POCT analyzer, detection kit and detection reagent card

Abstract

The utility model discloses a POCT analyzer, a detection kit and a detection reagent card, the POCT analyzer combines an impedance detection assembly and a fluorescence detection assembly, and the impedance detection assembly is used for performing impedance detection on a to-be-detected sample to obtain a counting result of red blood cells and blood platelets; the fluorescence detection assembly and the impedance detection assembly are arranged at intervals and are used for performing fluorescence detection on the to-be-detected sample to obtain a leukocyte counting result. The impedance detection assembly and the fluorescence detection assembly are arranged in the POCT analyzer at the same time, the impedance detection assembly obtains the counting result of red blood cells and blood platelets, the fluorescence detection assembly obtains the counting result of white blood cells, the two detection assemblies are integrated in the same POCT analyzer, and the detection capabilities of the two detection assemblies are complementary. The condition that the detection efficiency of a single detection assembly on the to-be-detected sample is low is avoided, the detection efficiency of the POCT analyzer on the to-be-detected sample is improved, and the use experience of a user on the POCT analyzer is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a POCT analyzer, a test kit, and a test kit card. Background Technology

[0002] Single-person POCT blood analyzers basically use pure impedance methods and pure microscopic imaging methods to count, classify and detect items such as red blood cells, platelets, white blood cells and hemoglobin in blood cells.

[0003] Impedance detection is a relatively mature technology that can detect red blood cells, platelets, and white blood cells in three differential counts. For single-use impedance detection equipment for point-of-care testing (POCT), the main challenge lies in the manufacturing process and cost control of single-use impedance reagent kits.

[0004] In the detection of white blood cell differential using POCT blood analyzers, considering the usage scenarios and cost requirements of POCT, pure microscopic imaging is generally used. Unlike the traditional microscopic examination method of smear staining, liquid-based staining is mainly used to simplify the operation steps. However, the test cells need to be spread out on the same layer by natural sedimentation. Since platelets are relatively small, it takes a long time for platelets to settle into the same layer, which will affect the overall test time. Utility Model Content

[0005] To address the aforementioned technical problems, this application provides a POCT analyzer, comprising:

[0006] Impedance detection component, used to perform impedance detection on the sample to obtain the counting results of red blood cells and platelets;

[0007] A fluorescence detection component, spaced apart from the impedance detection component, is used to perform fluorescence detection on the sample to be tested in order to obtain white blood cell count results.

[0008] A pipetting assembly, spaced apart from the impedance detection assembly and the fluorescence detection assembly, is used to move liquid to the impedance detection assembly and / or the fluorescence detection assembly.

[0009] The impedance detection component includes:

[0010] A first support is used to place a test kit, the test kit being used to load the sample to be tested;

[0011] A first transmission module is disposed inside the POCT analyzer, and a first support is disposed on the first transmission module, and the first support slides relative to the first transmission module, so that the first support has a first state located inside the POCT analyzer and a second state located outside the POCT analyzer.

[0012] The first carrier is switched to the first state to move the test kit into the POCT analyzer, and the pipetting assembly is used to move the liquid into the test kit to form the test sample in the test kit.

[0013] The impedance detection component includes:

[0014] The detection electrode module is disposed inside the POCT analyzer and spaced apart from one end of the first transmission module. When the first carrier is switched to the first state, the detection electrode module abuts against the contact electrode of the test kit on the first carrier to perform impedance detection on the sample to be tested in the test kit.

[0015] The pressure building module is located inside the POCT analyzer and is spaced apart from one end of the first transmission module. When the first support is switched to the first state, the pressure building module is connected to the test kit on the first support to provide pressure to the test kit, so that the sample to be tested forms a liquid flow in the test kit.

[0016] The impedance detection component further includes a colorimetric detection module, which is disposed on the first carrier. When the first carrier is switched to the first state, the colorimetric detection module is used to perform optical detection on the test sample in the test kit on the first carrier.

[0017] The fluorescence detection component includes:

[0018] The second support is used to place the test reagent card, which is used to load the sample to be tested.

