WO2015157976A1 - 细胞分析方法和系统、装置 - Google Patents

细胞分析方法和系统、装置 Download PDF

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WO2015157976A1
WO2015157976A1 PCT/CN2014/075627 CN2014075627W WO2015157976A1 WO 2015157976 A1 WO2015157976 A1 WO 2015157976A1 CN 2014075627 W CN2014075627 W CN 2014075627W WO 2015157976 A1 WO2015157976 A1 WO 2015157976A1
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Prior art keywords
sample
cell
flow cytometer
analyzer
item
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PCT/CN2014/075627
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English (en)
French (fr)
Inventor
郭文恒
霍子凌
钱程
李为公
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深圳迈瑞生物医疗电子股份有限公司
北京深迈瑞医疗电子技术研究院有限公司
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Application filed by 深圳迈瑞生物医疗电子股份有限公司, 北京深迈瑞医疗电子技术研究院有限公司 filed Critical 深圳迈瑞生物医疗电子股份有限公司
Priority to CN201480074677.8A priority Critical patent/CN105980852B/zh
Priority to PCT/CN2014/075627 priority patent/WO2015157976A1/zh
Publication of WO2015157976A1 publication Critical patent/WO2015157976A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N15/14—Optical investigation techniques, e.g. flow cytometry
    • G01N15/1456—Optical investigation techniques, e.g. flow cytometry without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals
    • G01N15/1459—Optical investigation techniques, e.g. flow cytometry without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals the analysis being performed on a sample stream
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N2015/1006—Investigating individual particles for cytology

Definitions

  • the present application relates to the field of cell analysis, and in particular to a cell analysis method, system and device.
  • the cell analyzer includes a three-class cell analyzer and a five-class cell analyzer.
  • the five-class cell analyzer uses flow cytometry to identify the five classifications of white blood cells in a blood sample, usually including only DIFF channels for collecting scattered light.
  • cell analysis is increasingly focusing on the analysis of abnormal samples, such as immature granulocytes (IG), atypical lymphocytes (Atypical Lymphocyte, blasts, etc., in order to enable the identification of the above abnormal cells, a fluorescent channel is added to the five-class cell analyzer, and abnormal cells are identified by laser scattering combined with fluorescence staining multidimensional analysis technology. Therefore, currently advanced blood cell analyzers typically include a DIFF channel and a fluorescent channel.
  • the blood test is usually performed by a cell analyzer in the clinic, and when an abnormal sample is found, the abnormal sample is microscopically examined.
  • preparations for microscopy such as push-staining, can be done by automatic equipment, but because quite a lot of samples still need to be confirmed by microscopy, especially large-scale hospitals have more samples of microscopic examinations, which greatly consumes the hospital. Labor costs.
  • Flow cytometry also uses flow particle detection technology to perform immunoassay on cells.
  • the use of flow cytometry for immunoassay mainly includes lymphocyte subsets, bone marrow cells and tumor cells.
  • the working principle is at the cellular level. Multi-parameter, rapid quantitative analysis of individual cells or other biological particles by specific recognition of cellular antigens by fluorescein-labeled monoclonal antibodies.
  • the flow cytometer also includes multiple fluorescent channels. Some flow cytometers even include more than ten detection channels, so multiple parameters can be measured from one cell at the same time, and tens of thousands of cells can be analyzed at high speed. Fast, high precision and good accuracy are one of the most advanced cell quantitative analysis techniques in the world.
  • flow cytometry is an analysis of cells by antigen-antibody-specific binding reaction
  • the accuracy of analysis is greatly improved compared with the traditional blood cell analyzer, but currently, flow cytometry is not used clinically for blood routine.
  • the reason for the test is that the cost of the monoclonal antibody reagent used in the antigen-antibody-specific binding reaction by the flow cytometer is relatively high, and the sample preparation process is complicated, which results in the analysis cost of the flow cytometer is much higher than that of the blood cell analyzer. .
  • an embodiment provides a cell analysis system comprising:
  • a first transport device is connected to the cell analyzer and the flow cytometer for transferring the sample to be analyzed from the cell analyzer to the flow cytometer.
  • the cell analysis system further includes a sample distribution module for acquiring a detection item of the analyzed sample, and controlling transmission of the analyzed sample according to the detection item.
  • an embodiment provides a cell analysis method using the above cell analysis system, comprising:
  • the sample to be analyzed is tested using a cell analyzer
  • the detection item of the flow cytometer is determined according to the abnormal item
  • the flow cytometer detects the sample to be analyzed according to the determined test items.
  • an embodiment provides a cell analysis method using the above cell analysis system, comprising:
  • the detection item information is notified to a cell analyzer or a flow cytometer that executes the corresponding detection item.
  • an embodiment provides a method of cell analysis, comprising:
  • the detection item of the flow cytometer is determined according to the abnormal item
  • the first transport device is controlled to transmit the analyzed sample to the flow cytometer.
  • an embodiment provides a cell analysis device, comprising:
  • a transfer control unit for controlling a sample to be analyzed according to a test item to a cell analyzer or a flow cytometer that performs a corresponding test item
  • a communication unit for notifying a detection item information to a cell analyzer or a flow cytometer that executes a corresponding detection item.
