Sample analysis device, animal analysis device, and sample analysis method

Abstract

A sample analysis device, an animal analysis device, and a sample analysis method. In the analysis device, a processor (50) controls a sample supply unit (10) and a reagent supply unit (20) to respectively provide a sample and a reagent to a reaction unit (30). The reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting cell particles. The processor (50) controls a measuring unit (40) to detect the second sample to obtain second detection data related to the volume of cell particles. The processor (50) calculates the detection result of the cell particles based on at least the second detection data. The sample analysis device, the animal analysis device, and the sample analysis method can be applied to large platelet (PLT) samples, or samples in which the size difference between platelets (PLT) and red blood cells (RBC) is not very significant. In these cases, accurate platelet (PLT) counting can be achieved.

Description

Technical Field

[0001] The present invention relates to the field of in vitro diagnosis, and in particular to a sample analysis device, an analysis device for animals, and a sample analysis method. Background Art

[0002] Sample analysis devices, such as those for body fluids or blood, can detect cell particles in blood and body fluids, for example, they can count and classify cell particles such as white blood cells (WBC), red blood cells (RBC), platelets (PLT), nucleated red blood cells (NRBC), and reticulocytes (Ret).

[0003] Currently, the majority of blood cell measurements utilize the micropore impedance principle, based on the Coulter principle. The Coulter principle refers to the measurement of particles in a fluid based on the different electrical impedances of particles of varying volumes passing through a micropore. For example, blood cells are relatively poor conductors. When suspended in an electrolyte solution and passed through a detection micropore, they alter the previously constant resistance inside and outside the micropore. This is sensed by sensors within the micropore and processed by a processing circuit to generate electrical pulses. The size of the pulses can be used to determine the cell's volume, and the number of pulses can be used to determine the cell's number. These pulse signals, processed by the corresponding processing circuit, can be plotted into intuitive distribution charts. For example, a sample analyzer can simultaneously measure multiple data points for red blood cells, white blood cells, and platelets, and plot their volume (horizontally) and relative frequency of occurrence (vertically) on a coordinate graph, forming a blood cell volume distribution histogram.

[0004] Platelets (PLTs) and red blood cells (RBCs) can be measured using the impedance method described above, and both are measured simultaneously. Taking a blood sample as an example, an isotonic electrolyte solution is added to the blood sample to dilute it to prepare a cell suspension, which is then counted using the impedance method. Figure 1(a) shows a volume distribution histogram of the particles. The horizontal axis represents volume, in units such as femtoliters (FL), and the vertical axis represents the frequency of occurrence, or count value. As can be seen, due to the significant difference in volume between PLTs and RBCs, two peaks and a distinct dividing line are formed in the figure: the PLTs are on the left side of the dividing line, and the RBCs are on the right. This measurement method is simple, convenient, and relatively inexpensive, and can be found in both low-end and high-end hematology analyzers.

[0005] For abnormal samples, such as large PLT samples, the PLT histogram and RBC histogram may overlap. Figure 1(b) shows an example. In this case, PLT and RBC partially overlap, making it impossible to accurately determine the boundary between PLT and RBC, and thus impossible to accurately classify and count PLT and RBC.

[0006] One solution is to use fluorescent reagents. High-end hematology analyzers use fluorescence to accurately count PLTs. For example, the BC-6000 hematology analyzer produced by Shenzhen Mindray Bio-Medical Co., Ltd. counts PLTs using the RET channel. The principle is that after blood cells are treated with reagents, particularly fluorescent reagents, three optical signals—forward scattered light, side scattered light, and fluorescence—are used to distinguish cells. Forward scattered light reflects cell size, side scattered light reflects cell complexity, and fluorescence reflects the DNA and RNA content within the cell. These three optical signals can significantly distinguish PLTs from RBCs, effectively achieving PLT counting. While this method is accurate, it is relatively expensive. Summary of the Invention

[0007] The present invention mainly provides a sample analysis device, an analysis device for animals, and a sample analysis method, which are described in detail below.

[0008] According to a first aspect, an embodiment provides a sample analysis device, characterized by comprising:

[0009] A sample supply unit for supplying a sample, such as a blood sample or a body fluid sample; the body fluid sample may be, for example, cerebrospinal fluid, pleural effusion, ascites, cystic fluid, joint fluid, peritoneal dialysis dialysis fluid, or intraperitoneal lavage fluid;

[0010] A reagent supply unit, used for supplying reagents;

[0011] a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample;

[0012] a measuring unit, used for detecting the sample to obtain detection data;

[0013] The processor calculates a detection result based on the detection data; wherein:

[0014] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells;

[0015] The processor controls the measuring unit to detect the first sample to obtain first detection data related to the volume of the cell particles;

[0016] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject;

[0017] The processor controls the measuring unit to detect the second sample to obtain second detection data related to the volume of the cell particles;

[0018] The processor calculates the detection result of the cell particles according to the first detection data and the second detection data.

[0019] In one embodiment, the processor calculates the detection result of the cell particles based on the first detection data and the second detection data, including:

[0020] The processor obtains detection data whose volume is less than or equal to a first value from the first detection data;

[0021] The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value;

[0022] The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

[0023] In one embodiment, the processor determines the first value and / or the second value based on the second detection data.

[0024] In one embodiment, the first value is the volume value with the largest number in the volume distribution of platelets.

[0025] In one embodiment, the second value is a critical volume value of platelets and red blood cells.

[0026] In one embodiment, the processor calculates the detection result of the cell particles based on the first detection data and the second detection data, including:

[0027] The processor generates a first histogram of cell particles according to the first detection data;

[0028] The processor generates a second histogram of cell particles according to the second detection data;

[0029] The processor calculates the detection result of the cell particles according to the first histogram and the second histogram.

[0030] In one embodiment, the processor calculates the detection result of the cell particles based on the first histogram and the second histogram, including:

[0031] The processor obtains histogram information of a volume in the first histogram that is less than or equal to a first value;

[0032] The processor obtains histogram information of a volume in the second histogram that is greater than the first value and less than a second value;

[0033] The processor calculates the number of platelets based on histogram information of volumes less than or equal to a first value in the first histogram and histogram information of volumes greater than the first value and less than a second value in the second histogram.

[0034] In one embodiment, the processor calculates the detection result of the cell particles based on the first histogram and the second histogram, including:

[0035] The processor obtains histogram information of a volume in the first histogram that is less than or equal to a first value;

[0036] The processor obtains histogram information of a volume in the second histogram that is greater than the first value and less than a second value;

[0037] The processor performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value, to obtain histogram information in which the platelet volume is greater than or equal to the second value;

[0038] The processor calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to a first value, the histogram information in the second histogram whose volume is greater than the first value and less than a second value, and the histogram information in which the platelet volume is greater than or equal to the second value.

[0039] In one embodiment, the processor determines the first value and / or the second value based on the second histogram.

[0040] In one embodiment, the processor determines the first value and / or the second value according to the second histogram, comprising:

[0041] The processor removes the histogram information of the second histogram whose volume is smaller than the third value to eliminate the influence of the red blood cell fragments;

[0042] The processor determines the first value and / or the second value based on the second histogram excluding histogram information having a volume smaller than a third value.

