Method and system for detecting hemolysis effect of hematology analyzer

Abstract

The invention discloses a method and system for detecting the hemolysis effect of a hematology analyzer, and relates to the technical field of hemolysis effect detection.The method comprises the steps that a whole blood sample is obtained and pretreated, and a solution to be detected is obtained; detecting the solution to be detected by using a counting method to obtain a first detection result; detecting the solution to be detected by using a light absorption method to obtain a second detection result; comprehensive analysis is carried out based on the first detection result and the second detection result, a hemolysis effect detection result is obtained, and detection of the hemolysis effect of the hematology analyzer is achieved. By comprehensively analyzing the detection results of a counting method and a light absorption method, the risk of misjudgment of a single method is reduced to the maximum extent, the stability and credibility of overall detection are improved, misjudgment and missing detection are effectively avoided through double detection and recheck judgment, and the detection accuracy is improved. And the reliability of the hematology analyzer in a clinical or experimental environment is further enhanced.

Description

Technical Field

[0001] The present invention relates to the technical field of hemolytic effect detection, in particular to a method and system for detecting the hemolytic effect of a blood cell analyzer. Background Art

[0002] With the development of medical technology, the application of blood cell analyzers has become an indispensable and important tool in clinical diagnosis; blood cell analyzers can quickly and accurately count and classify red blood cells, white blood cells and platelets in the blood, greatly improving the efficiency and accuracy of laboratory diagnosis. Especially in the counting and classification of white blood cells, blood cell analyzers can accurately distinguish white blood cells from other blood cells through a variety of methods, such as impedance method and laser scattering method; however, in the process of white blood cell counting and classification, the lysis of red blood cells is an important link that cannot be ignored; in order to avoid the interference of red blood cells on the results of white blood cell analysis, the blood cell analyzer can accurately distinguish white blood cells from other blood cells. In order to prevent the red blood cells from being disturbed, it is usually necessary to use a hemolytic agent to process the white blood cells so that they can be separated from the red blood cells. In traditional blood cell analyzers, this process mainly includes mixing the whole blood sample with a diluent, then adding a hemolytic agent to dissolve the red blood cells physically or chemically, and counting and classifying the white blood cells through an optical system and laser technology. The selection and use of hemolytic agents are crucial to the accuracy and stability of the blood cell analyzer. Common hemolytic agents such as DIFF hemolytic agent and LH hemolytic agent can not only pierce and destroy the cell membrane of red blood cells, but also process the morphology of white blood cells for subsequent accurate classification and counting.

[0003] Although the existing blood cell analyzers have made significant progress in blood cell counting and classification, there are still shortcomings in the hemolysis process. First, the hemolysis process is greatly affected by the ambient temperature. Whether the ambient temperature is too high or too low, it may lead to reduced or unstable hemolysis efficiency, resulting in inaccurate white blood cell counting and classification results. Secondly, the quality difference of the hemolytic agent is also an important factor affecting the hemolysis effect. Hemolytic agents from different batches or sources may have inconsistent formulations, resulting in unstable hemolysis effects. In addition, the quality of the sample itself, such as the presence of difficult-to-dissolve red blood cells, may also lead to incomplete hemolysis, further increasing the incidence of errors. Finally, since the hemolytic agent cannot completely dissolve red blood cells, the blood cell analyzer may mistakenly misjudge incompletely dissolved red blood cell fragments as white blood cells, resulting in false leukocytosis or inaccurate classification. Therefore, there is an urgent need for a new technical solution that can effectively overcome the hemolysis efficiency problem in the existing technology and improve the accuracy and stability of the blood cell analyzer. Summary of the invention

[0004] In view of the above-mentioned problems, the present invention is proposed.

[0005] Therefore, the problem to be solved by the present invention is how to provide a method for detecting the hemolytic effect of a blood cell analyzer, by combining the counting method with the light absorption method to comprehensively analyze the hemolytic state of a blood sample, and by utilizing multi-step and multi-method detection and analysis to achieve the effect of improving the accuracy, stability and safety of hemolysis detection.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions: In a first aspect, an embodiment of the present invention provides a method for detecting the hemolytic effect of a blood cell analyzer, which includes obtaining a whole blood sample and performing pretreatment to obtain a solution to be tested; detecting the solution to be tested by a counting method to obtain a first detection result; detecting the solution to be tested by a light absorption method to obtain a second detection result; performing a comprehensive analysis based on the first detection result and the second detection result to obtain a hemolytic effect detection result, thereby realizing the detection of the hemolytic effect of the blood cell analyzer.

[0007] As a preferred embodiment of the method for detecting the hemolytic effect of a blood cell analyzer according to the present invention, the obtaining of a whole blood sample and pretreatment thereof include the following steps: mixing the whole blood sample with a diluent and mixing them thoroughly to obtain a preliminary mixed solution; adding a hemolytic agent to the preliminary mixed solution and mixing them thoroughly again to obtain a solution to be tested.

