Determination of high-concentration enzyme samples by FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer

doi:10.3969/j.issn.1673-8640.2016.08.012

Abstract

Abstract:

Objective To investigate the performance of FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer in the determination of high-concentration enzyme samples. Methods The high-concentration alanine aminotransferase （ALT）and aspartate aminotransferase（AST）samples（ALT：2 185-5 240 U/L,AST：2 520-6 625 U/L）were determined by FLEX mode and manual dilution mode,the relative deviation of 2 modes was calculated,and the 2 modes were analyzed by linear regression analysis. Results The relative deviation was <6% between FLEX mode and manual dilution mode,which met the health industry standard WS/T403-2012 requirements. The linear regression analysis showed that the 2 modes had a good correlation [ALT：coefficient of determination（R²）=0.999,P<0.001;AST：R²=0.999,P<0.001]. The medical decision levels of high-concentration ALT and AST generated into regression equation,and the relative deviations were 1.9% and 2.2% for calculating medical decision levels. Less than half of allowable total error from the Clinical Laboratory Improvement Amendments in 1988（CLIA'88）was used as clinical acceptable level. Conclusions The reportable range of enzyme activity determination is expanded by FLEX mode,which can ensure obtaining results accurately and rapidly and improve work efficiency, and FLEX mode is of significance.

Key words: FLEX mode, Alanine aminotransferase, Aspartate aminotransferase

CLC Number:

R446.1

TIAN Honglun, YIN Ke, HE Jun, LEI Wenmei, ZHANG Ziping. Determination of high-concentration enzyme samples by FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer[J]. Laboratory Medicine, 2016, 31(8): 684-687.

样本号	对照样本（U/L）			回收样本（U/L）			回收浓度（U/L）	加入浓度（U/L）	回收率（%）
样本号	结果1	结果2	均值	结果1	结果2	均值	回收浓度（U/L）	加入浓度（U/L）	回收率（%）
1	1 135	1 123	1 129.0	1 392	1 388	1 390.0	261.0	287.7	90.7
2	1 675	1 690	1 682.5	1 978	1 977	1 977.5	295.0	287.7	102.5
3	1 984	2 050	2 017.0	2 317	2 308	2 312.5	295.5	287.7	102.7

样本号	对照样本（U/L）			回收样本（U/L）			回收浓度（U/L）	加入浓度（U/L）	回收率（%）
样本号	结果1	结果2	均值	结果1	结果2	均值	回收浓度（U/L）	加入浓度（U/L）	回收率（%）
1	1 135	1 123	1 129.0	1 392	1 388	1 390.0	261.0	287.7	90.7
2	1 675	1 690	1 682.5	1 978	1 977	1 977.5	295.0	287.7	102.5
3	1 984	2 050	2 017.0	2 317	2 308	2 312.5	295.5	287.7	102.7

样本号	对照样本（U/L）			回收样本（U/L）			回收浓度（U/L）	加入浓度（U/L）	回收率（%）
样本号	结果1	结果2	均值	结果1	结果2	均值	回收浓度（U/L）	加入浓度（U/L）	回收率（%）
1	1 217	1 225	1 221.0	1 599	1 611	1 605	384.0	423.5	90.7
2	1 625	1 632	1 628.5	2 038	2 052	2 045	416.5	423.5	98.3
3	2 389	2 401	2 395.0	2 871	2 783	2 827	432.0	423.5	102.0

样本号	对照样本（U/L）			回收样本（U/L）			回收浓度（U/L）	加入浓度（U/L）	回收率（%）
样本号	结果1	结果2	均值	结果1	结果2	均值	回收浓度（U/L）	加入浓度（U/L）	回收率（%）
1	1 217	1 225	1 221.0	1 599	1 611	1 605	384.0	423.5	90.7
2	1 625	1 632	1 628.5	2 038	2 052	2 045	416.5	423.5	98.3
3	2 389	2 401	2 395.0	2 871	2 783	2 827	432.0	423.5	102.0

