CS-5100全自动血凝仪检测抗凝血酶Ⅲ、蛋白C、蛋白S活性的性能验证

doi:10.3969/j.issn.1673-8640.2018.011.009

摘要/Abstract

摘要：

目的评价CS-5100 全自动血凝仪（简称CS-5100）检测抗凝血酶Ⅲ（AT Ⅲ）、蛋白C（Pc）和蛋白S（Ps）活性的性能。方法参照美国临床实验室标准化协会（CLSI）系列指南文件对CS-5100检测AT Ⅲ、Pc和Ps活性的不精密度[以变异系数（CV）表示]、准确度、线性、携带污染率、参考区间性能进行验证。结果 CS-5100检测AT Ⅲ、Pc和Ps活性的批内不精密度均<1.9%,日间不精密度均<4.1%,符合厂家说明书给定的标准。准确性验证结果偏移在生物学CV要求内。ATⅢ线性验证试验理论值和实测值的回归方程均符合线性回归方程的斜率在（1±0.05）范围内以及r²≥0.95的要求,携带污染率各参数CV<10%。参考区间验证结果显示各项检测指标的R=1,符合要求（R≥0.9）,参考区间验证通过。结论 CS-5100检测抗AT Ⅲ、Pc和Ps活性项目的精密度、准确度、携带污染率、线性结果均符合质量控制的要求,能够保证检验质量。

关键词: 全自动血凝仪, 抗凝血酶Ⅲ, 蛋白C, 蛋白S, 性能验证

Abstract:

Objective To evaluate the performance of CS-5100 automatic blood coagulation analyzer for the determinations of antithrombin Ⅲ（AT Ⅲ）,protein C（Pc） and protein S（Ps） activities. Methods According to the Clinical and Laboratory Standards Institute （CLSI） guidelines,the imprecision [coefficient of variation （CV）],accuracy,linearity,carry-over rate and reference interval of CS-5100 for the determinations of AT Ⅲ,Pc and Ps activities were validated. Results The within-run CV of CS-5100 for the determinations of AT Ⅲ,Pc and Ps activities were <1.9%,and the inter-day CV were <4.1%,meeting manufacturers' requirements. The bias of accuracy verification results was within biology CV requirements. The linear regression equation between AT Ⅲ linear validation theoretical value and measured values met the slope of 1±0.05,the determination coefficient （r²）≥0.95 and carry-over CV<10%. Reference interval verification results showed that the determination index R was ≥0.9. Conclusions The precision,accuracy,linearity,carry-over rate and reference interval of CS-5100 meet the requirements of quality control,which can ensure determination quality.

Key words: Automatic blood coagulation analyzer, Antithrombin Ⅲ, Protein C, Protein S, Performance verification

中图分类号:

R446.1

李雯, 何爱丽, 张雯, 周挺. CS-5100全自动血凝仪检测抗凝血酶Ⅲ、蛋白C、蛋白S活性的性能验证[J]. 检验医学, 2018, 33(11): 1009-1012.

LI Wen, HE Aili, ZHANG Wen, ZHOU Ting. Performance verification of CS-5100 automatic blood coagulation analyzer for the determinations of antithrombin Ⅲ,protein C and protein S activities[J]. Laboratory Medicine, 2018, 33(11): 1009-1012.

图/表 7

参考文献 11

[1]	许文荣,王建中. 临床血液学与检验[M]. 4版. 北京: 人民卫生出版社,2009:350-352.
[2]	Clinical and Laboratory Standards Institute. Collection,transport,and processing of blood speciments for testing plasma-based coagulation assays and molecular hemostasis assays[S]. H21-A5, CLSI,2008.
[3]	Clinical and Laboratory StandardsInstitute. User verification of performance for precision and trueness[S]. EP15-A2,CLSI,2004.
[4]	Clinical and Laboratory StandardsInstitute. Evaluation of the linearity of quantitative measurement procedures[S]. EP6-A,CLSI,2003.
[5]	Clinical and Laboratory Standards Institute. How to define and determine reference intervals in the clinical laboratory[S]. C28-A2, CLSI,2000.
[6]	Clinicaland Laboratory StandardsInstituteProtocal for the evaluation,validation and implementation of coagulometers[S]. H57-A, CLSI,2008.
[7]	王芳,张军,徐唯傑,等. SYSMEX CS 5100 全自动血凝分析仪的性能评价[J]. 检验医学,2015,30(2):177-180.
[8]	闫宏斌,郑善銮,郝晓柯. SYSMEX CS5100血凝分析仪性能评估及凝血六项参考区间的调整[J]. 检验医学,2014,29(9):964-968.
[9]	朱铁楠,赵永强. 2012版易栓症诊断中国专家共识解读[J]. 临床血液学杂志,2013,26(2):156-157.
[10]	闫振宇,朱宝来,马西虎,等. 672例静脉血栓栓塞症相关危险因素分析[J]. 中华血液学杂志,2007,28(9):579-582.
[11]	杨有业,张秀明. 临床检验方法学评价[M]. 北京:人民卫生出版社, 2008:72-73.

项目	x	批内不精密度	日间不精密度
ATⅢ	51.64	0.16	1.42
	120.28	0.29	1.93
Pc	39.75	0.26	1.19
	107.93	0.27	1.82
Ps	38.82	0.89	1.39
	115.31	0.46	1.41

项目	x	批内不精密度	日间不精密度
ATⅢ	51.64	0.16	1.42
	120.28	0.29	1.93
Pc	39.75	0.26	1.19
	107.93	0.27	1.82
Ps	38.82	0.89	1.39
	115.31	0.46	1.41

项目	正常水平定值质控品			异常水平定值质控品
项目	x	靶值	偏移	x	靶值	偏移
ATⅢ	99.6	100	-0.40	32.2	33	-2.42
Pc	100.9	98	2.96	32.9	32	2.81
Ps	61.2	63	-2.86	31.3	30	4.33

项目	正常水平定值质控品			异常水平定值质控品
项目	x	靶值	偏移	x	靶值	偏移
ATⅢ	99.6	100	-0.40	32.2	33	-2.42
Pc	100.9	98	2.96	32.9	32	2.81
Ps	61.2	63	-2.86	31.3	30	4.33

项目	实测值范围（%）	参考区间（%）	R值
ATⅢ	80.2~109.0	79.4~112.0	1
Pc	75.1~132.2	70.0~140.0	1
Ps	63.4~121.0	60.0~130.0	1