[0008] As a preferred solution of the method for detecting the hemolytic effect of the blood cell analyzer of the present invention, the method of detecting the solution to be tested by counting method includes the following steps: using negative pressure to attract the solution to be tested to pass through the gemstone hole or using a syringe to send the solution to be tested into an optical system containing a laser light source; identifying the number of white blood cells passing through the gemstone hole or the laser light source irradiation area per second and counting for M seconds to obtain the count values ​​C1, C2, ..., CM per second within M seconds; using the count values ​​C1, C2, ..., CM as the ordinate and the time T serial number 1, 2, ..., M as the abscissa, using the least squares method to perform linear fitting to obtain the linear function of white blood cell count, the specific formula is as follows: ,in, For the The number of white blood cells passing through the detection area at that time; is the trend of white blood cell count over time; is the time serial number; is the predicted number of white blood cells before counting begins; a first test result is obtained by making a judgment based on the linear function of the white blood cell count.

[0009] As a preferred embodiment of the method for detecting the hemolytic effect of a blood cell analyzer according to the present invention, the first detection result is obtained by judging based on the linear function of the white blood cell count, and the following steps are included: based on the linear function of the white blood cell count, the slopes corresponding to the count values ​​C1, C2, ..., CM are calculated respectively. The absolute value of , if the slope corresponding to the count values ​​C1, C2, ..., CM The absolute value of If all of them are less than or equal to the threshold value Th1, the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis; if there are slopes corresponding to the count values ​​C1, C2, ..., CM The absolute value of If the value is greater than the threshold value Th1, it indicates that hemolysis is still in progress and the red blood cells are not completely lysed. The hemolysis effect of the blood cell analyzer is determined to be abnormal, and an alarm is sent to the operator through the software to execute the next step; when the hemolysis effect of the blood cell analyzer is determined to be abnormal, the initial and final white blood cell count ratio C1 / CM is calculated based on the count values ​​C1, C2, ..., CM. If the initial and final white blood cell count ratio C1 / CM is less than or equal to the threshold value Th2, it is determined that the test result is abnormal, and the slope corresponding to the count values ​​C1, C2, ..., CM is calculated again. The absolute value of Step; if the ratio of the initial and final white blood cell counts C1 / CM is greater than the threshold value Th2, it means that the red blood cells have not been completely lysed during the counting, and the hemolysis effect of the blood cell analyzer is determined to be abnormal hemolysis, and an alarm prompt is sent to the operator through the software and the next step is executed; based on the count values ​​C1, C2, ..., CM, the coefficient of variation CV is calculated. If the coefficient of variation CV is greater than the threshold value Th3, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, and the hemolysis effect of the blood cell analyzer is abnormal hemolysis, and an alarm prompt is sent to the operator through the software.

[0010] As a preferred embodiment of the method for detecting the hemolytic effect of a blood cell analyzer according to the present invention, the method comprises the following steps: using the light absorption method to detect the solution to be tested, measuring the hemoglobin concentration HGB receiving voltage of the solution to be tested for N seconds by the light absorption method, and obtaining light intensity voltage values ​​G1, G2, ..., GN; using the light intensity voltage values ​​G1, G2, ..., GN as the ordinate and the time as the ordinate. The serial numbers 1, 2, ..., N are the horizontal coordinates. The linear function of light absorption intensity is obtained by linear fitting using the least square method. The specific formula is as follows: ,in, is the light intensity voltage value received by the photoelectric receiving device at time T; is the trend of light intensity changing with time; is the time serial number; is a correction factor; a judgment is made based on the light absorption intensity linear function to obtain a second detection result.

[0011] As a preferred embodiment of the method for detecting the hemolytic effect of a blood cell analyzer according to the present invention, the second detection result is obtained by judging based on the linear function of light absorption intensity, and the following steps are included: based on the linear function of light absorption intensity, the slopes corresponding to the light intensity voltage values ​​G1, G2, ..., GN are calculated respectively. The absolute value of , if the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of The slope corresponding to the light intensity voltage value G1, G2, ..., GN is less than or equal to the threshold Th4 are equal, then the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis; if the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of If the value is greater than the threshold value Th4, it is determined that hemolysis is abnormal, and an alarm is sent to the operator through the software and the next step is executed; when it is determined that hemolysis is abnormal, the final light absorption intensity ratio GN / G1 to the initial light absorption intensity is calculated based on the light intensity voltage values ​​G1, G2, ..., GN. If the final light absorption intensity ratio GN / G1 to the initial light absorption intensity is less than or equal to the threshold value Th5, the test result is determined to be abnormal, and the slope corresponding to the light intensity voltage values ​​G1, G2, ..., GN is calculated again. The absolute value of Step; if the final light absorption intensity ratio GN / G1 is greater than the threshold value Th5, it indicates that the red blood cells have not been completely lysed during the measurement, and the hemolysis effect of the blood cell analyzer is determined to be abnormal hemolysis, and an alarm is sent to the operator through the software and the next step is executed; based on the light intensity voltage values ​​G1, G2, ..., GN, the coefficient of variation is calculated. , if the coefficient of variation If it is greater than the threshold value Th6, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, the hemolysis effect of the blood cell analyzer is abnormal, and an alarm prompt is sent to the operator through the software.

