POCT hematology analyzer and control method and kit assembly thereof

Abstract

The invention discloses a POCT blood cell analyzer, a control method thereof and a kit assembly. The POCT hematology analyzer comprises an acquisition unit, a detection unit and a processing unit. Wherein the acquisition unit is used for acquiring a calibration coefficient corresponding to the disposable kit, the kit comprises an impedance detection cell, and a microporous sheet is arranged in the impedance detection cell; the detection unit is used for being connected with the impedance detection pool and controlling a sample in the impedance detection pool to pass through the microporous sheet so as to detect a preset item of the sample; and the processing unit is used for obtaining a final detection value of the sample based on the detection result of the sample and the calibration coefficient. In the application, the POCT hematology analyzer corrects the detection result of the kit through the calibration coefficient of the kit, so that the accuracy of sample detection is improved.

Description

Technical Field

[0001] The present application relates to the field of in vitro diagnostic technology, and in particular to a POCT blood cell analyzer and a control method and a kit assembly thereof. Background Art

[0002] POCT (point-of-care testing) blood cell analyzer is a commonly used medical testing equipment. It is a type of instrument that detects parameters such as the number and proportion of blood cells (red blood cells, white blood cells, platelets) in the blood. By analyzing the blood, it can realize functions such as the type of microbial infection of the sample being tested, diagnosis and treatment of anemia, and diagnosis of blood diseases.

[0003] The test kit is a common disposable experimental item used for testing by POCT blood cell analyzers. It is used to test samples. The working principle of the test kit is to draw liquid so that the liquid in the front pool flows into the rear pool through the micropores of the microporous sheet, and then is drawn out through the outlet hole of the rear pool to count cells.

[0004] The disposable test kit contains a microporous sheet, but since both the microporous sheet and the test kit are disposable and can be discarded after use, it is impossible for each test kit to be exactly the same. Therefore, the sample test results measured by the POCT blood cell analyzer using different test kits may be significantly different, thus affecting the accuracy of the POCT blood cell analyzer's detection. Summary of the invention

[0005] The present application provides a POCT blood cell analyzer and a control method thereof, and a reagent kit assembly to solve the technical problem in the prior art that the results measured by the POCT blood cell analyzer through different reagent kits may have obvious differences, thereby affecting the accuracy of the POCT blood cell analyzer's detection.

[0006] In order to solve the above technical problems, a technical solution adopted by the present application is: to provide a POCT blood cell analyzer, which includes: an acquisition unit, a detection unit and a processing unit. The acquisition unit is used to obtain the calibration coefficient corresponding to the disposable test kit, wherein the test kit includes an impedance detection pool, and a microporous sheet is provided in the impedance detection pool; the detection unit is used to connect the impedance detection pool and control the sample in the impedance detection pool to pass through the microporous sheet to detect the preset items of the sample; the processing unit is used to obtain the final detection value of the sample based on the test result of the sample and the calibration coefficient.

[0007] Furthermore, the calibration coefficient is related to the production information of the kit and / or the production information of the microporous sheet.

[0008] Furthermore, the calibration coefficient corresponds to the batch and / or the mold cavity of the reagent kit, and the calibration coefficients of reagent kits of the same batch and / or the same mold cavity are the same or similar.

[0009] Furthermore, the reagent kit and the microporous sheet are provided separately.

[0010] Furthermore, the calibration coefficient corresponds to the batch and / or the mold cavity of the microporous sheet in the reagent kit, and the calibration coefficients of the microporous sheets of the same batch and / or the same mold cavity when installed in the reagent kit are the same or similar.

[0011] Furthermore, the acquisition unit includes a reader, the calibration coefficient is stored in a storage medium corresponding to the reagent kit, and the control unit is further used to: acquire the calibration coefficient of the reagent kit from the storage medium through the reader.

[0012] Furthermore, the processing unit is used to obtain a final detection value of the sample based on the detection result of the sample and the calibration coefficient, specifically including: calculating the product of the detection result of the sample and the calibration coefficient to obtain the final detection value of the sample.

