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Glycosylated hemoglobin assay kit

A technology of glycosylated hemoglobin and kits, which is applied in biological testing, measuring devices, instruments, etc., can solve problems such as susceptibility, measurement signal decline, complicated operation, etc., to eliminate the influence of physical adsorption, eliminate the influence of individual differences, The effect of promoting specific response

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

Because the immune complex formed by the monoclonal antibody and the secondary antibody has poor long-term storage stability, and the gradual inactivation leads to a decrease in the assay signal, so the operator needs to mix reagent 2 and reagent 3 before use. The operation is complicated, and the mixed reagent is stable. shorter validity period
In addition, since the latex immunoturbidimetric method measures the content of HbA1c in total hemoglobin, it is easily affected when detecting moderate to severe anemia samples, resulting in low test results

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prepare two groups of reagents 1-1 and 1-2 according to the following formula, detect 10 samples with different Hb content and HbA1c value of 5.2%, and observe the difference between the measured value and the real value. At the same time, under the storage condition of 2-8°C, the quality control products of the HbA1c project were measured in 0 month and March respectively, and the stability of the reagent was observed.

[0037] Reagent 1:

[0038] Reagent composition Reagent name 1-1 (pH:5) 1-2(pH:9) Physisorbed Bare Latex Physisorbed Bare Latex 0.2g / L 10g / L buffer Glycine 2mM 200mM Surfactant Tween-20 0.01ml / L 1ml / L

[0039] Reagent 2:

[0040]

[0041] According to the using method of the kit of the present invention, the above-mentioned 1-1, 1-2 two groups of reagents are respectively measured 10 cases of individual difference samples, and the results are as follows:

[0042] Table 1-1 Determination of HbA1c ...

Embodiment 2

[0051] Prepare five groups of reagents 2-1, 2-2, 2-3, 2-4, and 2-5 according to the following formula, detect 10 samples with different Hb content, and the HbA1c value is 5.2%, and observe the measured value and the real value difference. At the same time, under the storage condition of 2-8°C, the quality control products of the HbA1c project were measured in 0 month and March respectively, and the stability of the reagent was observed.

[0052] Reagent 1:

[0053]

[0054] Reagent 2:

[0055]

[0056] According to the use method of the kit of the present invention, the above-mentioned five groups of reagents 2-1, 2-2, 2-3, 2-4 and 2-5 were respectively measured for 10 cases of individual difference samples, and the results were as follows:

[0057] Table 2-1 Determination of HbA1c results of samples with individual differences

[0058]

[0059]

[0060] Under the storage condition of 2-8°C, the quality control products of the HbA1c project were measured in 0 mo...

Embodiment 3

[0066] Prepare two groups of reagents 3-1 and 3-2 according to the following formula:

[0067] Reagent 1:

[0068] Reagent composition Reagent name 3-1 (pH:4.4) 3-2 (pH:9.5) Physisorbed Bare Latex Physisorbed Bare Latex 0.1g / L 20g / L buffer Glycine 1mM 200mM Surfactant Tween-20 0.003ml / L 1.2ml / L preservative PC950 0.01ml / L 6ml / L

[0069] Reagent 2:

[0070] Reagent composition Reagent name 3-1 (pH: 4) 3-2 (pH:9) Antibody Glycosylated hemoglobin monoclonal antibody 0.01mg / ml 2mg / ml Surfactant 1 Tween-20 0.03ml / L 3ml / L Surfactant 2 A-90 0.02ml / L 4ml / L buffer Phosphate 5mM 300mM Protective agent Mannitol 1g / L 90g / L protein stabilizer BSA 0.5g / L 60g / L Salt NaCl 0.5g / L 80g / L preservative IZU 0.2g / L 6g / L Chelating agent EDTA.2Na 0.002g / L 5g / L

[0071] 3-1 The calibration curve of the experimental group i...

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Abstract

The invention relates to the biotechnical field, and concretely relates to a glycated hemoglobin detection kit. The kit comprises a reagent 1 and a reagent 2, and the reagent 1 comprises a latex, a buffer solution and a surfactant; and the reagent 2 comprises a glycated hemoglobin monoclonal antibody, a dual surfactant and a buffer solution. The kit has the advantages of high detection accuracy, low cost and good stability.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a kit for measuring glycosylated hemoglobin. Background technique [0002] Glycated hemoglobin (glycosylated hemoglobin, HbA1c) is the product of the combination of hemoglobin and blood sugar in red blood cells in human blood. The combination of blood sugar and hemoglobin to form glycosylated hemoglobin is an irreversible reaction and is proportional to the blood sugar concentration. It lasts for about 120 days, so it can be observed The blood sugar concentration before 120 days is not affected by an occasional rise or fall in blood sugar. Therefore, the measurement of glycosylated hemoglobin can give a more comprehensive understanding of the blood sugar control level in the past period of time. [0003] Control of glycated hemoglobin and blood sugar: 4% to 6%, normal blood sugar control; 6% to 7%, ideal blood sugar control; 7% to 8%, average blood sugar control; 8% to 9%, unsatisfac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68
CPCG01N33/6893
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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