JP5841644B2 - Urine test method and urine test apparatus - Google Patents

Description

The present invention relates to urinalysis method and urinalysis apparatus.

  A urine qualitative analyzer and a urine sediment analyzer are widely known as analyzers used for urinalysis. Patent Document 1 discloses a measurement result check for mutually checking a measurement result obtained by a urine qualitative analyzer and a measurement result obtained by a urine sediment analyzer and evaluating the reliability of these measurement results. An apparatus is disclosed. The measurement result check device disclosed in Patent Document 1 is a combination of measurement items set in advance among the measurement results obtained by the urine qualitative analyzer and the measurement results obtained by the urine sediment analyzer, That is, the measurement results are mutually checked for each of the occult blood concentration and the red blood cell concentration, the white blood cell concentration and the white blood cell concentration, the protein concentration and the column concentration, the nitrite concentration and the bacterial concentration, and the specific gravity and conductivity.

JP 2006-98219 A

In the measurement result check apparatus described in Patent Document 1 described above, the measurement result is checked only for a combination of measurement items set in advance in the apparatus. For combinations of measurement items that are not set, The measurement result could not be checked. Therefore, when the user desires a new combination of measurement items, it has not been possible to flexibly cope with it.

The present invention has been made in view of such circumstances, the primary object is to provide a urinalysis method and urinalysis apparatus was checked for measured results by the combination of a new measurement item in the row e so that is there.

In the urine test method of one aspect of the present invention, an albumin / creatinine ratio and protein are measured for a urine sample, a column and red blood cells are measured for the urine sample, and the measured value of the albumin / creatinine ratio is higher than a predetermined value; when the measured value of the cylinder is higher than a predetermined value, and displays the first information suggests suspected early diabetic nephropathy, measurement of the protein is higher than a predetermined value, and a measurement of red blood cells is higher than a predetermined value The second information suggesting suspicion of chronic nephritis .

The urinalysis apparatus according to one aspect of the present invention includes a transport unit that transports a urine sample, a urine qualitative measurement unit that can measure at least an albumin / creatinine ratio and a protein of the urine sample transported by the transport unit, and the transport The measured value of the albumin / creatinine ratio obtained by the urine qualitative measurement unit and the urine formed component measurement unit capable of measuring at least a column and red blood cells with respect to the urine sample conveyed by the unit , and the above When the measured value of the column obtained by the urine sediment measuring unit is higher than a predetermined value, the first information suggesting the suspicion of early diabetic nephropathy is displayed , and the protein obtained by the urine qualitative measuring unit is displayed . Table measurements is higher than a predetermined value, and, if the measured value of red blood cells obtained by the urine formed component measurement unit is higher than a predetermined value, for displaying a second information indicative of suspected chronic nephritis And a part.

  The urinalysis apparatus according to one aspect of the present invention is transported by a transport unit that transports a urine sample, a urine qualitative measurement unit that can measure at least protein in the urine sample transported by the transport unit, and the transport unit. A urine sediment measurement unit capable of measuring at least red blood cells for a urine sample, a protein measurement result obtained by the urine qualitative measurement unit, and a red blood cell measurement result obtained by the urine sediment measurement unit And a display unit for displaying information indicating that the two measurement results are in a predetermined relationship.

According to urinalysis method and urinalysis apparatus according to the present invention, from the measurement results of the two measurement items albumin / creatinine ratio and cylinder, it is possible to know the suspected early diabetic nephropathy.
According to the urinalysis method and urinalysis apparatus according to the present invention, it is possible to know the suspicion of chronic nephritis from the measurement results of the two measurement items of protein and red blood cell.
According to the urinalysis method and the urinalysis apparatus according to the present invention, whether or not a specific disease is suspected based on the combination of other measurement items while determining the reliability of the measurement based on the combination of one measurement item. I can know.

The figure which shows the structure of the whole system containing the urine test | inspection apparatus which concerns on embodiment. The figure which shows the circuit structure of a urine qualitative measurement part, a urine sediment measurement part, a conveyance unit, and a host computer. The block diagram which shows the structure of the information processing unit which concerns on embodiment. The schematic diagram which shows the structure of a crosscheck setting value database. The figure which shows an example of a cross check table. The flowchart which shows the procedure of the cross check setting process in the urine test apparatus which concerns on embodiment. The figure which shows an example of a cross check setting dialog. The flowchart which shows the procedure of a setting reception process. The figure which shows an example of a rank value setting dialog. The flowchart which shows the process sequence by the information processing unit in the sample analysis operation | movement of the urine test apparatus which concerns on embodiment (first half). The flowchart (latter half) which shows the process sequence by the information processing unit in the sample analysis operation | movement of the urinalysis apparatus concerning embodiment. The flowchart which shows the procedure of the measurement result display process in the information processing unit which concerns on embodiment. The figure which shows an example of a measurement result screen.

  Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.

  This embodiment is a clinical sample that performs tests for urine protein, urine sugar, etc. (urine qualitative test), and tests for erythrocytes, leukocytes, epithelial cells, etc. contained in urine (test for urine formation) The present invention relates to an analyzer. The examination of the urinary formation is performed on a specimen that is further required to be examined for the urine formation as a result of the qualitative examination of urine. In the present embodiment, a plurality of sample containers that store different samples are set in a rack, and the rack is set in a sample analyzer to inspect each sample.

[Configuration of urinalysis device]
Hereinafter, the urine test apparatus according to the present embodiment will be described with reference to the drawings.

  FIG. 1 is a diagram showing the configuration of the entire system including the urine test apparatus 1. The urine test apparatus 1 according to the present embodiment includes a measurement unit 10, a transport unit 20, and an information processing unit 30.

  The measurement unit 10 includes a urine qualitative measurement unit 11 that performs a urine qualitative test and a urine sediment measurement unit 12 that performs a urine sediment test. The urine qualitative measurement unit 11 and the urine sediment measurement unit 12 are connected to be communicable with each other. In addition, each of the urine qualitative measurement unit 11 and the urine sediment measurement unit 12 is connected to the information processing unit 30 so as to be communicable. Furthermore, the urine qualitative measurement unit 11 is connected to the transport unit 20 so as to be communicable.

