3种检测系统常规血液凝固试验结果一致性比较

doi:10.3969/j.issn.1673-8640.2019.03.015

摘要/Abstract

摘要：

目的比较3种系统测定凝血酶原时间（PT）、国际标准化比值（PT-INR）、活化部分凝血活酶时间（APTT）、纤维蛋白原（Fib）、凝血酶时间（TT）、D-二聚体（DD）、纤维蛋白（原）降解产物（FDP）结果的一致性,并观察质控物的基质效应。方法选取不同水平患者样本100份,采用CA7000血液凝固分析仪、Top700血液凝固分析仪、CP2000血液凝固分析仪（分别简称CA7000、TOP700、CP2000）同时检测PT、PT-INR、APTT、Fib、TT、DD、FDP,采用线性回归分析评价不同系统检测患者样本结果的相关性,计算两两系统间相对偏差。选取18种不同来源质控物在3种检测系统上同时检测PT、Fib、DD,评价质控物互换性。结果不同系统检测患者样本PT、PT-INR、Fib结果有良好的相关性（r²为0.91~0.99）,两两系统间偏差分别<15%、15%、20%;3种系统检测DD的结果显著相关（r²≥0.90）,CA7000、CP2000检测DD一致性好,但Top700测定结果显著低于CA7000、CP2000;不同系统检测患者样本APTT、TT结果有中度相关性（r²为0.56~0.76）,且三者间测定结果有系统偏差。3种系统均采用同一品牌试剂盒及配套校准品检测FDP,系统间FDP检测结果有良好相关性（r²>0.99）。不同系统检测DD结果相关性良好（r²为0.92~0.99）,但两两系统间测定结果偏差显著。18种质控物PT、Fib、DD的检测结果在3种检测系统间均无互换性。结论不同检测系统血液凝固试验检测结果一致可比程度不同,血凝质控物基质效应显著,使其在不同系统上检测结果偏差大于患者样本的检测结果。

关键词: 血液凝固试验, 相关性, 质控品, 基质效应

Abstract:

Objective To investigate the consistency of 3 automated coagulation analyzers for coagulation items [prothrombin time（PT）,international normalized ratio（INR）,activated partial thromboplastin time（APTT）,fibrinogen（Fib）,thrombin time（TT）,D-dimer（DD）and fibrin/fibrinogen degradation product（FDP）] and the matrix effects of quality control materials. Methods A total of 100 samples were collected. Totally,PT,PT-INR,APTT,Fib,TT,DD and FDP were determined by 3 automated coagulation analyzers,including CA7000,Top700 and CP2000. Linear regression analysis was used to analyze the correlation of results. The relative deviation between any 2 analyzers was calculated. The matrix effect of 18 quality control materials for PT,Fib and DD was assessed with regression. Results There were good correlations among the 3 automated coagulation analyzers for PT,PT-INR and Fib （r²=0.91-0.99）. The deviations between any 2 analyzers were <15%,15% and 20%. The results of DD among the 3 automated coagulation analyzers had correlations （r²≥0.90）,CA7000 and CP2000 had good consistency,but the results of Top700 were lower than those of CA7000 and CP2000. Moderate correlations were observed for APTT and TT（r²=0.56-0.76）. Medical kits for FDP and matched calibrators were adopted to the 3 analyzers. There was a high correlation for FDP and DD （r²>0.99,r²=0.92-0.99）,and there was difference between any 2 analyzers. There was no compatibility for PT,Fib and DD on the 3 analyzers in 18 quality control materials. Conclusions The consistency of the results of the 3 automated coagulation analyzers is diverse. The matrix effects should be considered,which makes the deviation of quality control materials greater than that of patient.

Key words: Coagulation test, Correlation, Quality control material, Matrix effect

中图分类号:

R446.1

王悦, 屈晨雪, 龚岩, 高学硕, 王国洪, 徐国宾. 3种检测系统常规血液凝固试验结果一致性比较[J]. 检验医学, 2019, 34(3): 253-258.

WANG Yue, QU Chenxue, GONG Yan, GAO Xueshuo, WANG Guohong, XU Guobin. Comparison of the results' consistency of 3 automated coagulation analyzers for coagulation items[J]. Laboratory Medicine, 2019, 34(3): 253-258.

