Particle counting apparatus and method, blood cell counting apparatus, and poct blood cell analyzer

Abstract

A particle counting apparatus and a particle counting method. The apparatus comprises: a pressure creating assembly (11), a counting chamber (12), a pressure measurement member (13) and an impedance counting assembly (14), and the apparatus further comprises a control apparatus (15). The control apparatus (15) is used for: in a first stage, controlling the pressure creating assembly (11) to act to form an initial pressure P1 between the counting chamber (12) and the pressure creating assembly (11); in a second stage, controlling the pressure creating assembly (11) to act to acquire a fixed volume to form a process pressure P2 between the counting chamber (12) and the pressure creating assembly (11); and in a third stage, controlling the pressure creating assembly (11) to stop acting, such that the process pressure P2 decreases to the initial pressure P1 again, wherein a test sample passes through a counting hole (123) of the counting chamber (12) under the action of the pressure, and the impedance counting assembly (14) performs electrical impedance counting on the test sample in the second stage and the third stage. By means of the method, the accuracy and reliability of a counting result can be improved.

Description

Particle counting device and method, blood cell counting device and POCT blood cell analyzer

[0001] Citation of Related Applications

[0002] This application claims priority to Chinese patent application No. 2023118679641, filed on December 29, 2023, entitled “Particle counting device, particle counting method and blood cell counting device,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present application relates to the field of particle counting technology, and in particular to a particle counting device, a particle counting method, a blood cell counting device, and a POCT blood cell analyzer. Background Art

[0004] Particle counting devices use the impedance method to count and detect test samples. When performing electrical impedance counting, the device first raises the pressure to a high level using components such as a negative pressure tank. The valve between the negative pressure tank and the counting cell is then opened, providing the driving force for the test sample to pass through the counting aperture in the counting cell. Particle counting is then performed within a specified timeframe. This method is susceptible to variations in the size of the counting apertures or blockage of the counting apertures, resulting in inaccurate and unreliable counting results. For example, if the counting apertures are slightly blocked, the particle count result within the specified timeframe may be underestimated.

[0005] Summary of the Invention

[0006] The present application provides a particle counting device and a counting method thereof to solve the technical problems arising in the prior art.

[0007] To solve the above problems, the present application provides a particle counting device in a first aspect, comprising:

[0008] A pressure building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure building component is connected to the counting cell via a pipeline, the impedance counting component is connected to the counting cell, the pressure detection component is used to detect the pressure of the counting cell; the counting cell is used to load the test sample;

[0009] Also included is a control device, the control device being configured to:

[0010] In the first stage, the pressure building component is controlled to establish an initial pressure P1 for the counting pool;

[0011] In the first stage, the pressure building component is controlled to operate to obtain the fixed volume forming process pressure P2;

[0012] In the first stage, the pressure building component is controlled to stop its action so that the process pressure P2 drops back to the initial pressure P1;

[0013] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component performs electrical impedance counting on the test sample in the second stage and the third stage.

[0014] The fixed volume is calculated based on the test item, dilution ratio and preset linear concentration of the test sample.

[0015] When the particle counting device performs multiple counts, the initial pressure P1 of each count remains the same; or the initial pressure P1 of each count remains within the first fluctuation range. In the third stage, controlling the pressure-building component to stop operation so that the process pressure P2 returns to the initial pressure P1 specifically includes: controlling the pressure-building component to stop operation so that the process pressure P2 returns to the first pressure P3, where the first pressure P3 is within the second fluctuation range of the initial pressure P1.

[0016] In the first stage, the control device controls the pressure building component to operate to form an initial pressure P1 between the counting pool and the pressure building component. Specifically, the pressure building component is controlled to operate until the pressure value detected by the pressure detection component reaches near the preset pressure value, and the pressure value at this time is used as the initial pressure P1.

[0017] Wherein, the pressure building component includes a syringe or a metering pump or a plunger pump or a peristaltic pump or a diaphragm pump or a magnetic pump or a gear pump or an air source.

[0018] Wherein, the pressure building component includes a syringe;

[0019] In the first stage, the control device controls the pressure-building component to operate to form an initial pressure P1 between the counting cell and the pressure-building component. Specifically, the control device controls the piston of the syringe to move until the pressure value detected by the pressure detection component reaches a predetermined pressure value, and uses the pressure value at this time as the initial pressure P1.

[0020] In the second stage, the control device controls the pressure building component to move to obtain the fixed volume, specifically by controlling the piston of the syringe to continue moving the first range to obtain the fixed volume.

[0021] The area around the preset pressure value is [(1+5%)×preset pressure value, (1-5%)×preset pressure value].

[0022] The preset pressure value is between -50 kPa and -10 kPa.

[0023] Wherein, the control device controls the piston of the syringe to move at a first constant speed until the pressure value detected by the pressure detection element reaches near a preset pressure value;

[0024] and or,

[0025] The piston of the syringe is controlled to continue to move uniformly at a second speed over a first range to obtain the fixed volume.

[0026] The pressure change rate between the counting pool and the pressure building component caused by the first stage action is greater than the pressure change rate between the counting pool and the pressure building component caused by the second stage action;

[0027] or,

[0028] The first speed is greater than the second speed.

[0029] Wherein, the measuring range of the syringe is 1.5-15 ml.

[0030] In which, the pressure building component includes a metering pump, a peristaltic pump, a diaphragm pump, a magnetic pump, or a gear pump; in the second stage, the control device controls the pressure building component to operate to obtain the fixed volume: the control device controls the pressure building component to run at a working speed for a preset time to obtain the fixed volume.

[0031] The pressure building component includes an air source, a valve and a volume flow meter; the air source is connected to the valve, the volume flow meter and the counting pool in sequence;

[0032] In the second stage, the control device controls the pressure building component to take action to obtain a fixed volume, specifically: controlling the valve to open so that the gas from the gas source enters the volume flow meter, and when the volume flow meter detects that the gas volume is the fixed pressure, controlling the valve to close.

[0033] Wherein, the counting pool includes a front pool, a rear pool, and a counting hole connecting the front pool and the rear pool;

[0034] The pressure building component is connected to the rear pool through a pipeline, and a pressure detection component is also provided on the pipeline connecting the pressure building component and the rear pool; or the pressure detection component is connected in parallel to the pipeline connecting the pressure building component and the rear pool.

[0035] Wherein, the particle counting device includes a particle analysis instrument and a reagent kit, and the front pool, the rear pool and the counting hole are arranged in the reagent kit.

[0036] Wherein, the particle counting device includes a particle analysis instrument and a reagent kit, and the counting hole is arranged in the particle analysis instrument.

[0037] The rear pool includes a waste liquid chamber, which is used to store the test sample after the test is completed. The connection end of the pressure building component is connected to the waste liquid chamber through a pipeline.

[0038] To solve the above problem, the second aspect of the present application provides a counting method applied to the above particle counting device, the counting method comprising:

[0039] Controlling the pressure building component to perform the first stage action to establish an initial pressure P1 for the counting pool;

[0040] Controlling the pressure building component to perform a second stage action to obtain a fixed volume forming process pressure P2;

[0041] Controlling the pressure building component to stop operating in the third stage so that the process pressure P2 drops back to the initial pressure P1;

[0042] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component is controlled to perform electrical impedance counting on the test sample in the second stage and the third stage.

[0043] A third aspect of the present application provides a blood cell counting device, comprising a pressure building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure building component is connected to the counting cell via a pipeline, the impedance counting component is connected to the counting cell, the pressure detection component is used to detect the pressure between the counting cell and the pressure building component; the counting cell is used to load a test sample;

[0044] Also included is a control device, the control device being configured to:

[0045] In the first stage, the pressure building component is controlled to operate to form an initial pressure P1 between the counting pool and the pressure building component;

[0046] In the second stage, the pressure building component is controlled to operate to obtain a fixed volume so that a process pressure P2 is formed between the counting cell and the pressure building component;

[0047] In the third stage, the pressure building component is controlled to stop the action so that the process pressure P2 drops back to the initial pressure P1;

[0048] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component performs electrical impedance counting on the test sample in the second stage and the third stage.