[0013] In order to solve the above technical problems, another technical solution adopted by the present application is: to provide a control method for a POCT blood cell analyzer, based on the POCT blood cell analyzer of any of the above embodiments, the control method includes: obtaining the calibration coefficient corresponding to the disposable test kit through an acquisition unit; performing a test of preset items on the sample in the test kit through a detection unit to obtain the test result of the sample; and obtaining the final test value of the sample based on the test result of the sample and the calibration coefficient.

[0014] In order to solve the above technical problems, another technical solution adopted in the present application is: to provide a reagent kit assembly, applied to the POCT blood cell analyzer of any of the above embodiments, the reagent kit assembly includes: a disposable reagent kit and a storage medium, wherein the disposable reagent kit includes an impedance detection cell, and a microporous sheet is arranged in the impedance detection cell; the storage medium is used to store the calibration coefficient of the reagent kit.

[0015] Furthermore, the kit assembly also includes packaging, and the calibration coefficient is related to the production information of the kit and / or the production information of the microporous sheet; at least one of the packaging, the disposable kit and the microporous sheet has the production information of the kit and / or the production information of the microporous sheet.

[0016] Beneficial effects of the present application: Different from the prior art, in the present application, when the POCT blood cell analyzer detects the sample in the kit, it obtains the calibration coefficient corresponding to the kit, and after detecting the sample in the kit to obtain the test result, the test result is corrected by the calibration coefficient, thereby improving the accuracy of the sample test result of the POCT blood cell analyzer; in addition, in this way, the measurement error caused by different kits / microporous sheets can be reduced, and the consistency requirements for the accuracy of the kits / microporous sheets can be reduced, and the production cost of the kits / microporous sheets can be reduced while improving the accuracy of the sample test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 It is a schematic diagram of a framework of an embodiment of a POCT blood cell analyzer provided by the present application;

[0019] Figure 2 yes Figure 1 The schematic diagram of the structure of an embodiment of a disposable kit for use in a POCT blood cell analyzer is shown;

[0020] Figure 3 It is a flow chart of an embodiment of a control method of a POCT blood cell analyzer provided by the present application;

[0021] Figure 4 It is a schematic structural diagram of an embodiment of a kit assembly provided by the present application;

[0022] Figure 5 It is a schematic diagram of a framework of an embodiment of a sample analyzer provided by the present application;

[0023] Figure 6 It is a flow chart of an embodiment of a control method of a sample analyzer provided by the present application. DETAILED DESCRIPTION

[0024] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. It is to be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some structures related to the present application are shown in the accompanying drawings, rather than all structures. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0025] The terms "first", "second", etc. in this application are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but optionally includes steps or units that are not listed, or optionally includes other steps or units inherent to these processes, methods, products or devices.

[0026] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0027] In this application, the disposable test kits used by the POCT blood cell analyzer all have corresponding calibration coefficients. When the POCT blood cell analyzer detects the test kit, it first obtains the calibration coefficient corresponding to the test kit, detects the sample in the test kit to obtain the test result, and then multiplies the test result by the calibration coefficient of the test kit to obtain the final test value of the sample. In this way, the measurement error caused by different test kits / microporous sheets can be eliminated, the consistency requirements for the accuracy of the test kits / microporous sheets can be reduced, and the production cost of the test kits / microporous sheets can be reduced while ensuring the accuracy of the test results.

[0028] The present application first provides a POCT blood cell analyzer, which detects samples through a disposable kit. Figure 1 As shown, Figure 1 It is a schematic diagram of the framework of an embodiment of a POCT blood cell analyzer provided in the present application. Specifically, the POCT blood cell analyzer 10 includes: an acquisition unit 11, a detection unit 12 and a processing unit 13.

[0029] The acquisition unit 11 is used to acquire the calibration coefficient corresponding to the disposable test kit. Since the test kit is a disposable consumable, there are differences between different test kits, which may affect the test results of the sample. Therefore, when the POCT sample analyzer detects the sample through the test kit, it can first acquire the calibration coefficient corresponding to the test kit.

[0030] See also Figure 2 As shown, Figure 2 yes Figure 1 The schematic diagram of the structure of an embodiment of a disposable test kit for use in a POCT blood cell analyzer is shown. Specifically, the test kit 20 includes an impedance detection pool 21, and a microporous sheet 22 is provided in the impedance detection pool 21. The impedance detection pool 21 may include a front pool (not shown in the figure) and a rear pool (not shown in the figure) connected to the front pool, and the microporous sheet 22 is provided between the front pool and the rear pool, or the microporous sheet 22 is provided in the rear pool, or the microporous sheet 22 is provided in the front pool. The microporous sheet 22 is provided with micropores 221 that allow cells to pass through one by one. When performing sample testing, the liquid in the front pool enters the rear pool through the micropores 221 of the microporous sheet 22.

[0031] The detection unit 12 is used to detect preset items on the sample through the reagent kit 20. Specifically, the detection unit 12 in the POCT blood cell analyzer 10 is used to connect the impedance detection pool 21. The detection unit 12 includes components that cooperate with the reagent kit 20 to perform sample detection. For example, the detection unit 12 includes an impedance detection component (not shown in the figure), which is connected to the impedance detection pool 21 and is used to perform impedance detection on the sample in the reagent kit 20. Optionally, the detection unit 12 may also include an optical detection component (not shown in the figure), which is used to perform optical detection on the sample in the reagent kit 20.

[0032] The processing unit 13 is connected to the acquisition unit 11 and the detection unit 12. The processing unit 13 is used to obtain a final detection value of the sample based on the detection result of the sample and the calibration coefficient.

[0033] In the above embodiment, when the POCT blood cell analyzer 10 detects a sample through the test kit 20, it can first obtain the calibration coefficient corresponding to the test kit 20 through the acquisition unit 11, and then correct the test result of the sample based on the calibration coefficient. In this way, the measurement error caused by different test kits 20 can be reduced and the detection accuracy of the POCT blood cell analyzer 10 can be improved.

[0034] Optionally, the reagent kit 20 can be injection molded, which can simplify the manufacturing process of the reagent kit 20, increase the production speed and efficiency, and minimize the differences between different reagent kits 20. The microporous sheet 22 can also be injection molded, which can simplify the manufacturing process of the microporous sheet 22, increase the production speed and efficiency, and minimize the differences between different microporous sheets 20.

[0035] The production information of different test kits 20 may be different, resulting in differences between different test kits 20. The production information of the test kit 20 includes the material and injection molding information of the test kit 20. The difference in production information of different microporous sheets 22 may also affect the test results of the samples in the test kit 20. Therefore, in the present application, the calibration coefficient corresponding to the test kit 20 may be related to at least one of the production information of the test kit 20 and the production information of the microporous sheet 22. For example, the calibration coefficients of the test kits 20 with the same material and injection molding information may be the same, or the calibration coefficients of the test kits 20 corresponding to the microporous sheets 22 with the same material and injection molding information may be different.

[0036] The reagent kit 20 and the microporous sheet 22 can be separately provided, that is, the reagent kit 20 and the microporous sheet 22 are produced separately, and then the reagent kit 20 and the microporous sheet 22 are assembled, so that the processing accuracy of the reagent kit 20 can be improved, and the requirements for the processing technology are relatively low. It is understandable that in other embodiments, the reagent kit 20 and the microporous sheet 22 can also be integrally provided.

[0037] Optionally, the calibration coefficient corresponding to the test kit 20 can correspond to the batch and / or the mold cavity of the test kit 20, and the calibration coefficients of the test kits 20 of the same batch and / or the same mold cavity can be the same or similar. The batch of the test kit 20 can be determined by the identification information of the test kit 20, and the batches of the test kits 20 with the same identification information are the same. The identification information can be a batch number, that is, the batch numbers of the test kits 20 with the same batch are the same. The mold cavity of the test kit 20 refers to the acupuncture points of the production mold of the test kit 20. The calibration coefficients are similar, which means that the deviation of the calibration coefficients is within an acceptable range, for example, the calibration coefficients are similar, which means that the deviation of the calibration coefficients is less than 10%. Since the differences in the box bodies of the test kits 20 of the same batch and / or the same mold cavity are small, the differences between the box bodies of different test kits 20 can be reduced.

