Quality control method for blood cell analyzer and blood cell analyzer

Abstract

A quality control method for a blood cell analyzer and the blood cell analyzer are disclosed. The method comprises: obtaining a blood sample; adding a reagent to the blood sample for treatment to obtain a treated blood sample; transporting the treated blood sample to a detection device for testing to obtain measurement results of measurement parameters; and monitoring the blood cell analyzer for abnormalities based on the measurement results of the measurement parameters. This application utilizes blood samples to monitor the status of the blood cell analyzer in real time, eliminating the need for additional quality control materials and reducing monitoring costs.

Description

Technical Field

[0001] The present application relates to the technical field of blood analysis, and more specifically to a quality control method for a blood cell analyzer and a blood cell analyzer. Background Art

[0002] Hematology analyzers are used to perform operations such as classifying and counting various cells in the blood, thereby outputting measurement parameters such as white blood cells, red blood cells, platelets, and reticulocytes that have clinical guidance significance. In order to ensure the accuracy of measurement results, clinical laboratory quality control is essential. Currently, hematology analyzers use standard substances, commonly known as quality control materials, for quality control. Quality control materials are tested at a set time every day to obtain measurement results, which are then compared with reference values. If the deviation between the measurement result and the reference value exceeds the set tolerance, it is necessary to check whether there is any abnormality in the hematology analyzer and to check the instrument status.

[0003] The existing quality control scheme for blood cell analyzers has the following problems:

[0004] 1) It is necessary to ensure that the measurement results of various parameters of the quality control materials are stable within the validity period, and the cost of quality control materials is high;

[0005] 2) The testing of quality control materials on the blood cell analyzer is not carried out in real time. It can only be tested within a specific time period and the instrument status cannot be monitored in real time. Summary of the Invention

[0006] The Summary of the Invention introduces a series of simplified concepts that will be further described in the Detailed Description of the Invention. The Summary of the Invention of this application is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0007] In view of the problems existing in the prior art, an embodiment of the present invention provides a quality control method for a blood cell analyzer, the method comprising:

[0008] Obtaining a blood sample;

[0009] adding a reagent to the blood sample for treatment to obtain a treated blood sample;

[0010] The processed blood sample is transported to a detection device for detection to obtain measurement results of measurement parameters; and the blood cell analyzer is monitored for abnormality based on the measurement results of the measurement parameters.

[0011] In one embodiment, monitoring whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter includes:

[0012] calculating a statistical value of the measurement results of a current blood sample and a first number of blood samples before the current blood sample;

[0013] It is determined whether the statistical value is within a preset range. If the statistical value is not within the preset range, it is determined that an abnormality exists in the blood cell analyzer.

[0014] In one embodiment, the first number is a fixed value or a settable value, or the first number is the number of blood samples obtained within a preset time period before obtaining the current blood sample.

[0015] In one embodiment, the preset range is a fixed range or a floating range.

[0016] In one embodiment, when the preset range is a floating range, determining the floating range threshold for the current blood sample includes:

[0017] obtaining a statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence;

[0018] An upper limit value and a lower limit value of the statistical value sequence are determined, and the upper limit value and the lower limit value are determined as the floating range threshold value.

[0019] In one embodiment, the upper limit value and the lower limit value are respectively the maximum value and the minimum value in the statistical value sequence, or the upper limit value and the lower limit value are calculated based on the mean and standard deviation of the statistical value sequence.

[0020] In one embodiment, the method further comprises screening the blood sample to determine a qualified blood sample among the blood samples;

[0021] The monitoring of whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter is performed according to the measurement result of the qualified blood sample.

[0022] In one embodiment, the qualified blood sample includes a blood sample from a predetermined department, and the predetermined department includes a physical examination department or a preventive health care department.

[0023] In one embodiment, screening the blood sample comprises:

[0024] obtaining a scattergram or a histogram of blood cells in the blood sample;

[0025] Determine whether the blood sample is the qualified blood sample according to the scattergram or the histogram.

[0026] Another embodiment of the present invention provides a quality control method for a blood cell analyzer, the method comprising:

[0027] The sampling department obtains blood samples;

[0028] The reaction unit adds a reagent to the blood sample for treatment to obtain a treated blood sample;

[0029] The detection device detects the processed blood sample to obtain measurement results of measurement parameters;

[0030] The control device monitors whether the blood cell analyzer has any abnormality according to the measurement results of the measurement parameters.

[0031] Another aspect of the present invention provides a blood cell analyzer, comprising:

[0032] a sampling unit for obtaining a blood sample;

[0033] a reaction part, used for adding a reagent to the blood sample for treatment to obtain a treated blood sample;

[0034] a detection device, used to detect the processed blood sample to obtain measurement results of measurement parameters;

[0035] A control device is used to monitor whether the blood cell analyzer has any abnormality according to the measurement results of the measurement parameters.