[0012] As a preferred embodiment of the method for detecting the hemolytic effect of a blood cell analyzer according to the present invention, the comprehensive analysis based on the first detection result and the second detection result comprises the following steps: respectively obtaining the first detection result and the second detection result of the same test solution in the same time period and making a judgment, if the first detection result and the second detection result are both normal hemolysis, it indicates that the hemolytic effect of the blood cell analyzer is normal, and there is no need to send an alarm prompt to the operator; if the first detection result and the second detection result are both abnormal hemolysis, the hemolytic effect of the blood cell analyzer is determined to be abnormal hemolysis, and a first-level alarm prompt is directly sent to notify the operator to perform maintenance; if the first detection result is normal hemolysis and the second detection result is abnormal hemolysis, or the first detection result is abnormal hemolysis and the second detection result is normal hemolysis, the specific situation of the hemolytic effect of the blood cell analyzer cannot be determined, the first detection result step and the second detection result step are re-executed and judged, if the first detection result and the second detection result are the same, the corresponding processing operation is performed; if the first detection result and the second detection result remain unchanged for Q consecutive times, it is determined that there is an abnormality, a second-level alarm prompt is sent, and the operator is notified to check the blood cell analyzer to find the cause of the abnormality.

[0013] In the second aspect, in order to further solve the safety problems existing in the hemolytic effect detection, the embodiment of the present invention provides a system for detecting the hemolytic effect of a blood cell analyzer, which includes: a sample acquisition module, used to obtain a whole blood sample, and mix it with a diluent and a hemolytic agent to obtain a solution to be tested; a counting detection module, used to detect the count value in the solution to be tested using a counting method, and obtain a first detection result; a light absorption detection module, used to detect the light intensity voltage value in the solution to be tested using a light absorption method, and obtain a second detection result; a hemolytic effect module, used to perform a comprehensive analysis based on the first detection result and the second detection result to obtain a hemolytic effect detection result.

[0014] In a third aspect, an embodiment of the present invention provides a computer device, comprising a memory and a processor, wherein the memory stores a computer program, wherein: when the computer program is executed by the processor, any step of the method for detecting the hemolytic effect of a blood cell analyzer as described in the first aspect of the present invention is implemented.

[0015] In a fourth aspect, an embodiment of the present invention provides a computer-readable storage medium having a computer program stored thereon, wherein: when the computer program is executed by a processor, any step of the method for detecting the hemolytic effect of a blood cell analyzer as described in the first aspect of the present invention is implemented.

[0016] Beneficial effects of the present invention: The present invention obtains a whole blood sample and mixes it with a diluent, adds a hemolytic agent and mixes it to obtain a test solution, thereby ensuring the stability of the sample, reducing errors caused by improper operation or sample unevenness, and ensuring the accuracy of hemolysis effect detection; through precise counting and linear fitting analysis, the hemolysis process is quantified, so as to identify hemolysis abnormalities in advance, improve the accuracy of hemolysis effect detection, and avoid possible manual judgment errors in traditional methods; by using the light absorption method to monitor the changes in hemoglobin concentration in the blood, it is further verified whether the blood cells are fully lysed, thereby providing a test result complementary to the counting method; by comprehensively analyzing the test results of the counting method and the light absorption method, the risk of misjudgment of a single method is minimized, and the stability and credibility of the overall test are improved. Double detection and re-verification judgment effectively avoid erroneous judgments and missed detections, further enhancing the reliability of the blood cell analyzer in clinical or experimental environments. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. Among them: Figure 1 This is an overall flow chart of the method for detecting the hemolytic effect of a blood cell analyzer in Example 1; Figure 2 It is a detection flow chart of the counting method in Example 1; Figure 3 This is a flow chart of the detection of the light absorption method in Example 1; Figure 4 This is a flow chart of the hemolytic effect detection results in Example 1. DETAILED DESCRIPTION

[0018] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below in conjunction with the accompanying drawings.

[0019] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein, and those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0020] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The term "in one embodiment" that appears in different places in this specification does not necessarily refer to the same embodiment, nor does it refer to a separate or selective embodiment that is mutually exclusive with other embodiments. Example 1

[0021] Reference Figure 1~Figure 4 , which is the first embodiment of the present invention, provides a method for detecting the hemolytic effect of a blood cell analyzer.

[0022] The existing hemolysis methods of blood cell analyzers have the following main problems: first, the hemolysis process is greatly affected by the ambient temperature. Whether the ambient temperature is too high or too low, it may lead to reduced or unstable hemolysis efficiency, resulting in inaccurate white blood cell count and classification results; second, the quality difference of hemolytic agents is also an important factor affecting the hemolysis effect. Hemolytic agents from different batches or sources may have inconsistent formulations, resulting in unstable hemolysis effects; in addition, the quality of the sample itself, such as the presence of difficult-to-dissolve red blood cells, may also lead to incomplete hemolysis, further increasing the incidence of errors; finally, since the hemolytic agent cannot completely dissolve red blood cells, the blood cell analyzer may mistakenly misjudge incompletely dissolved red blood cell fragments as white blood cells, resulting in false leukocytosis or inaccurate classification.

[0023] The present application provides a method that can effectively solve the above-mentioned problems. Next, a method for detecting the hemolytic effect of a blood cell analyzer will be described in detail in combination with multiple embodiments.

[0024] Figure 1 The overall flow chart of the method for detecting the hemolytic effect of a blood cell analyzer is shown, including: S1: Obtain a whole blood sample and perform pretreatment to obtain a test solution.

