Sysmex CS-5100全自动血凝仪检测D-二聚体临床可报告范围的建立  

Establishment of clinical reportable range for detection of D-dimer by Sysmex CS-5100 automatic coagulation analyzer

作　　者：张霞 李济填 覃文琪 周杰 唐慧琴[1] Zhang Xia;Li Jitian;Qin Wenqi;Zhou Jie;Tang Huiqin(Department of Clinical Laboratory,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou Guangdong 510120,China;Department of Clinical Laboratory,Shenzhen University General Hospital,Shenzhen Guangdong 518055,China)

机构地区：[1]广州医科大学附属第一医院检验科,广东广州510120 [2]深圳大学总医院检验科,广东深圳518055

出　　处：《中华临床实验室管理电子杂志》2024年第1期27-32,共6页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：广州医科大学金域检验学院教育教学改革项目(02-408-2304-09016XM)。

摘　　要：目的建立Sysmex CS-5100全自动血凝仪检测D-二聚体的临床可报告范围(CRR)。方法根据美国临床实验室标准化委员会(CLSI)颁发的EP6-A文件,应用多项式回归分析方法在Sysmex CS-5100全自动血凝仪上进行D-二聚体分析测量范围(AMR)实验,通过对非线性系数的统计分析判断是否存在非线性关系,通过计算回归标准误差确定最适多项式方式,通过计算各个浓度点的线性偏差是否满足行业标准确定AMR的上限,结合功能灵敏度(FS)及最大稀释倍数建立其CRR。结果FS实验确定CV接近20%时D-二聚体浓度为0.0657 mg/L,故FS为0.0657 mg/L;AMR实验数据未发现离群点;实验样本重复测定的相对误差为1.89%,小于批内不精密度目标(2.5%);多项式回归分析舍弃最高两组数据后,第1~9点实验数据重新分析后确定最适拟合曲线为三次多项式,线性偏差均未超出设定目标(7.5%),确定D-二聚体的AMR为0.0657~5.26 mg/L;最大允许稀释度为1∶32,确定D-二聚体CRR为0.0657~168.32 mg/L。结论CRR的建立,对于高值有特别意义的检测项目至关重要。Objective To establish the clinical reportable range(CRR)of Sysmex CS-5100 automatic coagulation analyzer for the detection of D-dimer.Methods According to the EP6-A document issued by the Clinical and Laboratory Standard Institute(CLSI),the polynomial regression analysis method was used to carry out the D-dimer analysis measurement range(AMR)experiment on the Sysmex CS-5100 automatic coagulation analyzer.The statistical analysis of the nonlinear coefficient was used to determine whether there was non-linearity,and the optimal polynomial method was determined by calculating the regression standard error.This study determine the upper limit of the AMR by calculating whether the linear deviation of each concentration point meets the industrial standard,and establish its CRR in combination with the functional sensitivity(FS)and the maximum dilution ratio.Results According to FS test,the concentration of D-dimer is 0.0657 mg/L when CV is close to 20%,so FS is 0.0657 mg/L.No outliers were found in the experimental data of AMR.The relative error of repeated measurement of experimental samples was 1.89%,which was lower than the in batch imprecision target(2.5%).After the highest two groups of data were discarded in polynomial regression analysis,the best fitting curve was determined to be cubic polynomial after reanalysis of the first to ninth experimental data,and the linear deviation was not beyond the allowable deviation range(7.5%).The determined AMR of D-dimer is 0.0657~5.26 mg/L;The maximum allowable dilution is 1∶32,and the CRR of D-dimer is 0.0657~168.32 mg/L.Conclusions The CRR was established,which was significant for clinical diagnosis with the high test value.

关 键 词：Sysmex CS-5100 D-二聚体 临床可报告范围 功能灵敏度 分析测量范围 

分 类 号：R446[医药卫生—诊断学]