Patent Abstract:
A sample analyzer comprising: a light source for emitting light to particles contained in a measurement sample which is prepared from a reagent and a urine sample collected from a subject; a detector for detecting scattered light and fluorescence which are generated from the particles in the measurement sample; a display; and a controller, wherein the controller executes operations comprising: obtaining particle data based on the scattered light and the fluorescence which are detected from the particles by the detector; and controlling, when the particle data satisfies a predetermined condition, the display to display information indicating a possibility that the subject is infected with an uncomplicated urinary tract infection is disclosed.

Full Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119 to Japanese Patent Application No. 2010-3211 filed on Jan. 8, 2010 and Japanese Patent Application No. 2010-3215 filed on Jan. 8, 2010, the entire contents of which are hereby incorporated by reference. 
       FIELD OF THE INVENTION 
       [0002]    The present invention relates to a sample analyzer for analyzing a sample by irradiating, with light, a measurement sample which is prepared from a sample and a reagent. 
       BACKGROUND 
       [0003]    Currently, detection of bacteria is performed in clinical laboratory tests and the like. Detection of bacteria can be performed, for example, by a method in which a sample is cultured and colonies formed in the sample are visually examined. This method allows the types and number of bacteria contained in the sample to be identified. However, it takes a few days for the colonies to form in the cultured sample. Thus, this examination method has a problem in that it lacks promptness. 
         [0004]    In relation to this problem, U.S. patent application publication 20040219627 discloses a bacteria determination method that uses a scattergram. In this method, a scattergram is created, in which size information and fluorescence information about bacteria in a sample are used as parameters. Then, the state of distribution of bacteria in the scattergram is analyzed. Based on the analysis results, it is determined whether the type of bacteria in the sample is a bacillus or a coccus. 
         [0005]    However, with the method disclosed by U.S. patent application publication 20040219627, if multiple types of bacteria are contained in a sample, it is difficult to determine the respective types of bacteria in the sample. Therefore, even if the method of U.S. patent application publication 20040219627 is used in analysis of a urine sample, it is difficult for the user of the method to determine whether a urinary tract infection indicated by the urine sample is a complicated urinary tract infection or uncomplicated urinary tract infection. 
         [0006]    Moreover, although the method of U.S. patent application publication 20040219627 determines a bacterial type, the method is unable to provide other information to the user. In terms of treatment and diagnosis, if, for example, the user is promptly informed that the types of bacteria in a sample collected from a subject have changed as compared to another sample previously collected from the same subject, then the user can properly know the progression of a disease of the subject as well as the effectiveness of medication and treatment of the disease that have been performed. Such information allows the user to take appropriate measures to address the disease of the subject. 
       SUMMARY OF THE INVENTION 
       [0007]    A first aspect of the present invention is a sample analyzer comprising: a light source for emitting light to particles contained in a measurement sample which is prepared from a reagent and a urine sample collected from a subject; a detector for detecting scattered light and fluorescence which are generated from the particles in the measurement sample; a display; and a controller, wherein the controller executes operations comprising: obtaining particle data based on the scattered light and the fluorescence which are detected from the particles by the detector; and controlling, when the particle data satisfies a predetermined condition, the display to display information indicating a possibility that the subject is infected with an uncomplicated urinary tract infection. 
         [0008]    A second aspect of the present invention is a sample analyzer comprising: a light source for emitting light to particles contained in a measurement sample which is prepared from a sample and a reagent; a detector for detecting scattered light and fluorescence which are generated from the particles in the measurement sample; a display; and a controller, wherein the controller executes operations comprising: obtaining, for each particle in the measurement sample, particle data which comprise numerical values obtained from the scattered light and the fluorescence detected from the particle; determining one of a plurality of numerical ranges to which each of the particle data belongs; generating a histogram that indicates, for each numerical value range, the number of particles belonging thereto; and controlling the display to display the histogram. 
         [0009]    A third aspect of the present invention is a sample analyzer comprising: a light source for emitting light to a measurement sample which is prepared from a reagent and a sample collected from a subject; a detector for detecting scattered light and fluorescence which are generated from the measurement sample; a memory; a display; and a controller, wherein the controller executes operations comprising: obtaining a measurement result based on the scattered light and the fluorescence; storing the measurement result in the memory; determining, based on the measurement result of the subject that has most recently been obtained and the measurement result of the subject that has previously been stored in the memory, whether a type of bacteria that the subject is suspected to be infected with has changed; and controlling, when the type of bacteria has changed, the display to display information indicating that the type of bacteria has changed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  shows an external configuration of a urine sample analyzer according to an embodiment of the present invention; 
           [0011]      FIG. 2  shows a configuration of a measurement apparatus according to the embodiment; 
           [0012]      FIG. 3  is a schematic diagram showing configurations of an optical detector and an analogue signal processing circuit according to the embodiment; 
           [0013]      FIG. 4  shows a configuration of an information processing apparatus according to the embodiment; 
           [0014]      FIG. 5  shows flowcharts showing a measurement process of measuring a sample and an analysis process of analyzing the sample, according to the embodiment; 
           [0015]      FIG. 6  is a flowchart showing the analysis process according to the embodiment; 
           [0016]      FIG. 7A  shows a scattergram according to the embodiment; 
           [0017]      FIG. 7B  illustrates dividing the scattergram according to the embodiment; 
           [0018]      FIG. 7C  shows areas each used for measuring the number of bacteria on the scattergram, according to the embodiment; 
           [0019]      FIG. 8A  shows an example of a histogram according to the embodiment; 
           [0020]      FIG. 8B  shows an example of a histogram according to the embodiment; 
           [0021]      FIG. 9  is a flowchart showing a process of displaying change information according to the embodiment; 
           [0022]      FIG. 10  shows an example of an information display screen displayed by a display unit of the information processing apparatus according to the embodiment; 
           [0023]      FIG. 11  shows an example of a chronological display screen displayed by the display unit of the information processing apparatus according to the embodiment; 
           [0024]      FIG. 12  shows an example of a medication administration history screen displayed by the display unit of the information processing apparatus according to the embodiment; 
           [0025]      FIG. 13A  shows a variation of the flowchart showing the analysis process according to the embodiment; 
           [0026]      FIG. 13B  shows a variation of the flowchart showing the analysis process according to the embodiment; 
           [0027]      FIG. 14  shows a variation of the flowchart showing the process of displaying change information according to the embodiment; and 
           [0028]      FIG. 15  shows a variation of the information display screen displayed by the display unit of the information processing apparatus according to the embodiment. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0029]    In an embodiment described below, the present invention is applied to a urine sample analyzer for performing measurement on bacteria contained in a urine sample and determining based on the measurement results the types of bacteria in the urine sample. 
