北京地区脂蛋白(a)颗粒浓度参考区间的建立  

Establishment of reference interval of particle concentration for detecting lipoprotein(a)in Beijing

作　　者：朱旭 程歆琦[1] 钟远红 ZHU Xu;CHENG Xinqi;ZHONG Yuanhong(Department of Clinical Laboratory,Peking Union Medical College Hospital,Peking Union Medical College&Chinese Academy of Medical Science,Beijing 100730;Shenzhen Mindray Biomedical Electronics Co.,Ltd,Shenzhen 518057,Guangdong,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730 [2]深圳迈瑞生物医疗电子股份有限公司,广东深圳518057

出　　处：《临床检验杂志》2022年第3期204-208,共5页Chinese Journal of Clinical Laboratory Science

摘　　要：目的用2种市售脂蛋白(a)[Lp(a)]颗粒浓度试剂检测北京地区表观健康人群血清Lp(a)水平,建立北京地区Lp(a)颗粒浓度检测方法的参考区间。方法选择2019年11月至2020年8月北京协和医院415例体检健康成年人作为研究对象,其中男215例,女200例,按年龄段16~44岁、45~59岁、60~74岁、75岁及以上分为4组。分别用迈瑞BS-800全自动生化分析仪和罗氏Cobas 8000全自动生化分析仪及其配套的2种市售Lp(a)颗粒浓度试剂组成的检测系统A和B检测415份血清Lp(a)水平,分别对2种系统进行精密度评价,用Passing-Bablok回归分析和Bland-Altman分析进行方法学比对。根据Lp(a)检测数据类型选择不同的统计学方法,分析性别、年龄因素对血清Lp(a)水平的相关性,以及Lp(a)数据百分位分布。按照美国临床和实验室标准化协会(CLSI)C28-A3的要求,分别建立A、B检测系统的血清Lp(a)参考区间。结果A、B两种检测系统的精密度以CV表示,分别为1.3%~1.9%、0.9%~2.0%,回归方程的截距、斜率、医学决定系数(R ^(2))、相关系数(r)分别为-0.013、0.973、0.936、0.967,相关性良好。偏倚图显示2种检测系统的平均偏倚为2.4%,在医学决定水平处的预期偏倚为-2.69%。A、B系统血清Lp(a)检测数据均呈非正态分布,分别为16.73(8.64,46.52)nmol/L、16.90(8.80,47.40)nmol/L。男性和女性血清Lp(a)水平差异均有统计学意义(A:t=-2.121,P=0.034;B:t=-2.436,P=0.015),男性和女性各自4个年龄段内的血清Lp(a)水平差异均无统计学意义(A:F=2.604,P=0.052;B:F=2.456,P=0.063)。以<第80百分位数计算参考区间,检测系统A的Lp(a)颗粒浓度参考区间为:男(<50 nmol/L)、女(<70 nmol/L)、总(<62 nmol/L);检测系统B的Lp(a)颗粒浓度参考区间为:男(<51 nmol/L)、女(<63 nmol/L)、总(<60 nmol/L)。结论初步建立了2种市售Lp(a)颗粒浓度检测试剂的参考区间,血清Lp(a)颗粒浓度水平在男性与女性不同性别组间与厂家说明书提供的参考区�Objective To use two commercially available lipoprotein(a)[Lp(a)]particle concentration reagents to detect serum Lp(a)levels in apparently healthy population in Beijing,and to establish reference intervals for Lp(a)particle concentration detection methods.Methods A total of 415 healthy adults(215 males and 200 females)with physical examination in Peking Union Medical College Hospital were selected as the research objects during November 2019 and August 2020,they were divided into 4 groups by different gae,respectively 16-44 years old,45-59 years old,60-74 years old and above 75 years old.The levels of 415 serum Lp(a)were detected by Mindray BS-800(system A)and Roche Cobas 8000(system B)automatic biochemical analyzers and their matching two commercially available Lp(a)particle concentration reagents.Two systems were compared with the precision evaluation,Passing-Bablok regression analysis and Bland-Altman analysis method.Analyze the correlation of gender and age factors to the serum Lp(a)levels,and the percentile distribution of Lp(a)data by different statistical methods according to the Lp(a)detection data type.In accordance with the requirements of the Clinical and Laboratory Standards Institute(CLSI)C28-A3,the serum Lp(a)reference intervals of systems A and B were established respectively.Results The precisions of systems A and B were 1.3%-1.9%,0.9%-2.0%,and the intercept,slope,coefficient of determination(R^(2)),and correlation coefficient(r)of the regression equation were-0.013,0.973,0.936,0.967,the correlation is good.The bias graph showed that the average bias of two detection systems was 2.4%,and the expected bias at the medical decision level was-2.69%.The serum Lp(a)test data of two systems A and B were non-normally distributed,and the median(P_(25),P_(75))were 16.73(8.64,46.52)nmol/L and 16.90(8.80,47.40)nmol/L.The difference in serum Lp(a)levels between males and females was statistically significant(A:t=-2.121,P=0.034;B:t=-2.436,P=0.015).But the difference within 4 age groups was no statistically sign

关 键 词：脂蛋白(a) 颗粒浓度 参考区间 表观健康人群 检测系统 

分 类 号：R446[医药卫生—诊断学]