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METHOD AND KIT FOR DISTINGUISHING BETWEEN PROSTATE CARCINOMA AND BENIGN PROSTATIC HYPERPLASIA

机译:前列腺癌与良性前列腺增生症鉴别的方法和试剂盒

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 ±(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 ±(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 ±(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.
机译:本发明的目的是提供一种使用少量分析物样品以高灵敏度和良好再现性来区分前列腺癌和良性前列腺增生的方法。作为解决方案,根据本发明的区分前列腺癌和良性前列腺增生的方法包括:使含有前列腺特异性抗原(PSA)的分析物样品与固定有抗游离PSA抗体的载体接触。从而将游离PSA与固定在载体上的抗游离PSA抗体结合;然后,使其中结合有游离PSA的载体与固定化的抗游离PSA抗体接触的单克隆抗体能够特异性识别其中末端唾液酸残基通过±(2,3)与半乳糖结合的聚糖结合,从而结合能够特异性识别其中末端唾液酸残基通过±(2,3)键与半乳糖结合的聚糖的单克隆抗体与结合至固定在载体上的抗游离PSA抗体的游离PSA;测量具有N型聚糖的游离PSA的量,其中末端唾液酸残基通过±(2,3)键与半乳糖结合。将如此获得的测量值与预设的前列腺癌和良性前列腺增生的临界值进行比较,从而确定当测量值大于临界值时,前列腺癌发生或发生前列腺癌的可能性高,并且测量值小于临界值时,会出现良性前列腺增生或发生良性前列腺增生的可能性很高。

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