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Anaphylactic disease allergen colloidal gold diagnostic test strip and preparation method thereof

A technology for allergic diseases and test strips, applied in the field of allergen detection, can solve the problems of complex operation steps, affecting the popularization of in vitro detection methods for allergens, and expensive supporting equipment.

Active Publication Date: 2014-03-26
北京新华联协和药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Currently on the market, the allergen in vitro diagnostic test strips for allergic diseases are based on Western blot and enzyme-linked immunoassay. The operation time is long (150min-240min), and the operation steps are complicated (including incubation, elution, etc.) , the supporting equipment is expensive (100,000 to 300,000 yuan), and the operation requires professionally trained technicians to operate
Seriously affected the popularization of allergen in vitro detection methods. At present, only large domestic hospitals have the ability to detect allergens in vitro, while most grassroots hospitals and army field hospitals cannot carry out in vitro allergen detection methods.

Method used

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  • Anaphylactic disease allergen colloidal gold diagnostic test strip and preparation method thereof
  • Anaphylactic disease allergen colloidal gold diagnostic test strip and preparation method thereof
  • Anaphylactic disease allergen colloidal gold diagnostic test strip and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Preparation of Example 1 Allergen Colloidal Gold Diagnostic Test Strip for Allergic Diseases

[0080] 1. Coating the allergen marker molecular mixture to form three bands on the membrane strip

[0081]Among them, the allergens in the inhalation group I include: House dust mite, Dermatophex farinae, A. tropicalis, Blattella germanica, cat dander, dog dander, Alternaria, Aspergillus fumigatus, and a mixture of allergen marker molecules of Penicillium pointis wherein the signature allergen molecules in the mixture are: Derp1, Derp2, Derf1, Derf2, Blot5, Blag1, Blag2, Canf1, Canf2, Feld1, Feld2, Alta1, Aspf1, Aspf2, Aspf3, Aspf4, Aspf5, Aspf6, Penl3.

[0082] Inhalation group allergen II, including: artemisia pollen, ragweed pollen, humulus pollen, corn pollen, quinoa pollen, sycamore pollen, birch pollen, poplar pollen, willow pollen, elm, tree pollen; mixtures thereof The iconic allergen molecules in the medium are: Artv1, Artv4, Amb1, Humj1, Humj2, Zeam12.3, Cheal, Plaa...

Embodiment 2

[0108] Example 2 Quality Inspection of Allergen Colloidal Gold Diagnostic Test Strips for Allergic Diseases

[0109] The quality standard of the test strip prepared in Example 1 of the present invention is based on the three parts of the "Pharmacopia" of the People's Republic of China, and the minimum detection limit, the compliance rate of negative reference products, the compliance rate of positive reference products, and precision all meet the national standards (Table 1). .

[0110] Table 1 Quality standard and inspection of rapid diagnostic test strips for allergic diseases

[0111]

Embodiment 3

[0112] Example 3 Stability investigation of allergic disease allergen colloidal gold diagnostic test strips

[0113] The test strip prepared in Example 1 of the present invention was placed at 37°C for 8 days, and then tested with standard serum, CV<15% (Table 2).

[0114] The stability test result of table 2 test strip

[0115]

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Abstract

The invention discloses an anaphylactic disease allergen colloidal gold diagnostic test strip. The test strip comprises a sample hole, a colloidal gold pad, a film strip, an absorbent pad and a PVC board, wherein the film strip is coated with inhalation group allergen I, inhalation group allergen II, a food group allergen and a mouse anti-goat IgG antibody, so as to form three detecting strips and one quality control strip. Each allergen energy included in the test strip can represent allergen molecules of 80 percent of patients, and on the detecting film strip, a symbolic allergen coated molecule replaces an allergen extract, so that the purpose of quickly diagnosing the anaphylactic disease technically is achieved. The time for detecting by using the test strip lasts for 5 to 30 minutes, the specificity is high, the sensitivity is high, the testing is simple and quick, on-site detecting is achieved, special training for operators is not required, operation can be finished according to specification, and quick diagnosis to anaphylactic diseases can be achieved.

Description

technical field [0001] The invention relates to the field of allergen detection, in particular to an allergic disease allergen colloid gold diagnostic test strip and a preparation method thereof. Background technique [0002] Allergic diseases (also known as allergic diseases) include atopic dermatitis, food allergy, allergic rhinitis and allergic asthma, etc., and their incidence is increasing day by day, and the condition is becoming more and more complicated. WHO has listed allergic diseases as key research and prevention diseases in the 21st century. In recent years, with the development of immunohistochemistry, molecular biology techniques and clinical new technologies, such as fiberoptic bronchoscopy, there has been a consensus that this disease belongs to allergic inflammation, and there are a large number of inflammatory cells (including eosinophils) in the inflammatory area. granulocytes, lymphocytes, mast cells, basophils, etc.) The pathogenesis of the disease ma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558
CPCG01N33/531G01N33/558G01N33/6893G01N2800/70
Inventor 白彩明马晓晖汤承祁裴潇竹姜敏李雪妮王兆仿
Owner 北京新华联协和药业有限责任公司
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