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Application of combined metabolic marker for screening diabetes mellitus and kit of combined metabolic marker

A technology of markers and diabetes, which is applied in the field of kits for detecting and screening diabetic patients in the test population, and can solve the problems of rapid screening of diabetic populations and other problems

Active Publication Date: 2021-06-04
DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to solve the clinical practical problem that the rapid screening of diabetic population is difficult, and to provide a metabolite combination for the application of diabetes diagnosis. The detection method for the above-mentioned metabolite combination is as follows

Method used

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  • Application of combined metabolic marker for screening diabetes mellitus and kit of combined metabolic marker
  • Application of combined metabolic marker for screening diabetes mellitus and kit of combined metabolic marker
  • Application of combined metabolic marker for screening diabetes mellitus and kit of combined metabolic marker

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] 1. Serum Sample Collection

[0050] All volunteers included in the study signed an informed consent form before blood sample collection. A batch of serum samples were collected under the same conditions as a test set, including fasting serum samples from 65 healthy people and 221 diabetic patients (among them, 113 cases of prediabetes and 108 cases of diabetes), which were stored in a -80°C refrigerator for future testing.

[0051] 2. Analysis method

[0052] 2.1 Serum sample pretreatment:

[0053] Serum was thawed at 4°C, 50 μL of serum samples were taken and added to a 1.5 mL Eppendorf tube, and 200 μL of methanol extract containing internal standard (containing internal standard concentrations of 0.19 μg / mL hippuric acid-D5, 1.56 μg / mL glutamine-D5, 0.47μg / mL phenylalanine-D5, 0.31μg / mL choline-D4), vortex for 30s to mix evenly, and precipitate protein. The protein was removed by centrifuge filtration (14000 rpm for 15 min). After centrifugation, 200 μL of the su...

Embodiment 2

[0068] 1. Serum sample collection,

[0069] All volunteers included in the study signed an informed consent form before blood sample collection. The second batch of serum samples was collected under the same conditions as a validation set, including fasting serum samples from 31 healthy people and 117 diabetic patients (including 58 prediabetics and 59 diabetics), which were stored in a -80°C refrigerator for future testing.

[0070] 2. Analysis method

[0071] Same as Example 1

[0072]3. Serum test results and auxiliary diagnostic methods

[0073] The results of the verification set of Example 2 are consistent with the results of the test set of Example 1. The validation set results are as image 3 Shown, adopt the binary logistic regression equation P1 and P2 that test set constructs among the embodiment 1, the quantitative concentration of galactose, 1,5-sorbitol, N-acetylglucosamine, 2-hydroxybutyric acid ( μg / mL) and the concentration of fasting blood glucose (mmol / ...

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Abstract

The invention relates to a novel application of metabolites, namely galactose, 1, 5-sorbitan, N-acetyl glucosamine and 2-hydroxybutyric acid, in fasting serum as combined markers in preparation of a kit for rapidly diagnosing diabetic patients in subjects. Whether a subject suffers from diabetes mellitus or not is judged by detecting the concentrations of the four metabolites in an empty serum sample of the subject, the combined marker variable P is calculated based on a binary logistic regression equation and an intercept point value is judged, and whether the subject suffers from diabetes or not is judged. The kit can realize high-sensitivity and high-efficiency detection, and the small molecule metabolites involved in the invention have the characteristics of low detection cost and good repeatability. The kit can be applied to auxiliary rapid screening of diabetes people, has the characteristic of mutual complementation with the traditional clinical index fasting blood glucose, and has a relatively good application prospect.

Description

technical field [0001] The present invention relates to novel uses of known metabolites. The present invention relates to the combination of galactose, 1,5-sorbitol, N-acetylglucosamine and 2-hydroxybutyric acid in serum as a combined marker for diagnosing diabetes, and relates to the detection and screening of diabetes in the test population Patient kit. Background technique [0002] Diabetes is a global health problem, and its incidence is increasing year by year, but the diagnosis rate is less than 50%. Diabetic patients have various complications due to abnormal insulin function or secretion. China is the country with the largest number of diabetic patients in the world. If it cannot be intervened and treated in time, it will increase the burden on the national public health system. Currently, fasting blood glucose and the oral 75g glucose tolerance (OGTT) test are the gold standard for diagnosing diabetes. However, since the OGTT test needs to collect and test blood...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8813G01N2030/8822G01N2030/8836
Inventor 许国旺王利超赵欣捷刘心昱路鑫
Owner DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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