Blood testing method and blood analysis system

Abstract

The application provides a blood detection method and a blood analysis system. The method comprises: treating a blood sample with a first reagent to obtain a first test sample, wherein the first reagent comprises a hemolytic agent, and the hemolytic agent can lyse red blood cells in the blood sample into fragments with optical scattering characteristics significantly different from those of platelets; making particles in the first test sample pass through a flow chamber of an optical detection system one by one, and acquiring optical information of the first test sample; identifying platelets in the first test sample according to forward scattering light information in the optical information; and obtaining a detection result of the platelets according to optical information of the platelets. According to the blood detection method and the blood analysis system, platelets in a blood sample after deep hemolysis can be identified only by using forward scattering light signals of cells in the blood sample after deep hemolysis, and then a detection result of the platelets can be obtained according to optical information of the identified platelets.

Description

Technical Field

[0001] This application relates to the field of sample testing technology, and more specifically to a blood testing method and a blood analysis system. Background Technology

[0002] Most existing blood analyzers count platelets using impedance measurement. By measuring the impedance of a diluted blood sample, cell volume information can be obtained, allowing for the classification of platelets and red blood cells based on cell volume. While impedance measurement systems provide relatively accurate results in platelet counting in most cases, they still have limitations. For example, impedance measurement methods cannot distinguish between platelets and interfering particles, such as microcytes and schistocytes (also known as red blood cell fragments), leading to falsely high platelet counts. On the other hand, large and giant platelets may exceed the predetermined threshold for platelet counting in impedance measurement methods and be classified as red blood cells, resulting in falsely low platelet counts.

[0003] To overcome the shortcomings of impedance measurement methods, some high-end blood analyzers have added optical measurement channels for platelets. While optical measurement reduces the impact of the aforementioned interferences on platelet measurements, the additional optical detection channels for platelet detection significantly increase the complexity of blood analyzers and raise the costs of instrument manufacturing and maintenance services.

[0004] Therefore, there is a need for a simple, low-cost, and reliable blood testing method and instrument system to accurately detect platelets in blood samples in the presence of interfering substances. Summary of the Invention

[0005] This application is made to address the aforementioned problems. According to one aspect of this application, a blood testing method is provided, the method comprising: treating a blood sample with a first reagent to obtain a first test sample, the first reagent including a hemolysin, the hemolysin lysing red blood cells in the blood sample into fragments with light scattering characteristics significantly different from platelets; passing particles in the first test sample one by one through a flow chamber of an optical detection system to acquire optical information of the first test sample; identifying platelets in the first test sample based on forward-scattered light information in the optical information; and obtaining a platelet detection result based on the optical information of the platelets.

[0006] According to another aspect of this application, a blood analysis system is provided, the blood analysis system comprising: a sampling unit for acquiring a blood sample and conveying the blood sample to a reaction unit; a reagent supply unit for storing at least a first reagent and supplying it to the reaction unit as needed; the reaction unit including a first mixing chamber for mixing the blood sample with the first reagent to form a first test sample, wherein the first reagent includes a hemolytic agent that lyses red blood cells in the blood sample into fragments with light scattering characteristics significantly different from platelets; and an optical detection system including a light source, a flow chamber, and at least an optical detector, the light source being used to emit a light beam to illuminate the flow chamber. The system includes a flow chamber, which is connected to the first mixing chamber and through which particles in the first test sample can pass one by one; an optical detector for detecting optical information generated by particles passing through the flow chamber after being irradiated by light; and a data processing module operatively connected to the optical detection system, comprising a processor and a non-transitory computer-readable storage medium storing a computer program, wherein when the computer program is run by the processor, the processor performs the following steps: identifying platelets in the first test sample based on forward-scattered light information in the optical information; and obtaining platelet detection results based on the optical information of the platelets.

[0007] The blood testing method and blood analysis system according to the embodiments of this application can identify platelets in a deeply hemolyzed blood sample by using only the forward scattered light signal of cells in the blood sample. Then, the platelet detection results can be obtained based on the optical information of the identified platelets. Therefore, only the white blood cell counting channel or the classification channel (hemolysis channel) is needed to obtain platelet detection results, without the need to add an additional optical platelet detection channel, which reduces the cost of clinical testing and the complexity of instruments. Attached Figure Description

[0008] The above and other objects, features, and advantages of this application will become more apparent from the more detailed description of the embodiments of this application in conjunction with the accompanying drawings. The accompanying drawings are used to provide a further understanding of the embodiments of this application and form part of the specification. They are used together with the embodiments of this application to explain this application and do not constitute a limitation thereof. In the accompanying drawings, the same reference numerals generally represent the same components or steps.

