Blood cell analyzer and debugging method

Abstract

The embodiment of the invention relates to the field of hematology analyzers, and discloses a hematology analyzer and a debugging method.The debugging method comprises the steps that first feature values of test standard particles of different sizes on a target hematology analyzer are obtained, and a base line of the target hematology analyzer is calculated; the first characteristic value is an abscissa value which is corresponding to the peak value of the pulse distribution histogram and is used for representing the volume of the test standard particle; calculating a particle amplification degree difference between the target hematology analyzer and the standard hematology analyzer according to the base line and the first characteristic value; and adjusting a pulse distribution histogram generated by the target hematology analyzer according to the difference between the baseline and the particle amplification degree of the target hematology analyzer, so that the measured values of the target hematology analyzer and the standard hematology analyzer for the hematohematocrit or the average hematohematocrit of the same test standard particle are consistent. According to the application, the debugging problem of the hematology analyzer is solved, and the influence of instrument hardware on the pulse measurement value is avoided.

Description

Technical Field

[0001] This invention relates to the field of blood cell analyzers, and particularly to a blood cell analyzer and its debugging method. Background Technology

[0002] The principle of sheath flow impedance is based on flow cytometry's sheath flow technology, using traditional impedance methods to detect the counting and morphology of red blood cells and platelets. For example... Figure 1 As shown, cells, under the influence of fluid focusing, line up to pass through the detection orifice. A constant current source is applied to the front and rear chambers of the detection component. Since cells are poor conductors relative to the electrolyte solution, a resistance signal is generated according to the Coulter principle, which in turn generates a voltage pulse. The number of pulse signals reflects the cell count, and the intensity of the pulse signals reflects the cell volume. The back-end electronic hardware processing device amplifies and identifies the acquired voltage pulses and compares them with the voltage thresholds of normal red blood cells and platelets, thereby distinguishing and observing the number and morphology of red blood cells. In some related technologies, MCV (mean corpuscular volume) is used as the observed value, and HCT (hematocrit) is used as the calculated value; in other related technologies, the opposite is true, HCT is used as the observed value, and MCV is used as the calculated value.

[0003] Hemocytosis corpuscular cytology (HCT) is an important reporting parameter and a crucial indicator for assessing anemia, dehydration, or polycythemia, with significant clinical implications. Related techniques utilize calibration to reduce HCT value variability, following the calibration methods described in the WST 347-2024 Guideline for Calibration of Hematology Analysis, which involves calibration using a single calibrator or a single sample of fresh blood with a pre-determined value. However, the effects on HCT are non-linear; therefore, calibration can only reduce differences within a calibration range and may introduce scissor-like bias.

[0004] MCV (mean corpuscular volume) is a crucial indicator in a complete blood count (CBC) test, reflecting the average volume of a single red blood cell in the human body. The normal reference range for MCV is 80-100 fl, and it has significant clinical importance in classifying anemia. When the MCV value is below the normal range, it indicates a small mean corpuscular volume, a condition known as microcytic anemia. When the MCV value is above the normal range, it indicates an enlarged red blood cell volume, a condition known as macrocytic anemia. Even when the MCV is within the normal range, patients may still experience anemia symptoms; this condition is known as normocytic anemia.

[0005] The baseline position of the erythrocyte pulse map can affect the HCT measurement. Some manufacturers adjust the baseline value by adjusting the instrument's electronic baseline; a higher baseline results in a higher HCT value. However, due to variations in related detection components and processes, including impedance detection orifices, electronic hardware, fluid pressure, and flow rate, differences can occur in the count and morphology of erythrocytes and platelets of different sizes. These differences in the pulse distribution histogram ultimately lead to variations in the calculated HCT value. Therefore, adjusting the baseline alone has a limited impact on the accuracy of HCT.

[0006] In summary, how to avoid the influence of instrument hardware on HCT / MCV measurements is a problem that urgently needs to be solved in this field. Summary of the Invention

[0007] The purpose of this invention is to provide at least one method for debugging a blood cell analyzer and a method for correcting pulse measurement values, which can at least solve the debugging problem of blood cell analyzers and achieve the effect of avoiding the influence of instrument hardware on pulse measurement values.

[0008] To address the aforementioned technical problems, at least one embodiment of this application provides a method for debugging a hematology analyzer, comprising: acquiring first characteristic values ​​of test particles of different sizes on a target hematology analyzer, wherein the first characteristic value is an abscissa value representing the volume of the test particle corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the hematology analyzer through which the test particles pass; calculating the baseline of the target hematology analyzer based on the first characteristic values ​​of test particles of different sizes on the target hematology analyzer; calculating the particle amplification difference between the target hematology analyzer and the standard hematology analyzer based on the baseline of the target hematology analyzer, the baseline of a standard hematology analyzer, and the first characteristic values ​​of test particles of the same size on the target hematology analyzer and the standard hematology analyzer; and adjusting the pulse distribution histogram generated by the target hematology analyzer based on the baseline of the target hematology analyzer and the particle amplification difference, so that the hematocrit or mean corpuscular volume measurements of the target hematology analyzer and the standard hematology analyzer for the same test particle are consistent.