样本号	FLEX模式（U/L）		稀释模式（U/L）		相对偏差（%）
样本号	ALT	AST	ALT	AST	ALT	AST
1	2 187	2 740	2 260	2 790	3.23	1.79
2	2 861	4 410	2 895	4 520	1.17	2.43
3	2 788	4 831	2 835	4 920	1.66	1.81
4	4 410	4 791	4 520	4 875	2.43	1.72
5	3 128	3 318	3 190	3 410	1.94	2.70
6	3 985	4 862	4 165	4 950	4.32	1.78
7	4 133	5 341	4 190	5 455	1.36	2.09
8	3 027	2 867	3 085	2 910	1.88	1.48
9	2 840	3 241	2 890	3 320	1.73	2.38
10	2 482	3 737	2 520	3 800	1.51	1.66
11	2 149	4 653	2 185	4 710	1.65	1.21
12	2 739	2 487	2 810	2 520	2.53	1.31
13	4 214	3 708	4 290	3 800	1.77	2.42
14	2 504	3 545	2 565	3 650	2.38	2.88
15	2 428	6 502	2 480	6 625	2.10	1.86
16	2 455	2 671	2 510	2 715	2.19	1.62
17	5 145	3 273	5 240	3 320	1.81	1.42
18	3 824	3 894	3 890	3 960	1.70	1.67
19	3 430	2 831	3 515	2 875	2.42	1.53
20	2 256	2 750	2 325	2 815	2.97	2.31

Determination of high-concentration enzyme samples by FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer

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项目	可接受性能 [1/2TEa（%）]	Xc （U/L）	FLEX模式
项目	可接受性能 [1/2TEa（%）]	Xc （U/L）	检测结果（U/L）	偏差（U/L）	相对偏差（%）
ALT	10	300	294.3	5.7	1.9
AST	10	300	293.5	6.5	2.2

[1]	岳展伊,唐古生,杜大海,等. 全自动生化分析仪检测酶活性过程中底物耗尽的监测和处理[J]. 国际检验医学杂志,2010,31(4):414-415.
[2]	冯念伦,范卫华,范刚. 全自动生化分析仪弹性速率测定法解析[J]. 医疗设备信息,2005,20(8):23-24.
[3]	卫生部临床检验标准专业委员会. WS/T403-2012 临床生物化学检验常规项目分析质量指标[S]. 北京:中国标准出版社,2012.
[4]	Clinical and Laboratory Standards Instituts. Method comparison and bias estimation using patient samples[S]. EP9-A2,CLSI,2002.
[5]	宋云霄,张海晨,袁文华,等. 读点前移模式在拜耳ADVIA 1650全自动生化分析仪上的特点评价及临床应用[J]. 检验医学,2010,25(1):1-3.
[6]	国秀芝,吴洁,侯立安,等. 五种可溯源胱抑素C检测系统结果的一致性评价[J]. 中华检验医学杂志,2014,37(5):365-370.

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[3]	LIU Wenhui, BAI Jin'e, ZHANG Hui. Relations of serum alanine aminotransferase and gamma-glutamyltransferase with type 2 diabetes mellitus [J]. Laboratory Medicine, 2018, 33(1): 20-25.
[4]	OU Yuanzhu, YU Xiaoxuan, TANG Liping, JU Yi, WANG Meijuan, LIU Wenbin, JIN Zhonggan. Stability of alanine aminotransferase trueness control samples [J]. Laboratory Medicine, 2017, 32(8): 713-717.
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[7]	LIU Weiping, YI Qin, YIN Minggang.. Establishment and assessment of the cut-off value for ALT and HBV DNA combination determination to diagnose HBeAg negative chronic active hepatitis B [J]. , 2014, 29(5): 483-487.
[8]	TONG Hongmei. Analysis on serum ALT detection results and influence factors in the fresh students from some universities of Gansu province 2008-2010 year [J]. , 2013, 28(2): 117-119.
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