[0009] Figure 1 A schematic flowchart of a blood testing method according to an embodiment of this application is shown.

[0010] Figure 2 This diagram illustrates how platelets in a first test sample are separated from lysed red blood cell fragments and white blood cells based on forward-scattered light information in a blood testing method according to an embodiment of this application.

[0011] Figure 3 This is a schematic diagram showing a platelet volume distribution histogram obtained by a blood testing method according to an embodiment of this application.

[0012] Figure 4 This diagram illustrates a blood testing method according to an embodiment of the present application, in which leukocyte subpopulation data is obtained based on forward scattering light information and side scattering light information of leukocytes.

[0013] Figure 5 This diagram illustrates a blood testing method according to an embodiment of the present application, in which reticulocyte count results are obtained based on forward scatter light information and fluorescence information.

[0014] Figure 6 This diagram illustrates a blood testing method according to an embodiment of the present application, in which leukocyte subset data are obtained based on lateral scattered light information and fluorescence information.

[0015] Figure 7 This diagram illustrates the graphical differences between the distribution of the first and second platelets when platelet counts are normal and abnormal.

[0016] Figure 8 A schematic structural block diagram of a blood analysis system according to an embodiment of this application is shown. Detailed Implementation

[0017] To make the objectives, technical solutions, and advantages of this application more apparent, exemplary embodiments according to this application will be described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of this application, and not all embodiments of this application. It should be understood that this application is not limited to the exemplary embodiments described herein. Based on the embodiments of this application described herein, all other embodiments obtained by those skilled in the art without inventive effort should fall within the protection scope of this application.

[0018] First, refer to Figure 1 This application describes a blood testing method according to embodiments thereof. Figure 1 A schematic flowchart of a blood testing method 100 according to an embodiment of this application is shown. Figure 1 As shown, the blood testing method 100 according to an embodiment of this application may include the following steps:

[0019] In step S110, a blood sample is treated with a first reagent to obtain a first test sample. The first reagent includes a hemolytic agent, which lyses the red blood cells in the blood sample into fragments with light scattering properties significantly different from those of platelets.

[0020] In step S120, the particles in the first test sample are passed one by one through the flow chamber of the optical detection system to obtain the optical information of the first test sample.

[0021] In step S130, platelets in the first test sample are identified based on the forward scattered light information in the optical information.

[0022] In step S140, the platelet detection result is obtained based on the optical information of the platelets.

[0023] In embodiments of this application, a first reagent comprising a hemolytic agent is used to hemolyze blood samples. This first reagent can lyse red blood cells in the blood sample into fragments with light scattering characteristics significantly different from platelets. Compared to conventional hemolytic agents, this first reagent breaks the cell membranes of red blood cells into smaller fragments. Therefore, in the scatter plot of forward and side-scattered light intensity obtained by optical detection, only the forward-scattered light intensity can clearly distinguish between platelet regions and red blood cell fragment regions, achieving accurate and precise detection and counting of platelets.

[0024] In the embodiments of this application, the hemolytic agent included in the first reagent can be at least one of alkyl glycosides, triterpenoid saponins, and steroidal saponins. A specific hemolytic agent can be a glycoside compound having the general formula I: R-(CH2)n-CH3, wherein R is selected from the group consisting of monosaccharides, deoxymonosaccharides, and polysaccharides, and n is an integer from 5 to 17. The above-mentioned glycoside compounds can rapidly lyse red blood cells. Glycoside compounds are compounds formed by the dehydration of the hemiacetal hydroxyl group of a sugar (or polysaccharide) and the hydroxyl group of an alkanol. The glycoside compound in the hemolytic agent of this application can be a single compound or a mixture of two or more glycoside compounds conforming to the above general formula.

[0025] In embodiments of this application, the first reagent may further include, preferably, a nonionic surfactant of general formula II: R1-R2-(CH2CH2O)mH, and at least one organic acid or its salt. Wherein, R1 is a C8-C23 alkyl group, R2 is -O- or -COO-, and m is an integer from 10 to 50. The organic acid or its salt is selected from the group consisting of organic acids having at least one carboxyl or sulfonic acid group and their alkali metal salts. This nonionic surfactant can bind to the cell membrane to a certain extent, protecting the cell membranes of leukocytes and platelets from the influence of the aforementioned glycoside compounds and maintaining or substantially maintaining their cell morphology.

