Serological markers for preoperative clinical diagnosis of ocular adnexal extranodal marginal zone lymphoma

Abstract

The present invention relates to a serological marker for the preoperative clinical diagnosis of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL), belonging to the field of biomedicine. The present invention provides the use of a reagent for detecting serum IgM concentration in the preparation of a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma; the use of a reagent for detecting serum IgM concentration in the preparation of a diagnostic kit for the differential diagnosis of ocular adnexal extranodal marginal zone lymphoma; and a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma. The use of the present invention can reduce the cost of preoperative clinical diagnosis of OA-EMZL and address the difficulties in differential diagnosis.

Description

Technical Field

[0001] The present invention relates to a serological marker for preoperative clinical diagnosis of ocular adnexal extranodal marginal zone lymphoma, and belongs to the technical field of biomedicine. Background Art

[0002] Currently, the diagnostic criteria for ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) are primarily based on the World Health Organization (WHO) classification of hematopoietic and lymphoid tumors. Diagnosis is based on a comprehensive assessment of parameters such as cell morphology, immunophenotype, genetics, and clinical manifestations. Imaging studies, including diffusion-weighted magnetic resonance imaging (DWI) MRI and ADC values, can be used for preoperative differential diagnosis of ocular adnexal lymphoma (OAL) from benign space-occupying lesions. However, a major drawback of existing technologies is that the diagnosis of OA-EMZL requires a comprehensive diagnosis combining histopathology, immunohistochemistry, and molecular biology, resulting in a lengthy diagnostic cycle. Existing imaging preoperative differential diagnosis methods require high instrumentation, high diagnostic costs, and long diagnostic cycles. Furthermore, their primary differential diagnosis targets OAL, making it difficult to distinguish OA-EMZL from other orbital space-occupying lesions, including other lymphoma subtypes, lymphoproliferative tissue, and chronic inflammatory diseases. Therefore, there is an urgent need to address the technical problem of how to conveniently and quickly perform preoperative diagnosis of OA-EMZL. Summary of the Invention

[0003] The purpose of the present invention is to solve the technical problem of how to conveniently and quickly perform preoperative diagnosis of OA-EMZL.

[0004] To achieve the purpose of solving the above-mentioned problem, the technical solution adopted by the present invention is to provide a reagent for detecting IgM for use in preparing a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma.

[0005] Preferably, the reagent comprises IgM monoclonal antibody.

[0006] Preferably, the sample detected in the application includes serum.

[0007] Preferably, the application includes detecting the concentration of IgM.

[0008] The present invention provides an application of a reagent for detecting serum IgM concentration in preparing a diagnostic kit for differential diagnosis of ocular adnexal extranodal marginal zone lymphoma.

[0009] The present invention provides a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma, which comprises a reagent for detecting serum IgM concentration.

[0010] The present invention provides a detection system, comprising a data processing device and a substance for detecting IgM concentration; the system comprises a data processing device, the data processing device comprising a data input module, a data recording module, a data comparison module and a conclusion output module; the data input module is configured to input a concentration value of serum IgM of a test sample; the data recording module is configured to store the concentration value and a judgment threshold of the serum IgM of the test sample; the data comparison module is configured to receive the concentration value of the serum IgM of the test sample sent by the data input module, call the judgment threshold from the data recording module and compare it with the concentration value of the serum IgM of the test sample; the conclusion output module is configured to receive a comparison result sent by the data comparison module, and judge the comparison result according to a predetermined judgment condition; and determine whether the detected person is a patient with ocular adnexal extranodal marginal zone lymphoma.

[0011] Preferably, the substance for detecting IgM concentration is a reagent and / or instrument for detecting IgM concentration.

[0012] Compared with the prior art, the present invention has the following beneficial effects:

[0013] The present invention obtains a protein IgM that is specifically expressed in the serum of patients with ocular adnexal extranodal marginal zone lymphoma, which can be used as a serological marker for the preoperative clinical diagnosis of OA-EMZL. Through the application of the present invention, the cost of preoperative clinical diagnosis of OA-EMZL can be reduced and the difficulties in differential diagnosis can be solved. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 Flowchart obtained for potential serological differential diagnostic markers of OA-EMZL tumor tissue origin;

[0015] Figure 2 Figure 2 compares the specificity and sensitivity of serum IgM concentration as a differential diagnosis for OA-EMZL patients and controls. DETAILED DESCRIPTION

[0016] In order to make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0017] like Figure 1-2 As shown; the present invention provides an application of a reagent for detecting IgM in preparing a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma.

[0018] The above reagents include IgM monoclonal antibodies.

[0019] The samples tested in the above applications include serum.

[0020] The above applications include detecting the concentration of IgM.

[0021] The present invention provides an application of a reagent for detecting serum IgM concentration in preparing a diagnostic kit for differential diagnosis of ocular adnexal extranodal marginal zone lymphoma.

[0022] The invention provides a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma, which comprises a reagent for detecting serum IgM concentration.