[0019] The second transmission module is disposed inside the POCT analyzer, and the second support is disposed on the second transmission module and slides relative to the second transmission module;

[0020] The second transmission module is used to move the second support seat to the outside of the POCT analyzer to receive the test reagent card;

[0021] And / or, the second transmission module is used to move the second carrier to the sample dispensing position so that the pipetting assembly injects the liquid into the test reagent card on the second carrier;

[0022] And / or, the second transmission module is used to drive the second carrier to move to the detection position so as to perform fluorescence detection on the test sample on the test reagent card on the second carrier.

[0023] The fluorescence detection component further includes:

[0024] A fluorescence imaging module is disposed inside the POCT analyzer and above the detection position. When the second carrier moves the test reagent card to the detection position, the fluorescence imaging module is used to perform fluorescence detection on the test sample on the test reagent card.

[0025] During the fluorescence detection of the sample to be tested on the test reagent card by the fluorescence imaging module, the second transmission module is also used to drive the second carrier to move in the horizontal direction so that the fluorescence imaging module can image multiple parts of the sample to be tested on the test reagent card.

[0026] The fluorescence imaging module includes a fluorescence exciter and an image acquisition unit; the fluorescence exciter is used to emit excitation light onto the test reagent card to excite the fluorescence in the sample to be tested; the image acquisition unit is used to acquire the fluorescence image.

[0027] The pipetting assembly includes a third transmission module and a pipette, wherein the pipette is disposed on the third transmission module and slides relative to the third transmission module;

[0028] The third transmission module is used to drive the pipette to move in the horizontal and gravitational directions to move the liquid to the impedance detection component and / or the fluorescence detection component.

[0029] To address the aforementioned technical problems, this application also provides a test kit for use in the POCT analyzer described above, comprising a housing and contact electrodes;

[0030] The box body is provided with at least one cavity, and the cavities are arranged sequentially at intervals along the length direction of the box body. The contact electrode is disposed on the box body and communicates with the cavity on the box body, and is used to perform impedance detection on the sample to be tested in the cavity.

[0031] To address the aforementioned technical problems, this application also provides a test reagent card for use in the POCT analyzer described above. The test reagent card has a through-hole sample receiving cavity, and the two ports of the sample receiving cavity are located on the same surface of the test reagent card.

[0032] The beneficial effects of this application are as follows: Unlike existing technologies, the POCT analyzer of this application includes an impedance detection component, a fluorescence detection component, and a pipetting component. The impedance detection component is used to perform impedance detection on the sample to obtain red blood cell and platelet counts; the fluorescence detection component is spaced apart from the impedance detection component and is used to perform fluorescence detection on the sample to obtain white blood cell counts; the pipetting component is spaced apart from the impedance detection component and the fluorescence detection component and is used to move liquid to the impedance detection component and / or the fluorescence detection component. By simultaneously incorporating the impedance detection component and the fluorescence detection component in the POCT analyzer, the impedance detection component obtains red blood cell and platelet counts, and the fluorescence detection component obtains white blood cell counts. Integrating these two detection components into the same POCT analyzer allows their detection capabilities to complement each other, avoiding the low efficiency of a single detection component in detecting the sample, thus improving the POCT analyzer's efficiency in detecting the sample and enhancing the user experience. Attached Figure Description

[0033] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0034] in:

[0035] Figure 1 This is a schematic diagram of the structure of an embodiment of the POCT analyzer of this application;

[0036] Figure 2 This is a schematic diagram of the structure of an embodiment of the test kit of this application;

[0037] Figure 3 This is a schematic diagram of the structure of one embodiment of the test reagent card of this application.

[0038] Reference numerals: POCT analyzer 1; impedance detection component 11; fluorescence detection component 12; pipetting component 13; test kit 2; housing 21; contact electrode 22; pressure interface 23; test reagent card 3. Detailed Implementation

[0039] The embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0040] In the following description, specific details such as particular system architectures, interfaces, and technologies are presented for illustrative purposes rather than for limiting purposes, in order to provide a thorough understanding of this application.

[0041] In this application, the reference to "embodiment" means that a specific feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0042] In this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent three cases: A alone, A and B simultaneously, and B alone. Additionally, the character " / " generally indicates that the preceding and following related objects are in an "or" relationship. Furthermore, "many" in this application means two or more. Moreover, the term "at least one" in this application means any combination of at least two of any one or more of a plurality of objects. For example, including at least one of A, B, and C can mean including any one or more elements selected from the set consisting of A, B, and C. Furthermore, the terms "first," "second," and "third" in this application are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features.