  The transport unit 20 is a single unit common to the urine qualitative measurement unit 11 and the urine sediment measurement unit 12. The transport unit 20 is mounted on the front surface of the measurement unit 10 and includes a transport path 21. The conveyance path 21 has a flat bottom surface that is one step lower than the upper surface of the conveyance unit 20. The sample rack 50 transported on the transport path 21 is formed with ten holders so that ten sample containers 51 can be held. The sample container 51 is transported on the transport path 21 together with the sample rack 50 by being held in the holding portion of the sample rack 50. On the side surface of the sample container 51, a barcode label (not shown) for specifying the sample is attached. The information processing unit 30 is communicably connected to the host computer 40 via a communication line.

  The conveyance path 21 includes a square right tank area 21a provided on the right side, a square left tank area 21c provided on the left side, and a connection area 21b that connects the right tank area 21a and the left tank area 21c. The When the sample rack 50 is placed on the front side of the right tank area 21a by the user, the sample rack 50 placed on the right tank area 21a is moved backward (in the direction close to the measurement unit 10), and the right tank area It is positioned at the back end of 21a. The sample rack 50 positioned on the back side of the right tank region 21a is transferred leftward through the connection region 21b.

  The barcode reader 116 reads barcode information from the barcode label attached to the sample container 51 positioned in front of the barcode reader 116. The barcode reader 116 is controlled by the control unit 111 of the urine qualitative measurement unit 11 as will be described later.

  The connection region 21b is provided with two suction positions for aspirating the specimen from the specimen container 51 held in the specimen rack 50. The urine qualitative measurement unit 11 is provided with the specimen container 51 located at one of the suction positions. The sample is aspirated by the nozzle, and the sample is aspirated from the sample container 51 located at the other aspiration position by the nozzle provided in the urine sediment measurement unit 12. The sample rack 50 in which all the samples have been aspirated is transferred to the left along the connection region 21b, and is positioned on the back side of the left tank region 21c.

  The sample rack 50 positioned on the back side of the left tank area 21c is transferred forward and sequentially positioned on the front side of the left tank area 21c. In this way, the sample rack 50 positioned in front of the left tank region 21c is taken out by the user.

  FIG. 2 is a diagram illustrating a circuit configuration of the urine qualitative measurement unit 11, the urine sediment measurement unit 12, the transport unit 20, and the host computer 40.

  The urine qualitative measurement unit 11 includes a control unit 111, a communication unit 112, a suction unit 113, a test paper supply unit 114, a detection unit 115, and a barcode reader 116. The control unit 111 includes a CPU 111a and a storage unit 111b. The CPU 111a executes a computer program stored in the storage unit 111b and controls each unit of the urine qualitative measurement unit 11. In addition, the CPU 111 a controls each unit of the transport unit 20 via the communication unit 112. The storage unit 111b includes storage means such as a ROM, a RAM, and a hard disk. The urine qualitative measurement unit 11 can measure a sample for a plurality of measurement items (urine qualitative measurement items). The urine qualitative measurement items include glucose (GLU), protein (PRO), albumin (ALB), bilirubin (BIL), urobilinogen (URO), pH (PH), occult blood (BLD), ketone body (KET), nitrite (NIT), white blood cells (LEU), creatinine (CRE), albumin / creatinine ratio (A / C).

  The communication unit 112 processes the signal received from the control unit 111 and outputs the processed signal to the urinary particle measuring unit 12, the transport unit 20, and the information processing unit 30, and the urinary particle component is output. Signals received from the measurement unit 12, the transport unit 20, and the information processing unit 30 are processed, and the processed signals are output to the control unit 111. The suction unit 113 sucks the sample in the sample container 51 positioned at the one suction position described above via the nozzle of the urine qualitative measurement unit 11. The test paper supply unit 114 takes out the test paper necessary for the measurement from the test paper feeder in which the test paper is stored, and places the sample sucked by the suction unit 113 on the taken out test paper. The detection unit 115 measures the test paper on which the sample is spotted. Measurement data obtained by such measurement is output to the control unit 111 and analyzed by the control unit 111. The barcode reader 116 reads the barcode information from the barcode label attached to the sample container 51 and outputs the barcode information to the control unit 111.

  The urine sediment measurement unit 12 includes a control unit 121, a communication unit 122, a suction unit 123, a sample preparation unit 124, and a detection unit 125. The control unit 121 includes a CPU 121a and a storage unit 121b. The CPU 121a executes a computer program stored in the storage unit 121b, and controls each unit of the urine sediment measurement unit 12. The storage unit 121b includes storage means such as a ROM, a RAM, and a hard disk. The urine particle measurement unit 12 can measure a sample for a plurality of measurement items (urine particle measurement items). Urinary component measurement items include red blood cells (RBC), white blood cells (WBC), epithelial cells (EC), cylinders (CAST), bacteria (BACT), crystals (X'TAL), yeast-like fungi (YLC), Small round cell (SRC), pathological column containing cell components (Path.CAST), mucus thread (MUCUS), sperm (SPERM), urine conductivity (Cond.), Erythrocyte morphology information (RBC-Info.) , Urine concentration information (Cond.-Info.), UTI (urinary tract infection) information (UTI-Info.).

  The communication unit 122 processes the signal received from the control unit 121, outputs the processed signal to the urine qualitative measurement unit 11 and the information processing unit 30, and receives from the urine qualitative measurement unit 11 and the information processing unit 30. The processed signal is processed, and the processed signal is output to the control unit 111. The suction unit 123 sucks the sample in the sample container 51 positioned at the other suction position described above via the nozzle of the urine sediment measurement unit 12. The sample preparation unit 124 mixes and stirs the sample aspirated by the aspiration unit 123 and a reagent necessary for measurement, and prepares a sample for measurement by the detection unit 125. The detection unit 125 measures the sample prepared by the sample preparation unit 124. Measurement data obtained by such measurement is transmitted to the information processing unit 30.

  The transport unit 20 includes a communication unit 201, a transport drive unit 202, and a sensor unit 203. The communication unit 201 processes the signal received from the urine qualitative measurement unit 11, outputs the processed signal to each unit of the transport unit 20, processes the signal received from each unit of the transport unit 20, and outputs the processed signal. Output to the urine qualitative measurement unit 11.

  The conveyance driving unit 202 is controlled by the CPU 111 a of the urine qualitative measurement unit 11. The sensor unit 203 includes various sensors provided in the transport unit 20, and outputs output signals from these sensors to the urine qualitative measurement unit 11 via the communication unit 201.

  The host computer 40 has a control unit 401 and a communication unit 402. The control unit 401 includes a CPU 401a and a storage unit 401b. When the CPU 401a executes the computer program stored in the storage unit 401b and receives a measurement order inquiry from the information processing unit 30, the CPU 401a returns the measurement order stored in the storage unit 401b. In addition, the CPU 401a, based on the measurement data received from the urine qualitative measurement unit 11 via the information processing unit 30 and the measurement necessity criteria stored in the storage unit 401b, Determine the measurement order. The storage unit 401b includes storage means such as a ROM, a RAM, and a hard disk.

  FIG. 3 is a diagram illustrating a circuit configuration of the information processing unit 30.

  The information processing unit 30 includes a personal computer, and includes a main body 300, an input unit 310, and a display unit 320. 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. The RAM 303 is also used as a work area for the CPU 301 when executing these computer programs.

  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. That is, the hard disk 304 includes a program for inquiring the host computer 40 about the measurement order based on a later-described inquiry about the measurement order transmitted from the urine qualitative measurement unit 11 and the urine sediment measurement unit 12, and the host computer 40. A program for transmitting the measurement order transmitted from the urine to the urine qualitative measurement unit 11 and the urine sediment measurement unit 12 is installed. The hard disk 304 includes a program for displaying the urine qualitative test result on the display unit 320 based on the measurement data transmitted from the urine qualitative measurement unit 11, and the measurement data transmitted from the urine sediment measurement unit 12. A program or the like is installed on the display unit 320 for displaying the urinary component test result.

  The hard disk 304 is provided with a cross check setting value database. FIG. 4 is a schematic diagram showing the configuration of the cross check set value database. This cross check set value database DB includes a table T1 for storing set values of combinations of urine qualitative measurement items and urine sediment measurement items (cross check target items), and cross check for each cross check target item. And a table T2 for storing table information.

  The table T1 includes a field F11 for storing a set value number, a field F12 for storing a set value (use flag) as to whether or not to use the record, and a cross check mark on a measurement result screen described later. A field F13 for storing a setting value (display flag) indicating whether or not to display, a field F14 for storing a urine qualitative measurement item set as a cross check target item, and a cross check target item And a field F15 for storing urine sediment measurement items. That is, each record of the table T1 includes a pair of urine qualitative measurement items and urine sediment measurement items designated as cross check target items, use flags, and display flags.

  The table T2 includes a field F21 for storing a cross check target item set in the table T1, and a field F22 for storing cross check table information corresponding to the cross check target item. The cross check table information is information used to determine whether or not the measurement value of the corresponding urine qualitative measurement item and the measurement value of the urine sediment measurement item are in a specific relationship. is there. The cross check table information will be described later.

  The information processing unit 30 according to the present embodiment has a predetermined relationship between the measurement result of the urine qualitative measurement unit 11 and the measurement result of the urine sediment measurement unit 12 using the cross check setting value database DB. It is possible to execute a cross check of the measurement result to determine whether or not. Specifically, when a combination of a protein and a cylinder is set as a cross check target item in the cross check set value database DB, the measurement result of the protein (PRO) by the urine qualitative measurement unit 11 of the same specimen, It is determined whether or not the measurement result of the column (CAST) by the formation measuring unit 12 has a relationship defined in the cross check table information of the table T2. FIG. 5 is a diagram illustrating an example of the cross check table. In the cross check table CRT shown in FIG. 5, the vertical axis indicates the rank of the measurement value of the urine qualitative measurement item (protein), and the horizontal axis indicates the rank of the measurement value of the urine sediment measurement item (column). The rank is given by a rank setting value stored in the hard disk 304. The rank setting value will be described later. In the cross check table CRT, each combination of the rank of the measurement value of the urine qualitative measurement item and the rank of the measurement value of the urine sediment measurement item conforms (cells with hatched lines in the drawing) or does not conform (Fig. Medium white cell) is set. In the cross check of the measurement result, in the cross check table CRT, when the measurement value of the urine qualitative measurement item and the measurement value of the urine qualitative measurement item correspond to “conformity”, these measurement values have a predetermined relationship ( For example, if the measurement value of the urine qualitative measurement item and the measurement value of the urine qualitative measurement item fall under “nonconformity”, these measurement values are It is determined that the relationship does not fall under the relationship (for example, the reliability of the measurement result is low). The cross check table information of the table T2 indicates the cross check table CRT. Specifically, the cross check table information stored in the field F22 of the table T2 is expressed by a combination of two numerical values “0” and “1” as shown in FIG. Here, “0” indicates “nonconformity” in one cell of the cross check table CRT, and “1” indicates “conformity”. Cross check table information is data in which “0” and “1” indicating “conformity” and “nonconformity” of each cell are arranged in a predetermined order according to the arrangement of each cell in the cross check table CRT.

  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 on a recording medium. An input unit 310 including a mouse and a keyboard is connected to the input / output interface 306, and data is input to the information processing unit 30 when the user uses the input unit 310. 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. In addition, the communication interface 308 enables data transmission / reception to / from the urine qualitative measurement unit 11, the urine sediment measurement unit 12, and the host computer 40.

[Operation of urinalysis device]
<Crosscheck setting process>
Hereinafter, the operation of the urine test apparatus 1 according to the present embodiment will be described. First, the cross check setting process of the urinalysis apparatus 1 will be described. This cross check setting process is a process of setting a combination of a urine qualitative measurement item and a urine sediment measurement item designated by the user as a cross check target item to be described later.

  FIG. 6 is a flowchart showing the procedure of the cross check setting process in the urine test apparatus 1 according to the present embodiment.

  First, the CPU 301 of the information processing unit 30 determines whether or not a display instruction for a cross check setting dialog has been received from the user (step S101). The cross check setting dialog is a screen for the user to specify a combination of urine qualitative measurement items and urine sediment measurement items as cross check target items. When the display instruction of the cross check setting dialog is not accepted (NO in step S101), the CPU 301 ends the process.

  When the display instruction of the cross check setting dialog is received (YES in step S101), the CPU 301 reads the cross check setting value from the hard disk 304 and causes the display unit 320 to display the cross check setting dialog reflecting the cross check setting value. (Step S102), a setting reception process is executed (Step S103).

  FIG. 7 is a diagram illustrating an example of a cross check setting dialog. As shown in the figure, up to 10 cross check setting values can be registered in the cross check setting dialog D1. In the cross check setting dialog D1, the numbers (1 to 10) of the cross check setting values are displayed side by side, and a radio button C11 is displayed beside each number. A check box C12 for designating whether or not to use the cross check setting value is provided to the right of each radio button C11. On the right side of each check box C12, there is provided a check box C13 for designating whether or not to display a cross check mark on a measurement result screen described later. Further, selection boxes C14 and C15 for designating cross check target items are provided on the right side of each check box C13.

  FIG. 8 is a flowchart illustrating the procedure of the setting reception process. In the setting reception process, first, the CPU 301 determines whether any radio button C11 is selected (step S201). In the cross check setting dialog D1, the user can select any one of the ten radio buttons C11 by operating the input unit 310. When selection of any radio button C11 is accepted (YES in step S201), the CPU 301 performs a cross check of the cross check target item corresponding to the radio button C11 in the area A10 on the right side of the cross check setting dialog D1. A table is displayed (step S202), and the process proceeds to step S203. If the cross check target item corresponding to the radio button C11 selected here is not specified in the selection boxes C14 and C15, the cross check table is stored until the cross check target item is specified as described later. Do not show. If selection of the radio button C11 is not accepted in step S201 (NO in step S201), the CPU 301 moves the process to step S203.

  In step S203, the CPU 301 determines whether or not designation of a urine qualitative measurement item as a cross check target item is accepted by any selection box C14 (step S203). When the downward arrow symbol on the right side of the selection box C14 is selected, a pull-down menu of a list of all urine qualitative measurement items is displayed, and the user can designate one urine qualitative measurement item from the list. When the designation of the urine qualitative measurement item is accepted in step S203 (YES in step S203), the CPU 301 stores the designated urine qualitative measurement item in the RAM 303 in association with the set value number (step S204), and processing To step S205. If designation of the urine qualitative measurement item is not accepted in step S203 (NO in step S203), the CPU 301 moves the process to step S205.

  In step S205, the CPU 301 determines whether or not the designation of the urinary sediment measurement item as a cross check target item is accepted by any selection box C15 (step S205). When the downward arrow symbol on the right side of the selection box C15 is selected, a pull-down menu of a list of all urine sediment measurement items is displayed, from which the user designates one urine sediment measurement item. be able to. When the designation of the urine sediment measurement item is received in step S205 (YES in step S205), the CPU 301 stores the designated urine sediment measurement item in the RAM 303 in association with the set value number. (Step S206), the process proceeds to Step S207. If the designation of the urine sediment measurement item is not accepted in step S205 (NO in step S205), the CPU 301 advances the process to step S207.

  In step S207, the CPU 301 determines whether selection of a cell in the cross check table displayed in the area A10 has been accepted (step S207). Whether each cell of the cross check table displayed in the area A10 satisfies a predetermined relationship between the rank of the measurement value of the urine qualitative measurement item corresponding to the cell and the rank of the measurement value of the urine sediment measurement item Indicates whether or not. That is, blue cells (indicated by diagonal lines in the figure) indicate that the predetermined relationship is satisfied, and white cells indicate that the predetermined relationship is not satisfied. Each cell of the cross check table can be selected. When the user operates the input unit 310 to select one cell of the cross check table, the cell is changed to white when the cell is blue, and is changed to blue when the cell is white. In other words, when a cell that conforms to a predetermined relationship is selected, the cell is changed to a cell that does not conform to the predetermined relationship, and when a cell that does not conform to the predetermined relationship is selected, the cell becomes a predetermined relationship. Change to a cell that matches

  If selection of a cell in the cross check table is accepted in step S207 (YES in step S207), the CPU 301 stores the designated setting value in association with the setting value number in the RAM 303 (step S208), and processing To step S209. If selection of a cell in the cross check table is not accepted in step S207 (NO in step S207), the CPU 301 advances the process to step S209.

  In step S209, the CPU 301 determines whether any check box C12 is selected, thereby accepting designation of whether or not the cross check setting value can be used (step S209). The cross check setting value for which the check box C12 is selected (checked) is used for the cross check. On the other hand, the cross check setting value for which the check box C12 is not selected (check box is removed) is not used for the cross check. When designation of whether or not the cross check set value can be used is accepted in step S209 (YES in step S209), the CPU 301 stores a cross check set value use flag in the RAM 303 in association with the set value number ( The process proceeds to step S210) and step S211. Here, when it is specified that the cross check set value is not used, “0” is stored in the use flag, and when it is specified that the cross check set value is used, “1” is set in the use flag. "Is memorized. When the designation of whether or not the cross check set value can be used is not accepted in step S209 (NO in step S209), the CPU 301 moves the process to step S211.

  In step S211, the CPU 301 determines whether or not designation of whether or not to display a cross check mark is accepted by selecting any of the check boxes C13 (step S211). When the check box C13 is selected (checked), when the measurement result of the sample matches a predetermined relationship defined in the cross check table, a predetermined value is displayed on the measurement result screen described later to alert the user. A cross check mark indicating that the relationship has been met is displayed. On the other hand, when the check box C13 is not selected (the check is removed), even if the measurement result of the sample matches the predetermined relationship, the cross check mark is not displayed on the measurement result screen. When designation of whether or not to display a cross check mark is accepted in step S211 (YES in step S211), the CPU 301 stores a cross check set value display flag in the RAM 303 in association with the set value number (step S211). In step S212, the process returns to the call address for the setting reception process in the main routine. If the designation of whether or not to display the cross check mark is not accepted in step S211 (NO in step S211), the CPU 301 returns the process to the call address of the setting acceptance process in the main routine as it is.

  Returning to FIG. 6, in step S104, the CPU 301 determines whether or not the OK button provided in the cross check setting dialog D1 is selected (step S104). If the OK button has not been selected (NO in step S104), the CPU 301 determines whether or not the cancel button provided in the cross check setting dialog D1 has been selected (step S105). If the cancel button has not been selected (NO in step S105), the CPU returns the process to step S103 and executes the setting reception process again.

  On the other hand, when the OK button is selected in step S104 (YES in step S104), the CPU 301 registers the cross check setting value stored in the RAM 303 in the cross check setting value database DB (step S106). That is, the CPU 301 registers the combination of the urine qualitative measurement item and the plurality of urine sediment measurement items specified by the user in the cross check setting value database as the setting value of the cross check target item. Next, the CPU 301 closes the cross check setting dialog (step S107) and ends the process. If the cancel button is selected in step S105 (YES in step S105), the CPU 301 discards the cross check setting value stored in the RAM 303, closes the cross check setting dialog (step S107), and performs processing. finish.

  Further, in the information processing unit 30, the above-described rank value can be set for the urine sediment measurement item. When the user performs a predetermined input via the input unit 310, the rank value setting dialog is displayed on the display unit 320. FIG. 9 is a diagram illustrating an example of a rank value setting dialog. Using this rank value setting dialog, the user can set the rank value.

  The rank value can be set only for the urine sediment measurement item. The rank value for the urine qualitative measurement item is given in advance, and the user cannot change the setting. As shown in FIG. 9, the rank value setting dialog D2 is provided with a selection box C21 for designating urine sediment measurement items. When the selection box C21 is selected, a pull-down menu of a list of all urine sediment measurement items is displayed, from which the user can designate one urine sediment measurement item.

  In addition, the rank values 1 to 9 are vertically displayed below the selection box C21. To the right of each rank value, a range of measurement values corresponding to each rank value is designated. An input box C22 is provided. More specifically, the upper limit value of the measurement value corresponding to the rank value is input to the nine input boxes C22 corresponding to the rank values 1 to 9, respectively. For example, the upper limit value of the measurement value corresponding to the rank value 1 of the urine sediment measurement item designated by the selection box C21 is input to the input box C21 of the rank value 1. In the example of FIG. 9, 6 μm is specified as the upper limit value of the measurement value corresponding to the rank value 1 for the measurement item “red blood cell”.

  Using such a rank value setting dialog D2, the user designates the urine sediment measurement item for which the rank value is to be set, and the upper limit value of the measurement value corresponding to each rank value. When the user selects the OK button provided in the rank value setting dialog D2 in a state where such a rank value setting value is input, the input rank setting value is stored in the hard disk 304. When the cancel button provided in the rank value setting dialog D2 is selected, the input rank setting value is discarded and the rank value setting dialog is closed.

<Sample analysis operation>
Next, the sample analysis operation by the urinalysis apparatus 1 will be described. 10A and 10B are flowcharts showing a processing procedure by the information processing unit 30 in the sample analysis operation of the urinalysis apparatus 1 according to the present embodiment. The sample analysis operation is started when the user operates the input unit 310 of the information processing unit 30 to input a sample analysis start instruction to the urinalysis apparatus 1. When the sample analysis operation starts, the sample rack 50 is transported by the transport unit 20. When the CPU 111a of the urine qualitative measurement unit 11 reads the barcode information from the barcode label affixed to the sample container 51 transported by the transport unit 20 by the barcode reader 116, the urine of the sample indicated by the barcode information is read. The information processing unit 30 is inquired about the measurement order of the qualitative measurement unit 11.

  The information processing unit 30 inquires of the measurement order of the urine qualitative test to the host computer 40 (step S301). A sample measurement order is registered in advance in the host computer 40, and if the measurement order that matches the inquiry is included in the registered measurement order, the host computer 40 responds to the inquiry to perform the measurement. The order is transmitted to the information processing unit 30. When receiving the measurement order from the host computer (step S302), the information processing unit 30 transmits the measurement order to the urine qualitative measurement unit 11 (step S303). Such a measurement order includes the urine qualitative measurement items to be measured and the necessity of measurement. When the urine qualitative measurement unit 11 receives the measurement order from the information processing unit 30, the CPU 111a determines whether or not the urine qualitative measurement unit 11 needs to measure the sample.

  When the CPU 111a determines that the urine qualitative measurement unit 11 needs to perform measurement, the CPU 111a sucks the sample from the sample container 51 with the nozzle of the urine qualitative measurement unit 11, and the urine qualitative measurement unit 11 measures the sample. On the other hand, if the CPU 111a determines that the urine qualitative measurement unit 11 does not require measurement, the sample is not measured.

  The CPU 301 determines whether or not measurement data has been received from the urine qualitative measurement unit 11 (step S304). When the measurement data is not received from urine qualitative measurement unit 11 (NO in step S304), CPU 301 ends the process. On the other hand, when measurement data is received from the urine qualitative measurement unit 11 in step S304 (YES in step S304), the CPU 301 transmits the measurement data (specimen urine qualitative measurement result) to the host computer 40 (step S305). ). When the CPU 401a of the host computer 40 receives the measurement data of the urine qualitative measurement unit 11, based on the measurement data and a measurement necessity criterion stored in advance in the storage unit 401b, the urine sediment measurement unit Twelve measurement orders are determined.

  When the sample container 51 is positioned at the sample aspirating position of the urine particle measurement unit 12, the CPU 121 a of the urine particle measurement unit 12 sends the measurement order of the urine particle measurement unit 12 to the information processing unit 30. Inquire. Upon receiving this inquiry, the information processing unit 30 inquires the host computer 40 about the measurement order of the urine sediment component test (step S306). If the measurement order registered in the host computer 40 includes a measurement order that matches the inquiry, the host computer 40 transmits the measurement order to the information processing unit 30 in response to the inquiry. When receiving the measurement order from the host computer (step S307), the information processing unit 30 transmits the measurement order to the urine sediment measurement unit 12 (step S308). Such a measurement order includes the measurement item of urine sediment to be measured and the necessity of measurement. When the urine particle measuring unit 12 receives the measurement order from the information processing unit 30, the CPU 121a determines whether or not the urine particle measuring unit 12 needs to measure the sample.

