Total complement activity quality control product and preparation method and application thereof, and reagent

A technology of complement and properties, applied in the field of biochemical and immune reagents, can solve the problem of lack of total complement activity, and achieve the effects of small differences between finished products, reduced errors, and simple methods

Active Publication Date: 2020-02-11
上海昆涞实业发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Currently, there are no quality contr

Method used

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  • Total complement activity quality control product and preparation method and application thereof, and reagent
  • Total complement activity quality control product and preparation method and application thereof, and reagent
  • Total complement activity quality control product and preparation method and application thereof, and reagent

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Embodiment 1

[0045] This embodiment provides a method for preparing a total complement activity quality control product, which specifically includes the following steps:

[0046]Choose pH 7.79, total protein content 43g / L, hemoglobin content 70g / L, sterility test negative, mycoplasma test negative, 56 ℃ inactivated 30 minutes newborn bovine serum. Add complement C1, complement C2, complement C3, complement C4, complement C5, complement C6, complement C7, complement C8 and complement C9 in the above-mentioned newborn bovine serum to make the first mixed solution, ensure the content of each complement component in the first mixed solution Concentrations are: Complement C130U / mL, Complement C215U / mL, Complement C3 15U / mL, Complement C4 15U / mL, Complement C5 15U / mL, Complement C6 15U / mL, Complement C7 15U / mL, Complement C8 15U / mL and Complement C9 15U / mL, then add Proclin300, 3% trehalose and 5% mannitol in the first mixed solution in the mass ratio of 0.02%; Complement Activity Quality Contr...

Embodiment 2

[0048] This embodiment provides a method for preparing a total complement activity quality control product, which specifically includes the following steps:

[0049] Choose pH 7.82, total protein content 45g / L, hemoglobin content 67g / L, sterility test negative, mycoplasma test negative, 56 ℃ inactivated 30 minutes newborn bovine serum. Add complement C1, complement C2, complement C3, complement C4, complement C5, complement C6, complement C7, complement C8 and complement C9 in the above-mentioned newborn bovine serum to make the first mixed solution, ensure the content of each complement component in the first mixed solution Concentrations are: Complement C160U / mL, Complement C230U / mL, Complement C3 30U / mL, Complement C4 30U / mL, Complement C5 30U / mL, Complement C6 30U / mL, Complement C7 30U / mL, Complement C8 30U / mL and Complement C9 30U / mL, and then add 0.02% sodium azide, 2% gelatin and 3% lactose in the first mixed solution in the first mixed solution; Complement Activity Qu...

Embodiment 3

[0051] This embodiment provides a method for preparing a total complement activity quality control product, which specifically includes the following steps:

[0052] Choose pH 7.66, total protein content 38g / L, hemoglobin content 58g / L, sterility test negative, mycoplasma test negative, 56 ℃ inactivated 30 minutes newborn bovine serum. Add complement C1, complement C2, complement C3, complement C4, complement C5, complement C6, complement C7, complement C8 and complement C9 in the above-mentioned newborn bovine serum to make the first mixed solution, ensure the content of each complement component in the first mixed solution Concentrations are: Complement C1100U / mL, Complement C250U / mL, Complement C3 50U / mL, Complement C4 50U / mL, Complement C5 50U / mL, Complement C6 50U / mL, Complement C7 50U / mL, Complement C8 50U / mL and Complement C9 50U / mL, and then adding thimerosal, 1.5% polyvinylpyrrolidone K30 and 3% sucrose in the first mixed solution in a mass ratio of 0.05%; low-tempera...

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Abstract

The invention, which relates to the field of biochemical immune reagents, discloses a total complement activity quality control product and a preparation method and application thereof, and a reagent.The preparation method comprises the following step: mixing at least two of a complement C1, a complement C2, a complement C3, a complement C4, a complement C5, a complement C6, a complement C7, a complement C8 and a complement C9 with a matrix to prepare a first mixed solution. The matrix is a serum matrix. According to the invention, the total complement activity detection level calibration iscarried out on biochemical immunoassay equipment and reagents in laboratories or hospitals can be calibrated. Therefore, the accuracy of experimental data or clinical detection is ensured, and errorscaused by equipment, reagents and personnel operation are reduced.

Description

technical field [0001] The invention relates to the field of biochemical immune reagents, in particular to a total complement activity quality control product, reagent, preparation method and application. Background technique [0002] Complement is a serum protein that exists in the serum and interstitial fluid of humans and vertebrates. It is heat-labile, has enzymatic activity after activation, and can mediate immune and inflammatory responses. It can be activated by antigen-antibody complexes or microorganisms, leading to lysis or phagocytosis of pathogenic microorganisms. It can be activated through three independent and intersecting pathways, namely the classical pathway, the alternative pathway and the lectin pathway. Complement is one of the important immune effector systems of the body. It can not only participate in the defense effect and self-stabilization of the body, but also cause immune damage. The detection of total complement activity (CH50) reflects the co...

Claims

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Application Information

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IPC IPC(8): G01N33/96G01N33/531
CPCG01N33/96G01N33/531
Inventor 张卫国李玉君杨卫冲沈坤雪
Owner 上海昆涞实业发展有限公司
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