Quality-control product of drying human lymphocyte surface antigen and method for making same

A lymphocyte and surface antigen technology, applied in the field of freeze-dried human lymphocyte surface antigen quality control product and its preparation, can solve the problems of short validity period, high storage cost, inability to carry out, etc., to promote quality and level, improve quality and level, the effect of reducing storage costs

Inactive Publication Date: 2009-02-11
甘肃省医学科学研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in this technology, the cells must be frozen in liquid nitrogen, and the liquid nitrogen tank must be placed in a cold storage. The storage requirements are strict and the equipment conditions are harsh, which makes the storage cost very high; If the operation process and experimental conditions are slightly improper, the cells will be easily damaged and die, which will affect the cell antigenicity and test results. Therefore, ordinary clinical laboratories often cannot carry out this test due to lac

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 A freeze-dried human lymphocyte surface antigen quality control product, which is a cell suspension with a cell concentration of 4-6 million / mL composed of human lymphocytes fixed in a formaldehyde solution and a gelatin solution, which is freeze-dried Afterwards, it was a gray-white flocculent solid; the lymphocyte subsets (CD) were measured by flow cytometry, and the label value was CD3 + : 37.2~69.1%, CD4 + :17.9~33.7%, CD8 + :12.4~23.9%, CD4 + / CD8 + : 0.98~1.94.

[0031] The preparation method of the above-mentioned freeze-dried human lymphocyte surface antigen quality control product is as follows:

[0032] (1) First, through the cellular immune function of male or female 18-38 years old who are healthy, free from infectious diseases, other acute or chronic diseases, and without immune system diseases-lymphocyte CD3 + , CD4 + , CD8 + , CD4 + / CD8 + Carry out testing and determine those with normal results as qualified pre-test donors.

[0033]Then use hepari...

Embodiment 2

[0042] Example 2 When the freeze-dried human lymphocyte surface antigen quality control product is applied to the flow cytometry method to detect lymphocyte subsets (CD), 100-1000 μL, pH=7.0 is added to the human lymphocyte surface antigen quality control product ~7.4 calcium and magnesium-free Hank's solution; or add 100~1000μL phosphate buffer saline (PBS) with a molar concentration of 0.01mol / L and pH=7.0~7.4 to the quality control product; or add to the quality control product Dissolve in 100-1000μL of distilled water, then filter with 250-450 mesh nylon wire mesh for use.

Embodiment 3

[0043] Example 3 When the freeze-dried human lymphocyte surface antigen quality control material is used in immunofluorescence and AP-AAP bridged enzyme immunoassay to detect lymphocyte subsets (CD), add the human lymphocyte surface antigen quality control material 100~1000μL, pH=7.0~7.4 calcium-free and magnesium-free Hank'S solution containing 20% ​​newborn calf serum; or add 100~1000μL, molar concentration of 0.01mol / L, pH=7.0~7.4 to the quality control product PBS containing 20% ​​newborn calf serum; or add 100-1000 μL of distilled water containing 20% ​​newborn calf serum to the quality control product, and dissolve it for later use.

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Abstract

The invention relates to a product for controlling the quality of lyophilized human lymphocyte surface antigens, which is a grey-white solid prepared by lyophilizing a cell suspension having a cell concentration of 400,000-600,000/mL and containing lyophilized human lymphocytes immobilized by a neutral buffer formaldehyde solution and a protective agent. The mark values respectively are: CD<3> of 37.25-69.1%, CD<4> of 17.9-33.7%, CD<8> of 12.4-23.9%, and the ratio of CD<4>/CD<8> of 0.98-1.94. The invention also provides the preparation method of the quality control product. The product has the characteristics of good antigen storability and stable antigenicity, and can be used for the quality control reagent for detecting the lymphocyte surface mark antigenicity (CD series) by adopting the cell analyzer method, the immunofluorescence method, the immunoenzyme method, a SPA (Staphylococcus aureus A protein) rosettes method and the like.

Description

Technical field [0001] The invention relates to a quality control product in medical immunology, in particular to a freeze-dried human lymphocyte surface antigen quality control product and a preparation method thereof. Background technique [0002] Lymphocytes play a central role in the entire body's immune response. In peripheral blood leukocytes, lymphocytes account for 20% to 50% [absolute value (1~3.3)×10 9 / L], which mainly includes T cells, B cells and NK cells. Since lymphocytes are a heterogeneous cell population, it includes many subgroups with different immune functions. Therefore, the use of immunological techniques to determine the surface markers of lymphocytes can be used to determine the immune function of the human body, which is helpful for the prevention and health of the human body. Disease diagnosis, treatment and prognosis. [0003] At present, there are many methods to determine the surface markers of lymphocytes, but no matter which method, they all apply ...

Claims

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Application Information

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IPC IPC(8): G01N33/53
Inventor 姚伯程
Owner 甘肃省医学科学研究院
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