  When the CPU 121a determines that the measurement in the urine particle measurement unit 12 needs to be performed, the CPU 121a sucks the sample from the sample container 51 by the nozzle of the urine particle measurement unit 12, and the urine particle measurement unit 12 In this step, the sample is measured. The measurement data of the specimen is given from the urine sediment measurement unit 12 to the information processing unit 30 and analyzed by the CPU 301 of the information processing unit 30. On the other hand, if the CPU 121a determines that there is no need for measurement by the urine particle measuring unit 12, the measurement of this sample is not performed.

  The CPU 301 determines whether or not measurement data has been received from the urine particle measurement unit 12 (step S309). If the measurement data is not received from the urine sediment measurement unit 12 (NO in step S309), the CPU 301 moves the process to step S316 and stores only the result of the urine qualitative test in the hard disk 304 (step S316). S316), the process is terminated. On the other hand, when measurement data is received from the urine particle measurement unit 12 in step S309 (YES in step S309), the CPU 301 analyzes the measurement data and obtains the urine particle measurement result of the sample. (Step S310).

  Next, the CPU 301 reads the cross check setting value registered in the cross check setting value database DB and the rank setting value stored in the hard disk 304 (step S311), and uses the use flag in the read cross check setting value. It is determined whether or not there is a cross check target item for which “1” is set (step S312). In step S312, when there is no cross check target item whose use flag is set to “1” (NO in step S312), the process proceeds to step S316, and the urine qualitative test result and the urine sediment test result are displayed. The data is stored in the hard disk 304 (step S316), and the process is terminated.

  On the other hand, if there is a cross check target item for which the use flag is set to “1” in step S312 (YES in step S312), the CPU 301 sets the cross check target item for which the use flag is set to “1”. The measurement result of the sample for the urine qualitative measurement item set as and the measurement result of the sample for the urine sediment measurement item set as the cross check target item corresponding to the urine qualitative measurement item, It is determined whether or not the cell corresponds to a “conforming” cell in the cross check table (step S313).

  In step S313, when the urine qualitative measurement result and the urine sediment measurement result correspond to “conformity” in the cross check table (YES in step S313), the CPU 301 corresponds to the cross check target item, Information indicating whether the urine qualitative measurement result and the urine sediment measurement result correspond to “conformity” in the cross check table (hereinafter referred to as “cross check flag”) is “1” (the urine qualitative measurement result and The urine sediment measurement result is set to a value indicating that “corresponding” in the cross check table), the cross check flag is stored in the RAM 303 (step S314), and the process proceeds to step S315. The initial value of the cross check flag is set to “0” (a value indicating that the urine qualitative measurement result and the urine sediment measurement result correspond to “non-conformity” in the cross check table). It is remembered. In step S313, when the urine qualitative measurement result and the urine sediment measurement result do not correspond to “conformity” in the cross check table (NO in step S313), the CPU 301 advances the process to step S315.

  In step S315, the CPU 301 determines whether or not the cross check of the measurement result has been performed for all cross check target items for which the use flag is set to “1” (step S315), and the cross check is still performed. If an unchecked cross check target item remains (NO in step S315), the process returns to step S313, the use flag is set to “1”, and the cross check is not yet performed. A cross check of the measurement result is executed for the target item (step S313). On the other hand, in step S315, when the cross check of the measurement result is completed for all the cross check target items for which the use flag is set to “1” (YES in step S315), the CPU 301 determines that the analysis result is the above. (Including the cross check flag) is stored in the hard disk 304 (step S316), and the process ends.

<Measurement result display operation>
Next, the measurement result display operation of the urine test apparatus 1 according to the present embodiment will be described. In the urine test apparatus 1 according to the present embodiment, the measurement result display operation can be performed by the CPU 301 of the information processing unit 30 executing the measurement result display process described below.

  FIG. 11 is a flowchart showing the procedure of the measurement result display process in the information processing unit 30 according to the present embodiment.

  When the user performs a predetermined input via the input unit 310, the measurement result screen is displayed on the display unit 320. The CPU 301 determines whether or not an instruction to display the measurement result screen has been received from the user (step S401). When the display instruction for the measurement result screen is not received (NO in step S401), the CPU 301 ends the process. On the other hand, when an instruction to display the measurement result screen is received in step S401 (YES in step S401), the CPU 301 reads the sample measurement result (analysis result stored in step S316) from the hard disk (step S402). The measurement result screen is displayed on the display unit 320 (step S403), and the process ends.

FIG. 12 is a diagram illustrating an example of a measurement result screen. The measurement result screen D3 includes a display area A31 for specimen information such as a specimen ID, a patient name, and an examination date, a display area A32 for a measurement value of a urine qualitative measurement item, and a measurement value (numerical value of a urine sediment measurement item). Data) display area A33 and a display area A34 of a particle size distribution diagram (scattergram and histogram) included in the measurement result of urinary particles. In the display area A31, information on the specimen whose measurement result is displayed on the measurement result screen is displayed. In the display area A32, the measurement result obtained by the urine qualitative measurement unit 11 for the sample is displayed. In the display areas A32 and A33, the measurement results obtained by analyzing the measurement data obtained by the urine sediment measurement unit 12 for the same specimen as described above by the information processing unit 30 are displayed.

  Further, in the measurement result screen D3, when an abnormality is detected in the measurement of the sample and it is determined that the sample needs to be reexamined, a display area A35 for displaying information (review comment) regarding the abnormality, Among the urine sediment measurement items, the display area A36 for displaying the sample measurement results of items set in advance as research items and the urine sediment measurement items are set in advance as flag items. And a display area A37 for displaying the sample measurement result of the selected item.

