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Guiding method and kit for atorvastatin individualized medication gene
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A technology of atorvastatin and kit, which is applied in the field of gene guidance method and kit for individualized medicine of atorvastatin
Active Publication Date: 2021-04-13
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 atorvastatin medication, so it is urgent to establish a highly sensitive, economical and simple molecular technology screening method to fill the gap in China
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Embodiment 1
[0087] Feasibility analysis of SNP site screening of human atorvastatin individualized drug-related genes
[0088] By searching NCBI home and abroad genome-wide association study (genome-wide association study, GWAS) in large-scale pathological control group clinical research of atorvastatin individualized drug-related loci, the inventors made a screening and Assessed, 7 single nucleotide polymorphism sites that are significantly related to the individualized drug use of atorvastatin were selected, and they were independent of each other, and there was no linkage disequilibrium, so the site selection of the present invention is representative and independent And the accumulation of risk value can be used to guide the individualized medication of atorvastatin.
[0092] System validation includes accuracy, specificity, sensitivity, precision, and comparison among personnel.
[0093] Accuracy verification scheme: 20 cases were detected at each site, compared with Sanger sequencing, the expected target was 95%.
[0094] Specificity Validation Protocol: Included in Accuracy, expected target 95%.
[0095] 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.
[0096] The precision verification plan (including intra-batch, inter-batch, and personnel comparisons, not involving inter-instrument comparisons) has an expected target of 95%.
[0097] Intra-assay precision: The same batch of each sample was repeated 3 times to compare the intra-assay precision.
[0098] Inter-batch precision: The same operator tests the same sample in multiple batches to...
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Abstract
The invention provides a guiding method and a kit for an atorvastatin individualized medication gene, and in particular relates to a combination of SNP sites of an atorvastatin individualized medication related gene. A nucleic acidmassspectrometer is used for widely screening and inspecting atorvastatin-related genetic markers (high-throughput detection sites and high-throughput detection samples). The method 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 maximized use of the small sample; and the method provided has the technical advantages of high accuracy and high sensitivity, the detection result is stable, and the detection positive rate is improved.
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 atorvastatin. Background technique [0002] Statins are the first-line drugs for the clinical treatment of cardiovascular diseases, and belong to a class of oral lipid-lowering drugs widely used in clinical practice. At present, with the continuous updating of clinical application guidelines, it has been applied in the treatment of metabolic diseases, cerebrovascular diseases, and cardiovascular diseases. However, responses to these drugs show high interindividual variability, and some patients refuse or discontinue statins due to concerns about adverse effects. Therefore, it is of great significance to study the medication guidance methods of statins in clinical medication and to confirm their safety. [0003] Single nucleotide polymorphism (single nucleotide polymorphism, SNPs) is a kind of geneti...
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