[0043] In one embodiment, the first reagent comprises a hypotonic diluent.

[0044] In one embodiment, the measuring component includes an impedance counting component.

[0045] In one embodiment, the measuring component includes an optical detection unit; the optical detection unit includes a flow chamber, a light source and an optical detector; the flow chamber is connected to the reaction unit, and is used for allowing cells of the test sample to pass through one by one, the light source is used to illuminate the cells passing through the flow chamber, and the optical detector is used to obtain light signals of the cells passing through the flow chamber, and the light signals at least include forward scattered light signals.

[0046] According to a second aspect, an embodiment provides a sample analysis device, comprising:

[0047] A sample supply unit for supplying a sample, such as a blood sample or a body fluid sample; the body fluid sample may be, for example, cerebrospinal fluid, pleural effusion, ascites, cystic fluid, joint fluid, peritoneal dialysis dialysis fluid, or intraperitoneal lavage fluid;

[0048] A reagent supply unit, used for supplying reagents;

[0049] a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample;

[0050] a measuring unit, used for detecting the sample to obtain detection data;

[0051] The processor calculates a detection result based on the detection data; wherein:

[0052] The analysis device has a normal processing mode and an abnormal processing mode for cell particles, wherein the cell particles include platelets and / or red blood cells;

[0053] In normal processing mode of the cell particles:

[0054] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells;

[0055] The processor controls the measuring unit to detect the first sample to obtain first detection data related to the volume of the cell particles, wherein the first detection data is used to calculate the detection result of the cell particles;

[0056] In the abnormal processing mode of the cell particles:

[0057] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles;

[0058] The processor controls the measuring unit to detect the second sample to obtain second detection data related to the volume of the cell particles;

[0059] The processor calculates the detection result of the cell particles based on at least the second detection data.

[0060] In one embodiment, the processor calculates the detection result of the cell particles based on at least the second detection data, including:

[0061] The processor calculates a detection result of the cell particles according to the first detection data and the second detection data, wherein a sample used to prepare the first sample and a sample used to prepare the second sample are from the same subject.

[0062] In one embodiment, the processor calculates the detection result of the cell particles based on the first detection data and the second detection data, including:

[0063] The processor obtains detection data of which the volume is less than or equal to a first value in the first detection data;

[0064] The processor obtains detection data in the second detection data whose volume is greater than the first value (and less than the second value);

[0065] The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

[0066] In one embodiment, the processor determines the first value and / or the second value based on the second detection data.

[0067] In one embodiment, the first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

[0068] In one embodiment, the first reagent comprises a hypotonic diluent.

[0069] In one embodiment, it is characterized in that, in the normal processing mode of the cell particles:

[0070] The processor further determines whether the cell particles are abnormal based on the first detection data;

[0071] When an abnormality is determined, the processor generates a prompt message, and / or the processor switches to an abnormality processing mode of the cell particles to retest the sample.

[0072] According to a third aspect, an embodiment provides a sample analysis device, comprising:

[0073] A sample supply unit for supplying a sample, such as a blood sample or a body fluid sample; the body fluid sample may be, for example, cerebrospinal fluid, pleural effusion, ascites, cystic fluid, joint fluid, peritoneal dialysis dialysis fluid, or intraperitoneal lavage fluid;

[0074] A reagent supply unit, used for supplying reagents;

[0075] a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample;

[0076] a measuring unit, used for detecting the sample to obtain detection data;

[0077] The processor calculates a detection result based on the detection data; wherein:

[0078] The analysis device has a special processing mode for cell particles, wherein the cell particles include platelets and / or red blood cells; in the special processing mode for cell particles:

[0079] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles;

[0080] The processor controls the measuring unit to detect the second sample to obtain second detection data related to the volume of the cell particles;

[0081] The processor calculates the detection result of the cell particles based on at least the second detection data.

[0082] In one embodiment, in the special processing mode of the cell particles:

[0083] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor controls the measurement unit to detect the first sample to obtain first detection data related to the volume of the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject;

[0084] The processor calculates the detection result of the cell particles based on at least the second detection data, including: the processor calculates the detection result of the cell particles based on the first detection data and the second detection data.

[0085] In one embodiment, the processor calculates the detection result of the cell particles based on the first detection data and the second detection data, including:

[0086] The processor obtains detection data of which the volume is less than or equal to a first value in the first detection data;

[0087] The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value;

[0088] The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

[0089] In one embodiment, the processor determines the first value and / or the second value based on the second detection data.

[0090] In one embodiment, the first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

[0091] In one embodiment, the first reagent comprises a hypotonic diluent.

[0092] According to a fourth aspect, an embodiment provides an analysis device for animals, comprising:

[0093] A sample supply unit for supplying a sample, such as a blood sample or a body fluid sample; the body fluid sample may be, for example, cerebrospinal fluid, pleural effusion, ascites, cystic fluid, joint fluid, peritoneal dialysis dialysis fluid, or intraperitoneal lavage fluid;

[0094] A reagent supply unit, used for supplying reagents;

[0095] a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample;

[0096] a measuring unit, used for detecting the sample to obtain detection data;

[0097] The processor calculates a detection result based on the detection data; wherein:

[0098] The animal analysis device includes at least a first type of animal-specific mode. In the first type of animal-specific mode:

[0099] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles;

[0100] The processor controls the measuring unit to detect the second sample to obtain second detection data related to the volume of the cell particles;

[0101] The processor calculates the detection result of the cell particles based on at least the second detection data.

[0102] In one embodiment, in the first type of animal-specific mode:

[0103] The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor controls the measurement unit to detect the first sample to obtain first detection data related to the volume of the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject;

[0104] The processor calculates the detection result of the cell particles based on at least the second detection data, including: the processor calculates the detection result of the cell particles based on the first detection data and the second detection data.

[0105] In one embodiment, the processor calculates the detection result of the cell particles based on the first detection data and the second detection data, including:

[0106] The processor obtains detection data whose volume is less than or equal to a first value from the first detection data;

[0107] The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value;

[0108] The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

[0109] In one embodiment, the processor determines the first value and / or the second value based on the second detection data.

[0110] In one embodiment, the first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

[0111] In one embodiment, the first reagent comprises a hypotonic diluent.

[0112] In one embodiment, the first type of animals includes at least cats.

[0113] According to a fifth aspect, an embodiment provides a sample analysis method, including:

[0114] Treating the sample with a reagent, the reagent including a first reagent for increasing the volume of red blood cells in the sample, to prepare a second sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the sample may be a blood sample or a body fluid sample; the body fluid sample may be, for example, cerebrospinal fluid, pleural effusion, ascites, sacral fluid, joint fluid, peritoneal dialysis dialysate, or intraperitoneal lavage fluid;

[0115] treating a sample with a reagent that does not include the first reagent to prepare a first sample for detecting cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject;

[0116] detecting the first sample and the second sample to obtain first detection data and second detection data, respectively;

[0117] The detection result of the cell particles is calculated according to the first detection data and the second detection data.

[0118] In one embodiment, calculating the detection result of the cell particles based on the first detection data and the second detection data includes:

[0119] Acquire detection data of which the volume is less than or equal to a first value in the first detection data;

[0120] Acquire detection data of the second detection data, the volume of which is greater than the first value and less than the second value;

[0121] The number of platelets is calculated based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

[0122] In one embodiment, the analysis method further includes: determining the first value and / or second value based on the second detection data; the first value is the volume value with the largest number in the volume distribution of platelets, and the second value is the volume critical value of platelets and red blood cells.

[0123] In one embodiment, the first reagent comprises a hypotonic diluent.

[0124] According to a sixth aspect, an embodiment provides a computer-readable storage medium, wherein the computer-readable storage medium stores a program, and the program can be executed by a processor to implement the method described in any embodiment of the present invention.

[0125] According to the sample analysis device, animal analysis device, sample analysis method, and computer-readable storage medium of the above-described embodiments, by expanding RBCs, PLTs and RBCs are more easily distinguished in terms of volume information, thereby accurately counting PLTs and / or RBCs. BRIEF DESCRIPTION OF THE DRAWINGS

[0126] Figure 1(a) and Figure 1(b) are two examples of particle volume distribution histograms;

[0127] Figure 2 is a schematic structural diagram of a sample analysis device according to an embodiment;

[0128] Figure 3 is a schematic structural diagram of a sample analysis device according to another embodiment;

[0129] Figure 4 is a structural schematic diagram of an optical detection unit according to an embodiment;

[0130] Figure 5 is a structural schematic diagram of an optical detection unit according to an embodiment;

[0131] Figure 6 is a structural schematic diagram of an optical detection unit according to an embodiment;

[0132] Figure 7 This is a schematic structural diagram of an impedance counting component according to an embodiment;

[0133] Figure 8 An example of a volume distribution histogram of particles according to an embodiment;

[0134] FIG9(a) is an example of a histogram of a large PLT sample; FIG9(b) is an example of a histogram formed after processing according to the present invention;

[0135] Figure 10 is a schematic diagram showing the process of fusing the histograms of Figures 9(a) and 9(b);

[0136] Figure 11 is an example of the corrected PLT histogram;

[0137] FIG12( a ) is a schematic diagram of the PLT correlation effect obtained by counting using the prior art; FIG12( b ) is a schematic diagram of the PLT correlation effect obtained by counting using the present invention;

[0138] Figure 13 The figure is a flow chart of a sample analysis method according to an embodiment. DETAILED DESCRIPTION

[0139] The present invention will be further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. Similar elements in different embodiments are numbered with associated similar elements. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted in different circumstances, or may be replaced by other elements, materials, or methods. In some cases, some operations related to the present application are not shown or described in the specification. This is to avoid the core portion of the present application being overwhelmed by excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They will fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0140] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0141] The serial numbers assigned to components herein, such as "first," "second," etc., are used solely to distinguish the objects being described and do not convey any sequential or technical meaning. References to "connection" and "coupling" herein, unless otherwise specified, include both direct and indirect connections (couplings).

[0142] PLTs and RBCs can be distinguished and classified and counted using their volume information. However, in some samples with large PLTs, some PLTs overlap with RBCs in volume, making it impossible to accurately classify and count PLTs and RBCs using volume information.

[0143] RBCs are one of the most important blood cells, responsible for exchanging and transporting oxygen, carbon dioxide, metabolic products, and other substances. They typically appear pancake-shaped, with a concave center and protruding edges. For example, in the human body, the number of RBCs is 3.5 to 5.5 × 1012 / L, and the cell size is 7.5 to 8.5 μm.

[0144] Because RBCs are biconcave discs, not spheres, they are subject to volume expansion. While RBCs expand upon absorbing water, PLTs, being solid cell particles, maintain minimal volume change. This makes it easier to distinguish the volume information of RBCs and PLTs. For example, in histogram classification and counting, when an RBC swells, its histogram shifts to the right, increasing the distance between PLTs and RBCs on the histogram and improving the separation between RBCs and PLTs.

[0145] Specifically, the present invention proposes a solution for accurately counting PLTs and / or RBCs by using an RBC expansion method. The following first describes a sample analysis device.

[0146] Some embodiments disclose a sample analysis device. Figure 2 In some embodiments, the sample analysis device includes a sample supply unit 10, a reagent supply unit 20, a reaction unit 30, a measurement unit 40, and a processor 50. Specifically, the sample supply unit 10 is used to supply a sample; the sample can be a blood sample or a body fluid sample; the body fluid sample can be, for example, cerebrospinal fluid, pleural effusion, ascites, sacral fluid, joint fluid, peritoneal dialysis dialysis fluid, or intraperitoneal lavage fluid; the reagent supply unit 20 is used to supply a reagent; the reaction unit 30 is used to receive the sample provided by the sample supply unit 10 and the reagent provided by the reagent supply unit 20 to prepare a sample to be tested; the measurement unit 40 is used to test the prepared sample, or in other words, to test the sample to obtain test data; and the processor 50 is used to calculate a test result based on the test data. Each component is further described below.

[0147] In some embodiments, the sample supply portion 10 may include a sample needle, which 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 a container carrying the sample (such as a sample tube), and then move to a reaction site for providing a reaction for the sample to be tested and the reagent, such as the reaction portion 30, and add the sample to the reaction portion 30.

[0148] In some embodiments, the reagent supply unit 20 may include an area for holding reagent containers and a reagent liquid path connecting the reagent containers with the reaction unit 30, through which the reagent is added from the reagent container to the reaction unit 30. In some embodiments, the reagent supply unit 20 may also include a reagent needle, which is spatially moved in two or three dimensions by a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can move to absorb the reagent from the reagent container and then move to a reaction site for the sample to be tested and the reagent, such as the reaction unit 30, to add the reagent to the reaction unit 30.

[0149] The reaction section 30 may include one or more reaction cells. The reaction section 30 is used to provide a processing location or reaction site for samples and reagents. Different test items can share the same reaction cell; different test items can also use different reaction cells.

[0150] By using a reagent to treat the sample, a sample to be tested can be obtained. In some embodiments, the reagent includes one or more of a hemolytic agent, a fluorescent agent, and a diluent. A hemolytic agent is a reagent that can dissolve red blood cells in blood samples and body fluid samples. Specifically, it can be any one or a combination of cationic surfactants, nonionic surfactants, anionic surfactants, and amphiphilic surfactants. Fluorescent agents are used to stain blood cells, and the specific type is selected according to the test item. Isotonic electrolyte diluents can be used to maintain the morphology of cell particles to prepare samples for impedance counting, etc.

[0151] In some embodiments, please refer to Figure 3 The measuring unit 40 includes an optical detecting unit 60 and / or an impedance counting unit 80, which will be described in detail below.

[0152] In some embodiments, the measurement unit 40 may include an optical detection unit 60 . The optical detection unit 60 can measure the sample based on the principle of laser scattering. The principle is to irradiate laser light on cells and collect the optical signals generated by the cells, such as scattered light and fluorescence, to classify and count the cells. Of course, in some embodiments, if the cells are not treated with a fluorescent reagent, no fluorescence will be collected. The optical detection unit 60 in the measurement unit 40 is described below.