[0026] In this application, compounds of general formula I and general formula II are used in combination to achieve rapid and deep lysis of red blood cells, and to protect platelet cell membranes in order to effectively detect platelets.

[0027] The ratio of compounds of general formula I and general formula II varies depending on the compounds selected. However, generally speaking, the ratio of compounds of general formula I to general formula II is 1:100 to 1:3, preferably 1:25 to 1:5, and more preferably 1:10 to 1:5.

[0028] The first reagent of this application may further include conventional additives. These additives may be selectively added as needed, such as (but not limited to) buffers, metal chelating agents, osmotic pressure regulators, preservatives, etc.

[0029] The mixing ratio of the first reagent to the blood sample according to the embodiment is not particularly limited. For example, the volume mixing ratio of the blood sample to the first reagent can be 1:40 to 1:60. The hemolysis reaction is carried out at a temperature such as 40 to 60°C for 15 to 100 seconds, preferably 40 to 80 seconds. The reaction temperature and time can be adjusted according to specific conditions.

[0030] Generally, higher reaction temperatures and longer reaction times result in more severe lysis of red blood cells. However, since any hemolytic agent affects any cell membrane, in this paper, deep erythrocyte lysis (deep hemolysis) refers to reaction conditions chosen to further lyse red blood cells compared to the conventional approach, while platelets largely retain their cellular morphology, and preferably, white blood cells also largely retain their cellular morphology. On a scatter plot of light information, platelets, lysed red blood cells, and white blood cells can be distinguished into three groups solely through forward-scattered light information. See below for reference. Figure 2 To describe.

[0031] Figure 2 This diagram illustrates a blood testing method according to an embodiment of the present application, in which platelets in a first test sample are distinguished from lysed red blood cell fragments and white blood cells based on forward-scattered light information. Figure 2 As shown, in the scatter plot of forward scattered light (FSC) and side scattered light (SSC) information obtained from the test sample of blood sample, regardless of the side scattered light (SSC) information, the boundary line of the white blood cell region can be obtained solely based on the forward scattered light (FSC) information, which can distinguish white blood cells from platelets. At the same time, the boundary line of the platelet region can also be obtained, which can distinguish platelets from fragmented red blood cells.

[0032] Based on the optical information of platelets, platelet detection results can be obtained. Specifically, platelet counts can be directly obtained from a scatter plot. Furthermore, the scattered light information of particles corresponding to the platelet region can be analyzed to obtain the volume information of each particle, denoted as Vol, where volume is a function of scattered light information: Vol = f(SSC, FSC), where f can be in the following forms: 1) calculated using Mie scattering theory; 2) Vol = k * FSC, where k is a constant; 3) Vol = k * exp(b * FSC), where k and b are constants; where FSC in the above formulas represents the forward light scattering information of a single event in the platelet region of the aforementioned scatter plot. Based on the volume information of each particle, a platelet volume distribution histogram can be further obtained, such as... Figure 3 shown. Figure 3 This diagram illustrates a platelet volume distribution histogram obtained by a blood testing method according to an embodiment of this application. Figure 3 As shown, platelet morphological parameters, such as average platelet volume, volume distribution width, and proportion of large platelets, can be calculated from the platelet volume distribution histogram.

[0033] In a further embodiment of this application, the detection result of white blood cells in the blood sample can also be obtained based on the optical information of the distinguished white blood cell regions. Specifically, the white blood cell count result in the blood sample can be obtained based on the forward scatter light signal of the white blood cells. Alternatively, the classification result of white blood cells in the blood sample can be obtained based on the forward scatter light information and the side scatter light information in the optical information, including: classifying the white blood cells in the blood sample into subpopulations including monocytes, lymphocytes, and neutrophils, such as... Figure 4 shown. Figure 4 This diagram illustrates a blood testing method according to an embodiment of the present application, where leukocyte subpopulation data is obtained based on forward and side-scattered light information of leukocytes. For example... Figure 4 As shown, the magnified two-dimensional distribution of the distinguished leukocyte regions is displayed. This two-dimensional distribution of leukocytes is one form of leukocyte distribution obtained from the forward scattered light (FSC) and side scattered light (SSC) information of the leukocytes of the first test sample.

