国产Precil C3510全自动血凝分析仪检测常规凝血项目临床评价

doi:10.3969/j.issn.1673-8640.2020.06.018

摘要/Abstract

摘要：

目的评价国产Precil C3510全自动血凝分析仪（简称Precil C3510）检测常规凝血项目[凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原（Fib）、D-二聚体（DD）]临床性能及在华法林和普通肝素抗凝治疗效果监测中的应用。方法依据美国临床实验室标准化协会（CLSI）相关指南对Precil C3510检测PT、APTT、Fib、DD不精密度、抗干扰能力、线性、参考区间进行验证。同时,以STA-Compact全自动血凝分析仪（简称STA-Compact）为参考,应用Spearman相关分析、Passing-Bablok回归分析及Bland-Altman图对Precil C3510进行一致性评价。评价Precil C3510检测口服华法林患者国际标准化比值（INR）与STA-Compact检测结果的一致性。以STA-R Evolution全自动血凝分析仪（简称STA-R Evolution）检测的抗Xa活性（0.3~0.7 IU/mL）为标准,探讨Precil C3510监测普通肝素治疗的APTT参考区间。结果 Precil C3510不精密度、线性、参考区间均符合相应标准。3.2 mg/mL及更高浓度的三酰甘油对DD测定值有负干扰。2台仪器PT、Fib测定值具有较好的一致性（无系统差异、比例差异、随机差异,且偏移在临床接受区间内）;APTT测定值存在系统差异[回归方程截距为-18.121 6,95%可信区间（CI）为-26.003 9~-12.522 1]、比例差异（斜率为1.261 8,95%CI为1.123 4~1.435 6）、随机差异（92.31%的偏移位于±1.96 s区间内）、平均偏移（-18.9%,95%CI为-22.9%~-14.9%）不在临床接受区间内（-7.5%~7.5%）。2台仪器基于各自参考区间对APTT结果的判定具有较好的一致性（Kappa=0.87,95%CI为0.74~0.99）。Precil C3510检测普通肝素抗凝治疗的APTT参考范围为62~108.1 s。2台仪器的口服华法林患者INR具有较好的一致性[35例（87.5%）患者INR差异<0.5]。结论 Precil C3510在常规凝血项目检测中具有良好的分析性能,可用于华法林和普通肝素抗凝治疗的临床监测。

关键词: 血凝分析仪, 性能验证, 临床评价, 华法林, 普通肝素, 抗凝治疗

Abstract:

Objective To evaluate the clinical performance of homemade Precil C3510 automatic coagulation analyzer for routine coagulation parameters [prothrombin time（PT）,activated partial thromboplastin time（APTT）,fibrinogen（Fib） and D-dimer（DD）] and its application in monitoring the efficiency of warfarin and unfractionated heparin anticoagulant therapy. Methods According to the Clinical and Laboratory Standards Institute（CLSI） guidelines,the imprecision,interference,linearity and reference intervals of Precil C3510 for the determinations of PT,APTT,Fib and DD were validated. The consistency between Precil C3510 and STA-Compact automatic coagulation analyzer（STA-Compact） was evaluated by Spearman correlation,Passing-Bablok regression and Bland-Altman plot with STA-Compact as a reference system. The consistency of the international normalized ratio（INR） between Precil C3510 and STA-Compact for patients receiving warfarin therapy was evaluated. APTT monitoring range for Precil C3510 based on the standard of 0.3-0.7 IU/mL of anti-Xa activity determined by STA-R Evolution was investigated. Results The imprecision,linearity and reference intervals of Precil C3510 met the manufacturers' requirements. Triglyceride with 3.2 mg/mL and more higher concentrations had a negative effect on DD. The 2 instruments had good consistency in determining PT and Fib. There was no systematic,proportional and random differences,and the deviations were within clinical acceptance interval. APTT determined by the 2 instruments had systematic difference [regression equation intercept was -18.121 6,95% confidence interval（CI） -26.003 9--12.522 1],proportional difference （slope was 1.261 8,95%CI 1.123 4-1.435 6） and random difference（the bias within ±1.96s accounting for 92.31%）,and the average bias （-18.9%,95%CI -22.9%--14.9%）was not within the clinical acceptance interval（-7.5%-7.5%）. The results of the 2 instruments had a consistency in judging APTT based on their respective reference intervals（Kappa value was 0.87,95%CI 0.74-0.99）. The APTT-based unfractionated heparin anticoagulant therapeutic range of Precil C3510 was 62-108.1 s. The INR of 35 patients（87.5%）receiving warfarin therapy showed a INR difference<0.5,indicating a good correlation between the 2 instruments. Conclusions Precil C3510 has good analytical performance for routine coagulation parameters,and it can be used to monitor the anticoagulation effect of warfarin and unfractionated heparin for routine analysis.