[0009] At least one embodiment of this application also provides a blood cell analyzer, comprising: a sampling device having a sample needle for drawing a blood sample from a sample tube; a mixing device having a mixing component for mixing the sample tube before the sample needle draws the blood sample; an impedance detection device having an impedance detection channel, wherein the blood sample drawn by the sampling device is delivered to the impedance detection channel, and the impedance detection channel acquires an impedance pulse signal generated when the blood sample passes through; and a data processing device for acquiring the impedance pulse signal and generating a pulse distribution histogram, correcting the pulse distribution histogram using the baseline and particle amplification difference obtained through the debugging method of the blood cell analyzer, and calculating the hematocrit or mean corpuscular volume of the blood sample using the corrected pulse distribution histogram.

[0010] At least one embodiment of this application also provides a debugging device for a hematology analyzer, comprising: a feature acquisition module, configured to acquire first feature values ​​of test particles of different sizes on a target hematology analyzer, wherein the first feature value is an abscissa value representing the volume of the test particle corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the hematology analyzer through which the test particle passes; a baseline calculation module, configured to calculate the baseline of the target hematology analyzer based on the first feature values ​​of test particles of different sizes on the target hematology analyzer; and a difference calculation module, configured to calculate the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer based on the baseline of the target hematology analyzer, the baseline of a standard hematology analyzer, and the first feature values ​​of test particles of the same size on the target hematology analyzer and the standard hematology analyzer. The instrument adjustment module is used to adjust the pulse distribution histogram generated by the target blood cell analyzer according to the baseline of the target blood cell analyzer and the difference in particle amplification, so that the hematocrit or mean corpuscular volume measured by the target blood cell analyzer is consistent with the measurement values ​​of the standard blood cell analyzer for the same test standard particle.

[0011] At least one embodiment of this application also provides an electronic device, including: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor to enable the at least one processor to perform the above-described debugging method for a blood cell analyzer.

[0012] At least one embodiment of this application also provides a computer-readable storage medium storing a computer program that, when executed by a processor, implements the above-described debugging method for a blood cell analyzer.

[0013] The calibration method for a hematology analyzer provided in this application calculates the baseline of the target hematology analyzer based on the first characteristic values ​​of test particles of different sizes on the target hematology analyzer; further, based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test particles of the same size on the target hematology analyzer and the standard hematology analyzer, the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer is calculated; based on the baseline of the target hematology analyzer and the difference in particle amplification, the pulse distribution histogram generated by the target hematology analyzer is adjusted so that the hematocrit or mean corpuscular volume measurements of the target hematology analyzer and the standard hematology analyzer for the same test particles are consistent. Therefore, the hematocrit or mean corpuscular volume of the sample can be accurately calculated, and the pulse distribution histogram is corrected, avoiding the influence of instrument hardware on pulse measurement values.

[0014] In some optional embodiments, the test particles of different sizes include a first test particle and a second test particle with different radii; based on the first characteristic values ​​of the test particles of different sizes on the target hematology analyzer, a first calculation formula is used to calculate the baseline of the target hematology analyzer; The first calculation formula is as follows:

[0015]

[0016]

[0017] In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle.

[0018] In some optional embodiments, the test particles of different sizes include a first test particle and a second test particle with different radii; based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of the test particles of the same size on the target hematology analyzer and the standard hematology analyzer, a second calculation formula is used to calculate the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer; The second calculation formula is as follows: ) In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This represents the baseline of a standard blood cell analyzer. This represents the first characteristic value of the first test standard on a standard hematology analyzer. This indicates the difference in particle amplification between the target blood cell analyzer and the standard blood cell analyzer.

[0019] In some optional embodiments, adjusting the pulse distribution histogram generated by the target blood cell analyzer based on the baseline of the target blood cell analyzer and the difference in particle magnification includes: adjusting the baseline of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by moving the pulse distribution histogram left and right; and adjusting the particle magnification of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by overall scaling of the pulse distribution histogram.

[0020] In some optional embodiments, obtaining the first characteristic value of test particles of different sizes on the target blood cell analyzer includes: taking a quantitative amount of test solution containing test particles of different sizes through a sample needle and performing impedance detection to obtain a pulse distribution histogram corresponding to the test particles of different sizes, and the data at the horizontal axis position corresponding to the peak value in the pulse distribution histogram is the first characteristic value.

