JP5530723B2 - Sample analyzer and sample analysis method - Google Patents

Description

  The present invention relates to a sample analyzer and a sample analysis method for analyzing a sample by irradiating a measurement sample prepared from the sample and a reagent with light.

  Currently, bacteria are detected in clinical tests and the like. Such bacteria can be detected by, for example, a method in which a colony formed by culturing a specimen is directly visually inspected. In this test method, the type and number of bacteria contained in the specimen can be identified. However, since it takes several days for the specimen to be cultured and a colony to be formed, there is a problem that the examination is not rapid.

  On the other hand, Patent Document 1 discloses a method for determining bacteria using a scattergram. In this method, a scattergram is created using the size information of bacteria contained in the specimen and fluorescence information as parameters. Then, the distribution state of the bacteria on the scattergram is analyzed, and based on the analysis result, it is determined whether the type of bacteria in the sample is Neisseria gonorrhoeae or cocci.

JP 2004-305173 A

  In the method of Patent Document 1, the type of bacteria is determined, but other information cannot be presented to the user. In treatment / diagnosis, for example, if it is quickly shown that the type of bacteria has changed from the previous state, the user will be able to properly determine the progress of the disease state and the effectiveness of the medication / treatment performed so far. I can know. And based on this information, it is possible to take more appropriate measures for the subject.

  The present invention has been made in view of the above points, and provides a sample analyzer and a sample analysis method capable of quickly acquiring information on how the types of bacteria contained in a sample have changed. Objective.

The sample analyzer according to the first aspect of the present invention includes a light source unit that irradiates light to a measurement sample prepared from a subject's sample and a reagent, and scattering generated from particles in the measurement sample by light from the light source unit. a detector for detecting light and fluorescence, a storage unit, a scattergram plotting the particles in a sample based on the detected scattered light information and fluorescence information by the detecting unit, and a rotation about a predetermined point Control that divides into a plurality of regions for each predetermined inclination angle , acquires measurement results regarding the type of bacteria in the sample based on the number of plots included in each region, and stores the acquired measurement results in the storage unit And a display unit. Here, when the previous measurement result for the same subject as the measurement result acquired this time is stored in the storage unit, the control unit, based on the current measurement result and the previous measurement result, It is determined whether or not there is a change in the type of bacteria in the sample. If there is a change in the type of bacteria in the sample of the subject, information indicating that there is a change is displayed on the display unit.

  According to the sample analyzer according to this aspect, when there is a change in the type of bacteria in the sample, the fact is displayed on the display unit, so that the user has a change in the type of bacteria in the sample. Can be easily known. Thereby, when a treatment is performed on a subject who has collected a sample, an appropriate treatment can be taken on the subject.

Further, in the sample analyzer according to the present embodiment, the control unit, based on the not large, the number of plots than adjacent areas area may be a determining configuration bacteria types in a sample of said subject.

Further, in the sample analyzer according to the present embodiment, the control unit on the basis of the tilt angle peak in the histogram showing the frequency of number of plots for each tilt angle is present, determine the bacterial types in a sample of said subject It can be set as the structure to do.

  As described above, when the determination is made based on the number of plots in the region obtained by dividing the scattergram, a change in the type of bacteria can be accurately determined by a relatively simple process.

The control unit may be configured to determine whether or not there is a change in the number of types of bacteria in the specimen of the subject based on the current measurement result and the previous measurement result . In this way, it can be easily confirmed whether or not the number of types of bacteria has changed, and accordingly, an appropriate treatment can be taken on the subject from whom the specimen has been collected.

Further, in the sample analyzer according to this aspect, the sample analyzer is used for analyzing a urine sample of a subject, and the control unit is configured to acquire the measurement result acquired this time and the subject stored in the storage unit. Based on the measurement result, it is further determined whether or not the urinary tract infection of the subject has changed between simplicity and complexity, and if there is a change, information indicating that there is a change is measured. It can be set as the structure displayed on the said display part with a result . This makes it easy to see if the urinary tract infection has changed between simplicity and complexity. Thereby, an appropriate treatment can be performed on the subject who has collected the specimen.

  Moreover, in the sample analyzer according to this aspect, the control unit may be configured to store a medication administration history of a subject in the storage unit for each subject. In this way, since it is possible to determine how the type of bacteria in the sample has changed due to the administration of the drug, more effective drug administration can be performed.

  Moreover, the said control part may be set as the structure which displays the administration history of the said test subject collectively while performing the display regarding the said measurement result of the said test subject in time series. This makes it possible to more easily determine how the type of bacteria in the sample has changed due to the administration of the medicine.

Further, the control unit, as a display related to the measurement result of the subject, a scattergram generated on the basis of said scattered light information obtained from the sample from the subject and the fluorescence information, together with the display of the administration history of the agent It may be configured to display in time series. In this way, it becomes possible to appropriately determine how the type of bacteria contained in the specimen has changed due to the administration of the medicine by further viewing the scattergram.
Further, the control unit displays an information display screen including the scattergram, the histogram, the type of bacteria in the subject's sample, and information indicating that there is a change in the type of bacteria on the display unit. Can be configured to display.
In this case, the control unit may be configured to automatically display the information display screen on the display unit when the measurement result is acquired.

The sample analysis method according to the second aspect of the present invention irradiates a measurement sample prepared from a sample and a reagent of a subject with light, and the scattered light information obtained for the particles in the measurement sample by irradiation with the light and scattergrams plotting the particles in a sample based on the fluorescence information, divided into a plurality of regions at predetermined inclination angles and rotation about a predetermined point, based on the number of plots included in each region, the analyte When the measurement result relating to the type of bacteria in is acquired, the acquired measurement result is stored in a storage unit, and the previous measurement result for the same subject as the measurement result acquired this time is stored in the storage unit , Based on the current measurement result and the previous measurement result, it is determined whether there is a change in the type of bacteria in the subject's sample, and if there is a change, information indicating that there is a change is displayed. .

  According to the sample analysis method according to this aspect, when there is a change in the type of bacteria in the sample, this is displayed, so that the user can easily confirm that there is a change in the type of bacteria in the sample. I can know. Thereby, when a treatment is performed on a subject who has collected a sample, an appropriate treatment can be taken on the subject.

  As described above, it is possible to provide a sample analyzer and a sample analysis method that can quickly acquire information on how the type of bacteria contained in a sample has changed.

  The effects and significance of the present invention will become more apparent from the following description of embodiments. However, the embodiment described below is merely an example when the present invention is implemented, and the present invention is not limited to the following embodiment.

It is a figure which shows the structure of the urine sample analyzer which concerns on embodiment. It is a figure which shows the structure of the measuring apparatus which concerns on embodiment. It is a schematic diagram which shows the structure of the optical detection part and analog signal circuit which concern on embodiment. It is a figure which shows the structure of the information processing apparatus which concerns on embodiment. It is a flowchart which shows the measurement process and analysis process of the sample which concern on embodiment. It is a flowchart which shows the analysis process which concerns on embodiment. It is a figure explaining the scattergram which concerns on embodiment, the figure explaining the division | segmentation of a scattergram, and the area | region for measuring the number of bacteria on a scattergram. It is an illustration figure of the histogram which concerns on embodiment. It is a flowchart which shows the change information display which concerns on embodiment. It is an illustration figure of the information display screen displayed on the display part of the information processing apparatus which concerns on embodiment. It is an illustration figure of the time series display screen displayed on the display part of the information processing apparatus which concerns on embodiment. It is an illustration figure of the chemical | medical agent administration log | history screen displayed on the display part of the information processing apparatus which concerns on embodiment. It is the example of a change of the flowchart which shows the analysis process which concerns on embodiment. It is an example of a change of a flow chart which shows change information display concerning an embodiment. It is an illustration figure of the example of a change of the information display screen displayed on the display part of the information processing apparatus which concerns on embodiment.

  In the present embodiment, the present invention is applied to a urine sample analyzer that measures bacteria in a urine sample and determines the type of bacteria in the urine sample obtained from the measurement result.

  Hereinafter, the urine sample analyzer according to the present embodiment will be described with reference to the drawings.

  FIG. 1 is a diagram showing a configuration of a urine sample analyzer 1 according to the present embodiment.

  The urine sample analyzer 1 includes a measuring device 2 and an information processing device 3. The measuring device 2 optically measures bacteria contained in the urine sample with a flow cytometer. The information processing device 3 analyzes the measurement result obtained by the measurement device 2 and displays the analysis result on the display unit 320.

  FIG. 2 is a diagram illustrating the configuration of the measuring device 2.

  The measuring apparatus 2 includes a sample distribution unit 201, a sample preparation unit 202, an optical detection unit 203, a signal processing circuit 210, a CPU 204, a communication interface 205, and a memory 206. The signal processing circuit 210 includes an analog signal processing circuit 211, an A / D converter 212, a digital signal processing circuit 213, and a memory 214.

  The sample distribution unit 201 includes a pipette and a pump (not shown). By driving the pump, a predetermined amount of sample (urine) is aspirated into the pipette, and the aspirated sample is discharged into the pipette. With such a pipette and pump, the sample distribution unit 201 supplies a predetermined amount of sample sucked from the sample container to the sample preparation unit 202.

  The sample adjustment unit 202 includes a reagent container, a mixing container, and a pump (not shown). In the mixing container, the sample supplied from the sample distributor 201 is mixed with the diluent and the staining liquid supplied from the reagent container, and the measurement sample is prepared. The measurement sample prepared in the mixing container is supplied to the sheath flow cell 203c (see FIG. 3) of the optical detection unit 203 together with the sheath liquid by a pump.

  The optical detection unit 203 irradiates the measurement sample with laser light, and outputs to the analog signal processing circuit 211 electrical signals based on the forward scattered light, side fluorescence, and side scattered light generated thereby. The analog signal processing circuit 211 amplifies the electrical signal output from the optical detection unit 203 in accordance with an instruction from the CPU 204 and outputs the amplified signal to the A / D converter 212.

  The A / D converter 212 converts the electrical signal amplified by the analog signal processing circuit 211 into a digital signal and outputs the digital signal to the digital signal processing circuit 213. The digital signal processing circuit 213 performs predetermined waveform processing on the digital signal output from the A / D converter 212 in accordance with an instruction from the CPU 204. The digital signal subjected to the waveform processing is stored in the memory 214. Here, the digital signal stored in the memory 214 includes a signal based on a forward scattered light and a side fluorescence pulse signal generated each time bacteria pass through the sheath flow cell 203c.

  The CPU 204 controls the analog signal processing circuit 211 and the digital signal processing circuit 213. Further, the CPU 204 acquires the heights of forward scattered light and side fluorescent pulse signals from the digital signal stored in the memory 214. Here, the height of the pulse signal of the forward scattered light indicates the intensity of the forward scattered light generated by one bacterium passing through the sheath flow cell 203c. Similarly, the height of the side fluorescence pulse signal indicates the intensity of the side fluorescence produced by passage of one bacterium through the sheath flow cell 203c. The height of the pulse signal of the forward scattered light reflects the size of the bacteria, and the height of the pulse signal of the side fluorescence reflects the degree of staining of the nucleic acid contained in the bacteria.

  The CPU 204 acquires the height of the forward scattered light and the side fluorescence pulse signal, and then, based on the height of the pulse signal, the forward scattered light intensity and the side fluorescence intensity of each bacterium passing through the sheath flow cell 203c. A data group (hereinafter referred to as “measurement data”) is generated. The CPU 204 outputs such measurement data to the communication interface 205. Further, the CPU 204 receives a control signal from the information processing device 3 via the communication interface 205 and drives each unit of the measuring device 2 according to the control signal.

  The communication interface 205 transmits measurement data output from the CPU 204 to the information processing apparatus 3 and receives control signals output from the information processing apparatus 3. The memory 206 is used as a work area for the CPU 204.

  FIG. 3 is a schematic diagram illustrating the configuration of the optical detection unit 203 and the analog signal processing circuit 211 in the measurement apparatus 2.

  The optical detection unit 203 includes a light emitting unit 203a, an irradiation lens unit 203b, a sheath flow cell 203c, a condensing lens 203d, a pinhole plate 203e, a PD (photodiode) 203f, a condensing lens 203g, and a dichroic mirror. 203h, an optical filter 203i, a pinhole plate 203j, a PMT (photomultiplier tube) 203k, and a PD (photodiode) 203l. The analog signal processing circuit 211 includes amplifiers 211a, 211b, and 211c.

  The laser light emitted from the light emitting unit 203a is converted into parallel light by the irradiation lens unit 203b, and is irradiated to the sample flow including the measurement sample passing through the inside of the sheath flow cell 203c. Note that the measurement sample passing through the inside of the sheath flow cell 203c is a sample (urine) to be measured mixed with a diluent and a staining solution.

  The condensing lens 203d is disposed in the traveling direction of the laser light emitted from the light emitting unit 203a. The forward scattered light generated from the sheath flow cell 203c is converged by the condenser lens 203d, passes through the pinhole plate 203e, and is received by the PD 203f.

  The condensing lens 203g is disposed in a direction that intersects the traveling direction of the laser light emitted from the light emitting unit 203a. Side fluorescence and side scattered light generated from the sheath flow cell 203c are converged by the condenser lens 203g and incident on the dichroic mirror 203h. The dichroic mirror 203h separates side fluorescence and side scattered light. The side fluorescence separated by the dichroic mirror 203h passes through the optical filter 203i and the pinhole plate 203j and is received by the PMT 203k. On the other hand, the side scattered light separated by the dichroic mirror 203h is received by the PD 203l.

  The PD 203f, the PMT 203k, and the PD 203l output electrical signals according to the received forward scattered light, side fluorescence, and side scattered light, respectively. The amplifiers 211a, 211b, and 211c amplify the electrical signals output from the PD 203f, the PMT 203k, and the PD 2031, respectively, and output the amplified signals to the A / D converter 212. The amplifiers 211a, 211b, and 211c constitute the analog signal processing circuit 211 shown in FIG.

  FIG. 4 is a diagram illustrating the configuration of the information processing apparatus 3.

  The information processing apparatus 3 includes a personal computer and includes a main body 300, an input unit 310, and a display unit 320 (see FIG. 1). The main body 300 includes a CPU 301, a ROM 302, a RAM 303, a hard disk 304, a reading device 305, an input / output interface 306, an image output interface 307, and a communication interface 308.

The CPU 301 executes a computer program stored in the ROM 302 and a computer program loaded in the RAM 303. The RAM 303 is used for reading out computer programs recorded in the ROM 302 and the hard disk 304. Further, the RAM 303 executes these computer programs when
It is also used as a work area for the CPU 301.

  The hard disk 304 is installed with various computer programs to be executed by the CPU 301 such as an operating system and application programs, and data used for executing the computer programs. The hard disk 304 stores measurement data received from the measurement device 2 and a medication administration history described later.

  Further, the hard disk 304 is installed with a program for acquiring the number of bacteria contained in the sample based on the measurement data and analyzing the sample, and a display program for displaying the analysis result on the display unit 320. Yes. By installing these programs, analysis processing and display processing described later are performed. That is, the CPU 301 is provided with a function of executing the processing of FIG. 5B, FIG. 6, and FIG. 9 described later and a function of displaying the screens of FIGS.

  The reading device 305 is configured by a CD drive, a DVD drive, or the like, and can read a computer program and data recorded in an external storage such as a recording medium. Thereby, the program executed by the information processing apparatus 3 can be updated via an external storage such as a recording medium.

  An input unit 310 such as a mouse or a keyboard is connected to the input / output interface 306, and when the user uses the input unit 310, an instruction is given to the information processing apparatus 3. The image output interface 307 is connected to the display unit 320 configured by a display or the like, and outputs a video signal corresponding to the image data to the display unit 320. The display unit 320 displays an image based on the input video signal.

  Further, the communication interface 308 can receive the measurement data transmitted from the measurement device 2. Such measurement data is stored in the hard disk 304.

  FIG. 5 is a flowchart showing the control of the CPU 204 of the measurement apparatus 2 and the CPU 301 of the information processing apparatus 3. FIG. 5A is a flowchart showing measurement processing by the CPU 204 of the measurement apparatus 2, and FIG. 5B is a flowchart showing analysis processing by the CPU 301 of the information processing apparatus 3.

  Referring to FIG. 5B, when there is a measurement start instruction from the user via the input unit 310 (S11: YES), the CPU 301 transmits a measurement start signal to the measuring device 2 (S12). Subsequently, the CPU 301 determines whether measurement data has been received (S13). If the measurement data has not been received (S13: NO), the process waits.

  On the other hand, referring to FIG. 5A, when the CPU 204 receives a measurement start signal from the information processing device 3 (S21: YES), the CPU 204 measures the sample described above (S22). When the measurement of the sample is completed, the CPU 204 transmits measurement data to the information processing apparatus 3 (S23), and the process returns to S21.