[0049] To solve the above problems, the present application provides a POCT blood cell analyzer in the first aspect, comprising:

[0050] A pressure building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure building component is connected to the counting cell via a pipeline, the impedance counting component is connected to the counting cell, the pressure detection component is used to detect the pressure of the counting cell; the counting cell is used to load the test sample;

[0051] Also included is a control device, the control device being configured to:

[0052] In the first stage, the pressure building component is controlled to establish an initial pressure P1 for the counting pool;

[0053] In the first stage, the pressure building component is controlled to operate to obtain the fixed volume forming process pressure P2;

[0054] In the first stage, the pressure building component is controlled to stop its action so that the process pressure P2 drops back to the initial pressure P1;

[0055] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component performs electrical impedance counting on the test sample in the second stage and the third stage.

[0056] The beneficial effect of the present application is that, different from the prior art, the present application establishes an initial pressure P1 for the counting pool by controlling the pressure-building component to perform the first-stage action. The initial pressure P1 is the driving force for providing the particle flow of the test sample to pass through the counting hole; the fixed volume is obtained by controlling the pressure-building component to perform the second-stage action to form a process pressure P2. The fixed volume is the volume of the test sample required to flow through the counting hole to complete the test item; the pressure-building component stops the action in the third stage to allow the process pressure P2 to drop back to the initial pressure P1, and the test sample passes through the counting hole of the counting pool under the action of pressure. After this process is completed, the volume of the test sample flowing through the counting hole is equal to the above-mentioned fixed volume; the impedance counting component performs electrical impedance counting on the test sample in the second and third stages. Therefore, the second stage actually obtains the fixed volume and causes the pressure to rise, and then the pressure drops in the third stage and returns to the initial pressure P1 again, realizing the volume quantification of the test sample. It is a process in which the volume change of the pressure-building component is converted into pressure change, and the pressure change is then converted into the volume change of the test sample passing through the counting hole. In this process, the counting result is independent of the counting time. Changes in counting time caused by differences in the size of the counting holes or blockage of the holes will not affect the counting result, thereby improving the accuracy and reliability of the counting result. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without inventive efforts. Among them:

[0058] FIG1 is a schematic diagram of a framework of an embodiment of a particle counting device of the present application;

[0059] FIG2 is a schematic diagram of a framework of another embodiment of a particle counting device of the present application;

[0060] FIG3 is a schematic diagram of a framework of an embodiment of a POCT particle counting device of the present application;

[0061] FIG4 is a schematic structural diagram of the POCT particle counting device kit of the present application;

[0062] FIG5 is a schematic structural diagram of a particle counting device according to Example 1 of the present application;

[0063] FIG6 is a schematic diagram of the pressure change over time between the counting pool and the pressure building component of the present application;

[0064] FIG7 is a flow chart of an embodiment of a control method of the present application;

[0065] FIG8 is a schematic diagram of a framework of an embodiment of a computer-readable storage medium provided in the present application.

[0066] Figure numbers: particle analysis instrument 10; pressure building component 11; counting cell 12; pressure detection component 13; impedance counting component 14; control device 15; loading seat 16; pipetting component 17; pipeline 18; driving member 111; syringe piston 112; syringe measuring cylinder 113; front cell 121; back cell 122; counting hole 123; pressure interface 124; electrode 125; first electrode 141; second electrode 142; constant current source 143; signal acquisition and processing unit 144; reagent box 20; sample cell 21; reagent cell 22; microporous plate 23; diluent cell 221; hemolytic agent cell 222; waste liquid chamber 1221; initial pressure P1; process pressure P2; first pressure P3; computer-readable storage medium 80; program instruction 81. DETAILED DESCRIPTION

[0067] The present application will be further described in detail below in conjunction with the accompanying drawings and examples. It is particularly noted that the following examples are only intended to illustrate the present application and are not intended to limit the scope of the present application. Similarly, the following examples are only some examples of the present application and not all examples. All other examples obtained by those of ordinary skill in the art without creative work are intended to fall within the scope of protection of this application.

[0068] It is understood that the particle counting device of the present application may include, but is not limited to, urine counting devices, blood cell counting devices, microbial counting devices, and other medical devices that require and are capable of particle counting. Furthermore, the particle counting device can serve as a large-scale automated analyzer for integrated testing of multiple samples within a laboratory, or as a POCT (point-of-care testing) medical testing device. However, considering its adaptability, it may be more suitable for use as a POCT (point-of-care testing) medical testing device.

[0069] Please refer to Figure 1. The particle counting device in one embodiment of the present application includes a pressure building component 11, a counting cell 12, a pressure detection component 13 and an impedance counting component 14; the pressure building component 11 is connected to the counting cell 12 through a pipeline, the impedance counting component 14 is connected to the counting cell 12, the pressure detection component 13 is used to detect the pressure between the counting cell 12 and the pressure building component (or the pressure of the pipeline), and the pressure detection component 13 includes but is not limited to a pressure sensor; the counting cell 12 is used to load the test sample.

[0070] In a specific embodiment, referring to FIG2 , the counting pool 12 includes a front pool 121, a rear pool 122, a counting hole 123, a pressure interface 124, and two electrodes 125 (a front pool electrode provided in the front pool 121 and a rear pool electrode provided in the rear pool 122). The front pool 121 and the rear pool 122 are connected through the counting hole 123, and the pressure interface 124 is provided in the rear pool 122 and is connected to the pressure building component 11 through a pipeline. A pressure detection component 13 is also provided on the pipeline connecting the pressure building component 11 and the pressure interface 124 of the rear pool 122; or the pressure detection component 13 is connected to the pipeline connecting the pressure building component 11 and the pressure interface 124 of the rear pool 122. It can be understood that there are two detection methods for the pressure detection component 13. One is to detect in series in the pipeline, and the pressure detection component 13 itself also passes through the fluid in the pipeline. The other is to be connected in the pipeline through a three-way joint, that is, the three ends of the three-way joint are respectively connected to the pressure building component 11, the pressure interface 124 and the pressure detection component 13.

[0071] The impedance counting assembly 14 includes a first electrode 141, a second electrode 142, a constant current source 143, and a signal acquisition and processing unit 144. One end of the first electrode 141 is connected to the front cell electrode, one end of the second electrode 142 is connected to the rear cell electrode, the other end of the first electrode 141 is connected to the constant current source 143, and the other end of the second electrode 142 is grounded. The signal acquisition and processing unit 144 is connected to the other end of the first electrode 141 and is used to collect and process signals to perform impedance counting on the sample to be tested in the reagent kit 20.

[0072] The particle counting device also includes a control device 15, and the controller 15 can also be called a control chip, a control component or a control module. The control device 15 is respectively connected to the pressure building component 11, the pressure detection component 13 and the impedance counting component 14, and the control device 15 is used to control the action of the pressure building component 11, receive the pressure detection data of the pressure detection component 13, control the impedance counting component 14 to perform impedance counting, and receive the impedance counting result (data). In a specific embodiment, the control device 15 can be a board or multiple separate boards to realize the overall function, and this application does not limit this. In Figure 2, the control device 15 is connected to the signal acquisition and processing unit 144 for receiving the impedance counting result (data). Alternatively, the control device 15 includes a signal acquisition and processing unit 144, and the signal acquisition and processing unit 144 serves as a subunit of the control device 15, and this application does not limit this.

[0073] The pressure building component 11 may include any one of a syringe, a metering pump, a plunger pump, a peristaltic pump, a diaphragm pump, a magnetic pump, a gear pump or an air source. When the pressure building component 11 is a syringe, the pressure building component includes a driving member 111, a piston 112 of the syringe and a measuring cylinder 113 of the syringe. The driving member 111 is connected to the control device 15 and is used to drive the piston 112 to move in the measuring cylinder 113. The driving member 111 may also be designed as an integral part of the control device 15. In a specific embodiment, the driving member 111 is a motor. It can be understood that when the pressure building component 11 is the above-mentioned different pumps, the sub-components of the pressure building component are different, and the control method is also different.

