几种肿瘤标志物分析灵敏度的分析与确认  

Affirmance and analysis of analytic sensitivity of tumor marker

作　　者：周慜[1] 佟素香[2] 李一荣[2] 

机构地区：[1]华中科技大学同济医学院附属协和医院内分泌科,武汉市430022 [2]华中科技大学同济医学院附属协和医院检验科,武汉市430022

出　　处：《实用医学杂志》2005年第12期1337-1339,共3页The Journal of Practical Medicine

摘　　要：目的:研究肿瘤标志物糖抗原50(CA50)、糖抗原724(CA724)、神经元特异性烯醇化酶(NSE)、鳞状细胞癌相关抗原(SCC)、甲胎蛋白(AFP)试剂盒的分析灵敏度,以确认其临床应用价值。方法:以酶联免疫吸附试验双抗体夹心法,测定各肿瘤标志物试剂盒的零空白及标准品系列稀释浓度的吸光度“OD”值,并以计算的均值、标准差及变异系数(CV%),求得检测低限(LLD)、生物检测限(BLD)及功能灵敏度(FS),依此确认各试剂盒的最低检测浓度即生物检测限。结果:试剂盒CA50、CA724、NSE、SCC、AFP可定量报告肿瘤标志物的最低浓度依次为:1.75kU/L、0.5kU/L、1.088μg/L、0.625μg/L、0.625μg/L,与厂商提供的略有不同。结论:本研究中的几种肿瘤标志物试剂盒均具备一定的临床使用价值。实际使用中,应以实验室自行建立的生物检测限为主,参考试剂盒的灵敏度来应用。每使用一种新的试剂盒时,均须对分析灵敏度进行确认。Objective To investigate the analytic sensitivity of tu mo r marker(for example,CA50,CA724,SCC and AFP)kit and to affirm its clin ical applic able value.Methods For tumor marker,absorbance value o f a serial diluted standard and zero blank was detected with double antibodies sandwich me thod of enzyme linked immunoabsorben t assay.The low limit of determination(LL D),biological limit of determination(BLD)and functional sensitivity(FS)wer e calculated with the calculated average value,s tandard difference and coeffic ient of variable.Finally the minimal detectable concentrations of different tu mor k its(also called analytic sensitivity)were affirmed.Results For CA50, CA724,NSE,SCC and AFP kit,the minimal detectab le concentrations was 1. 75kU /L,0.5kU /L,1.088μg /L,0.625μg /L and0.625μg /L respectively and it was differen t with the numerical value that the ma nufa cture provided.Conclusion The above kits in our study have a certain clinical a pplicable value.In our wo rk,biological limit of determination must be founded mostly by the result of our laboratory and refers to the sensitivity the ma nuf acture provided,therefore befo re we use a new kit,analytic sensitivity must b e affirm ed.[

关 键 词：肿瘤标志物 分析灵敏度 神经元特异性烯醇化酶(NSE) 酶联免疫吸附试验双抗体夹心法 生物检测限 临床应用价值 试剂盒 癌相关抗原 功能灵敏度 CA724 鳞状细胞 甲胎蛋白 稀释浓度 变异系数 检测低限 检测浓度 CA50 使用价值 

分 类 号：R730.4[医药卫生—肿瘤]