公开(公告)号：EP2908136A1

公开(公告)日：2015-08-19

申请号：EP13846084.5

申请日：2013-10-09

申请人： Hirosaki University ,  Shizuoka Prefecture Public University Corporation

发明人： OHYAMA, Chikara ,  YONEYAMA, Tohru ,  TOBISAWA, Yuki ,  HATAKEYAMA, Shingo ,  SUZUKI, Takashi ,  JWA, Ilpal ,  YAMAGUCHI, Maho

IPC分类号： G01N33/574 ,  G01N33/553

CPC分类号： G01N33/57434 ,  G01N2333/96433 ,  G01N2400/02 ,  G01N2400/12

摘要： An object of the present invention is to provide a method for distinguishing between prostate carcinoma and benign prostatic hyperplasia with high sensitivity and good reproducibility using a small amount of an analyte sample. The method for distinguishing between prostate carcinoma and benign prostatic hyperplasia according to the present invention as a solution means thereof comprises: bringing an analyte sample containing a prostate-specific antigen (PSA) into contact with a carrier having an anti-free PSA antibody immobilized thereon, thereby binding free PSA to the anti-free PSA antibody immobilized on the carrier; thereafter bringing the carrier in which the free PSA is bound to the immobilized anti-free PSA antibody into contact with a monoclonal antibody capable of specifically recognizing a glycan in which a terminal sialic acid residue is bound to galactose through an α(2,3) bond, thereby binding the monoclonal antibody capable of specifically recognizing a glycan in which a terminal sialic acid residue is bound to galactose through an α(2, 3) bond to the free PSA bound to the anti-free PSA antibody immobilized on the carrier; measuring the amount of the free PSA having an N-type glycan in which a terminal sialic acid residue is bound to galactose through an α(2, 3) bond; comparing the measured amount thus obtained with a preset cutoff value for prostate carcinoma and benign prostatic hyperplasia, thereby determining that when the measured amount is larger than the cutoff value, prostate carcinoma is developed or the probability of developing prostate carcinoma is high, and when the measured amount is smaller than the cutoff value, benign prostatic hyperplasia is developed or the probability of developing benign prostatic hyperplasia is high.

摘要翻译： 本发明的目的是提供使用少量分析物样品，以高灵敏度和良好的再现性来区分前列腺癌和良性前列腺增生的方法。 根据本发明的前列腺癌和良性前列腺增生的区分方法作为其溶液方法包括：将含有前列腺特异性抗原（PSA）的分析物样品与其上固定有抗PSA抗体抗体的载体接触 从而将游离PSA结合到固定在载体上的抗自由PSA抗体; 然后将游离PSA结合的载体与固定的抗自由PSA抗体接触，与能够特异性识别末端唾液酸残基与半乳糖结合的聚糖的单克隆抗体通过±（2,3） 从而将能够特异性识别末端唾液酸残基与半乳糖结合的聚糖的单克隆抗体通过±（2,3）键结合到与固定在载体上的抗自由PSA抗体结合的游离PSA; 测量其中末端唾液酸残基通过±（2,3）键与半乳糖结合的N-型聚糖的游离PSA的量; 将由此获得的测量量与前列腺癌和良性前列腺增生的预设截止值进行比较，从而确定当测量量大于截止值时，前列腺癌发展或发展为前列腺癌的概率高，并且当 测量量小于临界值，发展良性前列腺增生或发展良性前列腺增生的可能性高。