         [0030]    Hereinafter, the urine sample analyzer according to the present embodiment will be described with reference to the drawings. 
         [0031]      FIG. 1  shows an external configuration of a urine sample analyzer  1  according to the present embodiment. 
         [0032]    The urine sample analyzer  1  includes a measurement apparatus  2  and an information processing apparatus  3 . The measurement apparatus  2  optically measures bacteria contained in a urine sample by means of a flow cytometer. The information processing apparatus  3  analyzes the results of the measurement performed by the measurement apparatus  2 , and displays the analysis results on a display unit  320 . 
         [0033]      FIG. 2  shows a configuration of the measurement apparatus  2 . 
         [0034]    The measurement apparatus  2  includes a sample dispenser  201 , a sample preparation section  202 , an optical detector  203 , a signal processing circuit  210 , a CPU  204 , a communication interface  205 , and a memory  206 . The signal processing circuit  210  includes an analogue signal processing circuit  211 , an A/D converter  212 , a digital signal processing circuit  213 , and a memory  214 . 
         [0035]    The sample dispenser  201  includes a pipette and a pump (not shown). When the pump is driven, a predetermined amount of sample (urine) is aspirated into the pipette, and then the sample that has been aspirated into the pipette is discharged. By means of the pipette and the pump, the sample dispenser  201  supplies the sample preparation section  202  with the predetermined amount of sample that the sample dispenser  201  has aspirated from a sample container. 
         [0036]    The sample preparation section  202  includes a reagent container, a mixing container, and a pump (not shown). In the mixing container, the sample supplied from the sample dispenser  201  is mixed with a diluent solution and a staining solution that are supplied from the reagent container, and thereby a measurement sample is prepared. The measurement sample prepared in the mixing container is supplied by the pump to a sheath flow cell  203   c  (see  FIG. 3 ) of the optical detector  203 , together with a sheath liquid. 
         [0037]    The optical detector  203  emits laser light to the measurement sample, and outputs electrical signals to the analogue signal processing circuit  211 , which electrical signals are based on forward scattered light, side fluorescence, and side scattered light which are generated when the measurement sample is irradiated with the laser light. In accordance with an instruction from the CPU  204 , the analogue signal processing circuit  211  amplifies the electrical signals outputted from the optical detector  203 , and outputs the amplified electrical signals to the A/D converter  212 . 
         [0038]    The A/D converter  212  converts the electrical signals amplified by the analogue signal processing circuit  211  into digital signals, and outputs the digital signals to the digital signal processing circuit  213 . In accordance with an instruction from the CPU  204 , the digital signal processing circuit  213  performs predetermined waveform processing on the digital signals outputted from the A/D converter  212 , and the digital signals on which the waveform processing has been performed are stored in the memory  214 . Here, the digital signals stored in the memory  214  include signals that are based on pulse signals of forward scattered light and side fluorescence which are generated each time a bacterium passes through the sheath flow cell  203   c.    
         [0039]    The CPU  204  controls the analogue signal processing circuit  211  and the digital signal processing circuit  213 . Also, the CPU  204  obtains, from the digital signals stored in the memory  214 , the magnitude of each of the pulse signals of the forward scattered light and the side fluorescence. Here, the magnitude of a pulse signal of forward scattered light indicates the intensity of the forward scattered light, which is generated when a bacterium passes through the sheath flow cell  203   c . Similarly, the magnitude of a pulse signal of side fluorescence indicates the intensity of the side fluorescence, which is generated when a bacterium passes through the sheath flow cell  203   c . Here, the magnitude of the pulse signal of the forward scattered light represents the size of the bacterium, and the magnitude of the pulse signal of the side fluorescence represents the degree of staining of the nucleic acid of the bacterium. 
         [0040]    After obtaining the magnitudes of the respective pulse signals of the forward scattered light and the side fluorescence, the CPU  204  generates, based on the magnitudes of the respective pulse signals, data cluster that indicates a forward scattered light intensity and a side fluorescence intensity for each of the bacteria that have passed through the sheath flow cell  203   c  (hereinafter, the data cluster is referred to as “measurement data”). The CPU  204  outputs the measurement data to the communication interface  205 . Further, the CPU  204  receives control signals from the information processing apparatus  3  via the communication interface  205 , and drives the respective components of the measurement apparatus  2  in accordance with the control signals. 
         [0041]    The communication interface  205  transmits to the information processing apparatus  3  the measurement data outputted from the CPU  204 , and receives the control signals outputted from the information processing apparatus  3 . The memory  206  is used as a work area for the CPU  204 . 
         [0042]      FIG. 3  is a schematic diagram showing configurations of the optical detector  203  and the analogue signal processing circuit  211  of the measurement apparatus  2 . 
         [0043]    The optical detector  203  includes a light emitter  203   a , an irradiation lens unit  203   b , the sheath flow cell  203   c , a condenser lens  203   d , a pinhole plate  203   e , a PD (photodiode)  203   f , a condenser lens  203   g , a dichroic mirror  203   h , an optical filter  203   i , a pinhole plate  203   j , a PMT (photomultiplier tube)  203   k , and a PD (photodiode)  203   l . The analogue signal processing circuit  211  includes amplifiers  211   a ,  211   b , and  211   c.    
         [0044]    Laser light emitted from the light emitter  203   a  is converted by the irradiation lens unit  203   b  into parallel light, and a sample flow containing the measurement sample is irradiated with the parallel light when passing through the sheath flow cell  203   c . Note that the measurement sample passing through the sheath flow cell  203   c  is a mixture of a sample (a urine sample) to be measured and the aforementioned diluent solution and staining solution. 
