Application of Six Sigma in the selection of quality objectives of tumor markers

doi:10.3877/cma.j.issn.2095-5820.2020.02.009

Abstract

Abstract:

Objective

Six Sigma theory was applied to evaluate the analytical performance of tumor markers, and the quality objectives of each project were preliminarily determined.

Methods

The internal quality control (IQC) data and external quality assessment (EQA) of National Center for Clinical Laboratories in our laboratory from January to December 2018 were collected, and the quality specification derived from biological variation and the standard of EQA were used as allowable total error (TEa) to calculate Sigma levels of six tumor markers. According to the flow chart of quality goal selection and the validation chart for analytical performance of tumor markers, the analytical performance of each project were evaluated, and then the appropriate quality objectives of tumor markers were determined.

Results

There were significant differences among sigma levels of tumor markers by applying the quality specification derived from different levels of biological variation and the standard of EQA. According to the quality objectives, choose flow chart "appropriate" quality criteria derived from biological variation as CA125 quality objectives, and "minimal" quality criteria derived from biological variation as t-PSA, CEA, AFP, CA199 and CA153 quality objectives.

Conclusion

Six Sigma can objectively evaluate the analytical performance of tumor markers and provide an important guidance for the selection of laboratory quality objectives.

Key words: Total quality management, Biological variation, Tumor marker, Quality objective

Fumeng Yang, Qian Liu, Ziling Zhang, Li Chen, Shijie Teng, Wei Liang. Application of Six Sigma in the selection of quality objectives of tumor markers[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2020, 08(02): 113-117.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhlcsysgldzzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.2095-5820.2020.02.009

https://zhlcsysgldzzz.cma-cmc.com.cn/EN/Y2020/V08/I02/113

Figures/Tables 5

References 16

1	Fraser CG. The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine[J]. Clin Chem Lab Med, 2015, 53(6):837-840.
2	Sandberg S, Fraser CG, Horvath AR, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine[J]. Clin Chem Lab Med, 2015, 53(6):833-835.
3	Panteghini M, Sandberg S. Total error vs. measurement uncertainty: the match continues[J]. Clin Chem Lab Med, 2016, 54(2):195-196.
4	Hollestelle MJ, Ruinemans-Koerts J, Idema RN, et al. Determination of sigma score based on biological variation for haemostasis assays: fit-for-purpose for daily practice?[J]. Clin Chem Lab Med, 2019, 57(8):1235-1241.
5	Taher J, Cosme J, Renley BA, et al. A novel Sigma metric encompasses global multi-site performance of 18 assays on the Abbott Alinity system[J]. Clin Biochem, 2019,63:106-112.
6	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):22682.
7	Varela B, Pacheco G. Comprehensive evaluation of the internal and external quality control to redefine analytical quality goals[J]. Biochem Med (Zagreb), 2018, 28(2):20710.
8	何赏, 陈琛, 王成彬. 精准医疗、精准检验、检验精准[J]. 中华检验医学杂志, 2017, 40(4):221-223.
9	Dainis AM, Ashley EA. Cardiovascular Precision Medicine in the Genomics Era[J]. JACC Basic Transl Sci. 2018, 3(2):313-326.
10	李润青, 宫丽君, 王腾蛟, 等. 西格玛方法在临床生化检验质量管理中的应用[J]. 中华检验医学杂志, 2017, 40(9):727-732.
11	张诗诗, 王薇, 赵海建, 等. 常规临床检验项目如何选择不同分析性能规范模型[J]. 临床检验杂志, 2017, 35(2):89-93.
12	Sten W, Hassan B, Westgard JO. Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories[J]. Biochem Med (Zagreb), 2018, 28(2):20502.
13	Guo X, Zhang T, Gao X, et al. Sigma metrics for assessing the analytical quality of clinical chemistry assays: a comparison of two approaches: Electronic supplementary material available online for this article[J]. Biochem Med (Zagreb), 2018, 28(2):20708.
14	Hens K, Berth M, Armbruster D, et al. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target[J]. Clin Chem Lab Med, 2014, 52(7):973-980.
15	章晓燕, 王薇, 赵海建, 等. 生物学变异推导出的质量规范在肿瘤标志物检测指标质量评价中的应用[J]. 临床检验杂志, 2016, 34(5):388-391.
16	El Sharkawy R, Westgard S, Awad AM, et al. Comparison between Sigma metrics in four accredited Egyptian medicallaboratories in some biochemical tests: an initiative towards sigma calculation harmonization[J]. Biochem Med (Zagreb), 2018, 28(2):20711.

项目	CV	Bias	允许总误差(TEa)				σ值
项目	CV	Bias	"适当的"生物学变异	"最低的"生物学变异	"最佳的"生物学变异	EQA评价标准	"适当的"生物学变异	"最低的"生物学变异	"最佳的"生物学变异	EQA评价标准
t-PSA	6.24	5.48	33.60	50.38	16.79	25.00	4.51	7.20	1.81	3.13
CEA	3.95	6.61	24.70	37.10	12.37	25.00	4.58	7.72	1.46	4.66
AFP	4.41	5.34	21.80	32.68	10.89	25.00	3.73	6.20	1.26	4.46
CA199	6.11	5.11	39.00	58.52	19.51	25.00	5.55	8.74	2.36	3.26
CA125	5.04	3.77	35.40	53.04	17.68	25.00	6.28	9.79	2.76	4.22
CA153	4.61	2.83	20.80	31.25	10.42	25.00	3.90	6.17	1.65	4.81