  • an embodiment provides a cell analysis device, comprising:
  • a result obtaining unit for obtaining a blood routine test result of the analyzed sample by the cell analyzer
  • a re-inspection determining unit for determining a detection item of the flow cytometer according to the abnormal item when the result is abnormal
  • a communication unit for notifying a flow cytometry detection item to a flow cytometer
  • a transfer control unit for controlling the first transport device to deliver the analyzed sample to the flow cytometer.
  • an embodiment provides a cell analysis system comprising:
  • analyzers are analyzers other than cell analyzers and flow cytometers;
  • a second transfer device is connected to the cell analyzer and other analyzers for transferring the analyzed sample from the cell analyzer to the other analyzer.
  • FIG. 1 is a schematic structural view of a cell analysis system in an embodiment of the present application.
  • FIG. 2 is a flow chart of analyzing blood samples in an embodiment of the present application.
  • FIG. 3 is a control flow chart during analysis of a blood sample in an embodiment of the present application.
  • FIG. 4 is a schematic structural view of a cell analysis system in the first embodiment of the present application.
  • FIG. 5 is a schematic structural view of another cell analysis system in the first embodiment of the present application.
  • FIG. 6 is a schematic structural view of a cell analysis system in the second embodiment of the present application.
  • Figure 7 is a schematic view showing the structure of a cell analysis system in the third embodiment of the present application.
  • the cell analysis system 10 includes a cell analyzer 11, a flow cytometer 12, and a sample distribution module 14.
  • the cell analyzer 11 may be a three-class cell analyzer or a five-class cell analyzer. In this embodiment, a five-class cell analyzer is taken as an example.
  • the cell analyzer 11 has a sample processing function, including sample suction and dilution. Etc., after the sample is processed, the cell five-class test is automatically performed.
  • the flow cytometer 12 has a sample processing function, including sample suction, adding fluorescein-labeled antibody, mixing, incubating, hemolysis, washing, fixing, etc., and the flow test is automatically performed after the sample is processed.
  • the first analyzer 13 is used to communicate between the cell analyzer 11 and the flow cytometer 12 through a first transport device 13 for transferring the sample to be analyzed from the cell analyzer to the flow cytometer.
  • the first transport device 13 can be, for example, Track device.
  • the sample distribution module 14 is communicatively coupled to the information system 20 of the laboratory for information exchange, and the information system 20 records the information of the detected organism and the inspection item.
  • the analysis process of the blood sample in this embodiment is as shown in FIG. 2, and includes the following steps:
  • step 100 a blood sample is subjected to a blood routine test using a cell analyzer.
  • step 110 if an abnormality is found in the blood routine test, the detection item of the flow cytometer is determined according to the abnormal item of the blood routine test.
  • Step 120 controlling the first transmission device to deliver the blood sample to the flow cytometer.
  • step 130 the flow cytometer detects the blood sample according to the determined test item.
  • step 140 it is determined whether a microscopic examination is performed according to the detection result of the flow cytometer.
  • the cells are further refined and abnormally confirmed by flow cytometry. If the type of abnormality can be determined, no microscopic examination is required, and if the type of abnormality cannot be determined, a microscopic examination is performed.
  • the sample distribution module 14 performs the acquisition of information and the flow of the blood sample to be tested, and the sample distribution module 14 is respectively connected to the cell analyzer 11 and the flow cytometer 12 by wire or wireless communication, and the cell analyzer. Information interaction between the 11 and the flow cytometer 12.
  • the control flow of the sample distribution module 14 is as shown in FIG. 3, and includes the following steps:
  • the sample allocation module 14 acquires the detected items of the analyzed sample.
  • the sample allocation module 14 obtains the detection item corresponding to the analyzed sample from the information system 20 according to the barcode information by reading the barcode information.
  • step 210 the detection item information is notified to the analyzer that executes the corresponding detection item.
  • the sample distribution module 14 notifies the cell analyzer of the test item information.
  • a sample is provided.
  • the sample to be analyzed is first placed in the aspiration position of the cell analyzer, and the cell analyzer is used to perform aspirating, sample processing, and detection, and the cell analyzer Automatic detection and analysis can be performed according to the test items, and the test results can be output.
  • the sample distribution module 14 controls the first transmission device 13 to transmit the analyzed sample to the analyzer that performs the corresponding detection item based on the detection item.
  • step 230 after the cell analyzer is detected, the test result of the analyzed sample by the cell analyzer is obtained.
  • Step 240 Perform separate processing according to the test result. If the result is normal, execute step 250 to end the test of the sample. If the result is abnormal, perform step 260.
  • Step 260 determining a detection item of the flow cytometer according to the abnormal item.
  • the detection item that needs to be analyzed by the flow cytometer corresponding to the abnormal item is set in advance, and is stored in the sample distribution module 14 in the form of an abnormal item and a flow detection item correspondence table, for example.
  • the detection items of the flow cytometer can be determined according to the abnormal items in the test results.
  • step 270 the flow cytometer is notified to the flow cytometer.
  • Step 280 controlling the first transmission device to transmit the analyzed sample to the flow cytometer.
  • the transfer of the sample from the blood cell analyzer to the flow cytometer is done automatically by a track device or other similar device; the flow cytometer can perform sample preparation functions such as staining, hemolysis, washing, etc., and then detect and analyze the blood sample. , output test results.
