JP4580976B2 - Biological sample analyzer with quality control function and method for displaying quality control measurement results - Google Patents

Description

  The present invention relates to a biological sample analyzer having an accuracy management function for a plurality of measurement items, and more particularly to a sample analyzer for measuring a plurality of types of components contained in a sample such as blood and urine.

  In the sample analyzer, it is necessary to periodically control the accuracy. For example, in the case of a blood analyzer, it is a common practice to use a blood sample for accuracy control in the blood analyzer and examine the difference between the accuracy control measurement result of each item obtained and the control target value. Yes. If the measurement result is far from the management target value, it is possible that there is some abnormality in the analyzer or the analysis reagent, and the maintenance is performed.

    An analyzer for analyzing a biological sample such as blood or urine can analyze a plurality of types of components contained in the sample. In such an analyzer, a plurality of types of detection units are provided, or a sample is stained or reacted using a plurality of types of reagents. These measurement items have the same or different detection parts and reagents in each measurement item. For this reason, there is a case where only one measurement item is insufficient for accuracy management, and in many cases, a plurality of or all measurement items are subjected to accuracy management measurement.

    If accuracy management is performed for a plurality of items in this way, it will be possible to more accurately capture the state of the analyzer or analysis reagent depending on the relationship between the measurement items. However, since it is difficult to easily grasp the values of the items, it is common to simply determine whether each item is within the management target range.

  In order to be able to easily use the measurement information of each item to be managed with accuracy management, how much multiple quality control results are in relation to the management target value as a value and whether it is within the management target range to that extent The purpose is to provide an analyzer that can be grasped at a glance.

The present invention has been made in view of such circumstances, and is a particle analyzer that acquires measurement values for each measurement item corresponding to the type of particles contained in blood or urine, and measures a quality control sample. In this case, a function is provided to create and display a radar chart diagram for each measurement item name, including the control target value, control target range, and control target value of the control sample. , quality control measurements obtained by measuring the quality control sample is, Ri measurements der of each measurement item corresponding to the type of the particles contained in the blood or urine, in a radar chart, the quality control measurement value management there is provided a particle analyzer which is characterized that you highlight the measurement item names that are not in the target range.

Further, the present invention provides a plurality of accuracy obtained by performing quality control measurement on a plurality of measurement items by a particle analyzer that acquires measurement values for each measurement item corresponding to the type of particle component contained in blood or urine. A method for displaying managed measurement values, a radar that displays the control target value, control target range, and control accuracy measurement value obtained by measuring the control target sample for each measurement item. creates and displays the chart, quality control measurements obtained by measuring the quality control sample is, Ri measurements der of each measurement item corresponding to the type of the particles contained in the blood or urine, a radar chart in, there is provided a display method of a quality control measure, it characterized that you highlight the measurement item names quality control measurement is not in the management target range.

  According to the present invention, since it is possible to grasp at a glance whether a plurality of quality control results are in relation to the management target value as a value or within the management target range, a large number of measurements obtained by quality control can be obtained. Information can be used easily.

  The control target value of the quality control sample in this invention refers to a value that should be obtained when the quality control sample is measured by the analyzer. The control target value itself is set by measuring the quality control sample with the standard device, the value measured by another method as the standard measurement method, the average value of the measurement results measured a lot with the analyzer, etc. From the above, it is set in consideration of the characteristics of the analysis item.

    The control target range of the quality control sample in this invention refers to a range of values that should be obtained when the quality control sample is measured by the analyzer. The setting of this range is set from the reproducibility of the analyzer, or is set in consideration of the characteristics of the analysis item from the allowable error range as a measurement result.