[0074] According to some embodiments of the present application, as shown in FIG3 , the particle counting device is a POCT particle counting device, comprising a particle analysis instrument 10 and a reagent kit 20. The reagent kit 20 is a disposable reagent kit, comprising a sample pool 21 and one or more reagent pools 22 for carrying a sample to be tested and a detection reagent. For example, when the particle counting device is a blood cell counting device, the sample to be tested is a blood sample, and the detection reagent may include a diluent, a hemolytic agent, etc. The particle analysis instrument 10 includes the control device 15, the pressure building component 11, the pressure detection component 13, and the impedance counting device 14, and also includes a loading seat 16 and a pipetting component 17.

[0075] In which, the loading seat 16 is provided with a loading slot, which is used to load the test kit 20. In a specific embodiment, the loading seat 16 can also integrate the impedance counting device 14 to become a detection seat, and the first electrode 1411 and the second electrode 142 are arranged on the side wall of the detection seat. The test kit 20 is installed on the detection seat so that the first electrode 141 is connected to the front pool electrode and the second electrode 142 is connected to the rear pool electrode.

[0076] The pipetting assembly 17 is used to configure the sample to be tested and the detection reagent carried by the test kit into a detection sample and move it to the fore cell 121 for detection.

[0077] In a specific embodiment, the loading base 16 and the pipetting assembly are driven by one or more motors controlled by the control device 15 to perform one-dimensional, two-dimensional or three-dimensional motion.

[0078] In a POCT particle counting device, in order to achieve no-cleaning, the counting pool 12 is usually set in its entirety in the reagent kit 20 rather than in the analytical instrument. After the counting / detection is completed, the entire reagent kit is discarded.

[0079] In a specific embodiment, please refer to Figure 4, the test kit 20 includes a box body and a microporous sheet 23, and the box body includes a sample pool 21, a reagent pool 22, a front pool 121 and a back pool 122. The sample pool 21 is located at the outermost side of the test kit 20, and can hold the sample to be tested, or it can be placed together with a sampler for holding the sample to be tested (the sampler and the sample to be tested are placed together in the sample pool 21). The reagent pool 22 includes a diluent pool 221 and a hemolytic agent pool 222, and the diluent pool 221 and the hemolytic agent pool 222 are arranged adjacent to each other for pre-packaging the diluent and the hemolytic agent, and sealing the film at the same time nearby. The back pool 122 is located on one side of the front pool 121, and a through hole is provided between the front pool 121 and the back pool 122, and the microporous sheet 23 is arranged at one end of the through hole. For example, the microporous sheet 23 is located at one end of the through hole close to the front pool 121, or the microporous sheet 23 is located at one end of the through hole close to the back pool 122. In Figure 4, the microporous sheet 23 is located at one end of the through hole near the back cell 122, and the micropores of the microporous sheet 23 are used to form the counting hole 123. When the particle counting device performs particle counting, the fore cell is used to load the test sample, and the counting hole 123 is used to allow particles in the test sample located in the fore cell 121 to pass through one by one. The diameter of the counting hole 123 can be set accordingly according to the different particle sizes.

[0080] Optionally, the test kit 20 further includes two electrodes 125 (a front cell electrode and a rear cell electrode), one end of the front cell electrode is located in the front cell 121, and the other end of the front cell electrode is located outside the box body, one end of the rear cell electrode is located in the rear cell 122, and the other end of the rear cell electrode is located outside the box body.

[0081] 4 , the front cell electrode and the rear cell electrode are located on the same side of the box body, which facilitates contact with the impedance counter component 14. In other embodiments, the front cell electrode and the rear cell electrode may be located on different sides of the box body, which will not be described in detail here.

[0082] Optionally, the back pool 122 includes a waste liquid chamber 1221, which is used to store the test sample after counting. The pressure building component 11 is connected to the waste liquid chamber 1221 via a pipeline 18. When the particle counting device completes one or more test items of the test sample, the waste liquid chamber 1221 is used to store the test sample (waste liquid) that has completed one or more test items.

[0083] In a specific embodiment, the counting hole 123 is provided in the particle analyzer 10, and only one of the front pool 121 and the rear pool 122 can be provided in the reagent box, the front pool 121 is provided in the reagent box, or the rear pool 25 is provided in the reagent box. That is, the front pool 121 and the rear pool 122 of the particle counting device are provided separately; for example, the front pool 121 is provided in the reagent box 20, and the rear pool 122 is provided in the particle analyzer 10, or the front pool 121 is provided in the particle analyzer 10, and the rear pool 122 is provided in the reagent box 10. During counting, the front pool 121 is connected to the rear pool 122 through the counting hole 123. Generally speaking, the counting hole 123 is provided on one side of the rear pool 122, and the position of the counting hole 123 can be used to determine the positions of the front pool and the rear pool.

[0084] Considering that the pressure building component 11 can be directly connected to the rear pool 122 of the counting pool 12, directly building pressure for the rear pool 122 and assisting in counting, which is faster, this application gives priority to using this method, but this application does not exclude the technical solution of setting a pressure chamber between the pressure building component 11 and the rear pool 122 to store the pressure generated by the pressure building component 11.

[0085] The above is the structural basis for realizing the particle counting device of the present application. The following describes in detail how the present application solves the problem of inaccurate and unreliable counting results in the prior art from the control process of the control device 15 .

[0086] This application replaces time quantitative counting with volume quantitative counting, which specifically includes three stages. The control device 15 is used to:

[0087] In the first stage, the pressure building component 11 is controlled to establish an initial pressure P1 for the counting pool;

[0088] In the second stage, the pressure building component 11 is controlled to operate to obtain a fixed volume forming process pressure P2;

[0089] In the third stage, the pressure building component 11 is controlled to stop so that the process pressure P2 drops back to the initial pressure P1;

[0090] The test sample passes through the counting hole 123 of the counting pool 12 under pressure, and the impedance counting component 14 performs electrical impedance counting on the test sample in the second stage and the third stage.

[0091] The first stage is the pressure building stage, in which the pressure building component 11 acts to establish an initial pressure P1 between the counting pool 122 and the pressure building component 11. The initial pressure P1 is used to drive the particles in the test sample from the front pool 121 through the counting hole 123 to flow into the back pool 122. It can be understood that after the test sample is loaded into the front pool 121, a closed chamber is formed between the back pool 122, the pipeline and the pressure building component 11. The pressure of the closed chamber can be detected by the pressure detection part 13. The pressure of the closed chamber can be characterized by the pressure between the counting pool and the pressure building component 11, the pressure of the back pool 122, the pressure of the pipeline and the pressure of the pressure building component 11 (the four are referred to as the same in the description in this application). When the size of the counting hole 123 is determined, the greater the initial pressure P1, the greater the power to drive the particles in the test sample from the front pool 121 through the counting hole 123 to flow into the back pool 122, and the faster the particle flow rate. In order to make the particle flow rate moderate, neither too fast nor too slow, taking the particle counting device as a blood cell counting device as an example, the initial pressure P1 is between -50 kPa and -10 kPa, and includes the endpoint values ​​of the two numerical ranges of -50 kPa and -10 kPa.

[0092] Specifically, in the first stage, the control device controls the pressure building component to operate to form an initial pressure P1 between the counting pool and the pressure building component. Specifically, the pressure building component is controlled to operate until the pressure value detected by the pressure detection component reaches near the preset pressure value, and the pressure value at this time is used as the initial pressure P1.

[0093] By using the pressure value detected by the pressure detection component 13 as the control quantity, the action of the pressure building component is controlled until the pressure value detected by the pressure detection component reaches near the preset pressure value. Since the data detected by the pressure detection component 13 has a certain data transmission delay and the control device 15 feedback controls the action of the pressure building component 11 based on the pressure detected by the pressure detection component 13, there will also be errors and delays; at the same time, the initial pressure P1 is used to drive the test sample through 123. As long as it can reach near a preset pressure, it does not need to be too precise and cannot be too precise. Therefore, it is sufficient to control the pressure within a range in the first stage. Taking the particle counting device as a blood cell counting device as an example, the preset pressure value is between -50kpa and -10kpa, and includes the endpoint values ​​of the two numerical ranges of -50kpa and -10kpa. The preset pressure value can be -20kpa, -25kpa, -30kpa, -35kpa or -40kpa. For example, the preset pressure value is -30kpa.