[0036] In one embodiment, monitoring whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter includes:

[0037] calculating a statistical value of the measurement results of a current blood sample and a first number of blood samples before the current blood sample;

[0038] It is determined whether the statistical value is within a preset range. If the statistical value is not within the preset range, it is determined that an abnormality exists in the blood cell analyzer.

[0039] In one embodiment, the first number is a fixed value or a settable value, or the first number is the number of blood samples obtained within a preset time period before obtaining the current blood sample.

[0040] In one embodiment, the preset range is a fixed range or a floating range.

[0041] In one embodiment, when the preset range is a floating range, the control device is further configured to:

[0042] obtaining a statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence;

[0043] An upper limit value and a lower limit value of the statistical value sequence are determined, and the upper limit value and the lower limit value are determined as floating thresholds of the floating range.

[0044] In one embodiment, the upper limit value and the lower limit value are respectively the maximum value and the minimum value in the statistical value sequence, or the upper limit value and the lower limit value are calculated based on the mean and standard deviation of the statistical value sequence.

[0045] In one embodiment, the control device is further configured to screen the blood samples to determine qualified blood samples among the blood samples;

[0046] The control device monitors whether there is an abnormality in the blood cell analyzer according to the counting result of the blood cells in the qualified blood sample.

[0047] In one embodiment, the qualified blood sample includes a blood sample from a predetermined department, and the predetermined department includes a physical examination department or a preventive health care department.

[0048] In one embodiment, screening the blood sample comprises:

[0049] obtaining a scattergram or a histogram of blood cells in the blood sample;

[0050] Determine whether the blood sample is the qualified blood sample according to the scattergram or the histogram.

[0051] The quality control method and the blood cell analyzer of the embodiment of the present invention use blood samples to monitor the status of the blood cell analyzer in real time without using additional quality control materials, thereby reducing monitoring costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The above and other purposes, features, and advantages of the present application will become more apparent through a more detailed description of the embodiments of the present application in conjunction with the accompanying drawings. The accompanying drawings are intended to provide a further understanding of the embodiments of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the present application and do not constitute a limitation of the present application. In the drawings, the same reference numerals generally represent the same components or steps.

[0053] Figure 1 A schematic flow chart showing a quality control method for a blood cell analyzer according to one embodiment of the present invention;

[0054] Figure 2A A schematic diagram illustrating a distribution of MCH parameter means using a fixed range according to one embodiment of the present invention;

[0055] Figure 2B A schematic diagram illustrating the mean distribution of MCH parameters using a floating range according to one embodiment of the present invention;

[0056] Figure 3A A schematic diagram illustrating a mean distribution of an MCV parameter using a fixed range according to one embodiment of the present invention;

[0057] Figure 3B A schematic diagram illustrating the mean distribution of MCV parameters using a floating range according to one embodiment of the present invention;

[0058] Figure 4A A schematic diagram illustrating a distribution of MCHC parameter means using a fixed range according to one embodiment of the present invention;

[0059] Figure 4B A schematic diagram illustrating the distribution of MCHC parameter means using a floating range according to one embodiment of the present invention;

[0060] Figure 5 A schematic flow chart showing a quality control method for a blood cell analyzer according to another embodiment of the present invention;

[0061] Figure 6 A structural block diagram of a blood cell analyzer according to an embodiment of the present invention is shown. DETAILED DESCRIPTION

[0062] In order to make the purpose, technical solutions and advantages of the present application more apparent, the following is a detailed description of example embodiments of the present application with reference to the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application, and it should be understood that the present application is not limited to the example embodiments described herein. Based on the embodiments of the present application described in this application, all other embodiments obtained by those skilled in the art without creative work should fall within the scope of protection of this application.

[0063] In the following description, a large number of specific details are provided to provide a more thorough understanding of the present application. However, it will be apparent to those skilled in the art that the present application can be implemented without one or more of these details. In other examples, some technical features well known in the art are not described in order to avoid confusion with the present application.

[0064] It should be understood that the present application can be implemented in different forms and should not be interpreted as being limited to the embodiments set forth herein. On the contrary, providing these embodiments will make the disclosure thorough and complete and will fully convey the scope of the present application to those skilled in the art.

[0065] The purpose of the terms used herein is only to describe specific embodiments and is not intended to limit the present application. When used herein, the singular forms "a", "an", and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the terms "comprising" and / or "including", when used in this specification, determine the presence of the features, integers, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, parts and / or groups. When used herein, the term "and / or" includes any and all combinations of the relevant listed items.

[0066] In order to fully understand the present application, a detailed structure will be provided in the following description to illustrate the technical solution proposed by the present application. The optional embodiments of the present application are described in detail below. However, in addition to these detailed descriptions, the present application may also have other implementation methods.

