Test method and test kit of glycosylated hemoglobin

A technology of glycosylated hemoglobin and a detection method, which is applied in the field of medical clinical biochemical diagnostic reagents, and achieves the effects of ensuring the sameness, being convenient to use, and shortening the operation time.

Inactive Publication Date: 2013-01-23
潍坊泽成生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Enzyme-linked immunoassay is to use enzyme-linked immunoassay technology to measure HbA1c, using microplate reader, plate washer, etc. This method is cumbersome to operate, takes a long time, and has many affected factors
Latex immunoagglutination method is to use the natural agglutination effect of the complex formed by the reaction of antigen and antibody, amplify the agglutination signal with latex, and measure the turbidity of the reaction solution. Generally, a fully automatic biochemical analyzer is used, which is widely used at present, but is limited by the method and equipment used. Specimens need to be measured centrally
Ion resin micro-column chromatography uses the specific adsorption of ion resin to flow the sample through the ion resin chromatography column, thereby separating HbA1c from the sample, and then comparing the content of the analyzer with total hemoglobin, with high specificity and precision It has high precision and good repeatability, and is widely used in clinical practice, but the operation is cumbersome and time-consuming, and is greatly affected by ambient temperature and volatile acid-base substances. Natural chromatography is a method of negative pressure drainage or positive pressure extrusion, which only shortens a certain amount of operation time, and at the same time brings the disadvantage of incomplete adsorption of liquid due to too fast flow rate and short contact time with resin

Method used

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  • Test method and test kit of glycosylated hemoglobin
  • Test method and test kit of glycosylated hemoglobin
  • Test method and test kit of glycosylated hemoglobin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1, a detection kit, including packaging box, ion resin, hemolytic agent, standard solution;

[0032] The ionic resin is 5-20mg / mld cation exchange resin suspension, which is Rex-70, and it is packaged as a single serving, and it is a disposable slit plastic cuvette with a cover or a disposable vial with a cover; the hemolytic agent is 0.1% saponin solution is used for hemolysis, and the standard solution is freeze-dried whole blood, which has been calibrated and assigned by the national standard, used for calibration, and reconstituted with distilled water before use.

[0033] The storage conditions and validity period are: the original reagent should be stored in the dark at 2-8°C, and the validity period is 18 months;

[0034] The above kit is used for in vitro quantitative determination of the concentration of glycosylated hemoglobin (Glycosylated hemoglobin A1, HbA1c) in human whole blood.

[0035] Applicable instruments are suitable for all kinds of equ...

Embodiment 2

[0053] Embodiment 2, a detection kit, including packing box, ion resin, hemolytic agent, standard solution;

[0054] The ion resin is a cation exchange resin suspension of 5 mg / mld, which is Rex-70, and it is packaged as a single serving, and it is a disposable slit plastic cuvette with a lid or a disposable vial with a lid, 3ml per serving Quantity; the hemolytic agent is 0.1% saponin solution, used for hemolysis, 0.5ml per person, the standard solution is freeze-dried whole blood, calibrated and assigned by the national standard, and reconstituted with distilled water before use.

[0055] The method for detecting glycosylated hemoglobin using the above-mentioned detection kit is carried out according to the following steps: the ion exchange resin homogeneous adsorption separation method is adopted, and the specific adsorption of the ion resin to hemoglobin is utilized. First, a hemolytic agent is used to prepare a hemoglobin sample. Under the condition of ~40°C, fully mix th...

Embodiment 3

[0070] Embodiment 3, a detection kit, including packaging box, ion resin, hemolytic agent, standard solution;

[0071] Ion resin is 10mg / mld cation exchange resin suspension, Rex-70, in single-serve packaging, in disposable slit plastic cuvettes with lids or in disposable vials with lids, 1.5ml per serving Filling volume: The hemolytic agent is 0.1% saponin solution, used for hemolysis, 0.5ml per person, the standard solution is freeze-dried whole blood, calibrated and assigned by the national standard, and reconstituted with distilled water before use.

[0072] The method for detecting glycosylated hemoglobin using the above-mentioned detection kit is carried out according to the following steps: the ion exchange resin homogeneous adsorption separation method is adopted, and the specific adsorption of the ion resin to hemoglobin is utilized. First, a hemolytic agent is used to prepare a hemoglobin sample. Under the condition of ~40°C, fully mix the ion resin with the prepared...

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Abstract

The invention relates to a test method of glycosylated hemoglobin, comprising the following steps of: by utilizing the specific adsorption of ion resin to hemoglobin, firstly preparing a hemoglobin sample, fully mixing ion resin with the prepared hemoglobin sample evenly at the temperature of 25-40 DEG C to completely adsorb hemoglobin not glycosylated in blood and keeping glycosylated hemoglobin in blood in liquid, then measuring absorbance values of the liquid and whole blood after adsorption treatment, and obtaining the content of glycosylated hemoglobin according to the ratio of the treated liquid to the treated absorbance value. According to the invention, a microcolumn chromatography is changed to a liquid homogeneous phase adsorption method of separation, so that the operation time is greatly shortened, the operation is simple, the labor intensity of operators is reduced, and the time that a patient waits for a result is shortened; and a disposable plastic cuvette or small bottle is used as a reaction vessel, thus reducing errors and improving degree of precision. The application range is wider, the test method and the test kit can be conveniently used in inspection departments, medical wards and basic medical institutions.

Description

technical field [0001] The present invention relates to a detection method of glycosylated hemoglobin, in particular to a method for detecting human glycosylated hemoglobin by an ion exchange resin homogeneous adsorption separation method and a detection kit for quantitative determination of glycosylated hemoglobin in human whole blood in vitro The concentration belongs to the field of medical clinical biochemical diagnostic reagents. [0002] Background technique [0003] Glycosylated hemoglobin A1 (HbA1c), hemoglobin A1 linked with hexose, is the product of non-enzymatic glycation reaction of hemoglobin under the action of hyperglycemia, usually accounting for 5-8% of total Hb. Under normal physiological conditions, the production of non-enzymatic saccharification reaction products is directly proportional to the concentration of the reactants. Since the protein concentration is relatively stable, the saccharification level is mainly determined by the blood glucose concent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/31G01N1/34
Inventor 孙希武秦英王永庆吐尔洪·买买提
Owner 潍坊泽成生物技术有限公司
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