Key words: Coagulation analyzer, Performance verification, Clinical evaluation, Warfarin, Unfractionated heparin, Anticoagulant therapy

中图分类号:

R446.1

张强, 林静, 宗晓龙, 孙光, 刘军锋. 国产Precil C3510全自动血凝分析仪检测常规凝血项目临床评价[J]. 检验医学, 2020, 35(6): 601-608.

ZHANG Qiang, LIN Jing, ZONG Xiaolong, SUN Guang, LIU Junfeng. Clinical evaluation of homemade Precil C3510 automatic coagulation analyzer for routine coagulation parameters[J]. Laboratory Medicine, 2020, 35(6): 601-608.

图/表 8

参考文献 17

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项目	$\bar{x}$	批内不精密度			实验室内总不精密度			允许范围/%
项目	$\bar{x}$	MS_批内	s_批内	CV/%	MS_批间	s_总	CV%	允许范围/%
生理值质控品
PT/s	11.84	0.026	0.16	1.35	0.06	0.18	1.53	±3
INR	0.96	0.000 27	0.016	1.71	0.000 65	0.019	1.93	±3
APTT/s	36.27	0.35	0.59	1.63	0.51	0.62	1.70	±4
Fib/（g/L）	2.72	0.017	0.13	4.79	0.011	0.13	4.79	±8
DD/（mg/L）	0.68	0.001 4	0.037	5.50	0.004 3	0.044	6.54	±10
病理值质控品
PT/s	38.1	1.94	1.39	3.65	5.85	1.65	4.34	±8
INR	3.92	0.024	0.15	3.83	0.07	0.18	4.63	±8
APTT/s	69.63	6.28	2.51	3.60	40.03	3.61	5.19	±8
Fib/（g/L）	1.87	0.008 4	0.084	5.35	0.007	0.092	5.86	±15
DD/（mg/L）	1.83	0.02	0.14	7.73	0.084	0.18	9.90	±15

项目	$\bar{x}$	批内不精密度			实验室内总不精密度			允许范围/%
项目	$\bar{x}$	MS_批内	s_批内	CV/%	MS_批间	s_总	CV%	允许范围/%
生理值质控品
PT/s	11.84	0.026	0.16	1.35	0.06	0.18	1.53	±3
INR	0.96	0.000 27	0.016	1.71	0.000 65	0.019	1.93	±3
APTT/s	36.27	0.35	0.59	1.63	0.51	0.62	1.70	±4
Fib/（g/L）	2.72	0.017	0.13	4.79	0.011	0.13	4.79	±8
DD/（mg/L）	0.68	0.001 4	0.037	5.50	0.004 3	0.044	6.54	±10
病理值质控品
PT/s	38.1	1.94	1.39	3.65	5.85	1.65	4.34	±8
INR	3.92	0.024	0.15	3.83	0.07	0.18	4.63	±8
APTT/s	69.63	6.28	2.51	3.60	40.03	3.61	5.19	±8
Fib/（g/L）	1.87	0.008 4	0.084	5.35	0.007	0.092	5.86	±15
DD/（mg/L）	1.83	0.02	0.14	7.73	0.084	0.18	9.90	±15