质控物名称	生产厂家	PT	APTT	Fib	DD
STA-Coag Control N	法国Stago公司	√	√	√	--
STA-Coag Control P		√	√	√	--
Emo D-Di QC 1		--	--	--	√
Emo D-Di QC 2		--	--	--	√
HemosIL Low Abnormal Control Assayed	美国IL仪器公司	√	√	√	--
HemosIL High Abnormal Control Assayed		√	√	√	--
HemosIL Low D-Dimer Control		--	--	--	√
HemosIL High D-Dimer Control		--	--	--	√
Dade Ci-Trol 1	德国Siemens公司	√	√	√	--
Dade Ci-Trol 2		√	√	√	--
INNOVANCE D-Dimer Control 1		--	--	--	√
INNOVANCE D-Dimer Control 2		--	--	--	√
Coagpia Control N	日本积水医疗株式会社	√	√	√	--
Coagpia Control P		√	√	√	--
FDP control L		--	--	--	√
FDP control H		--	--	--	√
Lyphocheck Hemostasis control 2	美国Bio-Rad公司	√	√	√	--
Lyphocheck Hemostasis control 3		√	√	√	--

质控物名称	生产厂家	PT	APTT	Fib	DD
STA-Coag Control N	法国Stago公司	√	√	√	--
STA-Coag Control P		√	√	√	--
Emo D-Di QC 1		--	--	--	√
Emo D-Di QC 2		--	--	--	√
HemosIL Low Abnormal Control Assayed	美国IL仪器公司	√	√	√	--
HemosIL High Abnormal Control Assayed		√	√	√	--
HemosIL Low D-Dimer Control		--	--	--	√
HemosIL High D-Dimer Control		--	--	--	√
Dade Ci-Trol 1	德国Siemens公司	√	√	√	--
Dade Ci-Trol 2		√	√	√	--
INNOVANCE D-Dimer Control 1		--	--	--	√
INNOVANCE D-Dimer Control 2		--	--	--	√
Coagpia Control N	日本积水医疗株式会社	√	√	√	--
Coagpia Control P		√	√	√	--
FDP control L		--	--	--	√
FDP control H		--	--	--	√
Lyphocheck Hemostasis control 2	美国Bio-Rad公司	√	√	√	--
Lyphocheck Hemostasis control 3		√	√	√	--

检测项目	CA7000	Top700	CP2000
PT	Thromborel S	RecombiPlasTin 2G	Coagpia PT-N
APTT	Dade Actin Activated Cephaloplastin Reagent	SynthASil APTT Reagent	Coagpia APTT-N
Fib	Dade Thrombin Reagent	HemosIL Fibrinogen-C XL	Coagpia Fbg
TT	Test Thrombin Reagent	HemosIL Thrombin Time	Test Thrombin Reagent
FDP	Nanopia P-FDP	Nanopia P-FDP	Nanopia P-FDP
DD	INNOVANCE D-Dimer	HemosIL D-Dimer	Nanopia D-dimer

检测项目	CA7000	Top700	CP2000
PT	Thromborel S	RecombiPlasTin 2G	Coagpia PT-N
APTT	Dade Actin Activated Cephaloplastin Reagent	SynthASil APTT Reagent	Coagpia APTT-N
Fib	Dade Thrombin Reagent	HemosIL Fibrinogen-C XL	Coagpia Fbg
TT	Test Thrombin Reagent	HemosIL Thrombin Time	Test Thrombin Reagent
FDP	Nanopia P-FDP	Nanopia P-FDP	Nanopia P-FDP
DD	INNOVANCE D-Dimer	HemosIL D-Dimer	Nanopia D-dimer