[0067] Next, first refer to Figure 1 A quality control method 100 for a blood cell analyzer according to one embodiment of the present application is described. Figure 1 As shown, the quality control method 100 of the blood cell analyzer may include the following steps:

[0068] In step S110, a blood sample is obtained;

[0069] In step S120, a reagent is added to the blood sample for treatment to obtain a treated blood sample;

[0070] In step S130, the processed blood sample is transported to a detection device for detection to obtain measurement results of measurement parameters;

[0071] In step S140, the blood cell analyzer is monitored for abnormality based on the measurement results of the measurement parameters.

[0072] Since the measurement results of blood sample parameters generally fall within a certain range, if the measurement results obtained by a blood cell analyzer exceed the normal range, there is a possibility that the blood cell analyzer is abnormal. Based on this, the quality control method 100 for a blood cell analyzer according to the blood sample measurement results during the blood sample testing process of the present invention monitors the status of the blood cell analyzer based on the blood sample measurement results, ensuring real-time monitoring. Furthermore, the blood cell analyzer can be monitored based on the blood sample measured by the blood cell analyzer, eliminating the need for additional quality control materials and reducing monitoring costs.

[0073] Specifically, in step S110, a blood sample is obtained. The blood sample may be a conventional blood sample analyzed using a blood cell analyzer. Exemplarily, step S110 may be performed by a sampling unit of the blood cell analyzer, specifically, the blood sample may be drawn by a sampling needle.

[0074] In some embodiments, whenever a blood sample is obtained for analysis, the quality control method 100 of the blood cell analyzer according to the present invention is executed. The blood cell analyzer's status is determined based on the blood sample's measurement results, without the need to screen the blood sample. For example, in an ordinary small hospital or medical examination institution, normal blood samples predominate. If the blood cell analyzer is in a normal state, the blood sample's measurement results should be within a fixed range.

[0075] In another embodiment, considering the difference between the measurement results of abnormal blood samples and normal blood samples, the blood samples can be screened to determine qualified blood samples among the blood samples, and the status of the blood cell analyzer can be monitored only based on the measurement results of the qualified blood samples.

[0076] For example, a qualified blood sample can be a blood sample from a predetermined department, which can be a physical examination department or a preventive health care department, or can also be other departments where the probability of abnormal blood samples is low. Alternatively, the blood cell analyzer can also obtain a scatter plot or histogram of blood cells in the current blood sample, such as a scatter plot or histogram of white blood cell differential count (DIFF), and judge whether the blood sample is a qualified blood sample based on the scatter plot or histogram. Among them, the scatter plot or histogram can be directly image analyzed to judge whether the blood sample is a qualified blood sample based on the image analysis results, or quantitative statistical results can be obtained based on the scatter plot or histogram, and the blood sample can be judged whether it is a qualified blood sample based on the quantitative statistical results.

[0077] In step S120 , a reagent is added to the blood sample for treatment to obtain a treated blood sample.

[0078] Exemplarily, step S120 is performed by a reaction unit of a blood cell analyzer. Exemplarily, the reaction unit of the blood cell analyzer includes multiple reaction cells, which provide a reaction site for the blood sample and reagents to react to form a sample solution. Different reagents can be added to the blood sample to produce different sample solutions for different measurement parameters.

[0079] Different types of hematology analyzers require different reagents for blood samples. Specifically, the measurement principles of hematology analyzers are primarily based on electrical impedance and light scattering. For hematology analyzers based on electrical impedance, the reagents added to the blood sample may include diluents or hemolytic agents. For hematology analyzers based on light scattering, the reagents primarily include fluorescent dyes.

[0080] In step S130 , the blood sample treated with the reagent is transported to a detection device for detection to obtain measurement results of the measurement parameters.

[0081] The measurement parameters may be any measurement parameter detectable by a blood cell analyzer, including but not limited to basic parameters such as MCH (mean hemoglobin content), MCHC (mean hemoglobin concentration), and MCV (mean corpuscular volume). They may also include any measurement parameter of a blood cell analyzer, such as white blood cell count, differential white blood cell count, and reticulocyte count. Step S130 may be performed by a detection device of the blood cell analyzer, which may measure a corresponding measurement result for at least one measurement parameter. Subsequently, quality control of the blood cell analyzer may be performed based on the measurement results of some or all of the measurement parameters.

[0082] For example, for a blood cell analyzer based on the light scattering method, the sheath flow principle is mainly used to wrap the blood cell particles in the blood sample in the sheath flow and pass through the orifice of the sheath flow flow chamber one by one. The laser irradiates the blood cell particles in the orifice to generate scattered light, and the corresponding optical signals are captured by setting lens groups in front of and to the side of the orifice. Among them, the scattered light includes three types of light signals: forward scattered light, side scattered light, and fluorescence signal. Generally, forward scattered light can reflect the size information of the cell, side scattered light can reflect the complexity of the internal structure of the cell, and fluorescence signal can reflect the content of substances that can be dyed by fluorescent dyes in the cell. The blood cell analyzer can generate a scatter plot or volume distribution histogram based on the fluorescence intensity information and scattered light intensity information of each cell, and then obtain the counting results of each cell group in the blood sample.