[0021] In some optional embodiments, the test standard particles of different sizes include a first test standard particle and a second test standard particle with different radii; The baseline calculation module is used to calculate the baseline of the target blood cell analyzer based on the first characteristic values ​​of test standard particles of different sizes on the target blood cell analyzer using a first calculation formula. The first calculation formula is as follows:

[0022]

[0023]

[0024] In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle. Attached Figure Description

[0025] One or more embodiments are illustrated by way of example with reference to the accompanying drawings, and these illustrative descriptions do not constitute a limitation on the embodiments.

[0026] Figure 1 This is a schematic diagram of the sheath flow impedance principle in the existing technology; Figure 2a This is an example of a red blood cell pulse diagram; Figure 2b yes Figure 2a Enlarged view of a specific area; Figure 2c Based on Figure 2a A plotted histogram of erythrocyte pulse distribution; Figure 3 Examples of pulse distribution histograms for the same sample under different baselines; Figure 4 This is a diagram illustrating the effect of the magnification factor; Figure 5 This is a flowchart of the debugging method for a blood cell analyzer provided in an embodiment of this application; Figure 6a This is a schematic diagram of the measurement distribution of the two instruments before adjustment in the relevant technology; Figure 6b This is a schematic diagram showing the distribution of measurements from the two instruments after adjustments in the relevant technology; Figure 7 This is a schematic diagram of the measurement distribution after applying the debugging method of the blood cell analyzer provided in the embodiments of this application; Figure 8 This is a schematic diagram of the debugging device for a blood cell analyzer provided in an embodiment of this application. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the various embodiments of this application will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been provided in the various embodiments of this application to help readers better understand this application. However, the technical solutions claimed in this application can be implemented even without these technical details and various changes and modifications based on the following embodiments. The division of the various embodiments below is for the convenience of description and should not constitute any limitation on the specific implementation of this application. The various embodiments can be combined with and referenced by each other without contradiction.

[0028] To facilitate understanding of the embodiments of this application, relevant content regarding red blood cell analysis will be introduced first.

[0029] In some related techniques, MCV (mean corpuscular volume) is used as the observed value and HCT (hematocrit) is used as the calculated value; in other related techniques, the opposite is true, HCT is used as the observed value and MCV is used as the calculated value.

[0030] Taking the method of using HCT as the observed value (i.e., calculating the HCT value based on the erythrocyte pulse distribution histogram) and MCV as the calculated value (calculating the MCV value based on the above HCT value) as an example, the conversion formula between HCT and MCV is: MCV = HCT / RBC × 10, RBC represents the number of red blood cells in the sample being tested.

[0031] The HCT calculation process is as follows: (1) Obtain red blood cell pulses, such as Figure 2a and 2b As shown, plot the histogram of erythrocyte pulse distribution, as follows. Figure 2c As shown.

[0032] (2) Calculate the HCT measurement value according to the following formula, where V RBC is the impedance volume factor, which is a known theoretical value.

[0033]

[0034] In the formula, , The x and y axes represent the histogram of erythrocyte pulse distribution, respectively.

[0035] Hemocytosis corpuscular cytology (HCT) is an important reporting parameter and a crucial indicator for assessing anemia, dehydration, or polycythemia, with significant clinical implications. Related techniques utilize calibration to reduce HCT value variability, following the calibration methods described in the WST 347-2024 Guideline for Calibration of Hematology Analysis, which involves calibration using a single calibrator or a single sample of fresh blood with a pre-determined value. However, the effects on HCT are non-linear; therefore, calibration can only reduce differences within a calibration range and may introduce scissor-like bias.

[0036] MCV (mean corpuscular volume) is a crucial indicator in a complete blood count (CBC) test, reflecting the average volume of a single red blood cell in the human body. The normal reference range for MCV is 80-100 fl. When the MCV value is below the normal range, it indicates that the mean corpuscular volume of red blood cells is small, a condition known as microcytic anemia. When the MCV value is above the normal range, it indicates that the red blood cell volume is enlarged, a condition known as macrocytic anemia. Even when the MCV is within the normal range, patients may still experience anemia symptoms; this condition is known as normocytic anemia.

[0037] The baseline position of the erythrocyte pulse map can affect the HCT measurement. Some manufacturers adjust the baseline value by adjusting the electronic baseline; a higher baseline results in a higher HCT value. However, due to variations in related detection components and processes, including the detection orifice, electronic hardware, fluid pressure, and flow rate, differences can occur in the count and morphology of erythrocytes and platelets of different sizes. These differences in the pulse distribution histogram ultimately lead to variations in the calculated HCT value. Therefore, adjusting the baseline alone has a limited impact on the accuracy of HCT.