[0153] In some embodiments, the optical detection unit 60 can measure samples based on the principle of laser scattering. This principle involves irradiating cells with laser light and collecting the resulting optical signals, such as scattered light and / or fluorescence, to classify and count the cells. Of course, in some embodiments, if the cells are not treated with a fluorescent reagent, no fluorescence can be collected. The optical detection unit 60 in the measurement unit 40 is described below.

[0154] Please refer to Figure 4 The optical detection unit 60 may include a light source 61, a flow chamber 62, and an optical detector 69. The flow chamber 62 is connected to the reaction unit 30 and is used for allowing cells to be tested to pass through one by one; the light source 61 is used to illuminate the cells passing through the flow chamber 62, and the optical detector 69 is used to obtain optical signals from the cells passing through the flow chamber 62. Figure 5As a specific example of the optical detection unit 60, the optical detector 69 may include a lens group 63 for collecting forward scattered light, a photodetector 64 for converting the collected forward scattered light from an optical signal to an electrical signal, a lens group 65 for collecting side scattered light and side fluorescence, a dichroic mirror 66, a photodetector 67 for converting the collected side scattered light from an optical signal to an electrical signal, and a photodetector 68 for converting the collected side fluorescence from an optical signal to an electrical signal; wherein the dichroic mirror 66 is used to split the light, dividing the mixed side scattered light and side fluorescence into two paths, one for side scattered light and the other for side fluorescence. It should be noted that the optical signal herein can refer to an optical signal or an electrical signal converted from an optical signal, and they are essentially the same in terms of the information contained in characterizing the cell detection results.

[0155] Let's take Figure 5 The structure of the optical detection unit 60 is taken as an example to illustrate how the optical detection unit 60 specifically obtains the optical signal of the sample to be tested.

[0156] The flow chamber 62 is used for allowing the cells of the sample to be tested to pass through one by one. For example, in the reaction part 30, the red blood cells in the sample are dissolved by some reagents such as hemolytic agents, or further stained with fluorescent agents, and then the sheath flow technology is adopted to allow the cells in the prepared sample to be tested to queue up one by one and pass through the flow chamber 62. The Y-axis direction in the figure is the direction of movement of the cells in the sample to be tested. It should be noted that the Y-axis direction in the figure is perpendicular to the paper surface. The light source 61 is used to irradiate the cells passing through the flow chamber 62. In some embodiments, the light source 61 is a laser, such as a helium-neon laser or a semiconductor laser. When the light emitted by the light source 61 irradiates the cells in the flow chamber 62, it will scatter to the surroundings. Therefore, when the cells in the prepared test sample pass through the flow chamber 62 one by one under the action of the sheath flow, the light emitted by the light source 61 irradiates the cells passing through the flow chamber 62. The light irradiated on the cells will be scattered in all directions, and the forward scattered light is collected by the lens group 63 - for example, in the direction of the Z axis in the figure, so that it reaches the photodetector 64, so that the information processing unit 70 can obtain the forward scattered light information of the cells from the photodetector 64; at the same time, the side light is collected by the lens group 65 in a direction perpendicular to the light irradiated on the cells - for example, in the direction of the X axis in the figure, and the collected side light is reflected and refracted by the dichroic mirror 66, wherein the side scattered light in the side light is reflected when passing through the dichroic mirror 66, and then reaches the corresponding photodetector 67, and the side fluorescence in the side light is refracted or transmitted and also reaches the corresponding photodetector 68, so that the processor 50 can obtain the side scattered light information of the cells from the photodetector 67, and obtain the side fluorescence information of the cells from the photodetector 68. Please refer to Figure 6, which is another example of the optical detection unit 60. In order to improve the light performance of the light source 61 irradiating the flow chamber 62, a collimating lens 61a can be introduced between the light source 61 and the flow chamber 62. The light emitted by the light source 61 is collimated by the collimating lens 61a and then irradiated to the cells passing through the flow chamber 62. In some examples, in order to reduce the collected fluorescence noise (i.e., without interference from other light), a filter 66a can be set in front of the photodetector 68. The side fluorescence after being split by the dichroic mirror 66 passes through the filter 66a before reaching the photodetector 68. In some embodiments, after the lens group 63 collects the forward scattered light, an aperture 63a is introduced to limit the angle of the forward scattered light that finally reaches the photodetector 64, for example, to limit the forward scattered light to forward scattered light with a low angle (or small angle).

[0157] It can be seen that by collecting the forward scattered light through the optical detection unit 60, detection data of cell particle related information can be obtained.

[0158] In some embodiments, please refer to Figure 7 The impedance counting component 80 includes a counting cell 81, a pressure source 83, a constant current power supply 85, and a voltage pulse detection component 87. The counting cell 81 includes a micropore 81a, and the counting cell 81 is used for the reaction unit 30 to receive the sample. The pressure source 83 is used to provide pressure so that the cells contained in the sample in the counting cell 81 pass through the micropore 81a. The two ends of the constant current power supply 85 are electrically connected to the two ends of the micropore 81a. The voltage pulse detection component 87 is electrically connected to the constant current power supply 85 and is used to detect the voltage pulse generated when the cells pass through the micropore 81a.

[0159] It can be seen that the impedance counting component 80 can also obtain detection data of cell particle related information.

[0160] In some embodiments of the present invention, the processor 50 includes, but is not limited to, a central processing unit (CPU), a microcontroller unit (MCU), a field-programmable gate array (FPGA), a digital signal processing unit (DSP), and other devices used to interpret computer instructions and process data in computer software. In some embodiments, the processor 50 is used to execute various computer applications stored in the non-transitory computer-readable storage medium, thereby causing the sample analysis device to perform the corresponding detection process.

[0161] In some embodiments, the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to provide samples and reagents to the reaction unit 30 respectively, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; in some embodiments, the first reagent includes a hypotonic diluent; the processor 50 controls the measuring unit 40 to detect the second sample to obtain second detection data related to the volume of the cell particles; the processor 50 calculates the detection results of the cell particles, such as PLT count and / or RBC count, based at least on the second detection data.

[0162] When the sample is treated with the first reagent to increase the volume of RBCs, i.e., to expand, it is necessary to control the concentration and amount of the hypotonic diluent so that the RBCs can absorb water and expand while ensuring that all or most of the RBCs do not lyse and produce RBC fragments due to excessive expansion. This is because PLTs are solid physical cells, so their volume will basically not change even in the hypotonic diluent, and RBC fragments will interfere with the counting of PLTs. Figure 8 For example, RBC fragments can interfere with the low-end signal of PLTs. Therefore, for more accurate PLT counting, it is necessary to consider removing the impact of RBC fragments. In some embodiments, PLT counting can be performed by combining the low-end signal of the unprocessed PLT histogram and the high-end signal of the PLT after the RBC expansion method. This can yield a more accurate PLT count, as described below.