    Hereinafter, a urine sediment analyzer will be described as an embodiment as an analyzer with reference to the drawings. The urine particle analyzer shown in FIG. 1 performs a predetermined staining process on the quality control sample, irradiates excitation light to the portion flowing in the flow cell, and analyzes the particle component in the sample. it can. First, by opening the valves 1 and 2 for a predetermined time, the sample liquid is filled into the valves 1 and 2 from the suction nozzle 3 by the negative pressure from the waste liquid chamber. When the syringe 4 pushes out the liquid at a constant flow rate, the sample liquid is discharged from the sample nozzle 6 and at the same time, the sheath liquid is supplied to the chamber 7 of the flow cell 5 by opening the valve 8. As a result, the sample is narrowed according to the inner diameter of the chamber 7 to form a sheath flow, and passes through the orifice 11. The shape of the orifice 11 is a prismatic shape with an inner diameter of 100 to 300 μm, and the material is made of optical glass (including quartz glass). By forming the sheath flow in this way, particles can be flowed one by one with the centers of the orifices 11 aligned in a line. The sample liquid and the sheath liquid that have passed through the orifice 11 are discharged through the collection tube 14 provided in the chamber 25.

    The laser beam oscillated from the laser 17 is irradiated to the sample flow 26 substantially at the center of the orifice 11 by the condenser lens 18 so as to be narrowed into an ellipse. The shape of the laser beam is as narrow as the blood cell particle diameter in the sample flow direction, for example, as narrow as about 10 μm, and the shape in the direction perpendicular to the sample flow direction and the irradiation optical axis direction is sufficiently wider than the blood cell particle diameter. It is about 150-300 micrometers. The laser beam irradiated to the sample stream 26 is shielded by the transmitted light beam stopper 19 that has passed through the flow cell 5 without hitting a cell (tangible object). Forward scattered light and forward fluorescence emitted to a cell (tangible object) and emitted at a narrow angle are collected by the collector lens 20 and pass through the pinhole 21 of the light shielding plate 30. The forward fluorescence passes through the dichroic mirror 22, and after the scattered light is further removed by the filter 23, it is detected by the photomultiplier tube (PMT) 24, converted into an electric signal 27, and output. The forward scattered light is reflected by the dichroic mirror 22, received by the photodiode 31, converted into an electric signal 28, and output.

    In the signal processing unit, the electric signal 27 which is a fluorescence signal by the cell is subjected to signal processing with the magnitude of the signal peak as fluorescence intensity (Fl) and the signal generation time as fluorescence pulse width (Flw). Similarly, the electrical signal 28 which is a forward scattered light signal by the cell is subjected to signal processing with the magnitude of the signal peak as the forward scattered light intensity (Fsc) and the signal generation time as the forward scattered light pulse width (Fscw).

    By using the forward scattered light signal intensity, the forward scattered light pulse width, the fluorescent signal intensity, and the fluorescent pulse width obtained as described above as parameters, the urine components having a large size distribution width are classified. In FIG. 3, cylinders (CAST) and epithelial cells (EC), which are large components, are classified and counted using parameters of the fluorescence pulse width (Flw) and the forward scattered light pulse width (Fscw). In FIGS. 4 and 5, red blood cells (RBC) and bacteria (BACT), which are small components, are combined using forward scattered light intensity (Fsc), forward scattered light pulse width (Fscw), and fluorescent intensity (Fl) as parameters. Classification by In FIG. 2, white blood cells (WBC), which are intermediate components, are classified and counted using parameters of fluorescence intensity (Fl) and forward scattered light intensity (Fsc). Fl2 is the fluorescence intensity processed by expanding the signal intensity range from Fl.

    As the quality control substance, a sample containing particles having scattered light and fluorescence similar to the urine formed components of red blood cells, white blood cells, bacteria, cylinders, and epithelial cells is used. For this sample, the management target value and the management target range are set not only for the concentration of each item but also for the measurement parameter average value of a specific item.

    As the quality control item, not only the density of each normal measurement item but also the measurement parameter value of a specific item is used, so that the quality control capability is enhanced. However, when there are so many quality control items, it becomes difficult to grasp the size of each item value. Therefore, FIG. 6 shows these quality control items divided into measurement item concentrations and measurement parameter values of specific items, and each quality control result is shown in a chart.

