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Quality control material of chromosome aneuploid (T21, T18 and T13) detection kit and application of quality control material

A detection kit and aneuploidy technology, applied in the biological field, can solve the problems of quality inspection and performance evaluation of the quality control kit, high use cost and high price.

Active Publication Date: 2015-11-11
CAPITALBIO CORP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these existing kits do not provide supporting quality control materials for quality verification and performance evaluation of the kits
Currently, only the "National Reference Materials for Peripheral Blood Fetal Chromosomal Aneuploidy (T21, T18, and T13) for High-throughput Sequencing" can be used for performance evaluation of related kits, but its price is relatively high (1.8 million / sets), the use cost is higher
There are no other related products on the market

Method used

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  • Quality control material of chromosome aneuploid (T21, T18 and T13) detection kit and application of quality control material
  • Quality control material of chromosome aneuploid (T21, T18 and T13) detection kit and application of quality control material
  • Quality control material of chromosome aneuploid (T21, T18 and T13) detection kit and application of quality control material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1. A complete set of quality control products of the kit for detecting 21-trisomy syndrome, 18-trisomy syndrome and 13-trisomy syndrome.

[0041] In this example, the chromosomal aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method) of Boao Biological Group Co., Ltd. is used as the quality control kit to clarify the detection of 21-trisomy syndrome, 18-trisomy A complete set of quality control materials for kits for trisomy syndrome and trisomy 13.

[0042] The complete set of quality control products of the kits for detecting 21-trisomy syndrome, 18-trisomy syndrome and 13-trisomy syndrome provided by this embodiment, referred to as the complete set of quality control products of T21, T18 and T13 detection kits Taste. A set of quality control materials for T21, T18 and T13 detection kits, consisting of six reference materials: positive reference, detection limit reference, negative reference, repeatability reference, microdeletion and m...

Embodiment 2

[0103] The performance of the complete quality control product of the test kit of the detection 21-trisomy syndrome of embodiment 2, embodiment 1, 18-trisomy syndrome and 13-trisomy syndrome

[0104] Chromosomal aneuploidy (T21, T18, T13) detection kit (Semiconductor Sequencing method) (product of Boao Biological Group Co., Ltd., National Machinery Note 20153400300), the results show that the quality of the chromosome aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method) is qualified, and the chromosome Aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method) verification embodiment 1 detection 21-trisomy syndrome, 18-trisomy syndrome and 13-trisomy syndrome kit kit quality control.

[0105] 1. The accuracy of the complete set of quality control products of the test kit for detecting 21-trisomy syndrome, 18-trisomy syndrome and 13-trisomy syndrome of embodiment 1

[0106] The results are shown in Table 2, P1-P7, N1-N7, L2, L4, L6, R1-R4...

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Abstract

The invention discloses a quality control material of a chromosome aneuploid (T21, T18 and T13) detection kit. The quality control material comprises a positive reference material and a negative reference material. The positive reference material is a reference material set composed of a solution P21, a solution P18 and a solution P13, wherein the solution P21 is composed of solute and solvent, the solution P18 is composed of solute and solvent, the solution P13 is composed of solute and solvent, and the solvent of the solution P21, the solvent of the solution P18 and the solvent of the solution P13 are normal solutions. The normal solutions are in-vitro plasma of normal non-pregnant women of which the chromosome karyotype is 46, XX according to the analysis result. The solute of the solution P21 is PL21, the solute of the solution P18 is PL18, and the solute of the solution P13 is PL13. The quality control material is economical, simple and convenient to use and effectively achieves quality verification and performance evaluation of the chromosome aneuploid (T21, T18 and T13) detection kit.

Description

technical field [0001] The invention relates to a quality control product of a chromosome aneuploidy (T21, T18, T13) detection kit in the biological field and an application thereof. Background technique [0002] Chromosomal diseases mainly refer to diseases caused by abnormalities in the number and structure of chromosomes. Clinically, chromosomal aneuploidy diseases such as 21-trisomy, 18-trisomy, and 13-trisomy are the most common. Developmental delay, multiple deformities, or adult fertility disorders, for which there is currently no effective treatment. Prenatal screening for fetal chromosomal aneuploidy is of great significance for the prevention of birth defects and eugenics. Current detection of fetal chromosomal aneuploidy is mainly based on serological screening, ultrasonography, and invasive prenatal diagnosis. Traditional non-invasive prenatal screening methods based on serology and ultrasound are not only limited by the age and gestational age of pregnant wome...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68
CPCC12Q1/6883C12Q2600/166
Inventor 郭弘妍田婕刘新新王晓杰郭晓丹周禹稀邢婉丽
Owner CAPITALBIO CORP
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