  • the blood cell analyzer and the flow cytometer are connected together by a track device or the like, and a sample is selectively performed according to a preset rule when the blood cell analyzer outputs an abnormal alarm.
  • the specific reagent combination for flow detection is determined by the abnormal sample alarm type or the sample distribution module.
  • the abnormal cells of the output detected by the blood cell analyzer can be further refined.
  • the confirmed sample can be not subjected to microscopic examination. On the one hand, the number of microscopic examinations is reduced, and manpower is saved.
  • the flow cytometer only rechecks a small number of abnormal samples, which not only saves the inspection cost, but also saves the inspection cost. Guarantee the accuracy and reliability of the test results.
  • the sample distribution module 14 acquires the detection items of the analyzed sample including a blood routine item requiring a cell analyzer test and a lymph immune clustering item requiring a flow cytometry test.
  • the control is first performed by a cell analyzer for blood routine examination. After the routine blood test is performed, the sample is delivered to the flow cytometer through the orbital device or other similar device, regardless of the blood routine test result, by flow cytometry.
  • the analyzer completes the preparation and testing of blood samples.
  • the tests performed by the flow cytometer at this time include the test items determined according to the abnormal items in the blood routine test and the lymphatic immune cluster items determined by the doctor. Similarly, if the doctor decides in advance that a sample does not perform a blood routine test and only performs flow detection, then in step 200, the sample distribution module 14 acquires the test item of the analyzed sample including only the immune item requiring flow cytometry test.
  • the sample to be tested is directly transferred to a flow cytometer through a orbital device or the like for preparation and detection of the flow sample.
  • the cell analysis apparatus of the present embodiment includes a sample distribution module 14, which has a structure as shown in FIG. 4, and specifically includes: an information acquisition unit 141, a transmission control unit 142, and a communication unit 143, and an information acquisition unit 141 and information.
  • the system 20 is communicatively coupled for acquiring a detected item of the analyzed sample; the transfer control unit 142 is coupled to the first transmitting means 13 for controlling the first transmitting means 13 to transfer the analyzed sample to the cell performing the corresponding detected item according to the detected item.
  • the analyzer or the flow cytometer; the communication unit 143 is communicably connected to the cell analyzer and the flow cytometer, respectively, for notifying the detection item information to the cell analyzer or the flow cytometer that executes the corresponding detection item.
  • FIG. 5 Another structure is shown in FIG. 5, and specifically includes: a result obtaining unit 144, a re-inspection determining unit 145, a transfer control unit 146, and a communication unit 147, and the result obtaining unit 144 is configured to acquire the blood of the analyzed sample by the cell analyzer 11. a routine test result; the re-inspection determining unit 145 is configured to determine a detection item of the flow cytometer according to the abnormal item when the result is abnormal; the communication unit 147 is configured to notify the flow cytometer 11 of the detection item of the flow cytometer; and the transmission control unit 146 is used to control the first transport device 13 to deliver the analyzed sample to the flow cytometer.
  • the sample distribution module 14 can be a discrete component or device, implemented by a hardware design or a computer executable program, or integrated into any analyzer, such as a cell analyzer, through a cell analyzer.
  • the external communication interface interacts with the flow cytometer and the information system, and the external communication interface can be a wired interface or a wireless communication module.
  • the work efficiency can be greatly improved, and the workflow efficiency is improved, and the flow detection is selectively performed, thereby reducing the cost of the flow detection application, and also promoting the doctor to actively carry out the flow cell clinical project and improve the flow cell.
  • the further popularization of the analysis in clinical applications helps to quickly and accurately diagnose the disease.
  • the abnormal information prompted by the blood cell analyzer is often highly correlated with the immunologically defined cells.
  • the abnormal blood is further classified and confirmed by the cellular immunology, thereby avoiding the loss of clinically relevant information at the first time.
  • the lymphocyte subset analysis project may be, for example, analysis of a subset of T lymphocytes, a subset of B lymphocytes, and a subset of NK cells, and the T lymphocyte subset may further assist/inducing a subset of T lymphocytes (CD3+CD4+). And suppression/cytotoxic T lymphocyte (CD3+CD8+) subpopulation analysis.
  • the target sample is an anticoagulant sample sampled by a vacuum blood collection tube.
  • the barcode item information outside the anticoagulant sample tube can be used to obtain the detection item of the sample in the information system. According to these detection items, the sample distribution module can perform sample distribution.
  • the sample allocation unit distributes the sample to a blood cell analyzer for detection, and outputs similar scatter plot information and other test results.
  • atypical lymphocytes Atypical Lymphocyte and immature granulocyte (IG) abnormalities
  • studies have shown that if atypical lymphocytes occur (Atypical Lymphocyte), then the corresponding immunological cells in this area are classified as activated B lymphocytes or plasma cells. These cells bear the immune function of the human body fluid system and have important clinical significance.
  • This cell population can be further identified by flow cytometry. In flow-through applications, this part of the cell can be confirmed by a CD19-positive and high-SSC-signaling cell population on the scatter plot, and its accuracy will be further improved by confirming whether the cell population is positive for cyIgM and CD138. .
  • the proportion of activated B lymphocytes or plasma cells can be obtained by flow analysis, and the abnormal lymphocyte alarm can be confirmed, and no microscopic examination is needed.
  • Immature granulocytes can be further confirmed as expressed by CD45, CD16 and CD11b.
