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Biomarker for diagnosing neuromyelitis optica spectrum disorder and application thereof

A technology of neuromyelitis optica and biomarkers, applied in the field of disease diagnosis, can solve the difficulty of diagnosing NMOSD and other problems, and achieve the effect of improving clinical management, high sensitivity, and less pain

Pending Publication Date: 2022-01-11
王进洋 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the process of realizing the present invention, the inventors found that there are at least the following problems in the prior art: Although the international diagnostic criteria for NMOSD have been established, due to similar clinical symptoms and imaging manifestations, and some patients' antibodies are unknown or all Negative, so it is still difficult to achieve early diagnosis of NMOSD
Compared with the current lumbar puncture and imaging examination, blood examination is more non-invasive and convenient, and it is more conducive to regular review and treatment of patients. High, but there are still no applicable blood biomarkers for clinical application

Method used

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  • Biomarker for diagnosing neuromyelitis optica spectrum disorder and application thereof
  • Biomarker for diagnosing neuromyelitis optica spectrum disorder and application thereof
  • Biomarker for diagnosing neuromyelitis optica spectrum disorder and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] In this embodiment, a biomarker for the diagnosis of neuromyelitis optica spectrum disease is provided, the biomarker is a combination of GFAP protein, NfL protein and UCHL1 protein; wherein, the amino acid sequence of GFAP protein is as SEQ ID NO: 1. As shown in SEQ ID NO:2 or SEQ ID NO:3, the amino acid sequence of NfL protein is shown in SEQ ID NO:4, and the amino acid sequence of UCHL1 protein is shown in SEQ ID NO:5.

[0056] Preferably, the three proteins contained in the above-mentioned biomarkers can be derived from peripheral blood samples, serum samples, plasma samples, urine samples, saliva samples or tissue samples; in a more preferred embodiment, the above-mentioned biomarkers The biomarkers are derived from serum, that is, the biomarkers include sGFAP protein, sNfL protein and sUCHL1 protein.

Embodiment 2

[0058] This embodiment provides a kit for diagnosing neuromyelitis optica spectrum disorders, including detection reagents, standards and quality controls. Among them, the detection reagent is a reagent that can specifically bind to the biomarker 1 in Example 1 and can detect the expression level of the biomarker in the sample by protein immunoassay technology; the detection sample is a serum sample.

[0059] Preferably, the above-mentioned detection reagent is a reagent that can be detected by ELISA or Simoa, and in a more preferred embodiment, a reagent that can be detected by Simoa is selected. Due to the low content of the biomarkers in serum, the sensitivity of Simoa (Single-molecule Array) is more than 1000 times higher than that of ELISA, and the independent identification and calculation of single-molecule signals can be realized, especially Simoa can be used in serum / Ultra-low-abundance neural factors such as NfL, Tau, pTau, Aβ40, Aβ42 are detected in plasma, so Sim...

Embodiment 3

[0062] In this example, the sera of the disease group and the healthy control group were all from whole blood, and were stored at -80°C before use, and were taken out for analysis.

[0063] 1. Experimental materials:

[0064] A total of 71 specimens were collected, including 9 healthy control specimens from healthy adults (Heather controls, HCs), 29 aquaporin antibody-positive neuromyelitis optica spectrum disorders (AQP4-IgG+NMOSD) specimens, 13 MOGAD specimens and 20 All MS specimens were obtained from serum samples of clinically diagnosed patients. Among them, 29 AQP4-IgG+NMOSD specimens, 13 MOGAD specimens and 20 MS specimens were provided by the First Medical Center of the Chinese People's Liberation Army General Hospital.

[0065] 2. Sample preparation:

[0066] 1) Sample 10,000g, centrifuge for 5min to remove impurities;

[0067] 2) 4-fold dilution of serum samples from 71 cases.

[0068] 3. Standard product preparation:

[0069] Add the diluted standards A-H provi...

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Abstract

The invention relates to a biomarker for diagnosing neuromyelitis optica spectrum disorder and application thereof. The biomarker comprises a combination of GFAP protein, NfL protein and UCHL1 protein. The application provided by the invention comprises application of a reagent for detecting the biomarker in a sample in preparation of a diagnostic product for neuromyelitis optica spectrum disorder and a diagnostic product for the neuromyelitis optica spectrum disorder. The biomarker can be used for early diagnosis, disease development and prognosis monitoring of neuromyelitis optica spectrum disorder, has the advantages of high sensitivity and high specificity, and has important scientific research and clinical application values.

Description

technical field [0001] The invention relates to the technical field of disease diagnosis, in particular to a biomarker for diagnosis of neuromyelitis optica spectrum disease and its application. Background technique [0002] Neuromyelitis optica spectrum disorder (NMOSD) is an inflammatory demyelinating disease of the central nervous system characterized by severe relapses and frequent exacerbations, mainly involving the optic nerve and spinal cord. [0003] Multiple sclerosis (MS) is an autoimmune disease characterized by white matter inflammatory demyelinating lesions of the central nervous system. NMOSD and MS were considered to be two different phenotypes of the same disease for a long time. This situation was not broken until the discovery of anti-aquaporin 4 antibody (Aquaporin 4 antibody, AQP4-IgG) and anti-myelin glial cell glycoprotein antibody (Myelin oligodendrocyte glycoprotein antibody, MOG-IgG). Myelin oligodendrocyte glycoprotein antibody-associated disease (...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/6893G01N2800/28Y02A50/30
Inventor 李芮冰王成彬王进洋王佳楠谢伟刘佳玉
Owner 王进洋
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