Assessment of internal quality control plan for microfluidic chip POCT

doi:10.3969/j.issn.1673-8640.2021.06.020

Abstract

Abstract:

Objective To preliminarily investigate the internal quality control （IQC） plan for microfluidic chip point-of-care testing （POCT）. Methods Microfluidic chip POCT analyzer was used to analyze potassium（K）,sodium（Na）,chlorine（Cl） and glucose （Glu） from clinical residual serum samples. The study lasted for 3 months and was divided into 2 phases. In Phase 1,electronic quality control and 2 levels of liquid quality control were carried out each day. In Phase 2,electronic quality control was tested on a daily basis,while the liquid quality control was tested once a week. Totally,3 levels of mixed serum samples for these 4 items were tested throughout the study. The results of electronic quality control,liquid quality control and mixed serum samples were analyzed. Results Each result of electronic quality control passed in 2 phases. The liquid quality control results were within control when they were assessed adopting Westgard sigma rules in different phases. The coefficient of variation （CV）of the mixed serum sample results for 4 items were all <1/3 allowable total error （TEa）. Conclusions When microfluidic chip POCT is used to test K,Na,Cl and Glu,under the condition of stable determination personnel and environment,the same batch of reagents,the use of daily electronic quality control with weekly liquid quality control can ensure the quality of analysis.

Key words: Microfluidic chip, Point-of-care testing, Internal quality control

CLC Number:

R446.1

GE Danhong, TANG Liping, OU Yuanzhu, YU Xiaoxuan, LIU Wenbin, LIN Feiran, GONG Jingkai, ZHU Yuqing. Assessment of internal quality control plan for microfluidic chip POCT[J]. Laboratory Medicine, 2021, 36(6): 674-678.

Figures/Tables 6

References 13

[1]	Centers for Medicare and Medicaid Services. State operations manual, appendix C - Survey procedures and interpretive guidelines for laboratories and laboratory services[EB/OL]. (2015-05-29) [2021-03-10]. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.
[2]	Australasian Association of Clinical Biochemists. Guidelines for conducting quality control and external quality assurance for POCT[EB/OL]. (2019-07-01) [2021-03-10]. https://www.aacb.asn.au/resources/guidelines-and-position-statements/position-statements-and-supporting-documentation.
[3]	周睿, 王清涛. POCT在临床引用中面临的机遇和挑战[J]. 中华检验医学杂志, 2019,42(5):323-327.
[4]	邹丽辉, 李英, 肖飞. 微流控技术在临床检验中的应用[J]. 中华检验医学杂志, 2018,41(9):631-633.
[5]	VON LODE P. Point-of-care immunotesting:approaching the analytical performance of central laboratory methods[J]. Clin Biochem, 2005,38(7):591-606. DOI URL
[6]	杨宇, 刘雅, 谷岚, 等. 全自动核酸分子诊断系统的现状与发展[J]. 中国生物工程杂志, 2017,37(3):115-123.
[7]	GOBLE J A, ROCAFORT P T. Point-of-care testing[J]. J Pharm Pract, 2017,30(2):229-237. DOI URL
[8]	Clinical and Laboratory Standards Institute. Evaluation of total analytical error for quantitative medical laboratory measurement procedures[S]. EP21,CLSI, 2016.
[9]	ISO15189 Medical laboratories-particular requirements for quality and competence[S]. Geneva:ISO, 2012.
[10]	MARTIN C L. Quality control issues in point of care testing[J]. Clin Biochem Rev, 2008,29(Suppl 1):S79-S82.
[11]	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.
[12]	WESTGARD J O, WESTGARD S A. Six sigma quality management system and design of risk-based statistical quality control[J]. Clin Lab Med, 2017,37(1):85-96. DOI URL
[13]	Clinical and Laboratory Standards Institute. Laboratory quality control based on risk management[S]. EP23-A,CLSI, 2010.