  • granulocytes can be identified by scatter plots of CD45/SSC, and neutrophils can be further identified by CD16/CD45 scatter plots,
  • IG Stage1 stage cells can be confirmed by CD16-CD11b-,
  • IG Stage2 stage cells can be confirmed by CD16-CD11b+, and mature granulocytes can pass CD16+ CD11b+ confirmation.
  • cell refinement can be performed specifically without further microscopy.
  • atypical lymphocytes appear (Atypical Lymphocyte) alarm, delivered to the flow analyzer, and accurately confirmed by CD19, cyIgM, CD138.
  • IG immature granulocyte
  • TdT-FITC/CD34-PE/CD45-PerCP If a raw cell (Blast) alarm occurs, use the combination TdT-FITC/CD34-PE/CD45-PerCP first. Screening, if CD34 positive, TdT negative, it is likely to be myeloid primordial cells; if CD34 positive, TdT positive +, it is likely to be lymphoid primordial cells, at this time, continue CD3-FITC/CD19-PE/ CD45-PerCP detection, if CD3 is positive, it is T-line original cells, and if CD19 is positive, it is B-line original cells.
  • lymphocyte Ly% or Ly# is above a certain threshold, the sample is sent to a cell analyzer for lymphatic analysis, including lymphoid leukemia testing.
  • a sample with monocyte Mo% or Mo# above a certain threshold is present, it is sent to a cell analyzer for analysis of a single-nuclear system, including a single-core leukemia test.
  • the flow is performed for myeloid analysis, including myeloid leukemia testing.
  • the cell analysis system includes a cell analyzer 31, a flow cytometer 32, and at least one other analyzer 33.
  • Other analyzers are analytical instruments other than cell analyzers and flow cytometers, such as saccharification analyzers, immunoluminescent analyzers, and the like.
  • the flow cytometer 32 is connected to the cell analyzer 31 via a first transfer device 34
  • the other analyzer 33 is connected to the cell analyzer 31 via a second transfer device 35
  • the second transfer device 35 is used to analyze the sample. It is transferred from the cell analyzer 31 to the other analyzer 33.
  • the other analyzer 33 may be an analyzer or a plurality of analyzers.
  • the design of the second transmission device 35 between the other analyzers 33 and the cell analyzer 31 may be a series connection. , that is, from the cell analyzer 31 to the first other analyzer, and then from the first other analyzer to the second other analyzer, and so on; or in parallel, that is, from the cell analyzer 31 Go to each other analyzer separately.
