Method and kit for distinguishing between prostate carcinoma and benign prostatic hyperplasia

Abstract

The present invention addresses the problem of providing a method for distinguishing between prostate carcinoma and benign prostatic hyperplasia with high sensitivity and good reproducibility using an analyte sample in a small amount. The method for distinguishing between prostate carcinoma and benign prostatic hyperplasia according to the present invention, which is a solution for the problem, is as follows: an analyte sample containing a prostate-specific antigen (PSA) is brought into contact with a carrier having an anti-free PSA antibody immobilized thereon, thereby causing the binding of a free PSA to the anti-free PSA antibody immobilized on the carrier; the carrier in which the free PSA has been bound to the immobilized anti-free PSA antibody is brought into contact with a monoclonal antibody capable of specifically recognizing a sugar chain in which a terminal sialic acid residue is bound to galactose via an α(2,3) bond, thereby causing the binding of the monoclonal antibody capable of specifically recognizing the sugar chain in which the terminal sialic acid residue has been bound to galactose via an α(2,3) bond to the free PSA that has been bound to the anti-free PSA antibody immobilized on the carrier; the amount of the free PSA that has an N-type sugar chain in which the terminal sialic acid residue has been bound to galactose via an α(2,3) bond is measured; and subsequently the amount measured in the proceeding step is compared with a preset cut-off value for prostate carcinoma and benign prostatic hyperplasia. When the measured amount is larger than the cut-off value, it is determined that prostate carcinoma is developed or the probability of prostate carcinoma is high. When the measured amount is smaller than the cut-off value, it is determined that benign prostatic hyperplasia is developed or the probability of benign prostatic hyperplasia is high.

Description

【Technical field】 [0001] The present invention relates to methods and kits for identifying prostate cancer and prostatic hypertrophy. 【Background technique】 [0002] It is well known that prostate cancer (prostate carcinoma: hereinafter referred to as "Pca") is the main cause of death in men, and prostate-specific antigen (prostate-specific antigen: hereinafter referred to as "PSA") is considered to be the most important tumor marker for Pca (non- Patent Document 1). PSA is a glycoprotein of about 34 kDa, and sugar chains account for about 8% thereof. The usefulness of the serum PSA test for the early diagnosis of Pca has been documented in various documents, but there is a debate among men suffering from Pca and men suffering from benign prostate hyperplasia (hereinafter referred to as "BPH"). A gray zone is an area that cannot be said to be either Pca or BPH (Non-Patent Document 2). Therefore, attempts to accurately distinguish the two types of lesions have been perform...

AI Technical Summary

Problems solved by technology

However, the method of identifying Pca and BPH by affinity chromatography using Sophora japonica agglutinin has attracted attention as a completely different method from the methods proposed so far, since there are terminal sialic acid residues connected to half The amount of PSA of lactose-bonded N-type sugar chains is only 1 to 2% of the total PSA amount, which is extremely small. In order to perform high-precision identification, there is a problem that a large amount (about 10ml) of serum is required as an analysis sample

In addition, since the Sophora japonica agglutinin used is an extract from natural products, there are also problems such as confirming variations in quality between batches.

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