Method for detecting platelets using electrical impedance and blood analysis system

Abstract

The application provides a method for detecting platelets by electrical impedance and a blood analysis system. The method comprises: mixing a first portion of a blood sample with a diluent to form a first suspension; mixing a second portion of the blood sample with a hemolytic agent to lyse red blood cells to form a second suspension; measuring a first electrical impedance signal of the first suspension flowing through a small aperture; measuring a second electrical impedance signal of the second suspension flowing through the small aperture; analyzing the first electrical impedance signal of the first suspension to obtain a first platelet distribution; analyzing the second electrical impedance signal of the second suspension to distinguish platelets from white blood cells and obtain a second platelet distribution; and determining a platelet concentration of the blood sample based on the first platelet distribution and the second platelet distribution. The application can obtain accurate platelet counting by combining a whole blood counting channel and a white blood cell classification channel, without the need to additionally increase an optical platelet detection channel, thereby reducing clinical testing costs and instrument complexity.

Description

Technical Field

[0001] This application relates to the field of blood testing technology, and more specifically to a method for detecting platelets using electrical impedance to analyze blood 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 method and instrument system for detecting platelets in blood samples, even 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 method for detecting platelets using electrical impedance tomography is provided. The method includes: mixing a first portion of a blood sample with a diluent to form a first suspension; mixing a second portion of the blood sample with a hemolytic agent to dissolve red blood cells to form a second suspension; measuring a first electrical impedance signal of the first suspension flowing through a small aperture; measuring a second electrical impedance signal of the second suspension flowing through a small aperture; analyzing the first electrical impedance signal of the first suspension to obtain a first platelet distribution; analyzing the second electrical impedance signal of the second suspension to distinguish between platelets and white blood cells and obtain a second platelet distribution; and determining the platelet concentration of the blood sample based on the first platelet distribution and the second platelet distribution.

[0006] According to another aspect of this application, a blood analysis system is provided, the blood analysis system comprising: a first mixing chamber for mixing a first portion of a blood sample with a diluent to form a first suspension; a second mixing chamber for mixing a second portion of the blood sample with a hemolytic agent to dissolve red blood cells to form a second suspension; an impedance detector for detecting a first impedance signal of the first suspension passing through a small aperture and a second impedance signal of the second suspension passing through the small aperture, wherein the impedance detector is mounted in the small aperture of a flow path, the flow path being connected to the first mixing chamber and the second mixing chamber; and a data processing module operatively connected to the impedance detector, the data processing module including a processor and a non-transitory computer-readable storage medium programmed with a computer application, wherein when the computer application is executed by the processor, the processor generates a first platelet distribution based on the first impedance signal of the first suspension, distinguishes platelets from white blood cells based on the second impedance signal of the second suspension and generates a second platelet distribution, and determines the platelet concentration of the blood sample based on the first platelet distribution and the second platelet distribution.

[0007] The method and blood analysis system for detecting platelets using electrical impedance according to the embodiments of this application can obtain accurate platelet counts by combining the whole blood count channel (CBC) and the white blood cell differential channel (three-part differential channel), without the need to add an additional optical platelet detection channel, thus reducing 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 illustrating a method for detecting platelets using applied electrical impedance according to an embodiment of this application is shown.

[0010] Figure 2 An exemplary schematic diagram shows a first platelet distribution obtained by the method of applying electrical impedance to detect platelets according to an embodiment of this application.

[0011] Figure 3 This diagram illustrates an exemplary form of a second platelet distribution obtained by a method for detecting platelets using applied electrical impedance to conform to an embodiment of this application.

[0012] Figure 4This is an exemplary schematic diagram showing another form of the second platelet distribution obtained in the method of platelet detection using applied electrical impedance to conform to an embodiment of this application.

[0013] Figure 5 Showing will Figure 2 and Figure 4 The above is a schematic diagram of the superimposed histograms.

[0014] Figure 6 This diagram illustrates an exemplary schematic of generating a fused platelet histogram in a method for detecting platelets using applied electrical impedance to conform to an embodiment of this application.

[0015] Figure 7 This diagram illustrates two boundary lines used to determine the platelet trough-to-peak ratio in a first platelet distribution during a method for detecting platelets using applied electrical impedance to an embodiment of this application.

[0016] Figure 8 This diagram illustrates a designated region in the second platelet distribution of a method for detecting platelets using applied electrical impedance to an embodiment of this application.

[0017] Figures 9A to 9C This illustrates an example procedure for determining platelet concentration in an abnormal blood sample.

[0018] Figures 10A to 10C This illustrates another example of the process for determining platelet concentration in an abnormal blood sample.

[0019] Figure 11 Showing based on Figure 3 The diagram shown is an exemplary schematic of leukocyte grouping based on the impedance histogram obtained after magnifying the leukocyte region.

[0020] Figure 12A and Figure 12B A schematic diagram illustrating the graphical differences between the distribution of the first and second platelets when platelet counts are normal and when abnormalities are present.

[0021] Figure 13 A schematic structural block diagram of a blood analysis system according to an embodiment of this application is shown.

[0022] Figure 14 This diagram illustrates the correlation between platelet counts obtained from conventional electrical impedance tomography (EIT) of interfered samples and reference values.

[0023] Figure 15 This diagram illustrates the correlation between platelet count results obtained after detecting an interfered sample and reference values ​​using a method for detecting platelets using electrical impedance to measure platelets according to an embodiment of this application.