[0034] In a further embodiment of this application, the first reagent may further include a fluorescent dye. In this embodiment, by staining the blood sample with the fluorescent dye, fluorescence information can be obtained in the first test sample. Based on the forward scattered light information and the fluorescence information, the reticulocyte (RET) count result can be obtained, such as... Figure 5 shown. Figure 5 This diagram illustrates a blood testing method according to an embodiment of the present application, where reticulocyte counts are obtained based on forward-scattered light information and fluorescence information. Figure 5As shown, a two-dimensional scatter plot based on forward scattered light (FSC) and fluorescence (FL) information is displayed, in which the reticulocyte count results can be obtained.

[0035] This embodiment arose because the applicant discovered in their research that, in some blood samples containing a large number of reticulocytes, detection using only forward-scattered light resulted in interference from reticulocytes with platelets. Therefore, a fluorescent dye can be used to trigger a reticulocyte alarm to address this phenomenon. Specifically, particles can be counted in a preset area of ​​a two-dimensional scatter plot of forward-scattered light and fluorescence information. When the count exceeds a predetermined value (e.g., exceeding a certain platelet count), a reticulocyte alarm can be triggered for further examination of the subject.

[0036] In a further embodiment of this application, the first reagent may further include a fluorescent dye. In this embodiment, by staining the blood sample with the fluorescent dye, fluorescence information can be obtained in the first test sample. Based on the side-scattered light information and the fluorescence information, the classification result of white blood cells can be obtained, including: classifying the white blood cells in the blood sample into subgroups including monocytes, lymphocytes, neutrophils, and eosinophils, and / or identifying immature granulocytes, such as... Figure 6 shown. Figure 6 This diagram illustrates a blood testing method according to an embodiment of the present application, where leukocyte subset data is obtained based on lateral scattered light information and fluorescence information. Figure 6 As shown, a two-dimensional scatter plot based on side-scattered light information (SSC) and fluorescence information (FL) is displayed. In this scatter plot, the four classification results of white blood cells can be obtained—monocytes, lymphocytes, neutrophils, and eosinophils, and immature granulocytes can also be identified.

[0037] In a further embodiment of this application, the blood detection method 100 may further include the following steps (not shown): treating the blood sample with a second reagent to obtain a second test sample, the second reagent including a diluent; flowing the second test sample through a test orifice and detecting the impedance signal of the second test sample flowing through the test orifice; obtaining a second platelet distribution of the blood sample based on the impedance signal; using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution; obtaining red blood cell detection data of the blood sample; determining whether the blood sample contains red blood cell fragments based on the first platelet distribution, the second platelet distribution, and the red blood cell detection data; and issuing an alarm message when it is determined that the blood sample contains red blood cell fragments.

[0038] Furthermore, the presence of large platelets in the blood sample can be determined based on the first platelet distribution (e.g., distinguishing large platelet regions from platelet regions to obtain their particle count; if the particle count exceeds a threshold, it is determined that large platelets are present). The presence of small red blood cells can be determined based on red blood cell detection data. When the blood sample does not contain large platelets and is not a small red blood cell sample, and the second platelet distribution is abnormal, it can be determined that red blood cell fragments are present in the blood sample and an alarm can be triggered.

[0039] Alternatively, the number of first particles can be obtained from the distribution of second platelets within a preset volume range (the normal volume of large platelets), and the number of particles in the large platelet region of the platelet region in the first platelet distribution can be obtained as the second particle number. The difference between the first particle number and the second particle number can be compared. When the difference meets the preset conditions and the blood sample is determined not to be a small red blood cell sample based on the red blood cell detection data, it can be determined that there are red blood cell fragments in the blood sample and an alarm can be triggered.

[0040] Specifically, the mean erythrocyte volume (MRC) of a blood sample can be obtained based on the impedance signal in the second platelet distribution, and the MRC can be used to determine whether the blood sample contains microcytic cells. Specifically, it can be determined whether the MRC is greater than a preset MRC threshold; if the MRC is greater than the preset threshold, the blood sample is determined not to contain microcytic cells. For example, an MRC less than 80 fL is generally considered to contain microcytic cells. When the MRC obtained using this method is less than 80 fL, it can be determined that the blood sample contains microcytic cells.

[0041] Alternatively, the red blood cell volume distribution data of the blood sample can be obtained based on the impedance signal in the second platelet distribution; the volume located at a preset red blood cell volume percentage, such as the 20th, 30th, 60th, or 80th percentile, can be obtained based on the red blood cell volume distribution data, and whether the blood sample is a microcytic sample can be determined based on the volume at the preset red blood cell volume percentage. Specifically, it can be determined whether the volume at the aforementioned preset red blood cell volume percentage is greater than a preset threshold; when the determination result is that the volume at the preset red blood cell volume percentage is greater than the preset threshold, it is determined that the blood sample is not a microcytic sample.

[0042] In another embodiment, the presence of small red blood cells in a blood sample can also be determined by optical methods, including: calculating the volume of a single red blood cell using the scattered light from a single red blood cell, then calculating the average volume of all red blood cells, and determining whether the blood sample is a small red blood cell sample based on the average red blood cell volume.

[0043] In a further embodiment of this application, the blood detection method 100 may further include the following steps (not shown): treating the blood sample with a second reagent to obtain a second test sample, the second reagent including a diluent; flowing the second test sample through a test orifice and detecting the impedance signal of the second test sample flowing through the test orifice; obtaining a second platelet distribution of the blood sample based on the impedance signal; using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution; determining whether the detection step of the impedance signal has an abnormality based on the first platelet distribution and the second platelet distribution; and issuing an alarm message when it is determined that the detection step of the impedance signal has an abnormality.

[0044] Specifically, the distribution of the first platelet can be as described above. Figure 3 The hemolytic channel PLT volume histogram shown is illustrated. The second platelet distribution can be represented as the impedance channel PLT volume histogram. By comparing the graphical differences between these two histograms, it can be determined whether there are any abnormalities in the impedance signal detection. The following section combines... Figure 7 To describe, among which Figure 7 The upper part of the image shows an example where the platelet count test is normal. Figure 7 The lower half of the image shows an example of abnormal platelet counts. From Figure 7 The upper part of the figure shows that the difference between the PLT volume histogram of the hemolytic channel and the PLT volume histogram of the impedance channel is small, indicating that the platelet detection is normal; from Figure 7 The lower half of the figure shows a significant difference between the PLT volume histogram of the hemolysis channel and the PLT volume histogram of the impedance channel. This difference indicates an anomaly in the impedance signal detection, triggering an alarm. In the example above, the difference between the two histograms can be calculated by subtracting the histograms and checking if the maximum, mean, median, etc., values ​​of the deviations exceed preset values. If so, an anomaly in the impedance signal detection is considered, and an alarm is triggered. In other embodiments, platelet counts can be obtained from each of the two histograms. When the difference between the platelet counts calculated from the two histograms exceeds a preset value, an anomaly in the impedance signal detection is considered, and an alarm is triggered. Furthermore, it should be understood that this method for determining whether the impedance signal detection is abnormal is applicable to normal blood samples. This is because abnormal blood samples may already have differences in the volume distribution histograms of the impedance channel and the hemolysis channel, and these differences are not solely due to an abnormal detection channel.

[0045] The above exemplarily illustrates a method for detecting blood samples according to embodiments of this application. Based on the above description, the blood detection method according to embodiments of this application can identify platelets in a deeply hemolyzed blood sample using only the forward scattered light signal of cells in the sample. The platelet detection result is then obtained based on the optical information of the identified platelets. Therefore, only a white blood cell counting channel or a classification channel (hemolysis channel) is needed to obtain the platelet detection result, eliminating the need for an additional optical platelet detection channel, thus reducing clinical testing costs and instrument complexity.

[0046] The following is combined Figure 8 Describes a blood analysis system provided according to another aspect of this application. Figure 8 A schematic structural block diagram of a blood analysis system 800 according to an embodiment of this application is shown. Figure 8 As shown, the blood analysis system 800 includes a sampling unit 810, a reagent supply unit 820, a reaction unit 830, an optical detection system 840, and a data processing module 850. The sampling unit 810 acquires a blood sample and delivers it to the reaction unit 830. The reagent supply unit 820 stores at least a first reagent and supplies it to the reaction unit 830 as needed. The reaction unit 830 includes a first mixing chamber for mixing the blood sample with the first reagent to form a first test sample, wherein the first reagent includes a hemolysin that lyses red blood cells in the blood sample into fragments with light scattering characteristics significantly different from platelets. The optical detection system 840 includes a light source, a flow chamber, and at least an optical detector. The light source emits a light beam to illuminate the flow chamber, which is connected to the first mixing chamber, allowing particles in the first test sample to pass through the flow chamber one by one. The optical detector detects the optical information generated by the particles passing through the flow chamber after being illuminated by light. The data processing module 850 is operatively connected to the optical detection system 840 and includes a processor and a non-transitory computer-readable storage medium storing a computer program, wherein when the computer program is run by the processor, the processor performs the following steps: identifying platelets in the first test sample based on forward-scattered light information in the optical information; and obtaining a platelet detection result based on the optical information of the platelets.