[0094] The pressure around the preset pressure value is [(1+5%)×preset pressure value, (1-5%)×preset pressure value]. For example, if the preset pressure value is -30 kPa, the pressure around the preset pressure value is [-31.5 kPa, -28.5 kPa]. In other words, the control device 15 controls the pressure-building component until the preset pressure value reaches between [-31.5 kPa, -28.5 kPa], for example, -29 kPa or -30 kPa. The pressure value at this point is used as the initial pressure P1.

[0095] Considering the repeatability (precision) of multiple counts by a particle counting device, it is preferred that the initial pressure P1 remain the same for each count, or that the initial pressure P1 remain within a first fluctuation range. Precision refers to the degree of consistency between measurement indications or values ​​obtained by a particle counting device when repeatedly measuring the same or similar objects. Because the initial pressure P1 is used to drive particles in the test sample from the front cell 121 through the counting hole 123 into the back cell 122, its magnitude can affect the counting results. To maintain consistency in multiple counting results, the initial pressure P1 is preferably kept the same for each count. However, due to detection errors in the pressure detection element 13 and / or data transmission delays and mechanical errors in the particle analyzer, the initial pressure P1 for each count may not be completely equal. Instead, the initial pressure P1 for each count may be maintained within a first fluctuation range, for example, (1±10%)*P1.

[0096] The second stage is the volume quantification stage, in which the pressure building component 11 operates to obtain a fixed volume to form a process pressure P2; the fixed volume is calculated based on the test items, dilution ratio and preset linear concentration of the sample to be tested. The second stage converts its own volume change into a pressure change, with the initial pressure P1 rising to the process pressure P2. It can be understood that since the aperture of the counting hole 123 is small, the speed at which the test sample flows through the counting hole 123 is slow, slower than the action speed of the pressure building component 11. The pressure building component 11 performs the second stage action to increase the volume in the closed chamber, and the initial pressure P1 rises to the process pressure P2 (negative pressure, the pressure value increases). This is the process of converting the volume change of the pressure building component 11 or the closed chamber itself into a pressure change.

[0097] The fixed volume is calculated based on the test item, dilution ratio, and preset linear concentration of the test sample. For example, when the particle counting device is a blood cell counting device, the test items include red blood cell detection and white blood cell detection. Red blood cell detection requires dilution of the blood sample to be tested, and white blood cells also require the addition of a hemolytic agent to dissolve the red blood cells. In order to make the final counting / testing result accurate and reliable, the volume of the test sample passing through the counting hole 123 is equal to the total number of particles multiplied by the dilution ratio divided by the preset linear concentration. The total number of particles is the number of particles in the test sample with the minimum concentration required for the test item, the dilution ratio is the dilution ratio of the sample to be tested, and the preset linear concentration is the linear concentration corresponding to the test item in the prior art, which will not be repeated here. In short, red blood cell detection corresponds to a first fixed volume, which is the volume of the test sample required for red blood cell detection flowing through the counting hole 123. White blood cell detection corresponds to a second fixed volume, which is the volume of the test sample required for white blood cell detection flowing through the counting hole 123. The fixed volume is used to ensure the validity of the counting / testing results.

[0098] Based on this, the second phase establishes a corresponding relationship between the volume of the test sample flowing through the counting hole 123 and the pressure change (P1→P2) required for counting / detection. It is worth noting that the initial pressure P1 needs to be detected by the pressure detection component 13, while the process pressure P2 can be detected or not, as it is irrelevant to the control of the pressure building component 11.

[0099] It can be understood that the second stage of obtaining a fixed volume has different methods for different pressure-building components. For example, when a syringe obtains a fixed volume, the syringe piston moves a certain range to extract a fixed volume. For other pumps, the volume is extracted according to the working mode of the pump, which is not limited here.

[0100] The third stage is the pressure release stage. In the third stage, the pressure building component 11 stops moving to allow the process pressure P2 to drop back to the initial pressure P1. During this process, the pressure detection component 13 detects the change in pressure. When the pressure drops to the initial pressure P1, the pressure change in the second stage is converted into a volume change of the detection sample flowing through the counting hole 123. The volume of the detection sample flowing through the counting hole 123 in the second and third stages is equal to the fixed volume. This is because the detection sample is also continuously flowing through the counting hole 123 in the second stage, so the sum of the volumes flowing through the counting hole 123 in the second and third stages is equal to the fixed volume.

[0101] Corresponding to the counting process, the impedance counting component 14 should also perform electrical impedance counting on the test sample during the second and third phases. Such counting results correspond to a fixed volume (volume-based) of the test sample, making the counting results independent of the counting time. Variations in counting time due to differences in counting hole size or hole blockage will not affect the counting results, thereby improving the accuracy and reliability of the counting results.

[0102] It is worth noting that in the third stage, controlling the pressure-building component to stop operation so that the process pressure P2 returns to the initial pressure P1 specifically includes controlling the pressure-building component to stop operation so that the process pressure P2 returns to a first pressure P3, where the first pressure P3 is within the second fluctuation range of the initial pressure P1. It is understood that due to detection errors of the pressure detection element 13 and / or data transmission delays, mechanical errors in the particle analyzer, etc., the return of P2 to the initial pressure P1 may specifically be caused by causing the process pressure P2 to return to the first pressure P3, where the first pressure P3 is within the second fluctuation range of the initial pressure P1. In one specific embodiment, the second fluctuation range is P1 ± 0.3 kPa. Experiments have shown that within the second fluctuation range of P1 ± 0.3 kPa, the accuracy of the particle counting results is minimally affected, and the allowable relative deviation range meets the accuracy requirements. For example, the allowable relative deviation range for WBC detection results is ≤ 15%, and the allowable relative deviation range for RBC detection results is ≤ 6%.

[0103] The following table shows the particle counting test results for different values ​​of P1 and P3. This particle counting test results only show the test results for 10 samples, numbered 1 to 10. The test particles are blood cells. The WBC column represents the white blood cell count results, the RBC column represents the red blood cell count results, the HGB column represents the hemoglobin concentration results, the MCV column represents the mean corpuscular volume results, and the PLT column represents the platelet count results. P1, P2, and P3 on the right represent the experimental conditions corresponding to these samples. It can be clearly seen from the table that the test results for sample numbers 1, 3, 4, 5, 6, 7, 9, and 10 are all within the allowable relative deviation range of the target value. This is because the P1 values ​​for these samples are within the first fluctuation range ((1±10%)*P1) and the P3 values ​​are within the second fluctuation range (P1±0.3kPa). However, the RBC result for sample number 2 is 3.85×10 12 / L, which has exceeded the target value of 4.42×10 12 / L is outside the relative deviation range of 6%. This is because the P1 of sample number 2 is -26.2KPa, which is outside the first fluctuation range (the standard value of P1 is 30.0KPa); the RBC result of the experimental result of sample number 8 is 4.01×10 12 / L, which has exceeded the target value of 4.42×1012 The 6% relative deviation range of the sample number 8 is due to the value of P3 being -30.6 kPa, which is outside the second fluctuation range (the standard value of P1 is 30.0 kPa). The target value is the result of the sample microscopy.

[0104] Table 1 Particle counting test results under different values ​​of P1 and P3

[0105] To meet precision and accuracy requirements, the pressure sensing element 13 used in this application has a resolution of no less than 0.1 kPa, for example, 0.01 kPa. Resolution measures the minimum pressure change a pressure sensing element can detect. For example, when the resolution of the pressure sensing element 13 is 0.01 kPa, the pressure detection value of the pressure sensing element 13 can be accurate to two decimal places, for example, -30.45 kPa.

[0106] It can be understood that even if there are differences in the size of the counting holes or the counting holes are slightly blocked, the particle counting device of the present application can still complete the counting, but the detection time will be different.

