A multi-center evaluation of a domestic glutathione reductase determination kit

doi:10.3969/j.issn.1673-8640.2022.05.011

Laboratory Medicine ›› 2022, Vol. 37 ›› Issue (5): 449-455.DOI: 10.3969/j.issn.1673-8640.2022.05.011

• Original article • Previous Articles Next Articles

A multi-center evaluation of a domestic glutathione reductase determination kit

ZHU Yuqing¹, WANG Haibin², WANG Lianming³, ZHAO Fang⁴, FENG Pinning⁵, ZHANG Peng⁶, GUO Shuren⁷, PENG Yibing⁸, CHENG Liming⁹, CHUAN Liangmin¹⁰, WANG Hualiang¹()

1. Department of Clinical Chemistry and Immunology,Shanghai Center for Clinical Laboratory,Shanghai 200126,China
2. Clinical Laboratory Center,Chinese People's Liberation Army General Hospital,Beijing 100039,China
3. Department of Clinical Laboratory,the First Affiliated Hospital of Harbin Medical University,Harbin 150001,Heilongjiang,China
4. Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China
5. Department of Clinical Laboratory,the First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080,Guangdong,China
6. Department of Clinical Laboratory,Nanfang Hospital,Southern Medical University,Guangzhou 510515,Guangdong,China
7. Department of Clinical Laboratory,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,Henan,China
8. Department of Clinical Laboratory,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China
9. Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei,China
10. Department of Clinical Laboratory,Sichuan Provincial People's Hospital,Chengdu 610072,Sichuan,China

Received:2021-11-30 Revised:2022-01-25 Online:2022-05-30 Published:2022-07-20
Contact: WANG Hualiang

Abstract

Abstract: Objective To investigate the performance of a domestic glutathione reductase（GR） determination kit through a multi-center evaluation. Methods Totally,9 clinical laboratories of tertiary hospitals located in different geographic regions of China formed a multi-center evaluation group. According to the same evaluation scheme,the repeatability,within-laboratory precision,between-run variations,linearities,the maximum dilution ratio and estimation of bias of a domestic GR determination kit were investigated,which were classified and compared. Results The repeatability and within-laboratory precision of the 9 laboratories met the requirements [less than 1/4 standard of external quality assessment（EQA）（5%） and 1/3 standard of EQA（6.67%）,respectively]. Except a low-level sample of one laboratory and a middle-level sample of another laboratory（>8%）,the between-run variations of all the other laboratories met the manufacturer's stated requirements. All the laboratories demonstrated the linear range claimed by the manufacturer. The recovery rates at maximum dilution ratio（5 times） of the 9 laboratories were 92.6%-106.3%. In the estimation of bias by using 40 patient samples compared with imported reagent,the correlation coefficients（r） were 0.997-1.000,the biases were less than 1/2 standard of EQA（10%）. There was a significant correlation among the results of the 9 laboratories in the imported group and the domestic group respectively（P<0.01）. The consistency of imported reagent and domestic reagent was good,and the difference of paired t-test was not significant statistically（P>0.05）,and the correlation coefficients（r） were 1.000（P<0.01）. The average coefficient of variation（CV） of imported reagent and domestic reagent was 6.48% and 6.68%,respectively. Pairwise paired t-test was performed on the results of instrument group A,B and C. There was statistical significance between group B and C for domestic reagent（P<0.01）. There was statistical significance between group A and C,B and C for imported reagent（P<0.01）. Conclusions The results of the multi-center evaluation show that the performance of the domestic GR reagent is good,and it can meet the clinical determination needs.

Key words: Glutathione reductase, Multi-center evaluation, Determination performance

ZHU Yuqing, WANG Haibin, WANG Lianming, ZHAO Fang, FENG Pinning, ZHANG Peng, GUO Shuren, PENG Yibing, CHENG Liming, CHUAN Liangmin, WANG Hualiang. A multi-center evaluation of a domestic glutathione reductase determination kit[J]. Laboratory Medicine, 2022, 37(5): 449-455.

