Method and kit for guiding carbamazepine individualized medication genes
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A technology of carbamazepine and kit, applied in the field of guidance method and kit of carbamazepine individualized drug gene
Pending Publication Date: 2021-03-16
广东南芯医疗科技有限公司
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At present, there is no very effective clinical guidance method for carbamazepine medication, so it is urgent to establish a highly sensitive, economical and simple molecular technology screening method to evaluate the risk and effectiveness of carbamazepine medication for patients at one time
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Embodiment 1
[0089] Feasibility analysis of SNP site screening of human carbamazepine individualized drug-related genes
[0090] By searching NCBI domestic and foreign genome-wide association study (genome-wide association study, GWAS) in the large-scale pathological control group clinical research verified carbamazepine drug safety and effectiveness related sites, the inventor made its Screening and evaluation, selected 8 single nucleotide polymorphism sites that are significantly related to carbamazepine individualized drug use, and are independent of each other, there is no linkage disequilibrium, so the site selection of the present invention is representative and independent It can be used to guide the individualized medication of carbamazepine.
[0094] System validation includes accuracy, specificity, sensitivity, precision, and comparison among personnel.
[0095] Accuracy verification scheme: 20 cases were detected at each site, compared with Sanger sequencing, the expected target was 95%.
[0096] Specificity Validation Protocol: Included in Accuracy, expected target 95%.
[0097] 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.
[0098] The precision verification plan (including intra-batch, inter-batch, and personnel comparisons, not involving inter-instrument comparisons) has an expected target of 95%.
[0099] Intra-assay precision: The same batch of each sample was repeated 3 times to compare the intra-assay precision.
[0100] Inter-batch precision: The same operator tests the same sample in multiple batches to...
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Abstract
The invention provides a method and kit for guiding carbamazepine individualized medication genes. Particularly, a combination of SNP loci of genes related to carbamazepine individualized medication is screened out by considering the difference of medication curative effects of different epileptic patients, and genetic markers related to carbamazepine are widely screened and inspected (with high-throughput detection sites and high-throughput detection samples) by utilizing a nucleic acid mass spectrometer. The method disclosed by the invention is high in detection success rate, good in technical reproducibility and high in cost performance, can realize detection of multiple genes of a single small sample, and meets the maximized use demand of the small sample; and the method provided by the invention has the technical advantages of high accuracy and high sensitivity, the detection result is stable, and the detection positive rate 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 individualized drug use of carbamazepine. 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 sam...
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