[0043] Existing POCT blood analyzers basically use pure impedance methods and pure microscopic imaging methods to count, classify and detect red blood cells, platelets, white blood cells and hemoglobin in blood cells.

[0044] Among them, the impedance method has a relatively mature detection principle and can complete the counting of red blood cells and platelets, as well as the detection of three-part differential white blood cells, but it cannot detect five-part differential white blood cells.

[0045] For the five-part differential white blood cell count, the traditional method uses flow cytometry. The principles of traditional flow cytometry are well-developed, and its quality control and calibration systems are also well-established and widely accepted in clinical medicine. In point-of-care testing (POCT) white blood cell differential analyzers, considering the usage scenarios and cost requirements, pure microscopic imaging is primarily used. Unlike traditional microscopic slide staining, liquid-based staining simplifies the process, but requires natural sedimentation to allow the cells to spread evenly into a monolayer. However, due to the small size of platelets, sedimentation takes a long time, impacting the overall testing time.

[0046] Considering the advantages and disadvantages of impedance detection and microscopic imaging detection, and in order to address the limitations of existing products in meeting the requirements of white blood cell differential and detection time, this application provides a POCT analyzer that integrates impedance detection and microscopic imaging detection into the same POCT analyzer, thereby shortening the detection time of the POCT analyzer and meeting the requirements of the POCT analyzer for white blood cell differential detection.

[0047] Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of an embodiment of the POCT analyzer of this application. The POCT analyzer 1 provided in this embodiment includes an impedance detection component 11, a fluorescence detection component 12, and a pipetting component 13.

[0048] Impedance detection component 11 is used to perform impedance detection on the sample to obtain the counting results of red blood cells and platelets; fluorescence detection component 12 is arranged at an interval from impedance detection component 11 and is used to perform fluorescence detection on the sample to obtain the counting results of white blood cells.

[0049] In practical applications, due to the small size of platelets and red blood cells, the detection time required for fluorescence microscopy using the fluorescence detection component 12 is relatively long, while the impedance detection component 11 cannot detect the five-part differential of white blood cells. Therefore, the POCT analyzer 1 provided in this embodiment integrates the impedance detection component 11 and the fluorescence detection component 12 into the same analyzer. The impedance detection component 11 acquires the platelet and red blood cell counts, while the fluorescence detection component 12 acquires the white blood cell counts. The detection capabilities of the two components are complementary, enabling faster acquisition of platelet, red blood cell, and white blood cell counts in the sample within the POCT analyzer 1, thus improving the detection efficiency of the POCT analyzer 1.

[0050] The POCT analyzer 1 also includes a pipetting assembly 13, which is spaced apart from the impedance detection assembly 11 and the fluorescence detection assembly 12, for moving liquid to the impedance detection assembly 11 and / or the fluorescence detection assembly 12.

[0051] Specifically, the liquid moved by the pipetting assembly 13 can be a blood sample, detection auxiliary reagents (such as hemolysin, dye, etc.), or the sample to be tested. During the detection process of the impedance detection assembly 11, the pipetting assembly 13 can pass the required liquid through it; similarly, during the detection process of the fluorescence detection assembly 12, the pipetting assembly 13 can also provide the required liquid to the fluorescence detection assembly 12. By reusing the pipetting assembly 13, the number of devices in the POCT analyzer 1 can be increased, and the internal structure of the POCT analyzer 1 can be simplified.

[0052] In summary, the POCT analyzer 1 provided in this application improves the accuracy and repeatability of erythroid parameters by setting up the impedance detection component 11 to detect platelets and red blood cells; and improves the classification accuracy of white blood cells by setting up the fluorescence detection component 12 to detect white blood cells, utilizing the strong specificity of fluorescence to enhance the characteristic differences of different white blood cells. The detection capabilities of the two detection components complement each other, enabling the POCT analyzer 1 to quickly obtain the counting results of platelets, red blood cells, and white blood cells in the sample, thereby improving the detection efficiency of the POCT analyzer 1.

