Quality control product, preparation method thereof, kit and method for detecting trisomy 21 and 18 syndromes of fetuses

A quality control product and three-body technology, applied in biochemical equipment and methods, microbiological determination/inspection, etc., can solve the problems of high detection cost, long detection cycle, high technical threshold, etc., and achieve positive detection rate and detection accuracy The effect of improving the performance and ensuring the detection sensitivity

Pending Publication Date: 2019-08-09
苏州行知康众生物科技有限公司
View PDF4 Cites 6 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the non-invasive prenatal detection technology based on next-generation sequencing still has shortcomings such as long detection cycle, 15 working days for detect...

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Quality control product, preparation method thereof, kit and method for detecting trisomy 21 and 18 syndromes of fetuses
  • Quality control product, preparation method thereof, kit and method for detecting trisomy 21 and 18 syndromes of fetuses
  • Quality control product, preparation method thereof, kit and method for detecting trisomy 21 and 18 syndromes of fetuses

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0047] The preparation of described positive class reference product:

[0048] 1) Preparation of P21

[0049] Extract the cellular genomic DNA of the T21 trisomy-positive cell line, break it up by ultrasound, and obtain a fragmented T21 trisomy-positive cell line DNA solution that is close in size to the DNA extracted from maternal plasma and the fetal free DNA in the maternal plasma. The P21 solution is obtained by mixing the degraded T21 trisomy-positive cell line DNA solution with the isolated plasma DNA solution of normal non-pregnant women, wherein the content of the fragmented T21 trisomy-positive cell line DNA solution is 10- 20%wt;

[0050] 2) Preparation of P18

[0051] Extract the cellular genomic DNA of the T18 trisomy-positive cell line, break it with ultrasound, and obtain a fragmented T18 trisomy-positive cell line DNA solution that is close in size to the DNA extracted from the maternal plasma and the fetal free DNA in the maternal plasma. The P18 solution is...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention relates to a quality control product, a preparation method thereof, a kit and a method for detecting trisomy 21 and 18 syndromes of fetuses. The digital PCR technology with single-molecule detection sensitivity and absolute quantitative capability is used, and a new simple and effective chromosome aneuploid non-invasive prenatal detection method is developed. By using peripheral blood of a pregnant woman, non-invasive prenatal detection can be completed on one sample within about 5 hours. By adopting the non-invasive prenatal detection technology based on the digital PCR, accurate, rapid and simple prenatal screening can be realized. The accuracy of the detection kit reaches 99%, the cost is only 1/5 that of the NIPT technology, and the detection time is 5 hours.

Description

technical field [0001] The invention relates to a quality control product, a preparation method thereof, a kit and a method for detecting fetal trisomy 21 and 18. Background technique [0002] Fetal chromosomal aneuploidy is a serious birth defect, the most common of which is trisomy 21 (i.e. Down syndrome, whose unintervented combined incidence is as high as 1 / 750, and the risk increases sharply with maternal age increase), 18-trisomy syndrome, etc. Such diseases will lead to mental retardation, growth retardation, multiple deformities and even death in newborns, and there is no effective treatment, and prenatal screening and diagnosis can most effectively prevent the birth of such children. [0003] Prenatal testing for chromosomal diseases is mainly based on serological screening and amniocentesis. However, the accuracy of serological screening is low, with a false positive rate of 5% and a missed diagnosis rate of 20-40%. Although the accuracy of amniocentesis is high,...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): C12Q1/6883C12Q1/6806C12Q1/6851
CPCC12Q1/6883C12Q1/6806C12Q1/6851C12Q2600/166C12Q2523/301C12Q2531/113C12Q2545/113
Inventor 林文楚朱琦偶健
Owner 苏州行知康众生物科技有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap