WO2023056712A1 - Appareil d'analyse de sang et procédé d'analyse de sang pour animaux - Google Patents

Appareil d'analyse de sang et procédé d'analyse de sang pour animaux Download PDF

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Publication number
WO2023056712A1
WO2023056712A1 PCT/CN2021/140471 CN2021140471W WO2023056712A1 WO 2023056712 A1 WO2023056712 A1 WO 2023056712A1 CN 2021140471 W CN2021140471 W CN 2021140471W WO 2023056712 A1 WO2023056712 A1 WO 2023056712A1
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WIPO (PCT)
Prior art keywords
measurement mode
animal
blood
blood sample
particle
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PCT/CN2021/140471
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English (en)
Chinese (zh)
Inventor
孔繁钢
史涛
杨翥翔
王胜昔
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深圳迈瑞动物医疗科技股份有限公司
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Priority to CN202180071276.7A priority Critical patent/CN116420074A/zh
Priority to PCT/CN2021/140471 priority patent/WO2023056712A1/fr
Publication of WO2023056712A1 publication Critical patent/WO2023056712A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • 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

Definitions

  • reaction part configured to receive the blood sample provided by the blood sample supply part and the reagent provided by the reagent supply part to prepare a sample
  • the animal measurement mode has a mode characteristic parameter; the processor is also used to obtain the value of the mode characteristic parameter of the blood sample in the currently selected animal measurement mode according to the measurement signal, and according to the value of the mode characteristic parameter Judging whether the current animal measurement mode is wrongly selected; when the processor judges that the current animal measurement mode is wrongly selected, perform a predetermined operation when the animal measurement mode is wrongly selected.
  • the processor judges whether the particle distribution of the blood sample in the particle scattergram in the preset area conforms to the currently selected animal measurement mode in the particle scattergram in the preset area. Preset particle distribution;
  • the processor judges whether the mean red blood cell volume result of the blood sample is within the preset mean red blood cell volume result range of the currently selected animal measurement mode;
  • the processor also judges the animal measurement mode matched by the current blood sample according to the characteristic parameters, and retests the current blood sample according to the animal measurement mode.
  • the measurement signal includes at least two kinds of optical signals;
  • the mode characteristic parameter includes particle distribution in a preset area of a particle scatter diagram generated based on the at least two kinds of optical signals;
  • the judging whether the current animal measurement mode is wrongly selected includes:
  • the predetermined operation includes at least one of the following:
  • the animal measurement mode matched by the current blood sample is judged according to the characteristic parameters, and the current blood sample is retested according to the animal measurement mode.
  • the multiple animal measurement modes include at least a cat measurement mode and a dog measurement mode.
  • the value of the mode characteristic parameter of the blood sample in the current animal measurement mode is obtained according to the measurement signal, and the value of the mode characteristic parameter of the blood sample in the current animal measurement mode is obtained. , judging whether the current animal measurement mode is selected incorrectly, so that it can be judged that the blood sample is set to the wrong animal measurement mode.
  • Fig. 2(a) and Fig. 2(b) are a list of test results of 8 cases of cat blood samples in the animal blood analysis device respectively selecting the cat measurement mode and the dog measurement mode;
  • Fig. 3 is a schematic structural diagram of an animal blood analysis device according to an embodiment
  • Fig. 4 is a schematic structural diagram of an animal blood analysis device according to an embodiment
  • Fig. 5 is a schematic structural diagram of an optical detection part of an embodiment
  • Fig. 6 is a schematic structural diagram of an optical detection part of an embodiment
  • Fig. 7 is a schematic structural diagram of an optical detection part of an embodiment
  • Fig. 8 is a schematic diagram of the interface setting of the animal measurement mode of an embodiment
  • Fig. 9 is an example of a scattergram of DIFF channel classification results after a dog blood sample is detected in the dog measurement mode of the blood analysis device for animals in an embodiment
  • Fig. 11 is an example of a scattergram of DIFF channel classification results after a dog blood sample is detected in the cat measurement mode of the blood analysis device for animals in an embodiment
  • Fig. 12 is an example of a scattergram of DIFF channel classification results after a cat blood sample is detected in the dog measurement mode of an animal blood analysis device in an embodiment
  • Fig. 13 is a flowchart of a blood analysis method in an embodiment.
  • connection and “connection” mentioned in this application include direct and indirect connection (connection) unless otherwise specified.
  • the animal blood analysis device will call the processing algorithm of the corresponding animal measurement mode to measure and analyze the current sample. analysis to get the corresponding analysis results.
  • Inventor randomly selected 8 For example, after the blood sample of a dog is tested in the dog measurement mode and cat measurement mode on the animal blood analysis device, the results are shown in the figure 1 ( a ) and figure 1 ( b ), the inventor also randomly selected 8 For example, after the blood sample of a cat is tested in the cat measurement mode and the dog measurement mode on the animal blood analysis device, the results are shown in the figure 2 ( a ) and figure 2 ( b ). The inventors found that, for an animal blood analysis device, selecting or setting the correct sample type (ie, the animal measurement mode) before measurement has a great influence on the measurement results and final clinical diagnosis results.
  • selecting or setting the correct sample type ie, the animal measurement mode
  • WBC refers to white blood cells
  • RBC refers to red blood cells
  • HCT refers to the hematocrit
  • MCV is the mean corpuscular volume
  • MCHC is the mean corpuscular hemoglobin concentration
  • Ret% refers to the percentage of reticulocytes
  • PLT_I Refers to the counting of platelets by the electrical impedance method channel
  • PLT_O refers to the counting of platelets by the optical method channel
  • alarm result column are some alarm prompts, for example Eosinophilia Indicates eosinophilia, Anemia indicates anemia, PLT Clump Indicates platelet aggregation, Macrocytosis Indicates macrocytic erythrocytes, Atypical Lympho Indicates atypical lymphocytes, Lipid Particles represent lipid particles, Lymphocytosis Indicate
  • the animal blood analysis device of some embodiments includes a blood sample supply unit 10 , Reagent Supply Department 20 , Response Department 30 , Measurement Department 40 ,processor 50 and animal measurement mode selection section 60 .
  • the blood sample supply unit 10 For the supply of blood samples; reagent supply 20 It is used to supply reagents, such as hemolytic agents, fluorescent agents and / Or diluent, etc.; Reaction Department 30 It is used to provide a reaction place for samples and reagents to prepare samples formed by the reaction of samples and reagents; the determination part 40 It is used to detect the prepared sample, or to detect the sample to obtain detection data or measurement signals; the processor 50 It is used to analyze the measurement signal to obtain the analysis result of the blood, and to invent the processor in some embodiments 50 including but not limited to CPU ( Central Processing Unit , CPU ), micro control unit (Micro Controller Unit , MCU) , Field Programmable Gate Array ( Field-Programmable Gate Array , FPGA ) and digital signal processing ( DSP ) and other devices used to interpret computer instructions and process data in computer software. In some embodiments, the processor 50 It is used to execute each computer application program in the non-transitory computer-readable storage medium, so that
  • the blood sample supply unit 10 may include a sample needle, and the sample needle performs two-dimensional or three-dimensional movement in space through a two-dimensional or three-dimensional driving mechanism, so that the sample needle can move to absorb the sample in the container (such as a sample tube) carrying the sample, and then move to It is used to provide a reaction place for the tested sample and reagent, such as the reaction part 30 , to the Response Department 30 Join the sample.
  • a sample needle performs two-dimensional or three-dimensional movement in space through a two-dimensional or three-dimensional driving mechanism, so that the sample needle can move to absorb the sample in the container (such as a sample tube) carrying the sample, and then move to It is used to provide a reaction place for the tested sample and reagent, such as the reaction part 30 , to the Response Department 30 Join the sample.
  • the reagent supply 20 Can include areas for carrying reagent containers and connecting the reagent containers to the reaction section 30 Connected reagent liquid path, the reagent is added from the reagent container to the reaction part through the reagent liquid path 30 middle.
  • the reagent supply 20 It can also include a reagent needle, the reagent needle can move two-dimensionally or three-dimensionally in space through a two-dimensional or three-dimensional drive mechanism, so that the reagent needle can move to absorb the reagent in the reagent container, and then move to the test sample and reagents provide a reaction site such as a reaction section 30 , to the Response Department 30 Add reagents.
  • the reagent includes one or more of a hemolytic agent, a fluorescent agent, and a diluent.
  • a hemolytic agent is a reagent capable of lysing red blood cells in blood samples and body fluid samples, specifically, it can be any one of cationic surfactants, nonionic surfactants, anionic surfactants, and amphiphilic surfactants one or a combination of several.
  • the fluorescent agent is used to stain blood cells, and the specific type is selected according to the detection item.
  • Measurement Department 40 including at least the optical detection unit 60 , as explained below.
  • the optical detection unit 60 The sample can be measured by the principle of laser scattering.
  • the principle is: the laser is irradiated on the cells, and the light signals generated after the cells are irradiated, such as scattered light and / Or fluorescence, to classify and count cells, etc.-of course, in some embodiments, if the cells are not treated with fluorescent reagents, then naturally no fluorescence can be collected.
  • the measurement department 40 Optical detection unit in 60 Be explained.
  • a specific example of an optical detector 69 Can include lens stacks to collect forward scattered light 63 , a photodetector used to convert the collected forward scattered light from an optical signal to an electrical signal 64 , a lens set for collecting side scattered light and side fluorescence 65 , dichroic mirror 66 , a photodetector used to convert the collected side scattered light from an optical signal to an electrical signal 67 , a photodetector used to convert the collected lateral fluorescence from an optical signal to an electrical signal 68 ; where the dichroic mirror 66 For light splitting, the mixed side scattered light and side fluorescence are divided into two paths, one is side scattered light and the other is side fluorescence.
  • the optical signal herein may refer to an optical signal, or may refer to an electrical signal converted from an optical signal, and they are substantially consistent in characterizing the information contained in the cell detection result.
  • the optical detection section shown 60 structure as an example to illustrate the optical detection section 60 How to specifically obtain the optical signal of the sample to be tested.
  • the cells for the samples to be tested are passed one by one. e.g. in the reaction section 30 After the red blood cells in the sample are dissolved by some reagents such as hemolytic agents, or further dyed by fluorescent agents, the sheath flow technology is used to make the cells in the prepared test sample flow from the flow chamber 62 queued up one after the other.
  • the axis direction is the direction of cell movement in the sample to be tested. It should be noted that, in the figure Y The axis direction is the direction perpendicular to the paper surface.
  • the light source 61 When the light source 61 The emitted light illuminates the flow chamber 62 When the cells in the cell will scatter to the surrounding. Therefore, when the cells in the prepared sample to be tested pass through the flow chamber one by one under the action of the sheath flow 62 when the light source 61 flow chamber 62 The cells illuminated, the light irradiated on the cells will scatter to the surroundings, and pass through the lens group 63 to collect forward scattered light - for example in the Z axis so that it reaches the photodetector 64 , so that the information processing department 70 available from the photodetector 64 Obtain the forward scattered light information of the cells; at the same time, pass through the lens group in the direction perpendicular to the light irradiating the cells 65 Collect side light - for example in the picture x axis direction, the collected side light passes through the dichroic mirror 66 Reflection and refraction occur, where the side scattered light in the side light passes through the dichroic mirror 66 reflection occurs, and then reaches
  • the processor 50 available from the photodetector 67 Obtain the side scattered light information of the cell from the photodetector 68 Obtain the lateral fluorescence information of the cells.
  • the optical detection unit 60 for the optical detection unit 60 another example.
  • the light performance is better and can be used in light source 61 and flow chamber 62 collimating lens 61a ,light source 61 The emitted light is collimated by the lens 61a collimated and back through the flow cell 62 cells irradiated.
  • the photodetector in order to make the collected fluorescence noise less (that is, there is no interference from other light), can be 68 set a filter in front of the 66a , via a dichroic mirror 66 The side fluorescence after splitting is passed through a filter 66a before reaching the photodetector 68 .
  • an aperture is introduced 63a to define the eventual arrival photodetector 64 The angle of the forward scattered light, for example, the forward scattered light is limited to low angle (or small angle) forward scattered light.
  • the white blood cells can be classified and counted by the laser light scattering method, and the above-mentioned optical detection part 60 Just one example.
  • the scattered light produced by the cells irradiated by the laser beam is related to the cell size, the refractive index of the cell membrane and the internal structure of the cell. According to the scattered light signal, the distribution diagram of blood cell size and cell internal information can be obtained, which is called particle scatter diagram, classification scatter diagram, or scatter diagram for short.
  • the determination part 40 The assay signal obtained by detecting, in some embodiments, refers to the above optical signal.
  • the animal measurement mode selection unit 60 Used to select one of various animal measurement modes as the current animal measurement mode.
