骨钙素酶免疫检测方法的研究和应用  

Study on the enzyme immunoassay for osteocalcin in serum

作　　者：郑佐娅[1] 王强[1] 杭勤[1] 王鸿利[1] 陶义训[1] 

机构地区：[1]上海第二医科大学医学检验重点实验室,200023

出　　处：《中华检验医学杂志》2002年第6期349-351,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的　建立骨钙素酶免疫测定方法 ,并应用于临床检测血清骨钙素。方法　应用了3种检测模式 ,根据检测灵敏度、剂量反应曲线的形态进行分析 ,选择出合适的模式进一步应用于临床血清标本的骨钙素检测。结果　所采用的骨钙素单克隆抗体是钙离子依赖型的。固相抗原竞争法适合于临床定量测定骨钙素。最低可测限为 1 4μg/L ;2 0 μg/L骨钙素样品批内 CV =3 98% ,批间CV =1 2 67%。测定正常献血员 1 4 0名 (年龄 1 7～ 45岁 ) ,第 5～ 95百分位点的骨钙素含量 ,男性为7 5～ 1 5 0 μg/L女性为 7 0～ 1 7 5μg/L。 70例疑有骨质疏松症患者血清骨钙素含量2 91～ 30 2 0 μg/L ,以第 95百分位点的骨钙素含量为cut off值 ,升高 5例。与进口试剂盒 (Novocalcin ,USA)相比较 ,有较好的相关性 ,r=0 81。结论　固相抗原竞争法酶免疫测定可以灵敏地检测血清中骨钙素含量 。Objective To develop an enzyme immunoassay for osteocalcin in serum and its clinical application Methods Three kinds of testing formats were employed Based on sensitivity and shape of dose reaction curve, the most suitable testing pattern was selected for further application Results Binding of the monoclonal antibody to osteocalcin was calcium dependent Solid phase antigen competitive ELISA was suitable The detection limit for osteocalcin was 1 4 μg/L At the concentration of 20 μg/L osteocalcin the intra assay CV and inter assay CV were 3 98% and 12 67% respectively The 5～95 th percentile ranges of serum osteocalcin measured in 140 normal subjects (at the age of 17～45 years) were 7 5～15 0 μg/L in healthy men and 7 0～17 5 μg/L in althy women, respectively Values of osteocalcin determined in serum from 70 suspected cases with osteoporosis were 2 91～30 20 μg/L,ases were abnormal based on the osteocalcin concentrations at 95 th percentile as cut off value The coefficient of correlation between solid phase antigen competive ELISA and Novocalcin (USA) was 0 81 Conclusions The solid phase antigen competive ELISA for osteocalcin was sensitive and may be used clinically [

关 键 词：骨钙素 免疫酶技术 骨质疏松 固相抗原竞争法 酶免疫测定 

分 类 号：R446.6[医药卫生—诊断学] R681[医药卫生—临床医学]