[0083] When measuring the average hemoglobin content, a blood cell analyzer based on the light scattering method can first distinguish the red blood cell particle group in the blood sample based on the scattered light information, count the red blood cell particles in the red blood cell particle group, and determine the hemoglobin content of each red blood cell particle from the scattered light intensity of each red blood cell particle. Finally, the average hemoglobin content of the red blood cell particle group is determined based on the statistically obtained red blood cell particle count value and the hemoglobin content of each red blood cell particle.

[0084] Hematology analyzers based on the electrical impedance method rely on the non-conductivity of blood cells. This principle allows for cell counting and volume determination based on the resistance change caused by blood cell particles suspended in an electrolyte solution passing through a counting aperture. When blood cells of varying sizes pass through the counting aperture, the resistance of the constant current source circuit between the inner and outer electrodes of the aperture increases instantaneously, generating a voltage pulse signal. The number of pulses is proportional to the number of cells, and the amplitude of the pulses is proportional to the volume of the blood cells. This pulse signal can be used to determine information such as the volume and number of the blood cells being measured.

[0085] For example, the measurement principle of hemoglobin concentration by a blood cell analyzer based on the electrical impedance method is as follows: after adding a hemolytic agent to a diluted blood sample, the red blood cells are lysed, releasing hemoglobin, which then combines with relevant components in the hemolytic agent to form a hemoglobin derivative, which enters the hemoglobin testing system and is colorimetrically compared at a specific wavelength. The change in absorbance is proportional to the hemoglobin content in the solution, thereby measuring the hemoglobin concentration in the blood sample.

[0086] It should be noted that the blood cell measurement principle described above is only an example. The quality control method 100 of the blood cell analyzer in the embodiment of the present application can be applied to various blood cell analyzers. The present application does not limit the specific measurement method of the blood cell analyzer.

[0087] In step S140, the blood cell analyzer is monitored for abnormalities based on the measurement results of the measurement parameters. When it is determined that the blood cell analyzer has an abnormality, the output of the measurement results can be paused and an alarm prompt message can be generated to prompt the user to confirm the instrument status.

[0088] In one embodiment, since the measurement results of the measurement parameters of the blood sample are generally distributed within a certain range, if the measurement results of the measurement parameters of the current blood sample exceed the preset range, it is considered that there is an abnormality in the blood cell analyzer.

[0089] In other embodiments, in order to eliminate the influence caused by abnormal blood samples, the status of the blood cell analyzer can be monitored based on the statistical values ​​of the measurement results of multiple blood samples. Specifically, the statistical values ​​of the measurement results of the current blood sample and the first number of blood samples before the current blood sample are calculated, and it is determined whether the statistical values ​​are within a preset range. If the statistical value is within the preset range, it is considered that the blood cell analyzer is in normal working condition; if the statistical value is not within the preset range, it is considered that the blood cell analyzer is abnormal. In this way, misjudgment caused by abnormal blood samples themselves can be avoided. The statistical value is, for example, the average value, median value, quartile value, sum of multiple measurement results, or other statistical results of multiple measurement results.

[0090] For example, assuming that the current blood sample is the i-th blood sample and the first quantity is recorded as N, the average value of the measurement results of a certain measurement parameter of the i-N+1-th blood sample to the current i-th blood sample can be calculated and recorded as Mean(i). If Mean(i) is not within the preset range, the blood cell analyzer may have an abnormality, and an alarm can be given at this time.

[0091] The first number N may be a fixed value or a user-settable value. Alternatively, statistics may be performed in units of time periods, i.e., the number of blood samples obtained within a preset time period before the current blood sample is obtained is used as the first number. The preset time period may be a fixed value or a user-settable value. For example, the preset time period may be one or more days. Assuming that the preset time period is one day, the statistical value of the measurement results obtained by the blood cell analyzer on the blood samples within one day before the current moment may be calculated, and the statistical value may be used to determine whether the blood cell analyzer has an abnormality.

[0092] In one embodiment, the preset range used for comparison with the statistical value of the measurement result is a fixed range, that is, the preset threshold used for comparison with the statistical value of the measurement result is a fixed threshold. For example, for the three basic measurement parameters MCH, MCHC, and MCV, the mean value of the MCH parameter measurement results obtained from different blood samples measured over different time periods is within the range of 30.5±0.5pg, the mean value of the MCV parameter measurement results is within the range of 89.5±1.5fL, and the mean value of the MCHC parameter measurement results is within the range of 340±5.0g / L. If the mean values ​​of the measurement results of the above three parameters measured by the hematology analyzer exceed the above ranges, it can be considered that the hematology analyzer has an abnormality.