         [0045]    The condenser lens  203   d  is disposed in the path of the laser light emitted from the light emitter  203   a . The forward scattered light, which is generated at the sheath flow cell  203   c , is converged by the condenser lens  203   d , and passes through the pinhole plate  203   e , before being received by the PD  203   f.    
         [0046]    The condenser lens  203   g  is disposed in a path that intersects the path of the laser light emitted from the light emitter  203   a . The side fluorescence and the side scattered light, which are generated at the sheath flow cell  203   c , are converged by the condenser lens  203   g  and fall on the dichroic mirror  203   h . The dichroic mirror  203   h  separates the side fluorescence and the side scattered light. The side fluorescence separated by the dichroic mirror  203   h  passes through the optical filter  203   i  and the pinhole plate  203   j , and is then received by the PMT  203   k . The side scattered light separated by the dichroic mirror  203   h  is received by the PD  203   l.    
         [0047]    The PD  203   f , the PMT  203   k , and the PD  203   l  output electrical signals based on the received forward scattered light, side fluorescence, and side scattered light, respectively. The amplifiers  211   a ,  211   b , and  211   c  amplify the electrical signals outputted from the PD  203   f , the PMT  203   k , and the PD  203   l , respectively, and output the resultant signals to the A/D converter  212 . Note that the amplifiers  211   a ,  211   b , and  211   c  are included in the analogue signal processing circuit  211  shown in  FIG. 2 . 
         [0048]      FIG. 4  shows a configuration of the information processing apparatus  3 . 
         [0049]    The information processing apparatus  3  is structured as a personal computer, and includes a body  300 , an input unit  310 , and the display unit  320  (see  FIG. 1 ). The body  300  includes a CPU  301 , a ROM  302 , a RAM  303 , a hard disk  304 , a readout device  305 , an input/output interface  306 , an image output interface  307 , and a communication interface  308 . 
         [0050]    The CPU  301  executes a computer program stored in the ROM  302  and a computer program loaded into the RAM  303 . The RAM  303  is used for loading computer programs that are stored in the ROM  302  and the hard disk  304 . The RAM  303  is also used as a work area for the CPU  301  when these computer programs are executed. 
         [0051]    In the hard disk  304 , various computer programs executed by the CPU  301 , such as an operating system and application programs, and data used for executing these computer programs, are installed. Further, the hard disk  304  stores measurement data received from the measurement apparatus  2  and a medication administration history which will be described below. 
         [0052]    In addition, in the hard disk  304 , a program for obtaining based on the measurement data the number of bacteria contained in a sample and for performing analysis of the sample, and a display program for displaying the analysis results on the display unit  320 , are installed. These installed programs allow an analysis process and a display process to be performed. These processes will be described below. That is, owing to these programs, the CPU  301  has functions of performing processing as shown in (b) of  FIG. 5 ,  FIG. 6 , and  FIG. 9  as well as functions of displaying screens as shown in  FIG. 10  to  FIG. 12 . These functions will be described below. 
         [0053]    The readout device  305  is structured as a CD drive, DVD drive, or the like. The readout device  305  is configured to read a computer program and data that are stored in an external storage, for example, an external storage medium. Accordingly, programs executed by the information processing apparatus  3  can be updated via an external storage, for example, an external storage medium. 
         [0054]    The input unit  310 , which includes a mouse and a keyboard, is connected to the input/output interface  306 . The user uses the input unit  310  to give instructions to the information processing apparatus  3 . The image output interface  307  is connected to the display unit  320 , which includes a display and the like. The image output interface  307  outputs image signals based on image data to the display unit  320 . The display unit  320  displays images based on the image signals that are inputted from the image output interface  307 . 
         [0055]    By means of the communication interface  308 , the information processing apparatus  3  can receive measurement data that is transmitted from the measurement apparatus  2 . The received measurement data is stored in the hard disk  304 . 
         [0056]      FIG. 5  shows flowcharts showing control performed by the CPU  204  of the measurement apparatus  2  and control performed by the CPU  301  of the information processing apparatus  3 . A flowchart (a) in  FIG. 5  shows a measurement process performed by the CPU  204  of the measurement apparatus  2 , and a flowchart (b) in  FIG. 5  shows an analysis process performed by the CPU  301  of the information processing apparatus  3 . 
         [0057]    Referring to (b) in  FIG. 5 , when a measurement start instruction is provided from the user via the input unit  310  (S 11 : YES), the CPU  301  transmits a measurement start signal to the measurement apparatus  2  (S 12 ). Next, the CPU  301  determines whether measurement data has been received (S 13 ). If measurement data has not been received (S 13 : NO), the CPU  301  does not advance the processing. 
         [0058]    Referring to (a) in  FIG. 5 , when the CPU  204  receives the measurement start signal from the information processing apparatus  3  (S 21 : YES), the CPU  204  performs a sample measurement as described above (S 22 ). When the sample measurement is completed, the CPU  204  transmits measurement data to the information processing apparatus  3  (S 23 ), and returns the processing to S 21 . 
         [0059]    Referring to (b) in  FIG. 5 , when the CPU  301  receives the measurement data from the measurement apparatus  2  (S 13 : YES), the CPU  301  stores the measurement data in the hard disk  304 , and performs the analysis process based on the measurement data (S 14 ). Then, the CPU  301  causes the display unit  320  to display analysis results obtained at S 14  (S 15 ), and causes the display unit  320  to display change information based on the analysis results (S 16 ). Thereafter, the processing returns to S 11 . Note that the analysis process performed at S 14  is described below with reference to  FIG. 6 , and the process of displaying change information that is performed at S 16  is described below with reference to  FIG. 9 . 
         [0060]      FIG. 6  is a processing flowchart showing the analysis process performed at S 14  of  FIG. 5 . 
         [0061]    First, the CPU  301  loads the measurement data from the hard disk  304  into the RAM  303 . Based on the loaded measurement data, the CPU  301  creates a two-dimensional scattergram of which the vertical axis represents forward scattered light intensity and the horizontal axis represents side fluorescence intensity (S 101 ). In the two-dimensional scattergram, pieces of the measurement data are plotted. Each piece of the measurement data indicates a forward scattered light intensity and a side fluorescence intensity of a single bacterium.  FIG. 7A  shows an example of the scattergram created at S 101 . Based on the created two-dimensional scattergram, the CPU  301  measures the total number of bacteria contained in the measurement sample (S 102 ). 
