Quality control rule softwares for datum analysis in external quality assessment of quantitative assays

doi:10.3969/j.issn.1673-8640.2016.04.016

Abstract

Abstract:

External quality assessment plays an important role in quality evaluation and improvement,but most laboratories often focus on the unsatisfied data only. With appropriate quality control rules, laboratories can detect not only the error sources of unsatisfied data but also the potential error sources of satisfied data. The article mainly analyzes developed quality control rule softwares, which can be used to analyze external quality assessment data, evaluate the performance of assay and detect error sources.

Key words: Quality control rule, Standard deviation index, Bias, External quality assessment, Computer simulation

CLC Number:

R446.1

ZHAO Haijian, ZHANG Chuanbao, WANG Jing, DU Zhongli, WANG Zhiguo. Quality control rule softwares for datum analysis in external quality assessment of quantitative assays[J]. Laboratory Medicine, 2016, 31(4): 319-323.

规则	含义	SE	RE
1_2.0SDI	5个样本中1个测定结果的SDI值同时超过+2.0或-2.0
1_3.0SDI	5个样本中1个测定结果的SDI值同时超过+3.0或-3.0		√
2_2.0SDI	5个样本中2个测定结果的SDI值同时超过+2.0或-2.0	√
x_1.5SDI	5个样本测定结果SDI均值超过+1.5或-1.5	√
x_2.0SDI	5个样本测定结果SDI均值超过+2.0或-2.0	√
R_3.0SDI	最大及最小测定结果的SDI值间的差值>3.0		√
R_4.0SDI	最大及最小测定结果的SDI值间的差值>4.0		√
1_75%TEa	5个样本中至少1份结果的偏差超过TEa的75％		√
5_x	5个样本结果在均值同一侧	√
2_TEa	5个样本中至少2个结果的偏差超过了TEa （EQA不合格）	√	√

规则	含义	SE	RE
1_2.0SDI	5个样本中1个测定结果的SDI值同时超过+2.0或-2.0
1_3.0SDI	5个样本中1个测定结果的SDI值同时超过+3.0或-3.0		√
2_2.0SDI	5个样本中2个测定结果的SDI值同时超过+2.0或-2.0	√
x_1.5SDI	5个样本测定结果SDI均值超过+1.5或-1.5	√
x_2.0SDI	5个样本测定结果SDI均值超过+2.0或-2.0	√
R_3.0SDI	最大及最小测定结果的SDI值间的差值>3.0		√
R_4.0SDI	最大及最小测定结果的SDI值间的差值>4.0		√
1_75%TEa	5个样本中至少1份结果的偏差超过TEa的75％		√
5_x	5个样本结果在均值同一侧	√
2_TEa	5个样本中至少2个结果的偏差超过了TEa （EQA不合格）	√	√

规则	含义	SE	RE
5_x & 1_50%TEa	同时违背这2个规则	√
1_75%TEa/R_3.0SDI	违背其中任一规则		√
1_3.0SDI/x_1.5SDI/R_4.0SDI	违背其中任一规则		√
x_1.5SDI/1_75%TEa/R_4.0SDI	违背其中任一规则		√
1_75%TEa/5_x/1_50%TEa	违背其中任一规则	√

规则	含义	SE	RE
5_x & 1_50%TEa	同时违背这2个规则	√
1_75%TEa/R_3.0SDI	违背其中任一规则		√
1_3.0SDI/x_1.5SDI/R_4.0SDI	违背其中任一规则		√
x_1.5SDI/1_75%TEa/R_4.0SDI	违背其中任一规则		√
1_75%TEa/5_x/1_50%TEa	违背其中任一规则	√

项目	TEa （％）	CV（％）	差值均值（%）	σ值均值	s_g/s_i比值	临界系统误差	所选规则	P_ed	P_fr
P	10.7	6.70	4.19	1.69	0.85	-0.68	x_1.5SDI	1.000	0.013
TP	10.0	3.78	0.52	2.69	0.74	0.86	x_1.5SDI	1.000	0.014
Urea	9.0	2.40	3.30	3.31	1.20	0.72	x_1.5SDI	0.996	0.000
TC	10.0	2.37	1.09	4.22	1.53	2.11	1_75%TEa/5_x/1_50%TEa	1.000	0.002
UA	17.0	3.12	1.54	5.90	1.38	3.31	1_75%TEa/5_x/1_50%TEa	1.000	0.005
GGT	20.0	3.06	3.70	6.41	1.81	3.68	x_1.5SDI/1_75%TEa/R_4SDI	0.996	0.000
ALP	30.0	3.64	1.29	8.25	2.86	6.19	1_3SDI/x_1.5SDI/R_4SDI	0.639	0.000

Quality control rule softwares for datum analysis in external quality assessment of quantitative assays

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项目	TEa（%）	s_g/s_i比值的均值	σ均值	分析质量	SDI	SDI均值	偏差/TEa（%）	违反质控规则	误差类型
P	10.7	0.82	1.69	不可接受	-0.20	1.52	-23.66	x_1.5SDI	系统误差
					1.13		60.08
					1.43		42.29
					2.56		83.64
					2.70		80.62
TP	10.0	0.74	2.69	临界	0.45	0.70	12.70	无	无
					0.45		11.70
					1.13		32.30
					0.74		19.70
					0.71		20.20
Urea	9.0	1.10	3.24	一般	-2.27	1.12	-10.40	R_3.0SDI和1_75%TEa	随机误差
Urea					1.09		33.70
					0.56		20.20
					1.07		49.80
					0.60		27.90
TC	10.0	2.57	4.22	良好	0.17	0.34	9.40	无	无
TC					-0.07		-2.80
					0.80		24.80
					0.54		17.90
					0.24		34.80
UA	10.7	1.21	5.23	良好	-0.92	0.53	-20.80	无	无
UA					0.07		1.35
					0.50		7.70
					0.84		19.00
					0.37		11.80
GGT	20.0	1.80	6.41	优秀	-0.15	0.21	-4.70	无	无
					-0.12		-12.90
					0.57		13.75
					-0.21		-6.00
					0.00		0.00
ALP	30.0	2.69	8.25	优秀	-0.56	0.25	-23.80	无	无
					-0.25		-6.93
					0.00		0.00
					0.06		1.97
					0.39		12.40

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