[0024] Figure 16This diagram illustrates the correlation between platelet count results obtained after detecting an interfered sample and reference values ​​using a method for detecting platelets using applied electrical impedance to another embodiment of this application, according to another embodiment of the present application. Detailed Implementation

[0025] 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.

[0026] First, refer to Figure 1 This application describes a method for detecting platelets using applied electrical impedance according to embodiments of the present application. Figure 1 A schematic flowchart of a method 100 for detecting platelets using applied electrical impedance to an embodiment of this application is shown. Figure 1 As shown, the method 100 for detecting platelets using electrical impedance to measure platelets according to an embodiment of this application may include the following steps:

[0027] In step S110, the first blood sample is mixed with a diluent to form a first suspension.

[0028] In step S120, a second portion of the blood sample is mixed with a hemolytic agent to dissolve the red blood cells, forming a second suspension.

[0029] In step S130, the first impedance signal of the first suspension flowing through the orifice is measured.

[0030] In step S140, the second impedance signal of the second suspension flowing through the orifice is measured.

[0031] In step S150, the first impedance signal of the first suspension is analyzed to obtain the first platelet distribution.

[0032] In step S160, the second electrical impedance signal of the second suspension is analyzed to distinguish between platelets and white blood cells and to obtain the second platelet distribution.

[0033] In step S170, the platelet concentration of the blood sample is determined based on the first platelet distribution and the second platelet distribution.

[0034] In the embodiments of this application, the first suspension formed in step S110 is a diluted blood sample. Blood diluents are commonly used in hematology analyzers to dilute blood samples for measuring red blood cells and platelets. Diluents typically include one or more salts, such as alkali metal salts, and are adjusted to be isotonic to maintain red blood cell volume. A first sample of blood can be diluted with commercially available blood diluents to form the first suspension, for example, using M-68DS diluent, M-53D diluent, etc., manufactured by Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, China).

[0035] In embodiments of this application, the direct current (DC) impedance signal of the first suspension can be measured via a flow path equipped with a DC impedance detector and either a non-focusing or a focusing flow orifice. When particles or blood cells suspended in a conductive solution pass through the orifice, the electrical signal can be measured based on impedance changes. The pulse shape, height, and width of this impedance signal are directly related to the size or volume of the particles and can be converted into the volume of the dominant particles. When two or more particles of different sizes are measured, the frequency histogram obtained from the impedance measurement can reflect the size distribution of these particles. Techniques for detecting blood cells using a blood analyzer equipped with a DC impedance measurement device are known and described in U.S. Patents US2,656,508 and US3,810,011, the entire disclosure of which is incorporated herein by reference.

[0036] According to the method disclosed herein, a histogram of platelet and red blood cell volume distribution in the diluted blood sample can be generated by analyzing the DC impedance signal from the first suspension. Figure 2 As shown, the first platelet distribution D1 is the first platelet impedance histogram H from the first suspension. Plt-I The histogram represents the size distribution of platelet 10a in the first suspension. In this histogram, the volume (Volp) of platelet 10a is expressed in femtoliters (fL). Figure 2 As can be seen from the histogram, a portion of red blood cell 20 is closely adjacent to platelet 10a.

[0037] In the embodiments of this application, the second suspension formed in step S120 is a hemolyzed blood sample. The red blood cells in the blood sample can be dissolved by a hemolytic agent, which can be any one or a combination of several of cationic, nonionic, anionic, and amphiphilic surfactants. The hemolytic agent used in this disclosure to dissolve the red blood cells in the second sample can be any known dissolving reagent used for white blood cell classification in a blood analyzer. Dissolving reagents used for white blood cell classification in a blood analyzer are typically aqueous solutions containing one or more hemolytic agents, which may include cationic, nonionic, anionic, amphiphilic surfactants, or combinations thereof.

[0038] In embodiments of this application, the impedance signal of the second suspension can be measured via a flow path equipped with an impedance detector and either a non-focused flow orifice or a focused flow orifice. This is similar to the measurement method of the impedance signal of the first suspension described above.

[0039] According to the method disclosed herein, impedance distribution histograms of platelets and leukocytes in the hemolyzed blood sample can be generated by analyzing the impedance signal from the second suspension. For example... Figure 3 As shown, a second platelet impedance histogram of the second suspension is presented. In this histogram, the platelet region P (in this article, the platelet region refers to the region that may contain platelets, and it is not excluded that other particles overlap with the platelet particle group to a certain extent) and the leukocyte region W can be clearly distinguished. The platelet region corresponds to the position of platelet 10b in the second suspension in the second platelet impedance histogram, and the leukocyte region corresponds to the position of leukocytes in the second suspension in the second platelet impedance histogram.

[0040] Figures 4 to 6 This application further illustrates methods for determining platelet concentration in blood samples in some embodiments provided. For example... Figure 4 As shown, it can be based on Figure 3 The impedance information of platelet region P shown in the figure is used to obtain the true volume distribution information of the platelet region, that is, the platelet volume distribution information before hemolysis, such as... Figure 4 The impedance histogram H shown Plt-W Because it is based on Figure 3 The platelet impedance signal generated in the platelet region P shown in the figure can be called the derived platelet impedance histogram, or the second platelet distribution D2.