Figures/Tables 7

References 15

[1]	COUTO N, WOOD J, BARBER J. The role of glutathione reductase and related enzymes on cellular redox homoeostasis network[J]. Free Radic Biol Med, 2016, 95:27-42. DOI URL
[2]	BREWSTER M A, BERRY D H, MURPHEY M N. Automated reaction rate analysis of erythrocyte glucose-6-phosphate dehydrogenase and glutathione reductase activities[J]. Biochem Med, 1974, 10(3):229-235. DOI URL
[3]	MELISSINOS K G, DELIDOU A Z, VARSOU AG,et al.
	Serum and erythrocyte glutathione reductase activity in chronic renal failure[J]. Nephron, 1981, 28(2):76-79. DOI URL
[4]	YOSHIDA K, HIROKAWA J, TAGAMI S, et al. Weakened cellular scavenging activity against oxidative stress in diabetes mellitus:regulation of glutathione synthesis and efflux[J]. Diabetologia, 1995, 38(2):201-210. DOI URL
[5]	褚玲, 谢军, 王雨婷. 谷胱甘肽还原酶在心脑血管疾病中的应用[J]. 临床检验杂志(电子版), 2020, 9(3):157-159.
[6]	蔡鹏, 刘叙仪, 王萍. 谷胱甘肽还原酶循环法测定血浆谷胱甘肽含量在肿瘤化疗中的意义[J]. 中国肿瘤临床, 1994, 32(10):6-8.
[7]	李淑丽, 陆善词, 王军, 等. 血清谷胱甘肽还原酶活性水平评估乙型肝炎肝损伤患者的临床价值[J]. 国际检验医学杂志, 2020, 41(15):1844-1848.
[8]	中国合格评定国家认可委员会. CNAS-GL037 临床化学定量检验程序性能验证指南[S]. 北京: 中国合格评定国家认可委员会, 2019.
[9]	中华人民共和国国家卫生和计划生育委员会. WS/T 492—2016临床检验定量测定项目精密度与正确度性能验证[S]. 北京: 中华人民共和国国家卫生和计划生育委员会, 2016.
[10]	中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. GB/T 26124临床化学体外诊断试剂(盒)[S]. 北京: 中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会, 2007.
[11]	中华人民共和国卫生部. WS/T 408—2012临床化学设备线性评价指南[S]. 北京: 中国标准出版社, 2012.
[12]	张秀明. 浅析定量检验程序分析性能验证实验方案设计[J]. 中华检验医学杂志, 2015, 38(6):428-430.
[13]	李萍萍, 杨阳, 华玉涛. 我国体外诊断产业现状及发展建议[J]. 检验医学与临床, 2019, 16(12):1783-1786.
[14]	中国合格评定国家认可委员会. CNAS-CL02-A003医学实验室质量和能力认可准则在临床化学检验领域的应用说明[S]. 北京: 中国合格评定国家认可委员会, 2018.
[15]	中国合格评定国家认可委员会. CNAS-CL 02 医学实验室质量和能力认可准则[S]. 北京: 中国合格评定国家认可委员会, 2012.

实验室序号	CV
实验室序号	L1	L2	L3
1	3.91	4.08	1.51
2	2.46	3.89	1.57
3	2.36	1.47	1.01
4	2.63	2.05	1.50
5	2.96	2.14	1.29
6	2.87	2.00	1.31
7	3.47	2.55	1.12
8	1.27	1.05	0.68
9	3.53	2.58	1.52
x	2.83	2.42	1.28

实验室序号	CV
实验室序号	L1	L2	L3
1	3.91	4.08	1.51
2	2.46	3.89	1.57
3	2.36	1.47	1.01
4	2.63	2.05	1.50
5	2.96	2.14	1.29
6	2.87	2.00	1.31
7	3.47	2.55	1.12
8	1.27	1.05	0.68
9	3.53	2.58	1.52
x	2.83	2.42	1.28

实验室序号	CV
实验室序号	L1	L2	L3
1	3.29	2.19	1.88
2	4.01	5.05	3.16
3	3.21	2.84	2.85
4	1.81	5.48	1.48
5	2.15	2.77	1.51
6	4.62	4.40	1.76
7	2.37	1.54	1.07
8	2.77	2.88	2.40
9	4.15	3.83	2.48
x	3.15	3.44	2.07

实验室序号	CV
实验室序号	L1	L2	L3
1	3.29	2.19	1.88
2	4.01	5.05	3.16
3	3.21	2.84	2.85
4	1.81	5.48	1.48
5	2.15	2.77	1.51
6	4.62	4.40	1.76
7	2.37	1.54	1.07
8	2.77	2.88	2.40
9	4.15	3.83	2.48
x	3.15	3.44	2.07

实验室序号	批间差
实验室序号	L1	L2	L3
1	2.7	2.7	4.3
2	5.8	2.3	2.5
3	2.9	5.8	4.6
4	3.2	3.6	3.6
5	0.7	0.9	1.4
6	11.6	3.0	1.5
7	0.7	0.4	1.5
8	7.5	2.6	2.8
9	3.5	10.1	6.1
总体	2.8	0.5	0.6

A multi-center evaluation of a domestic glutathione reductase determination kit

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Figures/Tables 7

References 15

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Metrics

实验室序号	最优拟合方程	r值	ADL/%	ADL临界值/%^[11]	结论
1	Y=1.37X-0.63	1.000			一阶线性
2	Y=1.26X+0.86	1.000			一阶线性
3	Y=-0.000 5X²+1.38X-0.95	1.000	1.30	5.80	二阶线性
4	Y=1.43X-3.37	1.000			一阶线性
5	Y=2.63X-0.54	1.000			一阶线性
6	Y=1.31X+3.02	0.997			一阶线性
7	Y=0.000 003X³-0.001 2X²+1.48X-3.90	1.000	1.70	5.40	二阶线性
8	Y=0.000 4X²+1.22X-0.68	1.000	1.25	5.80	二阶线性
9	Y=1.31X+0.94	1.000			一阶线性

实验室序号	回归方程	r值	偏移/%
1	Y=0.962 1X+0.255 7	0.999	2.52
2	Y=0.971 7X-2.011 9	1.000	5.88
3	Y=1.077 0X-3.142 6	1.000	2.48
4	Y=0.982 2X+3.610 6	1.000	4.75
5	Y=0.960 7X+1.771 6	1.000	0.28
6	Y=1.020 1X-0.740 4	1.000	0.28
7	Y=1.010 5X+2.394 7	1.000	5.71
8	Y=0.969 0X+0.070 8	0.997	1.42
9	Y=0.977 7X+2.193 8	0.999	1.54

配对仪器组	国产试剂		进口试剂
配对仪器组	t值	P值（双侧）	t值	P值（双侧）
A-B	0.386	0.701 6	-1.231	0.228 4
A-C	-0.579	0.565 7	-5.965	0.000 1
B-C	-3.054	0.004 1	-3.881	0.000 6

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