  • the flow cytometer 32 and the cell analyzer 31 are connected by a first transfer device 34, and the other analyzer 33 is connected to the flow cytometer 32 by a third transfer.
  • the device 36 is in communication and the third transfer device 36 is used to transfer the analyzed sample from the flow cytometer 32 to the other analyzer 33.
  • the analyzers for inspecting different items are connected by the transmission device.
  • a plurality of inspection items can be performed by extracting only one analysis sample, thereby reducing the influence on the subject.

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Abstract

一种细胞分析方法、系统和装置，在对血液样本进行细胞分析吋，先采用细胞分析仪（11）对被分析样本进行检验，如果检验结果发现异常，则根据异常项目确定流式细胞仪的检测项目，将被分析样本传送到流式细胞仪（12），再采用流式细胞仪按照确定的检测项目对被分析样本进行检测。本申请由于只对细胞分析仪检验异常的样本才进行选择性的流式检测，降低了流式检测应用的成本，并且节约了镜检的人工成本。

Description

细胞分析方法和系统、装置 技术领域
本申请涉及细胞分析领域，具体涉及一种细胞分析方法、系统和装置。
 背景技术
细胞分析仪包括三分类细胞分析仪和五分类细胞分析仪。五分类细胞分析仪采用流式检测法识别血样中的白细胞五分类，通常只包括用于收集散射光的DIFF通道。目前细胞分析越来越注重异常样本的分析，比如未成熟粒细胞（IG）、异型淋巴细胞（Atypical Lymphocyte）、原始细胞（blasts）等，为了能够进行上述异常细胞的识别，五分类细胞分析仪上增加了一个荧光通道，通过激光散射结合荧光染色多维分析技术来识别异常细胞。因此，目前比较先进的血液细胞分析仪通常包括DIFF通道和一个荧光通道。
目前，临床上通常使用细胞分析仪进行血常规检验，当发现异常样本后，再对异常样本进行镜检。其中镜检的准备工作，比如推片染色等虽然可以由自动设备完成，但由于相当多的样本还是需要进行镜检确认，特别是大型医院机构镜检样本比较多，这极大地消耗了医院的人力成本。
流式细胞仪也是采用流式粒子检测技术对细胞进行免疫分析，目前临床中运用流式细胞仪进行免疫分析主要包括淋巴亚群、骨髓细胞和肿瘤细胞检测，其工作原理是在细胞分子水平上通过荧光素标记的单克隆抗体特异性识别细胞抗原，从而对单个细胞或其他生物粒子进行多参数、快速的定量分析。流式细胞仪除了DIFF通道还包括多个荧光通道，有些流式细胞仪甚至包括十多个检测通道，因此能同时从一个细胞中测得多个参数，可以高速分析上万个细胞，具有速度快、精度高、准确性好的优点，是当代最先进的细胞定量分析技术之一。
由于流式细胞仪是通过抗原抗体特异性结合反应对细胞进行分析测定，相对传统的血液细胞分析仪，其分析准确性大为提高，但目前临床上并未使用流式细胞仪来进行血常规检验，原因是流式细胞仪在抗原抗体特异性结合反应中所使用的单克隆抗体试剂的成本比较高，并且样本制备过程复杂，这导致流式细胞仪的分析成本远高于血液细胞分析仪。
 发明内容
依据本申请的第一方面，一种实施方式提供细胞分析系统，包括：
细胞分析仪；
流式细胞仪；
连通细胞分析仪和流式细胞仪的第一传输装置，所述第一传输装置用于将被分析样本从细胞分析仪传送到流式细胞仪。
具体实施例中，细胞分析系统还包括样本分配模块，用于获取被分析样本的检测项目，根据检测项目控制被分析样本的传送。
依据本申请的第二方面，一种实施方式提供一种采用上述细胞分析系统的细胞分析方法，包括：
采用细胞分析仪对被分析样本进行检验；
如果检验结果发现异常，则根据异常项目确定流式细胞仪的检测项目；
控制第一传输装置将被分析样本传送到流式细胞仪；
流式细胞仪按照确定的检测项目对被分析样本进行检测。
依据本申请的第三方面，一种实施方式提供一种采用上述细胞分析系统的细胞分析方法，包括：
获取被分析样本的检测项目；
根据检测项目将被分析样本传送到执行对应检测项目的细胞分析仪或流式细胞仪；
将检测项目信息通知执行对应检测项目的细胞分析仪或流式细胞仪。
依据本申请的第四方面，一种实施方式提供一种细胞分析方法，包括：
获取细胞分析仪对被分析样本的检验结果；
如果结果异常，则根据异常项目确定流式细胞仪的检测项目；
将流式细胞仪的检测项目通知流式细胞仪；
控制第一传输装置将被分析样本传送到流式细胞仪。
依据本申请的第五方面，一种实施方式提供一种细胞分析装置，包括：
用于获取被分析样本的检测项目的信息获取单元；
用于根据检测项目控制被分析样本传送到执行对应检测项目的细胞分析仪或流式细胞仪的传送控制单元；
用于将检测项目信息通知执行对应检测项目的细胞分析仪或流式细胞仪的通信单元。