  • Various animal measurement modes such as pig, horse, cow, dog, and cat, can be preset in the blood analysis device for animals.
  • the plurality of animal measurement modes includes at least a cat measurement mode and a dog measurement mode. The user can set or select a corresponding animal measurement mode for the blood sample through an input tool such as a keyboard or a mouse.
  • example figure 8 As an example, the user can select the corresponding animal measurement mode from the blood sample through the mouse and other tools from the drop-down box, the number in the figure is 001-A , 002-B , 003-C
  • the blood samples were set to cat measurement mode, cat measurement mode and dog measurement mode respectively.
  • different animal measurement modes have their own analysis algorithms, that is, after the measurement signal of the blood sample is obtained, the processor 50 According to the set animal measurement mode of the blood sample, a corresponding analysis algorithm can be selected to analyze the measurement signal and obtain the analysis result.
  • different animal measurement modes have respective analysis result range values
  • the processor 50 The analysis result of the blood sample can be calibrated according to the range value of the analysis result corresponding to the animal measurement mode in which the blood sample is set, such as whether it is negative or positive, whether it is within a normal range value, or the like.
  • the animal measurement mode has mode characteristic parameters, for example, the mode characteristic parameters include the particle distribution in the preset area of the particle scatter diagram generated by the measurement signal, and another example, the mode characteristic parameters include the final result such as the mean red blood cell volume result.
  • the mode characteristic parameters include the particle distribution in the preset area of the particle scatter diagram generated by the measurement signal
  • the mode characteristic parameters include the final result such as the mean red blood cell volume result.
  • R&D personnel can extract, select and set mode characteristic parameters according to the characteristics of the intermediate results or final results obtained by analyzing the blood samples of each animal from the measurement signals through experiments.
  • the solution proposed by some embodiments of the present invention can remind the user whether the type of the test sample (blood sample) or the animal measurement mode is wrong.
  • relevant features ie, the pattern feature parameters mentioned herein
  • Pattern feature parameters can also be final parameter results. For example, based on clinical statistics, the mean corpuscular volume ( MCV ) results are generally not less than 50fL (femtoliters), while the mean corpuscular volume of cat blood samples ( MCV ) results are generally not higher than 55fL ; Therefore, based on this feature, it can also judge whether the animal type is wrong, and then give a prompt to the user.
  • MCV mean corpuscular volume
  • some embodiments of the present invention can determine whether the blood sample is set or selected in the wrong animal measurement mode, for example, the blood sample of a cat is wrongly set to the dog measurement mode, which will be described in detail below.
  • the blood sample is measured by the blood analysis device for the animal, the measurement part can obtain the measurement signal, and the processor obtains the mode characteristic parameters of the blood sample in the currently selected animal measurement mode according to the measurement signal. value, and judge whether the current animal measurement mode is wrongly selected according to the value of the characteristic parameter of the mode.
  • the determination signal includes at least two kinds of light signals, such as side scattered light and fluorescence;
  • the mode characteristic parameter includes the particle distribution in the preset area of the particle scatter diagram generated based on the above-mentioned at least two kinds of light signals;
  • processing device 50 According to the measurement signal, the particle distribution of the blood sample in the above-mentioned preset area of the above-mentioned particle scatter diagram is obtained; the processor 50 Judging whether the particle distribution of the blood sample in the above-mentioned preset region of the particle scattergram conforms to the preset particle distribution of the currently selected animal measurement mode in the above-mentioned preset region of the particle scattergram; if not , the processor 50 It is judged that the current animal measurement mode is selected incorrectly, for example, the cat blood sample is selected as the dog measurement mode, for example, the dog blood sample is selected as the cat measurement mode.
  • the particle distribution in the preset area of the particle scattergram includes the number of particle clusters; the processor 50 Obtain the number of particle clusters of the blood sample in the preset area of the particle scatter diagram according to the measurement signal; the processor 50 Determine whether the number of particle clusters of the blood sample in the preset area of the particle scattergram is equal to the preset number of particle clusters in the preset area of the particle scattergram of the currently selected animal measurement mode; if not, then the processor 50 Judging that the current animal measurement mode selection is wrong, for example, when the blood sample is set to the cat measurement mode, the blood sample should be in the 10 middle EOS Region should have 2 particle clusters, if the measured signal of the blood sample is in the figure 10 middle EOS The region exhibits only 1 particle clusters, indicating that the selection of animal measurement mode for this blood sample is wrong.
