[1]孙江漫,李 敏,孟祥兆,等.胱抑素C国际一级和国家二级标准物质在临床实验室七种常规检测试剂系统中量值传递的应用研究[J].现代检验医学杂志,2025,40(05):189-193.[doi:10.3969/j.issn.1671-7414.2025.05.036]
　SUN Jiangman,LI Min,MENG Xiangzhao,et al.Application of Cystatin C International Primary and National Secondary Reference Materials in Dissemination of Quantity Value for Seven Routine Detection Reagent Systems in Clinical Laboratories[J].Journal of Modern Laboratory Medicine,2025,40(05):189-193.[doi:10.3969/j.issn.1671-7414.2025.05.036]
点击复制

胱抑素C国际一级和国家二级标准物质在临床实验室七种常规检测试剂系统中量值传递的应用研究()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第40卷
期数:
2025年05期
页码:
189-193
栏目:
质量控制·实验室管理
出版日期:
2025-09-15

文章信息/Info

Title:
Application of Cystatin C International Primary and National Secondary Reference Materials in Dissemination of Quantity Value for Seven Routine Detection Reagent Systems in Clinical Laboratories
文章编号:
1671-7414（2025）05-189-05
作者:
孙江漫1，李 敏1，孟祥兆1，于洪远1，陈宝荣2，邵 燕1
1.北京航天总医院检验科，北京100076;2.北京金域医学检验实验室有限公司，北京100015
Author(s):
SUN Jiangman1，LI Min1，MENG Xiangzhao1，YU Hongyuan1，CHEN Baorong2，SHAO Yan1
1.Department of Clinical Laboratory，Beijing Aerospace General Hospital，Beijing 100076，China;2.Beijing KingMed Medical Laboratory Co. Ldt，Beijing 100015，China
关键词:
胱抑素C; 国际一级标准物质; 国家二级标准物质; 量值传递; 方法学比对
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2025.05.036
文献标志码:
A
摘要:
目的评价胱抑素C（CysC）国际一级标准物质及国家二级标准物质在七种常规检测试剂系统中量值传递的应用。方法分别使用临床实验室常用的七种不同厂家CysC试剂同时测量2种标准物质[ERM-DA471/IFCC，GBW(E)091173~6]和42份单人份血清样本。将标准物质理论值和测量值进行线性拟合，单人份血清样本测量值代入拟合方程得出校准值，参考CLSIEP9-A3文件对测量值和校准值进行比对。结果ERM-DA471/IFCC和GBW(E)091173~6理论值和测量值线性拟合方程分别为Y=0.941X+0.159，Y=0.963X+0.162，相关系数均为1.000（以B系统为例）。各系统分析模型均使用Passing-Bablok回归分析。七个系统中经两种标准物质校准的校准值与测量值的比对偏倚分别为-20.38%～10.58%，-16.76%～9.90%，偏倚趋势相同；两种标准物质校准值的比对偏倚为-4.18%～2.31%，标准物质校准对于校准值与测量值比对偏倚超出±4%有明显改善。各系统两两组合中测量值在各医学决定水平处的偏倚为-17.87%～14.97%，GBW(E)091173~6校准值的偏倚为-4.96%～4.51%，大部分在±3%范围内；ERM-DA471/IFCC校准值的偏倚为-3.92%～6.30%，大部分在±4%范围内；其中以GBW(E)091173~6校准值偏倚小于ERM-DA471/IFCC校准值偏倚，ERM-DA471/IFCC校准值偏倚小于测量值偏倚最常见，有51.19%（43/84）的医学决定水平处的比对偏倚数据。结论两种标准物质对常规系统校准均可改善系统间的比对偏倚，GBW(E)091173~6校准效果优于ERM-DA471/IFCC。
Abstract:
Objective To evaluate the application of Cystatin C（Cys C）international primary reference material and national secondary reference materials for quantity transfer in seven conventional systems. Methods Seven Cys C reagents from different manufacturers commonly used in clinical laboratories were used to simultaneously measure two standard substances [ERM-DA471/IFCC, GBW (E) 091173~6] and 42 individual serum samples. The theoretical and measured values of the standard substances were linearly fitted, and the measured values of the single serum samples were substituted into the fitting equation to obtain the calibrated values, and the measured values and calibrated values were compared with CLSI EP9-A3 file. Results The theoretical and measured values of ERM-DA471/IFCC and GBW(E)091173~6 were linearly fitted, and the regression equations were Y=0.941X+0.159，Y=0.963X+0.162，respectively, with correlation coefficients of 1.000 (taking system B as an example). All system analysis models were analyzed using Passing-Bablok regression analysis.The comparison bias between the calibration values and measurement values of two standards in seven systems were -20.38%～10.58% and -16.76%～9.90%, respectively, with the same bias trend. The comparison bias of the calibrated values of the two standard substances was -4.18%～2.31%.The calibration of the standards had a significant improvement for the bias between calibration value and measurement value exceeding ±4%.The bias of the measured values in the pairwise combinations of each system at each medical decision level was-17.87%～14.97% and the bias range of GBW(E)091173~6 calibration values at each medical decision level was-4.96%～4.51%,with most values being less than 3% . The bias of ERM-DA471/IFCC calibration values was -3.92%～6.30%,with most values being less than 4%. Among them, the most common situation was that the bias of ERM-DA471/IFCC calibration value was less than that of measurement value, and the bias of GBW(E)091173~6 calibration value was less than that of ERM-DA471/IFCC calibration value, with 51.19% (43/84) of the comparison bias bata at the level of medical decisionmaking. Conclusion Both reference materials can improve the alignment bias of conventional system, and GBW(E)091173~6 calibration effect is better than ERM-DA471/IFCC.