项目	TEa	CV/%	Bias/%	σ值	推荐质控规则
K	±0.5 mmol/L	1.01	1.02	10.0	1₃_s
Na	±4 mmol/L	0.68	0.27	3.8	1₃_s/2₂_s/R₄_s/4₁_s/8_x
Cl	5%	0.72	0.83	5.8	1₃_s/2₂_s/R₄_s
Glu	10%	1.08	3.57	5.9	1₃_s/2₂_s/R₄_s

项目	TEa	CV/%	Bias/%	σ值	推荐质控规则
K	±0.5 mmol/L	1.01	1.02	10.0	1₃_s
Na	±4 mmol/L	0.68	0.27	3.8	1₃_s/2₂_s/R₄_s/4₁_s/8_x
Cl	5%	0.72	0.83	5.8	1₃_s/2₂_s/R₄_s
Glu	10%	1.08	3.57	5.9	1₃_s/2₂_s/R₄_s

项目	第1阶段				第2阶段				AD/ （mmol/L）	RD/%	TEa
项目	x/ （mmol/L）	s/ （mmol/L）	CV/%	TAE/%	x/ （mmol/L）	s/ （mmol/L）	CV/%	TAE/%	AD/ （mmol/L）	RD/%	TEa
K
L1	5.79	0.03	0.51	1.86	5.79	0.03	0.56	1.94	0.00	0.00	±0.5 mmol/L
L2	3.80	0.03	0.70	2.18	3.78	0.04	1.08	2.80	-0.02	-0.53
L3	4.40	0.02	0.35	1.60	4.40	0.00	0.00	1.02	0.00	0.00
Na
L1	150.50	0.88	0.58	1.23	150.60	0.78	0.52	1.13	0.10	0.07	±4 mmol/L
L2	124.70	1.03	0.83	1.64	124.30	0.81	0.65	1.34	-0.40	-0.32
L3	142.20	0.73	0.51	1.11	141.90	0.59	0.41	0.95	-0.30	-0.21
Cl
L1	120.90	0.83	0.68	1.95	121.50	0.85	0.70	1.99	0.60	0.50	±5%
L2	93.90	1.10	1.17	2.76	94.20	0.61	0.65	1.90	0.30	0.32
L3	107.40	0.81	0.76	2.08	107.80	0.74	0.68	1.95	0.40	0.37
Glu
L1	5.73	0.06	1.11	5.40	5.78	0.05	0.86	4.99	0.05	0.87	±10%
L2	21.26	0.23	1.07	5.34	21.38	0.17	0.79	4.87	0.12	0.56
L3	6.54	0.06	0.94	5.12	6.60	0.12	1.84	6.61	0.06	0.92

项目	第1阶段				第2阶段				AD/ （mmol/L）	RD/%	TEa
项目	x/ （mmol/L）	s/ （mmol/L）	CV/%	TAE/%	x/ （mmol/L）	s/ （mmol/L）	CV/%	TAE/%	AD/ （mmol/L）	RD/%	TEa
K
L1	5.79	0.03	0.51	1.86	5.79	0.03	0.56	1.94	0.00	0.00	±0.5 mmol/L
L2	3.80	0.03	0.70	2.18	3.78	0.04	1.08	2.80	-0.02	-0.53
L3	4.40	0.02	0.35	1.60	4.40	0.00	0.00	1.02	0.00	0.00
Na
L1	150.50	0.88	0.58	1.23	150.60	0.78	0.52	1.13	0.10	0.07	±4 mmol/L
L2	124.70	1.03	0.83	1.64	124.30	0.81	0.65	1.34	-0.40	-0.32
L3	142.20	0.73	0.51	1.11	141.90	0.59	0.41	0.95	-0.30	-0.21
Cl
L1	120.90	0.83	0.68	1.95	121.50	0.85	0.70	1.99	0.60	0.50	±5%
L2	93.90	1.10	1.17	2.76	94.20	0.61	0.65	1.90	0.30	0.32
L3	107.40	0.81	0.76	2.08	107.80	0.74	0.68	1.95	0.40	0.37
Glu
L1	5.73	0.06	1.11	5.40	5.78	0.05	0.86	4.99	0.05	0.87	±10%
L2	21.26	0.23	1.07	5.34	21.38	0.17	0.79	4.87	0.12	0.56
L3	6.54	0.06	0.94	5.12	6.60	0.12	1.84	6.61	0.06	0.92

