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Multiplex detection kit for neonatal disease screening and preparation method and use method thereof

A detection kit and technology for newborns, applied in biochemical equipment and methods, biological testing, and microbial determination/inspection, etc., can solve problems such as impact on newborns, delayed treatment, etc., to avoid life hazards and improve work efficiency , to avoid the effect of mental retardation

Pending Publication Date: 2021-11-16
广州俊通生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unqualified blood film collection is one of the most important reasons for missed diagnosis in screening, and missed diagnosis will delay treatment and have a lifelong impact on newborns

Method used

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  • Multiplex detection kit for neonatal disease screening and preparation method and use method thereof
  • Multiplex detection kit for neonatal disease screening and preparation method and use method thereof
  • Multiplex detection kit for neonatal disease screening and preparation method and use method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] A multiple detection kit for neonatal disease screening, including buffer, at least two detection reaction cups, acridinium ester marker microspheres, calibrator, quality control product, excitation solution, concentrated washing solution, and hemolysis agent;

[0064] The detection cuvette is used to detect TSH (thyrotropin), FT 4 (free thyroxine), 17a-OHP (17α-hydroxyprogesterone), GAA (acid-α-glucosidase).

[0065] The detection cuvette is a cuvette whose inner surface is coated with a target antibody or an antigen conjugate;

[0066] The target antibody or antigen conjugate is anti-TSH antibody protein, thyroxine T 4 Conjugated bovine serum albumin, 17α-hydroxyprogesterone conjugated bovine serum albumin, anti-GAA antibody protein.

[0067] The preparation method of the detection cuvette is:

[0068] Dilute the pure target antibody or antigen conjugate with coating buffer to a coating working solution with a concentration of 5 μg / ml; add 150 μl / well of coating wo...

Embodiment 2

[0099] A multiple detection kit for neonatal disease screening, including buffer solution, at least two detection reaction cups or blank reaction cups, acridinium ester marker microspheres, calibrator, quality control product, excitation solution, concentrated washing solution , hemolytic agent, phenylalanine reagent enzyme lyophilized microspheres, glucose-6-phosphate dehydrogenase reagent substrate lyophilized microspheres, galactose reagent enzyme lyophilized microspheres, creatine kinase reagent substrate lyophilized microspheres One or more of them, fluorescence reaction termination solution.

[0100] The detection cuvette is used to detect TSH (thyrotropin), FT 4 (free thyroxine), 17a-OHP (17α-hydroxyprogesterone), GAA (acid-α-glucosidase), and the blank cuvette is used to detect Phe (phenylalanine), G6PD (glucose-6- phosphate dehydrogenase), GALT (galactose and galactose-1-phosphate), CK (creatine kinase).

[0101] The detection cuvette is a cuvette whose inner surfac...

Embodiment 3

[0142] A multiple detection kit for neonatal disease screening, including buffer solution, four detection reaction cups, four blank reaction cups, acridinium ester marker microspheres, calibrator, quality control product, excitation solution, concentrated washing solution, hemolytic agent, phenylalanine reagent enzyme lyophilized microspheres, glucose-6-phosphate dehydrogenase lyophilized microspheres, galactose reagent enzyme lyophilized microspheres, creatine kinase lyophilized microspheres, fluorescence reaction termination solution .

[0143] The detection cuvette is used to detect TSH (thyrotropin), FT4 (free thyroxine), 17a-OHP (17α-hydroxyprogesterone), GAA (acid-α-glucosidase), and the blank cuvette is used to detect Phe (phenylalanine), G6PD (glucose-6- phosphate dehydrogenase), GALT (galactose and galactose-1-phosphate), CK (creatine kinase).

[0144] The detection cuvette is a cuvette whose inner surface is coated with a target antibody or an antigen conjugate;

...

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Abstract

The invention discloses a multiplex detection kit for neonatal disease screening and a preparation method and a use method thereof. The multiplex detection kit comprises a buffer solution, at least two reaction cups, acridinium ester marker microspheres, a calibration product, a quality control product, an excitation solution, a concentrated washing solution and a hemolytic agent, the reaction cup is a micropore of which the inner surface is coated with a target antibody or antigen conjugate; the target antibody or antigen conjugate is an anti-TSH antibody protein, thyroxine T4 coupled bovine serum albumin, 17 alpha-hydroxyprogesterone coupled bovine serum albumin and an anti-GAA antibody protein. According to the invention, one kit is used for combined screening of multiple (2-8) blood markers, so that the preparation work is greatly simplified, errors caused by manual operation are reduced, and the working efficiency is improved; the high performance of quantitative detection is ensured by applying a chemiluminescence labeling immunoassay technology and a fluorescence analysis method which take acridinium ester as a marker.

Description

technical field [0001] The invention relates to the technical field of neonatal disease screening, in particular to a multiple detection kit for neonatal disease screening and a preparation method and use method thereof. Background technique [0002] Neonatal disease screening refers to the group screening of certain serious congenital metabolic diseases and endocrine diseases through blood tests, so that children can be diagnosed and treated early, and avoid brain, liver, kidney and other damages that lead to growth and development. mental retardation and even death. The objects of neonatal disease screening are all live-born newborns within 72 hours of birth (at least 6-8 times of breastfeeding). The types of screening diseases vary by race, country, and region, and are also related to the society, development of science and technology, economic level, and degree of disease hazards of each country. The internationally recognized conditions for screening diseases are: ① a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/78G01N33/76G01N33/74G01N33/573G01N33/543G01N33/532C12Q1/48C12Q1/32
CPCG01N33/78G01N33/76G01N33/743G01N33/573G01N33/54313G01N33/532C12Q1/485C12Q1/32G01N2333/59G01N2333/924G01N2333/90622G01N2333/904G01N2333/91215G01N2333/9123
Inventor 李婉君李灿禧
Owner 广州俊通生物科技有限公司
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