参考文献/References:

[1] CHEN D W, JIANG L L, TAN Y, et al. Serum cystatin C within 24 hours after admission: a potential predictor for acute kidney injury in Chinese patients with community acquired pneumonia[J]. Renal Failure, 2023, 45(1): 2194444.
[2] CHAI L M, FENG W, ZHAI C, et al. The association between cystatin C and COPD: a meta-analysis and systematic review[J]. BMC Pulmonary Medicine, 2020, 20(1): 182.
[3] 周丽,任娟,秦欢,等.血清hs-CRP，Cys C，UA水平与H型高血压合并脑梗死患者动脉粥样硬化程度的关系研究[J]．国际检验医学杂志,2020,41(12): 1465-1467, 1472． ZHOU L, REN J, QIN H, et al. Study on the relationship between the levels of serum hs-CRP,Cys C,UA and the degree of atherosclerosis in patients with H-type hypertension and cerebral infarction[J]. International Journal of Laboratory Medicine, 2020, 41(12): 1465-1467, 1472.
[4] 王金金,徐黎明,俞宛君,等.医学检验结果同质化管理发展现状与趋势[J].中华预防医学杂志,2023,57 (9):1504-1509. WANG J J, XU L M, YU W J, et al. Current situation and trend of medical laboratory results homogeneity management[J]. Chinese Journal of Preventive Medicine, 2023, 57(9): 1504-1509.
[5] Clinical and Laboratory Standards Institute. CLSI EP9-A3：Measurement procedure comparison and bias estimation using patient samples. Approved guideline-Third edition: [S]. Wayne：PA，CLSI EP9-A3，2013.
[6] 欧元祝,陈宝荣,居漪.临床化学检测的标准化现状[J].检验医学,2021,36(3):240-244. OU Y Z, CHEN B R, JU Y. Current situation of standardization of clinical chemistry measurement[J]. Laboratory Medicine, 2021, 36(3): 240-244.
[7] 孙江漫,李敏,邵燕,等.冰冻人血清胱抑素C标准物质量值传递的评价[J].国际检验医学杂志,2022,43 (24):2829-2832. SUN J M, LI M, SHAO Y, et al. Evaluationon value transfer of cystatin C reference material in frozen human serum[J]. International Journal of Laboratory Medicine, 2022, 43(24): 2829-2832.
[8] 林斐然,欧元祝,刘文彬,等.不同品牌校准品对血清碱性磷酸酶检测结果可比性的影响[J].检验医学, 2022,37(2):183-187. LIN F R, OU Y Z, LIU W B, et al. Influence of different-brand calibrators on the comparability of serum alkaline phosphatase determination results[J]. Laboratory Medicine, 2022, 37(2): 183-187.
[9] 李敏,孙江漫,于洪远,等.不同评价方法对胱抑素C标准物质互换性评价结果的影响[J].标记免疫分析与临床,2021,28(8):1421-1425. LI M, SUN J M, YU H Y, et al. Effects of different evaluation methods on results of commutability[J]. Labeled Immunoassays and Clinical Medicine, 2021, 28(8): 1421-1425.
[10] 张传宝,赵海建,曾洁,等.胱抑素C标准物质 ERM-DA 471/IFCC的互通性研究[J].中华检验医学杂志,2015(5):306-309. ZHANG C B, ZHAO H J, ZENG J, et al. Commutability of certified reference material ERM-DA 471/IFCC for cystatin C measurement[J]. Chinese Journal of Laboratory Medicine, 2015(5): 306-309.