[0025] Preferably, obtaining a whole blood sample and pre-treating it comprises the following steps: mixing a quantitative whole blood sample with a quantitative diluent and mixing them thoroughly to obtain a preliminary mixed solution.

[0026] A predetermined amount of hemolytic agent is added to the preliminary mixed solution, and the mixture is fully mixed again to start the red blood cell lysis process to obtain a test solution, wherein the test solution is a solution of white blood cells to be counted and identified.

[0027] S2: Detect the solution to be tested by using a counting method to obtain a first detection result.

[0028] Preferably, Figure 2The figure shows a detection flow chart of the counting method. The detection of the solution to be tested by the counting method includes the following steps: using negative pressure to attract the solution to be tested through the small hole of the gemstone or using a syringe to send the solution to be tested into an optical system containing a laser light source.

[0029] In the process of counting and identifying white blood cells, the number of white blood cells passing through the gemstone holes or the laser light source irradiation area per second is identified and counted for M seconds to obtain the count values ​​C1, C2, ..., CM per second within M seconds.

[0030] With the count values ​​C1, C2, ..., CM as the ordinate and the time T sequence 1, 2, ..., M as the abscissa, the least square method is used for linear fitting to obtain the linear function of the white blood cell count. The specific formula is as follows: ,in, For the The number of white blood cells passing through the detection area at that time; is the slope, which indicates the trend of white blood cell count over time; is the time serial number; is the intercept, which represents the predicted number of white blood cells before the counting begins.

[0031] A judgment is made based on the linear function of the white blood cell count to obtain a first test result.

[0032] It should be noted that, due to normal hemolysis, that is, when the red blood cells are almost completely lysed and the white blood cell solution is a uniform solution, the count values ​​C1, C2, ..., CM should be equal, and the corresponding slope a of the white blood cell count linear function is 0.

[0033] Further, judging based on the linear function of white blood cell count to obtain the first test result includes the following steps: calculating the slopes corresponding to the count values ​​C1, C2, ..., CM respectively based on the linear function of white blood cell count The absolute value of , if the slope corresponding to the count values ​​C1, C2, ..., CM The absolute value of If both are less than or equal to the threshold value Th1, the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis; If there are count values ​​C1, C2, ..., CM corresponding to the slope The absolute value of If it is greater than the threshold value Th1, it indicates that hemolysis is still in progress and the red blood cells are not completely lysed. The hemolysis effect of the blood cell analyzer is judged to be abnormal, and an alarm is sent to the operator through the software to execute the next step; When the hemolysis effect of the blood cell analyzer is determined to be abnormal, the initial and final white blood cell count ratio C1 / CM is calculated based on the count values ​​C1, C2, ..., CM. If the initial and final white blood cell count ratio C1 / CM is less than or equal to the threshold value Th2, the test result is determined to be abnormal, and the slope corresponding to the count values ​​C1, C2, ..., CM is calculated again. The absolute value of step; If the ratio of the initial and final white blood cell counts C1 / CM is greater than the threshold Th2, it means that a large number of red blood cells have been dissolved within M seconds, and the red blood cells have not been completely dissolved when counting. The hemolysis effect of the blood cell analyzer is determined to be abnormal, and an alarm is sent to the operator through the software to execute the next step.

[0034] The coefficient of variation CV is calculated based on the count values ​​C1, C2, ..., CM. If the coefficient of variation CV is greater than the threshold Th3, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, the hemolysis effect of the blood cell analyzer is abnormal, and an alarm prompt is sent to the operator through the software.

[0035] It should be noted that, for the thresholds Th1 to Th3 in the counting method detection, the present invention analyzes the changing trend of the white blood cell count of normal hemolysis samples, selects the critical value that can effectively distinguish normal hemolysis from abnormal hemolysis, analyzes the fluctuation range of the white blood cell count and the distribution range of the coefficient of variation during normal hemolysis, adjusts the relevant thresholds according to actual needs, and finally obtains the optimal threshold.

[0036] Preferably, the traditional white blood cell counting method mainly focuses on the final counting result, which is difficult to reflect the dynamic changes in the hemolysis process. The present invention innovatively introduces a real-time counting mechanism that lasts for M seconds, and performs linear fitting through the least squares method, which can not only timely discover abnormal fluctuations in the count value, but also intuitively reflect the degree of completion of the hemolysis process through slope analysis, especially through multi-dimensional analysis of the counting ratio C1 / CM and the coefficient of variation CV, which can accurately identify the counting error caused by incomplete hemolysis.

[0037] S3: Detect the solution to be tested by using a light absorption method to obtain a second test result.

[0038] Preferably, Figure 3 The figure shows the detection flow chart of the light absorption method. The detection of the solution to be tested by the light absorption method includes the following steps: Since the white blood cell counting pool or the mixing pool is equipped with a light emitting device LED and a photoelectric receiving device, the hemoglobin concentration HGB is determined by the light absorption method. During the white blood cell counting and identification process, the hemoglobin concentration HGB receiving voltage of the solution to be tested is measured for N seconds to obtain light intensity voltage values ​​G1, G2, ..., GN.

