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 a significantly different electrical impedance characteristic from platelets; making the first test sample flow through a test micro-hole, detecting an electrical impedance signal of the first test sample flowing through the test micro-hole; and obtaining a detection result of platelets in the blood sample according to the electrical impedance signal. According to the blood detection method and the blood analysis system, the detection result of platelets can be obtained only through the electrical impedance signal of cells in the blood sample after deep hemolysis.

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 comprising a hemolysin, the hemolysin lysing red blood cells in the blood sample into fragments with electrical impedance characteristics significantly different from platelets; allowing the first test sample to flow through a test microwell and detecting the electrical impedance signal of the first test sample flowing through the test microwell; and obtaining a detection result of platelets in the blood sample based on the electrical impedance signal.

[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 hemolysin that lyses red blood cells in the blood sample into fragments with electrical impedance characteristics significantly different from platelets, the first test sample being capable of flowing through a test microwell in a flow path connected to the first mixing chamber; an electrical impedance detection component including the test microwell and an electrical impedance detector, the electrical impedance detector being used to detect the electrical impedance signal of the first test sample flowing through the test microwell, wherein the test microwell is connected to the first mixing chamber; and a data processing module operatively connected to the electrical impedance detector, and including 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: obtaining a detection result of platelets in the blood sample based on the electrical impedance signal.

[0007] The blood testing method and blood analysis system according to the embodiments of this application can obtain platelet detection results only through the impedance signal of cells in blood samples after deep hemolysis. 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 a blood testing method according to an embodiment of the present application, in which the regions of white blood cells and non-white blood cells are distinguished based on the electrical impedance signals of cells in a first test sample.

[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 subset data is obtained based on the electrical impedance signal of leukocytes.

[0013] Figure 5 This diagram illustrates the graphical differences between the distribution of the first and second platelets when platelet counts are normal and abnormal.

[0014] Figure 6 A schematic structural block diagram of a blood analysis system according to an embodiment of this application is shown. Detailed Implementation

[0015] 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.

[0016] 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:

[0017] In step S110, a blood sample is treated with a first reagent to obtain a first test sample. The first reagent includes a hemolysin, which lyses the red blood cells in the blood sample into fragments with electrical impedance characteristics significantly different from those of platelets.

[0018] In step S120, the first test sample is allowed to flow through the test micro-hole, and the impedance signal of the first test sample flowing through the test micro-hole is detected.

[0019] In step S130, the detection result of platelets in the blood sample is obtained based on the impedance signal.

[0020] In embodiments of this application, a blood sample is hemolyzed using a first reagent comprising a hemolytic agent. This first reagent can lyse red blood cells in the blood sample into fragments with significantly different electrical impedance characteristics than platelets. When using conventional hemolytic agents, the magnitude of the electrical impedance signal distribution histogram obtained by electrical impedance detection can already distinguish the leukocyte region from the non-leukocyte region. The non-leukocyte region includes platelets and may also include small red blood cells and red blood cell fragments. In embodiments of this application, the first reagent comprises a hemolytic agent capable of deep hemolysis, which can lyse red blood cells in the blood sample into fragments with significantly different electrical impedance characteristics than platelets. This means that red blood cells in the non-leukocyte region are processed into particles with significantly different sizes than platelets, thereby clearly distinguishing platelets from lysed red blood cells. Furthermore, compared to conventional hemolytic agents, this first reagent breaks the cell membrane of red blood cells into smaller fragments, making the non-leukocyte region almost entirely a platelet region, thus enabling the final platelet count to be obtained based on the particle distribution information of this region.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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 morphology, and preferably, white blood cells also largely retain their morphology. White blood cell regions and non-white blood cell regions can be distinguished on the impedance signal distribution histogram. See below for reference. Figure 2 To describe.

[0028] Figure 2 This diagram illustrates a blood testing method according to an embodiment of the present application, where a region of white blood cells and a region of non-white blood cells are distinguished based on the electrical impedance signal of cells in a first test sample. For example... Figure 2 As shown, in the histogram of the electrical impedance signal distribution obtained from the first test sample of the blood sample, the white blood cell (WBC) region and the non-white blood cell (WBC) region can be obtained according to the magnitude of the electrical impedance signal. Figure 2 The area to the left of the dividing line is the non-WBC area, and the area to the right of the dividing line is the WBC area.

[0029] As mentioned earlier, the non-leukocyte region can be considered the platelet region. Based on the electrical impedance signal of the platelet region, platelet count results and platelet morphology parameters can be obtained. These platelet morphology parameters can include at least one of the following: mean platelet volume, volume distribution width, and proportion of large platelets. Specifically, the electrical impedance signal of the platelet region can be analyzed to obtain the volume information of each particle, denoted as Vol_Ms; further, the true volume of each particle, i.e., the platelet volume information before hemolysis, can be obtained, denoted as Vol_Org, where Vol_Org = K * Vol_Ms. The coefficient K is positively correlated with the hemolytic strength of the hemolytic agent; the stronger the hemolytic ability, the larger K. After the above conversion, the true platelet volume distribution can be obtained from the particle volume of the platelet region. (See below for reference.) Figure 3 To describe.

