核酸条码标识法PSA检测试剂盒的研制及验证  

Preparation and evaluation of nucleic acid code assay-kit in ultra-micro PSA detection

作　　者：齐晖 孔小丽 李富荣 任莉莉 周汉新 

机构地区：[1]深圳市人民医院(暨南大学第二临床医学院)临床医学研究中心,深圳518020

出　　处：《中国免疫学杂志》2008年第12期1142-1144,1148,共4页Chinese Journal of Immunology

基　　金：国家863科技计划项目(2003BA310A23);深圳市科技计划项目(2004B110)

摘　　要：目的:建立核酸条码标识法检测前列腺特异性抗原(PSA)的方法,临床血清标本验证灵敏度、特异性等指标,并与试剂盒ELISA及RIA检测结果比较。方法:采用自制免疫磁球和双标记纳米金探针,利用双抗体夹心法原理,将PSA的检测转化为对核酸条码片段的检测,制备核酸条码法PSA检测试剂盒,对45例前列腺癌患者,45例前列腺良性增生患者,15例其它肿瘤患者,30例正常人群血清标本进行验证。结果:临床血清标本灵敏度约92,特异性约为68,假阳性率32,检测平均回收率大于95,批内变异系数(CV)为6.24,重复性平行性良好。与ELISA及RIA进口试剂盒检测结果比较,三法的差异无显著性(P>0.05),相关性良好,吻合度强。结论:建立的核酸条码标识PSA检测方法,为超微量蛋白质检测提供一种新的方法。Objective：To establish a new type of detection kit,the nucleic acid code assay,to detecte prostate specific antigen.Methods：The nucleic acid code assay was established based on preparation of immunomagnetic microspheres and double labeled gold nanoparticle probes according to the principle of double antibody sandwich mode.The sera 45 prostate cancer patients,45 benign prostate hyperplasia,15 cases of patients with various other tumors and 30 cases of healthy individuals were chosen for analysis.Results：The variations in the group was 6.24%,showing that reliability of the method was well.The mean recoveries was greater than 95%.The sensitivity in clinical examination for positive sera of PSA was 92% with specificity of 68%.In comparison with ELISA and RIA,the results showed that correlation coefficient of 0.950 and 0.967,respectively,indicating a fine correlation among the assays.The Κ coefficient of 0.918 to 0.960 was strongly similar to the standard method in currently clinical application.Conclusion：The nucleic acid code detection of PSA is shown of high sensitivity,excellent specificity,and no need for special device.It is possible and promising for ultrasensitive detection of proteins in the clinical diagnosis.

关 键 词：前列腺特异性抗原 免疫磁球 纳米金探针 核酸条码 检测 

分 类 号：R392.33[医药卫生—免疫学]