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Quality control material/control substance for urine visible component analyzer and preparation method of quality control material/control substance

A component analysis and quality control technology, which is applied in the field of quality control/control substances for urine formed component analyzers and its preparation, can solve the problems of limited shelf life, inability to be used for manual microscopic examination, limited items, etc.

Inactive Publication Date: 2017-10-20
桂林市贝丛医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] 1. The quality control substance / control substance itself contains limited items, such as quality control substances containing only red blood cells, or quality controls containing only red and white blood cells, etc.;
[0009] 2. The shape of red blood cells and white blood cells is irregular and difficult to identify;
[0010] 3. Non-cellular substances (such as plastic particles) are used to simulate the formed components of urine, which cannot be used for manual microscopy;
[0011] 4. Directly use clinical samples as quality control substances / control substances, with limited storage period, etc.

Method used

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  • Quality control material/control substance for urine visible component analyzer and preparation method of quality control material/control substance
  • Quality control material/control substance for urine visible component analyzer and preparation method of quality control material/control substance
  • Quality control material/control substance for urine visible component analyzer and preparation method of quality control material/control substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Preparation of red blood cell mimics:

[0051] (1) Collect pig blood with an anticoagulant, which is a solution containing trisodium citrate, citric acid, and glucose;

[0052] (2) Use centrifugation to separate and collect red blood cells for later use;

[0053] (3) Treat the obtained red blood cells with a cell treatment solution, the ratio of cells to cell treatment solution is 1:1 to 1:50, and the treatment time is 4 to -120 hours; the main components of the cell treatment solution include: 1% formaldehyde, Non-ionic detergent 1%;

[0054] (4) After the cells are treated with the cell treatment solution, the cells are washed and added to the storage solution to obtain the erythrocyte simulant.

[0055] refer to Figure 1-2 , by comparing the microscopic observation pictures of red blood cells obtained in step (3) before and after treatment:

[0056] Before treatment: the shape of red blood cells is irregular, inconsistent, and persimmon-like;

[0057] After tre...

Embodiment 2

[0060] Preparation of leukocyte mimics:

[0061] (1) Collect pig blood with an anticoagulant, which is a solution containing trisodium citrate, citric acid, and glucose;

[0062] (2) Separating and collecting white blood cells by standing or centrifuging;

[0063] Wherein, the step of collecting leukocytes by static method is as follows: after the collected pig blood is left to stand for 3-6 hours, remove the upper layer of plasma, and collect the white layer between the plasma layer and the red blood cell layer, which is the leucocyte layer;

[0064]The steps of centrifugation to collect leukocytes are as follows: after mixing the collected pig blood, divide it into centrifuge bottles, remove the upper layer of plasma after centrifugation, and collect the white layer between the plasma layer and the red blood cell layer, which is the leucocyte layer;

[0065] (3) Treat the collected white blood cells with a hemolytic agent, the ratio of the white blood cells to the hemolytic...

Embodiment 3

[0073] Preparation of leukocyte mimics:

[0074] (1) Collect pig blood with an anticoagulant, which is a solution containing trisodium citrate, citric acid, and glucose;

[0075] (2) Separating and collecting white blood cells by standing or centrifuging;

[0076] (3) Add the collected white blood cells to the cell treatment solution for treatment, the ratio of white blood cells to the cell treatment solution is 1:1, and the treatment time is 30 minutes; the main components of the cell treatment solution include: 1% formaldehyde;

[0077] (4) Treat the above-mentioned white blood cell liquid with a hemolytic agent, the ratio of white blood cells to hemolytic agent is 1:2, the treatment time is 15 minutes, and the white blood cells are collected by centrifugation for later use; the main components of the hemolytic agent include: 1% saponin;

[0078] (5) Treat the obtained white blood cells with cell treatment solution, the ratio of cells to cell treatment solution is 1:20, and...

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Abstract

The invention discloses a preparation method of a quality control material / control substance for a urine visible component analyzer. The preparation method comprises the following steps: preparation of an erythrocyte simulant, preparation of a leukocyte simulant, preparation of a tubular cell simulant and preparation of the quality control material; independent or random combination of the several simulants to synthesize the required quality control material / control substance, wherein the obtained quality control material / control substance can be applied to the urine visible component analyzer or a hematology analyzer. According to the preparation method, by cell treatment and improvement on a treatment liquid formula, the prepared quality control material / control substance can make up for the shortcoming of lack of quality control materials in China.

Description

technical field [0001] The invention relates to the analysis of urine formed components, in particular to a quality control substance / control substance for a urine formed component analyzer and a preparation method thereof, and the quality control substance prepared by the method is used in an in vitro diagnostic (IVD) instrument , including quality control of urine formed component analyzers, blood cell analyzers, etc. Background technique [0002] In clinical testing, the test method for urine formed components is to centrifuge the urine first, then take the bottom sediment for manual microscopic examination, and finally get the result. This inspection method is time-consuming and laborious, and relies more on the experience of inspectors. Therefore, in recent years, a fully automatic urine formed component analyzer has gradually replaced the method of manual microscopic examination to test and analyze the formed components of urine. The fully automatic urine formed compo...

Claims

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Application Information

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IPC IPC(8): G01N1/28
CPCG01N1/28
Inventor 张周文何刚胡朝云秦就强陈祥云
Owner 桂林市贝丛医疗科技有限公司
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