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Reagent composition for screening and/or diagnosing clonal diseases by one-step method and application of reagent composition

A composition and reagent technology, applied in the field of blood disease detection, can solve the problems of low detection efficiency of rare tumors and precancerous lesions, heavy workload of the two-step method, and large individual differences in schemes, so as to facilitate the accumulation of data and experience, The effect of speeding up reporting time and reducing workload

Active Publication Date: 2021-09-21
信纳克(北京)生化标志物检测医学研究有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In order to solve this problem, researchers have made research explorations, including the schemes launched by the European Flow Consortium (euroflow) since 2012, but the euroflow scheme still has the following defects: 1. It is a screening based on the first step The two-step method of investigation, which leads to the very important judgment of the first step, if the personnel make a wrong judgment in the first step, it will lead to the wrong choice of antibody in the second step; 2. The first step of the two-step method is relatively simple, not It may cover all disease screening, so it is easy to miss diagnosis; 3. The two-step method has a large workload and individual differences in the scheme, which is not conducive to the automation of pre-processing, automatic sample loading and other processes, as well as the development of multi-dimensional software analysis and artificial intelligence such as flowjo; 4. The focus is on the diagnosis of common hematological tumors such as acute leukemia and lymphoma. It does not involve metastatic cancer, and the detection efficiency of rare tumors and precancerous lesions is not high; 5. Most clinical patients are diagnosed with anemia, leukopenia, three It is difficult to solve the situation where there is no clinical information, and even if other tests are done, they cannot provide effective information.
[0006] After investigation, there is no more convenient and feasible method in the prior art that can be applied to flow cytometry screening for almost all clonal diseases (including tumors, AA, pure red AA, rare normal polymorphisms, and common precancerous lesions, immunodeficiency, etc.)

Method used

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  • Reagent composition for screening and/or diagnosing clonal diseases by one-step method and application of reagent composition
  • Reagent composition for screening and/or diagnosing clonal diseases by one-step method and application of reagent composition
  • Reagent composition for screening and/or diagnosing clonal diseases by one-step method and application of reagent composition

Examples

Experimental program
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Effect test

Embodiment 1

[0094] Preparation Example 1 of the embodiment of the reagent

[0095] Antibody composition of the present embodiment is used,

[0096] The first component: the first group comprises antibodies: anti-CD7 antibody, anti-CD117 antibody, anti-CD3 antibody, anti-CD4 antibody, anti-CD5 antibody, anti-CD8 antibody, anti-CD56 antibody, anti-CD45 antibody and anti-CD2 antibodies, each antibody fluorescein labeled sequence as FITC, PE, PerCP-Cy5.5, PE-Cy7, APC, APC-Cy7, BV421, V500 and BV605; taken over nine kinds of monoclonal antibody reagent in a volume ratio 5: 5: 5: 3 : 2: 3: 3: 3: 3 ratio by volume mixing device in a first container;

[0097] The second component is: an anti-CD16 antibody, anti-CD117 antibody, anti-CD34 antibody, anti-CD13 antibody, anti-CD33 antibody, anti-HLA-DR antibody, anti-CD11b antibodies and anti-CD45 antibody, fluorescein-labeled antibody is the order of FITC, PE, PerCP-Cy5.5, PE-Cy7, APC, APC-Cy7, BV421 and V500; monoclonal antibody reagent according to the...

Embodiment 2

[0106] Example 2 Processing of the specimens embodiment

[0107] According to the results of cell counting, bone marrow or peripheral blood samples in EDTA or heparin, is added to the flow tube in tube A, was added to ensure the cell was about 2 × 10 6 A, then Table 1 was added 32μl nine different fluorescein-labeled monoclonal antibody reagent membrane to flow tube, mix well with the cell suspension was incubated for 15 minutes at room temperature in the dark, was added 3ml 1 × hemolysin avoid light red blood cells lysed for 10 min, centrifuged at 1500rpm 5 minutes the supernatant was added to 3ml PBS mixed and centrifuged at 1500rpm 5 minutes the supernatant was added to 0.5ml PBS buffer, cells were resuspended, i.e. good handling specimens, for testing on the machine.

[0108] According to the results of cell counting, bone marrow or peripheral blood samples in EDTA or heparin, is added to the flow tube in tube B, was added to ensure cell is about 2 × 10 6 A, then Table 1 was a...

Embodiment 3

[0114] Example 3 Detection of the embodiment samples

[0115] After treatment according to Example 2 good samples, detects in the United States by Becton Dickinson 10 3-color FACS Canto plus laser flow cytometer, preferably one million cells per tube acquisition (recommend at least 300,000), using diva 2.8 software or other software kaluza and other analytical data.

[0116] Wherein the flow machine is provided in the following manner when the detection gate: ① fixed gating: cell adhesion sequentially removing the door, the door living cells, blood cells door; ② gated multi-marker combinations: starts from a single living cell, for preventing missing of tumor cells, and the definition of all gated cells, blood cells need to be tied at the door condition; ③ door provided in a multi-marker combination, the common display mode and developmental expression patterns of various combinations of flags, according to the normal different cells to identify tumor cells; or there is not a norm...

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Abstract

The invention provides a reagent composition for screening and / or diagnosing clonal diseases by a one-step method and application of the reagent composition. The reagent composition comprises eight groups of antibodies and is a flow cytometry detection composition capable of being used for one-step screening and / or diagnosis of clonal diseases, a five-tube parallel scheme is used during application, the first group of antibodies and the second group of antibodies are respectively used for different tube samples, the third group of antibodies and the sixth group of antibodies are used for the same tube sample, the fourth group of antibodies and the seventh group of antibodies are used for the same tube sample, and the fifth group of antibodies and the eighth group of antibodies are used for the same tube sample. The reagent composition disclosed by the invention can be applied to flow cytometry one-step screening / diagnosis of various clonal diseases and other abnormalities, comprising acute leukemia, mature lymphocyte tumor, chronic myeloid tumor, night paroxysmal sleep hemoglobinuria, metastatic cancer, precancerous lesions, rare normal human polymorphisms, aplastic anemia, other immune cell subset abnormalities and the like.

Description

Technical field [0001] The present invention relates to a one-step screeing and / or a reagent composition and application thereof for diagnosing clonal diseases, belonging to the technical field of blood disease testing. Background technique [0002] The clonal disease herein is a disease-related disease, not limited to malignant tumors, including chronic infection, genetic abnormalities and other factors such as night paroxysmal sleep hemoglobinuria. (Paroxysmal NOCTURNAL HEMOGLOBINURIA, PNH), Aplastic Anemia, AA), Pure Red AA, rare normal human polymorphism, and common cancer pre-cancer, immunodeficiency, etc. Malignant tumors have always been one of the important diseases affecting human health, all kinds of acute leukemia, al), lymphoma, metastatic cancer, chronic myeloid tumors, PNH, etc., the incidence of cloned diseases, total morbidity More than one, and with the extension of the total life of the population, the population aging, the incidence of these tumors presents a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/58G01N33/574G01N33/68G01N15/14
CPCG01N33/577G01N33/582G01N33/57492G01N33/57496G01N33/6893G01N15/14G01N2800/24G01N2800/34G01N2800/60G01N2800/22G01N15/1459G01N2015/1006G01N2015/1488G01N2015/1402G01N15/1429G01N2333/70596G01N33/56966G01N33/57426C07K16/2803C07K16/2887C07K16/289C07K16/2896
Inventor 王卉陈曼王爱先宫美维吴雪英甄军毅杜晴郭亚
Owner 信纳克(北京)生化标志物检测医学研究有限责任公司
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