[0038] The applicant argues that regardless of whether MCV is used as the observed value and HCT as the calculated value, or vice versa, the following two factors will affect the measured values ​​of HCT and MCV in relation to the pulse distribution histogram: (1) The baseline positions of different instruments differ, resulting in different positions of particles of the same size on different instruments. Figure 3 This is a histogram of pulse distribution for the same sample under different baselines. The horizontal axis, derived from pulse amplitude, represents the particle size in fL, while the vertical axis represents the number of pulses corresponding to the pulse amplitude. For example... Figure 3 As shown, the peak position of the histogram in the upper figure is marked with a red line. In the lower figure, the intersection of this red line and the pulse distribution histogram does not reach the peak; the peak is to the right of the intersection point. Therefore, the baseline in the lower figure is higher. To ensure the quality of the attached figures, Figure 2a , Figure 2b , Figure 2c and Figure 3 All accompanying drawings are in color.

[0039] (2) Different instruments amplify particles of different sizes differently. Assume the amplification factors for a unit volume of two instruments are k1 and k2, respectively. The pulse amplitudes of two particles on the first instrument are k1*V1 and k1*V2, respectively. The distance on the pulse distribution histogram is k1(V2-V1), and the distance on the second instrument is k2(V2-V1). If the amplification factors of the two instruments are different, the spacing between standard particles of different sizes will differ when tested on different instruments. Figure 4 As shown.

[0040] To address the aforementioned technical problem of adjusting a blood cell analyzer to avoid the influence of instrument hardware on measured values, this invention proposes a method for adjusting a blood cell analyzer. The implementation details of the blood cell analyzer adjustment method in this embodiment are described below. The following content is only for ease of understanding and is not necessary for implementing this solution.

[0041] Example 1: The debugging method for the blood cell analyzer in this embodiment can be applied to electronic devices with communication, computing, and data storage capabilities. The specific process can be as follows: Figure 5 As shown, it includes: Step 101: Obtain the first characteristic value of test standard particles of different sizes on the target blood cell analyzer.

[0042] Specifically, the first characteristic value is the abscissa value representing the volume of the test sample, corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the blood cell analyzer when the test sample passes through it.

[0043] In specific implementations, test particles of different sizes include first and second test particles with different radii. Further, the first characteristic values ​​of test particles of different sizes on the target hematology analyzer are obtained, including: Impedance detection was performed by drawing a quantitative amount of test solution containing test standard particles of different sizes using a sample needle. The pulse distribution histograms corresponding to the test standard particles of different sizes were obtained, and the data at the horizontal axis position corresponding to the peak value in the pulse distribution histogram were the first characteristic values.

[0044] In some examples, test solutions for test particles with radii R1 and R2 are added to different test tubes. The target hematology analyzer under test draws a quantitative amount of the test solution through a sample needle and tests the test particles with radii R1 and R2 respectively through the red blood cell impedance detection channel, obtaining two pulse distribution histograms. The horizontal axis positions corresponding to the highest points of the pulse distribution histograms are x1 and x2, respectively. Since the test particles are uniform spheres with a known diameter (radius), the amplification degree of different particle sizes can be better reflected. According to the theoretical size relationship of test particles of different sizes, the amplification degree and baseline position of the test particles can be accurately determined.

[0045] Step 102: Calculate the baseline of the target blood cell analyzer based on the first characteristic values ​​of test standard particles of different sizes on the target blood cell analyzer. Step 103: Calculate the difference in particle amplification between the target blood cell analyzer and the standard blood cell analyzer based on the baseline of the target blood cell analyzer, the baseline of the standard blood cell analyzer, and the first characteristic value of the test standard particles of the same size on the target blood cell analyzer and the standard blood cell analyzer.

[0046] Specifically, the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer includes the factor between the amplification factor per unit volume of the target hematology analyzer and the standard hematology analyzer. The target hematology analyzer is the hematology analyzer to be calibrated, while the standard hematology analyzer is a stable and reliable hematology analyzer that has been periodically calibrated using a traceability method.

[0047] Step 104: Adjust the pulse distribution histogram generated by the target blood cell analyzer according to the differences in baseline and particle amplification of the target blood cell analyzer, so that the hematocrit or mean corpuscular volume measurements of the target blood cell analyzer and the standard blood cell analyzer for the same test standard particles are consistent.