[0107] It should be noted that the particle counting device in the present application is used to count, or detect, the number of particles in the test sample. The counting described in the present application includes two stages: collecting electric pulses and performing data analysis on the electric pulses. It can be understood that the collection of electric pulses can be carried out continuously during the operation of the particle counting device, and only a portion of the electric pulses are finally selected for data analysis to ultimately form the counting or detection results of the present application. The impedance counting component 14 described in the present application performs electrical impedance counting on the test sample in the second and third stages, which means that the electric pulse signals in the second and third stages are used for data analysis to obtain the counting or detection results, and the collection of electric pulses can start from the first stage, and the present application does not impose any restrictions on this.

[0108] Example 1:

[0109] The following description will be based on Example 1, in which the pressure-building component 11 is directly connected to the rear cell 122 of the counting cell 12 and the pressure-building component 11 is a syringe, which is the embodiment corresponding to Figure 5. The pressure-building component 11 is a syringe. In the first stage, the control device controls the pressure-building component 11 to operate by controlling the driving member 111 to drive the piston 112 of the syringe until the pressure value detected by the pressure detection member 13 reaches approximately the preset pressure value, and the pressure value at this time is used as the initial pressure P1.

[0110] Since the data detected by the pressure detection part 13 has a certain data transmission delay and the control device 15 uses the pressure detected by the pressure detection part 13 to feedback control the driving part 111 to drive the piston 112, there will also be errors and delays; at the same time, the initial pressure P1 is used to drive the test sample through 123. As long as it can reach a preset pressure, it does not need to be too precise. Therefore, it is sufficient to control the pressure within a range in the first stage. Taking the particle counting device as a blood cell counting device as an example, the preset pressure value is between -50kpa and -10kpa, and includes the endpoint values ​​of the two numerical ranges of -50kpa and -10kpa. The preset pressure value can be -20kpa, -25kpa, -30kpa, -35kpa or -40kpa. For example, the preset pressure value is -30kpa.

[0111] The pressure around the preset pressure value is [(1+5%)×preset pressure value, (1-5%)×preset pressure value]. For example, if the preset pressure value is -30 kPa, the pressure around the preset pressure value is [-31.5 kPa, -28.5 kPa]. That is, the control device 15 controls the syringe piston via the driving member 111 to move until the preset pressure value reaches between [-31.5 kPa, -28.5 kPa], for example, -29 kPa or -30 kPa. The pressure value at this point is used as the initial pressure P1.

[0112] In the second stage, the control device controls the pressure building component to move to obtain a fixed volume, specifically: controlling the piston 112 of the syringe to continue moving the first range to obtain the fixed volume.

[0113] Since the measuring cylinder 113 of the syringe itself has a scale, or the piston 112 is driven by the driving member 111, the driving member 111 is a motor, and the range of movement of the piston 112 can be accurately controlled by controlling the number of steps of the motor. When the piston 112 moves the first range, since the size (cross-sectional area) of the measuring cylinder 113 of the syringe is determined by the specifications, the fixed volume can be accurately controlled by multiplying the cross-sectional area and the first range by the product equal to the fixed volume. The fixed volume is the volume of the test sample required for counting / detection passing through the counting hole 123. And the starting point of the first range should be from the time of recording the initial pressure P1, that is, after the syringe completes the first stage of action.

[0114] Optionally, the control device controls the piston 112 of the syringe to move at a uniform speed. For example, it moves at a first uniform speed until the pressure value detected by the pressure detection component reaches near a preset pressure value; and or, it controls the piston of the syringe to continue to move at a second uniform speed within a first range to obtain the fixed volume. The first speed is greater than the second speed. This is because the first stage does not participate in counting, and the syringe can quickly reach the initial pressure P1, while the second stage participates in counting, and the speed of the syringe should not be too fast, so as to prevent the particles of the test sample from quickly passing through the counting hole, resulting in inaccurate detection and counting by the impedance counting device 14.

[0115] Of course, the control device can also control the movement of the syringe piston 112 in a variable speed manner. However, it should at least be ensured that the pressure change rate of the counting pool caused by the first stage action is greater than the pressure change rate of the counting pool caused by the second stage action. The pressure change rate between the counting pool and the pressure building component caused by the first stage action is the pressure change value in the first stage divided by time, and the pressure change rate between the counting pool and the pressure building component caused by the second stage action is the pressure change value in the second stage divided by time. That is, the syringe piston 112 moves rapidly in the first stage and moves slowly in the second stage.

[0116] According to some embodiments of the present application, the range of the syringe is 1.5-15 ml, and the range of the syringe can be 1.5 ml, 5 ml, 10 ml or 15 ml.

[0117] Please refer to Figure 6, which is a schematic diagram of an embodiment of the pressure and time coordinates between the counting cell and the pressure-building assembly in Figure 4. The time period 0-T0 in Figure 6 represents the time when the control device 15 controls the syringe piston 112 to perform the first stage of movement. The time period T0-T1 in Figure 6 represents the time when the control device controls the syringe piston 112 to perform the second stage of movement of the first range to obtain a fixed volume. The line segments within each time period in Figure 6 are straight lines, representing that the syringe piston moves at a constant speed. In other embodiments, the line segments within each time period can be other shapes, such as curves, representing that the syringe piston moves at a variable speed. The slope of the line segment in the time period 0-T0 represents the rate of change of the counting cell pressure caused by the first stage of action, and the slope of the line segment in the time period T0-T1 represents the rate of change of the counting cell pressure caused by the second stage of action. It is obvious that the slope of the line segment in the time period 0-T0 is greater than the slope of the line segment in the time period T0-T1, that is, the rate of change of the counting cell pressure caused by the first stage of action is greater than the rate of change of the counting cell pressure caused by the second stage of action.

[0118] The pressure detection piece reading at time T0 is recorded as the initial pressure P1.

[0119] The time period T1-T2, T1-T3, or T1-T4 in FIG6 represents the time during which the control device 15 controls the syringe piston 112 to stop moving in the third stage. During this stage, the process pressure P2 decreases and reaches the initial pressure P1 at time T2, T3, or T4. The impedance counting component stops counting at time T2, T3, or T4. It should be noted that, assuming that the T0-T3 time period corresponds to the counting time when the aperture of the counting hole 123 is the first aperture, for example, 70 μm, due to differences in the production of microporous sheets, there is a deviation in the aperture of the microporous sheet (the micropores forming the counting hole 123) in the test kit. Under the same conditions, the time period T0-T2 may correspond to the counting time when the aperture of the counting hole 123 is larger than the first aperture, for example, 75 μm; under the same conditions, the time period T0-T4 may correspond to the counting time when the aperture of the counting hole 123 is smaller than the first aperture, for example, 65 μm; or, the time period T0-T4 may correspond to the counting time when the counting hole 123 is slightly blocked. Based on this, the time length of the time period T0-T2 or the time period T0-T3 or the time period T0-T4 can be used to assist in judging the aperture size or blockage condition of the counting hole of the test kit. However, regardless of whether there are differences in the pore diameters of the counting holes or whether blockage occurs, the volume quantification of the present application can complete the detection / counting without replacing the test kit for retesting, thereby improving the detection completion rate of the test kit and the accuracy and reliability of the test results.

[0120] Optionally, the control device 15 is provided with a detection time range, which represents the time range for performing electrical impedance counting on the detection sample in the second stage and the third stage. The detection time range includes a first detection time range and a second detection time range.

[0121] For example, the particle counting device is a blood cell counting device, and the blood cell counting device performs a first test item, red blood cell counting, on the test sample during the second and third stages, and the first test time range is 6-12 seconds, that is, the first test time can be 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 11 seconds, or 12 seconds. Alternatively, the blood cell counting device performs a first test item, white blood cell counting, on the test sample during the second and third stages, and the second test time range is 15-24 seconds, that is, the second test time can be 15 seconds, 16 seconds, 17 seconds, 18 seconds, 19 seconds, 20 seconds, 21 seconds, 22 seconds, 23 seconds, or 24 seconds. In a specific embodiment, the first test time can be 9 seconds, and the second test time can be 16 seconds.

[0122] The control device 15 is used to obtain the first detection time of the blood cell counting device performing the first detection item - red blood cell counting on the test sample in the second stage and the third stage, or to obtain the second detection time of the blood cell counting device performing the first detection item - white blood cell counting on the test sample in the second stage and the third stage.