  Referring to FIG. 5B, when CPU 301 receives measurement data from measurement device 2 (S13: YES), CPU 301 stores the measurement data in hard disk 304 and performs analysis processing based on the measurement data (S14). . Subsequently, the CPU 301 displays the analysis result acquired in S14 on the display unit 320 (S15), and displays change information based on the analysis result on the display unit 320 (S16). Thereafter, the process returns to S11. The analysis process of S14 will be described later with reference to FIG. 6, and the change information display of S16 will be described later with reference to FIG.

  FIG. 6 is a process flowchart of the “analysis process” in S14 of FIG.

  First, the CPU 301 reads measurement data from the hard disk 304 into the RAM 303, and creates a two-dimensional scattergram with the forward scattered light intensity as the vertical axis and the side fluorescence intensity as the horizontal axis based on the read measurement data (S101). . In this two-dimensional scattergram, data of forward scattered light intensity and side fluorescence intensity for each bacterium constituting the measurement data is plotted. FIG. 7A is an exemplary diagram of a scattergram created in S101. The CPU 301 measures the total number of bacteria contained in the sample to be measured based on the created two-dimensional scattergram (S102).

  Subsequently, the CPU 301 determines whether or not the number of bacteria contained in the sample to be measured is greater than or equal to a predetermined value (S103). That is, the number of bacteria contained in a 1 mL sample is acquired from the total number of bacteria measured in S102, and it is determined whether the number of bacteria is a predetermined value or more. In the present embodiment, the predetermined value used in the determination in S103 is a threshold value of the number of bacteria for determining whether or not the urinary tract infection is present, and is, for example, 1.0 for a 1 mL sample. X10 ^ 4 (pieces).

  If it is determined that the number of bacteria contained in the sample used for measurement is smaller than the predetermined value (S103: YES), the CPU 301 determines that the subject is not suspected of having a urinary tract infection (S104), and the process is performed. End. On the other hand, when it is determined that the number of bacteria contained in the sample to be measured is equal to or greater than a predetermined value (S103: NO), the process proceeds to S105.

  Next, the CPU 301 divides the two-dimensional scattergram created in S101 into a plurality of regions for each predetermined inclination angle (S105). The CPU 301 measures the number of bacteria included in each region on the two-dimensional scattergram divided in S105 (S106).

  Here, a plurality of regions on the scattergram will be described with reference to FIGS. 7B and 7C.

  FIG. 7B is a schematic diagram of the scattergram created in S105.

  The straight lines d0, d1, d2, d3, d4,... Are straight lines in the radial direction of a virtual circle A centered on the origin O of the scattergram. The straight line d0 is a straight line that coincides with the horizontal axis, and the other straight lines have an angle θ with respect to the adjacent straight lines as shown in the figure. The areas D0, D1, D2, D3,... Are areas divided by straight lines d0, d1, d2, d3, d4,. Note that θ can be arbitrarily determined, and may be set to 1 ° or 10 °, for example. After dividing the scattergram into a plurality of regions in this way, the rectangular region B including the origin O is further removed from the regions D0, D1, D2, D3,.

  FIG. 7C is a diagram showing each region for measuring the number of bacteria on the scattergram. As shown in the figure, the areas E0, E1, E2, E3,... For measuring the number of bacteria are areas obtained by removing the area B from the areas D0, D1, D2, D3,. It is.

Here, the reason why the region B is excluded from the regions D0, D1, D2, D3,... In FIG. 7B is to improve the accuracy of the determination of the classification of urinary tract infections and the determination of the type of bacteria described later. is there. That is, as can be seen from the scattergram of FIG. 7A, the bacterial distribution tends to be biased near the origin O. For this reason, if the bacteria near the origin O are counted in the areas D0, D1, D2, D3,..., Differences in the count results of the respective areas hardly occur, and the bacteria cannot be determined smoothly. In addition, in the region B, the region divided by the straight lines d0, d1, d2, d3, d4,... Is narrower than regions other than the region B (regions where the forward scattered light intensity and the side fluorescence intensity are large). . On the other hand, near the origin, the distribution of different bacteria tends to overlap each other. For this reason, if bacteria are counted in the vicinity of the origin, a large number of bacteria that should not be counted in that region are counted, and a large error is likely to be included in the count result.

  For this reason, in the determination of the classification of urinary tract infections and the determination of the type of bacteria, which will be described later, the difference in the number of bacteria contained in each region is noticeable without counting the number of bacteria near the origin O. In order to achieve this, the region B is excluded from the regions D0, D1, D2, D3,.

  The size of the region B is set so that the type of bacteria determined based on the number of bacteria contained in the regions E0, E1, E2, E3,... .

  Returning to FIG. 6, next, the CPU 301 creates a histogram based on the number of bacteria for each of the areas E0, E1, E2, E3,... Acquired in S106 (S107).

  FIG. 8A is an exemplary diagram of a histogram created in S107. 8A, the horizontal axis represents the angles of the straight lines d0, d1, d2, d3, d4,... Dividing the regions E0, E1, E2, E3,. That is, the horizontal axis corresponds to the regions E0, E1, E2, E3,. The vertical axis represents the number of bacteria contained in the regions E0, E1, E2, E3,.

  Returning to FIG. 6, next, the CPU 301 selects a region where the number of bacteria is peaked in the histogram created in S107 (S108).

  Here, the region where the number of bacteria is a peak is a region (angle range) corresponding to the apex of the portion in which the histogram is convex upward. That is, among the regions E0, E1, E2, E3,..., A region where the number of bacteria counted in its own region is larger than the number of bacteria counted in the preceding and following regions adjacent to the direction of change in angle. Is selected as the vertex region.

