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Quality control product of chromosome aneuploidy detection kit capable of being stably stored and application thereof

A detection kit, aneuploidy technology, applied in the direction of microbial determination/inspection, biochemical equipment and methods, etc., can solve the problem of not meeting the requirements for the validity period of quality control products, nucleic acid degradation, etc., to achieve inhibition of DNA degradation, The effect of easy storage and extended expiration date

Active Publication Date: 2018-06-29
GUANGZHOU JINQIRUI BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the quality control products used in the performance evaluation of high-throughput gene sequencing kits for detection of trisomy 21, 18, and 13 generally have serious problems of nucleic acid degradation, which is far from meeting the requirements for the validity period of quality control products in actual operations.

Method used

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  • Quality control product of chromosome aneuploidy detection kit capable of being stably stored and application thereof
  • Quality control product of chromosome aneuploidy detection kit capable of being stably stored and application thereof
  • Quality control product of chromosome aneuploidy detection kit capable of being stably stored and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Embodiment 1, the quality control product of the chromosomal aneuploidy (T21, T18, T13) detection kit that can be stored stably and its preparation

[0034]This example provides a complete set of quality control materials for a stable chromosomal aneuploidy (T21, T18, T13) detection kit, including not only positive reference materials, negative reference materials, detection limit reference materials, but also microdeletion micro Duplicate references, chimera references, duplicate references.

[0035] 1. Positive reference product and its preparation

[0036] The positive reference substance is used for the positive detection rate of the quality control kit to be quality controlled, and its preparation method comprises the following steps:

[0037] ① DNA extraction: Select and extract the T21 human genomic DNA with a karyotype of 47, the T18 human genomic DNA with a karyotype of 47, and the T13 human genomic DNA with a karyotype of 47; this step can be performed us...

Embodiment 2

[0083] Embodiment 2 is a modification example of Embodiment 1. The only difference is that the concentrations of aurintricarboxylate ammonium salt, glycine, and bestatin hydrochloride contained in each reference product of the quality control product are respectively 100 μm, 80 mM, and 20 nM.

Embodiment 3

[0084] Embodiment 3 is a modification example of Embodiment 1. The only difference is that the concentrations of aurintricarboxylate ammonium salt, glycine, and bestatin hydrochloride contained in each reference product of the quality control product are 500 μm, 180 mM, and 60 nM, respectively.

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Abstract

The invention provides a quality control product of a chromosome aneuploidy detection kit capable of being stably stored, and application. The quality control product comprises a positive reference product and a negative reference product, wherein the positive reference product contianins DNA protecting agents and DNA fragments from 150 to 200bp intervals with the nuclear type analysis result being 47 and TN1 human genome DNA amplification products; the negative reference product contains a DNA protecting agents and DNA fragments which are not from 150 to 200bp intervals with the nuclear typeanalysis result being 47 and TN1 human genome DNA amplification products; the TN1 is selected from one several kinds of materials from T21, T18 and T13; the DNA protection agents contain aurintricarboxylic acid ammonium salt, glycine and bestatin hydrochloride. The quality control product provided by the invention has the advantages that the protection agents are added into each reference product;the DNA degradation of the reference product in the quality control product is inhibited, so that the stability is higher; the storage is easy; the shelf life is prolonged.

Description

technical field [0001] The invention relates to the technical field of prenatal diagnosis, in particular to a quality control product and application of a stable-preservable chromosome aneuploidy detection kit. Background technique [0002] Chromosomal aneuploidy refers to the integer multiple of the number of chromosomes in a cell that is abnormal in gamete chromosomes, that is, the increase or decrease in the number of one or several chromosomes in a cell. Human chromosomal aneuploidy is extremely harmful, and it is one of the main causes of spontaneous abortion, embryo suspension, congenital birth defects, mental retardation, growth retardation, and multiple deformities. Common autosomal aneuploidy diseases include 21-trisomy syndrome, 18-trisomy syndrome and 13-trisomy syndrome, and the incidence rates in newborns are 1 / 800-1 / 600, 1 / 7000-1 / 3500, 1 / 6000-1 / 5000. [0003] Currently, there is no effective treatment for trisomy syndrome caused by chromosomal aneuploidy. T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6883C12Q1/6806
CPCC12Q1/6806C12Q1/6883C12Q2600/166C12Q2527/125
Inventor 陈嘉昌陈肖燕柳俊张瑶蒋圆玲
Owner GUANGZHOU JINQIRUI BIOTECHNOLOGY CO LTD
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