依据本申请的第六方面，一种实施方式提供一种细胞分析装置，包括：
用于获取细胞分析仪对被分析样本的血常规检验结果的结果获取单元；
用于当结果异常，根据异常项目确定流式细胞仪的检测项目的再检确定单元；
用于将流式细胞仪的检测项目通知流式细胞仪的通信单元；
用于控制第一传输装置将被分析样本传送到流式细胞仪的传送控制单元。
依据本申请的第七方面，一种实施方式提供一种细胞分析系统，包括：
细胞分析仪；
其它分析仪，所述其它分析仪为除细胞分析仪和流式细胞仪以外的分析仪；
连通细胞分析仪和其它分析仪的第二传输装置，所述第二传输装置用于将被分析样本从细胞分析仪传送到其它分析仪。
附图说明
图1是本申请一种实施例中细胞分析系统的结构示意图；
图2是本申请一种实施例中对血液样本的分析流程图；
图3是本申请一种实施例中对血液样本分析过程中的控制流程图；
图4是本申请实施例一中一种细胞分析系统的结构示意图；
图5是本申请实施例一中另一种细胞分析系统的结构示意图；
图6是本申请实施例二中细胞分析系统的结构示意图；
图7是本申请实施例三中细胞分析系统的结构示意图。
具体实施方式
实施例1：
请参考图1，细胞分析系统10包括细胞分析仪11、流式细胞仪12和样本分配模块14。细胞分析仪11可以是三分类细胞分析仪，也可以是五分类细胞分析仪，本实施例中以五分类细胞分析仪为例进行说明，细胞分析仪11具备样本处理功能，包括样本吸取和稀释等，样本处理完毕后自动进行细胞五分类测试。流式细胞仪12具备样本处理功能，包括样本吸取，加入荧光素标记抗体、混匀、孵育、溶血、洗涤、固定等，样本处理完毕后自动进行流式测试。细胞分析仪11和流式细胞仪12之间通过第一传输装置13连通，第一传输装置13用于将被分析样本从细胞分析仪传送到流式细胞仪，第一传输装置13例如可以是轨道装置。样本分配模块14与实验室的信息系统20通信连接，进行信息交互，信息系统20记录有被检测生物体的信息和检验项目。
以血液为例，本实施例对血液样本的分析过程如图2所示，包括以下步骤：
步骤100，采用细胞分析仪对血液样本进行血常规检验。
步骤110，如果血常规检验发现异常，则根据血常规检验的异常项目确定流式细胞仪的检测项目。
步骤120，控制第一传输装置将血液样本传送到流式细胞仪。
步骤130，流式细胞仪按照确定的检测项目对血液样本进行检测。
步骤140，根据流式细胞仪的检测结果确定是否进行镜检。通过流式细胞仪的检测对细胞进行进一步细化和异常确认，如果能够确定异常类型，则不需要进行镜检，如果仍不能确定异常类型，再进行镜检。
在检验过程中，通过样本分配模块14进行信息的获取和被测血样的流转，样本分配模块14分别与细胞分析仪11和流式细胞仪12通过有线或无线的方式通信连接，与细胞分析仪11和流式细胞仪12之间进行信息交互。以血常规检验为例，样本分配模块14的控制流程如图3所示，包括以下步骤：
步骤200，样本分配模块14获取被分析样本的检测项目。一种具体实例中，样本分配模块14通过读取条码信息，根据条码信息从信息系统20中获取对应被分析样本的检测项目。
步骤210，将检测项目信息通知执行对应检测项目的分析仪。当检测项目为血常规检验项目时，样本分配模块14将检测项目信息通知细胞分析仪。
步骤220，提供样本。在一种优选的实施例中，当检测项目需要细胞分析仪检测时，首先将被分析样本放入细胞分析仪的吸样位，由细胞分析仪执行吸样、样本处理和检测，细胞分析仪可根据检测项目进行自动检测和分析，并输出检验结果。在另外的实施例中，样本分配模块14根据检测项目控制第一传输装置13将被分析样本传送到执行对应检测项目的分析仪。
步骤230，待细胞分析仪检测完毕，获取细胞分析仪对被分析样本的检验结果。
步骤240，根据检验结果进行分别处理，如果结果正常则执行步骤250，结束该样本的测试，如果结果异常，则执行步骤260。
步骤260，根据异常项目确定流式细胞仪的检测项目。根据临床经验，事先设定异常项目所对应的需要流式细胞仪进行分析的检测项目，例如以异常项目和流式检测项目对应表的方式保存在样本分配模块14中。在实际检测过程中，可根据检验结果中的异常项目确定流式细胞仪的检测项目。
步骤270，将流式细胞仪的检测项目通知流式细胞仪。
步骤280，控制第一传输装置将被分析样本传送到流式细胞仪。样本从血液细胞分析仪到流式细胞仪的传递通过轨道装置或者其他类似设备自动完成；流式细胞仪能够完成样本的制备功能，如染色、溶血、洗涤等功能，然后对血样进行检测和分析，输出检验结果。
本实施例中，血液细胞分析仪和流式细胞分析仪通过轨道装置或者其他类似设备连接在一起，某个样本在血液细胞分析仪输出异常报警时候，按照事先设定规则，选择性的进行一项或多项流式检测，流式检测的具体试剂组合由异常样本报警类型或样本分配模块决定，针对特定的异常报警，可以对血液细胞分析仪检测出的输出的异常细胞进行进一步细化确认，确认后的样本可以不进行镜检，一方面减少了镜检的次数，节约了人力，另一方面流式细胞分析仪只对少量的异常样本进行复检，既节约了检验成本，又可保证检验结果的准确性和可靠性。
在其它的具体实例中，如果医生事先决定某个病人在进行血常规检测的同时，也需要进行流式相关检测，比如淋巴免疫分群测定, 则在步骤200中样本分配模块14获取到被分析样本的检测项目包括需要细胞分析仪检验的血常规项目和需要流式细胞仪检验的淋巴免疫分群项目。则控制首先由细胞分析仪进行血常规检验，在做完血常规检测后，无论血常规检验结果如何，都会通过轨道装置或者其他类似设备把样本传递到流式细胞分析仪中，通过流式细胞分析仪完成血液样本的制备和检测工作。此时流式细胞仪执行的检验包括根据血常规检验中的异常项目确定的检验项目和医生确定的淋巴免疫分群项目。同样，如果医生事先决定某个样本不做血常规检测，只做流式检测，则在步骤200中样本分配模块14获取到被分析样本的检测项目只包括需要流式细胞仪检验的免疫项目。则直接将被测样本通过轨道装置或者其他类似设备传递到流式细胞仪进行流式样本的制备和检测。
