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Instruction method for irinotecan individualized-medication genes and kit

A technology of irinotecan and kits, which can be used in biochemical equipment and methods, determination/inspection of microorganisms, DNA/RNA fragments, etc., and can solve problems such as single detection methods and indicators

Pending Publication Date: 2021-03-26
广东南芯医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the detection methods and indicators for clinical guidance of irinotecan medication are relatively simple, so it is urgent to establish a highly sensitive, economical and simple molecular technology screening method to predict toxicity, recommend a reasonable starting dose, effectively shorten the dose adjustment cycle, and avoid Risk of serious adverse reactions

Method used

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  • Instruction method for irinotecan individualized-medication genes and kit
  • Instruction method for irinotecan individualized-medication genes and kit
  • Instruction method for irinotecan individualized-medication genes and kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Feasibility analysis of SNP site screening of human irinotecan individualized drug-related genes

[0095] By searching NCBI home and abroad whole-genome association analysis (genome-wide association study, GWAS) in large-scale pathological control group clinical research verified irinotecan drug safety and effectiveness-related sites, the inventor made its Screening and evaluation, selected 11 single nucleotide polymorphism sites that are significantly related to irinotecan individualized medication, and are independent of each other, there is no linkage disequilibrium, so the site selection of the present invention is representative and independent and the accumulative risk value can be used to guide the individualized medication of irinotecan.

[0096] The screened SNP sites are as follows:

[0097] rs6072249, rs9351963, rs2032582, rs1128503, rs1045642, rs1801133, rs4148323, rs2306283, rs1051266, rs562, rs425215.

Embodiment 2

[0098] Embodiment 2 system verification

[0099] System validation includes accuracy, specificity, sensitivity, precision, and comparison among personnel.

[0100] Accuracy verification scheme: 20 cases were detected at each site, compared with Sanger sequencing, the expected target was 95%.

[0101] Specificity Validation Protocol: Included in Accuracy, expected target 95%.

[0102] Sensitive verification scheme: using human genomic DNA positive samples as templates, the DNA contents of calibration samples were 1ng / μL, 5ng / μL, 10ng / μL, 50ng / μL, and 100ng / μL for sensitivity inspection.

[0103] The precision verification plan (including intra-batch, inter-batch, and personnel comparisons, not involving inter-instrument comparisons) has an expected target of 95%.

[0104] Intra-assay precision: The same batch of each sample was repeated 3 times to compare the intra-assay precision.

[0105] Inter-batch precision: The same operator tests the same sample in multiple batches to c...

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Abstract

The invention provides an instruction method for irinotecan individualized-medication genes and a kit. Specifically, difference of medication treatment effects of different cancer patients is taken into account, a combination of SNP loci of genes related to irinotecan individualized-medication is screened out, and genetic markers related to irinotecan are extensively screened and inspected (high-pass detection locus and high-pass detection sample) by using a nucleic acid mass spectrograph. Through the method provided by the invention, the success rate of detection is high, the technical reproducibility is good, the cost performance is high, polygenic detection on single small samples can be achieved, and thus, the requirements of the small samples on maximized use are met; and the method provided by the invention has the technical advantages of high accuracy and high sensitivity and is stable in detection result, and the positive rate of detection is increased.

Description

technical field [0001] The invention belongs to the field of biotechnology, in particular, the invention relates to a gene guiding method and kit for irinotecan individualized medicine. Background technique [0002] Single nucleotide polymorphism (single nucleotide polymorphism, SNPs) is a kind of genetic marker, which refers to the polymorphism of DNA sequence caused by single nucleotide variation at the genome level. The frequency of occurrence in the population is greater than 1%, including single-base conversions, inversions, and single-base insertions or deletions. It is a new genetic marker that can be used for disease prediction, diagnosis, treatment, and new drugs. The development provides reliable and effective scientific basis. [0003] SNP occurs in the coding region and can affect protein function, thereby affecting human health or drug metabolism, mainly in individual differences in disease susceptibility, individual differences in the efficacy of the same drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886C12Q1/6858C12N15/11
CPCC12Q1/6886C12Q1/6858C12Q2600/106C12Q2600/156C12Q2600/16C12Q2531/113C12Q2537/143C12Q2533/101C12Q2565/627C12Q2521/525
Inventor 陈涛张静袁昕昕林金飞
Owner 广东南芯医疗科技有限公司
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