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Kit for measuring glycosylated hemoglobin and preparation method thereof

A technology of glycosylated hemoglobin and kits, applied in biological testing, measuring devices, instruments, etc., can solve the problems of low measured value of moderate to severe anemia samples, unstable reagents, cumbersome operation, etc., and achieve the elimination of the influence of individual differences and stability Good, the effect of promoting specific reactions

Active Publication Date: 2021-03-16
SICHUAN MACCURA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention solves the aforementioned problems of cumbersome operation and unstable reagents, as well as the problem of low measured values ​​of moderate to severe anemia samples

Method used

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  • Kit for measuring glycosylated hemoglobin and preparation method thereof
  • Kit for measuring glycosylated hemoglobin and preparation method thereof
  • Kit for measuring glycosylated hemoglobin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1. Detection principle and use of the glycosylated hemoglobin detection kit of the present invention

[0039] Detection principle : The hemoglobin and glycosylated hemoglobin in the sample have the same non-specific adsorption as the latex in reagent 1 and are solid-phased. When the mouse anti-human glycosylated hemoglobin antibody is added to form a glycosylated hemoglobin antigen-antibody immune complex, the amount of agglutination is due to the immobilization of the latex surface The amount of glycosylated hemoglobin varies. By measuring its absorbance and comparing it with the standard curve of the percentage concentration of glycated hemoglobin, the percentage of glycated hemoglobin in the sample to the total hemoglobin can be calculated. When the amount of total hemoglobin can meet the amount of latex adsorption, the test results will not be affected, but when the amount of total hemoglobin is not enough to meet the amount of latex adsorption, the i...

Embodiment 2

[0047] Example 2. The glycosylated hemoglobin detection kit of the present invention is effective in reducing the impact of individual differences and improving stability Effect

[0048] (1) The preparation of kit of the present invention : Prepare the test kits of experimental group 1 and experimental group 2 respectively according to the components and contents described in Table 1 below.

[0049] Table 1. Preparation of kits for experimental groups 1 and 2

[0050]

[0051]

[0052] Note: a Emulgen A90 is the surfactant distyrylphenol polyoxyethylene ether, which is the Emulgen series product of Kao Corporation.

[0053] (2) Effect verification method :

[0054] a. Verification of individual differences: 10 samples with the same concentration of HbA1c were measured, the difference lies in the concentration of hemoglobin (Hb). The HbA1c values ​​of the 10 samples were all 5.2%, which was determined by the internationally recognized IFCC mass spectrometry me...

Embodiment 3

[0066] Example 3. The effect test of the glycosylated hemoglobin detection kit of the present invention with different concentration values

[0067] (1) Kit preparation : Prepare the test kits of experimental groups 3-7 according to the components and contents described in Table 4 below.

[0068] Table 4. Composition Table of Experimental Groups 3-7

[0069]

[0070] (2) Effect verification method :

[0071] Individual difference verification and stability effect verification methods are the same as in Example 2.

[0072] (3) Experimental results :

[0073] The test kits of experimental groups 3-7 were compared with traditional kits (i.e. commercially available reagent 1 and commercially available reagent 2), and the verification results of individual differences and long-term stability verification results are shown in Tables 5 and 6 below:

[0074] Table 5. Experimental results of individual difference samples of experimental groups 3-7 (#1-#10 represent pathol...

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Abstract

The invention relates to the technical field of biology, in particular to a glycosylated hemoglobin measuring kit. The kit comprises a reagent R1 and a reagent R2; the reagent R1 comprises latex, a double-buffer solution and a surfactant; the reagent R2 comprises a glycosylated hemoglobin monoclonal antibody, a dual surfactant and a buffer solution. The kit is high in measuring accuracy, low in cost and good in stability.

Description

technical field [0001] The invention belongs to the technical field of detection of glycosylated hemoglobin, in particular to a detection kit for glycosylated hemoglobin. Background technique [0002] Glycosylated hemoglobin (HbAlc) is the product of the combination of hemoglobin and glucose in the blood. Its value is proportional to the blood sugar concentration, and it is an irreversible combination. It disappears with the death of red blood cells (the life span of red blood cells is about 120 days). Since glycosylated hemoglobin is related to the lifespan of red blood cells and the average blood sugar level, it is an ideal indicator for evaluating long-term blood sugar control in diabetic patients. It can reflect the average blood sugar level in the past 2 to 3 months and is not affected by daily blood sugar fluctuations. It is closely related to the occurrence of microvascular and macrovascular complications. Elevated levels of glycosylated hemoglobin are associated wit...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/72
CPCG01N33/723G01N2333/805
Inventor 甘萍萍耿英利黎明吴昌英龙腾镶
Owner SICHUAN MACCURA BIOTECH CO LTD
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