  For example, in the histogram shown in FIG. 8A, there is one peak of the number of bacteria, and the number of bacteria at the peak point is N1. In this case, the CPU 301 selects the region En1 corresponding to the peak. In the exemplary histogram shown in FIG. 8B, there are two bacteria peaks, and the number of bacteria at the two peak points is N2 and N3. In this case, the CPU 301 selects a region En2 corresponding to the left peak and a region En3 corresponding to the right peak.

  Next, when there is one region corresponding to the peak selected in S108 (S109: YES), the CPU 301 determines that the urinary tract infection of the specimen that is the basis of this measurement data is a simple urinary tract infection. (S110). On the other hand, when there are two or more regions corresponding to the peak (S109: NO), it is determined that the classification of the urinary tract infection of the specimen that is the basis of this measurement data is a complicated urinary tract infection (S111). .

Next, the CPU 301 determines the type of bacteria contained in the sample that is the source of the measurement data based on the region selected in S108 (S112). That is, the CPU 301 determines the type of bacteria depending on whether the angle range of the selected region with respect to the straight line d0 is included in the angle range set in advance to specify the type of bacteria. For example, in the case of FIG. 7B, the angle range of the region D2 is 2θ to 3θ. When the region selected in S108 is the region D2, the type of bacteria is determined depending on which angle range set for specifying the type of bacteria is included in the angle range of 2θ to 3θ.

  In the present embodiment, the angle range for specifying the type of bacteria is set as follows.

(A) 0 ° to 25 ° ... Neisseria gonorrhoeae (b) 26 ° to 44 ° ... Streptococcus (c) 45 ° to 80 ° ... Staphylococci (d) 81 ° to 90 ° ... Not applicable

  In the present embodiment, when the number of areas selected in S108 is three or more, the type of bacteria is determined only for the area from the largest number of counted bacteria to the second area. However, the bacteria type may be determined for the region from the number of counted bacteria to the third one, or the bacterial type may be determined for all selected regions.

  Next, the CPU 301 stores the analysis result including the classification of the urinary tract infection and the type of bacteria obtained as described above in the hard disk 304 (S113), and the process ends.

  FIG. 9 is a process flowchart of “change information display” in S16 of FIG.

  First, the CPU 301 determines whether the previous and current analysis results are in the hard disk 304 for the subject who has collected the sample this time (S201). If it is determined that there are no previous and current analysis results (S201: NO), the process ends. If it is determined that there are previous and current analysis results (S201: YES), the CPU 301 reads the previous and current analysis results into the RAM 303 (S202), and compares the previous analysis results with the current analysis results (S203). ).

  Next, as a result of the comparison in S203, the CPU 301 determines whether there is a change in the classification of the urinary tract infection between the previous analysis result and the current analysis result (S204). When it is determined that there is a change (S204: YES), the CPU 301 assigns 1 to the urinary tract infection flag (S205), and when it is determined that there is no change (S204: NO), the CPU 301 determines that there is no change. 0 is assigned to the flag (S206).

  Subsequently, as a result of the comparison in S203, the CPU 301 determines whether there is a change in the bacterial type between the previous bacterial type and the current bacterial type (S207). If it is determined that there is a change (S207: YES), the CPU 301 assigns 1 to the type flag (S208), and if it is determined that there is no change (S207: NO), the CPU 301 assigns 0 to the type flag. (S209).

  Next, the CPU 301 determines whether the urinary tract infection flag is 1 or the type flag is 1 (S210). If it is determined that the urinary tract infection flag is 1 or the type flag is 1 (S210: YES), the display unit 320 of the information processing device 3 displays that there is a change (S211), and the process ends. .

  FIG. 10 is an exemplary diagram of an information display screen 400 displayed on the display unit 320 of the information processing apparatus 3. The information display screen 400 is displayed according to S15 and S16 of FIG.

The information display screen 400 includes a subject ID area 401, a measurement date / time area 402, a scattergram area 403, a histogram area 404, a subject information area 405, a bacteria information area 406, a segment angle area 407, and a change information area. 408. The bacteria information area 406 includes a urinary tract infection classification area 406a and a type area 406b.

  In the subject ID area 401, a subject ID for identifying a subject who has collected the sample that is the source of this analysis is displayed. The measurement date and time area 402 displays the measurement date and time when this measurement was performed. In the scattergram area 403, the scattergram corresponding to FIG. 7A obtained by this measurement is displayed. In the histogram area 404, histograms corresponding to FIGS. 8A and 8B obtained based on the scattergram displayed in the scattergram 403 are displayed.

  In the subject information area 405, the name of the subject corresponding to the subject ID, the doctor in charge, comments from the doctor in charge, and the like are displayed. In addition, the information regarding the medicine administered to the subject may be input via the input unit 310 (see FIG. 4) and displayed in the subject information area 405.

  In the urinary tract infection classification area 406a, the result determined in S110 or S111 in the analysis process shown in FIG. 6 is displayed. That is, in the urinary tract infection classification area 406a, when the classification of the urinary tract infection of the specimen that is the basis of this analysis is a simple urinary tract infection, “simple infection?” Is displayed. If the classification of the urinary tract infection of the sample that is the basis of the analysis is a complicated urinary tract infection, “complex infection?” Is displayed.

  Note that the “?” Added to the end of the display content of the urinary tract infection classification area 406a means that this sample is likely to have a simple urinary tract infection or a complicated urinary tract infection. Is shown to the user. Further, when the classification of urinary tract infection is not determined or when the classification of urinary tract infection cannot be determined, blank or “UNKNOWN” is displayed in the urinary tract infection classification area 406a.

  In the type area 406b, the type of bacteria determined in S112 in the analysis process shown in FIG. 6 is displayed. Note that “?” Added to the end of the display content in the type area 406b indicates that there is a high possibility that the display content contains bacteria. Further, when the type of bacteria is not determined or when the type of bacteria cannot be determined, blank or “UNKNOWN” is displayed in the type area 406b.

  In the segmented angle area 407, an angle θ between the straight lines d0, d1, d2, d3, d4,... Dividing the areas D0, D1, D2, D3,... Shown in FIG. Is displayed.

  In the change information area 408, the fact that there is a change in the type of bacteria is displayed in accordance with the change information display shown in FIG. In the change information area 408 here, “changed” is displayed as if there was a change between the previous time and the current time, as shown in the figure. When the classification of urinary tract infection changes from simplicity to complexity, “Simpleness → Complexity” is also displayed, and when the type of bacteria changes, “Type” is also displayed. It is displayed. Note that the change information area 408 is blank when there is no change between the previous measurement and the current measurement, and when the number of bacteria in the current measurement is less than a predetermined value (when NO is determined in S103). It becomes.

  FIG. 11 is an exemplary view of a time-series display screen 500 displayed on the display unit 320 of the information processing apparatus 3. This display is performed by inputting a time-series display operation for a predetermined subject via the input unit 310 of the information processing device 3.

The time-series display screen 500 includes a subject ID area 501, measurement date / time areas 511, 521, 531, 541, scattergram areas 512, 522, 532, 542, histogram areas 513, 523, 533, 543, and bacteria information. Regions 514, 524, 534, 54
4, segment angle regions 515, 525, 535, 545, change information regions 526, 536, and medication information regions 551, 552, 553.

  Similar to the sample ID 401 in FIG. 10, the subject ID 501 area displays a subject ID that identifies the subject who collected the sample that is the source of this analysis.

  Four groups of 511 to 516, 521 to 526, 531 to 536, and 541 to 546 represent measurement results and analysis results obtained from one measurement, respectively. That is, in these four groups, information on corresponding areas of the information display screen 400 of FIG. 10 is displayed based on the measurement data of the samples collected four times from the same subject at different dates and times, respectively. Yes. In the present embodiment, these four groups are continuous in time series.

  In the change information areas 516 to 546, whether or not there is a change in the bacteria type information between the previous measurement and the current measurement, and the content of the change are displayed. When there is no change in the bacterial information between the previous measurement and the current measurement, and when the number of bacteria in the current measurement is less than a predetermined value (when NO is determined in S103), the change information area is blank. It becomes.

  In the case of the example of FIG. 11, when the measurement from the leftmost column is shifted to the measurement of the second column from the left, the type of bacteria has changed from “Koji mold?” To “Streptococcus?”. “Type” indicating that the type of bacteria has changed is displayed.

  Similarly, in the change information area 536 in the third column from the left, since the bacteria information has changed from the contents of the bacteria information area 524 to the contents of the bacteria information area 534, the classification of the urinary tract infection has changed, and the bacteria “Type” indicating that the type of the item has changed is displayed. That is, in this case, the classification of urinary tract infections has changed from “simple?” To “complexity?”, And the bacterial type has changed from “streptococcus?” To “streptococcus? . Therefore, in the change information 536, the classification of the bacteria changed from “simple to complex” indicating that the classification of urinary tract infection changed from simple urinary tract infection to complicated urinary tract infection. “Type” indicating this is also displayed.

  In the medication information areas 551, 552, and 553, information indicating whether or not medication has been performed on the subject between the previous measurement and the current measurement is displayed. In the example of FIG. 11, information indicating that the drug has been administered to the subject between the measurement date and time indicated by the measurement date and time area 511 and the measurement date and time indicated by the measurement date and time area 521 (here, the syringe) Is displayed in the medication information area 551. Similarly, the medication information area 553 also indicates that the drug has been administered to the subject between the measurement date and time indicated by the measurement date and time area 531 and the measurement date and time indicated by the measurement date and time area 541. Information is displayed.

  FIG. 12 is an exemplary diagram of a drug administration history screen 600 displayed on the display unit 320 of the information processing apparatus 3.

  The medicine administration history screen 600 includes a subject ID area 601, a medicine administration history area 602, and an edit command area 603.

  In the subject area ID 601, a subject ID for identifying a subject to whom drug administration has been performed is displayed. In the medicine administration history area 602, the history of medicine administration performed so far for the subject identified in the subject ID area 601 is displayed.

  In the medicine administration history area 602, a plurality of dates and times when the medicine is administered and the contents of the medicine administration at this time are displayed in association with each other. Such a medication administration history is stored in the hard disk 304 of the information processing device 3.

  In addition, in the screen shown in FIG. 11, the medication information area 551 in which information (picture of a syringe) is displayed among the medication information areas 551, 552, and 553 by the user via the input unit 310 of the information processing apparatus 3. When any one of 553 is pressed (for example, clicked), the screen in FIG. 12 is displayed. At this time, the drug administration date and time and the drug administration content line corresponding to the medication information area pressed on the screen of FIG. 11 are selected and displayed as shown. Thereby, the user can confirm the content of medication.

  The edit command area 603 includes add, edit, and delete buttons for editing the contents of the drug administration history area 602. When the user presses (for example, clicks) these buttons via the input unit 310, the contents of the drug administration history area 602 can be edited. When the contents of the drug administration history area 602 are changed, the display of the medication information areas 551, 552, and 553 on the time series display screen 500 of FIG. 11 is also changed in accordance with the change of the contents of the drug administration history area 602. The

  As described above, according to the present embodiment, the analysis process as shown in FIG. 6 is performed based on the forward scattered light and the side fluorescence received by the PD 203f and the PMT 203k, respectively. 10 is displayed on the display unit 320 of the information processing apparatus 3. If there is a change in the type of bacteria, change information 408 indicating this is displayed. Thereby, when the treatment is performed on the subject from whom the sample is collected, it can be confirmed whether the subject is effectively treated.

