Five-classification leucocyte simulacrum particle, method for preparing same, and quality control substance and calibration substance containing same

Abstract

The invention relates to a method for preparing five-classification leucocyte simulacrum particle by erythrocyte, comprising the following steps: selecting proper erythrocyte, processing the erythrocyte by multifunctional reagent to achieve the integrity of erythrocyte membrane and synchronous regulation of volume, shape and inclusion, intensifying and fixing the erythrocyte, and preserving afterwashing. The invention also relates to a leucocyte simulacrum particle prepared by the method, reagent system used for preparing the leucocyte simulacrum particle, and quality control substance and calibration substance used for hematology analyzer and containing the simulacrum particle.

Description

technical field [0001] The invention relates to the field of blood cell analysis, more specifically, to a five-class leukocyte simulant particle prepared by using red blood cells, a preparation method thereof, and a quality control substance and a calibrator containing the simulant particle. Background technique [0002] In the five-differential hematology analyzer using optical detection technology, the white blood cell particle simulant in its quality control and calibrator is very different from the white blood cell simulant used in the simple impedance method (see US 4,704,364) (see figure 1 ), not only must have a relatively good volume distribution, but also need to have a good cell optical complexity distribution, and some particles also need to have specific fluorescence characteristics. Since the red blood cells of humans or animals are biconcave or spindle-shaped, they cannot show the optical characteristics of concentrated distribution in the optical detection of ...

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Problems solved by technology

[0005] (1) It is difficult to obtain white blood cell particles, which directly leads to increased cost and complicated process

[0006] In the blood of humans and animals, the concentration of white blood cells is only 1 / 100-1 / 1000 of that of red blood cells, and the process of obtaining white blood cells without red blood cells is very complicated

However, the use of hemolytic agents may lead to changes in the characteristics of leukocytes, so that the physiological leukocyte state can no longer be used to evaluate the purified leukocyte particles

In addition, the process of removing red blood cells is very complicated, and it is not easy to achieve satisfactory results even if high-cost cell separation fluid is used, so the cost and products of the calibrator and quality control materials of the five-differential blood cell analyzer are greatly limited; and

[0007] (2) It is difficult to adopt enhanced aldehyde fixation technology using white blood cells, resulting in insufficient stability of the product

[0012] (2) The processing technology of the red blood cell material disclosed in the prior art is relatively complicated, and volume adjustment (including stability pretreatment before adjustment), adjustment of hemoglobin content and long-term low-temperature fixation are required. Due to the complicated processing links, especially Volume expansion regulation greatly reduces the integrity of the red blood cell membrane, resulting in problems with its stability and yield

In addition, too many processing steps make the process more difficult, and the repeatability of the product will also be affected to a certain extent, which will reduce the practicability and controllability of the process

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