Urine nucleic acid maker and detection reagent kit for assisting in early screening of prostatic cancer

Abstract

The invention discloses a urine nucleic acid maker and detection reagent kit for assisting in early screening of prostatic cancer. The nucleic acid marker comprises three prostatic cancer related genes of a T2E fusion gene, a PCA3 gene and an MMP-2 gene, and two internal reference genes of a PSA gene and an SPDEF gene. A multiple fluorescence reverse transcription polymerase chain reaction (RT-PCR) detection reagent comprising the five nucleic acid markers can be used for assisting in screening of prostatic cancer, an area under curve (AUC) of a testee operating characteristic (ROC) curve canachieve 0.81, and sensitivity predicted value and negative predicted value are respectively as high as 91.6% and 93.3%. The detection reagent kit is simple to operate, and quantitative detection of the nucleic acid markers and screening of the prostatic cancer can be completed in one pipe of the reagent. Unnecessary puncturing inspection of prostate can be notably reduced, and the reagent kit hasfavorable clinical application prospects.

Description

Technical field [0001] The invention relates to the fields of molecular biology and medical diagnostics, in particular to a urine nucleic acid marker and a detection kit for assisting in the early screening of prostate cancer. Background technique [0002] With the aging of our country's population structure and the changes in people's living habits, prostate cancer has quietly become one of the common tumors that seriously threaten the health of men in our country. The survey results in 2018 showed that the total number of prostate cancer patients in my country was nearly 145,000, and the compound growth rate in the last five years was nearly 10% higher. It is the tumor type with the fastest growing incidence. If prostate cancer is detected early and treated in time, the five-year survival rate can reach more than 95%, while the five-year survival rate of advanced prostate cancer that has metastasized is less than 30%. Only one-quarter to one-third of newly diagnosed patients i...

AI Technical Summary

Problems solved by technology

However, internal reference genes cannot eliminate the bias introduced by detection equipment

For example, the quantitative systems of nucleic acid markers in the above-mentioned patents work in different detection tubes, and the slight deviation in the matching degree between the detection tube and the detection equipment directly leads to slight deviations in the working efficiency of each detection system. After exponential amplification by polymerase chain reaction, it will have a non-negligible impact on the detection results

[0006] In addition, the above-mentioned patents all use a single internal reference gene for the calibration of gene expression. While eliminating sample differences, this design also has the risk of causing new systematic biases

The premise of ensuring the normal work of the internal reference gene is that its expression level should not be too low. When the concentration of the internal reference gene is low, the deviation introduced by the operation process (such as exosome enrichment, nucleic acid purification, template loading, etc.) will directly affect the expression level of the internal reference gene. Quantitative values, which in turn interfere with the relative expression levels of nucleic acid markers, resulting in abnormal screening results

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