Clinical evaluation of homemade Precil C3510 automatic coagulation analyzer for routine coagulation parameters

doi:10.3969/j.issn.1673-8640.2020.06.018

Abstract

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

CLC Number:

R446.1

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.

Figures/Tables 8

References 17

[1]	张强,宗晓龙,李东明,等. 用EP9-A3评价2种血凝分析仪凝血酶原时间检测结果的一致性[J]. 临床检验杂志,2019,37(1):71-74.
[2]	GEENS T,VERTESSEN F,MALFAIT R,et al.Validation of the Sysmex CS5100 coagulation analyzer and comparison to the Stago STA-R analyzer for routine coagulation parameters[J]. Int J Lab Hematol,2015,37(3):372-381.
[3]	Clinical and Laboratory Standards Institute. Users verification of precision and estimation of bias;approved guideline-third edition[S]. EP15-A3,CLSI,2014.
[4]	Clinical and Laboratory Standards Institute. Interference testing in clinical chemistry;approved guideline-second edition[S]. EP7-A2,CLSI,2005.
[5]	聂滨,陶天陆,黄涛,等. 应用EP7-A2文件评价免疫比浊法测定D-二聚体抗脂浊能力[J]. 检验医学,2015,30(4):324-326.
[6]	Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures:a statistical approach;approved guideline[S]. EP6-A,CLSI,2003.
[7]	李雯,何爱丽,张雯,等. 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.
[8]	Clinical and Laboratory Standards Institute. Defining establishing and verifying reference intervals in the clinical laboratory;approved guideline-third edition[S]. C28-A3,CLSI,2008.
[9]	Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples;approved guideline-third edition[S]. EP9-A3,CLSI,2013.
[10]	NOGUÉS-SABATÉ A,AVILES-JURADO F X,RUIZ-SEVILLA L,et al. Intra and interobserver agreement of narrow band imaging for the detection of head and neck tumors[J]. Eur Arch Otorhinolaryngol,2018,275(9):2349-2354.
[11]	王霞,毛志刚,周静,等. 应用活化部分凝血活酶时间监测普通肝素抗凝治疗范围的建立[J]. 现代预防医学,2010,37(22):4374-4375.
[12]	Clinical and Laboratory Standards Institute. One-stage prothrombin time(PT)test and activated partial thromboplastin time(APTT)test;approved guideline-second edition[S]. H47-A2,CLSI,2008.
[13]	Clinical and Laboratory Standards Institute. Protocol for the evaluation,validation,and implementation of coagulometers;approved guideline[S]. H57-A,CLSI,2008.
[14]	FRITSMA G A,DEMBITZER F R,RANDHAWA A,et al.Recommendations for appropriate activated partial thromboplastin time reagent selection and utilization[J]. Am J Clin Pathol,2012,137(6):904-908.
[15]	寿玮龄,陈倩,张建平,等. APTT ACTIN试剂和APTT ACTIN FSL试剂临床应用比较[J]. 临床检验杂志,2019,37(6):456-460.
[16]	MARTINUZZO M,BARRERA L,RODRIGUEZ M.Do PT and APTT sensitivities to factors' deficiencies calculated by the H47-A2 2008 CLSI guideline reflect the deficiencies found in plasmas from patients?[J]. Int J Lab Hematol,2015,37(6):853-860.
[17]	TREICHL B,BACHLER M,LORENZ I,et al.Efficacy of argatroban in critically ill patients with heparin resistance:a retrospective analysis[J]. Semin Thromb Hemost,2015,41(1):61-67.

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