[0047] The blood analysis system 800 according to the embodiments of this application can be used to perform the blood testing method 100 according to the embodiments of this application described above. Those skilled in the art can understand the structure and operation of the blood analysis system 800 in conjunction with the foregoing description of the blood testing method 100 according to the embodiments of this application. For the sake of brevity, the specific details of the operation of each component of the blood analysis system 800 will not be repeated here, but only their main operating steps will be briefly described.

[0048] In embodiments of this application, when the computer program is run by the processor, the processor executes the following steps: identifying platelets in the first test sample based on forward scattering information in the optical information; and obtaining platelet detection results based on the optical information of the platelets, including: distinguishing platelets in the first test sample from lysed red blood cell fragments and white blood cells based on forward scattering information in the optical information; and obtaining platelet counts and / or platelet morphology parameters based on the optical information of the platelets.

[0049] In an embodiment of this application, the reaction unit 830 further includes a second mixing chamber for mixing the blood sample with a second reagent to form a second test sample, wherein the second reagent includes a diluent, and the second test sample can flow through a test orifice in a flow path connected to the second mixing chamber; the system 800 further includes an impedance detector (not shown) for detecting the impedance signal of the second test sample flowing through the test orifice; the data processing module 850 is also operatively connected to the impedance detector, wherein when the computer program is run by the processor, the processor further performs the following steps: obtaining a second platelet distribution of the blood sample based on the impedance signal; using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution; obtaining red blood cell detection data of the blood sample; determining whether the blood sample contains red blood cell fragments based on the first platelet distribution, the second platelet distribution, and the red blood cell detection data; and issuing an alarm message when it is determined that the blood sample contains red blood cell fragments.

[0050] In an embodiment of this application, the reaction unit 830 further includes a second mixing chamber for mixing the blood sample with a second reagent to form a second test sample, wherein the second reagent includes a diluent, and the second test sample can flow through a test orifice in a flow path connected to the second mixing chamber; the system 800 further includes an impedance detector (not shown) for detecting the impedance signal of the second test sample flowing through the test orifice; the data processing module 850 is also operatively connected to the impedance detector, wherein when the computer program is run by the processor, the processor further performs the following steps: obtaining a second platelet distribution of the blood sample based on the impedance signal; using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution; determining whether an abnormality has occurred in the detection step of the impedance signal based on the first platelet distribution and the second platelet distribution; and issuing an alarm message when it is determined that an abnormality has occurred in the detection step of the impedance signal.

[0051] In an embodiment of this application, when the computer program is run by the processor, the processor also performs the following steps: classifying the white blood cells in the blood sample into subpopulations including monocytes, lymphocytes, and neutrophils based on the forward-scattered light information and the side-scattered light information in the optical information.

[0052] In embodiments of this application, the first reagent further includes a fluorescent dye, and when the computer program is run by the processor, the processor also performs the following steps: obtaining the reticulocyte count result based on the forward scattered light information and fluorescence information in the optical information.

[0053] Based on the above description, the blood analysis system according to the embodiments of this application can identify platelets in a deeply hemolyzed blood sample by using only the forward scattered light signal of cells in the blood sample. Then, it can obtain the platelet detection results based on the optical information of the identified platelets. Therefore, only the white blood cell counting channel or the classification channel (hemolysis channel) is needed to obtain the platelet detection results, without the need to add an additional optical platelet detection channel, which reduces the cost of clinical testing and the complexity of the instrument.

[0054] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

[0055] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0056] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another device, or some features may be ignored or not executed.

[0057] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of this application may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0058] Similarly, it should be understood that, in order to streamline this application and aid in understanding one or more of the various inventive aspects, features of this application may sometimes be grouped together in a single embodiment, figure, or description thereof in the description of exemplary embodiments of this application. However, this approach should not be construed as reflecting an intention that the claimed application requires more features than are expressly recited in each claim. Rather, as reflected in the corresponding claims, its inventive point lies in solving the corresponding technical problem with features fewer than all features of a single disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of this application.

