[1]吴 风,孔丽蕊,张 艳,等.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[J].现代检验医学杂志,2024,39(04):203-207+212.[doi:10.3969/j.issn.1671-7414.2024.04.037]
　WU Feng,KONG Lirui,ZHANG Yan,et al.Analytical Performance Specifications for Routine Items of Biochemical Inspection Based on EQA and IQC Data in Clinical Laboratory[J].Journal of Modern Laboratory Medicine,2024,39(04):203-207+212.[doi:10.3969/j.issn.1671-7414.2024.04.037]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第39卷
期数:
2024年04期
页码:
203-207+212
栏目:
质量控制·实验室管理
出版日期:
2024-07-15

文章信息/Info

Title:
Analytical Performance Specifications for Routine Items of Biochemical Inspection Based on EQA and IQC Data in Clinical Laboratory
文章编号:
1671-7414（2024）04-203-06
作者:
吴 风1; 2; 孔丽蕊1; 2; 张 艳1; 2; 何大海1; 2; 黄 英1; 2; 周朝琼1; 2; 刘燕群1; 2; 余 林1; 2
（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）
Author(s):
WU Feng1; 2; KONG Lirui1; 2; ZHANG Yan1; 2; HE Dahai1; 2; HUANG Ying1; 2; ZHOU Chaoqiong1; 2; LIU Yanqun1; 2; YU Lin1; 2
（1.Department of Clinical Laboratory, Traditional Chinese Medicine Hospital of Chengdu Pidu District, Chengdu 611730, China; 2. Department of Clinical Laboratory, the Third Affiliated Hospital of Chengdu University of Chinese Medicine, Chengdu 610031, China）
关键词:
生物学变异; 允许总误差; 允许不精密度; 允许偏移; 分析性能规范; 生物化学检验项目
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2024.04.037
文献标志码:
A
摘要:
目的 基于室间质量评估（external quality assessment，EQA）和室内质量控制（internal quality control，IQC）数据，设定生物化学检验常规项目分析性能规范（analytical performance specifications，APS）。方法 收集成都市郫都区中医医院检验科2021 ～ 2023 年参加国家卫生健康委员会临床检验中心生物化学检验常规项目EQA 和IQC 数据，将EQA 数据的百分差值与IQC 在控不精密度[ 以变异系数（coefficient of variation，CV）表示] 与基于生物学变异（biologicalvariation，BV）导出的三个标准进行比较，计算EQA 数据百分差值通过率和在控CV 通过率，以达到80% 及以上为该水平质控品的APS 设定为实验室常规生化检验项目的质量目标。对于未达到BV 导出三个标准APS 或达到标准而不适用的检验项目，采用WS/T 403-2012 行业标准或基于当前技术水平设定APS。结果 生物化学检验常规项目推荐的TEa/ 允许CV 分别为：钾（K）2.4% / 1.9%，钠（Na）4.0% / 0.9%，氯（Cl）4.0% / 0.9%，钙（Ca）3.4% / 1.8%，磷（P）9.6% / 1.9%，镁（Mg）3.8% / 2.0%，血糖（Glu）6.1% / 2.3%，肌酐（Crea）3.9% / 2.2%，尿素（Urea）8.6% / 3.3%，总蛋白（TP）4.9% / 2.0%，清蛋白（Alb）3.3% / 1.9%，总胆红素（TBil）6.3% / 2.4%，丙氨酸氨基转移酶（ALT）9.3%/ 2.9%，天门冬氨酸氨基转移酶（AST）6.2% / 2.1%，γ- 谷氨酰基转移酶（GGT）9.2% / 2.1%，乳酸脱氢酶（LDH）6.8%/ 2.2%，碱性磷酸酶（ALP）7.2% / 3.3%，总胆固醇（TC）8.3% / 2.6%，三酰甘油（TG）12.9% / 4.9%，淀粉酶（AMY）5.9% / 1.6%，肌酸激酶(CK)4.3% / 1.6% 和尿酸（UA）2.9% / 1.0%。结论 基于BV 或当前技术水平设定的APS 可作为实验室生物化学检验常规项目的质量目标，实验室根据实际情况选择适合自己的APS。
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.

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备注/Memo

备注/Memo:
基金项目： 成都中医药大学“杏林学者”医院专项课题（XJ2023013901），成都市医学科研课题（2022376）。
作者简介：吴风（1982-），男，本科，主管技师，研究方向：临床生化检验及实验室质量管理，E-mail：804648906@qq.com。
通讯作者：余林（1975-），男，本科，主任技师，研究方向：卫生监测检验及临床实验室管理，E-mail：746852945@qq.com。
更新日期/Last Update: 2024-07-15