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中华临床实验室管理电子杂志 ›› 2021, Vol. 09 ›› Issue (03) : 133 -137. doi: 10.3877/cma.j.issn.2095-5820.2021.03.002

质量控制

基于六西格玛模式评价糖化血红蛋白的分析性能及质控策略的设计
刘倩1, 付梅1, 姚丽1, 孙瑾1, 梁伟1, 杨伏猛1,()   
  1. 1. 222006 江苏连云港,连云港市第二人民医院检验科
  • 收稿日期:2020-09-02 出版日期:2021-08-26
  • 通信作者: 杨伏猛
  • 基金资助:
    江苏省卫健委科研面上项目(M2020079); 江苏省连云港市卫生科研计划项目(201817); 南京医科大学康达学院科研发展基金重点项目(KD2019KYJJZD010)

Design of analysis performance and quality control strategy for evaluating HbA1c based on six sigma model

Qian Liu1, Mei Fu1, Li Yao1, Jin Sun1, Wei Liang1, Fumeng Yang1,()   

  1. 1. Department of Clinical Laboratory, The Second People's Hospital of Lianyungang, Lianyungang Jiangsu 222006, China
  • Received:2020-09-02 Published:2021-08-26
  • Corresponding author: Fumeng Yang
引用本文:

刘倩, 付梅, 姚丽, 孙瑾, 梁伟, 杨伏猛. 基于六西格玛模式评价糖化血红蛋白的分析性能及质控策略的设计[J/OL]. 中华临床实验室管理电子杂志, 2021, 09(03): 133-137.

Qian Liu, Mei Fu, Li Yao, Jin Sun, Wei Liang, Fumeng Yang. Design of analysis performance and quality control strategy for evaluating HbA1c based on six sigma model[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2021, 09(03): 133-137.

目的

应用六西格玛(6σ)模式评价糖化血红蛋白(HbA1c)的分析性能,并初步建立HbA1c项目的室内质控策略和质量改进措施。

方法

收集本实验室HbA1c项目2020年国家卫健委临床检验中心室间质评数据及2020年1月至6月两个浓度水平的室内质控数据,并结合四个不同来源的允许总误差(TEa)分别计算HbA1c项目的σ水平,同时应用标准化的西格玛性能验证图进行标示。依据具有批长度的Westgard西格玛规则流程图和质量目标指数(QGI),制定HbA1c项目的室内质控策略和质量改进方案。

结果

基于西班牙室间质评标准和德国RiliBAK标准作为质量目标时,HbA1c的分析性能均处于“世界一流”水平;而基于“适当”生物学变异和我国室间质评标准作为质量目标时,HbA1c的分析性能分别处于“不可接受”和“优秀”水平。本研究依据我国室间质评标准作为质量目标,同时结合具有批长度的Westgard西格玛规则,初步建立以下质控策略:选择13s/22s/R4s多规则(N=2)且分析批长度为450个患者的样本作为HbA1c的室内质控方案。且QGI计算结果显示,HbA1c项目的偏倚是影响其分析性能的主要因素,需优先在正确度的提升方面制定相应的改进措施。

结论

6σ模式能够客观评价HbA1c项目的分析性能,且在实验室质控策略的设计和检测质量的改进方面具有重要的指导意义。

Objective

The six sigma model was used to evaluate the analytical performance of glycosylated hemoglobin (HbA1c), and the internal quality control (IQC) strategy and quality improvement measures for the HbA1c was initially established.

Methods

The data of external quality assessment (EQA) of HbA1c from National Center for Clinical Laboratories (NCCL) in 2020 and its IQC data of the two concentration levels from January to June 2020 were collected. And based on the allowable total error (TEa) from four different sources to calculate the sigma level of HbA1c respectively. Meanwhile, analytical performance of HbA1c was demonstrated on the standardized sigma performance verification chart. According to the Westgard sigma rule flow chart with batch length and quality goal index (QGI), IQC strategy and quality improvement plan of the HbA1c were formulated.

Results

The analytical performance of HbA1c was at the "world-class" level based on the Spanish EQA standard and the German RiliBAK standard, while the quality goals were based on the "desirable" biological variation and EQA standard of China, analytical performance of HbA1c was at the "unacceptable" and "excellent" levels, respectively. This study was based on EQA standard of China as the quality goal, and combined with the Westgard sigma rule with batch length, and initially established the following IQC strategy: 13s/22s/R4s multiple rules (N=2) with batch length of 450 samples was selected as the IQC strategy for HbA1c. Besides, the calculation of QGI showed that the bias of HbA1c was the main factor affecting its analytical performance, and it was necessary to prioritize the formulation of corresponding improvement measures in terms of accuracy.

Conclusion

The six sigma model can objectively evaluate the analytical performance of HbA1c, and has important guiding significance in the design of laboratory quality control strategies and the improvement of detection quality.

