化学发光免疫法检测B型利钠肽的检测限值和功能灵敏度研究  

Research on detection limits and functional sensitivity of chemiluminescence immunoassay in detection of BNP

作　　者：李飞[1] 王伟佳[2] 温冬梅[2] 索明环[2] 欧阳能良[2] 严海忠[2] 阚丽娟[2] 张秀明[2] 

机构地区：[1]中山大学附属第一医院,广州510080 [2]中山大学附属中山医院检验医学中心,广东中山528403

出　　处：《检验医学与临床》2011年第18期2185-2188,共4页Laboratory Medicine and Clinic

基　　金：广东省医学科研基金资助项目(A2009763);广东省中山市科技局资助项目(20091A038)

摘　　要：目的探讨西门子ADVIA Centaur 240化学发光免疫系统检测B型利钠肽（BNP）的检测限值和功能灵敏度。方法参照美国临床实验室标准化协会（CLSI）EP-17A文件和有关文献，选择BNP通用稀释液作为空白标本，批内重复测定10次，计算光量子值的均数、标准差和变异系数（CV），用以确定检测低限（LLD）；同时，空白标本每天上、下午各检测1批，每批重复检测3次，连续检测5d，共获得30个空白结果，用非参数方法确定空白限（LoB）。制备接近1～4倍LoB浓度的系列实验标本，各浓度每天上、下午各检测1次，连续检测5d，计算每个浓度水平光量子值的均数、标准差和CV，用以确定生物检测限（BLD）和CV值为10％条件下的功能灵敏度（FS）；同时对所有80个测定结果，按EP-17A文件采用非参数方法确定检出限（LoD）。结果ADVIA Centaur 240检测系统BNP的LLD为1．47pg／mL，LoB为0．86pg／mL，均低于厂家声明的灵敏度；BLD为3．27～3．71pg／mL，LoD为3．54pg／mL，10％CV条件下的FS为4．64pg／mL。结论厂商声明的LLD和BLD得到验证，同时建立了实验室BNP检测的LoB、LoD和FS，为临床提供了准确、可靠的检验结果。建议临床实验室使用EP-17A文件确定LoB和I．oD，并确定在一定精密度条件下的FS。Objective To evaluate the detection limits and functional sensitivity performance of Siemens ADVIA Centaur 240 automated B-type natriuretic peptide （BNP） assay. Methods We followed the document EP 17A published in 2004 by American Clinical and Laboratory Standards Institution （CLSI）. Each blank sample was performed tests for repeat 10 times and the low limit of detection（LLD） was calculated. For the determination of LOB,6 replicates of manufacturerrs dilution （0 pg/mL） on 5 separate runs （n= 30） were assayed. The RLUs of blank and a serial diluted samples detected by Bayer Centaur 240 chemiluminescence immunoassay system would be calculated for average value,standard deviations and coefficient of variance,which to establish the biologic limit of detection （BLD） and functional sensitivity of BNP. The limit of detection （LoD） was determined by assaying 2 replicates of 8 plasma pools （low levels of BNP） on 5 separate runs （n=80）. Results The LLD was 1. 47 pg/mL and LoB was 0. 86 pg/mL. They were both lower than the declaration of the manufacturer. The BLD was between 3. 27 pg/mL and 3.71 pg/mL and the LoD was 3.54 pg/mL. The functional sensitivity of the cardiac biochemical markers that can reflect some pathological changes of the functional sensitivity was 4.64 pg/mL （the value of 10% CV）. Conclusion The LLD,BLD,limit of blank （LOB） and LoD of BNP could meet the clinical requirements,which also validate the manufacturers declare. At the same time, we set up the LoB and LoD of BNP in our laboratory, which can provide more accurate and trusty results for our hospital. The evaluation documents are simple and useful, so we suggest that the clinical laboratory use document EP17-A to set up LoB,LoD and FS which must accord with the precision.

关 键 词：利钠肽 脑 化学发光测定法 免疫测定 敏感性与特异性 

分 类 号：R446.61[医药卫生—诊断学]