[0053] In some embodiments, the detection time of the impedance detection component 11 and the detection time of the fluorescence detection component 12 for the sample to be tested at least partially overlap, that is, the impedance detection component 11 and the fluorescence detection component 12 can be in detection state simultaneously. The test kit pre-stores reagents, such as hemolysin and dye. Through the reuse of the pipetting component 13, the sample to be tested in the test kit is pre-treated to a state suitable for detecting the corresponding item. The pipetting component 13 transfers the treated sample to the impedance detection component 11 and the fluorescence detection component 12 respectively to complete the corresponding detection. Because the detection time of the impedance detection component 11 and the detection time of the fluorescence detection component 12 for the sample to be tested at least partially overlap, the time required for the POCT analyzer 1 to complete the detection result of a complete sample is saved, further improving the detection efficiency of the POCT analyzer 1.

[0054] Optionally, the impedance detection component 11 includes a first support and a first transmission module.

[0055] The first support is used to place the test kit, and the test kit is used to load the sample to be tested; the first transmission module is disposed inside the POCT analyzer 1, the first support is disposed on the first transmission module, and the first support slides relative to the first transmission module so that the first support has a first state located inside the POCT analyzer 1 and a second state located outside the POCT analyzer 1.

[0056] In this process, the first support seat switches to the second state, meaning it slides relative to the first transmission module to the outside of the POCT analyzer 1. At this point, the user can place the test kit on the first support seat. Then, the first support seat switches to the second state to move the test kit into the POCT analyzer 1. Subsequently, the pipetting assembly 13 is used to move liquid into the test kit to form a sample to be tested within the test kit.

[0057] Specifically, the pipetting assembly 13 can first transfer the blood sample into the test kit. When counting platelets and red blood cells in the blood sample, the blood sample needs to be processed first, such as adding a hemolysin for mixing. After transferring the blood sample into the test kit, the pipetting assembly 13 can move again to transfer the hemolysin to the area where the blood sample is placed, so that the hemolysin mixes with the blood sample to form the test sample. The pipetting assembly 13 can also move to the mixture of the hemolysin and the blood sample and perform a mixing operation, such as aspiration or dispensing, to improve the mixing efficiency of the blood sample and the hemolysin.

[0058] The first transmission module can be a stepper motor working with a rack, a synchronous belt, or a lead screw to switch between the first and second states of the first bearing seat.

[0059] In one embodiment, as described above, the test kit may be loaded with auxiliary test reagents, such as a hemolysin. The pipetting assembly 13 can then move to the corresponding area to aspirate the auxiliary reagents on the test kit and move them to the blood sample to form a test sample in the test kit.

[0060] Optionally, the impedance detection assembly 11 may also include a detection electrode module and a voltage build-up module.

[0061] The detection electrode module is disposed within the POCT analyzer 1, spaced apart from one end of the first transmission module. When the first support is switched to the first state, the detection electrode module abuts against the contact electrode of the test kit on the first support to perform impedance detection on the test sample in the test kit. The pressure-building module is disposed within the POCT analyzer 1, spaced apart from one end of the first transmission module. The pressure-building module and the detection electrode module can be disposed at the same end of the first transmission module. When the first support is switched to the first state, the pressure-building module connects to the test kit on the first support to provide pressure to the test kit, causing the test sample to form a liquid flow within the test kit.

[0062] Specifically, the test kit may have a pre-cell and a post-cell, connected by micropores. The contact electrodes on the test kit include a pre-cell electrode and a post-cell electrode, with one end of the pre-cell electrode placed in the pre-cell and one end of the post-cell electrode placed in the post-cell. The sample to be tested is placed in the pre-cell. The detection electrode module abuts against the pre-cell and post-cell electrodes to provide current to them. The pressure-building module is connected to the post-cell to provide negative pressure, allowing the sample to pass through the micropores into the post-cell, forming a fluid flow within the test kit. The sample then enters the post-cell and contacts the post-cell electrode, thus forming a complete current loop within the test kit. The detection electrode module further detects the impedance signal between the micropores to detect red blood cells and platelets in the sample, obtaining the detection results for red blood cells and platelets.