The measurement result screen D3 is provided with a display area A38 for displaying the result of the cross check. In the display area A38, when there is a cross check target item that is determined to satisfy the predetermined relationship between the urine qualitative measurement result and the urine sediment measurement result in the cross check, the cross check target item name ( Information indicating a combination of urine qualitative measurement items and urine sediment measurement items) is displayed. That is, the cross check target item name in which “1” is set in the cross check flag is displayed in the display area A38. In the example shown in the figure, information “BLD × RBC?” Indicating the combination of the urine qualitative measurement item occult blood (BLD) and the urine sediment measurement item red blood cell (RBC) is displayed in the display area A38. , the cross check target item of the combination of the urine qualitative measurement items occult blood (BLD) and urinary chromatic formed component measurement items of red blood cells (RBC), it is shown that the measurement result is determined to correspond to a predetermined relationship ing.

  Thus, by displaying the cross check target item name in the display area A38, the measurement result of the urine qualitative measurement item of the cross check target item and the measurement result of the urine sediment measurement item are in a predetermined relationship. Will be notified. Therefore, for example, when the predetermined relationship indicates that the reliability of the measurement result is low, the user confirms the display in the display area A38, so that the reliability of the measurement result of the sample for the cross check target item is low. You can easily know that. When the predetermined relationship indicates that the predetermined disease is suspected for the patient, the user can easily know that the disease is suspected by confirming the display in the display area A38. In this case, the user can take necessary measures such as confirming the measurement results of other measurement items or performing a more detailed examination of the specimen.

  Further, the cross check target item whose cross check flag is set to “1” is included in the measurement result, and the display flag of the cross check target item is set to “1” in the cross check setting value database DB. In this case, a cross check mark CM for alerting the user is displayed next to the display area A38. The cross check mark CM is displayed in a color (yellow in the present embodiment) for alerting the user. Note that the color of the measurement result screen D3 is basically gray, and the background of the display areas A31 to A38 is white. Therefore, the cross check mark CM is displayed in a color that attracts the user's attention on the measurement result screen D3, and the user can easily recognize the cross check mark CM. For all the cross check target items whose cross check flag is set to “1” in the measurement result, when the display flag is set to “0” in the cross check setting value database DB, the cross check mark described above is used. CM is not displayed.

  With the configuration as described above, the user can freely set the cross check target item. For example, it is known that a measured value of occult blood (BLD) as a urine qualitative measurement item and a measured value of red blood cell (RBC) as a urine sediment measurement item have a certain relationship with respect to the same specimen. Therefore, when the measured value of occult blood and the measured value of red blood cells deviate from the above-mentioned fixed relationship, it is suspected that the measurement result is accurate in any of these measured values. Therefore, the user sets the occult blood (BLD) and the red blood cell (RBC) as cross check target items, and appropriately sets the cross check table, thereby causing the information processing unit 30 to determine whether or not the reliability of the measurement result is low. be able to.

  In addition, specimens collected from patients with early diabetic nephropathy tend to show high values in the column (CAST) and high values in the albumin / creatinine ratio (A / C). Therefore, the user sets the albumin / creatinine ratio (A / C) and the column (CAST) as the cross check target items, and sets the corresponding cross check table appropriately, so that the information processing unit 30 has the albumin / creatinine ratio ( A cross check between the measured value of (A / C) and the measured value of the cylinder (CAST) can be performed. As a result of such a cross check, when the measured value of the albumin / creatinine ratio (A / C) and the measured value of the cylinder (CAST) conform to a predetermined relationship, the display area A38 of the measurement result screen D3 In addition, an album name / creatinine ratio (A / C) and a column (CAST) cross check target item name “A / C × CAST?” Are displayed. When this cross check target item name “A / C × CAST?” Is displayed, the user can know that early diabetic nephropathy is suspected for the sample.

  In addition, a sample collected from a patient with chronic nephritis shows a high value in protein (PRO) and a tendency to show a high value in red blood cells (RBC). Therefore, the user sets the protein (PRO) and the red blood cell (RBC) as the cross check target items, and appropriately sets the corresponding cross check table, whereby the measured value of the protein (PRO) and the red blood cell ( Cross check with the measured value of RBC) can be performed. As a result of such a cross check, if the measured value of the protein (PRO) and the measured value of the red blood cell (RBC) are in a predetermined relationship, the protein (PRO) is displayed in the display area A38 of the measurement result screen D3. ) And red blood cell (RBC) cross check target item name “PRO × RBC?” Are displayed. When the cross check target item name “PRO × RBC?” Is displayed, the user can know that chronic nephritis is suspected for the sample.

  In addition to the above, specimens collected from patients with chronic nephritis tend to be “glomerular” in the erythrocyte morphology information. Accordingly, the user sets the protein (PRO) and the red blood cell morphology information (RBC-Info.) As the cross check target items, and appropriately sets the corresponding cross check table, so that the information processing unit 30 stores the protein (PRO). A cross check between the measured value and the measured value of the red blood cell morphology information (RBC-Info.) Can be performed. As a result of such a cross check, if the measured value of the protein (PRO) and the measured value of the red blood cell morphology information (RBC-Info.) Are in a predetermined relationship, the display area A38 of the measurement result screen D3 The cross check target item name “PRO × RBC-Info.?” Of the protein (PRO) and red blood cell morphology information (RBC-Info.) Is displayed. When the cross check target item name “PRO × RBC-Info.?” Is displayed, the user can know that chronic nephritis is suspected for the sample.

  In addition, the combination of the urine qualitative measurement item and the urine sediment measurement item used for the determination of the reliability of the measurement result as described above or the clinical diagnosis may differ depending on the medical facility (user) such as the hospital and the test center. is there. In the urine test apparatus 1 according to the present embodiment, since the user can freely set the cross check target item, the user can set the cross check target item according to the standards of his / her facility. it can.

  Thus, in the above embodiment, the degree of freedom of the combination of measurement items when checking the measurement result can be improved. Thereby, the combination of measurement items used for checking the reliability of the measurement result can be easily expanded as necessary. In addition, it is possible to acquire information for supporting diagnosis from the measurement results of the two measurement items, and the obtained measurement results can be used more than ever.