  Further, according to the present embodiment, the time series display screen 500 shown in FIG. 11 shows measurement results and analysis results based on the measurement data of samples collected from the same subject at different dates and times four times. Is displayed. Thereby, when treatment is performed on a subject who has collected a sample, it can be confirmed in time series whether effective treatment is being performed on the subject.

  Further, according to the present embodiment, medication information is displayed in the medication information areas 551 to 553 in the time series display screen 500 shown in FIG. By displaying the medication information in this way, it is possible to easily grasp how the type of bacteria in the sample has changed due to the administration of the drug to the subject. In addition, it can be confirmed whether an effective drug has been administered to the subject.

  Although the embodiments of the present invention have been described above, the present invention is not limited to the above embodiments, and the embodiments of the present invention can be variously modified in addition to the above.

  For example, in the above-described embodiment, urine is exemplified as a measurement target, but blood may also be a measurement target. That is, the present invention can be applied to a sample testing apparatus for testing blood, and further, the present invention can be applied to a sample testing apparatus for testing other samples.

  Further, in the above embodiment, it is determined in S109 of FIG. 6 whether the number of bacteria in the histogram is one peak, whereby the classification of the urinary tract infection of the specimen from which the measurement data is based is made. Although it is determined, whether or not there is one peak may be determined using the skewness of the histogram. Alternatively, in addition to the determination in S109 of the above embodiment, the classification of urinary tract infections may be determined using the skewness of the histogram.

  Hereinafter, a method for determining whether or not there is one peak using the skewness of the histogram will be described.

In the histogram of the above embodiment, assuming that the number of data is n, the number of bacteria corresponding to each angle is X _i , the average number of bacteria is X _a , and the standard deviation is S (X), the skewness α ₃ is It is calculated by the following formula.

When the histogram is a symmetrical distribution such as a normal distribution, the value of the skewness α ₃ is zero. When skewness alpha ₃ is negative, the distribution is skewed in the negative, the histogram skirt is long in the left. When the skewness α ₃ is positive, the distribution is positively distorted, and the histogram has a shape with a long tail on the right.

  When the histogram is bilaterally symmetric, there is a high possibility that only one peak appears on the histogram. On the other hand, if the histogram is greatly distorted in the positive or negative direction, multiple peaks appear on the histogram, or other peaks appear on the histogram but only one peak appears. There is a high possibility that the peak is buried.

Therefore, when the value of the skewness α ₃ is within a predetermined range from 0 to positive and negative, it is assumed that there is one peak. On the other hand, when the value of the skewness α ₃ is outside this range, the peak Can be determined to exist. That is, by adjusting the positive / negative threshold range of the skewness α ₃ for determining whether there are a plurality of peaks, the histogram has one peak depending on whether the skewness α ₃ is outside this threshold range. It can be determined whether or not there is.

  FIG. 13A is a part of a processing flowchart of “analysis processing” when S121 is used instead of S108 and S109 in FIG. 6 as to whether or not there is one peak. If the absolute value of the skewness of the histogram created in S106 is less than or equal to a predetermined value (threshold value) (S121: YES), it is assumed that there is one peak in the histogram, and the urinary tract infection of the sample that is the source of this measurement data Is determined to be a simple urinary tract infection (S110). On the other hand, when the absolute value of the skewness of the histogram created in S106 is larger than the predetermined value (S121: NO), the classification of the urinary tract infection of the specimen that is the basis of this measurement data is that there are a plurality of histogram peaks. It is determined that this is a complicated urinary tract infection (S111).

  According to this determination processing, even in a histogram in which a plurality of peaks appear due to the influence of noise or the like, it is assumed that there is one peak because the shape of the histogram is substantially bilaterally symmetrical. The classification of the urinary tract infection of the specimen is determined as simple urinary tract infection. In addition, when only one peak appears on the histogram but other peaks are buried in the long part, it is assumed that there are multiple peaks, and the urinary tract infection of the sample that is the source of this measurement data The symptom classification is determined to be complicated urinary tract infection.

  FIG. 13B is a part of a processing flowchart of “analysis processing” when S121 is added between S109 and S110 in FIG. 6 as to whether or not there is one peak. In this case, in addition to determining whether the histogram has one peak in S109, the shape of the histogram is determined based on the skewness in S121. In this way, even if it is determined that there is one peak, if the bottom of the histogram has a long left and right shape, the classification of the urinary tract infection of the specimen that is the basis of this measurement data is that it is a complicated urinary tract infection Determined.

  In the above embodiment, the measurement results and analysis results at the four measurement dates and times are displayed simultaneously on the time series display screen 500 in FIG. 11, but the measurement results and analyzes at a plurality of measurement dates and times are not limited to four. The results may be displayed simultaneously. When the measurement result and the analysis result do not fit into one screen, a scroll bar for moving the display area may be installed on the time series display screen 500, or a page switching button for switching pages is installed. May be.

  Further, although the display based on the measurement data continuous in time series is performed on the time series display screen 500, the display based on the measurement data not continuous in time series may be performed. Any four measurement dates arranged in time series by the user may be selected.

  In the above embodiment, characters are displayed in the change information area 408 of the information display screen 400 and the change information areas 516, 526, 536, and 546 of the time series display screen 500. In addition to the display, symbols and figures that are easy to grasp visually may be displayed.

  In the above embodiment, the medication information areas 551, 552, and 553 of the time-series display screen 500 indicate only that medication has been performed. You may be made to do. When the medication information area is pressed (for example, clicked), the medication date and time and the medication content corresponding to this medication information may be displayed in a pop-up manner.

  In the above embodiment, the change information area 408 in FIG. 10 compares the previous and current analysis results and displays change information indicating that the analysis results have changed. The previous analysis result and the current analysis result may be compared. For example, the analysis result obtained from the measurement at an arbitrary date and time before this time may be compared with the analysis result this time.