    The central solid line in the chart of FIG. 6 represents the management target value, and the outer and inner dashed lines represent the upper limit and the lower limit of the management target range. Concentrations of red blood cells (RBC), white blood cells (WBC), bacteria (BACT), cylinders (CAST), and epithelial cells (EC), which are measurement items, are shown in the left chart. The average fluorescence intensity (Fl, Fl2), average forward scattered light intensity (Fsc, Fsc2), and average forward scattered light pulse width (Fscw) are shown in the chart on the right as measurement parameter values of specific items. Since the distribution range of the urine formed component is large, the accuracy of the fluorescence intensity and the forward scattered light intensity is controlled by using two items of a large signal and a small item.

    In FIG. 6, the measurement items that are not within the management target range are reversed to make it easy to understand, and the magnitude of the management target value can be grasped at a glance together with other items. In addition, since not only the measurement items but also each parameter can be confirmed in the same manner, it is easy to specify the treatment and cause when the parameters are not within the management target range.

    By switching the display of the quality control measurement value with time as shown in FIG. 7 or the chart display at the time of the previous quality control measurement, it is possible to easily see the quality control result by making it immediately visible.

    Furthermore, if the chart of the quality control measurement result is provided with a function that can display the quality control measurement result of the previous time, the comparison with the previous time can be confirmed without switching the screen display, which is more useful. In addition, if the function of displaying the distribution range of the quality control measurement results up to the previous time is provided, it is more useful because it can be compared with the previous measurement results of this device.

1 is a configuration explanatory diagram of an analysis apparatus showing an embodiment of the present invention. FIG. It is one of the measurement signal distribution diagrams of the analyzer of the example. It is one of the measurement signal distribution diagrams of the analyzer of the example. It is one of the measurement signal distribution diagrams of the analyzer of the example. It is one of the measurement signal distribution diagrams of the analyzer of the example. It is an Example of the quality control chart figure of this invention. It is an example of a graph of the daily fluctuation of accuracy management.

Explanation of symbols

1; Valve 2; Valve 3; Suction nozzle 4; Syringe 5; Flow cell 6; Sample nozzle 7; Chamber 8; Valve 11; Orifice 14; Collection tube 17; Pinhole 22, dichroic mirror 23, filter 24, photomultiplier tube 25, chamber 26, sample flow 27, electrical signal 28, electrical signal 30, shading plate 31, photodiode

Claims (7)

A particle analyzer that obtains measurement values for each measurement item corresponding to the type of particles contained in blood or urine. When measuring a quality control sample, the control target value, control target range, and accuracy of the quality control sample A function to display the quality control measurement value obtained by measuring the quality control sample by creating a radar chart diagram for each measurement item name and displaying it, and the quality control measurement value obtained by measuring the quality control sample , measurements der of each measurement item corresponding to the type of the particles contained in the blood or urine is, in a radar chart, that you highlight the measurement item names quality control measurement is not in the management target range Characteristic particle analyzer.   2. The particle analyzer according to claim 1, wherein a radar chart diagram for a plurality of measurement parameter values used for obtaining a quality control measurement value is displayed. The particle analyzer according to claim 1 or 2 , further comprising a display function for displaying a graph showing a change over time of the quality control measurement value of the measurement item by switching the display. The particle analyzer according to any one of claims 1 to 3 , wherein a radar chart for the quality control measurement value measured last time by display switching is displayed. Method of displaying a plurality of quality control measurement values obtained by performing quality control measurement on a plurality of measurement items by a particle analyzer that acquires measurement values for each measurement item corresponding to the type of particle component contained in blood or urine A radar chart diagram is created for each measurement item, showing the control target value, control target range, and control target value of the control target sample used for measurement. displaying, quality control measurements obtained by measuring the quality control sample is, Ri measurements der of each measurement item corresponding to the type of the particles contained in the blood or urine, in a radar chart, quality control measurements display method of quality control measurements but characterized that you highlight the measurement item name that is not contained in the management target range. 6. The method of displaying quality control measurement values according to claim 5 , wherein a graph showing a change over time of the quality control measurement value of the measurement item is displayed by switching the display. The method for displaying quality control measurement values according to claim 5 or 6 , wherein a radar chart diagram for the quality control measurement value measured last time is displayed by switching the display.

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