(Other embodiments)
Note that a combination of urine qualitative measurement items and urine sediment measurement items that are generally used for determining the reliability of measurement results may be set in advance as the default value of the cross check target item. Thereby, when introducing the urine test apparatus 1 into the user facility, the cross check of the measurement result by the cross check target item that is generally used can be performed without setting the cross check target item. The burden is reduced. After introducing the urine test apparatus 1, know-how for determining the reliability of the original measurement results is accumulated at the user facility, or the measurement values of the urine qualitative measurement items and the measurement values of the urine sediment measurement items in a specific disease After the relationship is newly found, the user can set an original cross check target item.

  In the above embodiment, the configuration for accepting designation of both the urine qualitative measurement item and the urine sediment measurement item as the cross check target item in the cross check setting dialog has been described. However, the present invention is not limited to this. is not. A specific urine qualitative measurement item may be a fixed setting value, designation of a urine sediment measurement item corresponding to the urine qualitative measurement item may be accepted, and a combination of these may be set as a cross check target item. As a configuration in which a specific urine sediment measurement item is set as a fixed value, specification of a urine qualitative measurement item corresponding to the urine sediment measurement item is accepted, and a combination of these is set as a cross check target item Good.

  In addition, a combination of a plurality of urine correction measurement items and urine sediment measurement items is displayed on the screen, each combination can be selected, and selection of a desired combination to be set as a cross check target item from the user is accepted, The selected combination may be set as a cross check target item.

  Moreover, in said embodiment, the measurement unit 10 and the information processing unit 30 which have the urine qualitative measurement part 11 and the urine sediment measurement part 12 are provided separately, and the measurement unit 10 and the information processing unit 30 are provided. Although the configuration in which communication is possible has been described, the present invention is not limited to this. It is good also as a structure which mounts the urine qualitative measurement part 11, the urine sediment measurement part 12, and the information processing unit 30 in one housing | casing.

Further, in the above-described embodiment, the configuration in which the information processing unit 30 of the urinalysis apparatus 1 performs the setting of the cross check target item and the cross check of the measurement result is described, but is not limited thereto. . A urine qualitative test device and a urine sediment test device are provided separately, and in the urine sample test result processing device connected to be communicable with them, the cross check target items can be set. The urine qualitative analysis result by the urine qualitative test device and the urine tangential component analysis result by the urine tangential component analysis device are received, and the urine qualitative analysis result and the urine tangible component analysis result are set according to the set cross check target items. it may be configured to perform a cross-check of the.

DESCRIPTION OF SYMBOLS 1 Urine test apparatus 10 Measurement unit 11 Urine qualitative measurement part 111 Control part 111a CPU
111b Storage unit 112 Communication unit 113 Suction unit 114 Test paper supply unit 115 Detection unit 116 Bar code reader 12 Urine formation measurement unit 121 Control unit 121a CPU
121b Storage unit 122 Communication unit 123 Suction unit 124 Sample preparation unit 125 Detection unit 30 Information processing unit 300 Main body 301 CPU
302 ROM
303 RAM
304 Hard Disk 305 Reading Device 306 Input / Output Interface 307 Image Output Interface 308 Communication Interface 310 Input Unit 320 Display Unit 50 Sample Rack 51 Sample Container

Claims (7)

Measure albumin / creatinine ratio and protein for urine samples,
Measuring cylinders and red blood cells for the urine specimen;
Measurement of the albumin / creatinine ratio is higher than a predetermined value, and, if the measured value of the cylinder is higher than a predetermined value, and displays the first information suggests suspected early diabetic nephropathy,
A urinalysis method that displays second information suggesting a suspicion of chronic nephritis when a measured value of protein is higher than a predetermined value and a measured value of red blood cells is higher than a predetermined value . For the urine sample, and further measures the occult blood,
The urinalysis method according to claim 1, wherein when the occult blood measurement value and the erythrocyte measurement value deviate from a predetermined relationship , the third information indicating that the measurement value reliability is low is displayed. A first display area in which a measured value of albumin / creatinine ratio and a measured value of protein are displayed; a second display area in which a measured value of a cylinder and a measured value of red blood cells are displayed; and the first information and the second information The urine test method according to claim 1, wherein a measurement result screen including a third display area in which is displayed. A transport unit for transporting a urine sample;
A urine qualitative measurement unit capable of measuring at least the albumin / creatinine ratio and protein of the urine sample conveyed by the conveyance unit;
A urine sediment measurement unit capable of measuring at least a column and red blood cells for the urine sample transported by the transport unit;
If the measured value of the albumin / creatinine ratio obtained by the urine qualitative measuring unit is higher than a predetermined value and the measured value of the column obtained by the urine sediment measuring unit is higher than the predetermined value , early diabetic Measurement of red blood cells obtained by displaying the first information suggesting a suspicion of nephropathy, the protein measurement value obtained by the urine qualitative measurement unit being higher than a predetermined value, and the urine sediment measurement unit A urinalysis apparatus comprising: a display unit that displays second information that suggests suspicion of chronic nephritis when the value is higher than a predetermined value . The display unit is a urine sample in which a measurement value of occult blood obtained by the urine qualitative measurement unit and a measurement value of red blood cells obtained by the urine sediment measurement unit deviate from a predetermined relationship . The urinalysis apparatus according to claim 4 , wherein the third information indicating that the reliability of the measurement value is low is displayed. The display unit can display a measurement result screen for displaying a measurement result,
The measurement result screen includes a first display area the measured value of the measured value and the protein of the urine qualitative measuring section by Ri resulting albumin / creatinine ratio is display to change due to the urine formed component measurement unit 5. The urine according to claim 4 , comprising: a second display region in which the measured value of the obtained cylinder and the measured value of red blood cells are displayed; and a third display region in which the first information and the second information are displayed. Inspection device. The transport unit includes a first tank that stores a rack that stores a urine sample, a second tank that stores a rack after measurement, and a connection unit that connects the first tank and the second tank,
The urine qualitative measurement unit aspirates a urine sample stored in a rack at a first suction position on the connection unit,
The urine test apparatus according to any one of claims 4 to 6 , wherein the urine sediment measurement unit aspirates a urine sample stored in a rack at a second aspiration position on the connection unit.

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