[0163] Therefore, in some embodiments, the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to respectively provide a sample and a reagent to the reaction unit 30 to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor 50 controls the measurement unit 40 to detect the first sample to obtain first detection data related to the volume of the cell particles; the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to respectively provide a sample and a reagent to the reaction unit 30, the reagent including a first reagent for increasing the volume of red blood cells in the sample, to prepare a second sample for detecting the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; the processor 50 controls the measurement unit 40 to detect the second sample to obtain second detection data related to the volume of the cell particles; and the processor 50 calculates the detection result of the cell particles based on the first and second detection data. In some embodiments, the first reagent includes a hypotonic diluent.

[0164] In some embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 obtains detection data in the first detection data whose volume is less than or equal to a first value; the processor 50 obtains detection data in the second detection data whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the detection data in the first detection data whose volume is less than or equal to the first value, and the detection data in the second detection data whose volume is greater than the first value and less than the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second detection data. In some embodiments, the first value is the volume value with the largest number in the volume distribution of platelets. In some embodiments, the second value is the volume critical value of platelets and red blood cells.

[0165] In some specific embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 generates a first histogram of the cell particles based on the first detection data; the processor 50 generates a second histogram of the cell particles based on the second detection data; the processor 50 calculates the detection result of the cell particles based on the first histogram and the second histogram. For example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value and the histogram information in the second histogram whose volume is greater than the first value and less than the second value. For another example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value to obtain histogram information in which the platelet volume is greater than or equal to the second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value, the histogram information in the second histogram whose volume is greater than the first value and less than the second value, and the histogram information in which the platelet volume is greater than or equal to the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second histogram; specifically, the processor 50 removes the histogram information in the second histogram whose volume is less than a third value to eliminate the influence of red blood cell fragments; the processor 50 determines the first value and / or the second value based on the second histogram without the histogram information in which the volume is less than the third value. In some embodiments, the first value is the volume value with the largest number of platelets in the volume distribution, such as the value on the abscissa corresponding to the peak of PLT in a histogram. In some embodiments, the second value is the critical volume value of platelets and red blood cells, such as the value on the abscissa corresponding to the dividing line between PLT and RBC.

[0166] Let's take an example to illustrate this.

[0167] Let's use the impedance method as an example. When counting blood cells, both the cell count value and the cell volume distribution histogram are provided. The histogram uses cell volume as the horizontal axis and the cell number as the vertical axis to represent the distribution of a particular cell type. Conventional impedance counting methods count both PLTs and RBCs simultaneously. Therefore, when counting PLTs, it is necessary to first determine the boundary between PLTs and RBCs. In human blood samples, the size difference between PLTs and RBCs is significant, as shown in Figure 1(a). Consequently, there is a significant valley between the PLT histogram and the RBC histogram, making it relatively easy to determine the boundary. However, for abnormal human blood samples, such as large PLTs, or other large PLT samples, such as cat blood samples, where the size difference between PLTs and RBCs is not as significant, determining the boundary between PLTs and RBCs is extremely difficult, making PLT counting difficult. Figure 9(a) shows an example of a large PLT sample. From the histogram of Figure 9(a), it can be seen that the boundary between PLT and RBC overlaps seriously, making it difficult to demarcate; demarcation to the left will result in a low PLT count and a high RBC count; demarcation to the right will result in a high PLT count and a low RBC count. After treatment with a hypotonic diluent, this hypotonic diluent can ensure that the RBC cells absorb water and swell, but also ensure that most RBCs do not swell to the point of breaking; after swelling, the RBC's volume will increase, while the PLT is a solid entity cell, so its volume basically does not change; this is reflected in the histogram as the position of the PLT remains basically unchanged, while the RBC peak shifts to the right, as shown in Figure 9(b). As can be seen from Figure 9(b), after treatment with a hypotonic diluent, the RBC shifts to the right overall, generating some RBC fragments at the lower end of the signal, which affects the PLT histogram at the lower end. The PLT count can be calculated based on the histograms of Figures 9(a) and 9(b). Figure 10 The process of fusing the histograms of Figure 9(a) and Figure 9(b) is shown:

[0168] (1) In the histogram of Figure 9(b), the RBC fragment area on the left is excluded, for example, the histogram with x < 10 fL is removed;

[0169] (2) Calculate the peak position of the PLT histogram in Figure 9(b), which is recorded as X1; calculate the boundary position between RBC and PLT in Figure 9(b), which is recorded as X2;

[0170] (3) The area smaller than X1 takes the PLT histogram in Figure 9(a), and the area between X1 and X2 takes the PLT histogram in Figure 9(b); and the area larger than X2 can be fitted with a method such as LogNormal to give the remaining part, and finally get Figure 11 , which is the corrected PLT histogram.

[0171] PLT counts were performed using flow impedance cytometry on a large PLT sample (N = 49), such as a feline sample. The correlation of PLT counts obtained using the prior art is shown in Figure 12(a), with a correlation coefficient of R = 0.9274. The correlation of PLT counts using the present invention's solution is shown in Figure 12(b), with a correlation coefficient of R = 0.9892. This demonstrates that the present invention significantly improves PLT counting accuracy.

[0172] In some embodiments, the sample analysis device has a normal processing mode and an abnormal processing mode for cell particles. In some embodiments, the cell particles include platelets (PLTs) and / or red blood cells (RBCs). These two operating modes are described below.

[0173] In some embodiments, in a normal processing mode of cell particles: the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to respectively provide samples and reagents (e.g., isotonic diluent) to the reaction unit 30 to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor 50 controls the measurement unit 40 to detect the first sample to obtain first detection data related to the volume of the cell particles, and the first detection data is used to calculate the detection results of the cell particles; for example, the processor 50 calculates the detection results of the cell particles based on the first detection data, including PLT count and / or RBC count, etc.

[0174] In some embodiments, in the normal processing mode of cell particles: the processor 50 further determines whether the cell particles are abnormal based on the first detection data; when it is determined to be abnormal, the processor 50 generates a prompt message, and / or the processor 50 switches to the abnormal processing mode of the cell particles to retest the sample.

[0175] In some embodiments, in the abnormal processing mode of cell particles: the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to provide samples and reagents to the reaction unit 30 respectively, and the reagents include a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; in some embodiments, the first reagent includes a hypotonic diluent; the processor 50 controls the measuring unit 40 to detect the second sample to obtain second detection data related to the volume of the cell particles; the processor 50 calculates the detection results of the cell particles, such as PLT count and / or RBC count, etc., based at least on the second detection data.

[0176] When the sample is treated with the first reagent to increase the volume of the RBCs therein, i.e., to expand, the concentration and amount of the hypotonic diluent need to be controlled so that the RBCs can absorb water and expand while ensuring that all or most of the RBCs do not lyse and produce RBC fragments due to excessive expansion. This is because PLTs are solid, physical cells, and therefore their volume does not change substantially even in a hypotonic diluent. However, RBC fragments can interfere with PLT counting and the low-end signal of PLTs. Therefore, in order to more accurately count PLTs, it is necessary to consider removing the influence of RBC fragments. In some embodiments, when counting PLTs, the low-end signal of the untreated PLT histogram and the large signal of the PLT after the RBC expansion method can be used. By collecting and fusing the two, a more accurate PLT count can be obtained, as described in detail below.