[0041] In one example, the derived platelet impedance histogram H Plt-W The acquisition method can be: to Figure 3 The impedance signal of platelet 10b in the platelet region P is analyzed to obtain the volume information of each platelet, denoted as Vol_Ms. Further analysis yields the true volume of each platelet, i.e., the platelet volume before hemolysis, denoted as Vol_Org. This allows the generation of the derived platelet impedance histogram H. Plt-W The calculation of Vol_Org can be represented by equation (1):

[0042] Equation (1) is Vol_Org=K*Vol_Ms

[0043] The coefficient K is positively correlated with the hemolytic strength of the hemolytic agent; the stronger the hemolytic ability of the hemolytic agent, the larger K is.

[0044] Figure 5 The two histograms H obtained by the above method are illustrated schematically. Plt-I and H Plt-W Superimpose them. For example... Figure 5 As shown, the first platelet impedance histogram H of the first suspension from the blood sample is displayed. Plt-I Histogram H of derived platelet electrical impedance from a second suspension of the blood sample Plt-W These two are combined. Figure 5 The blood sample used in the illustrated embodiment is an abnormal blood sample containing red blood cell fragments, determined by a manual reference method. Figure 5 As shown, except in the high end of the platelet population, i.e., the region of approximately 20 fL and above, the first platelet impedance histogram (H) is affected by interference from erythrocyte debris. Plt-I Aside from the elevation, the two histograms essentially overlap. Understandably, the red blood cells in this second suspension, including microcytes and red blood cell fragments, are dissolved. Therefore, the derived platelet impedance histogram H obtained from this second suspension... Plt-W In the second suspension, the high-resolution platelet distribution reflects only platelet 10b information and is unaffected by interfering substances such as erythrocytes (microcytes) and erythrocyte fragments. Furthermore, for blood samples containing large platelets, the derived platelet impedance histogram H obtained from this second suspension... Plt-W The distribution of platelet 10b, including large platelets, is not as shown in the first platelet impedance histogram H obtained from this first suspension. Plt-I In such cases, platelets may overlap with red blood cells. Similarly, this characteristic also applies to blood samples containing giant platelets.

[0045] In some implementations, when obtaining the derived platelet impedance histogram H... Plt-W Subsequently, this method generates a fused platelet histogram H. Plt-IW The fusion platelet histogram H Plt-IW The first platelet impedance histogram H of the first suspension Plt-I Histogram H of platelet electrical impedance to the second suspension Plt-W The function: H Plt-IW =f(H Plt-I H Plt-W The fusion platelet histogram H Plt-IW Information from platelet detection in the first and second suspensions was incorporated.

[0046] In one exemplary embodiment, the fused platelet histogram HPlt-IW It is generated using equation (2):

[0047] H Plt-IW (i)=k i1 *H Plt-I (i)+k i2 *H Plt-W (i) (i=1,2,…,n) Equation (2)

[0048] Among them, H Plt-IW (i) is event (i) in the fused platelet histogram; H Plt-w (i) is event (i) in the derived platelet impedance histogram of the second suspension; H Plt-I (i) is event (i) in the first platelet impedance histogram of the first suspension; k i1 and k i2 It is a coefficient.

[0049] In some implementations, k in equation (2) i1 and k i2 It can be a constant or a variable. For example, in an exemplary embodiment, k i1 and k i2 The following criteria are established:

[0050] When Volp(i) > 20fL, k i1 =0,k i2 =1;

[0051] When Volp(i) ≤ 20fL, k i1 =1,k i2 =0;

[0052] Figure 6 The above method and the generation of the fused platelet histogram H are further illustrated. Plt-IW Criterion detection Figure 5 The process of obtaining abnormal blood samples. Figure 6 The histogram H of fused platelets shown Plt-IW In China, the size range of platelets is related to Figure 2 The first platelet impedance histogram H shown is Plt-I and Figure 4 The derived platelet histogram H shown Plt-W Same. For example... Figure 6 As shown, it occurred Figure 5 In the embodiment, the increase in the high segment of the platelet population curve caused by interference from red blood cell fragments in the blood sample is reflected in the histogram H of the fused platelets. Plt-IW The values ​​have been corrected. Then, based on the fused platelet histogram H... Plt-IWThe area under the curve can determine the platelet concentration in the blood sample.

[0053] The histograms in the above embodiments are graphical representations of volume distribution, a common form for presenting the probability distribution of continuous variables. Optionally, the histograms in the above embodiments may also be presented in a numerical form, such as a table or list, with the same or similar resolution as the volume histogram, or in any other suitable manner known in the art. Therefore, for the purposes of this disclosure, the above-described fused platelet histogram can be used to refer to the distribution of fused platelets, without being limited by its graphical representation. Similarly, the above-described derived platelet impedance histogram can also be used to refer to the volume distribution of derived platelets, without being limited by its graphical representation. Furthermore, the first platelet impedance histogram obtained from the first suspension can also be used to refer to the DC platelet volume distribution, without being limited by its graphical representation.

[0054] In other embodiments, the platelet concentration in the blood sample can be determined using a first platelet distribution obtained from a first suspension and a second platelet distribution obtained from a second suspension, as referred to below. Figures 7 to 10C The method described.

