Kit for determining content of digoxin by using magnetic particulate chemiluminescent immunoassay, and detection method thereof

A chemiluminescence and digoxin technology, which is used in measurement devices, biological tests, scientific instruments, etc., to achieve the effects of short reaction time, high sensitivity and accurate test results

Active Publication Date: 2018-06-22
TAIZHOU ZECEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] The technical problem to be solved by the present invention is to overcome the defect that the existing digoxigenin kits cannot be used for both solid-phase coupling and lumine

Method used

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  • Kit for determining content of digoxin by using magnetic particulate chemiluminescent immunoassay, and detection method thereof

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Experimental program
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Embodiment

[0043] One, the preparation process of digoxin antigen derivatives:

[0044] 1) Prepare 0.1M HCl solution;

[0045] 2) Prepare 0.01M NaHCO3 buffer solution of pH=9.0 and 0.15M NaHCO3 buffer solution of pH=9.5 respectively;

[0046] 3) Weigh 10 mg of digoxin and dissolve it in DMF buffer to 10 mg / mL to obtain a digoxin-DMF solution;

[0047] 4) Weigh 50 mg of succinic anhydride and dissolve it in 10 ml of DMF to 5 mg / mL to obtain a succinic anhydride-DMF solution;

[0048] 5) Weigh 20 mg of lysine and dissolve it in 1 mL of 0.01 M NaHCO3 buffer solution with pH=9.0 to 20 mg / mL;

[0049] 6) Add 0.5 mL of digoxin-DMF solution to 10 mL of succinic anhydride-DMF solution, and react at 65°C for 6 hours;

[0050] 7) After the reaction is completed, add 1.2 mL of tributylamine and 0.65 mL of isobutyl chloroformate, and react at room temperature for 30 minutes to obtain a DMF solution of digoxin-succinic anhydride;

[0051] 8) Add 1 mL of lysine solution with a concentration of 20 mg...

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Abstract

The invention provides a kit for determining the content of digoxin by using magnetic particulate chemiluminescent immunoassay, and a detection method thereof. The invention discloses a preparation method for digoxin antigen derivatives. The kit can realize indirect connection between a digoxin antigen and biotin or enzyme. Two detection systems are established in the kit, wherein one detection system is composed of a biotinylated digoxin antigen derivative, an enzyme-labelled antibody reagent and a calibrator, while the other detection system is composed of an enzyme-labelled digoxin antigenderivative, a biotinylated murine digoxi monoclonal antibody and the calibrator; so the kit is applicable to both solid-phase-coupled and luminescently-labeled digoxin derivatives and adapts to coupling of digoxin antigens with biotin, enzyme labels, or even proteins; and thus, different enterprises can flexibly use the kit during testing and only need to prepare the intermediates, i.e., the digoxin antigen derivatives, to realize testing. The correlations between given values and values measured by using different detection systems established by using the derivatives are 0.96 or more, and the correlation of the two detection systems is 0.9585. The kit of invention has the advantages that the whole reaction system is short in reaction time; radioactive pollution is avoided; the action period of reagents is realized; high sensitivity is obtained; testing results are accurate; and the flow of experimental operation is simplified.

Description

technical field [0001] The invention relates to a detection kit, in particular to a kit for measuring digoxin content by magnetic particle chemiluminescence method and a detection method thereof. Background technique [0002] Digoxin is the first-choice effective drug in the treatment of heart failure and rapid ventricular rate control, but the effective plasma concentration is narrow. The therapeutic concentration is 0.6-1.2ng / ml, and when the digoxin concentration exceeds 1.2ng / ml, the risk of death increases. In addition, the therapeutic index is low, the toxic and side effects are large, and the individual differences are large. The conventional dose may also lead to poisoning or fail to reach the effective dose, which also makes it difficult to control the clinical dose of digoxin. Therefore, the detection of serum digoxin concentration is a commonly used therapeutic drug monitoring (TDM). By measuring the concentration of drugs in blood or other body fluids, relevant ...

Claims

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Application Information

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IPC IPC(8): G01N33/58G01N33/531G01N33/534
CPCG01N33/531G01N33/534G01N33/58G01N33/9453
Inventor 鲁衡刘振世
Owner TAIZHOU ZECEN BIOTECH CO LTD
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