[1]	YUE Caidie, LI Junyan, DING Aijun, XIE Li, ZENG Weikun. Research progress of rapid determination methods for SARS-CoV-2 antigen [J]. Laboratory Medicine, 2023, 38(1): 87-93.
[2]	ZHENG Cuiling, WANG Li, CHENG Yan, CUI Wei. Fresh blood comparison program in daily internal quality control of hematology analyzers [J]. Laboratory Medicine, 2021, 36(6): 662-666.
[3]	ZHAO Ran, LIU Wenbin, LIN Feiran, GONG Jingkai, YU Xiaoxuan, GE Danhong, TANG Liping, OU Yuanzhu. Internal quality control and evaluation of blood gas analysis based on Westgard sigma rules [J]. Laboratory Medicine, 2021, 36(5): 544-548.
[4]	WEN Liangxue, ZHANG Lanyi, SU Li, WANG Mingfen, LIU Yongsheng. Internal quality control of HBV DNA determination in blood center nucleic acid laboratory [J]. Laboratory Medicine, 2021, 36(4): 437-440.
[5]	ZHANG Yu, PENG Aihong, YANG Lihua, YU Qihua. Evaluation of repeat-sampling quality control strategy based on 1:2s rule [J]. Laboratory Medicine, 2020, 35(5): 497-500.
[6]	NIU Jing, QUAN Wenqiang, LI Dong. Establishment and application of loop-mediated isothermal amplification for EGFR gene L858R mutation determination in non-small cell lung cancer patients [J]. Laboratory Medicine, 2020, 35(3): 273-277.
[7]	GAO Juyi, WU Chuanan, YANG Weikang, LUO Yuxuan, LIU Shengnan, XU Xiaoping. Role of COP microfluidic chip for the rapid detection of Escherichia coli O157:H7 [J]. Laboratory Medicine, 2020, 35(2): 148-152.
[8]	WANG Xinqin, QIU Wei, CHEN Sumei, LIU Dongsheng. Establishment of routine dry biochemical test IQC rules based on six sigma quality management method [J]. Laboratory Medicine, 2020, 35(1): 66-69.
[9]	HE Yong, WANG Hui, LI Xiaoling, NIE Xin, JIANG Hong. Establishment and analysis of comparison methods among POCT blood gas analyzers [J]. Laboratory Medicine, 2019, 34(8): 758-762.
[10]	HOU Weiwei, JIANG Lian, WAN Haiying. Design of intelligent clinical microbiological testing quality control management system [J]. Laboratory Medicine, 2019, 34(11): 973-977.
[11]	WANG Huiru, LI Guixia, HUANG Jing, WU Hao, DI Yang. Six sigma for evaluating the performance of blood cell analysis internal quality control inter-laboratory comparison among 17 laboratories from Grade 3 Class A hospitals in Hebei [J]. Laboratory Medicine, 2018, 33(6): 563-566.
[12]	TANG Liping, OU Yuanzhu, LIU Wenbin, YU Xiaoxuan. Evaluation of 2 HbA_1c POCT analyzers based on the results of external quality assessment in Shanghai [J]. Laboratory Medicine, 2018, 33(3): 248-251.
[13]	XIANG Ying, FU Qihua, JIANG Limin. Quality management for point-of-care testing of blood gas analysis [J]. Laboratory Medicine, 2017, 32(10): 911-916.
[14]	FEI Yang, WANG Wei, WANG Zhiguo. Application of Westgard sigma rules in selecting internal quality control rules for clinical hematology tests [J]. Laboratory Medicine, 2016, 31(11): 993-996.
[15]	GE Yajuan, XU Qunhuan, ZHANG Qing. Assessment on the validity of biochemical determination results after internal quality control out-of-control [J]. Laboratory Medicine, 2015, 30(8): 844-846.