[0063] The portion of the detection electrode module that contacts the contact electrode, as well as the contact electrode on the test kit, can be made of materials with high conductivity and high hardness, such as molybdenum or nickel. The pressure-building module can include a solenoid valve, a pressure storage chamber, a pressure detector, and a pressure-building power device, which includes, but is not limited to, a syringe or a pump. Furthermore, the pressure-building module can provide negative pressure to the rear chamber to allow the sample to enter the rear chamber, or it can provide positive pressure to the rear chamber to mix the mixture in the front chamber to obtain the sample to be tested.

[0064] Optionally, the impedance detection component 11 also includes a colorimetric detection module, which is disposed on the first carrier. When the first carrier is switched to the first state, the colorimetric detection module is used to perform optical detection on the sample to be tested in the test kit on the first carrier.

[0065] The colorimetric detection module includes an illumination source, a filter, and a photodetector. The illumination source can be positioned on one side of the first support, while the filter and photodetector are positioned on the opposite side of the first support. The illumination source generates a light beam that passes through the sample to be tested in the test kit. After passing through the sample, the light beam enters the filter to remove stray light before entering the photodetector. The photodetector analyzes the light beam information and calculates the hemoglobin concentration in the sample by measuring changes in the light intensity, thus obtaining the detection result of the hemoglobin concentration in the sample.

[0066] In summary, in the impedance detection component 11 of this embodiment, the first transmission module drives the first support seat to move, enabling the first support seat to move to the outside of the POCT analyzer 1 to receive the test kit, and the first support seat can also drive the test kit to the inside of the POCT analyzer 1. The detection electrode module and the pressure build-up module work together to detect the sample in the test kit, obtaining the counting results of red blood cells and platelets in the sample, thus improving the detection efficiency of the POCT analyzer 1. Simultaneously, a colorimetric detection module is provided to detect the hemoglobin concentration in the sample, improving the practicality of the POCT analyzer 1.

[0067] Optionally, the fluorescence detection assembly 12 includes a second support and a second transmission module.

[0068] The second support is used to hold the test reagent card, which is used to load the sample to be tested. The second transmission module is located inside the POCT analyzer 1, and the second support is located on the second transmission module and slides relative to the second transmission module. The second transmission module is used to move the second support to the outside of the POCT analyzer 1 to receive the test reagent card, and / or, the second transmission module is used to move the second support to the sample application position so that the pipetting assembly 13 injects liquid into the test reagent card on the second support, and / or, the second transmission module is used to move the second support to the detection position to perform fluorescence detection on the sample to be tested on the test reagent card on the second support.

[0069] The second transmission module moves the second carrier to the outside of the POCT analyzer 1, where the user can place the test reagent card on the second carrier. Then, the second transmission module moves the second carrier to the inside of the POCT analyzer 1 to move the test reagent card inside the POCT analyzer 1. Specifically, the second transmission module can move the second carrier to the sample dispensing position inside the POCT analyzer 1, where the pipetting assembly 13 can be located to inject liquid into the test reagent card on the second carrier that has moved to the sample dispensing position, so as to obtain the sample to be tested on the test reagent card.

[0070] In one embodiment, when performing fluorescence detection on a blood sample, the blood sample needs to be stained with fluorescence first. If the test kit card is pre-filled with dye, the pipetting assembly 13 can move the blood sample onto the test kit card. If the test kit card is not pre-filled with dye, after moving the blood sample onto the test kit card, the pipetting assembly 13 can also move the dye onto the test kit card to stain the blood sample; or, if the test kit card is not pre-filled with dye, another device in the POCT analyzer 1 can mix the blood sample and the dye to fluoresce the blood sample and obtain the test sample. Then, the pipetting assembly 13 moves the test sample onto the test kit card (as mentioned above, the test kit may be pre-filled with dye, so the pipetting assembly 13 can mix the blood sample and the dye on the test kit, stain the blood sample to obtain the test sample, and then the pipetting assembly 13 moves the test sample onto the test kit card).

[0071] After the test sample is placed on the test reagent card, the second transmission module can also drive the second carrier to move to the detection position to test the test sample on the test reagent card on the second carrier.

[0072] Optionally, the fluorescence detection component 12 also includes a fluorescence imaging module. The fluorescence imaging module is located inside the POCT analyzer 1 and positioned above the detection position. When the second carrier moves the test reagent card to the detection position, the fluorescence imaging module is used to perform fluorescence detection on the sample to be tested on the test reagent card.