[0030] 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, based on the platelet volume distribution histogram, the total number of platelets, average platelet volume, and platelet volume distribution width can be calculated. Furthermore, the boundary line for large platelet volumes is shown below. Figure 3 As shown, the total number and proportion of large platelets can be calculated based on this dividing line.

[0031] In a further embodiment of this application, the detection results of white blood cells in a blood sample can also be obtained based on the impedance signal of the distinguished white blood cell region. Specifically, the white blood cell count in the blood sample can be obtained based on the impedance signal of the white blood cell region. Furthermore, the classification results of white blood cells in the blood sample can also be obtained based on the impedance signal of the white blood cell region. Specifically, the white blood cells in the blood sample can be classified into lymphocyte populations, intermediate cell populations, and granulocyte populations based on the impedance signal of the white blood cell region. (See below for further details.) Figure 4 To describe.

[0032] Figure 4 This diagram illustrates a blood testing method according to an embodiment of the present application, where leukocyte subset data is obtained based on leukocyte impedance signals. Figure 4 As shown, it displays from Figure 2 The magnified histogram of the electrical impedance signal of the leukocyte region is shown. Based on the magnitude of the electrical impedance signal, the cells in the leukocyte region can be divided into lymphocytes, intermediate cells, and granulocytes.

[0033] 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; allowing the second test sample to flow through the test microwell and detecting the impedance signal of the second test sample flowing through the test microwell; obtaining a second platelet distribution of the blood sample based on the impedance signal of the second test sample flowing through the test microwell; using the platelet detection result obtained based on the impedance signal of the first test sample flowing through the test microwell as a first platelet distribution; acquiring 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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; allowing the second test sample to flow through the test microwell and detecting the impedance signal of the second test sample flowing through the test microwell; obtaining a second platelet distribution of the blood sample based on the impedance signal of the second test sample flowing through the test microwell; using the platelet detection result obtained based on the impedance signal of the first test sample flowing through the test microwell as a first platelet distribution; determining whether the impedance signal detection step 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 impedance signal detection step has an abnormality.

[0040] Specifically, the first platelet distribution can be the platelet (PLT) volume histogram of the hemolytic channel using the aforementioned hemolytic agent, and the second platelet distribution can be the impedance channel PLT volume histogram. Comparing the graphical differences between these two histograms can determine whether there are any abnormalities in the impedance signal detection. The following will combine... Figure 5 To describe, among which Figure 5 The upper part of the image shows an example where the platelet count test results are normal. Figure 5 The lower half of the image shows an example of abnormal platelet counts. From Figure 5 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 5The 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.

[0041] 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 obtain platelet detection results solely through the impedance signal of cells in a deeply hemolyzed blood sample. Therefore, only the white blood cell counting channel or the classification channel (hemolysis channel) is needed to obtain platelet detection results, eliminating the need for an additional optical platelet detection channel, thus reducing clinical testing costs and instrument complexity.

[0042] The following is combined with Figure 6 Describes a blood analysis system provided according to another aspect of this application. Figure 6 A schematic structural block diagram of a blood analysis system 600 according to an embodiment of this application is shown. Figure 6As shown, the blood analysis system 600 includes a sampling unit 610, a reagent supply unit 620, a reaction unit 630, an impedance detection unit 640, and a data processing module 650. The sampling unit 610 acquires a blood sample and delivers it to the reaction unit 630. The reagent supply unit 620 stores at least a first reagent and supplies it to the reaction unit 630 as needed. The reaction unit 630 includes a first mixing chamber for mixing the blood sample with the first reagent to form a first test sample. The first reagent includes a hemolysin that lyses red blood cells in the blood sample into fragments with impedance characteristics significantly different from platelets. The first test sample can flow through a test microwell in a flow path connected to the first mixing chamber. The impedance detection unit 640 includes the test microwell and an impedance detector. The impedance detector detects the impedance signal of the first test sample flowing through the test microwell, which is connected to the first mixing chamber. The data processing module 650 is operatively connected to the impedance detector 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: obtaining a detection result of platelets in the blood sample based on the impedance signal.

[0043] The blood analysis system 600 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 600 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 600 will not be repeated here, but only their main operating steps will be briefly described.

[0044] In an embodiment of this application, when the computer program is run by the processor, the processor executes a method to obtain the detection result of platelets in the blood sample based on the impedance signal, including: distinguishing particles in the first test sample into leukocytes and non-leukocytes based on the impedance signal; and obtaining platelet count results and / or platelet morphology parameters based on the impedance signal of the non-leukocytes.

[0045] In embodiments 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 lymphocyte populations, intermediate cell populations, and granulocyte populations based on the electrical impedance signals of the white blood cells.

[0046] In an embodiment of this application, when the computer program is run by the processor, the processor also performs the following steps: obtaining the count result of white blood cells in the blood sample based on the electrical impedance signal of the white blood cells.

