Allergen-specific IgE antibody quality control products and preparation method thereof

A quality control product, allergen technology, applied in material inspection products, measuring devices, instruments, etc., can solve the problems of inconsistent test results, batch differences, complex components, etc. wide range of effects

Inactive Publication Date: 2019-01-04
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the detection of allergen-specific IgE antibodies, due to the complex composition of most allergens, currently only D1 (house dust mite) and D2 (dust mite) have international standards, resulting in different detection methods or detection by differen...

Method used

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  • Allergen-specific IgE antibody quality control products and preparation method thereof
  • Allergen-specific IgE antibody quality control products and preparation method thereof
  • Allergen-specific IgE antibody quality control products and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1, preparation flow see figure 1 .

[0033] (1) Collect finished human serum or plasma, select the finished human plasma with sufficient sources and easy to obtain as the material, the composition of the organic matter after plasma treatment is completely consistent with the serum in theory, and the amount of additives and preparations is small, and the difference between bottles is small;

[0034] (2) Adding CaCl to finished human serum or plasma 2 After the solution was incubated at 36-38°C for 2 hours, centrifuged at a speed of 7000-9000 rpm to remove fibrin in the plasma; (3) Prepare corresponding quality control plates according to the requirements of quality control products;

[0035] (4) Add preservative (PC300), the addition ratio is 0.05% of the volume of finished human serum or plasma, and mix well;

[0036] (5) Analyze the content of each allergen in the quality control product and determine the value;

[0037] (6) Packing and labeling.

[0038...

Embodiment 2

[0039] Embodiment 2. Perform performance test on the quality control product-Panel A prepared in embodiment 1.

[0040] 1. In-bottle repeatability

[0041] (1) Test method: For each bottle of quality control product-Panel A (Panel A-L, Panel A-M, Panel A-H), measure continuously 10 times respectively, and calculate the average value of the measurement results and standard deviation S1, calculate the coefficient of variation in the bottle according to the following formula

[0042] (2) Test requirements: CV≤10%.

[0043] (3) Test results:

[0044]

[0045] (4) Result description: the repeatability in the quality control panel Panel-A bottle is ≤10%;

[0046] 2. Difference between bottles

[0047] (1) Test method: Take the repeated quality control products in the bottle - Panel A (Panel A-L, Panel A-M, Panel A-H) and other quality control products of the same batch number - Panel A (Panel A-L, Panel A-M, Panel A-H) four bottle, for the five bottles of quality control ...

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PUM

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Abstract

The invention relates to allergen-specific IgE antibody control products. The allergen-specific IgE antibody control products comprise the quality control product L, the quality control product M andthe quality control product H; the quality control product L, the quality control product M and the quality control product H all include raw material components including a substrate and at least twoallergens, and the concentrations of the allergens in the quality control product L, quality control product M and quality control product H are different. The quality control products have many components, inspection requirements for common allergens of allergy can be met, and various allergens can also be added as needed, so that the detection range is wider, the batch difference can be effectively controlled, and therefore detection results are more accurate and reliable.

Description

technical field [0001] The invention belongs to the field of inspection quality control, and in particular relates to an allergen-specific IgE antibody quality control product and a preparation method thereof. Background technique [0002] Allergic disease, also known as allergic disease, occurs when the body is triggered to produce excess immunoglobulin E by inhaling, ingesting, injecting, or coming into contact with a substance that contains an allergen (called an allergen or allergen). (IgE), a class of diseases that cause various functional disorders or tissue damage, often manifested as bronchial asthma, allergic rhinitis, allergic skin diseases, etc., and sometimes life-threatening anaphylactic shock. Allergic diseases affect nearly 1 / 4 of the world's population, and are listed by the World Health Organization as one of the three major diseases to be prevented and controlled in the 21st century. The main alternative to in vitro diagnostic reagents for allergen testing...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/96G01N33/531
CPCG01N33/531G01N33/6854G01N33/96G01N2333/46
Inventor 李庆春王燕钱林何晓静
Owner SUZHOU HAOOUBO BIOPHARML
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