[0039] The light intensity voltage value G1, G2, ..., GN is the ordinate, and the time is The serial numbers 1, 2, ..., N are the horizontal coordinates. The linear function of light absorption intensity is obtained by linear fitting using the least square method. The specific formula is as follows: ,in, is the light intensity voltage value received by the photoelectric receiving device at time T; is the slope, which indicates the trend of light intensity changing with time; is the time serial number; is the correction factor, which represents the light intensity voltage value before the measurement starts.

[0040] A judgment is made based on the linear function of light absorption intensity to obtain a second detection result.

[0041] It should be noted that if the solution to be tested is normally hemolyzed, that is, the red blood cells are almost completely lysed, and the white blood cell solution is a uniform solution, the light intensity G received by the photoelectric receiving device is stable; due to the influence of ambient temperature, failure of the hemolytic agent or difficult-to-dissolve samples, if the hemolysis is still in progress and the red blood cells are not completely lysed, the solution to be tested will gradually change from turbid (containing a large number of difficult-to-dissolve red blood cells) to clear (the red blood cells are dissolved). At this time, the light transmittance of the solution to be tested will gradually increase, and the light intensity G received by the photoelectric receiving device will gradually increase.

[0042] Specifically, judging based on the light absorption intensity linear function to obtain the second detection result includes the following steps: calculating the slopes corresponding to the light intensity voltage values ​​G1, G2, ..., GN respectively based on the light absorption intensity linear function The absolute value of , if the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of The slope corresponding to the light intensity voltage value G1, G2, ..., GN is less than or equal to the threshold Th4 If they are equal, the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis.

[0043] If the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of If it is greater than the threshold value Th4, it is determined that hemolysis is abnormal, and an alarm is sent to the operator through the software and the next step is executed.

[0044] When it is determined that hemolysis is abnormal, the final light absorption intensity ratio GN / G1 is calculated based on the light intensity voltage values ​​G1, G2, ..., GN. If the final light absorption intensity ratio GN / G1 is less than or equal to the threshold value Th5, the test result is determined to be abnormal, and the slope corresponding to the light intensity voltage values ​​G1, G2, ..., GN is calculated again. The absolute value of step.

[0045] If the final light absorption intensity ratio GN / G1 is greater than the threshold Th5, it means that a large number of red blood cells have been dissolved within N seconds, and the red blood cells have not been completely dissolved during measurement. The hemolysis effect of the blood cell analyzer is determined to be abnormal, and an alarm is sent to the operator through the software to execute the next step.

[0046] Calculate the coefficient of variation based on the light intensity voltage values ​​G1, G2, ..., GN , if the coefficient of variation If it is greater than the threshold value Th6, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, the hemolysis effect of the blood cell analyzer is abnormal, and an alarm prompt is sent to the operator through the software.

[0047] It should be noted that for the thresholds Th4 to Th6 in the light absorption method detection, the initial threshold data are obtained by studying the light intensity change characteristics of normal hemolysis samples and combining them with statistical analysis of a large amount of experimental data. In subsequent experiments, the threshold data are adjusted according to needs to obtain the optimal threshold that meets the requirements.

[0048] Preferably, the existing light absorption detection method is easily affected by the environmental temperature and the activity of the hemolytic agent, and the detection result is unstable. The present invention establishes a complete judgment system including slope judgment, final to initial light absorption intensity ratio GN / G1 analysis and coefficient of variation evaluation by measuring the light intensity for N seconds in combination with the linear fitting analysis of the light intensity voltage value, which significantly improves the anti-interference ability of light absorption detection and the reliability of the results.

[0049] S4: Perform comprehensive analysis based on the first test result and the second test result to obtain a hemolysis effect test result, thereby realizing the detection of the hemolysis effect of the blood cell analyzer.

[0050] Preferably, Figure 4 The figure shows a flow chart of the hemolysis effect test results. Comprehensive analysis based on the first test result and the second test result includes the following steps: respectively obtain the first test result and the second test result of the same test solution in the same time period and make a judgment. If the first test result and the second test result are both normal hemolysis, it indicates that the hemolysis effect of the blood cell analyzer is normal, and there is no need to send an alarm prompt to the operator.

[0051] If both the first test result and the second test result are abnormal hemolysis, the hemolysis effect of the blood cell analyzer is determined to be abnormal hemolysis, and a first-level alarm prompt is directly sent to notify the operator to perform maintenance.

[0052] If the first test result is normal hemolysis and the second test result is abnormal hemolysis, or the first test result is abnormal hemolysis and the second test result is normal hemolysis, it is impossible to determine the specific situation of the hemolysis effect of the blood cell analyzer. The first test result step and the second test result step are re-executed and judged. If the first test result and the second test result are the same, the corresponding processing operation is performed.

[0053] If the first test result and the second test result remain unchanged for Q consecutive times, it is determined that an abnormality exists, and a secondary alarm prompt is sent to notify the operator to check the blood cell analyzer to find the cause of the abnormality.

[0054] Preferably, the present invention uses two independent detection methods, counting method and light absorption method, to simultaneously evaluate the hemolytic effect. In the counting method, the hemolytic effect is evaluated by monitoring the time series changes of the white blood cell count; and in the light absorption method, the hemolytic state is judged by measuring the changing trend of the light intensity voltage value. This dual verification mechanism reflects the hemolytic process from different angles, complements and verifies each other, realizes a comprehensive evaluation of the hemolytic effect, and significantly improves the reliability of the detection results.