[0177] In some embodiments, in the abnormal processing mode of cell particles, the processor 50 calculates the detection result of the cell particles based on at least the second detection data, including: the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject.

[0178] In some embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 obtains detection data in the first detection data whose volume is less than or equal to a first value; the processor 50 obtains detection data in the second detection data whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the detection data in the first detection data whose volume is less than or equal to the first value, and the detection data in the second detection data whose volume is greater than the first value and less than the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second detection data. In some embodiments, the first value is the volume value with the largest number in the volume distribution of platelets. In some embodiments, the second value is the volume critical value of platelets and red blood cells.

[0179] In some specific embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 generates a first histogram of the cell particles based on the first detection data; the processor 50 generates a second histogram of the cell particles based on the second detection data; the processor 50 calculates the detection result of the cell particles based on the first histogram and the second histogram. For example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value and the histogram information in the second histogram whose volume is greater than the first value and less than the second value. For another example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value to obtain histogram information in which the platelet volume is greater than or equal to the second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value, the histogram information in the second histogram whose volume is greater than the first value and less than the second value, and the histogram information in which the platelet volume is greater than or equal to the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second histogram; specifically, the processor 50 removes the histogram information in the second histogram whose volume is less than a third value to eliminate the influence of red blood cell fragments; the processor 50 determines the first value and / or the second value based on the second histogram without the histogram information in which the volume is less than the third value. In some embodiments, the first value is the volume value with the largest number of platelets in the volume distribution, such as the value on the abscissa corresponding to the peak of PLT in a histogram. In some embodiments, the second value is the critical volume value of platelets and red blood cells, such as the value on the abscissa corresponding to the dividing line between PLT and RBC.

[0180] In some embodiments, the sample analysis device has a special processing mode for cell particles. In some embodiments, the cell particles include platelets (PLTs) and / or red blood cells (RBCs). This special processing mode is described below.

[0181] In some embodiments, in a special processing mode for cell particles: the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to provide a sample and a reagent to the reaction unit 30, respectively. The reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; in some embodiments, the first reagent includes a hypotonic diluent; the processor 50 controls the measuring unit 40 to detect the second sample to obtain second detection data related to the volume of the cell particles; the processor 50 calculates the detection result of the cell particles based at least on the second detection data.

[0182] In some embodiments, in a special processing mode for cell particles: the processor 50 further controls the sample supply unit 10 and the reagent supply unit 20 to provide samples and reagents to the reaction unit 30, respectively, to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor 50 controls the measurement unit 40 to detect the first sample to obtain first detection data related to the volume of the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data.

[0183] In some embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 obtains detection data in the first detection data whose volume is less than or equal to a first value; the processor 50 obtains detection data in the second detection data whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the detection data in the first detection data whose volume is less than or equal to the first value, and the detection data in the second detection data whose volume is greater than the first value and less than the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second detection data. In some embodiments, the first value is the volume value with the largest number in the volume distribution of platelets. In some embodiments, the second value is the volume critical value of platelets and red blood cells.

[0184] In some specific embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 generates a first histogram of the cell particles based on the first detection data; the processor 50 generates a second histogram of the cell particles based on the second detection data; the processor 50 calculates the detection result of the cell particles based on the first histogram and the second histogram. For example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value and the histogram information in the second histogram whose volume is greater than the first value and less than the second value. For another example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value to obtain histogram information in which the platelet volume is greater than or equal to the second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value, the histogram information in the second histogram whose volume is greater than the first value and less than the second value, and the histogram information in which the platelet volume is greater than or equal to the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second histogram; specifically, the processor 50 removes the histogram information in the second histogram whose volume is less than a third value to eliminate the influence of red blood cell fragments; the processor 50 determines the first value and / or the second value based on the second histogram without the histogram information in which the volume is less than the third value. In some embodiments, the first value is the volume value with the largest number of platelets in the volume distribution, such as the value on the abscissa corresponding to the peak of PLT in a histogram. In some embodiments, the second value is the critical volume value of platelets and red blood cells, such as the value on the abscissa corresponding to the dividing line between PLT and RBC.

[0185] In some embodiments, the sample analysis device may be an animal analysis device, which includes at least a first type of animal-specific mode. In some embodiments, the first type of animal includes at least cats.

[0186] In some embodiments, in the first type of animal-specific mode: the processor 50 controls the sample supply unit 10 and the reagent supply unit 20 to provide samples and reagents to the reaction unit 30, respectively, wherein the reagents include a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; in some embodiments, the first reagent includes a hypotonic diluent; the processor 50 controls the measuring unit 40 to detect the second sample to obtain second detection data related to the volume of the cell particles; the processor 50 calculates the detection result of the cell particles based at least on the second detection data.

[0187] In some embodiments, in the first type of animal-specific mode: the processor 50 further controls the sample supply unit 10 and the reagent supply unit 20 to provide samples and reagents to the reaction unit 30, respectively, to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor 50 controls the measurement unit 40 to detect the first sample to obtain first detection data related to the volume of the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data.

[0188] In some embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 obtains detection data in the first detection data whose volume is less than or equal to a first value; the processor 50 obtains detection data in the second detection data whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the detection data in the first detection data whose volume is less than or equal to the first value, and the detection data in the second detection data whose volume is greater than the first value and less than the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second detection data. In some embodiments, the first value is the volume value with the largest number in the volume distribution of platelets. In some embodiments, the second value is the volume critical value of platelets and red blood cells.

[0189] In some specific embodiments, the processor 50 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: the processor 50 generates a first histogram of the cell particles based on the first detection data; the processor 50 generates a second histogram of the cell particles based on the second detection data; the processor 50 calculates the detection result of the cell particles based on the first histogram and the second histogram. For example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value and the histogram information in the second histogram whose volume is greater than the first value and less than the second value. For another example, the processor 50 obtains histogram information in the first histogram whose volume is less than or equal to a first value; the processor 50 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; the processor 50 performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value to obtain histogram information in which the platelet volume is greater than or equal to the second value; the processor 50 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value, the histogram information in the second histogram whose volume is greater than the first value and less than the second value, and the histogram information in which the platelet volume is greater than or equal to the second value. In some embodiments, the processor 50 determines the first value and / or the second value based on the second histogram; specifically, the processor 50 removes the histogram information in the second histogram whose volume is less than a third value to eliminate the influence of red blood cell fragments; the processor 50 determines the first value and / or the second value based on the second histogram without the histogram information in which the volume is less than the third value. In some embodiments, the first value is the volume value with the largest number of platelets in the volume distribution, such as the value on the abscissa corresponding to the peak of PLT in a histogram. In some embodiments, the second value is the critical volume value of platelets and red blood cells, such as the value on the abscissa corresponding to the dividing line between PLT and RBC.

[0190] Some embodiments of the present invention also disclose a sample analysis method. Figure 13 In some embodiments, the sample analysis method includes the following steps:

[0191] Step 100: The sample is treated with a reagent, including a first reagent for increasing the volume of red blood cells in the sample, to prepare a second sample for detecting cell particles; the cell particles may include platelets and / or red blood cells. For example, the first reagent may include a hypotonic diluent, and the sample is treated with the hypotonic diluent to prepare the second sample.

