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Cardiac muscle control material, preparation method therefor, detection kit and detection device for cardiac muscle

A quality control product, cardiac troponin technology, which can be used in measurement devices, instruments, disease diagnosis, etc., and can solve problems such as unreasonable formula and poor stability of myocardial quality control products.

Inactive Publication Date: 2019-02-01
深圳天深医疗器械有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the unreasonable formula of the traditional myocardial quality control products, the stability of the myocardial quality control products is poor, which cannot meet the actual needs

Method used

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  • Cardiac muscle control material, preparation method therefor, detection kit and detection device for cardiac muscle
  • Cardiac muscle control material, preparation method therefor, detection kit and detection device for cardiac muscle
  • Cardiac muscle control material, preparation method therefor, detection kit and detection device for cardiac muscle

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preparation example Construction

[0069] A method for preparing a myocardial quality control product in an embodiment includes the following operations S110-S130:

[0070] S110. Add the protection component to the water and mix well and adjust the pH to 6.0-8.0 to obtain a protection solution. The protection component includes 5mM-100mM buffer, 0.5%-15% by mass of excipient, 0.05mM -5mM antioxidant, 0.05mM-15mM protease inhibitor, 0.5%-10% stabilizer and 0.01-2% surfactant.

[0071] In one embodiment, the water is ultrapure water.

[0072] In one of the embodiments, HCl or NaOH is used to adjust the pH.

[0073] In one of the embodiments, the protection component is added to the water to mix well and the pH is adjusted to 7-7.5.

[0074]S120. Add quality control components to the protection solution and mix to obtain a mixed solution. The quality control components include B-type natriuretic peptide at 50 pg / mL-2000 pg / mL, and D-dimer at 0.2 μg / mL-5 μg / mL , 50pg / mL~10000pg / mL N-terminal brain natriuretic pe...

Embodiment 1

[0098] 1. The myocardial quality control product in this embodiment includes 25mM Tris buffer, 5% glycogen by mass percentage, 2% polyethylene glycol 8000 by mass percentage, 1mM Ascorbic acid, 5mM disodium edetate, bovine serum albumin with a mass percentage of 2%, sodium chloride with a mass percentage of 0.9%, arginine with a mass percentage of 0.5%, mass The percentage content is 0.2% Tween-20, the mass percentage content is 0.05% ProClin300, 100pg / mL B-type natriuretic peptide, 0.5μg / mL D dimer, 125pg / mL N-terminal natriuretic peptide Natriuretic peptide precursor, 0.5 ng / mL cardiac troponin I, 5 ng / mL myoglobin, 25 ng / mL creatine kinase isoenzyme MB, and 5 ng / mL heart fatty acid binding protein.

[0099] The preparation process of the quality control product of the present embodiment is as follows:

[0100] Add protective components to ultrapure water and mix well and adjust the pH to 7.0 to obtain a protective solution; add quality control components to the protective ...

Embodiment 2

[0127] 1. The myocardial quality control product of the present embodiment includes 25mM phosphate buffer, 5% sucrose by mass, 3% polyvinylpyrrolidone by mass, and 1% sorbic acid by mass Alcohol, 1mM ascorbic acid, 1mM phenylmethylsulfonyl fluoride, 2% casein by mass, 0.9% sodium chloride by mass, 0.5% histidine by mass, The mass percent content is 0.2% Tween-20, the mass percent content is 0.05% ProClin300, the B-type natriuretic peptide of 1000pg / mL, the D dimer of 2.5μg / mL, the N-terminal brain of 5000pg / mL Pronatriuretic peptide, 5 ng / mL cardiac troponin I, 100 ng / mL myoglobin, 500 ng / mL creatine kinase isoenzyme MB, and 50 ng / mL heart fatty acid binding protein.

[0128] The preparation process of the quality control product of the present embodiment is as follows:

[0129] Add protective components to ultrapure water and mix well and adjust the pH to 7.5 to obtain a protective solution; add quality control components to the protective solution to obtain a mixed solution...

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Abstract

The invention relates to a cardiac muscle control material, a preparation method therefor, a detection kit and a detection device for cardiac muscle. The cardiac muscle control material comprises quality control component and protection component, the quality control component comprises at least one of B-type natriuretic peptide, D-dimer, NT-proBNP, cardiac troponin I, myoglobin, creatine kinase isozyme and cardioid fatty acid binding protein and heart fatty acid binding protein. The protective component comprises 5 mM to 100 mM of a buffer agent, 0.5 % to 5% by weight of an excipient, 0.05 mMto 5 mM of an antioxidant, 0.05 mM to 15 mM of a protease inhibitor, 0.5% to 10% by weight of a stabilizer and 0.01% to 2% by weight of a surfactant. The cardiac muscle control material disclosed bythe invention is good in stability.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a myocardial quality control product and a preparation method thereof, a cardiac muscle detection kit and cardiac muscle detection equipment. Background technique [0002] In the modern medical system, the importance of clinical testing has been paid more and more attention, especially immunodiagnosis is entering a period of rapid development. However, the quality of domestic immunological reagents varies greatly. How to further improve the quality of immunodiagnostics and ensure the accuracy, comparability and standardization of test results has become one of the main problems that need to be solved urgently. [0003] In the quality control of immunodiagnostics, quality control materials play a key role. According to the definition of IFCC (International Federation of Clinical Chemistry and laboratory medicine, the International Federation of Clinical Chemistry and Laboratory Medic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/531
CPCG01N33/531G01N33/54393G01N2800/325
Inventor 左淼刘挺陈馨姚天成
Owner 深圳天深医疗器械有限公司
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