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Quantitative detection kit for human Dickkopf-1 protein (DKK-1)

A detection kit, DKK-1 technology, applied in biological testing, measuring devices, material inspection products, etc., can solve the problems of inability to meet clinical application requirements, complicated operation steps, long reaction time, etc., to meet clinical application requirements, Simple sample processing and stable luminous value

Inactive Publication Date: 2015-12-30
CHENGDU CAPITALBIODX MEDICAL TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the commercially available human DKK-1 quantitative detection kits mainly use enzyme-linked immunosorbent technology (for research use only), which has problems such as narrow linear range, complicated operation steps, time-consuming, etc., and cannot meet the requirements of clinical application
In the traditional enzyme-linked immunosorbent method, the binding reaction of antigen and antibody is carried out on the surface of the solid phase (ELISA plate reaction well), and the reaction time is long. Generally, the quantitative detection result can be obtained after 3-4 hours, and the detection range is 31.2pg / mL-2000pg / mL, and the sample needs to be diluted

Method used

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  • Quantitative detection kit for human Dickkopf-1 protein (DKK-1)
  • Quantitative detection kit for human Dickkopf-1 protein (DKK-1)
  • Quantitative detection kit for human Dickkopf-1 protein (DKK-1)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1, human Dickkopf-1 protein (DKK-1) quantitative detection kit components and methods thereof

[0081] 1. Preparation of Human Dickkopf-1 Protein (DKK-1) Quantitative Detection Kit

[0082] The following 6 components are individually packaged and then packaged as a kit as a whole, which is the human Dickkopf-1 protein (DKK-1) quantitative detection kit: 1. Calibrators (containing a series of concentrations of DKK-1, used to establish standard curve); 2. Quality control product (containing a certain concentration of DKK-1); 3. Reagent A (containing a certain concentration of fluorescein isothiocyanate-labeled DKK-1 monoclonal antibody and containing a certain concentration of alkaline phosphatase Labeled DKK-1 monoclonal antibody solution); 4. Magnetic separation reagent (magnetic particle suspension combined with anti-fluorescein isothiocyanate antibody); 5. Cleaning solution (for preparing magnetic bead cleaning solution); 6 , Substrate solution. 1, 2, 3, ...

Embodiment 2

[0153] Embodiment 2, kit performance evaluation

[0154] According to the characteristics of in vitro diagnostic reagents, the linear range, minimum detection limit, accuracy and precision of the kit prepared in Example 1 were tested according to the usual practice. The specific operation steps are as follows:

[0155] 1. Reagent preparation:

[0156] Before the experiment, take out the reagent A, calibrator, magnetic separation reagent, substrate solution, cleaning solution, and quality control in the kit of Example 1, and equilibrate to room temperature.

[0157] 2. Instrument preparation:

[0158] This kit uses ChemLite from Boao Bio Group Co., Ltd. TM 1200 automatic chemiluminescent immunoassay analyzer.

[0159] details as follows:

[0160] Add calibrators, samples or quality control substances into the sample cup. The sample volume for a single tube reaction is 30 μL. Calculate the volume in the sample cup based on the number of repeated tubes. The minimum sample vo...

Embodiment 3

[0206] Embodiment 3, the kit provided by the present invention compares with foreign kits

[0207] 1. The test kit provided by the present invention is compared with foreign kit performance indicators as follows:

[0208] Detect same sample with existing test kit, compare as follows with the test result of test kit of the present invention:

[0209] Table 5 Performance Index Comparison Results

[0210]

[0211]

[0212] 2. The test kit provided by the present invention is compared with foreign kits for clinical sample measurement values

[0213] QuantikineELISAHumanDKK-1 assay kit (for research) produced by the kit provided by the invention and R&DSystems company is respectively detected simultaneously to 100 parts of human serum samples (patients are informed), and the results are shown in figure 2 The serum DKK-1 concentration measured by the kit provided by the present invention is the ordinate, and the result measured by the QuantikineELISAHumanDKK-1 kit produced ...

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Abstract

The invention provides a quantitative detection kit for human Dickkopf-1 protein (DKK-1). The quantitative detection kit comprises a calibrator, a quality control product, a DKK-1 monoclonal antibody labeled by fluorescein isothiocyanate and DKK-1 monoclonal antibody labeled by alkaline phosphatase solution, a magnetic separation reagent, cleaning liquid and a substrate solution. An adopted detection method combines magnetic particle separation chemiluminescence immune detection, enzyme labeling technology, magnetic separation technology and chemiluminescence technology, and is convenient and simple to operate, mild in reaction condition, stable in luminescence value and little in influence by outside conditions. Compared with existing detection methods, the quantitative detection kit has the advantages of simple sample treatment process, low detection cost, quickness in detection, accurate testing result and high repeatability.

Description

technical field [0001] The invention belongs to the technical field of immune detection and analysis, relates to the clinical differential diagnosis of hepatocellular carcinoma, especially early hepatocellular carcinoma, and provides a quantitative detection kit for human Dickkopf-1 protein (DKK-1), which is suitable for human Quantitative detection of serum DKK-1. Background technique [0002] Hepatocellular carcinoma (hepatocellular carcinoma, HCC) is one of the most common malignant tumors in the world, with the sixth highest incidence rate and the third highest mortality rate in the world. Hepatitis B virus infection is the main pathogenic factor of hepatocellular carcinoma, and liver cirrhosis is the most dangerous factor for the occurrence of hepatocellular carcinoma, and it is also the main cause of death of patients with liver cirrhosis. At present, the most commonly used methods for screening and diagnosing HCC are imaging (including ultrasound, CT, MRI, etc.) and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/574
CPCG01N33/68G01N33/57438
Inventor 郭健夫袁方安琳邢婉丽覃文新
Owner CHENGDU CAPITALBIODX MEDICAL TECH CO LTD
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