临床实验室应用不同检测系统检测血清心肌肌钙蛋白I结果的一致性分析研究  

Consistency Analysis of Serum Cardiac Troponin I with Different Detection Systems in Clinical Laboratory

作　　者：周伶俐 魏力强[2] ZHOU Ling-li;WEI Li-qiang(Xi’an Medical College,Xi’an 710021,China;Shaanxi Provincial People’s Hospital,Xi’an 710068,China)

机构地区：[1]西安医学院,西安710021 [2]陕西省人民医院,西安710068

出　　处：《现代检验医学杂志》2022年第2期137-141,161,共6页Journal of Modern Laboratory Medicine

摘　　要：目的分析心肌肌钙蛋白I(cardiac troponin I,cTnI)检测结果,探讨四种不同检测系统结果间是否具有可比性,检测结果的偏倚是否在允许范围内以及同一检测系统不同实验室检测结果的差异性。方法将20份不同浓度的cTnI患者血清样本在深圳迈瑞CL-2000i(A系统)、广州万孚FS-205(B系统)、Getein 1600(C系统)和UniCel DxI 800(D系统)配套检测系统上进行检测,每个系统分别选择10家实验室。参考美国临床实验室标准化协会(Clinical laboratory standardization institute,CLSI)的EP9-A2文件,对结果进行统计学分析,评价各检测系统间cTnI检测结果是否具有一致性;计算4种系统及各系统的均值(x)、标准差(s)及变异系数(CV%),分析四种不同检测系统间及同一检测系统不同实验室检测结果的差异性。结果不同系统检测患者血清样本cTnI结果的相关系数(r^(2))为0.8953~0.9899,A系统与D系统,A系统与B系统间相关性不佳(r^(2)<0.95);分别以各系统作为参考系统,除了B系统与C,D系统间结果存在差异外,其他检测系统间结果具有临床可接受性。各系统CV均较大(范围在12.36%~69.05%),在低浓度处CV明显高于高浓度处,差异有统计学意义;A,C,D系统的s,CV%及极差(R)均较小,CV范围基本<15%,其中C系统<10%,偶有个别在检测低限处CV较大,B系统的s,CV%及R均较大,CV%范围在16.14%~75.54%(在19,20号标本处CV为0.00%是由于<0.01ng/ml的值赋值为0.01ng/ml)。结论四种检测系统间cTnI的检测结果一致性较差,同一检测系统不同实验室检测结果间也存在一定差异。Objective The results of cardiac troponin I(cTnI) detection were analyzed to explore whether the results of four different detection systems were comparable and whether the bias of detection results was within the allowed range, as well as the dfferences of the results of different laboratories in the same detection system. Methods c TnI was detected in 20 serum samples of patients with different concentrations in Shenzhen Mindray CL-2000I(A system), Guangzhou Wanfu FS-205(B system),Getein 1600(C system), UniCel DxI 800 system(D system). According to the EP9-A2 document of the Clinical Laboratory Standardization Institute (CLSI), the results were statistically analyzed to evaluate the consistency of cTnI test results among different testingsystems.Calculate the mean value(x), standard deviation(s) and coefficient of variation (CV %) of 4 kindsof systems, and explore the difference of test results among four different testing systems and different laboratories of the same testing system. Results The correlation coefficients (r^(2)) of cTnI results in serum samples were 0.895 3~0.989 9, but the correlation between system A and system D, system A and system B was not good(r^(2)< 0.95). Taking each system as a reference system, the results of other testing systems were clinically acceptable for the difference between system B and system C,system B and system D.The coefficient of variation of each system was large (12.36% ~ 69.05%). The variation coefficient at low concentration was significantly higher than that at high concentration, and the difference was statistically significant. The s, CV % and range of system A, C and D were small, and the range of coefficient of variation was basically less than 15%. Among them, the coefficient of variation of system C was less than 10%, and occasionally the coefficient of variation was larger at the lower limit of detection,The s,CV % and R of system B werer large,CV% ranged from 16.14% to 75.54%(the CV value of 0.00% in 19 and 20 specimens was due to the value of 0.01ng/ ml

关 键 词：心肌肌钙蛋白I 检测系统 一致性分析 

分 类 号：R446[医药卫生—诊断学]