CN-122017240-A - 8-Color multi-parameter flow cytometry detection Panel and application thereof in plasma cell tumor diagnosis

Abstract

The invention discloses an 8-color multi-parameter flow cytometry detection Panel and application thereof in plasma cell tumor diagnosis, wherein the Panel comprises Tube1 and Tube2, the Tube1 consists of antibodies of CD19, CD45, kappa, lambda, CD, CD56, CD138 and CD20, and the Tube2 consists of antibodies of CD38, CD45, ki67, CD229, CD27, CD56, CD117 and CD81. According to the invention, two tubes are innovatively designed based on 8-color multi-parameter flow cytometry to detect Panel, and the clonality of B lymphocytes and plasma cells is analyzed synchronously, so that tumor cell sources can be accurately distinguished, disease subtypes can be clearly distinguished, and a powerful objective basis is provided for clinical diagnosis, prognosis evaluation and risk stratification.

Inventors

• HE CHENG
• SUN YUANLI
• ZHANG MEILAN
• JIANG LIJUN
• CHEN XING
• ZHAO LEI

Assignees

• 华中科技大学同济医学院附属同济医院

Dates

Publication Date

20260512

Application Date

20260224

Claims (8)

1. 1. An 8-color multi-parameter flow cytometry detection Panel is characterized by comprising Tube1 and Tube2, wherein the Tube1 consists of antibodies CD19, CD45, kappa, lambda, CD, CD56, CD138 and CD20, and the Tube2 consists of antibodies CD38, CD45, ki67, CD229, CD27, CD56, CD117 and CD81.
2. 2. Use of a Panel according to claim 1 for the preparation of a reagent for diagnosis of plasma cell neoplasms.
3. 3. Use of a Panel according to claim 1 for the preparation of a reagent for differentiation of plasma cell tumour subtypes.
4. 4. Use of a Panel according to claim 1 for the preparation of a reagent for prognosis evaluation of plasma cell tumors.
5. 5. Use of a Panel according to claim 1 for the preparation of a reagent for stratification of risk of plasma cell neoplasms.
6. 6. A flow cytometry kit is characterized in that the kit contains antibodies respectively marked with different luciferins, the antibodies are divided into two groups, the first group consists of antibodies CD19, CD45, kappa, lambda, CD, CD56, CD138 and CD20, the second group consists of antibodies CD38, CD45, ki67, CD229, CD27, CD56, CD117 and CD81, and each antibody in each group is respectively packaged.
7. 7. A diagnostic reagent comprising antibodies labeled with different luciferins, respectively, wherein the antibodies are divided into two groups, the first group is composed of antibodies CD19, CD45, kappa, lambda, CD, CD56, CD138 and CD20, and the second group is composed of antibodies CD38, CD45, ki67, CD229, CD27, CD56, CD117 and CD81, and each antibody in each group is packaged respectively.
8. 8. A diagnostic system comprising a detection section comprising the diagnostic reagent according to claim 7 and an analysis section for analyzing the detection result of the detection section.

Description

8-Color multi-parameter flow cytometry detection Panel and application thereof in plasma cell tumor diagnosis Technical Field The invention belongs to the technical field of biological detection, and particularly relates to an 8-color multi-parameter flow cytometry detection Panel and application thereof in plasma cell tumor diagnosis. Background Plasma cell (PLASMA CELL, PC) tumors are the second most common malignant clonal tumor in hematological tumors, with high malignancy and poor prognosis, and median age of onset is about 65-70 years. Clonal plasma cells tend to isomorphically preempt normal hematopoietic cells by producing large quantities of nonfunctional, structurally single monoclonal immunoglobulins (M proteins) leading to a range of health problems including unidentified monoclonal immunoglobulin blood (MGUS), plasmacytoma (isolated and extramedullary plasmacytoma), multiple Myeloma (MM), immunoglobulin deposition disease (primary light chain amyloidosis, light and heavy chain deposition), POEMS syndrome, and the like. Currently, diagnosis of plasma cell tumor and prognosis of disease at home and abroad are highly dependent on cell Morphology (Morphology), immunology (Immunology), cytogenetics (Cytogenetics) and molecular biology (Molecular biology). It is well known that plasma cells, also known as antibody secreting cells, are mainly differentiated and developed from B lymphocytes. The normal B lymphocyte is differentiated and developed through bone marrow hematopoietic stem cells, becomes activated B lymphocyte after being activated by corresponding antigen or polyclonal stimulant, then generates immunoglobulin gene heavy chain class conversion to gradually form plasma cell group with specific secretion antibody function, and obtains specific plasma cell antigen (CD 38, CD138, CD229, etc.). Disclosure of Invention The invention aims to provide an 8-color multi-parameter flow cytometry detection Panel and application thereof in plasma cell tumor diagnosis, and by synchronously analyzing the clonality of B lymphocytes and plasma cells, tumor cell sources can be accurately distinguished, disease subtypes can be clearly distinguished, and a powerful objective basis is provided for clinical diagnosis, prognosis evaluation and risk stratification. In order to achieve the above purpose, the present application adopts the following technical scheme: in a first aspect, the invention provides an 8-color multi-parameter flow cytometry detection Panel comprising Tube1 and Tube2, said Tube1 consisting of antibodies CD19, CD45, kappa, lambda, CD, CD56, CD138, CD20, said Tube2 consisting of antibodies CD38, CD45, ki67, CD229, CD27, CD56, CD117, CD81. In a second aspect, the invention provides the use of a Panel as described above in the preparation of a reagent for diagnosis of plasma cell neoplasms. In a third aspect, the invention provides the use of a Panel as described above in the preparation of a reagent for differentiation of plasma cell tumour subtypes. In a fourth aspect, the invention provides the use of a Panel as described above in the preparation of a reagent for prognosis evaluation of plasma cell tumors. In a fifth aspect, the invention provides the use of a Panel as described above in the preparation of a reagent for stratification of risk of plasma cell neoplasms. In a sixth aspect, the invention provides a flow cytometry kit comprising antibodies labeled with different luciferins, respectively, the antibodies being divided into two groups, the first group consisting of CD19, CD45, kappa, lambda, CD, CD56, CD138, CD20, and the second group consisting of CD38, CD45, ki67, CD229, CD27, CD56, CD117, CD81, each of the antibodies of each group being packaged separately. In a seventh aspect, the invention provides a diagnostic reagent comprising antibodies labeled with different luciferins, respectively, the antibodies being divided into two groups, the first group consisting of CD19, CD45, kappa, lambda, CD, CD56, CD138, CD20 and the second group consisting of CD38, CD45, ki67, CD229, CD27, CD56, CD117, CD81, each antibody of each group being packaged separately. In an eighth aspect, the present invention provides a diagnostic system comprising a detection section including the above diagnostic reagent and an analysis section for analyzing the detection result of the detection section. The invention has the beneficial effects that the invention innovatively designs two-tube 8-color multi-parameter flow cytometry-based Panel detection, and can accurately discriminate tumor cell sources and clearly distinguish disease subtypes by synchronously analyzing the clonality of B lymphocytes and plasma cells, thereby providing a powerful objective basis for clinical diagnosis, prognosis evaluation and risk stratification. Drawings FIG. 1 is a flow chart of the detection method of the present invention; FIG. 2 is a flow cytometric chart (Tube 1) of one embodiment of the present invention; FIG. 3 is a flow