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Combined reagent for detecting acute myelocytic leukemia cells and system thereof

A leukemia cell, acute myeloid technology, applied in the field of combined reagents and systems for detecting acute myeloid leukemia cells, can solve the problems of no uniform standard, easy missed diagnosis, low sensitivity, etc., and achieves wide coverage, rapid detection, and reduced professionalism The effect of knowledge level requirements

Active Publication Date: 2019-04-19
GUANGZHOU KINGMED DIAGNOSTICS CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Based on this, it is necessary to provide a combined reagent and system for detecting acute myeloid leukemia cells in view of the problems of low sensitivity, no uniform standard, and easy missed diagnosis in the existing detection methods. Rapid and highly sensitive detection of AML-MRD by multiparameter flow cytometry

Method used

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  • Combined reagent for detecting acute myelocytic leukemia cells and system thereof
  • Combined reagent for detecting acute myelocytic leukemia cells and system thereof
  • Combined reagent for detecting acute myelocytic leukemia cells and system thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] A combined reagent for detecting acute myeloid leukemia cells, specifically as follows:

[0082] Combination 1: CD38 / CD13 / CD34 / CD117 / CD33 / CD19 / HLA-DR / CD45;

[0083] Combination 2: CD38 / CD64 / CD34 / CD123 / CD56 / CD14 / HLA-DR / CD45;

[0084] Combination 3: CD38 / CD7 / CD34 / CD5 / CD11b / CD15 / CD45.

[0085] The fluorescent labels and dosages of relevant monoclonal antibodies in the above combinations are shown in the table below.

[0086] Table 2. The dosage of each monoclonal antibody

[0087]

[0088] Note: The concentration gradient of the commercially available antibodies was verified to determine the optimal dosage, so the above-mentioned monoclonal antibodies were loaded into flow tubes numbered 1, 2, and 3, respectively.

Embodiment 2

[0090] A system for detecting acute myeloid leukemia cells, comprising: a detection module, a data acquisition module and a data analysis module.

[0091] The detection module performs flow cytometry detection on the cells to be tested;

[0092] The data acquisition module acquires the flow cytometry detection result data of the cells to be tested stained with the combined reagent described in Example 1;

[0093] The data analysis module analyzes the above acquired data, and determines whether the cells to be tested are tumor cells according to predetermined criteria.

[0094] The specific workflow of using the above system is as follows:

[0095] 1. Prepare reagents.

[0096] The combination reagents described in Example 1 were prepared.

[0097] 2. Sample processing.

[0098] The sample source of the cells to be tested can be bone marrow, peripheral blood, pleural effusion, ascites, etc., and the concentration is adjusted to 1×10 according to the number of cells. 6 -5×1...

Embodiment 3

[0125] The system for detecting acute myeloid leukemia cells in Example 2 was used to detect minimal residues of acute myeloid leukemia, and 40 daily samples were randomly selected for detection. Compared with the gold standard of bone marrow smear morphology detection, there were 0 cases of false positive results , 0 cases of false negatives, confirming that the above system can detect AML-MRD comprehensively, quickly and with high sensitivity through multi-parameter flow cytometry analysis.

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Abstract

The invention relates to a combined reagent for detecting acute myelocytic leukemia cells and a system thereof, wherein the combined reagent and the system thereof belong to the field of medical technology. The combined reagent comprises at least one selected from the following antibody combinations: a first antibody combination which comprises CD38, CD13, CD34, CD117, CD33, CD19, HLA-DR and CD45antibodies; a second antibody combination which comprises CD38, CD64, CD34, CD123, CD56, CD14, HLA-DR and CD45 antibodies; and a third antibody combination which comprises CD38, CD7, CD34, CD5, CD11b,CD15 and CD45 antibodies. The antibody combinations of the invention cover the expression marks of three systems of granulocyte, single cell and lymphocyte. A normal antibody expression mode is established. Tumor cells can be identified maximally. Furthermore, through a large number of experiment data, the antibodies in each combination have no problem of mutual expression inhibition. FurthermoreAML-MRD can be comprehensively and quickly detected with high sensitivity through multi-parameter flow type cell analysis.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to a combined reagent and system for detecting acute myeloid leukemia cells. Background technique [0002] Acute myeloid leukemia (AML) is a malignant disease of myeloid hematopoietic stem / progenitor cells. It is mainly characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. The clinical manifestations are anemia, hemorrhage, infection and fever, visceral infiltration, and metabolic abnormalities. Most cases are acute and severe, and the prognosis is dangerous. If not treated in time Often life-threatening. The presence of minimal residual disease (MRD) is a high risk factor for relapse in patients undergoing chemotherapy induction and / or bone marrow reconstitution. Clinically, according to the level of MRD, it is necessary to adjust the treatment plan and adjust the dosage to achieve the purpose of cure. Therefore, wh...

Claims

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Application Information

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IPC IPC(8): G01N33/574G01N33/577G01N33/533
CPCG01N33/533G01N33/57426G01N33/577
Inventor 潘建华张静文何凯琴郑倩李明敏郭鸣琪
Owner GUANGZHOU KINGMED DIAGNOSTICS CENT
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