[0123] The first detection time and the second detection time are both related to the aperture of the counting hole, the initial pressure P1 and the type of the test sample. For example, if the aperture of the micropores in the microporous sheet is 70 μm and the initial pressure P1 is -30 kPa, then it can be calculated that the first detection time can be 9 seconds and the second detection time can be 16 seconds.

[0124] The control device 15 is configured to compare the first detection time with the minimum and maximum values ​​of the first detection time range, respectively. In response to the first detection time being less than the minimum value of the first detection time range, the control device 15 determines that the aperture of the counting hole of the reagent kit is large; that is, if the actual first detection time obtained by the control device 15 is less than the minimum value of the first detection time range, the control device 15 determines that the aperture of the counting hole is large. For example, if the actual first detection time obtained by the control device 15 is 4 seconds, which is less than 6 seconds, i.e., the first detection time is less than the minimum value of the first detection time range, the control device 15 determines that the aperture of the counting hole is large.

[0125] In response to the first detection time being greater than the maximum value of the first detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small. That is, if the actual first detection time obtained by the control device 15 is greater than the maximum value of the first detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small. For example, if the actual first detection time obtained by the control device 15 is 14 seconds, and 14 seconds is greater than 12 seconds, that is, the first detection time is greater than the maximum value of the first detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small.

[0126] The control device 15 is configured to compare the second detection time with the minimum and maximum values ​​of the second detection time range, respectively. In response to the second detection time being less than the minimum value of the second detection time range, the control device 15 determines that the aperture of the counting hole is large; that is, if the actual second detection time obtained by the control device 15 is less than the minimum value of the second detection time range, the control device 15 determines that the aperture of the counting hole is large. For example, if the actual second detection time obtained by the control device 15 is 13 seconds, which is less than 15 seconds, i.e., the second detection time is less than the minimum value of the second detection time range, the control device 15 determines that the aperture of the counting hole is large.

[0127] In response to the second detection time being greater than the maximum value of the second detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small. That is, if the actual second detection time obtained by the control device 15 is greater than the maximum value of the second detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small. For example, if the actual second detection time obtained by the control device 15 is 26 seconds, and 26 seconds is greater than 24 seconds, that is, the second detection time is greater than the maximum value of the second detection time range, the control device 15 determines that the counting hole is clogged or that the aperture of the counting hole is small.

[0128] Therefore, the particle counting device of this embodiment compares the first detection time with the first detection time range, and compares the second detection time with the second detection time range to confirm whether the aperture of the counting hole is too large or too small, or whether the counting hole is blocked, and then reminds the user to improve the user experience.

[0129] Example 2

[0130] The pressure building component 11 includes a metering pump, a peristaltic pump, a diaphragm pump, a magnetic pump, or a gear pump;

[0131] In the second stage, the control device controls the pressure building component to operate to obtain a fixed volume. Specifically, in the second stage, the control device controls the pressure building component to operate to obtain a fixed volume. Specifically, the control device controls the pressure building component to operate at a working speed for a preset time to obtain the fixed volume.

[0132] In this embodiment, since peristaltic pumps, diaphragm pumps, magnetic pumps, gear pumps, etc. use the working speed as the control quantity, they cannot be like syringe pumps and plunger pumps that can directly use the range or volume as the control quantity. In the second stage, the fixed volume must be obtained, so the working time can be calculated from the fixed volume. The control device uses the working time as the preset time and controls the pressure building component to run at the working speed for the preset time.

[0133] It can be understood that in the first stage, the control device 15 controls the above-mentioned multiple pumps to continuously operate at the operating speed until the pressure value detected by the pressure detection component 13 reaches near the preset pressure value.

[0134] Example 3

[0135] The pressure building component includes an air source, a valve and a volume flow meter; the air source is connected to the valve, the volume flow meter and the counting pool in sequence;

[0136] In the second stage, the control device controls the pressure building component to take action to obtain a fixed volume, specifically: controlling the valve to open so that the gas from the gas source enters the volume flow meter, and when the volume flow meter detects that the gas volume is the fixed pressure, controlling the valve to close.

[0137] The gas source may be a constant pressure gas source, and the valve may be an on-off valve.

[0138] In a specific embodiment, the pressure building component includes a first constant pressure gas source, a second constant pressure gas source and a switching valve, wherein the first constant pressure gas source and the second constant pressure gas source are sequentially connected to the volume flow meter and the counting cell through the switching valve.Wherein the first constant pressure gas source is used to establish an initial pressure P1, and the air pressure of the first constant pressure gas source is, for example, -30kpa, and the second constant pressure gas source is larger (negative pressure, large numerical value) than the initial pressure P1. During the first stage, the first constant pressure gas source is communicated with the counting cell through the switching valve so that the pipeline (between the counting cell and the gas source) forms an initial pressure P1. In the second stage, the switching valve switches the passage so that the second constant pressure gas source is connected to the volume flow meter and the counting cell, and the gas of the second constant pressure gas source is quantitatively measured by the volume flow meter, and the control switching valve is closed.

[0139] The present application also provides a blood cell counting device, which is no different from a particle counting device in implementation, except that the test sample is a blood sample to be tested, and the blood cell counting device can perform separate red blood cell counts, white blood cell counts, or a complete blood cell count as needed. The blood cell counting device includes a pressure building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure building component is connected to the counting cell via a pipeline, the impedance counting component is connected to the counting cell, the pressure detection component is used to detect the pressure between the counting cell and the pressure building component; the counting cell is used to load the test sample;

[0140] Also included is a control device, the control device being configured to:

[0141] In the first stage, the pressure building component is controlled to operate to form an initial pressure P1 between the counting pool and the pressure building component;

[0142] In the second stage, the pressure building component is controlled to operate to obtain a fixed volume so that a process pressure P2 is formed between the counting cell and the pressure building component;

[0143] In the third stage, the pressure building component is controlled to stop the action so that the process pressure P2 drops back to the initial pressure P1;

[0144] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component performs electrical impedance counting on the test sample in the second stage and the third stage.

[0145] The present application also provides a POCT blood cell analyzer, which is no different from a particle counting device in terms of its implementation. The POCT blood cell analyzer includes a pressure building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure building component is connected to the counting cell via a pipeline, the impedance counting component is connected to the counting cell, the pressure detection component is used to detect the pressure between the counting cell and the pressure building component; the counting cell is used to load a test sample;

[0146] Also included is a control device, the control device being configured to:

[0147] In the first stage, the pressure building component is controlled to operate to form an initial pressure P1 between the counting pool and the pressure building component;

[0148] In the second stage, the pressure building component is controlled to operate to obtain a fixed volume so that a process pressure P2 is formed between the counting cell and the pressure building component;

[0149] In the third stage, the pressure building component is controlled to stop the action so that the process pressure P2 drops back to the initial pressure P1;

[0150] The test sample passes through the counting hole of the counting pool under pressure, and the impedance counting component performs electrical impedance counting on the test sample in the second stage and the third stage.

[0151] The present application also provides a control method, as shown in FIG7 , which is a flow chart of an embodiment of the control method of the present application. The control method of this embodiment is applied to the particle counting device 20 of the above embodiment, and the control method includes the following steps:

[0152] S101: In the first stage, the pressure building component is controlled to establish an initial pressure P1 for the counting pool;

[0153] The first stage is the pressure building stage, in which the pressure building component 11 acts to establish an initial pressure P1 between the counting pool 122 and the pressure building component 11. The initial pressure P1 is used to drive the particles in the test sample from the front pool 121 through the counting hole 123 to flow into the back pool 122. It can be understood that after the test sample is loaded into the front pool 121, a closed chamber is formed between the back pool 122, the pipeline and the pressure building component 11. The pressure of the closed chamber can be detected by the pressure detection part 13. The pressure of the closed chamber can be characterized by the pressure between the counting pool and the pressure building component 11, the pressure of the back pool 122, the pressure of the pipeline and the pressure of the pressure building component 11 (the four are referred to as the same in the description in this application). When the size of the counting hole 123 is determined, the greater the initial pressure P1, the greater the power to drive the particles in the test sample from the front pool 121 through the counting hole 123 to flow into the back pool 122, and the faster the particle flow rate. In order to make the particle flow rate moderate, neither too fast nor too slow, taking the particle counting device as a blood cell counting device as an example, the initial pressure P1 is between -50kPa and -10kPa, and includes the endpoint values ​​of the numerical range of -50kPa and -10kPa. For example, the initial pressure can be -50kPa, -45kPa, -40kPa, -35kPa, -30kPa, -25kPa-20kPa, -15kPa, and -10kPa.