[0055] In one embodiment, the method includes: determining the platelet trough-to-peak ratio R in a first platelet impedance histogram of the first suspension. v / p The obtained platelet trough-to-peak ratio is compared with a predetermined ratio threshold R. T Comparison. For example... Figure 7 As shown, the platelet trough peak ratio is R v / p It is determined by dividing the platelet count corresponding to Line-C by the platelet count corresponding to the peak shown in Line-P; in other words, it is by dividing the height of the curve at Line-C by the height of the peak at Line-P. As mentioned above, Line-C is located at... Figure 7 The boundary region B between the two groups shows the bottom of the trough between platelets and red blood cells in the histogram. The predetermined ratio threshold R can be obtained using a large number of normal blood samples. T For example, the predetermined ratio threshold R T It can be the maximum value of the platelet trough-to-peak ratio in a normal blood sample.

[0056] Furthermore, such as Figure 8 As shown, the method further includes: determining a specified region P in the platelet region P of the second platelet impedance histogram of the second suspension. G The number of events N in the specified area is Figure 8 In the region between the two dashed lines, we found the designated region P within the platelet region P. GThe number of events N in the study is correlated with large platelets. For a normal blood sample, the number of events appearing in the specified region P is [missing information]. G The number of events in the specified region P is very limited. G An increase in the event number N indicates potential interference with the platelet count results of the first suspension measured by DC impedance measurement due to the overlap of large platelets and red blood cells. The degree of increase can further reflect the extent of this potential interference. A predetermined event number threshold G can be used. T Evaluate the designated area P G The increase in the number of events N. This is due to the predetermined event count threshold G. T It can be obtained from a large number of normal blood samples, and it reflects the specified region P in the normal blood sample. G The maximum number of events in the sample. In the analysis of blood samples, if the detected N value exceeds G... T The value indicates the specified area P. G The number of events is abnormally high.

[0057] When the platelet trough peak ratio of a blood sample is R v / p and the specified area P G After determining the number of events N, the method further determines the derived separation threshold T of the troughs between platelets and red blood cells in the first platelet impedance histogram obtained from the first suspension. d These parameters are used to distinguish platelets from red blood cells.

[0058] In one embodiment, the derived separation threshold T d It can be determined according to equation (3):

[0059] T d =T ap +F of Equation (3)

[0060] Among them, T ap The apparent separation threshold is H, which is the histogram H of the first platelet impedance in the first suspension in the prior art. Plt-I The thresholds for platelets and red blood cells in the blood are determined based on the location of the trough between these two populations and the known size range of platelets; F of The offset is H, which is the first platelet impedance histogram of the first suspension. Plt-I The ratio of platelet trough peak to R v / p The specified region P in the platelet region P of the second platelet impedance histogram of the second suspension mentioned above. G The number of events N in the function.

[0061] In one exemplary embodiment, F ofThe offset criterion can be used to determine the offset using equation (4) or equation (5):

[0062] F of =b1*R v / p –b2*N+c Equation (4)

[0063] Among them, R v / p The first platelet impedance histogram H of the first suspension Plt-I The platelet peak-to-valence ratio; N is the specified region P in the platelet region P of the second platelet impedance histogram of the second suspension. G The number of events in the value; b1 and b2 are constants greater than 0; c is a constant.

[0064] F of =b 11 *R v / p +b 21 *N+c1 Equation (5)

[0065] Among them, R v / p The meaning of N is the same as in equation (4); b 11 b 21 c1 is a constant greater than 0; c2 is a constant.

[0066] The offset criterion can be defined as follows: if R v / p Greater than R T And N is less than G T The derived separation threshold T in equation (3) is determined using equation (4). d If R v / p Greater than R T And N is also greater than G T The derived separation threshold T in equation (3) is determined using equation (5). d Furthermore, according to this offset criterion, if R v / p No more than R T Equation (4) or equation (5) is not used, that is, F in equation (3) of It is 0.

[0067] The derived separation threshold T is obtained through equations (3)-(5) and the offset criterion. d Subsequently, the derived separation threshold T d The first platelet electrical impedance histogram H used to distinguish the first suspension Plt-I The histogram contains two cell populations: platelets and red blood cells, used to separate them. The derived separation threshold T is based on this histogram. d The area under the curve of the determined platelet population can determine the platelet concentration of the blood sample.

[0068] Figures 9A-9C and Figures 10A-10C The procedures for determining platelet concentration in abnormal blood samples using the methods described above are illustrated. Figures 9A-9C The procedure for determining the platelet concentration in an abnormal blood sample containing large platelets is shown. Figure 9A As shown, in the second platelet impedance histogram of the second suspension from this blood sample, the designated region P... G A large number of events N occur, exceeding a predetermined event count threshold G. T On the other hand, in Figure 9B The first platelet impedance histogram H of the first suspension shown is shown. Plt-I In the middle, its platelet trough peak ratio is R v / p It also exceeded the predetermined ratio threshold R. T (i.e., the first platelet impedance histogram H) Plt-I An anomaly occurred in the middle boundary region B). Therefore, based on the above offset criterion, equation (5) was used to determine the offset F. of .like Figure 9C As shown, the first platelet impedance histogram H of the first suspension of this blood sample... Plt-I In the middle, the derived separation threshold T obtained from equation (3) d Relative to the apparent separation threshold T ap The deviation to the right is determined by F obtained from equation (5). of Decide.

[0069] exist Figures 9A-9C In the illustrated embodiment, the platelet concentration obtained by flow cytometry as a reference method was 87*10⁻⁶. 9 / L, and adopt Figure 9C The apparent separation threshold T shown ap The existing impedance detection method reports a platelet concentration of 63*10. 9 / L, the latter being far lower than the results obtained using the flow cytometry reference method. The derived separation threshold T obtained from equation (3) was used. d The platelet concentration obtained from the offset criterion mentioned above is 79*10. 9 / L. This demonstrates that this method can assess the presence of large platelets in the impedance histogram of the second suspension, and can also compensate for the influence of large platelets on the impedance histogram H of the first platelet. Plt-I This method can correct the errors that often occur in existing impedance methods for detecting platelet concentration in blood samples containing large platelets, thus reducing the impact on detection results.

