A chemiluminescent quantitative detection kit for inhaled allergens and its preparation method and detection method

A quantitative detection and chemiluminescence technology, which is applied in the field of immunoassay, can solve the problems of suffering, high risk and poor substitution of the subjects, and achieve the effect of simple operation, time saving, wide detection range and good accuracy

Active Publication Date: 2016-08-24
SUZHOU HAOOUBO BIOPHARML
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the skin test has the fatal disadvantages of pain for the examinee, high risk, failure to check during the attack period, and dependence on the judgment of the supervisor. There have been cases of death of patients due to skin tests in Jiangsu Province and Beijing
Moreover, there is currently no legal skin test product approved by the Food and Drug Administration in the country, so its substitution is poor

Method used

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  • A chemiluminescent quantitative detection kit for inhaled allergens and its preparation method and detection method
  • A chemiluminescent quantitative detection kit for inhaled allergens and its preparation method and detection method
  • A chemiluminescent quantitative detection kit for inhaled allergens and its preparation method and detection method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: the preparation of kit

[0034] (1) Preparation of magnetic separation reagents:

[0035] Materials and Instruments:

[0036] 1. Magnetic particle: Contains carboxyl group (COOH) active group, the carboxyl group content per gram (g) magnetic particle (dry weight) is 1 millimole (mmol), has superparamagnetism, and the diameter is 1 μm.

[0037] 2. Inhalation of allergens: Dissolve 10 mg of freeze-dried dust mite allergens in 2 ml of phosphate buffer (pH7.2, 0.02M) to obtain a solution of allergens with a concentration of 5 mg / ml. Put the resulting solution into a dialysis bag and fasten it After the dialysis bag, dialyze with 500ml of phosphate buffer at 4°C for 4-8 hours, change the solution 3-4 times, collect the dialyzed product, and the purity of the allergen protein is 90%.

[0038] 3. 2-Morpholineethanesulfonic acid (MES), carbodiimide (EDC), trishydroxymethylaminomethane (TRIS) and other reagents should be chemically pure.

[0039] Steps:

[0040...

Embodiment 2

[0055] Embodiment 2: the implementation of detection and the evaluation of detection effect:

[0056] (1) Implementation of testing

[0057] Materials and Instruments:

[0058] 1. Magnetic separation reagent and enzyme-labeled reagent, prepared by Example 1.

[0059] 2. IgE calibrators, quality control products, luminescent substrates, cleaning solutions, and specific IgE assay kits (fluorescence method) are produced by Pharmacia.

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Abstract

The invention relates to a chemiluminescence quantitative detection kit for inhaled allergens, which comprises a magnetic separation reagent (a 0.1-1.0 mg / ml inhaled-allergen-labeled magnetic particle suspension) and an ELIASA reagent (a 0.5-1 mu g / ml anti-human IgE antibody solution containing alkaline phosphatase label). The sensitivity of the kit prepared from the inhaled-allergen-labeled magnetic particle suspension and anti-human IgE antibody solution containing alkaline phosphatase label is up to 0.008 IU / ml, and the cross reaction rates of the kit with other immunoglobulins are respectively less than 0.04%; and the kit has the advantages of high accuracy, high precision, no need of prediluting the sample, and wide detection range, and is simple and time-saving to operate.

Description

technical field [0001] The invention relates to the field of immune analysis, in particular to a chemiluminescent quantitative detection kit for inhaled allergens, a preparation method and a detection method thereof. Background technique [0002] Chemiluminescent technology is relatively mature in developed countries in Europe and the United States, represented by imported brands such as Roche in Switzerland, Abbott in the United States, Beckman in the United States, and Siemens in Germany. Its quality is reliable and its performance is stable. It is mainly concentrated in domestic third-level and some second-level hospitals. However, due to the different product characteristics and domestic registration status of each reagent, generally tertiary hospitals will use different series of products from the above manufacturers at the same time. [0003] Allergic disease, also known as allergic disease, occurs when the body is triggered to produce excess immunoglobulin E by inhali...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/53G01N33/531G01N21/76
CPCG01N21/76G01N33/53G01N33/535
Inventor 李庆春孙婵丁俊荣宋孟杰李永红左云国
Owner SUZHOU HAOOUBO BIOPHARML
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