[0048] In this embodiment, the baseline of the target hematology analyzer is calculated based on the first characteristic values ​​of test particles of different sizes on the target hematology analyzer. Further, based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test particles of the same size on both the target and standard hematology analyzers, the difference in particle amplification between the target and standard hematology analyzers is calculated. Based on the baseline of the target hematology analyzer and the difference in particle amplification, the pulse distribution histogram generated by the target hematology analyzer is adjusted to ensure that the hematocrit or mean corpuscular volume measurements for the same test particles are consistent between the target and standard hematology analyzers. Therefore, accurate calculation of the hematocrit or mean corpuscular volume of the sample is possible, achieving correction of the pulse distribution histogram and avoiding the influence of instrument hardware on pulse measurements.

[0049] In some embodiments, the test standard particles of different sizes include a first test standard particle and a second test standard particle with different radii; based on the first characteristic value of the test standard particles of different sizes on the target blood cell analyzer, a first calculation formula is used to calculate the baseline of the target blood cell analyzer.

[0050] The first calculation formula is as follows:

[0051]

[0052]

[0053] In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle.

[0054] By using the unit volume and radius of the two different sized test particles mentioned above, the baseline of the target blood cell analyzer can be accurately calculated, which can then be used for subsequent calculations of particle amplification differences.

[0055] In some embodiments, test particles of different sizes include first test particles and second test particles with different radii; based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test particles of the same size on the target hematology analyzer and the standard hematology analyzer, a second calculation formula is used to calculate the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer. The second calculation formula is as follows: ) In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This represents the baseline of a standard blood cell analyzer. This represents the first characteristic value of the first test standard on a standard hematology analyzer. This indicates the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer.

[0056] In practice, by using the baselines of the target hematology analyzer and the standard hematology analyzer, as well as the first characteristic values ​​of particles of the same size on the target and standard hematology analyzers, the difference in particle amplification between the target and standard hematology analyzers can be accurately calculated. This difference can then be used to ensure that the target hematology analyzer and the standard hematology analyzer have the same measured value position for the same test particle on their pulse distribution histograms.

[0057] It should be understood that the first test standard in the above formula can be any size of test standard among the different sizes of test standard in the aforementioned steps, and does not specifically refer to a test standard of a certain size.

[0058] In some embodiments, adjusting the pulse distribution histogram generated by the target blood cell analyzer according to the difference in baseline and particle magnification of the target blood cell analyzer includes: adjusting the baseline of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by moving the pulse distribution histogram left and right; and adjusting the particle magnification of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by overall scaling of the pulse distribution histogram.

[0059] In practical implementation, the difference between the calculated baseline and the particle amplification level can be used as a reference. k Adjust the pulse distribution histogram of the target hematology analyzer to the same level as the standard hematology analyzer, and then calculate the hematocrit (HCT) or mean corpuscular volume (MCV). The baseline position difference between the target and standard analyzers can be adjusted by moving the pulse distribution histogram left or right, while the difference in particle magnification between the target and standard analyzers can be addressed. k This can be adjusted using a stretched pulse distribution histogram.

[0060] It should be understood that the method of this embodiment is used to correct the influence of hardware on the measured values ​​when the accuracy of the test results may be affected before the blood cell analyzer is put into use (new installation or reactivation of old instrument) or after replacement and repair of parts. For daily use, the instrument still needs to be calibrated in accordance with the calibration method described in the "Blood Cell Analysis Calibration Guide".

[0061] In related technologies, single-point calibration is used to reduce inter-instrument differences. The measurement distributions of the two instruments before adjustment are as follows: Figure 6a As shown, the distribution of measurements from the two instruments after adjustment is as follows: Figure 6b As shown, the horizontal axis represents the instrument's measured values, and the vertical axis represents the calibrated values. It can be seen that using single-point calibration can effectively reduce the difference in measured values ​​near the calibration value range, but it can easily cause a "scissor error" in ranges with large differences in measured values; that is, high values ​​may appear too low and low values ​​too high. The single-point calibration described above is the calibration method described in the "Hematology Analysis Calibration Guidelines".

[0062] The method in this embodiment innovatively uses two test standard particles of different sizes to adjust the impedance detection of the blood cell analyzer, which can significantly improve the accuracy of HCT measurement values ​​in samples from special regions (such as Guangdong).

[0063] For example, samples with an MCV value below 80 are considered anomalous samples. Related techniques require that the deviation between the HCT values ​​of 50% of the anomalous samples detected by the instrument and the true values ​​obtained from the source tracing method should be within ±3.5%. The true HCT value is traced using microcentrifugation, and then tested again on the same analytical instrument to obtain... Figure 7 The measured value distribution shown in the figure is as follows: blue represents the performance of a certain instrument before using this method, and orange represents the performance of the same instrument after using this method. It can be seen that before using this method, both HCT and the source tracing method showed negative deviations when the MCV was below 80, failing to meet the detection requirements; while after using this method, the deviations were evenly distributed across all MCV value ranges, meeting the detection requirements. To ensure the effectiveness of the attached figures, Figure 6a , Figure 6b and Figure 7 Color-coded attached diagrams.

