Kit for assistant diagnosis or screening of bladder cancer and application thereof

A technology of auxiliary diagnosis and kit, applied in the field of bladder cancer gene detection, to achieve the effects of high sensitivity, improved compliance and improved acceptance

Active Publication Date: 2019-07-26
GENETALKS BIO TECH CHANGSHA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, there is no cfDNA mutation detection program or related research reports on bladder cancer; therefore, the development of cfDNA mutation detection for bladder cancer is of great significance for early screening or prognosis of bladder cancer

Method used

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  • Kit for assistant diagnosis or screening of bladder cancer and application thereof
  • Kit for assistant diagnosis or screening of bladder cancer and application thereof
  • Kit for assistant diagnosis or screening of bladder cancer and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0037] The test samples in this case came from the Department of Urology, Xiangya Hospital, Central South University, and the clinical and pathological diagnosis results of all test samples were confirmed; in this case, the test results of the detection kit and method in this case were compared with the clinical and pathological diagnosis results , to evaluate the detection sensitivity, specificity, and consistency of the detection kit and method in this case. The details are as follows:

[0038] 1. Sample collection

[0039] Collect 80 mL of urine samples from 55 hematuria patients who have not undergone cystoscopy and surgery, and use them for free DNA extraction; the collection and storage methods of urine samples refer to patent application 201711107815.X, which is about urine All information on fluid sample collection is referenced in this example. The clinical information of the patients whose urine samples were collected in this case is shown in Table 1.

[0040] Tab...

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Abstract

The invention discloses a kit for assistant diagnosis or screening of bladder cancer and application thereof. The kit comprises a primer combination for high-flux sequencing detection of mutation conditions of four genes of PTEN, BRAF, PIK3CA and FGFR2. The kit is high in sensitivity and specificity, capable of increasing detection rate of hematuric patients' bladder cance, early-stage finding rate and patients' five-year survival rate. When the kit is adopted for bladder cancer assistant screening, urine is used as a detection sample, so that sampling is convenient; bladder cancer assistant screening belongs to noninvasive detection, so that acceptance degree of subjects can be improved, expanding of coverage population of bladder cancer screening is facilitated, bladder cancer occurrencerate in China is lowered, and public health is ensured. More importantly, by adopting the kit for screening, risks of urinary tract infection and urinary tract injury of negative patients caused whencystoscopy is performed can be avoided effectively, and compliance of patients is improved, so that medical experience and doctor-patient relation are improved.

Description

technical field [0001] The application relates to the field of bladder cancer gene detection, in particular to a kit for auxiliary diagnosis or screening of bladder cancer and its application. Background technique [0002] Bladder cancer is the most common malignant tumor of the urinary system, accounting for the first place in the incidence of urogenital tumors in my country. In 2015, the incidence of bladder cancer in the national tumor registration area was about 80,300, and the number of malignant tumor deaths was about 32,900. The incidence and mortality increased with age. Hematuria is the most common symptom of bladder cancer. Studies have found that 12% of patients with hematuria were found to be bladder cancer. [0003] At present, the blood and urine examinations in clinical application generally include urine routine, B-ultrasound, urine exfoliation cytology examination and bladder endoscopy. Cystoscopy is regarded as the gold standard for the diagnosis of bladd...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12Q1/6858C12N15/11C40B50/06
CPCC12Q1/6886C12Q1/6858C40B50/06C12Q2600/156C12Q2535/122C12Q2531/113
Inventor 戴应宋卓何庆王永利杨婷高堂杰
Owner GENETALKS BIO TECH CHANGSHA CO LTD
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