[0093] See also Figure 2A 、 Figure 3A and Figure 4A, which respectively shows the mean distribution information of MCH, MCV and MCHC when the preset range is a fixed range. Figure 2A In the example, the mean value of the measurement results of MCH is always greater than the fixed lower limit of the measurement result mean value and less than the fixed upper limit of the measurement result mean value. Therefore, it can be considered that Figure 2A During the monitoring process shown, there is no abnormality in the blood cell analyzer for the MCH measurement parameters. Figure 3A In the case where the mean values ​​of the MCV measurement results of three blood samples are lower than the fixed lower limit of the mean value of the measurement results, it can be considered that the blood cell analyzer has an abnormality when measuring the MCV parameters of these three blood samples. Figure 4A If the mean values ​​of the MCHC measurement results of three blood samples are higher than the fixed lower limit of the mean value of the measurement results, it can be considered that the blood cell analyzer has an abnormality when measuring the MCHC parameters of the three blood samples.

[0094] In another embodiment, taking into account the impact of changes in external conditions such as current environmental factors on the measurement results of the blood cell analyzer, the preset range can be a floating range, that is, the preset threshold used for comparison with the statistical value of the measurement result is a floating threshold. Exemplarily, when the preset range is a floating range, determining the floating range threshold for the current blood sample includes: obtaining a statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence; determining an upper limit value and a lower limit value of the statistical value sequence, and determining the upper limit value and the lower limit value as the floating range threshold.

[0095] The upper limit and lower limit of the statistical value sequence may be the maximum and minimum values ​​in the statistical value sequence; alternatively, the upper limit and lower limit of the statistical value sequence may be calculated using other computational methods. For example, the upper limit and lower limit of the statistical value sequence may be calculated based on the mean and standard deviation of each statistical value in the statistical value sequence. Practice has shown that when the difference between the mean and twice the standard deviation and the sum of the mean and twice the standard deviation of the statistical value sequence are used as the upper limit and lower limit of the statistical value sequence, respectively, a relatively accurate judgment result can be obtained.

[0096] Specifically, assuming that the current blood sample is the i-th blood sample, for the iM blood samples before the current i-th blood sample, the statistical value Mean(j) of the measurement result calculated when each of the blood samples is used as the current blood sample is obtained, j = iM, ..., i-1, to form a statistical value sequence. Exemplarily, M is not less than 20. Calculate the upper limit Mean(j) of the statistical value sequence Mean(iM), Mean(i-M+1), ..., Mean(i-1) max and lower bound Mean(j) min, as the threshold of the floating range, and judge whether Mean(i) is within Mean(j) max and Mean(j) min If Mean(i)>Mean(j) max or Mean(i)≤

[0097] Mean(j) min , it is considered that there is an abnormality in the blood cell analyzer and an alarm prompt is given.

[0098] See also Figure 2B 、 Figure 3B and Figure 4B , which respectively shows the mean distribution information of MCH, MCV and MCHC when the preset range is a floating range. Figure 2B In the example, the mean value of the measurement results of MCH is always greater than the lower limit of the floating measurement results and less than the upper limit of the floating measurement results. Therefore, it can be considered that Figure 2B During the monitoring process shown, there is no abnormality in the blood cell analyzer for the MCH measurement parameters. Figure 3B In the case where the mean values ​​of the MCV measurement results of three blood samples are lower than the lower limit of the floating measurement result mean value, it can be considered that the blood cell analyzer has an abnormality when measuring the MCV parameters of these three blood samples. Figure 4B In the example, if the mean of the MCHC measurement results of three blood samples is higher than the lower limit of the floating measurement result mean, it can be considered that the blood cell analyzer has an abnormality when measuring the MCHC parameters of these three blood samples. Figure 2B 、 Figure 3B and Figure 4B and Figure 2A 、 Figure 3A and Figure 4A It can be seen that when an appropriate fixed threshold or floating threshold is selected, both the fixed range and the floating range can more accurately monitor the abnormal state of the blood cell analyzer.

[0099] Based on the above description, the quality control method for a blood cell analyzer according to an embodiment of the present application uses blood samples to monitor the status of the blood cell analyzer in real time without using additional quality control materials, thereby reducing monitoring costs.

[0100] Below, reference Figure 5 A quality control method 500 for a blood cell analyzer according to one embodiment of the present application is described. Figure 5 As shown, the quality control method 500 of a blood cell analyzer may include the following steps:

[0101] In step S510, the sampling unit obtains a blood sample;

[0102] In step S520, the reaction unit adds a reagent to the blood sample for processing to obtain a processed blood sample;

[0103] In step S530, the detection device transmits the processed blood sample to the detection device for detection to obtain the measurement result of the measurement parameter;

[0104] In step S540, the control device monitors whether the blood cell analyzer has any abnormality according to the measurement results of the measurement parameters.

