Reagent composition and application thereof for one-step screening and/or diagnosis of clonal diseases

Abstract

The invention provides a reagent composition for one-step screening and / or diagnosis of clonal diseases and its application. The reagent composition includes eight groups of antibodies, which are compositions for flow cytometry detection that can be used for one-step screening and / or diagnosis of clonal diseases. When applied, a 5-tube parallel scheme is used, wherein the first group of antibodies, The second set of antibodies were used for different tube samples, the third set of antibodies and the sixth set of antibodies were used for the same tube samples, the fourth set of antibodies and the seventh set of antibodies were used for the same tube samples, the fifth set of antibodies and the eighth set of antibodies for samples in the same tube. The reagent composition of the present invention can be applied to one-step flow cytometry screening / diagnosis of various clonal diseases and other abnormalities, including: acute leukemia, mature lymphocytic tumor, chronic myeloid tumor, nocturnal paroxysmal nocturnal hemoglobin Urine, metastatic cancer, precancerous lesions, rare normal polymorphisms, aplastic anemia, abnormalities in other immune cell subsets, etc.

Description

technical field [0001] The invention relates to a reagent composition for one-step screening and / or diagnosis of clonal diseases and its application, belonging to the technical field of blood disease detection. Background technique [0002] The clonal disease here generally refers to a type of cell abnormality-related diseases, not limited to malignant tumors, but also includes a certain type of consistent cell proliferation caused by factors such as chronic infection and genetic abnormalities, such as nocturnal paroxysmal nocturnal hemoglobinuria (Paroxysmal Nocturnal Hemoglobinuria, PNH), aplastic anemia (AA), pure red AA, rare normal polymorphisms, common precancerous lesions, immune deficiency, etc. Malignant tumors have always been one of the important diseases that affect human health. The total incidence of malignant tumor clonal diseases such as acute leukemia (AL), lymphoma, metastatic cancer, chronic myeloid tumors, and PNH has reached 1 in 1,000 More than one, an...

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.)

Images