         [0062]    Next, the CPU  301  determines whether the number of bacteria contained in the measurement sample is greater than or equal to a predetermined value (S 103 ). To be specific, the CPU  301  obtains the number of bacteria contained in 1 mL of the sample from the total number of bacteria measured at S 102 , and determines whether the number of bacteria contained in 1 mL of the sample is greater than or equal to the predetermined value. Note that, in the present embodiment, the predetermined value used in the determination at S 103  is a threshold bacterial count that is used for determining whether a subject from whom the sample was collected is infected with a urinary tract infection. The threshold bacterial count is, for example, 1.0×10̂4 in 1 mL of the sample. 
         [0063]    If the CPU  301  determines that the number of bacteria contained in the measurement sample is not greater than or equal to the predetermined value (S 103 : NO), then the CPU  301  determines that the subject is not infected with a urinary tract infection (S 104 ) and ends the processing. On the other hand, if the CPU  301  determines that the number of bacteria contained in the measurement sample is greater than or equal to the predetermined value (S 103 : YES), the processing proceeds to S 105 . 
         [0064]    Next, the CPU  301  divides the two-dimensional scattergram created at S 101  into a plurality of areas by using predetermined slope angles (S 105 ). The CPU  301  measures the number of bacteria contained in each of the areas of the two-dimensional scattergram divided at S 105  (S 106 ). 
         [0065]    Hereinafter, the plurality of areas of the scattergram will be described with reference to  FIG. 7B  and  FIG. 7C . 
         [0066]      FIG. 7B  is a schematic diagram showing the scattergram divided at S 105 . 
         [0067]    In  FIG. 7B , straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc., are straight lines each extending in a radial direction of a virtual circle A whose center is the origin (i.e., origin O) of the scattergram. The straight line d 0  coincides with the horizontal axis of the scattergram. As shown in  FIG. 7B , each of the other straight lines forms an angle θ with straight lines adjacent thereto. Areas D 0 , D 1 , D 2 , D 3 , etc., are a result of dividing the scattergram by the straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc. Note that the angle θ may be set to any angle, for example, 1 degree or 10 degrees. After the scattergram is divided into the plurality of areas in this manner, a rectangular area B which contains the origin O is excluded from the areas D 0 , D 1 , D 2 , D 3 , etc. 
         [0068]      FIG. 7C  shows areas each used for measuring the number of bacteria on the scattergram. As shown in  FIG. 7C , areas E 0 , E 1 , E 2 , E 3 , etc., which are each used for measuring the number of bacteria, are a result of excluding the area B from the areas D 0 , D 1 , D 2 , D 3 , etc., shown in  FIG. 7B . 
         [0069]    Here, the area B is excluded from the areas D 0 , D 1 , D 2 , D 3 , etc., of  FIG. 7B  for the purpose of improving the accuracy of determination of the classification of a urinary tract infection and the accuracy of determination of types of bacteria. These determinations will be described below. To be specific, as shown in the scattergram of  FIG. 7A , distributions of bacteria tend to concentrate near the origin O. For this reason, if bacteria distributed near the origin O are counted in each of the areas D 0 , D 1 , D 2 , D 3 , etc., then differences are not likely to occur among the counting results of the respective areas. This hinders smooth determination of bacteria. Moreover, in the area B, as compared to other areas (i.e., areas where the forward scattered light intensity and the side fluorescence intensity are greater than those in the area B), areas divided by the straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc., are small. Furthermore, distributions of different types of bacteria tend to overlap each other near the origin O. Therefore, if bacteria are counted in an area near the origin, it is likely that a large number of bacteria that are not intended to be counted in the area are counted. This causes a significant error in the counting result. 
         [0070]    For the above reasons, the area B is excluded from the areas D 0 , D 1 , D 2 , D 3 , etc., so that bacteria near the origin O are not counted in the determination of the classification of a urinary tract infection and the determination of types of bacteria, which determinations are described below, and so that the numbers of bacteria contained in the respective areas, which are obtained from the counting, may significantly differ from each other. 
         [0071]    Note that the size of the area B is set such that types of bacteria that are determined based on the numbers of bacteria contained in the respective areas E 0 , E 1 , E 2 , E 3 , etc., are closest to those determined based on measurement results that would be obtained by a measurement method in which cultured bacteria are used. 
         [0072]    Returning to  FIG. 6 , next, the CPU  301  creates a histogram based on the numbers of bacteria that are obtained at S 106  for the areas E 0 , E 1 , E 2 , E 3 , etc., respectively (S 107 ). 
         [0073]      FIG. 8A  shows an example of the histogram created at S 107 . In  FIG. 8A , the horizontal axis represents angles, with respect to the straight line d 0 , of the straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc., which divide the areas E 0 , E 1 , E 2 , E 3 , etc. That is, the horizontal axis corresponds to the areas E 0 , E 1 , E 2 , E 3 , etc., in order of their angle with respect to the straight line d 0 , from the smallest angle to the greatest angle. The vertical axis represents the numbers of bacteria that are contained in the areas E 0 , E 1 , E 2 , E 3 , etc., respectively. 
         [0074]    Returning to  FIG. 6 , next, the CPU  301  selects, in the histogram created at S 107 , the area(s) that shows a peak of the number of bacteria (S 108 ). 
         [0075]    Here, an area that shows a peak of the number of bacteria is an area (an angular range) which corresponds to the peak of a raised portion of the histogram. That is, among the areas E 0 , E 1 , E 2 , E 3 , etc., an area for which the number of bacteria counted therein is greater than the number of bacteria counted in adjacent areas that precede and follow the area in terms of the size of the angle with respect to the straight line d 0 , is selected as a peak area. 