干扰物	浓度/ （mg/mL）	PT		APTT		Fib		DD
干扰物	浓度/ （mg/mL）	$\bar{x}$/s	d_obs	$\bar{x}$/s	d_obs	$\bar{x}$/（g/L）	d_obs	$\bar{x}$/（mg/L）	d_obs
对照	0	13.1		29.8		3.12		1.16
血红蛋白	1	13.2	0.1	30.3	0.5	3.06	-0.06	1.16	0.00
	2	13.1	0.0	30.1	0.3	3.15	0.03	1.17	0.01
	3	12.7	-0.4	29.4	-0.4	3.21	0.09	1.11	-0.05
	4	13.4	0.3	30.6	0.8	2.98	-0.14	1.08	-0.08
	5	12.9	-0.2	28.4	-1.4	3.20	0.08	1.06	-0.10
三酰甘油	0.8	12.9	-0.2	30.3	0.5	3.12	0.00	1.12	-0.04
	1.6	13.1	0.0	30.5	0.7	3.07	-0.05	1.09	-0.07
	2.4	13.1	0.0	28.9	-0.9	3.22	0.10	0.99	-0.17
	3.2	13.2	0.1	30.3	0.5	3.00	-0.12	0.94	-0.22
	4.0	13.3	0.2	31.1	1.3	3.19	0.07	0.86	-0.30
胆红素	0.06	13.5	0.4	30.0	0.2	3.11	-0.01	1.15	-0.01
	0.12	13.3	0.2	30.2	0.4	2.91	-0.21	1.18	0.02
	0.18	12.9	-0.2	29.8	0.0	3.28	0.16	1.09	-0.07
	0.24	13.1	0.0	31.5	1.7	2.99	-0.13	1.11	-0.05
	0.30	12.8	-0.3	31.1	1.3	3.15	0.03	1.07	-0.09

干扰物	浓度/ （mg/mL）	PT		APTT		Fib		DD
干扰物	浓度/ （mg/mL）	$\bar{x}$/s	d_obs	$\bar{x}$/s	d_obs	$\bar{x}$/（g/L）	d_obs	$\bar{x}$/（mg/L）	d_obs
对照	0	13.1		29.8		3.12		1.16
血红蛋白	1	13.2	0.1	30.3	0.5	3.06	-0.06	1.16	0.00
	2	13.1	0.0	30.1	0.3	3.15	0.03	1.17	0.01
	3	12.7	-0.4	29.4	-0.4	3.21	0.09	1.11	-0.05
	4	13.4	0.3	30.6	0.8	2.98	-0.14	1.08	-0.08
	5	12.9	-0.2	28.4	-1.4	3.20	0.08	1.06	-0.10
三酰甘油	0.8	12.9	-0.2	30.3	0.5	3.12	0.00	1.12	-0.04
	1.6	13.1	0.0	30.5	0.7	3.07	-0.05	1.09	-0.07
	2.4	13.1	0.0	28.9	-0.9	3.22	0.10	0.99	-0.17
	3.2	13.2	0.1	30.3	0.5	3.00	-0.12	0.94	-0.22
	4.0	13.3	0.2	31.1	1.3	3.19	0.07	0.86	-0.30
胆红素	0.06	13.5	0.4	30.0	0.2	3.11	-0.01	1.15	-0.01
	0.12	13.3	0.2	30.2	0.4	2.91	-0.21	1.18	0.02
	0.18	12.9	-0.2	29.8	0.0	3.28	0.16	1.09	-0.07
	0.24	13.1	0.0	31.5	1.7	2.99	-0.13	1.11	-0.05
	0.30	12.8	-0.3	31.1	1.3	3.15	0.03	1.07	-0.09

项目	线性比例	第1次	第2次	第3次	$\bar{x}$	理论值
Fib	5H	7.60	7.67	7.62	7.63	7.63
	4H+1L	6.12	5.83	6.01	5.99	6.24
	3H+2L	5.01	5.07	4.91	5.00	4.85
	2H+3L	3.70	3.71	3.64	3.68	3.47
	1H+4L	2.13	2.18	2.15	2.15	2.08
	5L	0.67	0.68	0.72	0.69	0.69
DD	5H	9.49	9.42	9.55	9.49	9.49
	4H+1L	8.28	8.44	8.62	8.45	7.69
	3H+2L	6.08	6.02	6.02	6.04	5.89
	2H+3L	4.06	4.11	4.15	4.11	4.08
	1H+4L	2.28	2.13	2.25	2.22	2.28
	5L	0.50	0.47	0.47	0.48	0.48