检测系统	PT	PT-INR	APTT	Fib
CP2000和CA7000	Y=0.830X+1.970, r²=0.948	Y=0.929X+0.078, r²=0.958	Y=0.792X+1.131, r²=0.754	Y=0.908X+9.039, r²=0.971
CP2000和Top700	Y=0.977X-0.699, r²=0.955	Y=1.088X-0.019, r²=0.976	Y=0.459X+14.88, r²=0.569	Y=0.764X+36.99, r²=0.917
CA7000和Top700	Y=1.049X-1.252, r²=0.964	Y=1.136X-0.065, r²=0.958	Y=0.561X+14.87, r²=0.708	Y=0.837X+30.79, r²=0.934
检测系统	TT	DD	FDP
CP2000和CA7000	Y=0.757X+7.138, r² =0.652	Y=0.737X+0.138, r²=0.928	Y=1.228X-1.700, r²=0.996
CP2000和Top700	Y=0.912X-0.529, r²=0.738	Y=0.277X-0.072, r²=0.937	Y=0.893X+0.022, r²=0.992
CA7000和Top700	Y=0.913X-3.300, r²=0.649	Y=0.366X-0.094, r²=0.957	Y=0.726X+1.277, r²=0.993

3种检测系统常规血液凝固试验结果一致性比较

Comparison of the results' consistency of 3 automated coagulation analyzers for coagulation items

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Metrics

质控物名称	PT			Fib			DD
质控物名称	CA7000与CP2000	Top700与CP2000	CA7000与Top700	CA7000与CP2000	Top700与CP2000	CA7000与Top700	CA7000与CP2000	Top700与CP2000	CA7000与Top700
STA-Coag Control N	- -	+++	+++	○	- - -	- - -	NA	NA	NA
STA-Coag Control P	- - -	- - -	+++	+++	+++	+++	NA	NA	NA
Lyphocheck Hemostasis Control 2	- - -	○	+++	+	+	++	NA	NA	NA
Lyphocheck Hemostasis Control 3	- - -	-	+++	+++	- -	- -	NA	NA	NA
HemosIL Special Test Control Level 1	○	+++	+++	- -	- - -	-	NA	NA	NA
HemosIL Special Test Control Level 2	○	+	+++	-	+++	+++	NA	NA	NA
Dade Ci-Trol 1	○	+	+++	-	+++	+++	NA	NA	NA
Dade Ci-Trol 2	-	+	+++	-	+++	+++	NA	NA	NA
Coagpia Control N	○	/	/	- -	○	++	NA	NA	NA
Coagpia Control P	- -	+++	+++	-	○	+	NA	NA	NA
Emo D-Di QC1	NA	NA	NA	NA	NA	NA	+	- - -	- - -
Emo D-Di QC2	NA	NA	NA	NA	NA	NA	/	- - -	/
HemosIL D-Dimer Controls 1	NA	NA	NA	NA	NA	NA	-	+++	+++
HemosIL D-Dimer Controls 2	NA	NA	NA	NA	NA	NA	- -	+++	+++
INNOVANCE D-Dimer Controls 1	NA	NA	NA	NA	NA	NA	- - -	+++	+++
INNOVANCE D-Dimer Controls 2	NA	NA	NA	NA	NA	NA	- -	-	○
FDP Control L	NA	NA	NA	NA	NA	NA	- - -	-	+++
FDP Control H	NA	NA	NA	NA	NA	NA	- - -	- - -	++

[1]	Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples[S]. EP9-A2,CLSI,2002.
[2]	张芹,欧阳红梅,甸自金,等. 2种全自动血凝分析仪凝血四项检测结果的比对研究[J]. 国际检验医学杂志, 2013,34(2):205-206.
[3]	颜存粮,彭黎明,黄海雄. 不同血凝分析仪检测结果的一致性研究[J]. 中华检验医学杂志, 2008,31(1):100-103.
[4]	SOLANO C, ZERAFA P, BIRD R.A study of atypical APTT derivative curves on the ACL TOP coagulation analyser[J]. Int J Lab Hematol, 2011,33(1):67-78.
[5]	FLANDERS M M, CRIST R, RODGERS G M.Comparison of five thrombin time reagents[J]. Clin Chem, 2003,49(1):169-172.
[6]	王延群,孙子涵,姚飞,等. 两种试剂检测D-二聚体结果比较[J]. 临床检验杂志, 2014,32(2):155.
[7]	LONG T.Statistical power in the detection of matrix effects[J]. Arch Pathol Lab Med, 1993,117(4):387-392.

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