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Dual-reagent glycosylated hemoglobin detection kit

A technology of glycosylated hemoglobin and detection kits, applied in the biological field, can solve problems such as reagent instability, manual operation errors, and differences in test results, and achieve the effects of good reagent stability, control of batch-to-batch differences, and cost savings for patients

Inactive Publication Date: 2015-12-09
BYRON DIAGNOSTICS SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It solves the problems of the difference in test results and the instability of reagents caused by manual operation errors during the determination of the aforementioned latex immunoturbidimetric direct method

Method used

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  • Dual-reagent glycosylated hemoglobin detection kit
  • Dual-reagent glycosylated hemoglobin detection kit
  • Dual-reagent glycosylated hemoglobin detection kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A two-reagent glycosylated hemoglobin detection kit, including reagents: a latex microsphere solution (reagent 2) labeled with a monoclonal antibody that specifically recognizes glycosylated hemoglobin replaces the traditional detection reagent HbA1C monoclonal antibody (traditional reagent 2) and the corresponding secondary antibody ( Traditional reagent 3), usually the HbA1C monoclonal antibody is a mouse monoclonal antibody, and the secondary antibody is an anti-mouse IgG antibody. This reagent 2 uses a chemical coupling method to label a monoclonal antibody that specifically recognizes glycosylated hemoglobin, referred to as HbA1C monoclonal antibody, on prepared on latex microspheres. Wherein, the particle size of the latex microsphere particles is 100 nm.

[0045] In this embodiment, direct quantitative detection of the content percentage of glycated hemoglobin in the test sample is carried out by immunoturbidimetric method. The experimental process is as follows...

Embodiment 2

[0052] A two-reagent glycated hemoglobin detection kit, according to the detection method of Example 1, three batches of Muti-Mab (polyglycosylated hemoglobin monoclonal antibody), as shown in Table 1, and three batches of the kit of the present invention , as shown in Table 2, also using the common blank latex solution (reagent 1) in the market, carried out the calibration test according to the general parameters, and compared the difference between batches of absorbance data, the results are as follows Figure 10 , Figure 11 As shown, the difference in the absorbance values ​​of the three batches of Muti-Mab is large, and the relative deviation of the absorbance values ​​is greater than 15%; while the difference between batches of the kit of the present invention is small, which meets the requirement that the difference between batches of conventional in vitro diagnostic reagents is less than 15%.

[0053] Table 1

[0054]

[0055] Table 2

[0056]

Embodiment 3

[0058] A double-reagent glycated hemoglobin detection kit, the preferred 50-200nm latex microspheres according to the detection method of embodiment 1 are used as HbA1C monoclonal antibody labeling, using 50nm ( Figure 12 ), 100nm ( Figure 13 ), 150nm ( Figure 14 ), 200nm ( Figure 15 ) latex microspheres were coupled with the same amount of commercial HbA1C monoclonal antibody according to the conventional chemical coupling method, and the clinical results were compared with those of common kits on the market such as Point reagent (traditional reagent 2 and traditional reagent 3 need to be mixed in advance), the accuracy of the results All are ideal, the correlation R of clinical results is greater than 0.98, and the relative deviation is less than 10%. When latex microspheres with smaller particle size are used, the antibody labeling process is prone to agglomeration, which makes it difficult to control the difference between batches of labeling. For example, if 30nm la...

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Abstract

The invention discloses a dual-reagent glycosylated hemoglobin detection kit. The kit comprises a reagent 2. The reagent 2 is prepared by labeling a monoclonal antibody (HbA1C monoclonal antibody), which can specifically recognize glycosylated hemoglobin, on latex microspheres through a chemical coupling method. The reagent 2 can replace the conventional reagent 2 (HbA1C monoclonal antibody) and the conventional reagent 3 (corresponding second antibody). The kit can be used to detect glycosylated hemoglobin, before detection, the kit does not to be shaken by an experimenter, the artificial operation error can be avoided, the kit is efficient and stable, and the detection results are more accurate. Furthermore, the reagent stability is high, so the application, storage and transportation become easier. A matured chemical coupling-latex labeling method is adopted, the kit can be produced massively, the difference between different batches of reagents can be controlled, and the cost is reduced. The detection cost of the method that uses the kit is lower, compared with that of HPLC method. The blank latex solutions produced by the mainstream factories can all be used to produce the kit. The kit can be promoted and used, and the economic burden for patients can be reduced.

Description

technical field [0001] The invention relates to a double-reagent glycosylated hemoglobin detection kit, which belongs to the field of biotechnology. Background technique [0002] 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 for 120 days The previous blood sugar concentration is not affected by an occasional rise or fall in blood sugar. Therefore, the measurement of glycosylated hemoglobin can provide 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%, unsatisfact...

Claims

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Application Information

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IPC IPC(8): G01N33/577
CPCG01N33/577
Inventor 王钊段茂华杨敏
Owner BYRON DIAGNOSTICS SHANGHAI
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