         [0076]    For example, the histogram of  FIG. 8A  shows a single peak of the number of bacteria. At the peak, the bacterial count is N 1 . In this case, the CPU  301  selects an area En 1  that corresponds to the peak.  FIG. 8B  shows another example of a histogram. The histogram of  FIG. 8B  shows two peaks of the number of bacteria. At these two peaks, the bacterial counts are N 2  and N 3 , respectively. In this case, the CPU  301  selects an area En 2  which corresponds to the peak at the left of the histogram and an area En 3  which corresponds to the peak at the right of the histogram. 
         [0077]    Next, if the number of areas selected at S 108  as corresponding to a peak of the number of bacteria is one (S 109 : YES), then the CPU  301  determines that the classification of a urinary tract infection indicated by the sample from which the measurement data has been obtained is an uncomplicated urinary tract infection (S 110 ). On the other hand, if the number of areas selected at S 108  as corresponding to a peak of the number of bacteria is two or more (S 109 : NO), then the CPU  301  determines that the classification of a urinary tract infection indicated by the sample from which the measurement data has been obtained is a complicated urinary tract infection (S 111 ). 
         [0078]    Subsequently, based on the area(s) selected at S 108 , the CPU  301  determines the type(s) of bacteria contained in the sample from which the measurement data has been obtained (S 112 ). To be specific, the CPU  301  determines the type(s) of bacteria contained in the sample based on whether the angular range, with respect to the straight line d 0 , of the area(s) selected at S 108  is included among angular ranges that are preset for the purpose of specifying bacterial types. For example, in the case of  FIG. 7B , the angular range of the area D 2  is 2θ to 3θ. If the area D 2  is selected at S 108 , the type of bacteria contained in the area D 2  is determined based on which angular range, among the angular ranges that are preset for the purpose of specifying bacterial types, includes the angular range of 2θ to 3θ. 
         [0079]    In the present embodiment, the angular ranges used for specifying bacterial types are set as shown below. 
         [0080]    (a) 0° to 25° . . . Bacilli 
         [0081]    (b) 26° to 44° . . . Streptococci 
         [0082]    (c) 45° to 80° . . . Staphylococci 
         [0083]    (d) 81° to 90° . . . Not Applicable 
         [0084]    Note that, in the present embodiment, if the number of areas selected at S 108  is three or more, then bacterial types are determined only for the areas for which the numbers of bacteria counted therein are the greatest and the second greatest among the selected areas. However, as an alternative, bacterial types may be determined for the areas for which the numbers of bacteria counted therein are the greatest, the second greatest, and the third greatest among the selected areas. As a further alternative, bacterial types may be determined for all of the select areas. 
         [0085]    Next, the CPU  301  stores the analysis results in the hard disk  304  (S 113 ), which analysis results contain the classification of urinary tract infection and the bacterial type(s) obtained in the above manner. Then, the processing ends. 
         [0086]      FIG. 9  is a processing flowchart showing the process of displaying change information that is performed at S 16  of  FIG. 5 . 
         [0087]    First, the CPU  301  determines whether the analysis results obtained from the most recently performed analysis and the analysis results obtained from the immediately previously performed analysis are all stored in the hard disk  304  regarding the subject from whom the sample was collected for the most recently performed analysis (S 201 ). If the analysis results obtained from the most recently performed analysis and the analysis results obtained from the immediately previously performed analysis are not all stored in the hard disk  304  (S 201 : NO), the processing ends. If the analysis results obtained from the most recently performed analysis and the analysis results obtained from the immediately previously performed analysis are all stored in the hard disk  304  (S 201 : YES), the CPU  301  loads the most recent analysis results and the immediately previous analysis results into the RAM  303  (S 202 ), and compares the most recent analysis results and the immediately previous analysis results (S 203 ). 
         [0088]    Next, based on the result of the comparison at S 203 , the CPU  301  determines whether the classification of urinary tract infection indicated by the most recent analysis results has changed from that indicated by the immediately previous analysis results (S 204 ). If it is determined that the classification of urinary tract infection has changed (S 204 : YES), the CPU  301  assigns 1 to a urinary tract infection flag (S 205 ). On the other hand, if it is determined that the type of urinary tract infection has not changed (S 204 : NO), the CPU  301  assigns 0 to the urinary tract infection flag (S 206 ). 
         [0089]    Subsequently, the CPU  301  determines based on the result of the comparison at S 203  whether the bacterial type indicated by the most recent analysis results has changed from that indicated by the immediately previous analysis results (S 207 ). If it is determined that the bacterial type has changed (S 207 : YES), the CPU  301  assigns 1 to a type flag (S 208 ). On the other hand, if it is determined that the bacterial type has not changed (S 207 : NO), the CPU  301  assigns 0 to the type flag (S 209 ). 
         [0090]    Next, the CPU  301  determines whether the urinary tract infection flag is 1 or the type flag is 1 (S 210 ). If it is determined that either the urinary tract infection flag is 1 or the type flag is 1 (S 210 : YES), the CPU  301  causes the display unit  320  of the information processing apparatus  3  to display a message indicating the change (S 211 ). Then, the processing ends. 
         [0091]      FIG. 10  shows an example of an information display screen  400  displayed by the display unit  320  of the information processing apparatus  3 . The information display screen  400  is displayed in accordance with S 15  and S 16  of  FIG. 5 . 
         [0092]    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 bacterial information area  406 , a division angle area  407 , and a change information area  408 . The bacterial information area  406  includes a urinary tract infection classification area  406   a  and a type area  406   b.    
         [0093]    The subject ID area  401  shows a subject ID. The subject ID identifies the subject from whom the sample was collected for the analysis of which the results are shown in the information display screen  400 . The measurement date/time area  402  shows the date and time when the measurement for the analysis was performed. The scattergram area  403  shows a scattergram as in  FIG. 7A  which is obtained based on the performed measurement. The histogram area  404  shows a histogram as in  FIG. 8A  or  8 B which is obtained based on the scattergram shown in the scattergram area  403 . 
         [0094]    The subject information area  405  shows, for example, the name of the subject, the name of the attending doctor, and comments from the attending doctor that are associated with the subject ID. In addition to these types of information, information about medication administered to the subject may be inputted via the input unit  310  (see  FIG. 4 ) and shown in the subject information area  405 . 
