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Kit and method for detecting allergen-specific IgE antibody of cat hair

An allergen and kit technology, applied in the direction of chemical reaction of materials for analysis, chemiluminescence/bioluminescence, etc., can solve problems such as unfavorable popularization and high price, and achieve small variation, good stability and good specificity. Effect

Inactive Publication Date: 2016-03-30
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In China, the clinical detection of cat hair allergen-specific IgE antibody (E1) is mainly based on the application of imported reagents and immunohistochemical reagents. The price of imported reagents is very expensive, which brings a great economic burden to patients and is not conducive to Popularize at the grassroots level
There is no domestic cat hair allergen-specific IgE antibody (E1) immunochemiluminescence detection kit with independent intellectual property rights

Method used

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  • Kit and method for detecting allergen-specific IgE antibody of cat hair
  • Kit and method for detecting allergen-specific IgE antibody of cat hair
  • Kit and method for detecting allergen-specific IgE antibody of cat hair

Examples

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Effect test

Embodiment 1

[0031] Provide a kit for quantitative detection of cat hair allergen-specific IgE antibody (E1) based on nano-magnetic particle automatic chemiluminescence method, including the following reagents:

[0032] (1) Biotin-labeled cat hair allergen solution with a concentration of 0.1-1.0ug / mL;

[0033] (2) streptavidin-labeled nano-magnetic particle suspension, the concentration is 0.1-1.0 mg / mL;

[0034] (3) Mouse anti-human IgE secondary antibody solution labeled with alkaline phosphatase, the concentration is 0.1-2.0ug / mL;

[0035] (4) Calibrators with 6 different concentration levels: 0IU / ml, 0.35IU / ml, 0.7IU / ml, 3.5IU / ml, 17.5IU / ml, 50IU / ml, 100IU / ml;

[0036] (5) Two quality control products with different concentration levels: 0.7IU / ml and 17.5IU / ml.

Embodiment 2

[0038] The preparation of a kit for the quantitative detection of serum cat hair allergen-specific IgE antibody by fully automatic chemiluminescence method provided by the invention comprises the following steps:

[0039] (1) Prepare buffer:

[0040] Prepare 0.01M phosphate buffer solution with a pH value of 7.4, 0.1M Tris-HCl buffer solution with a pH value of 7.4, and 0.05M MES buffer solution with a pH value of 6.0.

[0041] Preparation of 0.01M phosphate buffer solution with pH value of 7.4: take a beaker with a capacity of 1L, add 800ml deionized water, weigh 2.56gNa 2 HPO 4 12H 2 O, 0.44gNaH 2 PO 4 2H 2Add O and 9gNaCl into the beaker, stir to dissolve it fully, adjust the pH value to 7.4±0.05 with HCl or NaOH, add 2% mannitol and 1% glycerin, and stir for 0.5h until complete Dissolve, add deionized water to make up to 1L.

[0042] Preparation of 0.1M Tris-HCl buffer solution with a pH value of 7.4: Take a beaker with a capacity of 1L, add 800ml of deionized water...

Embodiment 3

[0058] Provides a detection method for the quantitative detection of serum cat hair allergen-specific IgE antibody kit by nano-magnetic particle automatic chemiluminescence method, and the detection is carried out on Lumiray series of automatic chemiluminescence instruments (Lumiray1200, Lumiray1220, Lumiray1260, Lumiray1280, etc.) , the specific instrument operation steps are as follows:

[0059] (1) Put the kit into the corresponding position of the reagent compartment of the automatic chemiluminescence analysis / determination instrument, and the information of the kit can be input into the instrument system through the barcode scanner, or can be set through the supporting software of the instrument.

[0060] (2) Place the calibrator in the sample compartment of the instrument. Identify the calibrator information through the barcode scanner and assign the calibrator location in the instrument system.

[0061] (3) Place the quality control substance / sample to be tested in the...

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Abstract

The invention discloses a kit and a method for detecting the allergen-specific IgE antibody of cat hair. The kit comprises a calibration product, a quality control product, a biotin-labeled cat hair allergen solution, an alkaline phosphatase labeled mouse anti-human IgE secondary antibody solution and streptavidin labeled nano magnetic micro particle suspension; the kit is used for detecting the allergen-specific IgE antibody of cat hair. By the mode above, each reagent component in the kit is good in stability, and the period of validity can be more than or equal to one year; the detection flexibility is high, the specificity is good, and variation is tiny. A perfect uniform technology is obtained via the technological optimization of a great amount of experiments, and production is carried out according to the standardized production operation instructions and quality control instructions vigorously. A user can perform standard operation according to the operation specification so as to obtain the reliable result. In the clinical study, the conforming relevance to imported reagents abroad is higher than or equal to 90%, and the expense is only 1 / 2 that of the imported reagents abroad.

Description

technical field [0001] The invention belongs to the field of biological immune in vitro diagnosis of medical equipment, in particular to a kit and method for cat hair allergen-specific IgE antibodies. Background technique [0002] Type I allergic diseases mediated by IgE antibodies are quite common. The total incidence of allergic diseases in countries around the world is about 15%-30%. In my country, about 5-10% of people are harassed by allergens. It is the current worldwide It is listed by the World Health Organization (WHO) as one of the three major diseases that should be prevented and controlled in the 21st century. [0003] Allergic diseases are triggered by the body's B cells to produce specific immunoglobulin E (ImmunoglobulinE, IgE) after the patient inhales, ingests, or injects substances containing allergens (called allergens or allergens, IgE), thereby triggering Allergic reaction (or allergy, Allergy) diseases and related symptoms, such as allergic asthma, hay ...

Claims

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Application Information

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IPC IPC(8): G01N21/76
CPCG01N21/76
Inventor 罗薇钱林韩霜何晓静丁俊荣宋孟杰李庆春
Owner SUZHOU HAOOUBO BIOPHARML
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