Quality control quality of freeze-dried human lymphocyte surface antigen and method for preparing same

Abstract

The present invention relates to a freeze-dry quality control material of human lymphocyte surface antigens. The quality control material is cell suspension which consists of human lymphocytes solidified by a fixative and a protective agent and has a cell concentration of 4,000,000 to 6,000,000 per milliliter, and appears as off-white flocculent solid after being dried; and the marked values are 37.2 to 69.1 percent of CD3<+>, 17.9 to 33.7 percent of CD4<+>, 12.4 to 23.9 percent of CD8<+>, and 0.98 to 1.94 percent of CD4<+> / CD8<+>. Simultaneously, the invention also discloses a preparation method of the quality control material. The invention has the advantages of excellent antigen conservation and stable antigenicity, and can be used as the quality control agent which is used for detecting the antigenicity of cell surface markers (CD Series) in such method as the flow cytometry, the immunofluorescence, the mmunoenzyme, SPA (staphylococcal protein A) rosette 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. Lymphocytes account for 20% to 50% of peripheral blood leukocytes [absolute value (1 to 3.3)×10 9 / L], which mainly includes T cells, B cells and NK cells. Since lymphocytes are a heterogeneous cell population, which includes many subpopulations with different immune functions, the detection of lymphocyte surface markers by immunological techniques can be used to judge the immune function of the human body, which is helpful for the prevention and health care of the human body. Disease diagnosis, treatment and prognosis. [0003] At present, there are many methods for measuring lymphocyte surface markers, but no matter which method is used, the principle of i...

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.