         [0095]    The urinary tract infection classification area  406   a  shows the determination result obtained at S 110  or  5111  of the analysis process shown in  FIG. 6 . That is, in a case where the classification of the urinary tract infection indicated by the sample analyzed in the analysis process is an uncomplicated urinary tract infection, the urinary tract infection classification area  406   a  shows “UNCOMPLICATED INFECTION?”. On the other hand, in a case where the classification of the urinary tract infection indicated by the sample analyzed in the analysis process is a complicated urinary tract infection, the urinary tract infection classification area  406   a  shows “COMPLICATED INFECTION?”. 
         [0096]    Note that “?” added at the end of the message shown in the urinary tract infection classification area  406   a  indicates to the user that the sample indicates a high possibility that the subject is infected with an uncomplicated urinary tract infection or a complicated urinary tract infection. If there is no determination provided regarding the classification of urinary tract infection, or the urinary tract infection of the sample cannot be determined to be a specific classification, then the urinary tract infection classification area  406   a  is left blank or shows a message “UNKNOWN”. 
         [0097]    The type area  406   b  shows the bacterial type(s) determined at S 112  of the analysis process shown in  FIG. 6 . Note that “?” added at the end of the message shown in the type area  406   b  indicates that there is a high possibility that the sample contains the bacteria of the type(s) shown in the type area  406   b . If there is no determination provided regarding the bacterial types, or the bacteria contained in the sample cannot be determined to be a specific type(s), the type area  406   b  is left blank or shows a message “UNKNOWN”. 
         [0098]    The division angle area  407  shows the angle θ which is formed between each of the straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc., and the respective straight line(s) adjacent thereto. The straight lines d 0 , d 1 , d 2 , d 3 , d 4 , etc., divide the areas D 0 , D 1 , D 2 , D 3 , etc., as shown in  FIG. 7B . 
         [0099]    The change information area  408  shows, in accordance with the process of displaying change information which is performed as shown in  FIG. 9 , a message indicating that the bacterial type has changed. Here, as shown in  FIG. 10 , the change information area  408  shows “CHANGED” indicating that the most recent analysis results have changed from the immediately previous analysis results. In a case where the classification of urinary tract infection has changed from an uncomplicated infection to a complicated infection, the change information area  408  shows “UNCOMPLICATED→COMPLICATED” together with “CHANGED”. In a case where the bacterial type has changed, the change information area  408  shows “TYPE” together with “CHANGED”. Note that if the analysis results obtained based on the most recent measurement have not changed from the analysis results obtained based on the immediately previous measurement, or if the number of bacteria determined based on the most recent measurement is not greater than or equal to the predetermined value (NO at S 103 ), then the change information area  408  is left blank. 
         [0100]      FIG. 11  shows an example of a chronological display screen  500  which is displayed by the display unit  320  of the information processing apparatus  3 . This screen is displayed when an input operation for displaying a chronological display regarding a particular subject is performed via the input unit  310  of the information processing apparatus  3 . 
         [0101]    The chronological display screen  500  includes: a subject ID area  501 ; measurement date/time areas  511 ,  521 ,  531 , and  541 ; scattergram areas  512 ,  522 ,  532 , and  542 ; histogram areas  513 ,  523 ,  533 , and  543 ; bacterial information areas  514 ,  524 ,  534 , and  544 ; division angle areas  515 ,  525 ,  535 , and  545 ; change information areas  516 ,  526 ,  536 , and  546 ; and medication information areas  551 ,  552 , and  553 . 
         [0102]    Similar to the subject ID area  401  shown in  FIG. 10 , the subject ID area  501  shows a subject ID. The subject ID identifies the subject from whom samples were collected for analyses of which the results are shown in the chronological display screen  500 . 
         [0103]    Each of the four groups of areas  511  to S 16 ,  521  to S 26 ,  531  to S 36 , and  541  to S 46  shows measurement results and analysis results obtained based on a corresponding single measurement. That is, these four groups show four sets of information that are based on four sets of measurement data obtained from four samples that were collected from the same subject at four different dates and times. Each group shows a corresponding one of the four sets of information, in the areas that correspond to the areas  402 ,  403 ,  404 ,  406 ,  407 , and  408  of the information display screen  400  shown in  FIG. 10 . Note that, in the present embodiment, the four sets of measurement data that correspond to these four groups are chronologically successive. 
         [0104]    Each of the change information areas  516 ,  526 ,  536 , and  546  shows whether the bacterial type information obtained based on the most recent measurement has changed from the bacterial type information obtained based on the immediately previous measurement, and if the bacterial type information has changed, shows the details of the change. If the bacterial type information obtained based on the most recent measurement has not changed from the bacterial type information obtained based on the immediately previous measurement, or the number of bacteria determined based on the most recent measurement is not greater than or equal to the predetermined value (NO at S 103 ), then the change information area is left blank. 
         [0105]    In the example of  FIG. 11 , in comparison with the analysis results shown at the leftmost position in  FIG. 11 , the analysis results shown at the second-from-left position in  FIG. 11  indicate a change in the bacterial type from “ BACILLUS ?” to “ STREPTOCOCCUS ?”. Accordingly, the change information area  526  shows “TYPE” indicating that the bacterial type has changed. 
         [0106]    Similarly, since the bacterial type information has changed, as shown in the bacterial information area  534 , from the bacterial type information indicated in the bacterial information area  524 , the change information area  536  at the third-from-left position in  FIG. 11  shows “TYPE” indicating that the bacterial type has changed, and also shows that the classification of urinary tract infection has changed. To be specific, in this case, the classification of urinary tract infection has changed from “UNCOMPLICATED?” to “COMPLICATED?”, and the bacterial type has changed from “ STREPTOCOCCUS ?” to “ STREPTOCOCCUS? STAPHYLOCOCCUS ?”. Therefore, the change information area  536  shows “UNCOMPLICATED→COMPLICATED” indicating that the classification of urinary tract infection has changed from an uncomplicated urinary tract infection to a complicated urinary tract infection, together with “TYPE” indicating that the bacterial type has changed. 