相似文献/References:

[1]沈云峰,胡远贵,张洪波,等.冠状动脉病变程度与血清胱抑素、 一氧化氮及超氧化物歧化酶水平的相关性研究[J].现代检验医学杂志,2015,30(01):82.[doi:10.3969/j.issn.1671-7414.2015.01.022]
　SHEN Yun-feng,HU Yuan-gui,ZHANG Hong-bo,et al.Study on the Relationship between Severity of Coronary Artery Lesion and the Level Cystatin C,Nitric Oxide and Superoxide Dismutase of Serum[J].Journal of Modern Laboratory Medicine,2015,30(05):82.[doi:10.3969/j.issn.1671-7414.2015.01.022]
[2]武冬娜,张文杰,唐招平,等.血清Cys C和24h尿微量清蛋白定量联合检测对妊娠期糖尿病肾病的早期诊断价值[J].现代检验医学杂志,2015,30(02):139.[doi:10.3969/j.issn.1671-7414.2015.02.044]
　WU Dong-na,ZHANG Wen-jie,TANG Zhao-ping,et al.Diagnostic Value of Combined Measuring of Serum Cystatin C and 24 h Urine Microalbumin in Early Gestational Diabetes Kidney Disease[J].Journal of Modern Laboratory Medicine,2015,30(05):139.[doi:10.3969/j.issn.1671-7414.2015.02.044]
[3]尹良琼,余艾霞.降钙素原、胱抑素C联合检测对脓毒症患儿28天死亡率的预测价值研究[J].现代检验医学杂志,2017,32(02):153.[doi:10.3969/j.issn.1671-7414.2017.02.043]
　YIN Liang-qiong,Y Ai-xia.Predictive Value of the Combined Detection of Procalcitonin and Cystatin C in Children with Sepsis 28 Days Mortality[J].Journal of Modern Laboratory Medicine,2017,32(05):153.[doi:10.3969/j.issn.1671-7414.2017.02.043]
[4]黄生金,郑利平,陆俊佳,等.广西地区壮族和汉族冠心病患者胱抑素C水平及其基因多态性的比较研究[J].现代检验医学杂志,2017,32(03):26.[doi:10.3969/j.issn.1671-7414.2017.03.007]
　HUANG Sheng-jin,ZHENG Li-ping,LU Jun-jia,et al.Comparative Study of Cystatin C and Its Gene Polymorphism of Pati ents with Coronary Heart Disease between Zhuang and Han in Guangxi Region[J].Journal of Modern Laboratory Medicine,2017,32(05):26.[doi:10.3969/j.issn.1671-7414.2017.03.007]
[5]张求霞,汪隆海,昌国庆,等.尿液6种蛋白与CysC水平检测对糖尿病肾病的诊断价值[J].现代检验医学杂志,2019,34(01):67.[doi:10.3969/j.issn.1671-7414.2019.01.017]
　ZHANG Qiu-xia,WANG Long-hai,CHANG Guo-qing,et al.Clinical Value of Detection of 6 Proteins and Cystatin C in Urine for Early Diagnosis of Diabetic Kidney Disease[J].Journal of Modern Laboratory Medicine,2019,34(05):67.[doi:10.3969/j.issn.1671-7414.2019.01.017]