[0038] The calibration coefficient corresponding to the test kit 20 can also correspond to the batch and / or the mold cavity of the microporous sheet 22 in the test kit 20, and the calibration coefficients of the microporous sheets 22 of the same batch and / or the same mold cavity when installed in the test kit 20 are the same or similar. Similarly, the batch of microporous sheets 22 can be determined by the identification information of the microporous sheets 22, and the batches of microporous sheets 22 with the same identification information are the same. The identification information can be a batch number, and the batch numbers of the microporous sheets 22 with the same batch are the same. The mold cavity of the microporous sheet 22 refers to the acupuncture points of the production mold of the microporous sheet 22. The calibration coefficients here are similar, which means that the difference of the calibration coefficients is within an acceptable range, for example, the calibration coefficients are similar, which means that the deviation of the calibration coefficients is less than 10%. Since the difference of the microporous sheets 22 of the same batch and / or the same mold cavity is small, the difference between the microporous sheets 22 of different test kits 20 can be reduced.

[0039] Preferably, the microporous sheets 22 of the same batch and / or out of the mold cavity can be installed in the reagent kits 20 of the same batch and / or out of the mold cavity to form a type of reagent kits 20, and the calibration coefficients of the type of reagent kits 20 are the same or similar. In this way, the differences of the type of reagent kits 20 are further reduced, and thus, the accuracy of sample detection can be further improved.

[0040] Based on the above-mentioned POCT blood cell analyzer 10, the present application also provides a control method of the POCT blood cell analyzer, such as Figure 3 As shown, Figure 3 The present application also provides a flow chart of an embodiment of a control method of a POCT blood cell analyzer. Specifically, the control method includes:

[0041] S11: Acquire the calibration coefficient corresponding to the disposable reagent kit through the acquisition unit.

[0042] The POCT blood cell analyzer 10 obtains the calibration coefficient corresponding to the disposable reagent kit 20 through the acquisition unit 11. Among them, the calibration coefficient may be related to the production information of the reagent kit 20 and / or the production information of the microporous sheet 22. The calibration coefficient may also correspond to the batch and / or the mold cavity of the reagent kit 20, and the calibration coefficients of the reagent kits 20 of the same batch and / or the same mold cavity are the same or similar. The calibration coefficient may also correspond to the batch and / or the mold cavity of the microporous sheet 22 in the reagent kit 20, and the calibration coefficients of the microporous sheet 22 of the same batch and / or the same mold cavity when installed in the reagent kit 20 are the same or similar. Please refer to the introduction of the above embodiment for details, which will not be repeated here.

[0043] The calibration coefficient of the reagent kit 20 may be stored in a storage medium corresponding to the reagent kit 20. For details about the storage medium corresponding to the reagent kit 20, please refer to the description of the following embodiment, which will not be described in detail here.

[0044] Specifically, the acquisition unit 11 may include a reader, and the reader may acquire the calibration coefficient corresponding to the reagent kit 20 from the storage medium corresponding to the reagent kit 20. For example, when the storage medium is a radio frequency card, the reader may read the calibration coefficient corresponding to the reagent kit 20 from the radio frequency card corresponding to the reagent kit 20. In other embodiments, the acquisition unit 11 may also acquire the calibration coefficient corresponding to the reagent kit 20 through manual input by the user.

[0045] S12: The detection unit performs a detection of preset items on the sample in the kit to obtain the detection result of the sample.

[0046] The detection unit 12 controls the sample in the reagent kit 20 to pass through the microporous sheet 22 to detect the preset items of the sample and obtain the detection result of the sample. The detection result is the actual detection result of the sample by the POCT blood cell analyzer 10.

[0047] The preset items include at least one of white blood cell count, red blood cell count, hemoglobin concentration, platelet count, mean platelet volume and mean red blood cell volume.

