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Preparation method of quality control material of glycosylated hemoglobin and quality control material thereof

A hemoglobin and saccharification technology, applied in the field of medical testing, can solve problems such as unfavorable industrialization, difficult to obtain, uncontrollable, etc., and achieve the effects of improving measurement accuracy, simple method, and eliminating bottle-to-bottle difference.

Active Publication Date: 2017-05-31
深圳市雷诺华科技实业有限公司
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  • Application Information

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Problems solved by technology

However, the HbA1c concentration of normal people is between 5% and 6%, and the acquisition of different concentration values ​​is random and uncontrollable, which is not conducive to industrialization; clinical red blood cell samples with an HbA1c concentration of 3% to 5% are very rare, not easy to get

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  • Preparation method of quality control material of glycosylated hemoglobin and quality control material thereof

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preparation example Construction

[0022] The present invention provides a method for preparing a glycosylated hemoglobin control product, which comprises the following steps:

[0023] Collect blood samples from non-diabetic patients, perform centrifugation and desizing to obtain red blood cells;

[0024] Adding a red blood cell preservation solution to the red blood cells to prepare a red blood cell sample;

[0025] Prepare cell separation solutions with different densities, and add the cell separation solutions to a centrifuge tube in order according to the density from large to small to obtain the layered solution;

[0026] The red blood cell sample is slowly added to the surface layer of the layering solution, and the layered red blood cells are obtained by centrifugation, and the red blood cells suitable for the cell separation solution are dispersed in each density of the cell separation solution;

[0027] The layered red blood cells are divided into different test tubes, and physiological saline is added to each t...

Embodiment 1

[0053] Collect healthy blood samples from normal people, where the hemoglobin concentration is 120g / L, and the number of red blood cells per unit volume is 4×10 12 Pieces / L, HbA1c: 5~6%;

[0054] The blood sample was first centrifuged at 2000r / min for 5min in a centrifuge, de-slurried, and then washed twice with PBS at 4°C at 2000r / min. After carefully aspirating and discarding the supernatant and buffy coat layer with a pipette, red blood cells are obtained.

[0055] Add the red blood cell preservation solution with equal red blood cell volume ratio to the red blood cells, mix well to obtain the red blood cell sample, and store it in the refrigerator at 4°C for later use.

[0056] Set 4 density gradients of Percoll cell separation solution, which are 1.120, 1.1193, 1.1180, 1.117g / mL, respectively, and each are contained in 4 centrifuge tubes, and 4 aliquots of 400μL of the above red blood cell samples are slowly superimposed on Percoll cell separation solution along the wall of the ...

Embodiment 2

[0063] Collect healthy blood samples from normal people, where the hemoglobin concentration is 120g / L, and the number of red blood cells per unit volume is 4×10 12 Pieces / L, HbA1c: 5~6%;

[0064] The blood sample was first centrifuged in a centrifuge at 2000r / min for 5 minutes, de-slurried, and then washed with PBS at 2°C for 5 times at a speed of 2000r / min. After carefully aspirating and discarding the supernatant and buffy coat layer with a pipette, red blood cells are obtained.

[0065] Add the red blood cell preservation solution with equal red blood cell volume ratio to the red blood cells, mix well to obtain the red blood cell sample, and store it in the refrigerator at 4°C for later use.

[0066] Percoll cell separation stock solution is a hypotonic medium. 1.5mol / L NaCl solution should be added during preparation to make the osmotic pressure of the prepared Percoll cell separation solution reach the required size of red blood cells (280-320mOsm / kg ·H 2 O).

[0067] According ...

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Abstract

The invention provides a preparation method of a quality control material of glycosylated hemoglobin, comprising the following steps: collecting a blood sample of a nondiabetic patient, performing centrifugation and plasmapheresis to obtain red blood cells; adding red blood cell preserving fluid to the red blood cells to obtain a red blood cell sample; adding the red blood cell sample slowly into separating fluid and centrifuging to obtain separated red blood cells, wherein red blood cells adaptive to the cell separation fluid are dispersed in the cell separation fluid of each density; separately charging the separated red blood cells into different test tubes, adding physiological saline to each test tube to obtain a red blood cell suspension, regulating the hemoglobin concentration of the red blood cell suspensions to 120g / L, and screening out red blood cell suspensions with the HbA1c value of 3-5% to obtain the quality control material of glycosylated hemoglobin. The invention also provides the quality control material. The preparation method provided by the invention can perform mass production of low-value quality control materials of glycosylated hemoglobin.

Description

Technical field [0001] The invention relates to the technical field of medical testing, in particular to a method for preparing a glycosylated hemoglobin control product and its quality control product. Background technique [0002] At present, clinical methods for determining the content of glycosylated hemoglobin (HbA1c) can be divided into two categories according to different physical and chemical properties: one is based on the different charges of glycosylated and non-glycated hemoglobin, such as ion exchange chromatography, electrophoresis; the other It is based on the different structure of glycosylated and non-glycated hemoglobin, such as immunoassay, affinity chromatography and enzymatic method. Use different measurement methods or the same measurement method to select reagents produced by different manufacturers. Before testing, you need to use quality control products for quality control or calibration products for calibration. Currently, homemade fresh frozen whole ...

Claims

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Application Information

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IPC IPC(8): G01N33/72
CPCG01N33/723G01N2333/805G01N2496/05
Inventor 王荣光
Owner 深圳市雷诺华科技实业有限公司
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