[6]廖衍强.糖尿病并发高血压患者血清Cys C 与P 物质水平之间的关系研究[J].现代检验医学杂志,2020,35(02):65.[doi:10.3969/j.issn.1671-7414.2020.02.019]
　LIAO Yan-qiang.Relationship between Serum Cys C and Substance P Levels in Patientswith Diabetes Mellitus Complicated with Hypertension[J].Journal of Modern Laboratory Medicine,2020,35(05):65.[doi:10.3969/j.issn.1671-7414.2020.02.019]
[7]刘倩倩,鲁作华,王 星,等.血浆D- 二聚体在2 型糖尿病患者早期肾损伤中的应用价值[J].现代检验医学杂志,2020,35(04):134.[doi:10.3969/j.issn.1671-7414.2020.04.034]
　LIU Qian-qian,LU Zuo-hua,WANG Xing,et al.Application Value of Serum D-Dimer in Early Kidney Injury in Patients with Type 2 Diabetes[J].Journal of Modern Laboratory Medicine,2020,35(05):134.[doi:10.3969/j.issn.1671-7414.2020.04.034]
[8]安映红,李　鹏,蔡　庆,等.成年人群血清胱抑素C与同型半胱氨酸水平升高的疾病谱分析[J].现代检验医学杂志,2021,36(02):39.[doi:doi:10.3969/j.issn.1671-7414.2021.02.010]
　AN Ying-hong,LI Peng,CAI Qing,et al.Disease Spectrum Analysis of Serum Hypercystatin C Accompanied by Hyperhomocysteine in Adults Polulation[J].Journal of Modern Laboratory Medicine,2021,36(05):39.[doi:doi:10.3969/j.issn.1671-7414.2021.02.010]
[9]陈丽媛.原发性高血压患者血清Ficolin-3，CysC和Hcy水平与颈动脉内膜中层厚度的相关性分析[J].现代检验医学杂志,2021,36(04):139.[doi:10.3969/j.issn.1671-7414.2021.04.030]
　CHEN Li-yuan.Analysis on the Correlation between Serum Ficolin 3, Cys C and Hcy Levelsand Carotid Intima-Media Thickness in Patients with Essential Hypertension[J].Journal of Modern Laboratory Medicine,2021,36(05):139.[doi:10.3969/j.issn.1671-7414.2021.04.030]
[10]侯　越,赵　妍,王友明,等.脑卒中患者血清胱抑素C水平与卒中后认知障碍相关性的Meta分析[J].现代检验医学杂志,2022,37(02):142.[doi:10.3969/j.issn.1671-7414.2022.02.029]
　HOU Yue,ZHAO Yan,WANG You-ming,et al.Meta Analysis of the Correlation between Cystatin C Level in Stroke Patientis and Post Stroke Cognitive Impairment[J].Journal of Modern Laboratory Medicine,2022,37(05):142.[doi:10.3969/j.issn.1671-7414.2022.02.029]

备注/Memo

备注/Memo:
基金项目：“国家质量基础的共性技术研究与应用”重点专项基金（2017YFF0205401）。
作者简介：孙江漫（1990-），女，硕士研究生，主管技师，研究方向：临床化学标准化研究，E-mail：jiangman_sun@163.com。
通讯作者：邵燕（1980-），女，本科，主任技师，研究方向：临床生化免疫检验、标准化与实验室质量管理，E-mail：shaoy711@126.com。
更新日期/Last Update: 2025-09-15