         [0107]    Each of the medication information areas  551 ,  552 , and  553  shows information as to whether medication was administered to the subject between a measurement and a measurement immediately previous thereto. In the example of  FIG. 11 , information indicating that medication was administered to the subject (in this example, a picture of a syringe) between the measurement date/time indicated in the measurement date/time area  511  and the measurement date/time indicated in the measurement date/time area  521 , is shown in the medication information area  551 . Similarly, information indicating that medication was administered to the subject between the measurement date/time indicated in the measurement date/time area  531  and the measurement date/time indicated in the measurement date/time area  541 , is shown in the medication information area  553 . 
         [0108]      FIG. 12  shows an example of a medication administration history screen  600  which is displayed by the display unit  320  of the information processing apparatus  3 . 
         [0109]    The medication administration history screen  600  contains a subject ID area  601 , a medication administration history area  602 , and an edit command area  603 . 
         [0110]    The subject ID area  601  shows a subject ID that identifies a subject to whom medications were administered. The medication administration history area  602  shows a history of medications administered to the subject identified by the subject ID indicated in the subject ID area  601 . 
         [0111]    In the medication administration history area  602 , dates and times when the medications were administered to the subject are shown in association with the details of the administered medications. Such medication administration history is stored in the hard disk  304  of the information processing apparatus  3 . 
         [0112]    Note that, while the screen shown in  FIG. 11  is displayed, if the user uses the input unit  310  of the information processing apparatus  3 , thereby pressing (e.g., by a click), among the medication information areas  551 ,  552 , and  553 , one of the medication information areas  551  and  553  that are showing information (i.e., a picture of a syringe), then the screen shown in  FIG. 12  is displayed. Here, in response to one of the medication information areas  551  and  553  being pressed in the screen shown in  FIG. 11 , a row showing a medication administration date/time and the details of administered medication that correspond to the pressed medication information area, is selectively displayed as shown in  FIG. 12 . In this manner, the user can check the details of the medication. 
         [0113]    The edit command area  603  includes “ADD”, “EDIT”, and “DELETE” buttons for editing the information shown in the medication administration history area  602 . The user can edit the information shown in the medication administration history area  602  by pressing (e.g., by a click) these buttons via the input unit  310 . Note that if the information in the medication administration history area  602  is altered, the information shown in the medication information areas  551 ,  552 , and  553  of the chronological display screen  500  of  FIG. 11  is also altered so as to be consistent with the alteration of the information in the medication administration history area  602 . 
         [0114]    As described above, in the present embodiment, the analysis process as shown in  FIG. 6  is performed based on the forward scattered light and the side fluorescence that are received by the PD  203   f  and the PMT  203   k , respectively. According to the analysis results obtained from the analysis process, the information display screen  400  as shown in  FIG. 10  is displayed by the display unit  320  of the information processing apparatus  3 . If a change in the bacterial type has occurred, the change information area  408  shows a message indicating the change. Accordingly, if treatment was given to the subject from whom the sample was collected, the user can check whether the treatment has been effective for the subject. 
         [0115]    Further, according to the present embodiment, the chronological display screen  500  as in  FIG. 11  shows measurement results and analysis results based on measurement data obtained from four samples that were collected from the same subject at four different dates and times. Accordingly, if treatment was given to the subject from whom the samples were collected, the user can check, chronologically, whether the treatment has been effective for the subject. 
         [0116]    Still further, according to the present embodiment, the medication information areas  551 ,  552 , and  553  in the chronological display screen  500  as in  FIG. 11  show medication information. Since the medication information is shown in this manner, the user can readily know how the types of bacteria found in the samples have changed owing to medications administered to the subject. This also allows the user to check if the medication administered to the subject has been effective. 
         [0117]    Although the embodiment of the present invention has been described as above, the present invention is not limited to the above embodiment. Moreover, various modifications of the above embodiment may be made. 
         [0118]    For example, although urine is measured in the above embodiment, blood may also or alternatively be measured. Thus, for example, the present invention is applicable to sample testing apparatuses for testing blood samples. Further, the present invention is applicable to sample testing apparatuses for testing other types of samples. 
         [0119]    In the above embodiment, it is determined at S 109  of  FIG. 6  whether the number of peaks of bacterial count in the histogram is one. Based on the determination result, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained, is determined. Here, whether the number of peaks of bacterial count in the histogram is one may be determined based on the skewness of the histogram. Moreover, in order to determine the classification of urinary tract infection, the skewness of the histogram may be used in addition to performing the determination at S 109  of the above embodiment. 
         [0120]    Described below is a method for determining based on the skewness of the histogram whether the number of peaks of bacterial count is one. 
         [0121]    In the histogram of the above embodiment, if the number of pieces of data is n; the number of bacteria at each angle is X i ; the average number of bacteria is X a ; and the standard deviation is S(X), then a skewness α 3  is calculated by an equation shown below. 
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         [0122]    If the histogram shows a symmetrical distribution such as a normal distribution, the value of the skewness α 3  is 0. If the skewness α 3  is a negative value, the distribution has a negative skew, and the histogram has an elongated tail at the left. On the other hand, if the skewness α 3  is a positive value, the distribution has a positive skew, and the histogram has an elongated tail at the right. 
         [0123]    If the histogram shows a symmetrical distribution, it is likely that the histogram shows only one peak. On the other hand, if the histogram shows a significant positive or negative skew, it is likely that the histogram shows multiples peaks, or that, although the histogram shows only one peak, other peaks are buried in the elongated tails. 
         [0124]    Accordingly, if the value of the skewness α 3  is within predetermined positive and negative value ranges from 0, the number of peaks may be determined to be one. On the other hand, if the value of the skewness α 3  is out of these ranges, the number of peaks may be determined to be plural. That is, proper adjustment of the positive and negative threshold ranges for the skewness α 3  that are used for determining whether the number of peaks is plural, makes it possible to determine whether the number of peaks of the histogram is one based on whether the skewness α 3  is within these threshold ranges. 
         [0125]      FIG. 13A  is part of a processing flowchart showing the analysis process in which S 121 , instead of S 108  and S 109  of  FIG. 6 , is performed in order to determine whether the number of peaks is one. If the absolute value of the skewness of the histogram created at S 107  is less than or equal to a predetermined value (i.e., a threshold) (S 121 : YES), the number of peaks of the histogram is determined to be one. Then, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained is determined to be an uncomplicated urinary tract infection (S 110 ). On the other hand, if the absolute value of the skewness of the histogram created at S 107  is not less than or equal to the predetermined value (S 121 : NO), the number of peaks of the histogram is determined to be plural. Then, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained is determined to be a complicated urinary tract infection (S 111 ). 