[0059] Those skilled in the art will understand that, apart from the mutual exclusion of features, all features disclosed in this specification (including the accompanying claims, abstract, and drawings) and all processes or units of any method or apparatus so disclosed can be combined in any combination. Unless otherwise expressly stated, each feature disclosed in this specification (including the accompanying claims, abstract, and drawings) may be replaced by an alternative feature that serves the same, equivalent, or similar purpose.

[0060] Furthermore, those skilled in the art will understand that although some embodiments described herein include certain features but not others included in other embodiments, combinations of features from different embodiments are intended to be within the scope of this application and form different embodiments. For example, in the claims, any one of the claimed embodiments can be used in any combination.

[0061] The various component embodiments of this application can be implemented in hardware, or as software modules running on one or more processors, or a combination thereof. Those skilled in the art will understand that microprocessors or digital signal processors (DSPs) can be used in practice to implement some or all of the functions of some modules in the article analysis device according to the embodiments of this application. This application can also be implemented as an apparatus program (e.g., a computer program and computer program product) for performing part or all of the methods described herein. Such an implementation of this application can be stored on a computer-readable medium, or can be in the form of one or more signals. Such signals can be downloaded from an Internet website, provided on a carrier signal, or provided in any other form.

[0062] It should be noted that the above embodiments are illustrative of this application and not restrictive, and that those skilled in the art can devise alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses should not be construed as limiting the claims. The word "comprising" does not exclude the presence of elements or steps not listed in the claims. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. This application can be implemented by means of hardware comprising several different elements and by means of a suitably programmed computer. In the unit claims enumerating several means, several of these means may be embodied by the same item of hardware. The use of the words first, second, and third, etc., does not indicate any order. These words can be interpreted as names.

[0063] The above description is merely a specific embodiment or illustration of the embodiments of this application. The scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. The scope of protection of this application shall be determined by the scope of the claims.

Claims

1. A blood testing method, characterized in that, The method includes: A blood sample is treated with a first reagent to obtain a first test sample, the first reagent including a hemolytic agent, which lyses the red blood cells in the blood sample into fragments with light scattering properties significantly different from those of platelets; The particles in the first test sample are passed one by one through the flow chamber of the optical detection system to obtain the optical information of the first test sample; Platelets in the first test sample are identified solely based on the forward-scattered light information in the optical information. Based on the optical information of the platelets, the platelet detection results are obtained; The step of identifying platelets in the first test sample solely based on the forward-scattered light information in the optical information, and obtaining the platelet detection result based on the optical information of the platelets, includes: Based solely on the forward scattering light information in the optical information, platelets in the first test sample are distinguished from lysed red blood cell fragments and white blood cells; Based on the optical information of the platelets, platelet counts and / or platelet morphology parameters are obtained.

2. The method according to claim 1, characterized in that, The platelet morphological parameters include at least one of the following: average platelet volume, volume distribution width, and proportion of large platelets.

3. The method according to claim 1, characterized in that, The method further includes: Based on the forward and side-scattered light information in the optical information, the white blood cells in the blood sample are classified into subgroups including monocytes, lymphocytes, and neutrophils.

4. The method according to claim 1, characterized in that, The first reagent further includes a fluorescent dye, and the method further includes: The reticulocyte count results are obtained based on the forward scattered light information and fluorescence information in the optical information.

5. The method according to claim 1, characterized in that, The first reagent further includes a fluorescent dye, and the method further includes: Based on the side-scattered light information and fluorescence information in the optical information, the white blood cells in the blood sample are classified into subgroups including monocytes, lymphocytes, neutrophils and eosinophils, and / or immature granulocytes are identified.

6. The method according to claim 1, characterized in that, The method further includes: The blood sample is treated with a second reagent to obtain a second test sample, the second reagent comprising a diluent; The second test sample is flowed through the test orifice, and the impedance signal of the second test sample flowing through the test orifice is detected; The second platelet distribution of the blood sample is obtained based on the impedance signal; The platelet detection results obtained based on the optical information of the platelets are used as the first platelet distribution; Obtain red blood cell detection data from the blood sample; The presence of red blood cell fragments in the blood sample is determined based on the first platelet distribution, the second platelet distribution, and the red blood cell detection data. An alarm is issued when it is determined that the blood sample contains fragments of red blood cells.

