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Allergen-specific IgE antibody detection kit and preparation method thereof

A detection reagent and antibody detection technology, applied in the field of clinical laboratory diagnostics, can solve the problems of the popularization of in vitro detection methods for allergens, the inability to carry out in vitro diagnosis of allergens, the loss of bedside detection, etc., so as to reduce the occurrence of false negative results , Improve the diagnostic compliance, the effect of less sample consumption

Pending Publication Date: 2021-10-26
GLALLERGEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, allergen in vitro diagnostic products that have been approved in China generally require expensive supporting equipment and specialized technical personnel to operate, and the popularization of allergen in vitro detection methods has been greatly affected.
At present, only some tertiary hospitals in China have professional allergen in vitro detection capabilities, while most grassroots hospitals, clinics and military field hospitals cannot carry out allergen in vitro diagnosis
Moreover, the sample tested can only be serum, and it takes a certain amount of time from blood collection to sample processing into serum.
Even currently marketed colloidal gold assays use serum assays, which defeats the purpose of point-of-care testing

Method used

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  • Allergen-specific IgE antibody detection kit and preparation method thereof
  • Allergen-specific IgE antibody detection kit and preparation method thereof
  • Allergen-specific IgE antibody detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] The preparation of embodiment 1 allergen raw material extract

[0096] 1. Prepare extraction buffer:

[0097] Weigh disodium hydrogen phosphate 26.48g, potassium dihydrogen phosphate 1.68g, sodium chloride 2.92g, add ultrapure water to 1000ml and mix well.

[0098] 2. Extraction steps

[0099] (1) Weigh 10g of the allergen raw material, add the extraction buffer according to the mass ratio of the raw material to the extract solution at 1:20-1:50, and mix evenly; under the condition of 2-8°C, put the mixed raw material on a magnetic stirrer Stir and extract for 24 hours (the speed is 100-300 rpm);

[0100] (2) Distribute the above-mentioned raw materials evenly into centrifuge tubes, and put them into a centrifuge; under the condition of 4°C, adjust the speed of the centrifuge to 5000-8000 rpm, and centrifuge for 10-20 minutes;

[0101] (3) After centrifugation, take out the supernatant, and use a 0.8um filter membrane for coarse filtration; then use a 0.22um filter m...

Embodiment 2

[0103] Example 2 Allergen-specific IgE antibody detection test strip

[0104]The test strip includes a film strip (NC film coated with allergen), a sample pad, a colloidal gold pad, an absorbent pad and a large PVC board. The sample pad, colloidal gold pad, film strip and water-absorbing pad are pasted on the center of the PVC large board sequentially from the lower end to the upper end. The film strip is pasted in the middle of the PVC large board, and the absorbent paper is pasted on the top of the large board. The top of the colloidal gold pad is pressed with a nitrocellulose membrane 3 mm, and the upper end of the sample pad is stacked under the colloidal gold pad, and the lower end of the sample pad is flush with the PVC large plate; the upper edge of the PE film exceeds the upper edge of the colloidal gold pad by 3 mm. On the nitrocellulose membrane, the bottom of the PE membrane is flush with the colloidal gold pad.

[0105] The film strip is provided with 5 detection...

Embodiment 3

[0106] Example 3 Allergen-specific IgE antibody detection test strip

[0107] The test strip includes a film strip (NC film coated with allergen), a sample pad, a colloidal gold pad, an absorbent pad and a large PVC board. The sample pad, colloidal gold pad, film strip and water-absorbing pad are pasted on the center of the PVC large board sequentially from the lower end to the upper end. The film strip is pasted in the middle of the PVC large board, and the top of the large board is pasted with absorbent paper. The upper edge of the absorbent paper is 3mm away from the upper edge of the large board, and the lower edge of the absorbent paper is pressed against the nitrocellulose membrane by 2mm; a colloidal gold pad is pasted below the large board. , the top of the colloidal gold pad presses the nitrocellulose membrane 3mm, the upper end of the sample pad is stacked below the colloidal gold pad, and the lower end of the sample pad is flush with the PVC large plate; the upper e...

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Abstract

The invention belongs to the field of clinical laboratory diagnostics, and relates to an allergen-specific IgE antibody detection kit and a preparation method thereof. The reagent strip comprises a membrane strip, a sample pad, a colloidal gold pad, a water absorption pad and a PVC plate; the membrane strip is provided with at least one detection line, and the detection line is coated with an allergen extracting solution; the coating concentration of the allergen extracting solution is 0.5 to 5 mg / mL. The colloidal gold reagent strip and the kit disclosed by the invention can be used for detecting fingertip blood and whole blood, so that the bedside detection of allergens in a real sense is realized; the patient can be diagnosed in time, and even if the patient himself / herself can buy a reagent for self-inspection, so that the possibility is provided for early discovery and early treatment of more allergic disease patients.

Description

technical field [0001] The invention belongs to the field of clinical laboratory diagnosis and relates to an allergen-specific IgE antibody detection kit and a preparation method thereof. Background technique [0002] The World Health Organization (WHO) believes that allergic diseases (allergic asthma, rhinitis, rash, etc.) are major health problems worldwide, and listed them as the fourth most important chronic disease in the world in 2010. The total incidence of allergic diseases worldwide is about 10-20%. As a diagnostic and therapeutic drug for allergic diseases, allergen vaccines have been included in relevant guidelines by WHO, and have entered the stage of rapid industrialization and large-scale development in developed countries. [0003] Among the respiratory allergic diseases in China, asthma (9.2%), sinusitis (13.3%) and non-specific dermatitis (16.4%) were the most common. In the urban population, 2 / 3 patients with allergic rhinitis need to go to the hospital, ...

Claims

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Application Information

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IPC IPC(8): G01N33/558G01N33/531
CPCG01N33/558G01N33/531
Inventor 贾丽霞周延白彩明董山山张苗苗夏吉涵姜敏菅丽萍
Owner GLALLERGEN CO LTD
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