[0192] Step 110: Treat the sample with a reagent that does not include the first reagent to prepare a first sample for detecting cell particles. The sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject. For example, the sample is treated with an isotonic diluent to prepare the first sample.

[0193] Step 120: Detect the first sample and the second sample to obtain first detection data and second detection data respectively.

[0194] Step 130: Calculate the detection result of the cell particles according to the first detection data and the second detection data.

[0195] In some embodiments, step 130 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: step 130 obtaining detection data in the first detection data whose volume is less than or equal to a first value; step 130 obtaining detection data in the second detection data whose volume is greater than the first value and less than a second value; step 130 calculating the number of platelets based on the detection data in the first detection data whose volume is less than or equal to the first value and the detection data in the second detection data whose volume is greater than the first value and less than the second value. In some embodiments, step 130 determines the first value and / or the second value based on the second detection data. In some embodiments, the first value is the volume value with the largest number in the volume distribution of platelets. In some embodiments, the second value is the volume threshold value of platelets and red blood cells.

[0196] In some specific embodiments, step 130 calculates the detection result of the cell particles based on the first detection data and the second detection data, including: step 130 generating a first histogram of cell particles based on the first detection data; step 130 generating a second histogram of cell particles based on the second detection data; and step 130 calculating the detection result of the cell particles based on the first histogram and the second histogram. For example, step 130 obtains histogram information in the first histogram whose volume is less than or equal to a first value; step 130 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; and step 130 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value and the histogram information in the second histogram whose volume is greater than the first value and less than the second value. For another example, step 130 obtains histogram information in the first histogram whose volume is less than or equal to a first value; step 130 obtains histogram information in the second histogram whose volume is greater than the first value and less than a second value; step 130 performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value to obtain histogram information in which the platelet volume is greater than or equal to the second value; step 130 calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to the first value, the histogram information in the second histogram whose volume is greater than the first value and less than the second value, and the histogram information in which the platelet volume is greater than or equal to the second value. In some embodiments, step 130 determines the first value and / or the second value based on the second histogram; specifically, step 130 removes the histogram information in the second histogram whose volume is less than a third value to eliminate the influence of red blood cell fragments; step 130 determines the first value and / or the second value based on the second histogram without the histogram information in which the volume is less than the third value. In some embodiments, the first value is the volume value with the largest number of platelets in the volume distribution, such as the value on the abscissa corresponding to the peak of PLT in a histogram. In some embodiments, the second value is the critical volume value of platelets and red blood cells, such as the value on the abscissa corresponding to the dividing line between PLT and RBC.

[0197] The present invention can be applied to situations where there are large PLT samples, or situations where there is not a significant difference in size between PLT and RBC. In these situations, the present invention can also achieve accurate counting of PLTs.

[0198] This document is described with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope of this document. For example, the various operational steps and components used to perform the operational steps may be implemented in different ways (e.g., one or more steps may be deleted, modified, or incorporated into other steps) depending on the specific application or considering any number of cost functions associated with the operation of the system.

[0199] In the above embodiments, all or part of the embodiments may be implemented through software, hardware, firmware, or any combination thereof. Furthermore, as will be appreciated by those skilled in the art, the principles herein may be embodied in a computer program product on a computer-readable storage medium pre-installed with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions may be loaded onto a general-purpose computer, a special-purpose computer, or other programmable data processing device to form a machine, such that the instructions executed on the computer or other programmable data processing device can generate a device that implements a specified function. These computer program instructions may also be stored in a computer-readable memory, which can instruct the computer or other programmable data processing device to operate in a specific manner, such that the instructions stored in the computer-readable memory can form an article of manufacture, including an implementation device that implements a specified function. The computer program instructions may also be loaded onto a computer or other programmable data processing device, thereby causing the computer or other programmable device to execute a series of operational steps to generate a computer-implemented process, such that the instructions executed on the computer or other programmable device can provide the steps for implementing the specified function.

[0200] Although the principles of this invention have been shown in various embodiments, many modifications of structure, arrangement, proportion, elements, materials and components that are particularly suitable for specific environments and operational requirements can be used without departing from the principles and scope of this invention. The above modifications and other changes or amendments are intended to be included within the scope of this invention.

[0201] The foregoing detailed description has been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, the present disclosure will be considered in an illustrative rather than a restrictive sense, and all such modifications will be included within its scope. Similarly, the advantages, other advantages and solutions to the problems of the various embodiments have been described above. However, the benefits, advantages, solutions to the problems and any elements that can produce these, or make them more specific, should not be interpreted as critical, required or necessary. The term "comprising" and any other variants used in this article are all non-exclusive inclusions, so that a process, method, article or device that includes a list of elements includes not only these elements, but also other elements that are not explicitly listed or do not belong to the process, method, system, article or device. In addition, the term "coupled" and any other variants used in this article refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections and / or any other connections.

[0202] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the present invention should be determined solely by the claims.

Claims

1. A sample analysis device, characterized in that: include: A sample supply unit, used for supplying samples; A reagent supply unit, used for supplying reagents; a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample; A measuring unit, configured to detect the sample to obtain detection data; the measuring unit includes an impedance counting component; The processor calculates the detection result based on the detection data; wherein: The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; The processor controls the impedance counting component to detect the first sample to obtain first detection data related to the volume of the cell particles; The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; The processor controls the impedance counting component to detect the second sample to obtain second detection data related to the volume of the cell particles; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data, including: The processor obtains detection data whose volume is less than or equal to a first value from the first detection data; The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value; The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

2. The sample analysis device according to claim 1, wherein The processor determines the first value and / or the second value according to the second detection data.

3. The sample analysis device according to claim 1 or 2, wherein: The first value is the volume value with the largest number in the volume distribution of platelets.

4. The sample analysis device according to claim 1 or 2, wherein: The second value is a critical value of the volume of platelets and red blood cells.

5. The sample analysis device according to claim 1, wherein: The processor calculates the detection result of the cell particles according to the first detection data and the second detection data, including: The processor generates a first histogram of cell particles according to the first detection data; The processor generates a second histogram of cell particles according to the second detection data; The processor calculates the detection result of the cell particles according to the first histogram and the second histogram.

6. The sample analysis device according to claim 5, wherein: The processor calculates the detection result of the cell particles according to the first histogram and the second histogram, including: The processor obtains histogram information of a volume in the first histogram that is less than or equal to a first value; The processor obtains histogram information of a volume in the second histogram that is greater than the first value and less than a second value; The processor calculates the number of platelets based on histogram information of volumes less than or equal to a first value in the first histogram and histogram information of volumes greater than the first value and less than a second value in the second histogram.