7. The method according to claim 1, characterized in that, The method further includes: The blood sample is treated with a second reagent to obtain a second test sample, the second reagent comprising a diluent; The second test sample is flowed through the test orifice, and the impedance signal of the second test sample flowing through the test orifice is detected; The second platelet distribution of the blood sample is obtained based on the impedance signal; The platelet detection results obtained based on the optical information of the platelets are used as the first platelet distribution; Determine whether the detection step of the impedance signal is abnormal based on the first platelet distribution and the second platelet distribution; An alarm message is issued when an abnormality is detected in the impedance signal detection step.

8. A blood analysis system, characterized in that, include: A sampling unit is used to acquire blood samples and transport the blood samples to a reaction unit; A reagent supply unit is used to store at least the first reagent and supply it to the reaction unit as needed; The reaction unit includes a first mixing chamber for mixing the blood sample with a first reagent to form a first test sample, wherein the first reagent includes a hemolytic agent that lyses the red blood cells in the blood sample into fragments with light scattering properties significantly different from those of platelets. An optical detection system includes a light source, a flow chamber, and at least an optical detector. The light source is used to emit a light beam to illuminate the flow chamber. The flow chamber is in communication with a first mixing chamber and particles in the first test sample can pass through the flow chamber one by one. The optical detector is used to detect the optical information generated by the particles passing through the flow chamber after being illuminated by light. A data processing module, operatively connected to the optical detection system, includes a processor and a non-transitory computer-readable storage medium storing a computer program, wherein when the computer program is executed by the processor, the processor performs the following steps: Platelets in the first test sample are identified solely based on the forward scattered light information in the optical information; the platelet detection result is obtained based on the optical information of the platelets. When the computer program is run by the processor, the processor performs the action of identifying platelets in the first test sample based solely on the forward-scattered light information in the optical information. Based on the optical information of the platelets, the platelet detection results are obtained, including: Based solely on the forward scattering light information in the optical information, platelets in the first test sample are distinguished from lysed red blood cell fragments and white blood cells; Based on the optical information of the platelets, platelet counts and / or platelet morphology parameters are obtained.

9. The system according to claim 8, characterized in that, The reaction section further includes a second mixing chamber for mixing the blood sample with a second reagent to form a second test sample, wherein the second reagent includes a diluent, and the second test sample can flow through a test orifice in a flow path, the flow path being connected to the second mixing chamber. The system also includes an impedance detector for detecting the impedance signal of the second test sample flowing through the test orifice; The data processing module is also operatively connected to the electrical impedance detector, wherein when the computer program is run by the processor, the processor further performs the following steps: obtaining a second platelet distribution of the blood sample based on the electrical impedance signal; and using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution. Obtain red blood cell detection data from the blood sample; determine whether the blood sample contains red blood cell fragments based on the first platelet distribution, the second platelet distribution, and the red blood cell detection data; and issue an alarm message when it is determined that the blood sample contains red blood cell fragments.

10. The system according to claim 8, characterized in that, The reaction section further includes a second mixing chamber for mixing the blood sample with a second reagent to form a second test sample, wherein the second reagent includes a diluent, and the second test sample can flow through a test orifice in a flow path, the flow path being connected to the second mixing chamber. The system also includes an impedance detector for detecting the impedance signal of the second test sample flowing through the test orifice; The data processing module is also operatively connected to the electrical impedance detector, wherein when the computer program is run by the processor, the processor further performs the following steps: obtaining a second platelet distribution of the blood sample based on the electrical impedance signal; using the platelet detection result obtained based on the optical information of the platelets as a first platelet distribution; and determining whether an abnormality has occurred in the detection step of the electrical impedance signal based on the first platelet distribution and the second platelet distribution. An alarm message is issued when an abnormality is detected in the impedance signal detection step.

11. The system according to claim 8, characterized in that, When the computer program is run by the processor, the processor also performs the following steps: Based on the forward and side-scattered light information in the optical information, the white blood cells in the blood sample are classified into subgroups including monocytes, lymphocytes, and neutrophils.

12. The system according to claim 8, characterized in that, The first reagent also includes a fluorescent dye, and when the computer program is run by the processor, the processor further performs the following steps: The reticulocyte count results are obtained based on the forward scattered light information and fluorescence information in the optical information.

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