项目	CV	Bias	允许总误差(TEa)				σ值
项目	CV	Bias	"适当的"生物学变异	"最低的"生物学变异	"最佳的"生物学变异	EQA评价标准	"适当的"生物学变异	"最低的"生物学变异	"最佳的"生物学变异	EQA评价标准
t-PSA	6.24	5.48	33.60	50.38	16.79	25.00	4.51	7.20	1.81	3.13
CEA	3.95	6.61	24.70	37.10	12.37	25.00	4.58	7.72	1.46	4.66
AFP	4.41	5.34	21.80	32.68	10.89	25.00	3.73	6.20	1.26	4.46
CA199	6.11	5.11	39.00	58.52	19.51	25.00	5.55	8.74	2.36	3.26
CA125	5.04	3.77	35.40	53.04	17.68	25.00	6.28	9.79	2.76	4.22
CA153	4.61	2.83	20.80	31.25	10.42	25.00	3.90	6.17	1.65	4.81

质量目标	A区	C区	D区
"适当的"生物学变异	16.7	83.3	0.0
"最低的"生物学变异	100.0	0.0	0.0
"最佳的"生物学变异	0.0	83.3	16.7
EQA评价标准	0.0	100.0	0.0

质量目标	A区	C区	D区
"适当的"生物学变异	16.7	83.3	0.0
"最低的"生物学变异	100.0	0.0	0.0
"最佳的"生物学变异	0.0	83.3	16.7
EQA评价标准	0.0	100.0	0.0

[1]	Jia Yan, Shuangchi Liu, Zhengyu Wang. Progress in the research and application of tumor markers for gallbladder cancer [J]. Chinese Archives of General Surgery(Electronic Edition), 2023, 17(05): 391-394.
[2]	Xiaoman Chen, Haibo Zhang, Manjie Xue, Bo Wei, Jun Shao, Xiaoyan Han. Impact of -80℃ cryopreservation on miRNA markers in colorectal cancer plasma sample [J]. Chinese Archives of General Surgery(Electronic Edition), 2023, 17(01): 24-27.
[3]	Sizhe Xu, Gongjian He, Li Zeng, Huijia Yang, Fang Wang. The predictive value of ultrasonography combined with tumor markers for occult lymph node metastasis in central area of cN0 stage micropapillary thyroid carcinoma [J]. Chinese Journal of Operative Procedures of General Surgery(Electronic Edition), 2021, 15(03): 314-318.
[4]	Zhenxiang Lin, Xiaoyong Pu, Jiumin Liu, Xuecheng Bi, Teng Li, Jianxiong Fang, Xiewu Zhang. Clinical significance of combined detection of Survivin and MUC7 in urine in the detection of bladder cancer [J]. Chinese Journal of Endourology(Electronic Edition), 2019, 13(03): 166-169.
[5]	Le Qian, Qinxiang Kong, Yue Cheng, Jingting Zhou. Analysis of clinical features of patients with pulmonary tuberculosis complicated with lung cancer [J]. Chinese Journal of Lung Diseases(Electronic Edition), 2019, 12(04): 469-472.
[6]	Xinxiong Li, Zaizhong Zhang, Hu Zhao, Chunhong Xiao, Lie Wang. Progress of exosome contents as diagnostic markers for pancreatic cancer [J]. Chinese Journal of Cell and Stem Cell(Electronic Edition), 2023, 13(01): 53-57.
[7]	Chengming Ding, Jiafeng Hou, Guangwei Tao. Early diagnosis and screening of hepatocellular carcinoma [J]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2023, 12(01): 22-28.
[8]	Chunlin Wang, Yuliuming Wang, Hao Zhang, Yunxiao Liu, Meng Wang, Guiyu Wang. Clinical predictive model for predicting distant metastasis of colorectal cancer: combined with preoperative CEA, CA19-9 and clinicopathological factors [J]. Chinese Journal of Colorectal Diseases(Electronic Edition), 2022, 11(03): 205-211.
[9]	Chenfan Li, Lihua Wu, Zeyu Zheng, Yueping Zheng, Yun Xie, Jie Liu, Bifang Wu, Ruizhang Su, Man Wan, Zhaoxu Tian, Yiqun Hu. Progress of diagnostic methods of pancreatic cancer by endoscopic ultrasound-guided fine-needle aspiration [J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2022, 12(02): 102-107.
[10]	Jing Mo, Guowei Chen, Shiyu Zhang. Effect of intraperitoneal hyperthermic perfusion chemotherapy at different times after operation on tumor marker levels in patients with ovarian cancer [J]. Chinese Journal of Clinicians(Electronic Edition), 2023, 17(02): 165-170.
[11]	Hongyi Wang. Progress in research of tumor markers in colorectal cancer [J]. Chinese Journal of Clinicians(Electronic Edition), 2021, 15(01): 47-51.
[12]	Zhicheng Wu, Wenyue Xie, Maoting Shen, Juan Chen. Application of Westgard Sigma analysis batch length rules based on risk management in the quality control of urine forming composition [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2022, 10(01): 29-33.
[13]	Qian Liu, Mei Fu, Li Yao, Jin Sun, Wei Liang, Fumeng Yang. Application of six sigma model to evaluate the analytical performance of hematology analytes and the design of quality control strategy [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2021, 09(02): 105-109.
[14]	Dongling Li, Shoufang Liu, Guangfeng Ying, Xiaofei Li, Songpeng Li. Clinical value of combined detection of serum ProGRP, CEA, CYFRA211, NSE, CA199 and AFP in diagnosis of lung cancer [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2019, 07(03): 145-149.
[15]	Qiang Wang, Huan Zhang, Jun Pan. Significance of tumor markers in the differential diagnosis of pleural effusion in elderly patients [J]. Chinese Journal of Geriatrics Research(Electronic Edition), 2022, 09(04): 16-21.

Please choose a citation manager

Content to export