  • the processor 50 According to the measurement signal, the mean red blood cell volume result of the blood sample is obtained; the processor 50 Determine whether the mean red blood cell volume result of the blood sample is within the preset mean red blood cell volume result range of the currently selected animal measurement mode; if not, the processor 50 It is judged that the current animal measurement mode selection is wrong.
  • the predetermined operation can be performed when the animal measurement mode selection is wrong, such as giving the user a corresponding prompt message, prompting "the animal type of the current sample may be wrong" or "the animal measurement mode of the current sample may be incorrect".
  • mode setting error etc.; it can also be expressed as MCV And other mode characteristic parameters are specially marked to assist in prompting.
  • the processor 50 The predetermined operation when the selection of the animal measurement mode is wrong includes at least one of the following:
  • ( 1 )processor 50 Generate an error prompt for animal mode selection
  • ( 3 )processor 50 The animal measurement mode matched by the current blood sample is judged according to the characteristic parameters, and the current blood sample is retested according to the animal measurement mode.
  • step 140 According to the measurement signal, the value of the mode characteristic parameter of the blood sample in the current animal measurement mode is obtained, and according to the value of the mode characteristic parameter of the blood sample in the current animal measurement mode, it is judged whether the current animal measurement mode is selected incorrectly.
  • the steps 140 Obtain the mean red blood cell volume result of the blood sample according to the determination signal; step 140 Determine whether the mean red blood cell volume result of the blood sample is within the preset mean red blood cell volume result range of the currently selected animal measurement mode; if not, then step 140 It is judged that the current animal measurement mode selection is wrong.
  • step 150 When it is judged that the current selection of the animal measurement mode is wrong, perform the predetermined operation when the selection of the animal measurement mode is wrong.
  • the predetermined operation when the selection of the animal measurement mode is wrong includes at least one of the following:
  • These computer program instructions can be loaded into a general purpose computer, special purpose computer or other programmable data processing apparatus to form a machine, so that these instructions executed on the computer or other programmable data processing apparatus can generate an apparatus for realizing specified functions.
  • These computer program instructions may also be stored in a computer-readable memory which can instruct a computer or other programmable data processing device to operate in a particular manner such that the instructions stored in the computer-readable memory form a Manufactures, including implementing devices for implementing specified functions.
  • Computer program instructions can also be loaded on a computer or other programmable data processing device, thereby performing a series of operational steps on the computer or other programmable device to produce a computer-implemented process, so that the computer or other programmable device Instructions may provide steps for performing specified functions.

Abstract

L'invention concerne un appareil d'analyse de sang et un procédé d'analyse de sang pour des animaux. Le procédé comprend les étapes consistant à : acquérir le mode de mesure de l'animal actuel, le procédé d'analyse de sang ayant une pluralité de modes de mesure d'animal, et les modes de mesure d'animal ayant des paramètres de caractéristique de mode ; préparer un échantillon au moyen d'un échantillon de sang et d'un réactif ; tester l'échantillon pour obtenir un signal de test ; en fonction du signal de test, obtenir la valeur de l'échantillon de sang à un paramètre de caractéristique de mode du mode de mesure de l'animal actuel, et en fonction de la valeur de l'échantillon de sang au paramètre de caractéristique de mode du mode de mesure de l'animal actuel, déterminer si la sélection du mode de mesure de l'animal actuel est erronée ; et s'il est déterminé que la sélection du mode de mesure de l'animal actuel est erronée, exécuter une opération prédéterminée pour une sélection de mode de mesure d'animal erronée. Au moyen de la présente invention, il est possible de déterminer si un mode de mesure erroné d'animal est fixé pour un échantillon de sang.
PCT/CN2021/140471 2021-12-22 2021-12-22 Appareil d'analyse de sang et procédé d'analyse de sang pour animaux WO2023056712A1 (fr)

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Application Number Priority Date Filing Date Title
CN202180071276.7A CN116420074A (zh) 2021-12-22 2021-12-22 一种动物用血液分析装置和血液分析方法
PCT/CN2021/140471 WO2023056712A1 (fr) 2021-12-22 2021-12-22 Appareil d'analyse de sang et procédé d'analyse de sang pour animaux

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