[0048] S13: Based on the test result of the sample and the calibration coefficient, a final test value of the sample is obtained.

[0049] The processing unit 13 can calculate the correction value of the sample detection result based on the sample detection result and the obtained calibration coefficient, that is, obtain the final detection value of the sample. In this way, the accuracy of the sample detection result can be improved.

[0050] Specifically, the processing unit 13 may multiply the detection result of the sample by the calibration coefficient to obtain the final detection value of the sample.

[0051] When the POCT blood cell analyzer 10 provided in the present application detects the disposable test kit 20, it can first obtain the calibration coefficient corresponding to the test kit 20. For example, the acquisition unit 11 obtains the calibration coefficient corresponding to the test kit 20 through the storage medium corresponding to the test kit 20. When the POCT blood cell analyzer 10 detects the sample through the test kit 20, it corrects the test result according to the calibration coefficient. In this way, the influence of the dimensional error of the test kit 20 on the test result can be reduced, and the accuracy of the sample detection can be improved. Moreover, the consistency requirements for the accuracy of the test kit 20 and the microporous sheet 22 can be reduced, and the production cost of the test kit 20 and the microporous sheet 22 can be reduced while improving the accuracy of the test result.

[0052] The present application also provides a kit component, see Figure 4 As shown, Figure 42 is a schematic diagram of a structure of an embodiment of a kit assembly provided by the present application. Specifically, the kit assembly includes a disposable kit 20 and a storage medium 23. The kit assembly can be applied to a POCT blood cell analyzer in any of the above embodiments, wherein the kit 20 includes an impedance detection cell 21, and a microporous sheet 22 is disposed in the impedance detection cell 21. The microporous sheet 22 is disposed in the box body 21. For the structure of the kit 20 and the microporous sheet 22, please refer to Figure 2 The kit assembly may also include a packaging member (not shown), which may be used to package the kit 20 and the storage medium 23 .

[0053] The storage medium 23 is used to store the calibration coefficient corresponding to the reagent kit 20. The calibration coefficient may be related to the production information of the reagent kit 20 and / or the production information of the microporous sheet 22. At least one of the package, the disposable reagent kit 20 and the microporous sheet 22 has the production information of the reagent kit 20 and / or the production information of the microporous sheet 22. For example, the calibration coefficients corresponding to the reagent kits 20 with the same production information may be the same. When the POCT blood cell analyzer detects the reagent kits 20 with the same production information, it only needs to obtain the calibration coefficient once, which simplifies the detection process of the POCT blood cell analyzer.

[0054] The calibration coefficients of the reagent kits 20 of the same batch and / or the same mold cavity can be the same or similar. The calibration coefficients of the microporous sheets of the same batch and / or the same mold cavity when installed in the reagent kit can be the same or similar. Moreover, the microporous sheets 22 of the same batch and / or the same mold cavity can be installed in the reagent kits 20 of the same batch and / or the same mold cavity to reduce the differences between the reagent kits 20. The method for obtaining the calibration coefficient can refer to the description of the following embodiments, which will not be repeated here.

[0055] The storage medium 23 may include an RF (Radio Frequency) card, a QR code label or a barcode label, etc. When the POCT blood cell analyzer detects the reagent kit 20, it may first obtain the calibration coefficient of the reagent kit 20 through the storage medium 23, store it in the instrument, and then calibrate the sample test result of the reagent kit 20 based on the calibration coefficient.

[0056] It is understandable that the calibration coefficients of the test kits 20 of the same batch and / or the same mold cavity can be the same. Therefore, when the test kits 20 of the same batch and / or the same mold cavity are sold, their corresponding calibration coefficients can be stored in the same storage medium. For example, when the test kits 20 of the same batch are sold, the calibration coefficients are written into an RF card or a QR code and packaged and sold together with the batch of test kits 20. In other embodiments, each test kit 20 can also be equipped with a storage medium 23. Before each test kit 20 is used, the POCT blood cell analyzer can first read the calibration coefficient corresponding to the test kit 20 through the storage medium 23 corresponding to the test kit 20, and when the test kit 20 is tested, the test results of the sample can be corrected by the calibration coefficient.

