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

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...

AI Technical Summary

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.)

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