Rapid specific antibody IgE detection kit and preparation method thereof
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A kit and specific technology, applied in the field of rapid detection of specific antibody IgE kit and its preparation, can solve the problems of low sensitivity and achieve the effects of good stability, convenient carrying and simple operation
Active Publication Date: 2013-12-11
北京新华联协和药业有限责任公司
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Colloidal gold immunoassay method has been widely used in the early diagnosis and prevention of infectious diseases and tumor diseases, but combined with the special properties of allergens, the allergen extract is a complex containing allergenic proteins, non-allergenic proteins, pigments, etc. Molecular, traditional colloidal gold analysis method for allergen detection, low sensitivity
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Embodiment 1
[0072] The preparation of embodiment 1 allergen-specific antibody IgE rapid detection kit
[0073] 1. Preparation of catalase-labeled allergen
[0074] (I) All the allergen combination I, allergen combination II, allergen combination III and allergen combination IV were diluted to 5 μg / ml.
[0075] in:
[0076] Allergen combination I is an inhalation group of allergens, including: house dust mite / dust mite, artemisia pollen, ragweed pollen, dog hair / cat hair, cockroach, lawn pollen, mold mixture (Cladospora / Aspergillus fumigatus / Alternaria), tree pollen combination (willow / triangle poplar / juniper / English sycamore / poplar / elm) allergens;
[0077] Allergen combination II is an inhalation group of allergens, including: spring pollen I (cedar / fir / poplar / elm / willow), spring pollen II (birch / maple / oak / walnut / rape), Polyvalent fungi I (Penicillium chrysogenum / A. fungus / baker's yeast), polyvalent fungi III (Chemophagocystis sp. English sycamore / white wax / elm) allergens;
[0078...
Embodiment 2
[0108] Embodiment 2 quality inspection
[0109] The quality standard of the kit of the present invention is based on three parts of the "Pharmacopoeia" of the People's Republic of China, and the minimum detection limit, negative reference product compliance rate, positive reference product compliance rate, and precision all meet the national standard (Table 1).
[0114] The allergen-specific antibody IgE detection kit was placed at 37°C for 8 days, and then tested with standard serum, CV<15% (Table 2).
[0115] Table 2: Stability Test
[0116]
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Abstract
The present invention relates to a rapid allergic disease allergen diagnosis kit through a two-step method, a preparation method and a use method thereof. During use of the kit, a serum sample requiring detection and catalase-labeled allergen are subjected to equal volume mixing, room temperature incubation is performed for 5-15 min, the mixed sample is added to a sample hole of colloidal gold test paper strip, and the result is read after 5-15 min, wherein the test strip comprises the sample hole, a colloidal gold pad, a film strip and a water suction pad, colloidal gold is conjugated with biotin labeled goat anti-catalase antibody through streptomycin protein and mouse anti-human IgE monoclonal antibody is coated on the film strip so as to form the colloidal gold-streptomycin protein-biotin-goat anti-catalase antibody-catalase-allergen-specific human IgE antibody-mouse anti-human IgE antibody complex, and the quality control zone is coated with mouse anti-goat IgG antibody. The total detection time of the kit is 10-30 min. The kit has characteristics of strong specificity, high sensitivity, simpleness, rapidness, on-site inspection and no requirement of professional training on operators, wherein operations on allergen specific IgE detection reagents can be completed according to the instruction.
Description
technical field [0001] The invention relates to a diagnostic kit (colloidal gold method) for an allergic disease allergen, a preparation method thereof, and a use method of the kit. Background technique [0002] Allergic diseases (also known as allergic diseases) include atopic dermatitis, food allergy, allergic rhinitis and allergic asthma, etc., the incidence of which 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.) infiltration. The pathogenesis of this diseas...
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