[0154] Considering the repeatability (precision) of multiple counts by a particle counting device, it is preferred that the initial pressure P1 remain the same for each count, or that the initial pressure P1 remain within a first fluctuation range. Precision refers to the degree of consistency between measurement indications or values ​​obtained by a particle counting device when repeatedly measuring the same or similar objects. Because the initial pressure P1 is used to drive particles in the test sample from the front cell 121 through the counting hole 123 into the back cell 122, its magnitude can affect the counting results. To maintain consistency in multiple counting results, the initial pressure P1 is preferably kept the same for each count. However, due to detection errors in the pressure detection element 13 and / or data transmission delays and mechanical errors in the particle analyzer, the initial pressure P1 for each count may not be completely equal. Instead, the initial pressure P1 for each count may be maintained within a first fluctuation range, for example, (1±10%)*P1.

[0155] S102: In the second stage, the pressure building component is controlled to operate to obtain a fixed volume forming process pressure P2;

[0156] The second stage is the volume quantification stage, in which the pressure building component 11 performs the second stage action to obtain a fixed volume to form a process pressure P2; the fixed volume is calculated based on the test items, dilution ratio and preset linear concentration of the sample to be tested. The second stage converts its own volume change into a pressure change, with the initial pressure P1 rising to the process pressure P2. It can be understood that since the aperture of the counting hole 123 is small, the speed at which the test sample flows through the counting hole 123 is slow, slower than the action speed of the pressure building component 11. The pressure building component 11 performs the second stage action to increase the volume in the closed chamber, and the initial pressure P1 rises to the process pressure P2 (negative pressure, the pressure value increases). This is the process of converting the volume change of the pressure building component 11 or the closed chamber itself into a pressure change.

[0157] The fixed volume is calculated based on the test item, dilution ratio, and preset linear concentration of the test sample. For example, when the particle counting device is a blood cell counting device, the test items include red blood cell detection and white blood cell detection. Red blood cell detection requires dilution of the blood sample to be tested, and white blood cells also require the addition of a hemolytic agent to dissolve the red blood cells. In order to make the final counting / testing result accurate and reliable, the volume of the test sample passing through the counting hole 123 is equal to the total number of particles multiplied by the dilution ratio divided by the preset linear concentration. The total number of particles is the number of particles in the test sample with the minimum concentration required for the test item, the dilution ratio is the dilution ratio of the sample to be tested, and the preset linear concentration is the linear concentration corresponding to the test item in the prior art, which will not be repeated here. In short, red blood cell detection corresponds to a first fixed volume, which is the volume of the test sample required for red blood cell detection flowing through the counting hole 123. White blood cell detection corresponds to a second fixed volume, which is the volume of the test sample required for white blood cell detection flowing through the counting hole 123. The fixed volume is used to ensure the validity of the counting / testing results.

[0158] Based on this, the second phase establishes a corresponding relationship between the volume of the test sample flowing through the counting hole 123 and the pressure change (P1→P2) required for counting / detection. It is worth noting that the initial pressure P1 needs to be detected by the pressure detection component 13, while the process pressure P2 can be detected or not, as it is irrelevant to the control of the pressure building component 11.

[0159] S103: in the third stage, the pressure building component is controlled to stop the action so that the process pressure P2 drops back to the initial pressure P1;

[0160] The sample to be tested passes through the counting hole of the counting pool under the action of pressure, and the impedance counting component is controlled to perform electrical impedance counting on the sample to be tested in the second stage and the third stage.

[0161] The third stage is the pressure release stage. The pressure building component 11 stops working in the third stage to allow the process pressure P2 to drop back to the initial pressure P1. During this process, the pressure detection component 13 detects the change in pressure. When the pressure drops to the initial pressure P1, the pressure change in the second stage is converted into a volume change of the detection sample flowing through the counting hole 123. The volume of the detection sample flowing through the counting hole 123 in the second and third stages is equal to the fixed volume. This is because the detection sample is also continuously flowing through the counting hole 123 in the second stage, so the sum of the volumes flowing through the counting hole 123 in the second and third stages is equal to the fixed volume.

[0162] Corresponding to the counting process, the impedance counting component 14 should also perform electrical impedance counting on the test sample during the second and third phases. Such counting results correspond to a fixed volume (volume-based) of the test sample, making the counting results independent of the counting time. Variations in counting time due to differences in counting hole size or hole blockage will not affect the counting results, thereby improving the accuracy and reliability of the counting results.

[0163] It is worth noting that causing the process pressure P2 to return to the initial pressure P1 includes causing the process pressure P2 to return to the second fluctuation range of the initial pressure P1. It is understood that due to detection errors of the pressure detection element 13 and / or data transmission delays, mechanical fit errors, etc. of the particle analyzer, the return of P2 to the initial pressure P1 may fall within the second fluctuation range of the initial pressure P1. In one specific embodiment, the second fluctuation range is P1±0.3 kPa. Experiments have shown that within the second fluctuation range of P1±0.3 kPa, the accuracy of the particle counting results is minimally affected, and the allowable relative deviation range meets the accuracy requirements. For example, the allowable relative deviation range for WBC detection results is ≤15%, and the allowable relative deviation range for RBC detection results is ≤6%.

[0164] In order to meet the requirements of precision and accuracy, the pressure detection member 13 used in the present application has an accuracy of not less than 0.1% FS, for example, 0.01% FS.

[0165] Optionally, the fixed volume is calculated based on the test item of the sample to be tested, the dilution ratio and a preset linear concentration.

[0166] Optionally, the pressure building component includes a syringe or a metering pump or a plunger pump or a peristaltic pump or a diaphragm pump or a magnetic pump or a gear pump or an air source.

[0167] The present application also provides a computer-readable storage medium. Please continue to refer to Figure 8, which is a schematic diagram of a framework of an embodiment of a computer-readable storage medium provided by the present application. The computer-readable storage medium 80 stores program instructions 81, which, when executed by a processing unit, are used to implement the method of the above embodiment.

[0168] When the embodiments of the present application are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application is essentially or the part that contributes to the prior art or all or part of the technical solution can be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for enabling a computer device (which can be a personal computer, computer device, or network device, etc.) or a processor to execute all or part of the steps of the method described in each embodiment of the present application. The aforementioned storage medium includes various media that can store program codes, such as a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk or an optical disk.

[0169] The above description is only an implementation method of the present application and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the description and drawings of this application, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. Particle counting device, characterized in that: Comprising: A pressure - building component, a counting cell, a pressure detection component, and an impedance counting component; the pressure - building component is connected to the counting cell through a pipeline, the impedance counting component is connected to the counting cell, and the pressure detection component is used to detect the pressure between the counting cell and the pressure - building component; the counting cell is used to hold a test sample. It further includes a control device, and the control device is used for: In the first stage, controlling the pressure - building component to act to form an initial pressure P1 between the counting cell and the pressure - building component. In the second stage, controlling the pressure - building component to act to obtain a fixed volume so as to form a process pressure P2 between the counting cell and the pressure - building component. In the third stage, controlling the pressure - building component to stop acting so that the process pressure P2 drops back to the initial pressure P1. Wherein, under the action of pressure, the test sample passes through the counting holes of the counting cell, and the impedance counting component performs impedance counting on the test sample in the second stage and the third stage.

2. The particle counting device according to claim 1, wherein When the particle counting device performs multiple counts, the initial pressure P1 for each count remains equal; or the initial pressure P1 for each count remains within a first fluctuation range.

3. The particle counting device according to claim 2, wherein The first fluctuation range is (1 ± 10%) * P1.

4. The particle counting device according to claim 1, characterized in that, In the third stage, controlling the pressure - building component to stop acting so that the process pressure P2 drops back to the initial pressure P1 specifically includes: controlling the pressure - building component to stop acting so that the process pressure P2 drops back to a first pressure P3, and the first pressure P3 is within a second fluctuation range of the initial pressure P1.