基于上述方法，本实施例的细胞分析装置包括样本分配模块14，其一种结构如图4所示，具体包括：信息获取单元141、传送控制单元142和通信单元143，信息获取单元141与信息系统20通信连接，用于获取被分析样本的检测项目；传送控制单元142耦合到第一传输装置13，用于根据检测项目控制第一传输装置13将被分析样本传送到执行对应检测项目的细胞分析仪或流式细胞仪；通信单元143分别与细胞分析仪和流式细胞仪通信连接，用于将检测项目信息通知执行对应检测项目的细胞分析仪或流式细胞仪。
另一种结构如图5所示，具体包括：结果获取单元144、再检确定单元145、传送控制单元146和通信单元147，结果获取单元144用于获取细胞分析仪11对被分析样本的血常规检验结果；再检确定单元145用于当结果异常，根据异常项目确定流式细胞仪的检测项目；通信单元147用于将流式细胞仪的检测项目通知流式细胞仪11；传送控制单元146用于控制第一传输装置13将被分析样本传送到流式细胞仪。
本实施例中样本分配模块14可以是一个分立的组件或器件，通过硬件设计或计算机可执行程序实现功能，也可以集成在任一个分析仪中，例如集成在细胞分析仪中，通过细胞分析仪的对外通信接口与流式细胞仪和信息系统进行信息交互，对外通信接口可以是一个有线接口，也可以是一个无线通信模块。
通过本实施例可以大大提升工作效率，并且由于工作效率的提升，同时选择性进行流式检测，降低了流式检测应用的成本，也可以推动医生积极开展流式细胞临床项目，提升流式细胞分析在临床应用中的进一步普及，有助于对疾病的快速准确诊断。
血液细胞分析仪提示的异常信息，往往和免疫学定义的细胞高度相关，采用本实施例及时对异常的血液进一步进行细胞免疫学分类确认，避免了在第一时间丢失临床相关信息。
另外，在医生对某个病人确定需要同时进行血常规检测和流式相关检测时，可以只对病人采集一管血样，与现在的需要针对血常规检测和流式检测分别采集两管血样相比，减少了对病人的损伤，同时也节约了采血器械。
以下举例说明本实施例的具体应用。
如果医生事先决定某个病人在进行血常规检测的同时，也需要进行流式相关检测，比如淋巴免疫分群测定，则该样本在信息系统中事先已经包含了血常规检测项目和流式检测项目。淋巴细胞亚群分析项目例如可以是对T淋巴细胞亚群、B淋巴细胞亚群、NK细胞亚群的分析，T淋巴亚群又可进一步进行辅助/诱导T淋巴细胞（CD3+CD4+）亚群和抑制/细胞毒T淋巴细胞（CD3+CD8+）亚群分析。
目标样本为通过真空采血管采样的抗凝血样本，通过抗凝血样本管外部的条码信息可以获取到信息系统中该样本的检测项目，根据这些检测项目，通过样本分配模块可以进行样本分配。
首先样本分配单元将该样本分配到血液细胞分析仪进行检测，输出类似散点图信息和其他测试结果。
假设血液分析仪输出的散点图包含了异常信息报警，比如异型淋巴细胞（Atypical Lymphocyte）和未成熟粒细胞（IG）异常，研究表明，如果出现异型淋巴细胞（Atypical Lymphocyte）报警，那么这块区域的对应的免疫学细胞分类为活化B淋巴细胞或者浆细胞，上述细胞承担了人体体液系统的免疫功能，具有十分重要的临床意义。通过流式细胞仪可以进一步对该细胞群分类进行确认。在流式应用中，这部分细胞可以通过散点图上CD19阳性表达且高SSC信号的细胞群进行确认，如果通过对该细胞群cyIgM和CD138是否阳性表达进步确认，其准确性将会进一步提高。通过流式分析获得活化B淋巴细胞或者浆细胞的比例，可对异型淋巴细胞报警进行确认，则不用再进行镜检。
同样，针对未成熟粒细胞（IG），也可以通过流式方法进行进一步确认。如通过CD45、CD16和CD11b表达可以对未成熟粒细胞进行进一步确认。具体来说，通过CD45/SSC的散点图可以识别出粒细胞，然后通过CD16/CD45散点图可进一步将中性粒细胞识别出来，IG Stage1阶段细胞可以通过CD16- CD11b-确认，IG Stage2阶段细胞可以通过CD16- CD11b+确认，成熟粒细胞则可通过CD16+ CD11b+确认。通过具体流式散点图设门方案及散点图，可以具体进行细胞细化，不用进一步进行镜检。
综上，血液细胞分析仪检测后，如果出现异型淋巴细胞（Atypical Lymphocyte）报警，配送到流式分析仪，通过CD19、cyIgM、CD138进行精确确认。
血液细胞分析仪检测后，如果出现未成熟粒细胞（IG）报警，配送到流式细胞分析仪进行CD45、CD16和CD11b组合流式分析，进行陈述阶段确认。
同样，血液细胞分析仪检测的其他异常报警，也可以根据具体报警项目进行流式细胞分析仪相关检测：
如果出现原始细胞（Blast）报警，先使用组合TdT-FITC/CD34-PE/CD45-PerCP 进行筛查，若CD34阳性、TdT阴性，则很可能是髓系原始细胞；若CD34阳性、TdT阳性+，则很可能是淋巴系原始细胞，此时，继续进行CD3-FITC/CD19-PE/CD45-PerCP检测，如果CD3阳性，则为T系原始细胞，如果CD19阳性，则为B系原始细胞。
如果出现淋巴细胞Ly%或Ly#高于某阈值的样本，配送到细胞分析仪进行淋巴系的分析，包括淋巴系的白血病测试。
如果出现单核细胞Mo%或Mo#高于某阈值的样本，配送到细胞分析仪进行单核系的分析，包括单核系的白血病测试。
如果出现粒细胞Ne%或Ne#（包括嗜酸性粒细胞）高于某阈值的样本，配送到流式进行髓系的分析，包括髓系的白血病测试。
