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An anti-interference and stable serum direct bilirubin (enzymatic method) assay kit and its preparation method and application

A bilirubin oxidase, bilirubin technology, applied in biochemical equipment and methods, microbial determination/inspection, biological testing, etc. problems, to achieve the effect of enhancing anti-interference ability, excellent stability and performance, and excellent performance indicators

Active Publication Date: 2021-11-02
中拓生物有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The diazonium salt method is widely used in clinical laboratories to detect bilirubin, but the method is susceptible to interference from many factors, and the reagents cannot be stable for a long time, which is affected to a certain extent in disease diagnosis
The vanadic acid oxidation method is easy to contaminate the instrument and affect other tests
The oxidase method has high specificity and high accuracy, but existing kits have shortcomings such as poor anti-interference ability, poor stability, and being easily affected by blood lipids. The present invention improves the shortcomings of the existing direct bilirubin kits to meet Requirements for clinical testing and chemical analysis

Method used

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  • An anti-interference and stable serum direct bilirubin (enzymatic method) assay kit and its preparation method and application
  • An anti-interference and stable serum direct bilirubin (enzymatic method) assay kit and its preparation method and application
  • An anti-interference and stable serum direct bilirubin (enzymatic method) assay kit and its preparation method and application

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Experimental program
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Effect test

Embodiment 1

[0051] A conventional direct bilirubin assay kit includes reagent R1 and reagent R2.

[0052] Reagent R1 contains the following ingredients:

[0053] Phosphate buffer 25mmol / L;

[0054] NaCl 1g / L;

[0055] N-acetylcysteine ​​1g / L;

[0056] Sodium fluoride 0.1g / L;

[0057] Disodium edetate 0.1g / L;

[0058] Ascorbate oxidase 1KU / L;

[0059] Sorbitan Laurate 1%;

[0060] Polyoxypropylene Mannitol Dioleate 1%;

[0061] proclin300 1 ml / L.

[0062] The pH value of reagent R1 is 5.2.

[0063] Reagent R2 contains the following ingredients:

[0064] Piperazine-1,4-diethanesulfonic acid (PIPES) buffer solution 50mmol / L;

[0065] Bovine serum albumin (BSA) 5g / L;

[0066] Mannitol 10g / L;

[0067] Triton 100 1%;

[0068] Bilirubin oxidase 1KU / L;

[0069] proclin300 1ml / L.

[0070] Reagent R2 has a pH of 9.0.

[0071] Wherein said percentage is volume ratio.

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Abstract

The invention provides a direct bilirubin (DB) assay kit, the kit contains reagent R1 and reagent R2; the reagent R1 contains the following components: phosphate buffer, NaCl, N-acetylcysteine, sodium fluoride , Disodium EDTA, Ascorbate Oxidase, Surfactant, Preservative. Reagent R2: tris-hydrochloric acid buffer, bilirubin oxidase, stabilizer, preservative. The invention also provides the preparation method and application of the kit. The kit uses different types of stabilizers and surfactants, which can effectively avoid the interference of blood lipids. It has strong anti-interference ability, high sensitivity and good stability. Low cost liquid kit.

Description

technical field [0001] The invention relates to the technical field of biochemical reagent determination, in particular to a direct bilirubin determination kit, and also relates to a preparation method and application of the direct bilirubin determination kit. Background technique [0002] Bilirubin is a type of bile pigment, the main pigment in human bile. Bilirubin is the main metabolite of iron porphyrin compounds in the body. It is toxic and can cause irreversible damage to the brain and nervous system, but it also has an antioxidant function and can inhibit the oxidation of linoleic acid and phospholipids. Bilirubin is an important basis for judging jaundice clinically, and it is also an important indicator of liver function. [0003] Direct bilirubin: High indirect bilirubin and high direct bilirubin indicate hepatocellular jaundice, damage to liver cells, decreased liver function, and the liver cannot completely convert indirect bilirubin into direct bilirubin. The ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/72C12Q1/26G01N33/52
CPCC12Q1/26G01N33/52G01N33/728
Inventor 刘安娜
Owner 中拓生物有限公司
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