[0105] The quality control method 500 for a blood cell analyzer is generally similar to the quality control method 100 for a blood cell analyzer described above, with the difference being that the specific execution components of each step are defined, i.e., steps S510 to S540 are respectively executed by the sampling unit, reaction unit, detection device, and control unit of the blood cell analyzer, without the need for manual execution by the user; the functions of the above components can be found in the relevant description of the blood cell analyzer 600 below. For example, steps S510 to S530 can be executed by the sampling unit, reaction unit, and detection device controlled by the control device of the blood cell analyzer, i.e., the control device automatically performs quality control on the blood cell analyzer throughout the entire process without the need for human intervention, thereby improving the user experience. Other specific details of the quality control method 500 for a blood cell analyzer can be found in the relevant description above and will not be elaborated on here.

[0106] Reference Figure 6 , an embodiment of the present invention further provides a blood cell analyzer 600, which includes a sampling unit 610, a reaction unit 620, a detection device 630, and a control device 640. The sampling unit 610 is used to obtain a blood sample; the reaction unit 620 is used to add a reagent to the blood sample for processing to obtain a processed blood sample; the detection device 630 is used to detect the processed blood sample to obtain a measurement result of a measurement parameter; and the control device 640 is used to monitor whether the blood cell analyzer has any abnormalities based on the measurement result of the measurement parameter. The blood cell analyzer 600 can be used to implement the quality control method 100 or the quality control method 500 for a blood cell analyzer. The following only describes the main functions of the blood cell analyzer 600, and omits the details described above.

[0107] For example, the sampling unit 610 includes a sampling needle for drawing a blood sample and distributing the blood sample to the reaction unit 620. The sampling needle can be fixed on a transmission mechanism, and the control device 640 controls the transmission mechanism to drive the sampling needle to a specified position.

[0108] Exemplarily, the reaction section 620 includes a reaction pool and a reagent supply component. The reagent supply component is used to provide reagents, and the reaction pool is used to provide a reaction site. This allows the blood sample distributed by the sampling unit 610 to the reaction section 620 and the reagents provided by the reagent supply component to react in the reaction pool to obtain a blood sample to be tested. The reaction section 620 may also include piping and drive components (such as a syringe, air pump, etc.) to allow blood cells in the blood sample to be tested to flow through the detection device 630 one by one.

[0109] Exemplarily, the detection device 630 may include a detection module and an analysis module, wherein the detection module is used to detect the blood sample to obtain optical information or electrical impedance information, and the analysis module is used to obtain measurement results of various measurement parameters based on the optical information or electrical impedance information.

[0110] Taking a learning cell analyzer based on light scattering as an example, the detection module may include an optical detection system for irradiating blood cells in a blood sample to be tested as they flow through a flow chamber and collecting optical information generated by the blood cells due to the irradiation. Exemplarily, the optical detection system may include a laser, a front-light processing component, a flow chamber, and a scattered light detector. The flow chamber is configured to allow blood cells in the blood sample to flow in a predetermined direction; the laser is configured to emit a laser beam toward the flow chamber; the front-light processing component is disposed between the laser and the flow chamber along the direction of emission of the laser beam and is configured to focus the laser beam emitted by the laser onto the flow chamber, thereby causing the blood cells flowing in the flow chamber to generate scattered light. The front-light processing component may include a focusing component and a pinhole aperture, etc. The scattered light detector is configured to detect scattered light information. The analysis module obtains measurement results based on the scattered light information.

[0111] The control device 640 is used to monitor whether the blood cell analyzer has any abnormality based on the measurement results.

[0112] In one embodiment, the control device 640 calculates a statistical value of the measurement results of the current blood sample and a first number of blood samples before the current blood sample; determines whether the statistical value is within a preset range, and if the statistical value is not within the preset range, determines that there is an abnormality in the blood cell analyzer.

[0113] Exemplarily, the first number may be a fixed value or a settable value, or the first number may be the number of blood samples acquired within a preset time period before the current blood sample is acquired.

[0114] Exemplarily, the preset range is a fixed range or a floating range. When the preset range is a floating range, the control device 640 is further configured to: obtain statistical values ​​calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence; determine an upper limit value and a lower limit value of the statistical value sequence, and determine the upper limit value and the lower limit value as floating threshold values ​​of the floating range.

[0115] The upper limit value and the lower limit value may be the maximum value and the minimum value in the statistical value sequence, or the upper limit value and the lower limit value may be calculated based on the mean value and the standard deviation of the statistical value sequence.

[0116] In one embodiment, the control device 640 is further configured to screen the blood samples to identify qualified blood samples; the control device 640 monitors the blood cell analyzer for abnormalities based on the blood cell count results of the qualified blood samples. Qualified blood samples include blood samples from predetermined departments, such as physical examination departments or preventive health care departments.

