Kit detecting dermatophagoides-farinae allergen specific IgE antibody and method

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

Inactive Publication Date: 2016-02-24
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, the clinical detection of dust mite allergen-specific IgE antibody (D2) 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 dust mite allergen-specific IgE antibody (D2) immunochemiluminescence detection kit with independent intellectual property rights

Method used

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  • Kit detecting dermatophagoides-farinae allergen specific IgE antibody and method
  • Kit detecting dermatophagoides-farinae allergen specific IgE antibody and method
  • Kit detecting dermatophagoides-farinae allergen specific IgE antibody and method

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Embodiment 1

[0032] Provide a kit for quantitative detection of dust mite allergen-specific IgE antibody (D2) based on nano-magnetic particle automatic chemiluminescence method, including the following reagents:

[0033] (1) Biotin-labeled 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 quantitatively detecting serum dust mite allergen-specific IgE antibodies provided by the present invention with nano-magnetic particles fully 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 2.56gNa 2 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 ...

Embodiment 3

[0059] Provides a detection method for the quantitative detection of serum dust mite allergen-specific IgE antibody kit by nano-magnetic particle automatic chemiluminescence method, and the detection is carried out on the Lumiray series of automatic chemiluminescence instruments (Lumiray1200, Lumiray1220, Lumiray1260, Lumiray1280, etc.) , 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 i...

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Abstract

The invention discloses a kit detecting dermatophagoides-farinae allergen specific IgE antibody and a method. The kit comprises a calibration substance, a quality-control substance, a biotin-labeled dermatophagoides-farinae allergen solution, an alkaline-phosphatase-labelled mouse anti-human IgE secondary-antibody solution and a streptavidin-labeled nanometer-magnetic-particle suspension. The kit is utilized to detect the dermatophagoides-farinae allergen specific IgE antibody. Through the above manner, the reagent compositions in the kit are good in stability, the expiration data is one year or more, the detection sensitivity is high, the specificity is good, and variation is small. An improved unified technology is obtained after a large amount of experiments are performed for technology optimization, and production is performed strictly according to standard production operation rules and quality control rules. A user can perform standard operation and obtain a reliable result only according to the operation instruction. During clinic research, the coincidence correlation with a foreign imported reagent is up to 90% or more, and the cost only is 1 / 2 of the foreign imported reagent.

Description

technical field [0001] The invention belongs to the field of biological immune in vitro diagnosis of medical equipment, and in particular relates to a kit and a method for detecting specific IgE antibodies of dust mite allergens. 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, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/543G01N21/76
CPCG01N33/6854G01N21/763G01N33/54326
Inventor 丁俊荣钱林罗薇宋孟杰韩霜何晓静李庆春
Owner SUZHOU HAOOUBO BIOPHARML
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