[0073] In the process of fluorescence detection of the sample on the test reagent card by the fluorescence imaging module, the second transmission module is also used to drive the second carrier to move in the horizontal direction so that the fluorescence imaging module can image multiple parts of the sample on the test reagent card.

[0074] Specifically, the fluorescence imaging module can emit excitation light to the sample on the test reagent card. The cells in the sample will emit different colors of fluorescence after being excited by the excitation light. The fluorescence imaging module images the sample and counts the different colors of fluorescence to obtain the number of stained cells and obtain the detection result of the five-part differential white blood cell count in the sample.

[0075] The second transmission module can be a horizontal two-dimensional transmission structure, ensuring that the second carrier is moved from the sample application position to the detection position. During the fluorescence detection of the sample by the fluorescence imaging module, it drives the second carrier to move horizontally in two dimensions, shifting the image field of view acquired by the fluorescence imaging module. This allows the fluorescence imaging module to image multiple locations on the sample on the test reagent card, improving the detection efficiency of the fluorescence imaging module. The second transmission module can be a stepper motor working with a rack, pinion belt, or lead screw to drive the movement of the second carrier.

[0076] Optionally, the fluorescence imaging module employs a confocal structure, including a fluorescence exciter and an image acquisition unit. The fluorescence exciter emits excitation light onto the test reagent card to excite fluorescence in the sample. In one embodiment, the fluorescence exciter can be configured for single-fluorescence excitation or dual-fluorescence excitation. The image acquisition unit acquires fluorescence images, and the white blood cell five-part differential count result in the sample can be obtained through information analysis of the fluorescence images. In one embodiment, the image acquisition unit can be a CMOS (Complementary Metal Oxide Semiconductor) camera.

[0077] The fluorescence imaging module may also include a one-dimensional transmission module in the direction of gravity to move the image acquisition device relative to the test reagent card, thereby enabling the image acquisition device to focus and improving the acquisition effect of the imaging acquisition device on the fluorescence image.

[0078] Furthermore, the fluorescence imaging module may also include dichroic mirrors, filters, etc., which are used to filter fluorescence and improve the detection efficiency of the fluorescence imaging module.

[0079] In summary, in the fluorescence detection component 12 of this embodiment, the second transmission module drives the second carrier to move, so that the second carrier receives the test reagent card outside the POCT analyzer 1 and moves the test reagent card to the sample application position for sample application. After sample application, it moves to the detection position for fluorescence detection. The fluorescence imaging module is located at the detection position to perform fluorescence detection on the sample to be tested on the test reagent card to obtain the white blood cell count result in the sample to be tested.

[0080] Optionally, the pipetting assembly 13 includes a third transmission module and a pipette, the pipette being disposed on the third transmission module and sliding relative to the third transmission module. The third transmission module is used to drive the pipette to move along the horizontal direction and the direction of gravity, so as to move the liquid onto the impedance detection assembly and / or the fluorescence detection assembly 12.

[0081] The pipette can be a movable quantitative pipetting system consisting of a solenoid valve, syringe or metering pump, tubing, and tip connector, or it can be an integrated air metering pump (ADP). The third transmission module can be a three-dimensional transmission structure to move the pipette horizontally above the impedance detection component 11, and then move it in the direction of gravity to bring the pipette close to the first support seat and inject the liquid into the test kit on the first support seat; and to move the pipette horizontally above the fluorescence detection component 12, and then move it in the direction of gravity to bring the pipette close to the second support seat and inject the liquid into the test kit card on the second support seat.

[0082] In summary, the POCT analyzer 1 provided in this application improves the accuracy and repeatability of erythroid parameters by setting up the impedance detection component 11 to detect platelets and red blood cells; and improves the classification accuracy of white blood cells by setting up the fluorescence detection component 12 to detect white blood cells, utilizing the strong specificity of fluorescence to enhance the characteristic differences of different white blood cells. The detection capabilities of the two detection components complement each other, enabling the POCT analyzer 1 to quickly obtain the counting results of platelets, red blood cells, and white blood cells in the sample, thereby improving the detection efficiency of the POCT analyzer 1.