7. The sample analysis device according to claim 5, wherein: The processor calculates the detection result of the cell particles according to the first histogram and the second histogram, including: The processor obtains histogram information of a volume in the first histogram that is less than or equal to a first value; The processor obtains histogram information of a volume in the second histogram that is greater than the first value and less than a second value; The processor performs data fitting based on the histogram information in the second histogram whose volume is greater than the first value and less than the second value, to obtain histogram information in which the platelet volume is greater than or equal to the second value; The processor calculates the number of platelets based on the histogram information in the first histogram whose volume is less than or equal to a first value, the histogram information in the second histogram whose volume is greater than the first value and less than a second value, and the histogram information in which the platelet volume is greater than or equal to the second value.

8. The sample analysis device according to claim 6 or 7, wherein: The processor determines the first value and / or the second value based on the second histogram.

9. The sample analysis device according to claim 8, wherein: The processor determines the first value and / or the second value according to the second histogram, including: The processor removes the histogram information of the second histogram whose volume is smaller than the third value to eliminate the influence of the red blood cell fragments; The processor determines the first value and / or the second value based on the second histogram excluding histogram information having a volume smaller than a third value.

10. The sample analysis device according to claim 1, wherein: The first reagent includes a hypotonic diluent.

11. The sample analysis device according to claim 1, wherein: The measuring component also includes an optical detection unit; the optical detection unit includes a flow chamber, a light source and an optical detector; the flow chamber is connected to the reaction unit and is used to allow cells of the test sample to pass through one by one, the light source is used to illuminate the cells passing through the flow chamber, and the optical detector is used to obtain light signals of the cells passing through the flow chamber, and the light signals at least include forward scattered light signals.

12. A sample analysis device, characterized in that: include: A sample supply unit, used for supplying samples; A reagent supply unit, used for supplying reagents; a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample; A measuring unit, configured to detect the sample to obtain detection data; the measuring unit includes an impedance counting component; The processor calculates the detection result based on the detection data; wherein: The analysis device has a normal processing mode and an abnormal processing mode for cell particles, wherein the cell particles include platelets and / or red blood cells; In normal processing mode of the cell particles: The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; The processor controls the impedance counting component to detect the first sample to obtain first detection data related to the volume of the cell particles, wherein the first detection data is used to calculate the detection result of the cell particles; In the abnormal processing mode of the cell particles: The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; The processor controls the impedance counting component to detect the second sample to obtain second detection data related to the volume of the cell particles; The processor calculates a detection result of the cell particles based on the first detection data and the second detection data, wherein a sample used to prepare the first sample and a sample used to prepare the second sample are from the same subject; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data, including: The processor obtains detection data whose volume is less than or equal to a first value from the first detection data; The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value; The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

13. The sample analysis device according to claim 12, wherein: The processor determines the first value and / or the second value according to the second detection data.

14. The sample analysis device according to claim 12 or 13, wherein: The first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

15. The sample analysis device according to claim 12, wherein: The first reagent includes a hypotonic diluent.

16. The sample analysis device according to claim 12, wherein: In normal processing mode of the cell particles: The processor further determines whether the cell particles are abnormal based on the first detection data; When an abnormality is determined, the processor generates a prompt message, and / or the processor switches to an abnormality processing mode of the cell particles to retest the sample.

17. A sample analysis device, characterized in that: include: A sample supply unit, used for supplying samples; A reagent supply unit, used for supplying reagents; a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample; A measuring unit, configured to detect the sample to obtain detection data; the measuring unit includes an impedance counting component; The processor calculates the detection result based on the detection data; wherein: The analysis device has a special processing mode for cell particles, wherein the cell particles include platelets and / or red blood cells; in the special processing mode for cell particles: The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor controls the impedance counting component to detect the first sample to obtain first detection data related to the volume of the cell particles; The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; The processor controls the impedance counting component to detect the second sample to obtain second detection data related to the volume of the cell particles; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data, including: The processor obtains detection data whose volume is less than or equal to a first value from the first detection data; The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value; The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

18. The sample analysis device according to claim 17, wherein: The processor determines the first value and / or the second value according to the second detection data.

19. The sample analysis device according to claim 17 or 18, wherein: The first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

20. The sample analysis device according to claim 17, wherein: The first reagent includes a hypotonic diluent.

21. An analysis device for animals, characterized in that: include: A sample supply unit, used for supplying samples; A reagent supply unit, used for supplying reagents; a reaction unit, the reaction unit being configured to receive the sample provided by the sample supply unit and the reagent provided by the reagent supply unit to prepare a test sample; A measuring unit, configured to detect the sample to obtain detection data; the measuring unit includes an impedance counting component; The processor calculates the detection result based on the detection data; wherein: The animal analysis device includes at least a first type of animal-specific mode. In the first type of animal-specific mode: The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit to prepare a first sample for detecting cell particles; the cell particles include platelets and / or red blood cells; the processor controls the impedance counting component to detect the first sample to obtain first detection data related to the volume of the cell particles; The processor controls the sample supply unit and the reagent supply unit to respectively provide a sample and a reagent to the reaction unit, wherein the reagent includes a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting the cell particles; The processor controls the impedance counting component to detect the second sample to obtain second detection data related to the volume of the cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data; The processor calculates the detection result of the cell particles according to the first detection data and the second detection data, including: The processor obtains detection data whose volume is less than or equal to a first value from the first detection data; The processor obtains detection data of the second detection data whose volume is greater than the first value and less than the second value; The processor calculates the number of platelets based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

22. The animal analysis device according to claim 21, wherein The processor determines the first value and / or the second value according to the second detection data.

23. The analysis device according to claim 21 or 22, characterized in that The first value is the volume value of the largest number of platelets in the volume distribution; the second value is the volume critical value of platelets and red blood cells.

24. The animal analysis device according to claim 21, wherein The first reagent includes a hypotonic diluent.

25. The animal analysis device according to claim 21, wherein The first category of animals includes at least cats.

26. A sample analysis method, characterized in that: include: Treating the sample with a reagent comprising a first reagent for increasing the volume of red blood cells in the sample to prepare a second sample for detecting cell particles; the cell particles comprising platelets and / or red blood cells; treating a sample with a reagent that does not include the first reagent to prepare a first sample for detecting cell particles; wherein the sample used to prepare the first sample and the sample used to prepare the second sample are from the same subject; detecting the first sample and the second sample by an impedance counting component to obtain first detection data and second detection data respectively; Calculating a detection result of the cell particles according to the first detection data and the second detection data; Calculating the detection result of the cell particles according to the first detection data and the second detection data includes: Acquire detection data of which the volume is less than or equal to a first value in the first detection data; Acquire detection data of the second detection data, the volume of which is greater than the first value and less than the second value; The number of platelets is calculated based on the detection data of the first detection data having a volume less than or equal to a first value and the detection data of the second detection data having a volume greater than the first value and less than a second value.

27. The sample analysis method according to claim 26, wherein: Also includes: determining the first value and / or the second value according to the second detection data; The first value is the volume value of the largest number of platelets in the volume distribution, and the second value is the volume critical value of platelets and red blood cells.

28. The sample analysis method according to claim 26, wherein: The first reagent includes a hypotonic diluent.

29. A computer-readable storage medium, characterized in that The computer-readable storage medium stores a program, which can be executed by a processor to implement the method according to any one of claims 26 to 28.

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