[0057] In the reagent kit 20 provided in the above embodiment, the calibration coefficient corresponding to the reagent kit 20 is stored by the storage medium 23. When the reagent kit 20 is in use, the POCT blood cell analyzer can obtain the calibration coefficient corresponding to the reagent kit 20 through the storage medium 23, and the POCT blood cell analyzer can correct the test result of the sample based on the calibration coefficient. In this way, the accuracy of sample detection by the POCT blood cell analyzer can be improved, thereby improving the reliability of the POCT blood cell analyzer.

[0058] The present application also provides a sample analyzer, which is used to measure the calibration coefficient of the kit to obtain the calibration coefficient corresponding to the kit. Figure 5 As shown, Figure 5 It is a schematic diagram of a framework of an embodiment of a sample analyzer provided by the application. Specifically, the sample analyzer 50 includes: a detection unit 51 and a control unit 52 , and the control unit 52 is connected to the detection unit 51 .

[0059] The detection unit 51 is used to detect the standard sample through the reagent kit. For the structure of the reagent kit, please refer to the introduction of the above embodiment, which will not be repeated here.

[0060] The detection unit 51 is connected to the impedance detection pool of the reagent kit. The detection unit 51 includes components for cooperating with the reagent kit to perform sample detection. For example, the detection unit 51 includes an impedance detection component (not shown), which is used to perform impedance detection on the sample in the reagent kit.

[0061] The control unit 52 is used to control the detection unit 51 so that the detection unit 51 detects the sample in the reagent kit.

[0062] In the present application, when the sample analyzer 50 measures the calibration coefficient of the test kit, the microporous sheet can be randomly loaded into the test kit to measure the calibration coefficient of the test kit through the sample analyzer 50. Or the sample analyzer 50 measures the calibration coefficient of the test kit according to the production information of the test kit / the production information of the microporous sheet. For example, test kits with the same production information of the test kit / microporous sheet are classified as one category, and the calibration coefficients of this category of test kits are the same. For the introduction of the production information of the test kit / microporous sheet, please refer to the introduction of the above embodiment, which will not be repeated here.

[0063] Optionally, the kits of the same batch and / or the same mold cavity can be classified as one type, and the box bodies of the kits of this type are slightly different, and the sample analyzer 50 can measure the calibration coefficient of the kits of this type. In this way, the sample test results of the kits of this type can be corrected by the calibration coefficient.

[0064] Optionally, when microporous sheets of the same batch and / or the same mold cavity are installed in the test kit, they can be regarded as a class, and the microporous sheets in this class of test kits have small differences, and the sample analyzer 50 can measure the calibration coefficient of this class of test kits. In this way, the sample test results of this class of test kits can be corrected by the calibration coefficient.

[0065] Optionally, microporous sheets from the same batch and / or the same mold cavity can be installed in test kits from the same batch and / or the same mold cavity to obtain a class of test kits in which the differences between the test kits are further reduced, and then the calibration coefficients of the test kits are measured to correct the sample test results of the test kits by the calibration coefficients.

[0066] Based on the sample analyzer 50 of any of the above embodiments, the present application also provides a calibration method for the sample analyzer, see Figure 6 As shown, Figure 6 1 is a flow chart of an embodiment of a calibration method of a sample analyzer provided by the present application. Specifically, the calibration method includes:

[0067] S61: After detecting that the first reagent kit containing the first microporous sheet is placed in the detection unit, the detection unit controls the standard sample in the first reagent kit to pass through the first microporous sheet to perform a detection of preset items on the standard sample to obtain a detection result of the standard sample.

[0068] After the first reagent box containing the first microporous sheet is placed in the detection unit 51, the control unit 52 controls the detection unit 51 to detect the preset items on the standard sample in the reagent box 20. Specifically, the control unit 52 controls the standard sample in the first reagent box to pass through the first microporous sheet through the detection unit 51, so as to detect the preset items on the standard sample, thereby obtaining the detection result of the standard sample.

