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Glycosylated hemoglobin detection reagent

A technology of glycosylated hemoglobin and detection reagents, which is applied in the fields of medicine and biochemistry, can solve the problems of reduced detection sensitivity and accuracy, and decreased resistance to activity, and achieve the effects of long-term storage, activity maintenance, and high detection sensitivity and accuracy

Pending Publication Date: 2020-06-05
SUZHOU DIAGVITA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to aim at the randomness of the combination of the two antibodies in the R2 reagent of the existing glycosylated hemoglobin detection reagent described in the background technology, which may affect its combination with HbA1c, reduce the sensitivity and accuracy of detection, and Provide a glycosylated hemoglobin detection reagent that can solve the problems of long-term storage such as the decline of primary antibody activity

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0015] The glycated hemoglobin detection reagent includes R1 reagent, R2 reagent and R3 reagent.

[0016] The R1 reagent includes latex and a buffer, the latex particle size is 50nm, and the concentration is 0.5% (mass / volume ratio); the buffer is glycine, the pH value is 8.0, and the concentration is 0.1mol / L.

[0017] The R2 reagent includes mouse anti-human HbA1c monoclonal antibody and rabbit anti-mouse IgG Fc polyclonal antibody. The concentration of mouse anti-human HbA1c monoclonal antibody is 50mg / L, and the concentration of rabbit anti-mouse IgG Fc-terminal polyclonal antibody is 10mg / L L.

[0018] The R3 reagent is Triton X-100 with a concentration of 1% (volume / volume ratio).

[0019] Glycosylated hemoglobin accuracy test:

[0020]

Embodiment 2

[0022] The glycated hemoglobin detection reagent includes R1 reagent, R2 reagent and R3 reagent.

[0023] The R1 reagent includes latex and a buffer, the latex particle size is 300nm, and the concentration is 0.2% (mass / volume ratio); the buffer is glycine, the pH value is 6.0, and the concentration is 0.06mol / L.

[0024] The R2 reagent includes mouse anti-human HbA1c monoclonal antibody and rabbit anti-mouse IgG Fc polyclonal antibody. The concentration of mouse anti-human HbA1c monoclonal antibody is 70mg / L, and the concentration of rabbit anti-mouse IgG Fc-terminal polyclonal antibody is 16mg / L L.

[0025] The R3 reagent is NP-40 at a concentration of 0.6% (vol / vol).

[0026] Glycosylated hemoglobin accuracy test:

[0027]

Embodiment 3

[0029] The glycated hemoglobin detection reagent includes R1 reagent, R2 reagent and R3 reagent.

[0030] The R1 reagent includes latex and a buffer, the latex particle size is 500nm, and the concentration is 0.05% (mass / volume ratio); the buffer is glycine, the pH value is 5.0, and the concentration is 0.01mol / L.

[0031] The R2 reagent includes mouse anti-human HbA1c monoclonal antibody and rabbit anti-mouse IgG Fc polyclonal antibody. The concentration of mouse anti-human HbA1c monoclonal antibody is 100mg / L, and the concentration of rabbit anti-mouse IgG Fc-terminal polyclonal antibody is 20mg / L L.

[0032] R3 reagent is Triton X-100, the concentration is 0.1% (volume / volume ratio).

[0033] Glycosylated hemoglobin accuracy test:

[0034]

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Abstract

The invention discloses a glycosylated hemoglobin detection reagent. The reagent comprises a reagent R1, a reagent R2 and a reagent R3, the reagent R1 is a latex reagent, the reagent R2 comprises a primary antibody and sensitizing protein, the primary antibody is a mouse anti-human HbA1c monoclonal antibody, the sensitizing protein is protein capable of being directionally combined with a region outside a mouse IgG Fab region on the primary antibody, and the reagent R3 comprises a hemolytic agent. According to the glycosylated hemoglobin detection reagent disclosed by the invention, the sensitizing protein and the primary antibody can be directionally combined, the combination of the primary antibody and glycosylated hemoglobin is not influenced, the detection sensitivity and accuracy of glycosylated hemoglobin are higher, and the detection reagent is convenient to store for a long time and can also keep the activity of the antibody.

Description

technical field [0001] The invention relates to the technical fields of medicine and biochemistry, in particular to a reagent for detecting glycosylated hemoglobin. Background technique [0002] At present, the detection methods of glycosylated hemoglobin that are widely used clinically are mainly high-performance liquid chromatography, affinity chromatography, electrophoresis, etc. These detection methods are complicated to operate, time-consuming, and require special instruments, and the cost is high. There are also other detection methods in the world, but they generally have the defect of low measurement accuracy. However, currently commercially available latex turbidimetric assay kits generally adopt three kinds of reagents (R1, R2 and R3), wherein R3 is a hemolytic agent, R1 is a latex reagent, and R2 contains a mouse anti-human HbA1c monoclonal antibody (called a Anti-) and goat anti-mouse IgG polyclonal antibody (secondary antibody), HbA1c is glycosylated hemoglobin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/72G01N33/577G01N33/543
CPCG01N33/54346G01N33/577G01N33/723
Inventor 赵年福张辉贾引军王明伟金君玉吴一凡
Owner SUZHOU DIAGVITA BIOTECH
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