[0083] This application also provides a detection kit; please refer to [link / reference]. Figure 2 , Figure 2 This is a schematic diagram of the structure of one embodiment of the test kit of this application. The test kit 2 can be applied in the POCT analyzer 1 as described above, placed on the first support, and participates in the impedance detection of the impedance detection component 11.

[0084] The test kit 2 includes a housing 21 and a contact electrode 22. The housing 21 has at least one cavity, which are arranged sequentially at intervals along the length of the housing 21. The contact electrode 22 is disposed on the housing 21 and communicates with the cavity on the housing 21, and is used to perform impedance detection on the sample to be tested in the cavity.

[0085] like Figure 2As shown, the housing 21 has multiple cavities, including a tip placement cavity, a tip unloading cavity, a pre-dilution area, a reagent storage area, a hemoglobin detection chamber, and a red blood cell detection chamber. The tip placement and unloading cavities are used to replace the tip on the pipetting assembly 13. The pre-dilution area can be a dilution chamber for blood samples, or a washing chamber or cell staining chamber for the pipetting assembly 13. The reagent storage area can store auxiliary detection reagents, such as red blood cell lysing agents, diluents, and white blood cell staining solutions. The hemoglobin detection chamber corresponds to the colorimetric detection module to detect the hemoglobin concentration in the sample. The red blood cell detection chamber works in conjunction with the detection electrode module and the pressure build-up module to detect red blood cells and platelets in the sample.

[0086] In one embodiment, after filling the reagent storage cavity of the housing 21 with reagent, a film or rubber stopper can be used to seal the cavity to prevent the reagent from being contaminated.

[0087] In another embodiment, the cavity can be integral with the box 21, or it can be independently installed or detached from the box 21, thereby improving the flexibility of the box 21 in setting the cavity.

[0088] The red blood cell detection chamber may include a pre-chamber and a post-chamber. The pre-chamber has an upper opening, serving as the inlet for injecting reagents and blood samples. The post-chamber is a closed cavity connected to the pre-chamber via micropores. A pressure interface 23 may be provided at the post-chamber, which is connected to a pressure-building module via the pressure interface 23. The contact electrode 22 on the test kit 2 includes a pre-chamber electrode and a post-chamber electrode. One end of the pre-chamber electrode is disposed in the pre-chamber, and one end of the post-chamber electrode is disposed in the post-chamber. The sample to be tested is placed in the pre-chamber. The detection electrode module abuts against the pre-cell electrode and the post-cell electrode to provide current to them. The pressure-building module is connected to the post-cell via pressure interface 23 to provide negative pressure to the post-cell, allowing the sample to be tested in the pre-cell to enter the post-cell through the micropores and form a liquid flow in the test kit 2. The sample enters the post-cell and contacts the post-cell electrode, thus forming a complete current loop in the test kit 2. The detection electrode module further detects the impedance signal between the micropores to detect red blood cells and platelets in the sample and obtain the detection results for red blood cells and platelets.

[0089] The hemoglobin detection cell has parallel, equally high transparent detection windows on opposite sides for optical detection. The light beam emitted from the illumination source in the colorimetric detection module passes through these transparent windows into the sample, and then through the opposite window into the corresponding photodetector to detect the hemoglobin concentration in the sample. The detection windows are slightly thin and grooved to prevent wear and contamination.

[0090] This application also provides a test kit card, such as Figure 3As shown, Figure 3 This is a schematic diagram of an embodiment of the test reagent card of this application. The test reagent card 3 can be used in the POCT analyzer 1 as described above, placed on the second support, and participate in the fluorescence detection of the fluorescence detection component 12. The test reagent card 3 is provided with a through sample receiving cavity, and the two ports of the sample receiving cavity are located on the same surface of the test reagent card 3.

[0091] The sample receiving cavity has a fixed height, with one of its two ports serving as a sample application port and the other as a vent. The pipetting assembly 13 injects the sample into the cavity through the application port. The cavity contains a microfluidic structure that allows the sample to lie flat within the detection area. The subsequent fluorescence detection assembly 12 performs fluorescence imaging on the sample in the detection area to obtain the white blood cell count.

[0092] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.

