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Liquid quality control serum for clinical chemical detection

A technology for quality control of serum and liquid, which is applied in the field of preparing the liquid quality control serum, and can solve problems such as no practical use, unsatisfactory stability, and influence on the development of indoor quality control.

Active Publication Date: 2011-03-30
PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Another document (CN1316521A, Chinese patent application number: 01107739.5, application date: on January 11, 2001, publication date: on October 10, 2001) has reported a kind of method of enzymatic activity in the quality control serum of protecting clinical chemistry, The method includes the conventional process steps of preparing the serum from animal serum, adding trehalose as a serum enzyme stabilizer before the liquid serum is frozen or dehydrated in the preparation process, and the amount of trehalose added per liter of liquid serum is 0.10-0.25mol, the thus obtained quality control serum can be used as the quality control material of serum components such as serum enzymes, and according to the inventor, this quality control serum is used in the quality control of serum enzyme test results. Liquid quality control serum products with trehalose as a protective agent have not been used in practice
[0005] Although liquid quality control serum can avoid many shortcomings of freeze-dried quality control serum, there are not many liquid quality control serum products on the market at present. At present, only liquid quality control serum produced by BIO-RAD company can be bought in the domestic market. Imported products, which are expensive and unaffordable for many grassroots laboratories, thus affecting the continuous and effective implementation of indoor quality control
[0006] In addition, the inventors found that the liquid quality control serum prepared with ethylene glycol as a protective agent has unsatisfactory stability for some detection items, especially for the preparation and detection of ALT, AST, CK, Glu, BUN, CR In the liquid quality control serum of 12 items such as , CA, P, K, NA, TC, TBA, etc., the stability of some items still fluctuates within the expected validity period

Method used

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  • Liquid quality control serum for clinical chemical detection
  • Liquid quality control serum for clinical chemical detection
  • Liquid quality control serum for clinical chemical detection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] Example 1. Preparation of liquid quality control serum

[0111] a) Take 1000ml of serum raw material. The serum raw material comes from healthy volunteers. Its ALT index is normal (below 40U / L), and the following indexes are negative: HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV-Ab, HIV- Ab, and RPR, these serums are all obtained by centrifugation and blood collection using a vacuum blood collection tube with separating gel. Mix these serums thoroughly, store this mixed serum in a refrigerator at -20℃, and store the mixture at -20℃ before use. After the serum is thawed in a refrigerator at 2~8℃ overnight, mix well at room temperature and set aside;

[0112] b) Pretreat the dialysis bag according to the conventional method. Put a dialysis bag with a width of 2 to 3 cm into a beaker, soak it in deionized water for about half an hour, then place the beaker on the induction cooker and boil for 10 minutes, and wash it with deionized water 3 times , Boil for another 10 minutes, wash 3 ...

Embodiment 2

[0118] Example 2. Preparation of liquid quality control serum

[0119] Refer to the method of Example 1 to prepare the liquid quality control serum of this example, but differently, the following parameters are used in the following operations:

[0120] 1) In step d), about 30% of the water content of the serum raw material is removed;

[0121] 2) In step e), a mixture of ethylene glycol and propylene glycol having a dehydration amount equivalent to that in step d) is used, wherein ethylene glycol: propylene glycol = 1:1.5 (v / v).

[0122] The liquid quality control serum thus prepared was stored in a refrigerator at -20°C.

Embodiment 3

[0123] Example 3. Preparation of liquid quality control serum

[0124] Refer to the method of Example 1 to prepare the liquid quality control serum of this example, but differently, the following parameters are used in the following operations:

[0125] 1) In step d), about 35% of the water content of the serum raw material is removed;

[0126] 2) In step e), a mixture of ethylene glycol and propylene glycol having the same amount of dehydration as in step d) is used, wherein ethylene glycol: propylene glycol=1:1.8 (v / v).

[0127] The liquid quality control serum thus prepared was stored in a refrigerator at -20°C.

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Abstract

The invention relates to liquid quality control serum for clinical chemical detection, in particular to application of combination of glycol and propylene glycol in preparing liquid quality control serum, a method for stabilizing the liquid quality control serum by using the combination of glycol and propylene glycol, liquid quality control serum containing glycol and propylene glycol serving as protective agents, and a method for preparing the liquid quality control serum. The liquid quality control serum prepared by the method keeps the stability for at least one year when stored at -20 DEGC, keeps the stability for at least two weeks when stored and used at 2 to 8 DEG C, can stabilize for 4 hours at room temperature, and has some quality control indexes superior to those of the liquidquality control serum prepared by the prior art or the liquid quality control serum on sale.

Description

Technical field [0001] The invention relates to a liquid quality control serum used for routine chemistry part test items in clinical laboratories. Specifically, it relates to the use of the combination of ethylene glycol and propylene glycol in the preparation of liquid quality control serum, the method of using the combination of ethylene glycol and propylene glycol to stabilize the liquid quality control serum, the combination of ethylene glycol and propylene glycol to stabilize the liquid quality control serum, and A method for preparing the liquid quality control serum. Background technique [0002] In clinical laboratory testing, especially chemical testing, for many years, in order to make the test results of different laboratories, different instruments, and different methodologies comparable on a reliable and consistent basis, and to correctly evaluate the quality of work between laboratories As well as the quality control in the laboratory, there must be a good quality...

Claims

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Application Information

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IPC IPC(8): G01N33/96
Inventor 宋耀虹齐志宏
Owner PEKING UNION MEDICAL COLLEGE HOSPITAL CHINESE ACAD OF MEDICAL SCI
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