[0117] Alternatively, the control device 640 may also screen the qualified blood sample in the following manner: obtaining a scattergram or a histogram of blood cells in the blood sample; and determining whether the blood sample is the qualified blood sample based on the scattergram or the histogram.

[0118] As an example, the control device 640 includes at least a processing component, RAM, ROM, a communication interface, a memory, and an I / O interface. The processing component, RAM, ROM, communication interface, memory, and I / O interface communicate via a bus. The processing component can be a CPU, GPU, or other chip with computing capabilities. The memory contains various computer programs, such as an operating system and application programs, for execution by the processing component, as well as the data required to execute these computer programs. Furthermore, during the blood sample analysis process, any data that requires local storage can be stored in the memory. The I / O interface comprises a serial interface such as USB, IEEE 1394, or RS-232C, a parallel interface such as SCSI, IDE, or IEEE 1284, and an analog signal interface comprising a D / A converter and an A / D converter. The I / O interface is connected to an input device such as a keyboard, mouse, touch screen, or other control buttons, allowing the user to directly input data into the control device. Furthermore, the I / O interface can also be connected to an output unit with a display function, such as an LCD screen, touch screen, or LED display. The control device can output processed data as graphical display data to an output unit for display, such as analytical data and instrument operating parameters. The communication interface can be an interface that uses any currently known communication protocol. The communication interface communicates with the outside world via a network. The control device can transmit data between any device connected to the network using a specific communication protocol via the communication interface.

[0119] Based on the above description, the quality control method and blood cell analyzer of the embodiments of the present invention use blood samples to monitor the status of the blood cell analyzer in real time without using additional quality control materials, thereby reducing monitoring costs.

[0120] Although example embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above example embodiments are merely illustrative and are not intended to limit the scope of the present application. Various changes and modifications may be made therein by those skilled in the art without departing from the scope and spirit of the present application. All such changes and modifications are intended to be included within the scope of the present application as required by the appended claims.

[0121] Those skilled in the art will appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0122] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For example, the division of the units described is merely a logical function division. In actual implementation, other division methods may be used, such as combining or integrating multiple units or components into another device, or ignoring or not performing some features.

[0123] In the description provided herein, a large number of specific details are described. However, it is understood that the embodiments of the present application can be practiced without these specific details. In some instances, well-known methods, structures, and techniques are not shown in detail so as not to obscure the understanding of this description.

[0124] Similarly, it should be understood that in order to streamline the present application and aid in understanding one or more of the various inventive aspects, in the description of the exemplary embodiments of the present application, the various features of the present application are sometimes grouped together into a single embodiment, figure, or description thereof. However, this approach of the present application should not be interpreted as reflecting the intention that the application claimed for protection requires more features than those explicitly recited in each claim. More precisely, as reflected in the corresponding claims, the inventive point is that the corresponding technical problem can be solved with fewer features than all the features of a single disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into the detailed description, with each claim itself serving as a separate embodiment of the present application.

[0125] It will be understood by those skilled in the art that, except where mutually exclusive, all features disclosed in this specification (including the accompanying claims, abstract, and drawings) and all processes or units of any method or apparatus disclosed herein may be combined in any combination. Unless expressly stated otherwise, each feature disclosed in this specification (including the accompanying claims, abstract, and drawings) may be replaced by an alternative feature providing the same, equivalent, or similar purpose.

[0126] Furthermore, those skilled in the art will appreciate that although some embodiments described herein include certain features included in other embodiments but not other features, combinations of features from different embodiments are intended to be within the scope of this application and to form different embodiments. For example, in the claims, any of the claimed embodiments may be used in any combination.

[0127] The various component embodiments of the present application can be implemented in hardware, or in software modules running on one or more processors, or in a combination thereof. It should be understood by those skilled in the art that a microprocessor or digital signal processor (DSP) can be used in practice to implement some or all of the functions of some modules in the article analysis device according to the embodiment of the present application. The application can also be implemented as a device program (e.g., computer program and computer program product) for executing a part or all of the methods described herein. Such a program implementing the present application can be stored on a computer-readable medium, or can have the form of one or more signals. Such a signal can be downloaded from an Internet website, or provided on a carrier signal, or provided in any other form.

[0128] It should be noted that the above embodiments illustrate rather than limit the present application, and that a person skilled in the art may devise alternative embodiments without departing from the scope of the appended claims. In the claims, any reference symbols placed between brackets should not be construed as limiting the claims. The word "comprising" does not exclude the presence of elements or steps not listed in the claims. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. The present application may be implemented by means of hardware comprising several different elements and by means of appropriately programmed computers. In a unit claim enumerating several means, several of these means may be embodied by the same item of hardware. The use of the words first, second, and third etc. does not indicate any order. These words may be interpreted as names.