[0055] In summary, the present invention obtains a whole blood sample and mixes it with a diluent, adds a hemolytic agent and mixes it to obtain a test solution, thereby ensuring the stability of the sample, reducing errors caused by improper operation or uneven samples, and ensuring the accuracy of hemolysis effect detection; through precise counting and linear fitting analysis, the hemolysis process is quantified, so as to identify hemolysis abnormalities in advance, improve the accuracy of hemolysis effect detection, and avoid possible manual judgment errors in traditional methods; by utilizing the light absorption method to monitor changes in hemoglobin concentration in the blood, it is further verified whether the blood cells are fully lysed, thereby providing a test result complementary to the counting method; by comprehensively analyzing the test results of the counting method and the light absorption method, the risk of misjudgment of a single method is minimized, and the stability and credibility of the overall test are improved. Double detection and re-verification judgment effectively avoid erroneous judgments and missed detections, further enhancing the reliability of the blood cell analyzer in clinical or experimental environments. Example 2

[0056] As one embodiment of the present invention, a system for detecting the hemolytic effect of a blood cell analyzer is provided, comprising: a sample acquisition module, used to obtain a whole blood sample and mix it with a diluent and a hemolytic agent to obtain a solution to be tested; a counting detection module, used to detect the count value in the solution to be tested using a counting method to obtain a first detection result; a light absorption detection module, used to detect the light intensity voltage value in the solution to be tested using a light absorption method to obtain a second detection result; and a hemolytic effect module, used to perform a comprehensive analysis based on the first detection result and the second detection result to obtain a hemolytic effect detection result. Example 3

[0057] It is an embodiment of the present invention, which is different from the previous embodiment in that: If the functions are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, or the part that contributes to the prior art, or the part of the technical solution, can be embodied in the form of a software product. The computer software product is stored in a storage medium, including several instructions to enable a computer device (which can be a personal computer, server, or network device, etc.) to perform all or part of the steps of the methods described in various embodiments of the present invention. The aforementioned storage medium includes: U disk, mobile hard disk, read-only memory (ROM, Read-Only Memory), random access memory (RAM, Random Access Memory), disk or optical disk, etc., which can store program codes.

[0058] The logic and / or steps represented in the flowchart or otherwise described herein, for example, can be considered as an ordered list of executable instructions for implementing logical functions, and can be embodied in any computer-readable medium for use by an instruction execution system, device or apparatus (such as a computer-based system, a system including a processor, or other system that can fetch instructions from an instruction execution system, device or apparatus and execute instructions), or in conjunction with such instruction execution systems, devices or apparatuses. For the purposes of this specification, "computer-readable medium" can be any device that can contain, store, communicate, propagate or transmit a program for use by an instruction execution system, device or apparatus, or in conjunction with such instruction execution systems, devices or apparatuses.

[0059] More specific examples of computer-readable media (a non-exhaustive list) include the following: an electrical connection with one or more wires (electronic device), a portable computer disk case (magnetic device), a random access memory (RAM), a read-only memory (ROM), an erasable and programmable read-only memory (EPROM or flash memory), an optical fiber device, and a portable compact disk read-only memory (CDROM). In addition, the computer-readable medium may even be a paper or other suitable medium on which the program is printed, since the program may be obtained electronically, for example, by optically scanning the paper or other medium, followed by editing, deciphering or, if necessary, processing in another suitable manner, and then stored in a computer memory.

[0060] It should be understood that the various parts of the present invention can be implemented by hardware, software, firmware or a combination thereof. In the above-mentioned embodiments, multiple steps or methods can be implemented by software or firmware stored in a memory and executed by a suitable instruction execution system. For example, if implemented by hardware, as in another embodiment, it can be implemented by any one of the following technologies known in the art or their combination: a discrete logic circuit having a logic gate circuit for implementing a logic function for a data signal, a dedicated integrated circuit having a suitable combination of logic gate circuits, a programmable gate array (PGA), a field programmable gate array (FPGA), etc. Example 4

[0061] As an embodiment of the present invention, a method for detecting the hemolytic effect of a blood cell analyzer is provided. In order to verify the beneficial effects of the present invention, a scientific demonstration is carried out through simulation experiments.

[0062] In this example, a certain model of blood cell analyzer was selected as the research object, and the hemolysis effect was tested. Before the experiment, fresh whole blood samples were selected from healthy volunteers aged between 25 and 45 years old to ensure the representativeness and reliability of the samples. After the whole blood samples were collected, they were immediately pretreated. The hemolytic agent used in this experiment was a new low-irritation hemolytic agent. During the mixing process, the color change and transparency of the solution were observed in real time, and the microscopic characteristics of the hemolysis process were recorded.

