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Preparation method of anti-Mullerian hormone quality control substance

A quality and hormone technology, applied in the field of preparation of anti-Mullerian hormone quality control products, can solve the problems of affecting detection, plasma matrix precipitation, etc., and achieve the effect of high consistency, good stability and stable performance

Inactive Publication Date: 2019-02-15
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

Since the treated human plasma is used as the matrix fluid, although it is relatively similar to the type of human test samples, the plasma matrix is ​​prone to precipitation after repeated freezing and thawing, which affects the detection

Method used

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  • Preparation method of anti-Mullerian hormone quality control substance
  • Preparation method of anti-Mullerian hormone quality control substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Preparation of Anti-Müllerian Hormone Quality Control Products

[0026] The first step is to use commercial hormone-free serum to measure HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody in the serum respectively;

[0027] In the second step, select hormone-free serum that is negative for HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody, and then add 0.2% sodium azide, 0.2% Proclin300, 0.2% gentamicin sulfate, and 0.2% thimerosal , 5% trehalose, and mix well;

[0028] The third step is to measure the background value of anti-Müllerian hormone and store it temporarily at 2-8°C;

[0029] In the fourth step, according to the background value determined in the third step, anti-Müllerian hormone-positive substances are added, and the concentrations are 1.0ng / ml, 5.0ng / ml, and 15.0ng / ml respectively;

[0030] The fifth step is to store the substance obtained in the fourth step at a temperature of 2-8°C for 3-14 days, so that the com...

Embodiment 2

[0031] The performance measurement of the quality control product prepared in embodiment 2 embodiment 1

[0032] 1. Stability

[0033] Three-level (1.0ng / ml, 5.0ng / ml, 15.0ng / ml) quality control products were tested in turn by storing them at 2-8°C after reconstitution, accelerating at 37°C in a freeze-dried state, and testing the number of freeze-thaw cycles after reconstitution. The test data are shown in Table 1 below:

[0034] Table 1

[0035]

[0036] From the data in the table, it can be seen that the anti-Müllerian hormone quality control product was opened and reconstituted, stored at 2-8°C for 14 days, heat-accelerated at 37°C for 14 days, and after repeated freezing and thawing for 5 times, the decrease was less than 5%. The stability meets the requirements.

[0037] 2. Check the consistency between platforms

[0038] Three-level (1.0ng / ml, 5.0ng / ml, 15.0ng / ml) quality control substances were tested on mainstream platforms (Roche, Beckman) respectively. The te...

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Abstract

The invention discloses a preparation method of an anti-Mullerian hormone quality control substance. The preparation method comprises the following steps: selecting hormone removing blood serum meeting the demand; adding Proclin300, gentamicin sulfate, sodium azide, thiomersalate and trehalose to be uniformly mixed; first, measuring a background value of the anti-Mullerian hormone; then adding ananti-Mullerian hormone positive substance to the set value 0.5-20.0 ng / mL; and sub-packaging the substance obtained in the S4 in a specification of 1.0 ml / bottle in a 4 ml brown glass bottle for vacuum freezing and drying to obtain the anti-Mullerian hormone quality control substance and storing the anti-Mullerian hormone quality control substance at 2-8 DEG C. The quality control substance selects the hormone removing blood serum and can be in commercial production. Meanwhile, as the anti-Mullerian hormone quality control substance is high in consistence to a normal human sample, the matrix effect is reduced to the maximum extent, so that the anti-Mullerian hormone quality control substance is suitable for instruments and reagents of mainstream factories. The quality control substance isa freeze-dried quality control substance which is high in stability, is not affected by factors such as transportation and temperature, and is stable in performance.

Description

technical field [0001] The invention relates to biological products, in particular to a preparation method of an anti-Müllerian hormone quality control product. Background technique [0002] Serum anti-Mullerian hormone (Anti-Mullerian Hormone, AMH) is a dimeric glycoprotein secreted by female follicular granulosa cells and male testicular Sertoli cells, which can inhibit the recruitment and growth of female follicles and regulate the function of male testicular Leydig cells . Most of the articles published so far describe its clinical application. For example, detecting serum AMH levels can be used to evaluate ovarian reserve, predict ovarian response in assisted reproduction, evaluate ovarian reserve in tumor patients, and assist in the diagnosis of polycystic ovary syndrome, ovarian cancer, and ovarian cancer. Premature aging and predicting menopause, etc. [0003] The level of AMH is not affected by pituitary gonadotropins, and the value changes little throughout the m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/74
CPCG01N33/74
Inventor 杨建乐王新明赵晓转王亚洲刘功成
Owner 郑州标源生物科技有限公司
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