[0023] The present invention provides a detection system, comprising a data processing device and a substance for detecting IgM concentration; the system comprises a data processing device, the data processing device comprising a data input module, a data recording module, a data comparison module and a conclusion output module; the data input module is configured to input a concentration value of serum IgM of a test sample; the data recording module is configured to store the concentration value and a judgment threshold of the serum IgM of the test sample; the data comparison module is configured to receive the concentration value of the serum IgM of the test sample sent by the data input module, call the judgment threshold from the data recording module and compare it with the concentration value of the serum IgM of the test sample; the conclusion output module is configured to receive a comparison result sent by the data comparison module, and judge the comparison result according to a predetermined judgment condition; and determine whether the detected person is a patient with ocular adnexal extranodal marginal zone lymphoma.

[0024] The substance for detecting IgM concentration is a reagent and / or instrument for detecting IgM concentration.

[0025] Example

[0026] The present invention uses DIA LC-MS quantitative protein profiling to detect preoperative serum samples from 28 OA-EMZL patients and 30 control patients. The control group includes patients with common differential diagnosis diseases of OA-EMZL, including 10 patients with diffuse large B-cell lymphoma, 10 patients with idiopathic orbital inflammation, and 10 patients with reactive lymphoproliferation. Combined analysis with transcriptome data (such as Figure 1 Figure A), using full sample difference analysis (such as Figure 1 Figure B), paired sample protein-mRNA correlation analysis (such as Figure 1 The results of the middle C figure showed that IGHM was a potential serological differential diagnostic marker for OA-EMZL tumor tissue (e.g. Figure 1 Figure D). IGHM encodes the constant region of the IgM heavy chain. Secretory IgM in humans is mainly secreted by marginal zone B cells. IGHM is significantly overexpressed in OA-EMZL and is significantly different from other diagnoses (e.g. Figure 1 Figure E).

[0027] The above findings were confirmed by measuring serum IgM concentrations in 205 patients at presentation. These included 68 patients with OA-EMZL and 137 controls (33 with other lymphoma subtypes, 78 with chronic inflammation, and 26 with lymphoproliferative disease). Serum IgM concentrations were significantly elevated in OA-EMZL and differed significantly from each diagnosis (e.g., Figure 2 Figures A and B in the middle). In the ROC analysis, the AUC of IgM could reach 0.81 [0.75-0.88] and remained stable in different diagnoses. Restricted cubic spline analysis (RCS) showed that IgM was linearly associated with the risk of EMZL. When converted to a hierarchical variable, the optimal cut-off points were 0.88 g / L (specificity 56%, sensitivity 85.3%), 1.46 g / L (specificity 89.7%, sensitivity 55.9%) (e.g. Figure 2 Figures C and D in the middle).

[0028] The above results demonstrate that IgM is a protein that is specifically and highly expressed in OA-EMZL plasma and can be used as a serological marker for preoperative clinical diagnosis of OA-EMZL.

[0029] Experimental verification:

[0030] IgM monoclonal antibodies were used to quantitatively detect serum levels of 68 OA-EMZL patients and 137 control patients (33 with other lymphoma subtypes, 78 with chronic inflammation, and 26 with lymphoproliferation) at the time of consultation. Figure 2 Serum IgM concentration was significantly increased in OA-EMZL and significantly different from other diagnoses.

[0031] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form or substance. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the scope of protection of the present invention. Any equivalent changes, modifications and evolutions made by technicians familiar with this profession without departing from the spirit and scope of the present invention by using the technical content disclosed above are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. Use of a reagent for detecting IgM in the preparation of a diagnostic kit for ocular adnexal extranodal marginal zone lymphoma, characterized in that: The sample tested in the application is serum.

2. The use according to claim 1, characterized in that The reagent includes IgM monoclonal antibody.

3. The use according to claim 1, characterized in that The application includes detecting the concentration of IgM.

4. Use of a reagent for detecting serum IgM concentration in the preparation of a diagnostic kit for the differential diagnosis of ocular adnexal extranodal marginal zone lymphoma.

5. A detection system, characterized in that: The system comprises a data processing device and a substance for detecting serum IgM concentration; the system comprises a data processing device, the data processing device comprising a data input module, a data recording module, a data comparison module and a conclusion output module; the data input module is configured to input the concentration value of serum IgM of the test sample; the data recording module is configured to store the concentration value of serum IgM of the test sample and a judgment threshold; the data comparison module is configured to receive the concentration value of serum IgM of the test sample sent by the data input module, and call the judgment threshold from the data recording module and compare it with the concentration value of serum IgM of the test sample; The conclusion output module is configured to receive the comparison result sent by the data comparison module, and judge the comparison result according to a predetermined judgment condition; and determine whether the person being tested is a patient with ocular adnexal extranodal marginal zone lymphoma.

6. The system according to claim 5, characterized in that: The substance for detecting IgM concentration is a reagent and / or instrument for detecting IgM concentration.

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