表1 HbA1c的项目偏倚
表2 HbA1c项目室内质控的变异系数(2020年1-6月)
表3 不同TEa来源时HbA1c项目的σ水平
图1 不同TEa条件时HbA1c标准化的西格玛性能验证图
图2 具有批长度的Westgard西格玛规则流程图
1
中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2020年版)[J]. 中华糖尿病杂志, 2021, 13(4):315-409.
2
中华医学会糖尿病学分会, 中华医学会内分泌学分会. 中国成人2型糖尿病患者糖化血红蛋白控制目标及达标策略专家共识[J]. 中华糖尿病杂志, 2020, 12(1):1-12.
3
Lu Y, Yang H, Xu Z, et al. Association Between Different Obesity Patterns and the Risk of Developing Type 2 Diabetes Mellitus Among Adults in Eastern China: A Cross-Sectional Study[J]. Diabetes Metab Syndr Obes, 2021, 14:2631-2639.
4
Long J, Yang H, Yang Z, et al. Integrated biomarker profiling of the metabolome associated with impaired fasting glucose and type 2 diabetes mellitus in large-scale Chinese patients[J]. Clin Transl Med, 2021, 11(6):e432.
5
Wang B, Mu XL, Zhao J, et al. Effects of lifestyle interventions on rural patients with type 2 diabetes mellitus[J]. World J Diabetes, 2020, 11(6):261-268.
6
Muñoz-Torres AV, Medina-Bravo P, Valerio-Pérez BE, et al. Positive health beliefs are associated with improvement of glycated hemoglobin and lipid profiles in Mexican patients with type 2 diabetes mellitus: a cross-sectional study[J]. BMC Public Health, 2020, 20(1):761.
7
Yang F, Wang W, Liu Q, et al. The application of Six Sigma to perform quality analyses of plasma proteins[J]. Ann Clin Biochem, 2020, 57(2):121-127.
8
Fasano T, Bedini JL, Fle PA, et al. Multi-site performance evaluation and Sigma metrics of 20 assays on the Atellica chemistry and immunoassay analyzers[J]. Clin Chem Lab Med, 2019, 58(1):59-68.
9
刘倩, 杨伏猛, 梁伟, 等. 西格玛度量在临床血液学项目分析质量上的应用研究[J]. 中国实用医刊, 2018, 45(7):28-32.
10
王治国. 临床检验质量控制技术[M]. 第3版. 北京:人民卫生出版社, 2014:742-769.
11
Liu Q, Fu M, Yang F, et al. Application of Six Sigma for evaluating the analytical quality of tumor marker assays[J]. J Clin Lab Anal, 2019, 33(2):e22682.
12
Westgard JO, Westgard SA. Establishing Evidence-Based Statistical Quality Control Practices[J]. Am J Clin Pathol, 2019, 151(4):364-370.
13
Liu Q, Zhu W, Bian G, et al. Application of the sigma metrics to evaluate the analytical performance of cystatin C and design a quality control strategy[J]. Ann Clin Biochem, 2021, 58(3):203-210.
14
Peng S, Zhang J, Zhou W, et al. Practical application of Westgard Sigma rules with run size in analytical biochemistry processes in clinical settings[J]. J Clin Lab Anal, 2021, 35(3):e23665.
15
Basit A, Fawwad A, Abdul Basit K, et al. Glycated hemoglobin (HbA1c) as diagnostic criteria for diabetes: the optimal cut-off points values for the Pakistani population; a study from second National Diabetes Survey of Pakistan (NDSP) 2016-2017[J]. BMJ Open Diabetes Res Care, 2020, 8(1):e001058.
16
Moreno B, de Faria AP, Ritter AMV, et al. Glycated hemoglobin correlates with arterial stiffness and endothelial dysfunction in patients with resistant hypertension and uncontrolled diabetes mellitus[J]. J Clin Hypertens (Greenwich), 2018, 20(5):910-917.
17
Saliba W, Barnett-Griness O, Gronich N, et al. Association of Diabetes and Glycated Hemoglobin With the Risk of Intracerebral Hemorrhage: A Population-Based Cohort Study[J]. Diabetes Care, 2019, 42(4):682-688.
18
Welsh C, Welsh P, Celis-Morales CA, et al. Glycated Hemoglobin, Prediabetes, and the Links to Cardiovascular Disease: Data From UK Biobank[J]. Diabetes Care, 2020, 43(2):440-445.
19
Gilani M, Aamir M, Akram A, et al. Comparison of Turbidimetric Inhibition Immunoassay, High-Performance Liquid Chromatography, and Capillary Electrophoresis Methods for Glycated Hemoglobin Determination[J]. Lab Med. 2020, 51(6):579-584.
20
Nanda SK, Ray L. Quantitative application of sigma metrics in medical biochemistry[J]. J Clin Diagn Res, 2013, 7(12):2689-2691.
21
Westgard S, Petrides V, Schneider S, et al. Assessing precision, bias and sigma-metrics of 53 measurands of the Alinity ci system[J]. Clin Biochem, 2017, 50(18):1216-1221.
22
杜雨轩, 段敏, 王薇, 等. 通过ISO 15189认可医学实验室检验前质量指标结果分析[J]. 临床检验杂志, 2020, 38(7):548-552.
23
Teshome M, Worede A, Asmelash D. Total Clinical Chemistry Laboratory Errors and Evaluation of the Analytical Quality Control Using Sigma Metric for Routine Clinical Chemistry Tests[J]. J Multidiscip Healthc. 2021, 14:125-136.
24
Panteghini M, Sandberg S. Total error vs. measurement uncertainty: the match continues[J]. Clin Chem Lab Med, 2016, 54(2):195-196.
25
张诗诗, 王薇, 赵海建, 等. Westgard西格玛规则在糖化血红蛋白检验项目室内质量控制中的选择应用[J].现代检验医学杂志, 2016, 31(2):157-160.
26
Wang X, Wen D, Wang W, et al. Application of biological variation and six sigma models to evaluate analytical quality of six HbA1c analyzers and design quality control strategy[J]. Artif Cells Nanomed Biotechnol, 2019, 47(1):3598-3602.
27
Liu Q, Chen X, Han J, et al. Application of a six sigma model to the evaluation of the analytical performance of serum enzyme assays and the design of a quality control strategy for these assays: A multicentre study[J]. Clin Biochem, 2021, 91:52-58.
28
Zhou B, Wu Y, He H, et al. Practical application of Six Sigma management in analytical biochemistry processes in clinical settings[J]. J Clin Lab Anal, 2020, 34(1):e23126.
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