  In the above embodiment, the change information area 408 and the change information areas 516, 526, 536, and 546 display “no change” in the change information area when there is no change in the analysis result. Alternatively, the change information area itself may not be displayed.

  In the above embodiment, when it is determined whether there is a change in the analysis result, it is determined that there is a change in the classification of the urinary tract infection or the type of bacteria, as shown in S210 of FIG. However, the present invention is not limited to this, and it may be determined that the number of types of bacteria has changed.

  FIG. 14 is a process flowchart of “change information display” in this case. In FIG. 14, S221 to S223 are added and S210 is changed to S224 from the flowchart of FIG. Only the additional part will be described below.

  As a result of the comparison in S203, the CPU 301 determines whether there is a change in the number of bacterial types between the previous bacterial type and the current bacterial type (S221). When it is determined that there is a change (S221: YES), the CPU 301 assigns 1 to the type number flag (S222), and when it is determined that there is no change (S221: NO), the CPU 301 sets the type number flag to 0. Substitute (S223).

Next, the CPU 301 determines whether the urinary tract infection flag is 1, the type flag is 1, or the type number flag is 1 (S224). When it is determined that the urinary tract infection flag is 1, the type flag is 1, or the number of types flag is 1 (S224: YES), the display unit 320 of the information processing device 3 displays that there is a change. (S211), the process ends.

  FIG. 15 is an exemplary diagram of an information display screen 400 displayed on the display unit 320 of the information processing device 3 in this case. In FIG. 15, the content displayed in the change information area 408 of FIG. 10 is changed.

  In the change information area 411, in addition to the display contents of the change information area 408 in FIG. 10, “number of types” indicating that the number of types has changed is displayed. In this case, also in the time-series display screen 500 shown in FIG. 11, “number of types” indicating that the number of types has changed is displayed in the change information areas 516, 526, 536, and 546.

  In addition, the embodiment of the present invention can be variously modified as appropriate within the scope of the technical idea shown in the claims.

1 ... Urine sample analyzer (sample analyzer)
2 ... Measuring device 203 ... Optical detector (detector)
203a ... Light emitting part (light source part)
203f PD (detection unit)
203k PMT (detector)
301 ... CPU (control unit)
304: Hard disk (storage unit)
320 ... Display section

Claims (11)

A light source unit for irradiating light to a measurement sample prepared from a specimen and a reagent of a subject;
A detection unit for detecting scattered light and fluorescence generated from particles in the measurement sample by light from the light source unit;
A storage unit;
Scattergrams plotting the particles in a sample based on the detected scattered light information and fluorescence information by the detecting unit, is divided into a plurality of regions in a predetermined tilt angle every was rotated around a predetermined point, the Based on the number of plots included in the region, obtain a measurement result regarding the type of bacteria in the sample, and store the obtained measurement result in the storage unit,
A display unit,
When the previous measurement result for the same subject as the measurement result acquired this time is stored in the storage unit, the control unit, based on the current measurement result and the previous measurement result, in the sample of the subject It is determined whether there is a change in the type of bacteria, and if there is a change in the type of bacteria in the subject's sample, information indicating that there is a change is displayed on the display unit.
A sample analyzer characterized by that. The sample analyzer according to claim 1 ,
Wherein, based on the number of the plot than adjacent regions have the multi-area to determine bacterial types in a sample of said subject,
A sample analyzer characterized by that. The sample analyzer according to claim 1 or 2 ,
Wherein, based on the inclination angle peak in the histogram showing the frequency of number of plots for each tilt angle is present, determines bacteria types in a sample of said subject,
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 3 ,
The control unit determines whether there is a change in the number of types of bacteria in the specimen of the subject based on the current measurement result and the previous measurement result,
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 4 ,
The sample analyzer is used for analyzing a urine sample of a subject,
Based on the measurement result obtained this time and the measurement result of the subject stored in the storage unit, whether the urinary tract infection of the subject has changed between simplicity and complexity. Whether or not there is a change, and information indicating that there is a change is displayed on the display unit together with the measurement result .
A sample analyzer characterized by that. In the sample analyzer according to any one of claims 1 to 5 ,
The control unit stores the administration history of the subject's medicine in the storage unit for each subject.
A sample analyzer characterized by that. The sample analyzer according to claim 6 ,
The control unit displays the measurement results of the subject in chronological order and also displays the administration history of the subject's medicine.
A sample analyzer characterized by that. The sample analyzer according to claim 7 ,
The control unit displays, as a display related to the measurement result of the subject, a scattergram generated based on the scattered light information and the fluorescence information acquired from the specimen of the subject, along with a display of the administration history of the medicine, in time series To display,
A sample analyzer characterized by that. In the sample analyzer according to claim 3,
The control unit causes the display unit to display an information display screen including the scattergram, the histogram, the type of bacteria in the subject's sample, and information indicating that there is a change in the type of bacteria. ,
A sample analyzer characterized by that. The sample analyzer according to claim 9,
When the control unit obtains the measurement result, the information display screen is automatically displayed on the display unit.
A sample analyzer characterized by that. Irradiate the measurement sample prepared from the subject's specimen and reagent with light ,
A plurality of scattergrams plotting the particles in a sample based on the scattered light information and fluorescence information obtained for particles in the measurement sample by the irradiation of the light, for each predetermined angle of inclination and the rotation around a predetermined point , And based on the number of plots included in each region, obtain measurement results regarding the type of bacteria in the sample , store the obtained measurement results in the storage unit ,
When the previous measurement result for the same subject as the measurement result acquired this time is stored in the storage unit, the type of bacteria in the subject's sample changes based on the current measurement result and the previous measurement result. If there is a change, information indicating that there is a change is displayed.
A sample analysis method characterized by the above.

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