012 industry standard or based on current technical level.Results TEa/allowable CV of biochemical inspection items were as follows:Potassium(K)2.4％/1.9％,Sodium(Na)4.0％/0.9％,Chloride(Cl)4.0％/0.9％,Calcium(Ca)3.4％/1.8％,Phosphate(P)9.6％/1.9％,Magnesium(Mg)3.8％/2.0％,Glucose(Glu)6.1％/2.3％,Creatinine(Crea)3.9％/2.2％,Urea(Urea)8.6％/3.3％,Total protein(TP)4.9％/2.0％,Albumin(Alb)3.3％/1.9％,Total bilirubin(TBil)6.3％/2.4％,Alanine transaminase(ALT)9.3％/2.9％,Asparpartate transaminase(AST)6.2％/2.1％,γ-glutamyl transferase activity(GGT)9.2％/2.1％,Lactate dehydrogenase(LDH)6.8％/2.2％,Alkaline phosphatase(ALP)7.2％/3.3％,Total cholesterol(TC)of 8.3％/2.6％,Triglyceride(TG)12.9％/4.9％,Amylase(AMY)5.9％/1.6％,Creatine kinase(CK)4.3％/1.6％and Uric acid(UA)2.9％/1.0％.Conclusion The APS set based on BV or current technical level can be used as a quality target for routine laboratory clinical biochemistry testing programs,and the laboratory can select the suitable APS according to the actual situation.