[0129] The above description is merely a specific embodiment or illustration of a specific embodiment of the present application, and the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. The scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. A quality control method for a blood cell analyzer, characterized in that: The method comprises: Obtaining a blood sample; adding a reagent to the blood sample for treatment to obtain a treated blood sample; transporting the processed blood sample to a detection device for detection to obtain measurement results of measurement parameters; monitoring whether the blood cell analyzer has abnormalities according to the measurement results of the measurement parameters; The step of monitoring whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter includes: calculating a statistical value of the measurement results of a current blood sample and a first number of blood samples before the current blood sample; Determining whether the statistical value is within a preset range, and if the statistical value is not within the preset range, determining that an abnormality exists in the blood cell analyzer; The preset range is a floating range, and determining the floating range threshold for the current blood sample includes: obtaining the statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence; An upper limit value and a lower limit value of the statistical value sequence are determined, and the upper limit value and the lower limit value are determined as the floating range threshold value.

2. The method according to claim 1, characterized in that The first number is a fixed value or a settable value, or the first number is the number of blood samples obtained within a preset time period before obtaining the current blood sample.

3. The method according to claim 1, characterized in that The upper limit value and the lower limit value are respectively the maximum value and the minimum value in the statistical value sequence, or the upper limit value and the lower limit value are calculated based on the mean value and the standard deviation of the statistical value sequence.

4. The method according to claim 1, wherein Also included is screening the blood sample to determine a qualified blood sample among the blood samples; The monitoring of whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter is performed according to the measurement result of the qualified blood sample.

5. The method according to claim 4, characterized in that The qualified blood sample includes a blood sample from a predetermined department, and the predetermined department includes a physical examination department or a preventive health care department.

6. The method according to claim 4, characterized in that The screening of the blood sample comprises: obtaining a scattergram or a histogram of blood cells in the blood sample; Determine whether the blood sample is the qualified blood sample according to the scattergram or the histogram.

7. A quality control method for a blood cell analyzer, characterized in that: The method comprises: The sampling department obtains blood samples; The reaction unit adds a reagent to the blood sample for treatment to obtain a treated blood sample; The detection device detects the processed blood sample to obtain measurement results of measurement parameters; The control device monitors whether the blood cell analyzer has any abnormality according to the measurement results of the measurement parameters; The step of monitoring whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter includes: calculating a statistical value of the measurement results of a current blood sample and a first number of blood samples before the current blood sample; Determining whether the statistical value is within a preset range, and if the statistical value is not within the preset range, determining that an abnormality exists in the blood cell analyzer; The preset range is a floating range, and determining the floating range threshold for the current blood sample includes: obtaining the statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence; An upper limit value and a lower limit value of the statistical value sequence are determined, and the upper limit value and the lower limit value are determined as the floating range threshold value.

8. A blood cell analyzer, characterized in that: The blood cell analyzer comprises: a sampling unit for obtaining a blood sample; a reaction part, used for adding a reagent to the blood sample for treatment to obtain a treated blood sample; a detection device, used to detect the processed blood sample to obtain measurement results of measurement parameters; a control device, configured to monitor whether the blood cell analyzer has any abnormality according to the measurement results of the measurement parameters; The step of monitoring whether the blood cell analyzer has an abnormality according to the measurement result of the measurement parameter includes: calculating a statistical value of the measurement results of a current blood sample and a first number of blood samples before the current blood sample; Determining whether the statistical value is within a preset range, and if the statistical value is not within the preset range, determining that an abnormality exists in the blood cell analyzer; The preset range is a floating range, and determining the floating range threshold for the current blood sample includes: obtaining the statistical value calculated for each blood sample in a second number of blood samples before the current blood sample to form a statistical value sequence; An upper limit value and a lower limit value of the statistical value sequence are determined, and the upper limit value and the lower limit value are determined as the floating range threshold value.

9. The blood cell analyzer according to claim 8, characterized in that: The first number is a fixed value or a settable value, or the first number is the number of blood samples obtained within a preset time period before obtaining the current blood sample.

10. The blood cell analyzer according to claim 8, characterized in that: The upper limit value and the lower limit value are respectively the maximum value and the minimum value in the statistical value sequence, or the upper limit value and the lower limit value are calculated based on the mean value and the standard deviation of the statistical value sequence.

11. The blood cell analyzer according to claim 8, characterized in that: The control device is further configured to screen the blood samples to determine qualified blood samples among the blood samples; The control device monitors whether there is an abnormality in the blood cell analyzer according to the counting result of the blood cells in the qualified blood sample.

12. The blood cell analyzer according to claim 11, characterized in that: The qualified blood sample includes a blood sample from a predetermined department, and the predetermined department includes a physical examination department or a preventive health care department.

13. The blood cell analyzer according to claim 11, characterized in that: The screening of the blood sample comprises: obtaining a scattergram or a histogram of blood cells in the blood sample; Determine whether the blood sample is the qualified blood sample according to the scattergram or the histogram.

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