Kit for early diagnosis of bladder cancer and preparation method of kit

Abstract

The invention discloses a kit for early diagnosis of bladder cancer and a method for preparing the kit, and relates to the field of biomedical immune analysis. The detecting kit, which is fast, sensitive, highly specific in the early diagnosis of the bladder cancer is created by detecting a tumor marker of the bladder cancer tumor marker, namely, abnormally glycosylated integrin AG-alpha3beta, in human urine by means of microplate chemiluminescence immunoassay. The kit provided by the invention has the advantages of simplicity, convenience, quickness, sensitivity, high specificity, stability and the like, can be applied to early screening of the bladder cancer in a routine examination and to tracking observation and prognostic evaluation of the bladder cancer, and can satisfy the need that the existing in-vitro diagnosis of the bladder cancer is lack in specific diagnosis method.

Description

technical field [0001] The invention relates to a method for detecting tumor markers in the urine of bladder cancer patients. The method non-invasively realizes the early diagnosis of bladder cancer by quantitatively detecting the content of abnormally glycosylated integrin AG-α3β1 in the urine . Background technique [0002] Bladder cancer is the most common malignant tumor of the urinary system. In the United States, the incidence rate is listed as the fourth among male malignant tumors, the eighth among females, and the seventh among malignant tumors. In my country, the incidence rate of urological tumors ranks first. About 95% of bladder cancer originates from the bladder epithelium, most of which are malignant, and only a few are benign, including papilloma, transitional cell carcinoma, squamous cell carcinoma and adenocarcinoma. Among them, transitional cell carcinoma is the most common, accounting for more than 80%. At present, the curative effect of surgery, radio...

AI Technical Summary

Problems solved by technology

The sensitivity reaches 57-83%, and the specificity reaches 60-92%. The specificity of patients with hematuria can only reach 46%. In addition, benign prostatic hyperplasia, kidney stones and urinary tract infection all affect the specificity of BTA detection; Immunocyt kit passed Immunofluorescence detection of urine exfoliated cells, although the sensitivity and specificity are very high, in order to achieve high accuracy, a large number of urine exfoliated cells are required, so it has high application value in the treatment and prognosis of bladder cancer patients. However, the application in early diagnosis is unsatisfactory; among them, NMP22 is currently the most widely used bladder cancer marker, and the marketization of ELISA kits has realized the convenience and rapid detection of early diagnosis of bladder cancer, and the detection sensitivity and specificity are also high. In the case of viral infection, kidney / bladder stones, etc., false positives may still occur; the UroVysion kit uses a multi-target fluorescence in situ hybridization (FISH) technology, although the sensitivity and specificity have been greatly improved, and the US FDA has approved it. However, similar to the Immunocyt kit, a large number of urine exfoliated cells are required

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