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Biomarker combination for evaluating Alzheimer's disease and application and kit thereof

A technology of biomarkers and kits, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of no blood markers, disappointing results, no detection kits for detecting AD with blood markers, etc.

Pending Publication Date: 2022-01-11
北京豪思生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, studies have found that blood levels of Aβ42 or Aβ42 / tau in blood correlate poorly with AD clinical symptoms, and the results are disappointing
[0004] In the prior art, there are no blood markers for diagnosing AD, let alone detection kits for detecting AD using blood markers

Method used

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  • Biomarker combination for evaluating Alzheimer's disease and application and kit thereof
  • Biomarker combination for evaluating Alzheimer's disease and application and kit thereof
  • Biomarker combination for evaluating Alzheimer's disease and application and kit thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0070] S2. Preparation steps of quality control working solution and internal standard working solution:

[0071] The above-mentioned high-concentration quality control products and low-concentration quality control products can be directly used as quality control product working solutions; the mixture of the above-mentioned internal standard products can be directly used as internal standard working solutions;

[0072] S3. Sample pretreatment:

[0073] Precisely transfer 135 μL of sample extract to each well of a 96-well plate, and add 20 μL of the plasma sample to be tested, blank control, negative control, positive control, calibrator working solution, and quality control working solution to different wells , and then add 45 μL of internal standard working solution (three mixed internal standards: d4-PC-14, 2 h 3 -C-3, DHBA, that is, the above-mentioned internal standard mixed solution), sealed, mixed for 2 minutes, left at room temperature for 5 minutes, centrifuged at 4...

Embodiment 1

[0119] This embodiment is the composition and detection method of the kit of the present invention.

[0120] One, the test kit of the present embodiment comprises:

[0121] Internal standard mixed solution: d4-PC-14, the concentration is 600ng / ml (solvent: methanol / acetonitrile 9:1); 2 h 3 -C-3, the concentration is 20ng / ml (solvent: methanol / acetonitrile 9:1); DHBA, the concentration is 50μg / mL (solvent: 80% methanol water);

[0122] High-concentration calibrator mixed solution: PC-14 (DMPC), with a concentration of 30 μg / ml (solvent: methanol / acetonitrile 9:1); C-3, with a concentration of 8 μg / ml (solvent: methanol / acetonitrile 9 : 1); Ach and GABA, use concentration is 2.5 μ g / ml (solvent is: 80% methanol water); 5-HIAA and Glu, use concentration is 12.5 μ g / ml (solvent is: 80% methanol water);

[0123] Multi-concentration quality control product mixed solution: (1) low quality control product mixed solution: PC-14 (DMPC), the use concentration is 1.8μg / ml (solvent: met...

Embodiment 2

[0212] This embodiment is the composition and detection method of the kit of the present invention.

[0213] One, the test kit of the present embodiment comprises:

[0214] Internal standard: d4-PC-14, the concentration is 600ng / ml, 2 h 3 -C-3, the concentration is 20ng / ml; DHBA, the concentration is 50μg / mL;

[0215] High-concentration calibrator mixed solution: PC-14 (DMPC), used at a concentration of 30 μg / ml; C-3, used at a concentration of 8 μg / ml; Ach and GABA, used at a concentration of 2.5 μg / ml; 5-HIAA and Glu, The concentration used is 12.5μg / ml;

[0216] Multi-concentration quality control mixed solution: (1) Low quality control mixed solution: PC-14 (DMPC), the use concentration is 1.8 μg / ml; C-3, the use concentration is 0.48 μg / ml; Ach and GABA, The concentration used is 0.03 μg / ml; 5-HIAA and Glu, the concentration used is 1.8 μg / ml; (2) High-quality control product mixed solution: PC-14 (DMPC), the concentration used is 22.5 μg / ml; C-3 , the concentration ...

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Abstract

The invention provides a biomarker combination for evaluating the Alzheimer's disease of a subject, a diagnostic product containing a detection reagent of the biomarker combination and application of the diagnostic product. The biomarker combination comprises a phosphatidylcholine substance, a carnitine substance and a neurotransmitter substance, and is used for evaluating and diagnosing the Alzheimer's disease.

Description

technical field [0001] The present invention relates to the fields of biomarkers and kits using the same and detection methods, in particular to biomarker combinations for evaluating Alzheimer's disease, applications and kits thereof. Background technique [0002] The existing markers used in the clinical diagnosis of Alzheimer's disease (AD) mainly include β-amyloid protein (Aβ), total tau protein (T-tau), and phosphorylated tau protein (P-tau) in cerebrospinal fluid; structural MRI and Functional MRI imaging detection; Aβ PET imaging (using 11 C-PIB and 18 F-FDDNP as a tracer) imaging detection; presenilin 1 (PS1) gene, presenilin 2 (presenilin 2) gene located on chromosome 14, 1, and 21 in familial Alzheimer's disease (FAD) , PS2) gene, amyloid precursor protein (amyloid precursor protein, APP) gene detection of pathogenic genes. However, these methods have poor sensitivity and specificity, are more damaging to patients, take a long time, and are expensive. [0003] A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72
CPCG01N30/02G01N30/06G01N30/34G01N30/7233G01N2030/045
Inventor 肖冰心孙念栗琳贾子强邵立军高雅何启鑫丁亮周立
Owner 北京豪思生物科技股份有限公司
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