[0070] Figures 10A-10CThe procedure for determining the platelet concentration in an abnormal blood sample containing red blood cell fragments is further illustrated. For example... Figure 10B As shown, in the detection of this blood sample, the first platelet impedance histogram H from the first suspension... Plt-I The ratio of platelet trough peak to R v / p Exceeding the predetermined ratio threshold R T (i.e., the first platelet impedance histogram H) Plt-I An anomaly appeared in the middle boundary region B); however, as Figure 10A As shown, the designated region P in the second platelet impedance histogram of the second suspension is... G The number of events N is normal and has not exceeded the predetermined event threshold G. T Based on the above offset criterion, equation (4) is used to determine the offset F. of .like Figure 10C As shown, the first platelet impedance histogram H of the first suspension of this blood sample... Plt-I In the middle, the derived separation threshold T obtained from equation (3) d Relative to the apparent separation threshold T ap The deviation to the left is determined by F obtained from equation (4). of Decision. In this embodiment, the platelet concentration obtained based on the flow cytometry reference method is 46*10⁻⁶. 9 / L, and adopt Figure 10C The apparent separation threshold T shown ap The existing impedance detection method reports a platelet concentration of 66*10. 9 / L, which is 40% higher than the result obtained by the flow cytometry reference method. The derived separation threshold T obtained from equation (3) was used. d The platelet concentration obtained from the offset criterion mentioned above is 49*10. 9 / L. This demonstrates that this method can correct the errors that frequently occur in existing impedance methods for detecting platelet concentration in blood samples containing red blood cell fragments.

[0071] Furthermore, in some implementations, the derived separation threshold can also be determined based on equation (6):

[0072] T d '=T ap +g*(NG T )+h*(R v / p -R T Equation (6) + s

[0073] Wherein, N is the specified region P in the platelet region P of the impedance histogram of the second suspension. G The number of events in G; TR is a predetermined threshold number of events; v / p The first platelet impedance histogram H of the first suspension Plt-I Platelet trough-to-peak ratio; R T The predetermined ratio threshold; g, h, and s are constants, where when R v / p ≤R T At that time, the values ​​of g, h, and s are all 0.

[0074] When using equation (6) to determine the platelet concentration of a blood sample, this derived separation threshold T d’ Through N and R v / p The function calculations are derived from the analysis of the DC impedance signals of the second suspension and the first suspension, respectively, as described above. Through comparison with... Figure 9C and Figure 10C In the same manner shown, the derived separation threshold T obtained by equation (6) is used. d’ The first platelet impedance histogram H can distinguish the first suspension. Plt-I Platelets and red blood cells in the histogram. Then, based on the derived separation threshold T in this histogram... d’ The area under the curve of the determined platelet population can determine the platelet concentration of the blood sample.

[0075] It is understandable that, in the embodiments related to equations (3)-(6) above, the platelet distribution obtained after distinguishing platelets from red blood cells using the first platelet impedance histogram derived from the first suspension with a derived separation threshold can be regarded as a third platelet distribution, which is obtained based on the first platelet distribution from the first suspension and the second platelet distribution from the second suspension. Platelet concentration can be obtained from this third platelet distribution. The fused platelet distribution mentioned above can also be regarded as a third platelet distribution.

[0076] It is understood that, in any of the embodiments described above, based on the obtained third platelet distribution, such as the fused platelet histogram H... Plt-Iw Or utilize the derived separation threshold T d or T d’ The curves representing platelet populations differentiated in the first platelet impedance histogram can yield various forms of platelet analysis data. These data include, but are not limited to, platelet count (PLT), mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT).

[0077] Furthermore, in some embodiments, the method may further include the step of using a second impedance signal from the second suspension to distinguish leukocytes into their subpopulations. Figure 11 Showing based on Figure 3 The impedance histogram obtained after magnifying the white blood cell region W shown is as follows: Figure 11 As shown, based on the electrical impedance signal of the leukocyte region, leukocytes in a blood sample can be distinguished into lymphocyte populations, intermediate cell populations, and granulocyte populations. In other embodiments, the method may further include the steps of counting the number of leukocytes in a second suspension and reporting the leukocyte count in the blood sample.

[0078] In a further embodiment of this application, the method may further include the following steps: 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. Furthermore, the form of the alarm is not limited; it can be displayed on the screen, displayed in a report (e.g., highlighted, marked with symbols), or any other method that serves as an alarm notification.

[0079] Furthermore, the presence of large platelets in the blood sample can be determined based on the second 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 first 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.

[0080] Alternatively, the number of first particles can be obtained from the distribution of the first platelet within a preset volume range (the normal volume of a large platelet), and the number of particles in the large platelet region of the second 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.

[0081] Specifically, the mean erythrocyte volume (MRC) of a blood sample can be obtained based on the impedance signal in the first platelet distribution, and the MRC can be used to determine whether the blood sample contains small red blood 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 small red blood cells. For example, an MRC less than 80 fL is generally considered to contain small red blood cells. When the MRC obtained using this method is less than 80 fL, it can be determined that the blood sample contains small red blood cells.

