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Kit and method for detecting dermatophagoides pteronyssinus allergen specificity IgE antibody

A technology for house dust mites and allergens, applied in the field of kits for detecting allergen-specific IgE antibody house dust mites, can solve the problems of high price and unfavorable popularization, and achieve good stability, small variation and high detection sensitivity Effect

Inactive Publication Date: 2016-03-16
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, the detection of house dust mite allergen-specific IgE antibody (D1) 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. conducive to popularization at the grassroots level
There is no domestic house dust mite allergen-specific IgE antibody (D1) immunochemiluminescence detection kit with independent intellectual property rights

Method used

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  • Kit and method for detecting dermatophagoides pteronyssinus allergen specificity IgE antibody
  • Kit and method for detecting dermatophagoides pteronyssinus allergen specificity IgE antibody
  • Kit and method for detecting dermatophagoides pteronyssinus allergen specificity IgE antibody

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Embodiment 1

[0032] Provide a kit for quantitative detection of house dust mite allergen-specific IgE antibody (D1) based on nano-magnetic particle automatic chemiluminescence method, including the following reagents:

[0033] (1) Biotin-labeled house dust mite allergen solution with a concentration of 0.1-1.0ug / mL;

[0034] (2) streptavidin-labeled nano-magnetic particle suspension, the concentration is 0.1-1.0 mg / mL;

[0035] (3) Mouse anti-human IgE secondary antibody solution labeled with alkaline phosphatase, the concentration is 0.1-2.0ug / mL;

[0036] (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;

[0037] (5) Two quality control products with different concentration levels: 0.7IU / ml and 17.5IU / ml.

Embodiment 2

[0039] The preparation of a kit for the quantitative detection of serum house dust mite allergen-specific IgE antibody by nano-magnetic particle automatic chemiluminescence method comprises the following steps:

[0040] (1) Prepare buffer:

[0041] 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.

[0042] 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 2.56gNa2 HPO 4 12H 2 O, 0.44gNaH 2 PO 4 2H 2 Add 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.

[0043] 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, w...

Embodiment 3

[0059] Provides a detection method for the quantitative detection of serum house dust mite allergen-specific IgE antibody kit by nano-magnetic particle automatic chemiluminescence method, which is detected on Lumiray series of automatic chemiluminescence instruments (Lumiray1200, Lumiray1220, Lumiray1260, Lumiray1280, etc.) To carry out, the specific instrument operation steps are as follows:

[0060] (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.

[0061] (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.

[0062] (3) Place the quality control substance / sample to be tested in...

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Abstract

The invention discloses a kit and a method for detecting a dermatophagoides pteronyssinus allergen specificity IgE antibody. The kit comprises a calibration material, a quality control material, a biotin-marked dermatophagoides pteronyssinus allergen solution, an alkaline phosphatase-marked mouse-antihuman IgE second antibody solution and a streptavidin-marked nanometer magnetic particle suspension liquid. The kit is utilized to detect the dermatophagoides pteronyssinus allergen specificity IgE antibody. In such a mode, all reagent components in the kit are excellent in stability; the period of validity can reach over one year; the detecting sensitivity is high, the peculiar performance is excellent and the variation is small; a perfect uniform technique is acquired through technical optimization in a large number of experiments; the production is performed in strict accordance with standard production operation specification and quality control regulation; a user can acquire a reliable result by only performing standard operation according to the operation specification; in the clinical research, the conforming relevance with a foreign imported reagent reaches up to over 90% and the cost of the kit is only 1 / 2 of the cost of the foreign imported reagent.

Description

technical field [0001] The invention belongs to the field of in vitro diagnosis of biological immunity of medical equipment, in particular to a kit and method for detecting allergen-specific IgE antibody house dust mite. 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 when patients inhale, ingest or inject substances containing allergens, which are called allergens or allergens, and then trigger the body's B cells to produce specific immunoglobulin E (ImmunoglobulinE, IgE), thereby triggering Allergic reaction (or allergy, Allergy) diseases and related symptoms, such as ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/535
CPCG01N33/53G01N33/535
Inventor 韩霜钱林何晓静丁俊荣罗薇李庆春
Owner SUZHOU HAOOUBO BIOPHARML
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