[0064] Example 2: Another embodiment of this example relates to a blood cell analyzer, including: A sampling device with a sample needle for drawing blood samples from a sample tube; A mixing device having a mixing component for mixing the sample tube before the sample needle draws a blood sample; An impedance detection device has an impedance detection channel. The blood sample drawn by the sampling device is transported to the impedance detection channel, and the impedance detection channel acquires the impedance pulse signal generated when the blood sample passes through it. The data processing device acquires impedance pulse signals and generates a pulse distribution histogram. It corrects the pulse distribution histogram using the baseline and particle amplification differences obtained through the debugging method of the blood cell analyzer described in the aforementioned embodiment. It then calculates the hematocrit or mean corpuscular volume of the blood sample using the corrected pulse distribution histogram.

[0065] In this embodiment, by executing the blood cell analyzer debugging method in the aforementioned embodiment, the target blood cell analyzer is adjusted so that the pulse measurement positions for the same test standard on the pulse distribution histogram of the target blood cell analyzer and the standard blood cell analyzer are consistent. This enables the target blood cell analyzer to accurately calculate the pulse measurement values ​​and avoids the influence of instrument hardware on the measurement values.

[0066] For details on the specific implementation of the data processing device, please refer to the content of Embodiment 1, which will not be repeated here.

[0067] Example 3: Another embodiment of this application relates to a debugging device for a blood cell analyzer. The implementation details of the debugging device for the blood cell analyzer in this embodiment are described below. The following implementation details are provided for ease of understanding and are not essential for implementing this solution. A schematic diagram of the debugging device for the blood cell analyzer in this embodiment can be seen as follows: Figure 8 As shown, it includes a measurement acquisition module 301, a baseline calculation module 302, a difference calculation module 303, and an instrument adjustment module 304.

[0068] The feature acquisition module 301 is used to acquire the first feature value of test particles of different sizes on the target blood cell analyzer. The first feature value is the abscissa value representing the volume of the test particle corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the blood cell analyzer through the test particle. The baseline calculation module 302 is used to calculate the baseline of the target blood cell analyzer based on the first characteristic value of test standard particles of different sizes on the target blood cell analyzer. The difference calculation module 303 is used to calculate the difference in particle amplification between the target blood cell analyzer and the standard blood cell analyzer based on the baseline of the target blood cell analyzer, the baseline of the standard blood cell analyzer, and the first characteristic value of the test standard particles of the same size on the target blood cell analyzer and the standard blood cell analyzer. The instrument adjustment module 304 is used to adjust the pulse distribution histogram generated by the target blood cell analyzer according to the differences in baseline and particle amplification of the target blood cell analyzer, so that the hematocrit or mean corpuscular volume measured by the target blood cell analyzer and the standard blood cell analyzer for the same test standard particles are consistent.

[0069] In this embodiment, the baseline of the target hematology analyzer is calculated based on the first characteristic values ​​of test particles of different sizes on the target hematology analyzer. Further, based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test particles of the same size on both the target and standard hematology analyzers, the difference in particle amplification between the target and standard hematology analyzers is calculated. Based on the baseline of the target hematology analyzer and the difference in particle amplification, the pulse distribution histogram generated by the target hematology analyzer is adjusted to ensure that the hematocrit or mean corpuscular volume measurements for the same test particles are consistent between the target and standard hematology analyzers. Therefore, accurate calculation of the hematocrit or mean corpuscular volume of the sample is possible, achieving correction of the pulse distribution histogram and avoiding the influence of instrument hardware on pulse measurements.

[0070] In some embodiments, obtaining the first characteristic value of test particles of different sizes on the target blood cell analyzer includes: taking a quantitative amount of test solution containing test particles of different sizes through a sample needle and performing impedance detection to obtain a pulse distribution histogram corresponding to the test particles of different sizes, wherein the data at the horizontal axis position corresponding to the peak value in the pulse distribution histogram is the first characteristic value.

[0071] In some embodiments, test particles of different sizes include first test particles and second test particles with different radii; the baseline calculation module is used to calculate the baseline of the target blood cell analyzer based on the first characteristic values ​​of test particles of different sizes on the target blood cell analyzer using a first calculation formula; The first calculation formula is as follows:

[0072]

[0073]

[0074] In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle.

[0075] By using the unit volume and radius of the two different sized test particles mentioned above, the baseline of the target blood cell analyzer can be accurately calculated, which can then be used for subsequent calculations of particle amplification differences.