[0069] A standard sample refers to a sample with a known target value. The preset items include at least one of white blood cell count, red blood cell count, hemoglobin concentration, platelet count, mean platelet volume and mean red blood cell volume. The control unit 52 can control the detection unit 51 to detect all the above preset items on the standard sample to calculate the calibration coefficients corresponding to all the above preset items. In actual applications, each preset item is corrected to improve the accuracy of the sample detection results. In other embodiments, the control unit 52 can control the detection unit 51 to detect some of the above preset items on the standard sample to calculate the calibration coefficients corresponding to the preset items that are greatly affected by the differences of the test kit 20 to simplify the operation process.

[0070] Optionally, the detection unit 51 can perform preset item tests on the same standard sample in sequence through multiple first test kits to obtain multiple test results, and calculate the calibration coefficient of the batch of test kits 20 based on the multiple test results to improve the accuracy of the calibration coefficient.

[0071] S62: Obtain the target value of the standard sample, compare the target value with the test result, and obtain the calibration coefficient of the second test kit.

[0072] The control unit 52 obtains the target value of the standard sample, compares the target value with the test result obtained by the sample analyzer 50, and obtains the calibration coefficient of the batch of reagent kits 20. The calibration coefficient is used to correct the sample test result of the second reagent kit.

[0073] Specifically, the calibration coefficient is used to correct the detection results of the preset items obtained by the second reagent kit, and the second reagent kit contains a second microporous sheet.

[0074] Optionally, the box body and the microporous sheet in the first reagent box and the second reagent box can be assembled randomly.

[0075] Optionally, the production information of the first kit and the second kit is the same, or the production information of the first microporous sheet and the second microporous sheet is the same. For the introduction of the production information of the kit and the microporous sheet, please refer to the introduction of the above embodiment, which will not be repeated here.

[0076] Further, the batch and / or mold cavity of the first test kit and the second test kit are the same to reduce the difference between the box bodies of the first test kit and the second test kit. Alternatively, the batch and / or mold cavity of the first microporous sheet and the second microporous sheet are the same to reduce the difference between the first microporous sheet and the second microporous sheet.

[0077] Preferably, the batch and / or mold cavity of the first and second reagent kits are the same, and the batch and / or mold cavity of the first and second microporous sheets are the same, so as to further reduce the overall difference between the first and second reagent kits.

[0078] When multiple test results are obtained by repeatably testing the standard sample in step S61, the calibration coefficient of the second test kit can be obtained by the mean of the multiple test results and the target value of the standard sample. Specifically, the coefficient of variation of the multiple test results can be calculated, and when the coefficient of variation is within a preset range, the quotient obtained by dividing the target value of the standard sample by the mean of the multiple test results can be used as the calibration coefficient of the second test kit.

[0079] For example, as shown in Table 1, the target value of the white blood cell (WBC) count of the known standard sample is 8.3, the target value of the red blood cell (RBC) count is 5.1, the target value of the hemoglobin concentration (HGB) is 136, the target value of the mean corpuscular volume (MCV) is 84.1, the target value of the mean platelet volume (MPV) is 9.8, and the target value of the platelet count (PLT) is 275.

[0080] As shown in Table 2, multiple preset items of the above-mentioned standard samples are tested for repeatability through multiple test kits of a certain batch, so that multiple test results are obtained for each preset item. Then the mean and coefficient of variation of the multiple test results corresponding to each preset item are calculated. When the coefficient of variation is within the preset range, the calibration coefficient of the batch of test kits can be calculated based on the mean of the multiple test results and the target value of the standard sample. When the coefficient of variation is not within the preset range, it can be considered that the above-mentioned mean does not meet the conditions, and the standard sample can be re-measured to improve the accuracy of the calibration coefficient calculation. In this embodiment, the calculated calibration coefficient corresponding to each preset item is shown in Table 3. When the sample analyzer performs the detection of the preset items on the batch of test kits, the test results can be corrected by the calibration coefficient.

