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

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 ...

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 lack of such conditions and capabilities. In actual use, it is often difficult to be effectively promoted due to the high technical requirements of cell separation, cryopreservation, and recovery processes, complex operations, time-consuming and laborious operations, and short validity periods.

[0006] Since lymphocyte surface antigens are unstable antigens, they are easily lost during storage. Therefore, the use of live lymphocyte quality control products cannot solve the problems commonly used in practical work.