5. The particle counting device according to claim 4, characterized in that, The second fluctuation range is P1 ± 0.3 kPa.

6. The particle counting device according to claim 1, wherein In the first stage, the control device controls the pressure - building component to act to form an initial pressure P1 between the counting cell and the pressure - building component specifically as follows: controlling the pressure - building component to act until the pressure value detected by the pressure detection component reaches near a preset pressure value, and taking this pressure value as the initial pressure P1.

7. The particle counting device according to claim 1, characterized in that, The pressure - building component includes a syringe or a metering pump or a piston pump or a peristaltic pump or a diaphragm pump or a magnetic pump or a gear pump or a gas source.

8. The particle counting device according to claim 1, wherein The pressure - building component includes a syringe. In the first stage, the control device controls the pressure - building component to act to form an initial pressure P1 between the counting cell and the pressure - building component specifically as follows: controlling the piston of the syringe to move until the pressure value detected by the pressure detection component reaches near a preset pressure value, and taking this pressure value as the initial pressure P1. In the second stage, the control device controls the pressure - building component to act to obtain the fixed volume specifically as follows: controlling the piston of the syringe to continue moving a first range to obtain the fixed volume.

9. The particle counting device according to claim 6 or 8, characterized in that, Near the preset pressure value is [(1 + 5%) × preset pressure value, (1 - 5%) × preset pressure value].

10. The particle counting device according to claim 6 or 8, characterized in that, The preset pressure value is between - 50 kPa and - 10 kPa.

11. The particle counting device according to claim 8, characterized in that, The control device controls the piston of the syringe to move uniformly at a first speed until the pressure value detected by the pressure detection component reaches near the preset pressure value; And / or, controlling the piston of the syringe to continue moving uniformly at a second speed for a first range to obtain the fixed volume.

12. The particle counting device according to claim 8 or 11, characterized in that, The pressure change rate of the counting cell and the pressure building component caused by the first-stage action is greater than that caused by the second-stage action; Alternatively, the first speed is greater than the second speed.

13. The blood cell counting device according to claim 8, characterized in that, The measuring range of the syringe is 1.5 - 15 ml.

14. The particle counting device according to claim 1 or 7, characterized in that The pressure building component includes a metering pump, a peristaltic pump, a diaphragm pump, a magnetic pump, or a gear pump; In the second stage, the control device controls the pressure building component to act to obtain the fixed volume specifically as follows: the control device controls the pressure building component to operate at the working speed for a preset time to obtain the fixed volume.

15. The particle counting device according to claim 1 or 7, characterized in that The pressure building component includes a gas source, a valve, and a volume flow meter; the gas source is sequentially connected to the valve, the volume flow meter, and the counting cell; In the second stage, the control device controls the pressure building component to act to obtain the fixed volume specifically as follows: controlling the valve to open so that the gas from the gas source enters the volume flow meter, and when the volume flow meter detects that the gas volume is the fixed volume, controlling the valve to close.

16. The particle counting device according to claim 1, wherein The counting cell includes a front cell, a rear cell, and a counting hole connecting the front cell and the rear cell; The pressure building component is connected to the rear cell through a pipeline, and a pressure detection component is further provided on the pipeline connecting the pressure building component and the rear cell; or the pressure detection component is connected in parallel to the pipeline connecting the pressure building component and the rear cell.

17. The particle counting device according to claim 13, characterized in that, The particle counting device includes a particle analysis instrument and a reagent kit, and the front cell, the rear cell, and the counting hole are arranged in the reagent kit.

18. The particle counting device according to claim 13, characterized in that, The particle counting device includes a particle analysis instrument and a reagent kit, and the counting hole is arranged in the particle analysis instrument.

19. The particle counting device according to claim 1, characterized in that, The resolution of the pressure detection component is not less than 0.1 kPa.

20. A counting method for a particle counting device, characterized in that, Applied to the particle counting device according to any one of claims 1 - 19, the counting method includes: In the first stage, controlling the pressure building component to act to establish an initial pressure P1 between the counting cell and the pressure building component; In the second stage, controlling the pressure building component to act to obtain the fixed volume to form a process pressure P2 between the counting cell and the pressure building component; In the third stage, controlling the pressure building component to stop acting so that the process pressure P2 drops back to the initial pressure P1; Wherein, the test sample is detected to pass through the counting hole of the counting cell under pressure, and the impedance counting component is controlled to perform impedance counting on the test sample in the second stage and the third stage.

21. The counting method according to claim 20, wherein The pressure building component includes a syringe; In the first stage, controlling the pressure building component to act to establish an initial pressure P1 between the counting cell and the pressure building component includes: in the first stage, controlling the piston of the syringe to move until the pressure value detected by the pressure detection component reaches near the preset pressure value, and taking the pressure value at this time as the initial pressure P1; In the second stage, controlling the pressure building component to act to obtain the fixed volume so as to form a process pressure P2 between the counting cell and the pressure building component, includes: in the second stage, controlling the piston of the syringe to continue to move a first range to obtain the fixed volume, so that a process pressure P2 is formed between the counting cell and the pressure building component; In the third stage, controlling the pressure building component to stop acting so that the process pressure P2 drops back to the initial pressure P1, includes: in the third stage, controlling the pressure building component to stop acting so that the process pressure P2 drops back to a first pressure P3, and the first pressure P3 is within a second fluctuation range of the initial pressure P1.

22. The counting method according to claim 21, wherein Controlling the piston of the syringe to move until the pressure value detected by the pressure detection member reaches near the preset pressure value, includes: controlling the Piston of the syringe to move at a first constant speed until the pressure value detected by the pressure detection member reaches near the preset pressure value; Controlling the piston of the syringe to continue to move a first range to obtain the fixed volume, includes: controlling the piston of the syringe to continue to move at a second constant speed for a first range to obtain the fixed volume.

23. The counting method according to claim 20, wherein The pressure building component includes a gas source, a valve and a volume flow meter; the gas source is sequentially connected to the valve, the volume flow meter and the counting cell; In the second stage, controlling the pressure building component to act to obtain the fixed volume so as to form a process pressure P2 between the counting cell and the pressure building component, includes: In the second stage, controlling the valve to open so that the gas from the gas source enters the volume flow meter, and when the volume flow meter detects that the gas volume is the fixed volume, controlling the valve to close.

24. A blood cell counting device, characterized in that, A pressure building component, a counting cell, a pressure detection member and an impedance counting component; the pressure building component is connected to the counting cell through a pipeline, the impedance counting component is connected to the counting cell, and the pressure detection member is used to detect the pressure between the counting cell and the pressure building component; the counting cell is used to load a test sample; Further includes a control device, and the control device is used for: In the first stage, controlling the pressure building component to act to form an initial pressure P1 between the counting cell and the pressure building component; In the second stage, controlling the pressure building component to act to obtain a fixed volume so as to form a process pressure P2 between the counting cell and the pressure building component; In the third stage, controlling the pressure building component to stop acting so that the process pressure P2 drops back to the initial pressure P1; Wherein, the test sample passes through the counting holes of the counting cell under the action of pressure, and the impedance counting component performs impedance counting on the test sample in the second stage and the third stage.

25. A POCT blood cell analyzer, characterized in that, A pressure building component, a counting cell, a pressure detection member and an impedance counting component; the pressure building component is connected to the counting cell through a pipeline, the impedance counting component is connected to the counting cell, and the pressure detection member is used to detect the pressure between the counting cell and the pressure building component; the counting cell is used to load a test sample; Further includes a control device, and the control device is used for: In the first stage, control the pressure building component to act to form an initial pressure P1 between the counting cell and the pressure building component; In the second stage, control the pressure building component to act to obtain a fixed volume so as to form a process pressure P2 between the counting cell and the pressure building component; In the third stage, control the pressure building component to stop acting so that the process pressure P2 drops back to the initial pressure P1; Wherein, it is detected that the test sample passes through the counting holes of the counting cell under the action of pressure, and the impedance counting component performs impedance counting on the test sample in the second stage and the third stage.

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