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Chemiluminiscence detection kit for diagnosing gastropathy in combined manner and preparation and application method thereof

A chemiluminescence detection and kit technology, applied in the field of immunodetection, can solve the problems of cumbersome operation, narrow detection range and clinical application, and low sensitivity.

Inactive Publication Date: 2016-12-07
山东康华生物医疗科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Immunoturbidimetry and enzyme-linked immunoassay have disadvantages such as cumbersome operation, poor specificity, low sensitivity, and long time. However, other chemiluminescence detection reagents on the market have a relatively narrow detection range and clinical application, and the effective detection range for PGⅠ is only in the 1~200ng / mL; therefore, finding a more effective detection method has become the key to clinical application

Method used

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  • Chemiluminiscence detection kit for diagnosing gastropathy in combined manner and preparation and application method thereof
  • Chemiluminiscence detection kit for diagnosing gastropathy in combined manner and preparation and application method thereof
  • Chemiluminiscence detection kit for diagnosing gastropathy in combined manner and preparation and application method thereof

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Experimental program
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Effect test

Embodiment 1

[0084] Embodiment one, Chemiluminescence detection kit for combined diagnosis of gastric disease

[0085] A chemiluminescence detection kit for combined diagnosis of gastric disease, the kit includes PGⅠ coated microwell plate, PGⅠ enzyme conjugate, PGⅠ reference substance and quality control substance, PGⅡ coated microwell plate, PGⅡ enzyme conjugate, PGⅡ reference Products and quality control products, concentrated washing solution, luminescence substrate solution A, luminescence substrate solution B.

[0086] Among them, PGⅠantibody-coated microplates and PGⅡantibody-coated microplates are preferably imported milky white opaque polystyrene 48-well or 96-well chemiluminescence microplate-coated microplates; PGⅠcoated microplates are coated with PGⅠ antibody; PGⅠ reference and quality control products are PGⅠ antigen after serial dilution; PGⅠ enzyme conjugate is PGⅠ antibody labeled with horseradish peroxidase, which is another monoclonal paired with the PGⅠ antibody coated...

Embodiment 2

[0101] Embodiment two, Preparation method of chemiluminescent detection kit for combined diagnosis of gastric disease

[0102] (1) Preparation of PGⅠ-coated microwell plates;

[0103] (2) Prepare PGⅡ-coated microwell plates;

[0104] (3) Preparation of PGⅠ reference materials and quality control materials;

[0105] (4) Preparation of PGⅡ reference materials and quality control products;

[0106] (5) Preparation of PGⅠ enzyme conjugates;

[0107] (6) Preparation of PGⅡ enzyme conjugates;

[0108] (7) prepare concentrated washing liquid;

[0109] (8) Prepare luminescent substrate solution A and luminescent substrate solution B;

[0110] (9) Subpackaging of enzyme conjugates, reference substances, quality control substances, concentrated washing solution, luminescent substrate solution A and luminescent substrate solution B.

[0111] Wherein, the preparation method of PGⅠ coated microwell plate is:

[0112] (1) Preparation of coating buffer solution: the coating buffer s...

Embodiment 3

[0132] Embodiment three, Method for using chemiluminescent detection kit for combined diagnosis of gastric disease

[0133] (1) Sample collection

[0134] The serum to be tested is allowed to stand still for 30 minutes, and the serum to be tested is subjected to centrifugation for 10 to 20 minutes, and then the test can be carried out.

[0135] (2) Detection method

[0136] PGⅠdetermination:

[0137] a. Equilibrate the reagents stored in a refrigerated environment at room temperature for more than 15 minutes;

[0138] b. Dilute the concentrated washing solution at a ratio of 1:40, shake well and set aside, as the application washing solution;

[0139] c. Determine the number of holes required according to the PGⅠ reference substance, quality control substance and sample to be tested;

[0140] d. Directly take 50 μL each of PGⅠ reference substance, quality control substance and sample to be tested and add to corresponding wells;

[0141] e. Add 50 μL PGⅠ enzyme conjugate...

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Abstract

The invention discloses a chemiluminiscence detection kit for diagnosing gastropathy in a combined manner. The detection kit is mainly used for performing pepsinogen I detection and pepsinogen II detection. On the basis of the detection kit, the invention further provides a marker combined standard value, which is applicable to the detection kit and can provide reference for gastropathy detection, for detection. The detection kit has the advantages that the detection kit is wide in linearity range, high in specificity, convenient to operate, and the like in terms of gastropathy diagnosis and early gastric cancer screening; in addition, the detection kit is accurate and detailed in gastropathy diagnosis and high in market popularization value, and damage, caused by X-rays, on human bodies and the inconvenience of a gastroscope are avoided.

Description

technical field [0001] The invention relates to the field of immunodetection, in particular to a chemiluminescent detection kit for combined diagnosis of gastric disease and its preparation and use methods. Background technique [0002] Gastric cancer is one of the common malignant tumors, and its morbidity and mortality rate rank high among common malignant tumors. China is a high-incidence area of ​​gastric cancer. According to the "2012 China Tumor Registration Annual Report", the incidence of gastric cancer ranks second, second only to lung cancer, and the mortality rate of gastric cancer ranks third, second only to lung cancer and liver cancer. According to the epidemiology of gastric cancer According to research, China is one of the countries with the highest incidence of gastric cancer in the world, and the number of deaths from gastric cancer in my country ranks first in the world every year. At present, the diagnosis of gastric cancer and other gastric diseases stil...

Claims

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Application Information

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IPC IPC(8): G01N33/574
CPCG01N33/57446
Inventor 杨致亭彭新国张美山程永智李爱茜杨峰斌
Owner 山东康华生物医疗科技股份有限公司
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