[0076] In some embodiments, test standard particles of different sizes include first test standard particles and second test standard particles with different radii; Based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test standard particles of the same size on the target hematology analyzer and the standard hematology analyzer, the second calculation formula is used to calculate the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer. The second calculation formula is as follows: ) In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. Indicates the baseline of the target blood cell analyzer. This represents the baseline of a standard blood cell analyzer. This represents the first characteristic value of the first test standard on a standard hematology analyzer. This indicates the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer.

[0077] In practice, by using the baselines of the target hematology analyzer and the standard hematology analyzer, as well as the first characteristic values ​​of particles of the same size on the target and standard hematology analyzers, the difference in particle amplification between the target and standard hematology analyzers can be accurately calculated. This difference can then be used to ensure that the target hematology analyzer and the standard hematology analyzer have the same measured value position for the same test particle on their pulse distribution histograms.

[0078] It should be understood that the first test standard in the above formula can be any size of test standard among the different sizes of test standard in the aforementioned steps, and does not specifically refer to a test standard of a certain size.

[0079] In some embodiments, adjusting the pulse distribution histogram generated by the target blood cell analyzer according to the difference in baseline and particle magnification of the target blood cell analyzer includes: adjusting the baseline of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by moving the pulse distribution histogram left and right; and adjusting the particle magnification of the target blood cell analyzer to be consistent with that of the standard blood cell analyzer by overall scaling of the pulse distribution histogram.

[0080] The specific implementation of this embodiment can also refer to the specific implementation of Embodiment 1, which will not be elaborated further here.

[0081] It is worth mentioning that all modules involved in this embodiment are logical modules. In practical applications, a logical unit can be a physical unit, a part of a physical unit, or a combination of multiple physical units. Furthermore, to highlight the innovative aspects of this application, this embodiment does not introduce units that are not closely related to solving the technical problems proposed in this application; however, this does not mean that other units are absent in this embodiment.

[0082] Example 4: Another embodiment of this application relates to an electronic device, including: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor to enable the at least one processor to perform the debugging method of the blood cell analyzer in the above embodiments.

[0083] The memory and processor are connected via a bus, which can include any number of interconnecting buses and bridges, connecting various circuits of one or more processors and memories. The bus can also connect various other circuits, such as peripheral devices, voltage regulators, and power management circuits, which are well known in the art and will not be described further herein. The bus interface provides an interface between the bus and the transceiver. The transceiver can be a single element or multiple elements, such as multiple receivers and transmitters, providing a unit for communicating with various other devices over a transmission medium. Data processed by the processor is transmitted over the wireless medium via an antenna, which further receives data and transmits it to the processor.

[0084] The processor manages the bus and general processing, and also provides various functions, including timing, peripheral interfaces, voltage regulation, power management, and other control functions. Memory is used to store data used by the processor during operation.

[0085] Example 5: Another embodiment of this application relates to a computer-readable storage medium storing a computer program. When executed by a processor, the computer program implements the above-described embodiment of the debugging method for a blood cell analyzer.

[0086] That is, those skilled in the art will understand that all or part of the steps in the methods of the above embodiments can be implemented by a program instructing related hardware. This program is stored in a storage medium and includes several instructions to cause a device (which may be a microcontroller, chip, etc.) or processor to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0087] Those skilled in the art will understand that the above embodiments are specific embodiments for implementing this application, and in practical applications, various changes can be made to them in form and detail without departing from the spirit and scope of this application.

Claims

1. A method for debugging a blood cell analyzer, characterized in that, include: The first characteristic value of test particles of different sizes on the target hematology analyzer is obtained. The first characteristic value is the abscissa value representing the volume of the test particle corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the hematology analyzer through the test particle. The baseline of the target hematology analyzer is calculated based on the first characteristic value of test standard particles of different sizes on the target hematology analyzer; Based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic value of a test standard particle of the same size on the target hematology analyzer and the standard hematology analyzer, the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer is calculated. Based on the baseline of the target hematology analyzer and the difference in particle amplification, the pulse distribution histogram generated by the target hematology analyzer is adjusted to ensure that the hematocrit or mean corpuscular volume measurements of the target hematology analyzer and the standard hematology analyzer for the same test standard particles are consistent.

2. The debugging method for the blood cell analyzer according to claim 1, characterized in that, The test standard particles of different sizes include a first test standard particle and a second test standard particle with different radii; Based on the first characteristic value of test standard particles of different sizes on the target blood cell analyzer, the baseline of the target blood cell analyzer is calculated using the first calculation formula; The first calculation formula is as follows: In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target hematology analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle.