[0081] Table 1 Target value table of standard samples

[0082] Standard sample parameters <![CDATA[WBC(10 9 / L)]]> <![CDATA[RBC(×10 12 / L)]]> HGB(g / L) MCV(fL) MPV(fL) <![CDATA[PLT(10 9 / L)]]> Standard sample target value 8.3 5.1 136 84.1 9.8 275

[0083] Table 2 Test results of the same batch of test kits

[0084]

[0085] Table 3 Calibration coefficients of this batch of kits

[0086] parameter WBC RBC HGB MCV MPV PLT Kit calibration factor 102.55％ 98.15％ 101.27％ 102.56％ 109.50％ 88.51％

[0087] In the above embodiment, the calibration coefficient of the test kit is calculated by the sample analyzer 50, so that when the POCT blood cell analyzer detects the sample in the test kit, the test result of the sample can be corrected based on the above calibration coefficient, thereby improving the accuracy of the POCT blood cell analyzer. In addition, in this way, the measurement error caused by different test kits can be reduced, the consistency requirements for the accuracy of the test kit / microporous sheet can be reduced, and the production cost of the test kit / microporous sheet can be reduced while improving the accuracy of the test result.

[0088] 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 present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A POCT blood cell analyzer, characterized in that: The POCT blood cell analyzer comprises: An acquisition unit, used for acquiring a calibration coefficient corresponding to a disposable reagent kit, wherein the reagent kit comprises an impedance detection cell, wherein a microporous sheet is provided in the impedance detection cell; A detection unit, used to connect to the impedance detection cell and control the sample in the impedance detection cell to pass through the microporous sheet so as to perform a preset item detection on the sample; A processing unit is used to obtain a final detection value of the sample based on the detection result of the sample and the calibration coefficient.

2. The POCT blood cell analyzer according to claim 1, characterized in that: The calibration coefficient is related to the production information of the kit and / or the production information of the microporous sheet.

3. The POCT blood cell analyzer according to claim 2, characterized in that: The calibration coefficient corresponds to the batch and / or the mold cavity of the kit, and the calibration coefficients of the kits of the same batch and / or the same mold cavity are the same or similar.

4. The POCT blood cell analyzer according to claim 2, characterized in that: The reagent kit and the microporous sheet are separately arranged.

5. The POCT blood cell analyzer according to claim 4, characterized in that: The calibration coefficient corresponds to the batch and / or the mold cavity of the microporous sheets in the reagent kit, and the calibration coefficients of the microporous sheets of the same batch and / or the same mold cavity when installed in the reagent kit are the same or similar.

6. The POCT blood cell analyzer according to claim 1, characterized in that: The acquisition unit includes a reader, the calibration coefficient is stored in a storage medium corresponding to the reagent kit, and the control unit is further used for: The calibration coefficient of the reagent kit is obtained from the storage medium by the reader.

7. The POCT blood cell analyzer according to claim 1, characterized in that: The processing unit is used to obtain a final detection value of the sample based on the detection result of the sample and the calibration coefficient, specifically including: calculating the product of the detection result of the sample and the calibration coefficient to obtain the final detection value of the sample.

8. A control method for a POCT blood cell analyzer, characterized in that: Based on the POCT blood cell analyzer according to any one of claims 1 to 7, the control method comprises: Acquiring a calibration coefficient corresponding to the disposable reagent kit through an acquisition unit; Performing a detection of preset items on the sample in the kit through a detection unit to obtain a detection result of the sample; Based on the detection result of the sample and the calibration coefficient, a final detection value of the sample is obtained.

9. A kit component, characterized in that: The POCT blood cell analyzer according to any one of claims 1 to 7, wherein the kit assembly comprises: A disposable test kit includes an impedance detection cell, wherein a microporous sheet is arranged in the impedance detection cell; A storage medium is used to store the calibration coefficient of the reagent kit.

10. The kit assembly according to claim 9, characterized in that: The kit assembly further includes a packaging member, and the calibration coefficient is related to the production information of the kit and / or the production information of the microporous sheet; At least one of the package, the disposable kit and the microporous sheet has production information of the kit and / or production information of the microporous sheet.

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