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Stable NSE quality control product and preparation method thereof

A technology of quality control products and human serum, applied in the biological field, can solve the problems of inconvenient detection, decreased NSE level, poor reconstitution stability, etc., and achieve the effects of high accuracy, reduced decline speed, and good stability

Pending Publication Date: 2021-04-02
郑州标源生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the existing invention, the NSE quality control product is not 100% human serum, and there is a matrix effect with clinical samples; and the reconstitution stability is poor
And affected by temperature, long-distance transportation, etc., the NSE level dropped significantly during the storage process
Inconvenience to detection

Method used

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  • Stable NSE quality control product and preparation method thereof
  • Stable NSE quality control product and preparation method thereof
  • Stable NSE quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Effect of magnesium ions on the liquid stability of NSE compared with other ions

[0033] In the serum of a healthy person, add ADP to a mass fraction of 0.3%, add Proclin300 to a mass fraction of 0.2%, add gentamicin sulfate to a mass fraction of 0.1%, add trehalose to a mass fraction of 3%, and stir thoroughly Mix well until the matrix solution is clear, place it at 2-8°C, add NSE antigen (from Zhengzhou Yimenuo Biotechnology Co., Ltd.), divide the solution into three levels according to the amount of NSE antigen added, and the concentration of NSE antigen is respectively 20ng / mL, 60ng / mL, 120ng / mL.

[0034] Each level of antigen-containing solution is divided into four groups, a total of 12 groups, adding sodium ions (to a mass fraction of 0.2%), magnesium ions (to a mass fraction of 0.2%), iron ions (to a mass fraction of 0.2%) and 12 groups in total. ) and copper ions (to a mass fraction of 0.2%) were prepared into 12 kinds of NSE quality control products.

[003...

Embodiment 2

[0040] To verify the effect of magnesium ions on the stability of NES quality control (liquid).

[0041] In the serum of a healthy person, add ADP to a mass fraction of 0.3%, add Proclin300 to a mass fraction of 0.2%, add gentamicin sulfate to a mass fraction of 0.1%, add trehalose to a mass fraction of 3%, and stir thoroughly Mix well until the matrix solution is clear, place it at 2-8°C, add NSE antigen (from Zhengzhou Yimenuo Biotechnology Co., Ltd.), divide the solution into three levels according to the amount of NSE antigen added, and the concentration of NSE antigen is respectively 20ng / mL, 55ng / mL, 100ng / mL.

[0042] The solutions containing antigens at each level were divided into 2 groups (with or without magnesium ions), a total of 6 groups, and were prepared into 12 kinds of NSE quality control products.

[0043] Two replicates were set up for each quality control product, and the liquid state was stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d, and the concentra...

Embodiment 3

[0048] To verify the effect of magnesium ions on the stability of NES quality control (lyophilized).

[0049] In the serum of healthy people, add ADP to a mass fraction of 0.3%, add Proclin300 to a mass fraction of 0.2%, add gentamicin sulfate to a mass fraction of 0.1%, add trehalose to a mass fraction of 3%, and then Add magnesium chloride to a mass fraction of 0.2%, stir and mix well until the matrix solution is clear, place it at 2-8°C, add NSE antigen (from Zhengzhou Yimenuo Biotechnology Co., Ltd.), and divide the solution according to the amount of NSE antigen added. There are three levels, in which the concentration of NSE antigen is 20ng / mL, 55ng / mL, 100ng / mL respectively.

[0050]The NSE quality control product prepared into three levels is subpackaged and freeze-dried. The freeze-drying procedure is: primary drying (sublimation drying) and secondary drying (desorption drying). Specific freeze-drying parameters:

[0051] During the cooling process, the temperature d...

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Abstract

The invention relates to the technical field of biology, in particular to a stable NSE quality control product and a preparation method thereof. The NSE quality control product provided by the invention is prepared from an NSE antigen, a protein protective agent, a preservative, an antibiotic, a freeze-drying protective agent, magnesium ions and human serum. The product can effectively weaken thedescending speed of a tumor marker NSE in a matrix liquid, has good product uniformity, long-term storage stability and stability after redissolution, is not influenced by transportation, temperatureand other factors, has long stabilization time in the detection process after redissolution, has detection repeatability and high accuracy, and can be suitable for the quantitative detection of different instrument models and different reagents. The product can be used for detecting by operators in different regions and different laboratories, can be suitable for quantitative detection kits of different brands, can meet the clinical quality control requirement on the tumor marker NSE, and can more accurately detect the accuracy of a clinical sample detection result.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a stable NSE quality control product and a preparation method thereof. Background technique [0002] Saccharolytic enolase (2-phospho-D-glycerate hydrolase. EC 4.2.4.11, molecular weight about 80kDa) has a variety of dimeric isomers, composed of three subunits α, β and γ. The α subunit of enolase is found in many types of mammalian tissues, while the β subunit is mainly found in heart and muscle tissue. The αγ and γγ enzyme isoforms are called neuron-specific enolase (NSE) or γ-enzyme, and are present in high concentrations in nerve cells and neuroendocrine cells, as well as in the tumor cells induced by these cells. Serum NSE can be used as a specific marker of neuroendocrine tumors, such as neuroblastoma, medullary thyroid carcinoma and small cell lung cancer (70% increase), which can be used for differential diagnosis, disease monitoring, efficacy evaluation and recurrence predic...

Claims

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Application Information

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IPC IPC(8): G01N33/574G01N33/573
CPCG01N33/57407G01N33/57423G01N33/57488G01N33/573G01N2333/988
Inventor 王亚洲张亚彤赵晓转杨建乐王新明刘功成
Owner 郑州标源生物科技有限公司
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