         [0126]    In the above determination process, even in a case where the histogram shows multiple peaks due to noise or the like, the number of peaks is determined to be one if the shape of the histogram is substantially symmetrical. Accordingly, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained is determined to be an uncomplicated urinary tract infection. Further, even in a case where the histogram shows only one peak, the number of peaks is determined to be plural if other peaks are buried in the elongated tails of the histogram. Then, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained is determined to be a complicated urinary tract infection. 
         [0127]      FIG. 13B  is part of a processing flowchart showing the analysis process in which S 121  is additionally performed between S 109  and  5110  of  FIG. 6  in order to determine whether the number of peaks is one. In this case, the shape of the histogram is determined at S 121  based on its skewness, in addition to the determination being performed at S 109  as to whether the number of peaks of the histogram is one. In this manner, even if the number of peaks is determined to be one, the classification of the urinary tract infection indicated by the sample from which the measurement data has been obtained is determined to be a complicated urinary tract infection if the histogram has elongated tails at the right and left. 
         [0128]    In the above embodiment, the chronological display screen  500  of  FIG. 11  shows the four sets of measurement results and analysis results for the respective four sets of measurement dates and times, at the same time. However, the number of sets of measurement dates and times for which the measurement results and analysis results are shown is not limited to four. The measurement results and analysis results may be shown at the same time for any multiple number of sets of measurement dates and times. If the measurement results and analysis results to be shown do not entirely fit in a single screen, a scrollbar may be provided on the chronological display screen  500  so as to allow scrolling of the display screen, or a page switching button may be provided so as to allow switching of the page to view. 
         [0129]    Further, the chronological display screen  500  shows information based on multiple sets of measurement data that are chronologically successive. However, the chronological display screen  500  may show information based on multiple sets of measurement data that are not chronologically successive. For example, the user may select, among the past measurement dates and times, any four sets of measurement dates and times for which information is to be shown chronologically. 
         [0130]    Still further, in the above embodiment, characters are used to show information in the change information area  408  of the information display screen  400  and in the change information areas  516 ,  526 ,  536 , and  546  of the chronological display screen  500 . However, not only characters but also symbols and figures that are easier to visually recognize may be used to show information in these areas. 
         [0131]    Still further, in the above embodiment, each of the medication information areas  551 ,  552 , and  553  of the chronological display screen  500  merely indicates that medication has been administered to the subject. However, the present invention is not limited thereto. Each medication information area may show a date and time when medication was administered and the details of the medication. Moreover, when any one of the medication information areas is pressed (e.g., clicked), the date and time when medication was administered and the details of the medication that correspond to the pressed medication information area may be shown as a pop-up. 
         [0132]    Still further, in the above embodiment, the change information area  408  of  FIG. 10  shows, based on the comparison of the most recent analysis results and the immediately previous analysis results, change information indicating that the most recent analysis results have changed from the immediately previous analysis results. However, the present invention is not limited thereto. The most recent analysis results may be compared with analysis results earlier than the immediately previous analysis results. For example, the most recent analysis results may be compared with analysis results obtained based on measurement performed at any date and time that precede the date and time of the measurement for the most recent analysis results. 
         [0133]    Still further, in the above embodiment, each of the change information areas  516 ,  526 ,  536 ,  546 , and change information area  408  may show a message “UNCHANGED” if the corresponding analysis results show no changes from the previous analysis results. Alternatively, the display may be performed in such a manner that each of these areas is not shown if the corresponding analysis results show no changes from the previous analysis results. 
         [0134]    Still further, in the above embodiment, in the determination as to whether the analysis results have changed, it is determined as shown in S 210  of  FIG. 9  whether the classification of urinary tract infection or the bacterial type has changed. However, the present invention is not limited thereto. The determination may be additionally performed as to whether the number of bacterial types has changed. 
         [0135]      FIG. 14  is a processing flowchart showing the process of displaying change information in the above case. The flowchart of  FIG. 14  is different from the flowchart of  FIG. 9  in that S 221  to S 223  are added and S 210  is replaced with S 224 . Hereinafter, these added and replaced steps are described. 
         [0136]    Based on the result of the comparison at S 203 , the CPU  301  determines whether the number of bacterial types indicated by the most recent analysis results has changed from that indicated by the immediately previous analysis results (S 221 ). If it is determined that the number of bacterial types indicated by the most recent analysis results has changed from that indicated by the immediately previous analysis results (S 221 : YES), the CPU  301  assigns 1 to a type number flag (S 222 ). On the other hand, if it is determined that the number of bacterial types indicated by the most recent analysis results has not changed from that indicated by the immediately previous analysis results (S 221 : NO), the CPU  301  assigns 0 to the type number flag. 
         [0137]    Next, the CPU  301  determines whether the urinary tract infection flag is 1, or the type flag is 1, or the type number flag is 1 (S 224 ). If it is determined that the urinary tract infection flag is 1, or the type flag is 1, or the type number flag is 1 (S 224 : YES), the CPU  301  causes the display unit  320  of the information processing apparatus  3  to display a message indicating the change (S 221 ), and ends the processing. 
         [0138]      FIG. 15  shows an example of the information display screen  400  displayed by the display unit  320  of the information processing apparatus  3  in the above case.  FIG. 15  shows, in a change information area  411 , information that is different from the information shown in the change information area  408  of  FIG. 10 . 
         [0139]    The change information area  411  shows, in addition to the information shown in the change information area  408  of  FIG. 10 , “NUMBER OF TYPES” indicating that the number of bacterial types has changed. Note that, in the above case, each of the change information areas  516 ,  526 ,  536 , and  546  of the chronological display screen  500  in  FIG. 11  is also configured to show “NUMBER OF TYPES” so as to indicate that the number of bacterial types has changed. 
         [0140]    In addition to the above, various modifications of the embodiment of the present invention may be made without departing from the scope of the technical idea defined by the claims.

Technology Classification (CPC): 6