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
10.3969/j.issn.1671-7414.2025.05.036
- VernacularTitle: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
- Author:
Jiangman SUN
1
;
Min LI
;
Xiangzhao MENG
;
Hongyuan YU
;
Baorong CHEN
;
Yan SHAO
Author Information
1. 北京航天总医院检验科,北京 100076
- Publication Type:Journal Article
- Keywords:
cystatin C;
international primary reference material;
national secondary reference materials;
dissemination of quantity value;
methodological comparison
- From:
Journal of Modern Laboratory Medicine
2025;40(5):189-193
- CountryChina
- Language:Chinese
-
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.
