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Bevacizumab kit and drug-resistant antibody kit thereof

A technology of bevacizumab and reagent kit, which is applied in the direction of chemical reaction of materials for analysis, chemiluminescence/bioluminescence, etc., which can solve the problems of rapid diagnosis, cross-contamination of reagents, low detection range and sensitivity, etc. , to achieve the effect of fully automated detection, simple and convenient operation, and shortened detection time

Inactive Publication Date: 2016-03-23
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] (1) The detection reagents are open during the detection process, which may easily cause cross-contamination among various reagents and affect the detection results;
[0007] (2) ELISA methods mostly use horseradish peroxidase for detection, and its detection range and sensitivity are low
[0008] (3) The detection time of the ELISA method is usually relatively long, and the total time required to complete a test is generally more than 2 hours, which cannot fully meet the needs of clinical rapid diagnosis
[0009] (4) The ELISA method cannot be randomly injected for detection, and there is a lag in the detection results

Method used

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  • Bevacizumab kit and drug-resistant antibody kit thereof
  • Bevacizumab kit and drug-resistant antibody kit thereof
  • Bevacizumab kit and drug-resistant antibody kit thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A Bevacizumab kit is provided, including biotinylated anti-Bevacizumab antibody, Bevacizumab calibrator, Bevacizumab quality control product, AP-anti-human IgG1 antibody, magnetic particle reagent, chemiluminescence substrate and cleaning solution. The biotinylated anti-Bevacizumab antibody is an anti-Bevacizumab antibody coupled with biotin. The AP-anti-human IgG1 antibody is an AP-labeled anti-human IgG1 antibody, in which alkaline phosphatase AP is coupled to an anti-human IgG antibody. The magnetic particle reagent is nano magnetic particle suspension liquid with avidin SA group on the surface. The cleaning solution may be a cleaning concentrate, which is prepared when used.

[0031] The biotinylated anti-Bevacizumab antibody is biotin and -NH on the surface of the anti-Bevacizumab antibody molecule 2 group reaction. The diameter of the magnetic particle in the magnetic particle reagent is 0.1-0.5 μm, and the magnetic particle reagent has superparamagnetism. The...

Embodiment 2

[0034]An Anti-Bevacizumab anti-drug antibody detection kit is provided, including biotinylated Bevacizumab, anti-Bevacizumab antibody calibrator, anti-Bevacizumab antibody quality control, AP-anti-ADA antibody, magnetic particle reagent and cleaning solution. The biotinylated Bevacizumab is Bevacizumab coupled with biotin. The AP-anti-ADA antibody is an AP-labeled anti-ADA antibody, in which alkaline phosphatase AP is coupled to an anti-ADA (Anti-Bevacizumab) antibody. The magnetic particle reagent is nano magnetic particle suspension liquid with avidin SA group on the surface. The cleaning solution may be a cleaning concentrate, which is prepared when used. Among them, ADA refers to anti-drug antibody Anti-DrugAntibody, here specifically refers to Anti-Bevacizumab.

[0035] The biotinylated Bevacizumab is biotin and -NH on the surface of Bevacizumab 2 group reaction. The diameter of the magnetic particle in the magnetic particle reagent is 0.1-0.5 μm, and the magnetic par...

Embodiment 3

[0038] Performance evaluation of the kit:

[0039] 1. Bevacizumab kit of the present invention

[0040] (1) Sample comparison

[0041] The kit of the present invention detects the content of Bevacizumab in 200 cases of clinical serum, and performs clinical comparison with similar products of well-known foreign companies. The results show that the Bevacizumab test kit detection concentration value of the present invention has a good correlation with the detection concentration value of similar products of well-known foreign companies, and the results are as follows: image 3 shown.

[0042] (2) Sensitivity: The LOD of the Bevacizumab detection kit of the present invention is 2 ng / mL, while the sensitivity of the ELISA is 30 ng / mL.

[0043] (3) Linearity: according to 1 / 4, 1 / 16, 1 / 64, 1 / 256 of a high-value serum, use the Bevacizumab kit of the present invention to detect the diluted sample, and perform linear regression between the theoretical concentration and the actual det...

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Abstract

The invention discloses a Bevacizumab kit and a drug-resistant antibody kit thereof. The Bevacizumab kit contains a biotinylated anti-Bevacizumab antibody or Bevacizumab, a calibration material, a quality control material, an AP-anti-human IgG1 antibody or an AP-anti-ADA antibody, a magnetic particle reagent, a chemiluminescence substrate and a cleaning fluid. In the mode, the Bevacizumab kit adopts a full-automatic magnetic particle chemiluminescence detection method, selects an alkaline phosphatase AP-adamantane AMPPD system, has the advantages of good stability, high sensitivity, good repeatability and the like, the detection time is greatly shortened, the total time required for completing a test is less than 50 minutes, operation is simple, easy and convenient, and full-automatic detection is really achieved.

Description

technical field [0001] The invention relates to the field of magnetic particle chemiluminescence immunodiagnosis, in particular to a bevacizumab kit and an anti-drug antibody kit. Background technique [0002] In recent years, the research on therapeutic antibodies at home and abroad has become more and more in-depth, widely used in the treatment of inflammatory diseases, immune diseases, infectious diseases and cancer, and has made rapid progress, involving pathogenesis, clinical diagnosis, clinical treatment, prognosis, genetics , and gradually developed to the study of antibodies produced during the administration of related drugs, namely anti-drug antibodies (ADA). [0003] Vascular endothelial growth factor (VEGF) plays an important role in the occurrence and development of tumors. VEGF activates downstream signals through the VEGFR2 receptor on the surface of vascular endothelial cells, which can induce the growth, migration and tube formation of endothelial cells, pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/76
CPCG01N21/76
Inventor 秦枫马竹凤王静张伟柳乐徐娟李庆春
Owner SUZHOU HAOOUBO BIOPHARML