[0082] Alternatively, the red blood cell volume distribution data of the blood sample can be obtained based on the impedance signal in the first platelet distribution; based on the red blood cell volume distribution data, the volume located at a preset red blood cell volume percentage, such as the 20th, 30th, 60th, or 80th percentile, can be obtained, and the blood sample can be determined as a microcytic sample 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, the blood sample is determined not to be a microcytic sample.

[0083] 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.

[0084] In a further embodiment of this application, the method may further include the following steps: determining whether the detection of the first platelet and / or the detection of the impedance signal is abnormal based on the first platelet distribution and the second platelet distribution; when it is determined that the platelet detection is abnormal, issuing an alarm message. Furthermore, the form of the alarm is not limited; it can be displayed on the screen, displayed in a report (e.g., highlighted, marked with symbols), or other methods such as voice, sound, or light, as long as they serve an alarm prompting function.

[0085] Specifically, the presence of abnormalities in platelet detection can be determined based on the graphical differences between the aforementioned first platelet impedance histogram and the derived platelet impedance histogram. The following section combines... Figure 12A and Figure 12B To describe, among which Figure 12A This is an example where the platelet count test shows no abnormalities. Figure 12B This is an example of an abnormal platelet count. From Figure 12A It can be seen that the graphical differences between the first platelet impedance histogram (i.e., the impedance channel PLT volume histogram) and the derived platelet impedance histogram (i.e., the hemolytic channel PLT volume histogram) are small, indicating that platelet detection (i.e., the detection of the first platelet and / or the impedance signal) is normal; from Figure 12BIt can be seen that under abnormal conditions, such as abnormal blood samples containing small red blood cells or abnormalities in the impedance detection channel, there is a significant difference between the first platelet impedance histogram (i.e., the impedance channel PLT volume histogram) and the derived platelet impedance histogram (i.e., the hemolysis channel PLT volume histogram). This indicates an abnormality in platelet detection and triggers an alarm. In the above example, 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 are greater than preset values. If so, an abnormality in platelet detection can be considered, and an alarm can be triggered. In other embodiments, the platelet count can be obtained from each of the two histograms. When the difference between the platelet counts calculated from the two histograms is greater than a preset value, an abnormality in platelet detection can be considered, and an alarm can be triggered. Furthermore, it should be understood that this method for determining abnormalities in the impedance detection channel is applicable to normal blood samples, because abnormal blood samples may already have differences in the volume distribution histograms of the impedance channel and the hemolysis channel, and the difference is not solely due to an abnormal impedance channel. In one embodiment, during the testing of normal blood samples, if the first platelet impedance histogram (i.e., the impedance channel PLT volume histogram) and the derived platelet impedance histogram (i.e., the hemolytic channel PLT volume histogram) show significant differences in their graphs during the testing of the first and second platelet suspensions using the same impedance detection component, it can be considered that there is an abnormality in the impedance detection channel or the impedance detection component. Furthermore, the first and second platelet detection data of multiple samples can be continuously recorded and compared. Statistical analysis shows that if the data for multiple consecutive samples are inconsistent, an alarm is triggered indicating an abnormality in the impedance detection component, improving the accuracy of the alarm.

[0086] It should be noted that the anomalies described in this article may be caused by analyzer malfunctions. These analyzer malfunctions include, but are not limited to, malfunctions in the impedance detection component.

[0087] The above exemplifies a method for detecting platelets using electrical impedance to measure platelets according to embodiments of this application. Based on the above description, the method for detecting platelets using electrical impedance to measure platelets according to embodiments of this application can obtain accurate platelet counts by combining a whole blood count (CBC) channel and a white blood cell differential channel (three-part differential channel), without the need for an additional optical platelet detection channel, thus reducing clinical testing costs and instrument complexity.

[0088] The following is combined with Figure 13 Describes a blood analysis system provided according to another aspect of this application. Figure 13 A schematic block diagram of a blood analysis system 1300 according to an embodiment of this application is shown. Figure 13As shown, the blood analysis system 1300 may include a first mixing chamber 1310 for mixing a first portion of a blood sample with a diluent to form a first suspension; a second mixing chamber 1320 for mixing a second portion of the blood sample with a hemolysin to dissolve red blood cells to form a second suspension; and an impedance detector 1340 for detecting a first impedance signal of the first suspension passing through an orifice 1330 and a second impedance signal of the second suspension passing through an orifice 1330, wherein the impedance detector is mounted in the orifice 1330 of the flow path, and the flow path is connected to the first mixing chamber 1310 and the second mixing chamber 1320. The data processing module 1350 is operatively connected to the impedance detector. The data processing module includes a processor 1351 and a non-transitory computer-readable storage medium 1352 programmed with a computer application. When the computer application is executed by the processor 1351, the processor 1351 generates a first platelet distribution based on the first impedance signal of the first suspension, distinguishes platelets from white blood cells based on the second impedance signal of the second suspension and generates a second platelet distribution, and determines the platelet concentration of the blood sample based on the first platelet distribution and the second platelet distribution.

[0089] The blood analysis system 1300 according to the embodiments of this application can be used to perform the method for detecting platelets by applied electrical impedance as described above according to the embodiments of this application. Those skilled in the art can understand the structure and operation of the blood analysis system 1300 in conjunction with the foregoing description of the method for detecting platelets by applied electrical impedance 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 1300 will not be repeated here, but only their main operating steps will be briefly described.

