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Anti-TNF-alpha monoclonal antibody drug antibody detection reagent kit

An anti-drug antibody and detection kit technology, applied in biological testing, material testing products, etc., can solve the problems of low detection range and sensitivity of ELISA method, cross-contamination of reagents, affecting detection results, etc., and achieve fully automatic detection and operation. Simple and convenient, the effect of shortening the detection time

Inactive Publication Date: 2016-01-27
SUZHOU HAOOUBO BIOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] (1) The detection reagent is an open method during the detection process, which may easily cause cross-contamination between various reagents and affect the detection results
[0008] (2) The detection range and sensitivity of the ELISA method are low
[0009] (3) The detection time of the ELISA method is 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
[0010] (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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  • Anti-TNF-alpha monoclonal antibody drug antibody detection reagent kit
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Experimental program
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Effect test

Embodiment 1

[0023] Provide an anti-TNF-α monoclonal antibody drug antibody detection kit, including biotinylated monoclonal antibody drug, anti-monoclonal antibody drug antibody calibrator, anti-monoclonal antibody drug antibody quality control product, enzyme conjugate, magnetic particle reagent and cleaning solution . The biotinylated monoclonal antibody drug is a monoclonal antibody drug coupled with biotin. The enzyme conjugate is an AP-labeled monoclonal antibody drug, and the alkaline phosphatase AP is coupled with the monoclonal antibody drug. 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. Wherein ADA refers to anti-drug antibody Anti-DrugAntibody.

[0024] The biotinylated monoclonal antibody drug is biotin and -NH on the surface of the monoclonal antibody drug 2 group reaction. The diameter of the magnetic particle in the magnetic ...

Embodiment 2

[0027] Performance evaluation of kit of the present invention:

[0028] 1. Anti-TNF-α monoclonal antibody drug antibody detection kit of the present invention

[0029] (1) Sample comparison

[0030] Negative and positive coincidence rate: The kit of the present invention detects the content of anti-TNF-α monoclonal antibody drug antibody in 200 cases of clinical serum, and conducts clinical comparison with similar products of well-known foreign companies. The results are shown in the table below. The results show that the anti-TNF-α monoclonal antibody drug antibody detection kit of the present invention has a negative coincidence rate of 99% (99 / 100), and a positive coincidence rate of 99% (99 / 100), indicating that the kit has a high clinical coincidence rate.

[0031]

[0032] (2) Sensitivity: The LOD of the anti-TNF-α monoclonal antibody drug antibody detection kit of the present invention is 5 ng / mL, while the sensitivity of the ELISA is 30 ng / mL.

[0033] (3) Lineari...

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Abstract

The invention discloses an anti-TNF-alpha monoclonal antibody drug antibody detection reagent kit. The reagent kit comprises biotinylation monoclonal antibody drugs, a calibrator, a quality control product, an enzyme conjugate, magnetic particle reagent, a chemiluminiscence substrate and cleaning fluid. In this way, the full-automatic magnetic particle chemiluminiscence detection method is adopted, an alkaline phosphatase (AP)-adamantane AMPPD system is selected, the method has the advantages that stability and repeatability are good, and sensitivity is high, meanwhile, detection time is greatly shortened, one test is completed within 50 minutes, operation is easy and convenient, and detection full automation is really achieved.

Description

technical field [0001] The invention relates to the field of magnetic particle chemiluminescence immunodiagnosis, in particular to an anti-TNF-α monoclonal antibody drug antibody detection kit. Background technique [0002] After more than 30 years of development, therapeutic monoclonal antibody drugs have become one of the most important components of biomedicine, and have been successfully used to treat various diseases such as tumors, autoimmune diseases, infectious diseases, and transplant rejection. [0003] TNF-α (tumornecrosisfactor, TNF) is a polypeptide cytokine with multiple biological activities produced by activated monocyte-macrophages, and is closely related to the body's immune response, acute phase response and inflammatory response. Therapeutic monoclonal antibody drugs targeting TNF-α are currently the most successful class of biological drugs for autoimmune diseases, and can be used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease and ank...

Claims

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Application Information

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IPC IPC(8): G01N33/53
CPCG01N33/53
Inventor 秦枫马竹凤王静张伟柳乐徐娟李庆春
Owner SUZHOU HAOOUBO BIOPHARML
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