上述检测分析过程的结果最后汇总进入实验室信息系统。
实施例2：
在上述实施例的基础上，还可以细胞分析仪的后端还可以增加其它分析仪。请参考图6，细胞分析系统包括细胞分析仪31、流式细胞仪32和至少一个其它分析仪33。其它分析仪为除细胞分析仪和流式细胞仪之外的分析仪器，例如糖化分析仪、免疫发光分析仪等。流式细胞仪32与细胞分析仪31之间通过第一传输装置34连通，其它分析仪33与细胞分析仪31之间通过第二传输装置35连通，第二传输装置35用于将被分析样本从细胞分析仪31传送到其它分析仪33。其它分析仪33可以是一个分析仪，也可以是多个分析仪，当其它分析仪33有多个时，第二传输装置35在其它分析仪33与细胞分析仪31之间的设计可以是串联式的，即从细胞分析仪31到第一个其它分析仪，然后从第一个其它分析仪再到第二个其它分析仪，依次类推；也可以是并联式的，即从细胞分析仪31分别到各个其它分析仪。
在另一种具体实例中，如图7所示，流式细胞仪32与细胞分析仪31之间通过第一传输装置34连通，其它分析仪33与流式细胞仪32之间通过第三传输装置36连通，第三传输装置36用于将被分析样本从流式细胞仪32传送到其它分析仪33。
另外，也可以直接将流式细胞仪替换成其它分析仪，相应的检验项目也随之改变。
本实施例将检验不同项目的分析仪通过传输装置连接起来，当需要检测多个检验项目时，只用抽取一次分析样本即可进行多个检验项目，从而可减少对被检测者的影响。
本领域技术人员可以理解，上述实施方式中各种方法的全部或部分步骤可以通过程序来指令相关硬件完成，该程序可以存储于一计算机可读存储介质中，存储介质可以包括：只读存储器、随机存储器、磁盘或光盘等。
以上应用了具体个例对本申请进行阐述，只是用于帮助理解本申请并不用以限制本申请。对于本领域的一般技术人员，依据本申请的思想，可以对上述具体实施方式进行变化。

Claims (15)

  1. 一种细胞分析系统，其特征在于包括：
    细胞分析仪；
    流式细胞仪；
    连通细胞分析仪和流式细胞仪的第一传输装置，所述第一传输装置用于将被分析样本从细胞分析仪传送到流式细胞仪。
  2. 如权利要求1所述的细胞分析系统，其特征在于还包括：
    至少一个其它分析仪，所述其它分析仪为除细胞分析仪和流式细胞仪之外的以血液为分析样本的仪器，所述其它分析仪与细胞分析仪之间通过第二传输装置连通，所述第二传输装置用于将被分析样本从细胞分析仪传送到其它分析仪；或者所述其它分析仪与流式细胞仪之间通过第三传输装置连通，所述第三传输装置用于将被分析样本从流式细胞仪传送到其它分析仪。
  3. 如权利要求1或2所述的细胞分析系统，其特征在于还包括：
    样本分配模块，用于获取被分析样本的检测项目，根据检测项目控制被分析样本的传送。
  4. 如权利要求3所述的细胞分析系统，其特征在于，所述样本分配模块分别与细胞分析仪和流式细胞仪之间进行信息交互。
  5. 如权利要求3所述的细胞分析系统，其特征在于，所述样本分配模块集成在细胞分析仪内，所述样本分配模块通过细胞分析仪的对外通信接口与流式细胞仪进行信息交互。
  6. 如权利要求1所述的细胞分析系统的细胞分析方法，其特征在于包括：
    采用细胞分析仪对被分析样本进行检验；
    如果检验结果发现异常，则根据异常项目确定流式细胞仪的检测项目；
    控制第一传输装置将被分析样本传送到流式细胞仪；
    流式细胞仪按照确定的检测项目对被分析样本进行检测。
  7. 如权利要求6所述的方法，其特征在于还包括：
    根据流式细胞仪的检测结果确定是否进行镜检。
  8. 如权利要求6所述的方法，其特征在于：细胞分析仪对被分析样本进行的检验为血常规检验。
  9. 如权利要求1所述的细胞分析系统的细胞分析方法，其特征在于包括：
    获取被分析样本的检测项目；
    根据检测项目将被分析样本传送到执行对应检测项目的细胞分析仪或流式细胞仪；
    将检测项目信息通知执行对应检测项目的细胞分析仪或流式细胞仪。
  10. 如权利要求9所述的方法，其特征在于通过读取条码信息获取被分析样本的检测项目。
  11. 一种细胞分析方法，其特征在于包括：
    获取细胞分析仪对被分析样本的检验结果；
    如果结果异常，则根据异常项目确定流式细胞仪的检测项目；
    将流式细胞仪的检测项目通知流式细胞仪；
    控制第一传输装置将被分析样本传送到流式细胞仪。
  12. 一种细胞分析装置，其特征在于包括：
    用于获取被分析样本的检测项目的信息获取单元；
    用于根据检测项目控制被分析样本传送到执行对应检测项目的细胞分析仪或流式细胞仪的传送控制单元；
    用于将检测项目信息通知执行对应检测项目的细胞分析仪或流式细胞仪的通信单元。
  13. 如权利要求12所述的装置，其特征在于，所述信息获取单元通过读取条码信息获取被分析样本的检测项目。
  14. 一种细胞分析装置，其特征在于包括：
    用于获取细胞分析仪对被分析样本的血常规检验结果的结果获取单元；
    用于当结果异常，根据异常项目确定流式细胞仪的检测项目的再检确定单元；
    用于将流式细胞仪的检测项目通知流式细胞仪的通信单元；
    用于控制第一传输装置将被分析样本传送到流式细胞仪的传送控制单元。
  15. 一种细胞分析系统，其特征在于包括：
    细胞分析仪；
    其它分析仪，所述其它分析仪为除细胞分析仪和流式细胞仪以外的分析仪；
    连通细胞分析仪和其它分析仪的第二传输装置，所述第二传输装置用于将被分析样本从细胞分析仪传送到其它分析仪。
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