3. The debugging method for the blood cell analyzer according to claim 1, characterized in that, The test standard particles of different sizes include a first test standard particle and a second test standard particle with different radii; Based on the baseline of the target hematology analyzer, the baseline of the standard hematology analyzer, and the first characteristic values ​​of test standard particles of the same size on the target hematology analyzer and the standard hematology analyzer, the second calculation formula is used to calculate the difference in particle amplification between the target hematology analyzer and the standard hematology analyzer. The second calculation formula is as follows: ) In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. Indicates the baseline of the target hematology analyzer. This represents the baseline of a standard blood cell analyzer. This represents the first characteristic value of the first test standard on a standard hematology analyzer. This indicates the difference in particle amplification between the target blood cell analyzer and the standard blood cell analyzer.

4. The debugging method for the blood cell analyzer according to claim 1, characterized in that, Based on the baseline of the target hematology analyzer and the difference in particle amplification, the pulse distribution histogram generated by the target hematology analyzer is adjusted, including: By moving the pulse distribution histogram left and right, the baseline of the target blood cell analyzer is adjusted to be consistent with that of the standard blood cell analyzer. By using the overall stretched pulse distribution histogram, the amplification of particles by the target blood cell analyzer and the standard blood cell analyzer is adjusted to be consistent.

5. The debugging method for the blood cell analyzer according to claim 1, characterized in that, Obtain the first characteristic values ​​of test particles of different sizes on the target hematology analyzer, including: Impedance detection was performed by drawing a quantitative amount of test solution containing test standard particles of different sizes using a sample needle. The pulse distribution histograms corresponding to the test standard particles of different sizes were obtained, and the data at the horizontal axis position corresponding to the peak value in the pulse distribution histogram were the first characteristic values.

6. A blood cell analyzer, characterized in that, include: A sampling device with a sample needle for drawing blood samples from a sample tube; A mixing device having a mixing component for mixing the sample tube before the sample needle draws a blood sample; An impedance detection device has an impedance detection channel. A blood sample drawn by the sampling device is delivered to the impedance detection channel, and the impedance detection channel acquires the impedance pulse signal generated when the blood sample passes through it. The data processing device acquires the impedance pulse signal and generates a pulse distribution histogram, corrects the pulse distribution histogram using the baseline and particle amplification difference obtained by the debugging method of the blood cell analyzer according to any one of claims 1 to 5, and calculates the hematocrit or mean corpuscular volume of the blood sample using the corrected pulse distribution histogram.

7. A debugging device for a blood cell analyzer, characterized in that, include: The feature acquisition module is used to acquire the first feature value of test particles of different sizes on the target blood cell analyzer. The first feature value is the abscissa value representing the volume of the test particle corresponding to the peak value of the pulse distribution histogram generated by the impedance detection channel of the blood cell analyzer through the test particle. The baseline calculation module is used to calculate the baseline of the target blood cell analyzer based on the first feature value of test standard particles of different sizes on the target blood cell analyzer; The difference calculation module is used to calculate the difference in particle amplification between the target blood cell analyzer and the standard blood cell analyzer based on the baseline of the target blood cell analyzer, the baseline of the standard blood cell analyzer, and the first characteristic value of the test standard particles of the same size on the target blood cell analyzer and the standard blood cell analyzer. The instrument adjustment module is used to adjust the pulse distribution histogram generated by the target blood cell analyzer according to the baseline of the target blood cell analyzer and the difference in particle amplification, so that the hematocrit or mean corpuscular volume measured by the target blood cell analyzer is consistent with the measurement values ​​of the standard blood cell analyzer for the same test standard particle.

8. The debugging device for a blood cell analyzer according to claim 7, characterized in that, The test standard particles of different sizes include a first test standard particle and a second test standard particle with different radii; The baseline calculation module is used to calculate the baseline of the target blood cell analyzer based on the first characteristic values ​​of test standard particles of different sizes on the target blood cell analyzer using a first calculation formula. The first calculation formula is as follows: In the formula, This represents the first characteristic value of the first test standard on the target blood cell analyzer. This indicates the first characteristic value of the second test standard on the target blood cell analyzer. Indicates the baseline of the target hematology analyzer. This indicates the volume of the first test standard particle. This indicates the volume of the second test standard particle. Indicates the radius of the first test standard particle. This indicates the radius of the second test standard particle.

9. An electronic device, characterized in that, include: At least one processor; as well as, A memory communicatively connected to the at least one processor; wherein, The memory stores instructions that can be executed by the at least one processor to enable the at least one processor to perform the debugging method of the blood cell analyzer as described in any one of claims 1 to 5.

10. A computer-readable storage medium storing a computer program, characterized in that, When the computer program is executed by the processor, it implements the debugging method of the blood cell analyzer according to any one of claims 1 to 5.

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