Claims

1. A POCT analyzer, characterized in that, include: Impedance detection component, used to perform impedance detection on the sample to obtain the counting results of red blood cells and platelets; A fluorescence detection component, spaced apart from the impedance detection component, is used to perform fluorescence detection on the sample to be tested in order to obtain white blood cell count results. A pipetting assembly, spaced apart from the impedance detection assembly and the fluorescence detection assembly, is used to move liquid to the impedance detection assembly and / or the fluorescence detection assembly.

2. The POCT analyzer according to claim 1, characterized in that, The impedance detection component includes: A first support is used to place a test kit, the test kit being used to load the sample to be tested; A first transmission module is disposed inside the POCT analyzer, and a first support is disposed on the first transmission module, and the first support slides relative to the first transmission module, so that the first support has a first state located inside the POCT analyzer and a second state located outside the POCT analyzer. The first carrier is switched to the first state to move the test kit into the POCT analyzer, and the pipetting assembly is used to move the liquid into the test kit to form the test sample in the test kit.

3. The POCT analyzer according to claim 2, characterized in that, The impedance detection component includes: The detection electrode module is disposed inside the POCT analyzer and spaced apart from one end of the first transmission module. When the first carrier is switched to the first state, the detection electrode module abuts against the contact electrode of the test kit on the first carrier to perform impedance detection on the sample to be tested in the test kit. The pressure building module is located inside the POCT analyzer and is spaced apart from one end of the first transmission module. When the first support is switched to the first state, the pressure building module is connected to the test kit on the first support to provide pressure to the test kit, so that the sample to be tested forms a liquid flow in the test kit.

4. The POCT analyzer according to claim 2, characterized in that, The impedance detection component further includes a colorimetric detection module, which is disposed on the first carrier. When the first carrier is switched to the first state, the colorimetric detection module is used to perform optical detection on the sample to be tested in the test kit on the first carrier.

5. The POCT analyzer according to claim 1, characterized in that, The fluorescence detection component includes: The second support is used to place the test reagent card, which is used to load the sample to be tested. The second transmission module is disposed inside the POCT analyzer, and the second support is disposed on the second transmission module and slides relative to the second transmission module; The second transmission module is used to move the second support seat to the outside of the POCT analyzer to receive the test reagent card; And / or, the second transmission module is used to move the second carrier to the sample dispensing position so that the pipetting assembly injects the liquid into the test reagent card on the second carrier; And / or, the second transmission module is used to drive the second carrier to move to the detection position so as to perform fluorescence detection on the test sample on the test reagent card on the second carrier.

6. The POCT analyzer according to claim 5, characterized in that, The fluorescence detection component also includes: A fluorescence imaging module is disposed inside the POCT analyzer and above the detection position. When the second carrier moves the test reagent card to the detection position, the fluorescence imaging module is used to perform fluorescence detection on the test sample on the test reagent card. During the fluorescence detection of the sample to be tested on the test reagent card by the fluorescence imaging module, the second transmission module is also used to drive the second carrier to move in the horizontal direction so that the fluorescence imaging module can image multiple parts of the sample to be tested on the test reagent card.

7. The POCT analyzer according to claim 6, characterized in that, The fluorescence imaging module includes a fluorescence exciter and an image acquisition unit; the fluorescence exciter is used to emit excitation light onto the test reagent card to excite the fluorescence in the sample to be tested; the image acquisition unit is used to acquire the fluorescence image.

8. The POCT analyzer according to claim 1, characterized in that, The pipetting assembly includes a third transmission module and a pipette, wherein the pipette is disposed on the third transmission module and slides relative to the third transmission module; The third transmission module is used to drive the pipette to move in the horizontal and gravitational directions to move the liquid to the impedance detection component and / or the fluorescence detection component.

9. A test kit, characterized in that, Applied to a POCT analyzer as described in any one of claims 1-8, comprising a housing and contact electrodes; The box body is provided with at least one cavity, and the cavities are arranged sequentially at intervals along the length direction of the box body. The contact electrode is disposed on the box body and communicates with the cavity on the box body, and is used to perform impedance detection on the sample to be tested in the cavity.

10. A test reagent card, characterized in that, Applied to the POCT analyzer as described in any one of claims 1-8, the test reagent card has a through sample receiving cavity, and the two ports of the sample receiving cavity are located on the same surface of the test reagent card.

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