[0090] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 distinguishes between platelet regions and white blood cell regions in the second platelet impedance histogram obtained from the second suspension.

[0091] In an embodiment of this application, the first platelet distribution is a first platelet impedance histogram obtained from the first suspension.

[0092] In an embodiment of this application, the second platelet distribution is a derived platelet impedance histogram generated using the impedance signals of platelets in the platelet region.

[0093] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 generates a fused platelet histogram using the first platelet impedance histogram and the derived platelet impedance histogram, and obtains the platelet concentration based on the fused platelet histogram.

[0094] In embodiments of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 causes the processor to: determine the platelet trough-to-peak ratio of the first platelet impedance histogram; determine the number of events in a specified region of the derived platelet impedance histogram; determine a derived separation threshold for the troughs between platelets and red blood cells in the first platelet impedance histogram based on the platelet trough-to-peak ratio and the number of events in the specified region; and use the derived separation threshold to distinguish between platelets and red blood cells in the first platelet impedance histogram to obtain the platelet concentration of the blood sample.

[0095] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 further distinguishes the white blood cells in the blood sample into subpopulations of white blood cells based on the second impedance signal of the second suspension; wherein, distinguishing the white blood cells in the blood sample into subpopulations of white blood cells includes: distinguishing lymphocyte populations, intermediate cell populations and granulocyte populations.

[0096] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 is also caused to: perform a white blood cell count of the blood sample on the second suspension.

[0097] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 is also configured to: acquire red blood cell detection data of 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.

[0098] In an embodiment of this application, when the computer application of the data processing module 1350 is executed by the processor 1351, the processor 1351 is also configured to: determine whether there is an abnormality in the detection of platelets and / or the detection of electrical impedance signals based on the first platelet distribution and the second platelet distribution; and issue an alarm message when it is determined that there is an abnormality in the detection of platelets and / or the detection of electrical impedance signals.

[0099] Based on the above description, the blood analysis system according to the embodiments of this application can obtain accurate platelet counts by combining the whole blood count channel (CBC) and the white blood cell detection channel (three-part differential channel), without the need to add an additional optical platelet detection channel, thus reducing the cost of clinical testing and the complexity of instruments.

[0100] The following is combined with Figures 14 to 16 The study describes the interference samples (at least 5 red blood cell fragment samples, at least 5 normal samples, and at least 5 large platelet samples, totaling 25 samples), the platelet results obtained after processing by conventional electrical impedance methods, and the correlation analysis between the platelet results obtained after processing by the method described in this paper and the reference values.

[0101] Figure 14 The correlation between platelet concentrations in these blood samples obtained using conventional electrical impedance tomography (EIT) and those obtained using a flow cytometry reference method is shown. As illustrated, the correlation between platelet concentrations obtained using EIT and the reference method is poor. This is because most of the blood samples contained abnormalities known to interfere with conventional platelet EIT detection, such as red blood cell fragments, small red blood cells, or large platelets. The correlation coefficient R in the linear regression analysis of these 25 blood samples is shown. 2 The value was 0.8343. We found that the platelet concentration obtained by the conventional electrical impedance tomography (EIT) method for blood samples containing red blood cell fragments or small red blood cells was significantly higher than that obtained by the reference method, while the platelet concentration obtained by the conventional EIT method for blood samples containing large platelets was significantly lower than that obtained by the reference method.

[0102] Figure 15 The histogram H of fused platelets generated by equation (2) in the method of this disclosure is shown. Plt-IW The correlation between the platelet concentrations of these 25 blood samples and the results obtained from the flow cytometry reference method is shown in the figure. The two are closely correlated, with a correlation coefficient R0. 2 The value is 0.989. This demonstrates that using the fusion platelet histogram H described in this disclosure... Plt-IW It can effectively correct the errors in platelet detection results of conventional impedance methods for abnormal blood samples containing red blood cell fragments, small red blood cells, or large platelets.

[0103] Similarly, Figure 16 The correlation between the platelet concentrations of these 25 blood samples obtained by equations (3)-(5) in the method of this disclosure and the results obtained by the flow cytometry reference method is shown in the figure. The two are closely correlated, with a correlation coefficient R. 2The value was 0.987. This indicates that the method can accurately detect the platelet concentration in blood samples and effectively correct the errors in platelet detection results of conventional impedance methods for abnormal blood samples containing red blood cell fragments, small red blood cells, or large platelets.

[0104] Based on the above description, the method and blood analysis system for detecting platelets using electrical impedance to analyze platelets according to the embodiments of this application can obtain accurate platelet counts by combining the whole blood count channel (CBC) and the white blood cell differential channel (three-part differential channel), without the need to add an additional optical platelet detection channel, thus reducing the cost of clinical testing and the complexity of instruments.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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 method for detecting platelets using electrical impedance tomography, characterized in that, The method includes: The first blood sample was mixed with the diluent to form the first suspension; The second portion of the blood sample was mixed with a hemolytic agent to dissolve the red blood cells, forming a second suspension; Measure the first impedance signal of the first suspension flowing through the orifice; Measure the second impedance signal of the second suspension flowing through the orifice; Analyze the first impedance signal of the first suspension to obtain the first platelet distribution; Analyze the second impedance signal of the second suspension to distinguish platelets from white blood cells and obtain the second platelet distribution; and The platelet concentration of the blood sample is determined based on the first platelet distribution and the second platelet distribution.