[0047] In embodiments of this application, the reagent supply unit 620 is further configured to store a second reagent and supply it to the reaction unit 630 as needed. The reaction unit 630 also includes a second mixing chamber for mixing the blood sample with the second reagent to form a second test sample, wherein the second reagent includes a diluent, and the second test sample is capable of flowing through a test micropore in a flow path connected to the second mixing chamber. The test micropore is also connected to the second mixing chamber. An impedance detector 640 is further configured to detect the impedance signal of the second test sample flowing through the test micropore. When the computer program is run by the processor, the processor also performs the following steps: obtaining a second platelet distribution of the blood sample based on the impedance signal of the second test sample flowing through the test microwell; using the platelet detection result obtained based on the impedance signal of the first test sample flowing through the test microwell 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 / or, acquiring red blood cell detection data of the blood sample, and 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 an abnormality has occurred in the detection step of the impedance signal or when it is determined that the blood sample contains red blood cell fragments.

[0048] Based on the above description, the blood analysis system according to the embodiments of this application can obtain platelet detection results only through the electrical impedance signal of cells in blood samples after deep hemolysis. 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, thus reducing clinical testing costs and instrument complexity.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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 hemolysin that lyses the red blood cells in the blood sample into fragments with electrical impedance characteristics significantly different from those of platelets. The first test sample is allowed to flow through the test micro-orifice, and the impedance signal of the first test sample flowing through the test micro-orifice is detected. The detection results of platelets in the blood sample are obtained based on the impedance signal.

2. The method according to claim 1, characterized in that, The detection results of platelets in the blood sample are obtained based on the impedance signal, including: Based on the electrical impedance signal, the particles in the first test sample are distinguished into white blood cells and non-white blood cells; Platelet count results and / or platelet morphology parameters are obtained based on the impedance signals of the non-leukocytes.

3. The method according to claim 2, 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.

4. The method according to claim 2, characterized in that, The method further includes: Based on the electrical impedance signal of the white blood cells, the white blood cells in the blood sample are classified into lymphocytes, intermediate cells, and granulocytes.

5. The method according to claim 2, characterized in that, The method further includes: The count of white blood cells in the blood sample is obtained based on the electrical impedance signal of the white blood cells.

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 allowed to flow through the test micropore, and the impedance signal of the second test sample flowing through the test micropore is detected; The second platelet distribution of the blood sample is obtained based on the impedance signal of the second test sample flowing through the test micropore; The platelet detection result obtained based on the impedance signal of the first test sample flowing through the test micropore is 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 allowed to flow through the test micropore, and the impedance signal of the second test sample flowing through the test micropore is detected; The second platelet distribution of the blood sample is obtained based on the impedance signal of the second test sample flowing through the test micropore; The platelet detection result obtained based on the impedance signal of the first test sample flowing through the test micropore is 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 detection step of the impedance signal.

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 section 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 hemolysin that lyses the red blood cells in the blood sample into fragments with electrical impedance characteristics significantly different from those of platelets, and the first test sample can flow through a test micropore in a flow path connected to the first mixing chamber. An impedance detection component includes the test microhole and an impedance detector, wherein the impedance detector is used to detect the impedance signal of the first test sample flowing through the test microhole, and wherein the test microhole is connected to the first mixing chamber; A data processing module, operatively connected to the impedance detector, 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: obtaining a detection result of platelets in the blood sample based on the impedance signal.

9. The system according to claim 8, characterized in that, When the computer program is run by the processor, the processor performs the following: obtaining the detection result of platelets in the blood sample based on the impedance signal: Based on the electrical impedance signal, the particles in the first test sample are distinguished into white blood cells and non-white blood cells; Platelet count results and / or platelet morphology parameters are obtained based on the impedance signals of the non-leukocytes.

10. The system according to claim 9, characterized in that, When the computer program is run by the processor, the processor also performs the following steps: Based on the electrical impedance signal of the white blood cells, the white blood cells in the blood sample are classified into lymphocytes, intermediate cells, and granulocytes.

11. The system according to claim 9, characterized in that, When the computer program is run by the processor, the processor also performs the following steps: The count of white blood cells in the blood sample is obtained based on the electrical impedance signal of the white blood cells.

12. The system according to claim 8, characterized in that, The reagent supply unit is also used to store the second reagent and supply it to the reaction unit as needed; 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 is able to flow through a test micropore in a flow path, the flow path being connected to the second mixing chamber, and the test micropore being connected to the second mixing chamber. The impedance detector is also used to detect the impedance signal of the second test sample flowing through the test micropore; When the computer program is run by the processor, the processor also performs the following steps: The second platelet distribution of the blood sample is obtained based on the impedance signal of the second test sample flowing through the test micropore; The platelet detection result obtained based on the impedance signal of the first test sample flowing through the test micropore is used as the first platelet distribution. Whether the detection step of the impedance signal is abnormal is determined based on the first platelet distribution and the second platelet distribution; and / or, red blood cell detection data of the blood sample is obtained, and whether red blood cell fragments are present 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 an abnormality is detected in the detection step of the impedance signal or when red blood cell fragments are found in the blood sample.

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