[0063] First, in the process of leukocyte counting and identification, negative pressure suction was used to make the test solution pass through the gemstone hole with a diameter of 50 microns. The continuous detection time M was set to 10 seconds in the experiment, and the number of leukocytes passing through the gemstone hole was recorded every second. The laser light source was used to illuminate the detection area synchronously to accurately capture the detailed information of the leukocytes passing through. Secondly, the light absorption method was used for detection simultaneously. An LED light-emitting device and a photoelectric receiving device were installed on the leukocyte counting pool. The detection duration N was set to 10 seconds, and the changes in the light intensity voltage value were recorded. During the experiment, the ambient temperature was strictly controlled at 20±2℃ and the humidity was controlled at 45%-55% to reduce the influence of external factors on the test results. To ensure the scientific nature of the experiment, this study set up four groups of control experiments with different conditions, including: standard hemolysis group, slow hemolysis group, incomplete hemolysis group and abnormal sample group. Each group of experiments was repeated 5 times to ensure the statistical reliability of the data. The detection results of the counting method and the light absorption method are shown in Tables 1 and 2.

[0064] Table 1 White blood cell count test results

[0065] Table 2 Absorption test results

[0066] It can be seen from Tables 1 and 2 that, firstly, from the results of the white blood cell count test, the data of different experimental groups showed obvious gradient changes. The white blood cell count value of the standard hemolysis group remained highly stable, with a slope close to 0 and a coefficient of variation of only 0.02, which fully demonstrated the accuracy of the method of the present invention. In contrast, the slope of the abnormal sample group reached 0.78, and the coefficient of variation was as high as 0.40, which clearly revealed the instability in the hemolysis process; secondly, the results of the light absorption method test further confirmed the observation of the counting method. The light intensity voltage value of the standard hemolysis group remained constant, the slope of the light intensity change was only 0.02, and the light intensity ratio was 1.00, indicating that the red blood cells had been completely and evenly dissolved. The slope of the light intensity change of the abnormal sample group increased significantly to 0.52, and the light intensity ratio reached 1.90, which intuitively reflected the heterogeneity and complexity of the hemolysis process.

[0067] Finally, the detection results of the counting method and the light absorption method were comprehensively analyzed, and the obtained hemolysis effect detection results are shown in Table 3. It can be seen that compared with the traditional detection method which often relies on a single indicator, the present invention greatly improves the accuracy and reliability of the detection through the dual verification of the white blood cell counting method and the light absorption method; the experimental data show that even in the slow hemolysis group with slight abnormalities, the method of the present invention can timely capture potential risks and give early warning prompts; in addition, in the abnormal sample group, the method of the present invention shows excellent abnormality recognition ability. When the white blood cell counting and light absorption methods detect abnormalities at the same time, the system immediately triggers a first-level alarm; if the two detection methods give different judgments, the system will continuously monitor and upgrade to a second-level alarm after 3 times to ensure that the operator can timely discover and solve potential problems of the instrument.

[0068] Table 3 Hemolytic effect test results

[0069] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A method for detecting the hemolytic effect of a blood cell analyzer, characterized in that: include: obtaining a whole blood sample and performing pretreatment to obtain a test solution; Detecting the solution to be tested by using a counting method to obtain a first test result; Detecting the solution to be tested by light absorption method to obtain a second test result; A comprehensive analysis is performed based on the first detection result and the second detection result to obtain a hemolytic effect detection result, thereby realizing the detection of the hemolytic effect of the blood cell analyzer.

2. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 1, characterized in that: The whole blood sample is obtained and pre-processed, comprising the following steps: The whole blood sample is mixed with the diluent and mixed thoroughly to obtain a preliminary mixed solution; A hemolytic agent is added to the preliminary mixed solution, and the mixture is thoroughly mixed again to obtain a solution to be tested.

3. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 2, characterized in that: Detecting the solution to be tested by counting method comprises the following steps: Use negative pressure to attract the solution to be tested through the small hole of the gemstone or use a syringe to send the solution to be tested into the optical system containing the laser light source; Identify the number of white blood cells passing through the gemstone hole or the laser light source irradiation area per second and count them for M seconds to obtain the count values ​​C1, C2, ..., CM per second within M seconds; With the count values ​​C1, C2, ..., CM as the ordinate and the time T sequence 1, 2, ..., M as the abscissa, the least square method is used for linear fitting to obtain the linear function of the white blood cell count. The specific formula is as follows: ,in, For the The number of white blood cells passing through the detection area at that time; is the trend of white blood cell count over time; is the time serial number; is the predicted number of white blood cells before counting begins; a first test result is obtained by making a judgment based on the linear function of the white blood cell count.

4. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 3, characterized in that: Determining based on the linear function of white blood cell count to obtain a first test result includes the following steps: Based on the white blood cell count linear function, the slopes corresponding to the count values ​​C1, C2, ..., CM are calculated respectively. The absolute value of , if the slope corresponding to the count values ​​C1, C2, ..., CM The absolute value of If both are less than or equal to the threshold value Th1, the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis; If there are count values ​​C1, C2, ..., CM corresponding to the slope The absolute value of If it is greater than the threshold value Th1, it indicates that hemolysis is still in progress and the red blood cells are not completely lysed. The hemolysis effect of the blood cell analyzer is judged to be abnormal, and an alarm is sent to the operator through the software to execute the next step; When the hemolysis effect of the blood cell analyzer is determined to be abnormal, the initial and final white blood cell count ratio C1 / CM is calculated based on the count values ​​C1, C2, ..., CM. If the initial and final white blood cell count ratio C1 / CM is less than or equal to the threshold value Th2, it is determined that the test result is abnormal, and the slope corresponding to the count values ​​C1, C2, ..., CM is calculated again. The absolute value of step; If the ratio of the initial and final white blood cell counts C1 / CM is greater than the threshold Th2, it means that the red blood cells have not been completely lysed during the counting, and the hemolysis effect of the blood cell analyzer is determined to be abnormal, and an alarm prompt is sent to the operator through the software and the next step is executed; The coefficient of variation CV is calculated based on the count values ​​C1, C2, ..., CM. If the coefficient of variation CV is greater than the threshold Th3, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, the hemolysis effect of the blood cell analyzer is abnormal, and an alarm prompt is sent to the operator through the software.

5. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 4, characterized in that: Detecting the solution to be tested by light absorption method comprises the following steps: By using the light absorption method, the hemoglobin concentration HGB receiving voltage of the solution to be tested is measured for N seconds to obtain light intensity voltage values ​​G1, G2, ..., GN; The light intensity voltage value G1, G2, ..., GN is the ordinate, and the time is The serial numbers 1, 2, ..., N are the horizontal coordinates. The linear function of light absorption intensity is obtained by linear fitting using the least square method. The specific formula is as follows: ,in, is the light intensity voltage value received by the photoelectric receiving device at time T; is the trend of light intensity changing with time; is the time serial number; is the correction factor; A judgment is made based on the light absorption intensity linear function to obtain a second detection result.

6. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 5, characterized in that: Determining based on the light absorption intensity linear function to obtain a second detection result includes the following steps: Based on the light absorption intensity linear function, the slopes corresponding to the light intensity voltage values ​​G1, G2, ..., GN are calculated respectively. The absolute value of , if the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of The slope corresponding to the light intensity voltage value G1, G2, ..., GN is less than or equal to the threshold Th4 If they are equal, the hemolysis effect of the blood cell analyzer is judged to be normal hemolysis; If the slope corresponding to the light intensity voltage value G1, G2, ..., GN The absolute value of If it is greater than the threshold value Th4, it is determined that hemolysis is abnormal, and an alarm is sent to the operator through the software and the next step is executed; When it is determined that hemolysis is abnormal, the final light absorption intensity ratio GN / G1 is calculated based on the light intensity voltage values ​​G1, G2, ..., GN. If the final light absorption intensity ratio GN / G1 is less than or equal to the threshold value Th5, the test result is determined to be abnormal, and the slope corresponding to the light intensity voltage values ​​G1, G2, ..., GN is calculated again. The absolute value of step; If the final to initial light absorption intensity ratio GN / G1 is greater than the threshold Th5, it indicates that the red blood cells have not been completely lysed during the measurement, and the hemolysis effect of the blood cell analyzer is determined to be abnormal, and an alarm is sent to the operator through the software and the next step is executed; The coefficient of variation is calculated based on the light intensity voltage values ​​G1, G2, ..., GN , if the coefficient of variation If it is greater than the threshold value Th6, it is determined that the hemolysis process is unstable, the sample is not fully hemolyzed, the hemolysis effect of the blood cell analyzer is abnormal, and an alarm prompt is sent to the operator through the software.

7. The method for detecting the hemolytic effect of a blood cell analyzer according to claim 6, characterized in that: Performing a comprehensive analysis based on the first detection result and the second detection result includes the following steps: The first test result and the second test result of the same test solution in the same time period are respectively obtained and judged. If both the first test result and the second test result are normal hemolysis, it indicates that the hemolysis effect of the blood cell analyzer is normal, and there is no need to send an alarm prompt to the operator; If both the first test result and the second test result are hemolytic abnormalities, the hemolytic effect of the blood cell analyzer is determined to be hemolytic abnormalities, and a first-level alarm prompt is directly sent to notify the operator to perform maintenance; If the first test result is normal hemolysis and the second test result is abnormal hemolysis, or the first test result is abnormal hemolysis and the second test result is normal hemolysis, it is impossible to determine the specific situation of the hemolysis effect of the blood cell analyzer, and the first test result step and the second test result step are re-executed and determined. If the first test result and the second test result are the same, the corresponding processing operation is performed; If the first test result and the second test result remain unchanged for Q consecutive times, it is determined that an abnormality exists, and a secondary alarm prompt is sent to notify the operator to check the blood cell analyzer to find the cause of the abnormality.

8. A system for detecting the hemolytic effect of a blood cell analyzer, based on the method for detecting the hemolytic effect of a blood cell analyzer according to any one of claims 1 to 7, characterized in that: include, A sample acquisition module is used to obtain a whole blood sample and mix it with a diluent and a hemolytic agent to obtain a solution to be tested; A counting detection module, used to detect the count value in the solution to be tested by using a counting method to obtain a first detection result; A light absorption detection module, used to detect the light intensity voltage value in the solution to be tested by using a light absorption method to obtain a second detection result; The hemolysis effect module is used to perform a comprehensive analysis based on the first test result and the second test result to obtain a hemolysis effect test result.

9. A computer device comprising a memory and a processor, wherein the memory stores a computer program, wherein: When the processor executes the computer program, the steps of the method for detecting the hemolytic effect of a blood cell analyzer according to any one of claims 1 to 7 are implemented.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the steps of the method for detecting the hemolytic effect of a blood cell analyzer according to any one of claims 1 to 7 are implemented.

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