2. The method according to claim 1, characterized in that, The distinction between platelets and white blood cells includes: The platelet region and the white blood cell region are distinguished in the second platelet impedance histogram obtained from the second suspension.

3. The method according to claim 2, characterized in that, The first platelet distribution is the first platelet impedance histogram obtained from the first suspension.

4. The method according to claim 3, characterized in that, The second platelet distribution is a derived platelet impedance histogram generated using the platelet impedance signals of the platelet regions.

5. The method according to claim 4, characterized in that, The step of determining the platelet concentration of the blood sample includes: A fused platelet histogram is generated using the first platelet impedance histogram and the derived platelet impedance histogram, and platelet concentration is obtained based on the fused platelet histogram.

6. The method according to claim 4, characterized in that, The step of determining the platelet concentration of the blood sample includes: Determine the platelet peak-to-valley ratio of the first platelet impedance histogram; Determine the number of events in a specified region of the derived platelet impedance histogram; Based on the platelet peak-to-trough ratio and the number of events in the specified region, determine the derived separation threshold of the troughs between platelets and red blood cells in the first platelet impedance histogram; and The platelet concentration of the blood sample is obtained by using the derived separation threshold to distinguish between platelets and red blood cells in the first platelet impedance histogram.

7. The method according to claim 1, characterized in that, The method further includes classifying leukocytes in the blood sample into leukocyte subpopulations based on the second impedance signal of the second suspension; The step of classifying the white blood cells in the blood sample into subgroups of white blood cells includes: distinguishing lymphocytes, intermediate cells, and granulocytes.

8. The method according to claim 1, characterized in that, The method further includes: The second suspension was subjected to a white blood cell count of the blood sample.

9. The method according to any one of claims 1-8, characterized in that, The method further includes: 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.

10. The method according to any one of claims 1-8, characterized in that, The method further includes: Determine whether there are any abnormalities in the detection of the first platelet and / or the detection of the impedance signal based on the first platelet distribution and the second platelet distribution; An alarm message is issued when abnormalities are detected in platelet count and / or impedance signal detection.

11. A blood analysis system, characterized in that, The blood analysis system includes: The first mixing chamber is used to mix a first portion of the blood sample with a diluent to form a first suspension. The second mixing chamber is used to mix a second portion of the blood sample with a hemolytic agent to dissolve red blood cells and form a second suspension. An impedance detector is used to detect a first impedance signal of the first suspension passing through the orifice and a second impedance signal of the second suspension passing through the orifice, wherein the impedance detector is mounted in the orifice of the flow path, and the flow path is connected to the first mixing chamber and the second mixing chamber; A data processing module, operatively connected to the impedance detector, includes a processor and a non-transitory computer-readable storage medium programmed with a computer application. When the computer application is executed by the processor, the processor generates a first platelet distribution based on the first impedance signal of the first suspension, distinguishes platelets from leukocytes based on the second impedance signal of the second suspension and generates a second platelet distribution, and determines the platelet concentration of the blood sample based on the first platelet distribution and the second platelet distribution.

12. The blood analysis system according to claim 11, characterized in that, When the computer application of the data processing module is executed by the processor, the processor distinguishes between platelet regions and white blood cell regions in the second platelet impedance histogram obtained from the second suspension.

13. The blood analysis system according to claim 12, characterized in that, The first platelet distribution is the first platelet impedance histogram obtained from the first suspension.

14. The blood analysis system according to claim 13, characterized in that, The second platelet distribution is a derived platelet impedance histogram generated using the platelet impedance signals of the platelet regions.

15. The blood analysis system according to claim 14, characterized in that, When the computer application of the data processing module is executed by the processor, the processor generates a fused platelet histogram using the first platelet impedance histogram and the derived platelet impedance histogram, and obtains the platelet concentration based on the fused platelet histogram.

16. The blood analysis system according to claim 14, characterized in that, When the computer application of the data processing module is executed by the processor, the processor: Determine the platelet peak-to-valley ratio of the first platelet impedance histogram; Determine the number of events in a specified region of the derived platelet impedance histogram; The derived separation threshold of the trough between platelets and red blood cells in the first platelet impedance histogram is determined based on the platelet trough-to-peak ratio and the number of events in the specified region. as well as The platelet concentration of the blood sample is obtained by using the derived separation threshold to distinguish between platelets and red blood cells in the first platelet impedance histogram.

17. The blood analysis system according to claim 11, characterized in that, When the computer application of the data processing module is executed by the processor, the processor is also made to distinguish the white blood cells in the blood sample into subpopulations of white blood cells based on the second impedance signal of the second suspension; The step of classifying the white blood cells in the blood sample into subgroups of white blood cells includes: distinguishing lymphocytes, intermediate cells, and granulocytes.

18. The blood analysis system according to claim 11, characterized in that, When the computer application of the data processing module is executed by the processor, the processor is also made to: The second suspension was subjected to a white blood cell count of the blood sample.

19. The blood analysis system according to any one of claims 11-18, characterized in that, When the computer application of the data processing module is executed by the processor, the processor is also made to: 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.

20. The blood analysis system according to any one of claims 11-18, characterized in that, When the computer application of the data processing module is executed by the processor, the processor is also made to: Determine whether there is any abnormality in the detection of the first platelet and / or the detection of the impedance signal based on the first platelet distribution and the second platelet distribution; An alarm message is issued when abnormalities are detected in platelet count and / or impedance signal detection.

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