Patent Description:
In a specimen analyzer, a specimen is measured and analyzed per measurement item. A measurement value of each measurement item is referred to in, for example, diagnosis. A calculation value calculated from measurement values of a plurality of measurement items has clinical significance in some cases. For example, in <NPL>, it is reported that a ratio between a measurement value of amyloid beta <NUM> (Aβ <NUM>-<NUM>) and a measurement value of amyloid beta <NUM> (Aβ <NUM>-<NUM>) is effective in diagnosing Alzheimer-type dementia.

Among measurement items that are measured by the specimen analyzer, there are measurement items corresponding to target substances, in a specimen, the amounts of which decrease in association with elapse of time. For example, amyloid beta <NUM> and amyloid beta <NUM> in a blood specimen collected from a subject decrease in association with elapse of time. Therefore, the reliability of the above ratio might decrease depending on the measurement conditions for these measurement items.

An object of the present invention is to provide a specimen analysis method and a specimen analyzer that enable the reliability of a calculation value obtained from measurement values of a plurality of measurement items to be kept high even if the amounts of target substances, in a specimen, corresponding to the plurality of measurement items decrease in association with elapse of time.

In the specimen analysis method of the present invention, the process related to the time difference between a measurement of the first measurement item and a measurement of the second measurement item is executed, and thus the reliability of the calculation value can be kept high.

In the specimen analyzer of the present invention, the process related to the time difference between a measurement of the first measurement item and a measurement of the second measurement item is executed in the same manner as in the above specimen analysis method, and thus a calculation value with a high reliability can be obtained.

The present invention enables the reliability of a calculation value obtained from measurement values of a plurality of measurement items to be kept high even if the amounts of target substances, in a specimen, corresponding to the plurality of measurement items decrease in association with elapse of time.

<FIG> schematically shows a configuration of a specimen analyzer <NUM> according to Embodiment <NUM>. The specimen analyzer <NUM> analyzes a specimen regarding a plurality of measurement items. Among the plurality of measurement items, there is a combination (described later) of measurement items that need to be measured at as close timings as possible. In the specimen analyzer <NUM>, a process related to a time difference between measurements is executed on such a combination of measurement items.

In <FIG>, for convenience, a measurement device <NUM> is shown in a state where a housing 2a thereof is transparent so that components inside the measurement device <NUM> in a plan view are shown. In addition, a left-right direction and a front-rear direction in the plan view of the measurement device <NUM> are indicated in <FIG>.

The specimen analyzer <NUM> is an immuno analyzer for performing tests on a specimen regarding various items such as hepatitis B, hepatitis C, a tumor marker, a thyroid hormone, and a dementia marker. The specimen is, for example, whole blood, plasma, serum, cerebrospinal fluid (CSF), or the like.

The specimen analyzer <NUM> includes the measurement device <NUM> and a control device <NUM>. The measurement device <NUM> includes a specimen transport unit <NUM>, a specimen dispensing unit <NUM>, an urgent specimen/tip transport unit <NUM>, a pipette tip supply device <NUM>, a tip detachment unit <NUM>, reagent tables <NUM> and <NUM>, a primary reaction unit <NUM>, reagent dispensing units <NUM> and <NUM>, a primary BF separation table <NUM>, a primary BF separation unit <NUM>, a transfer mechanism <NUM>, a secondary reaction unit <NUM>, a reagent dispensing unit <NUM>, a secondary BF separation table <NUM>, a secondary BF separation unit <NUM>, an R4 reagent dispensing unit <NUM>, an R5 reagent dispensing unit <NUM>, a detector <NUM>, a disposal hole <NUM>, and a temperature sensor <NUM>.

In a measurement by the measurement device <NUM>, a specimen and an R1 reagent (a reagent containing a capture antibody that binds to a protein such as an antigen or a peptide contained in the specimen) are mixed with each other, and an R2 reagent (a reagent containing magnetic particles that bind to the capture antibody) is added to the obtained liquid mixture. The magnetic particles and the capture antibody having bound to the protein are attracted to a magnet of the primary BF separation unit <NUM>, and a contaminant that has not been attracted to the magnet is removed through suction so that the R1 reagent containing an unreacted capture antibody is removed. An R3 reagent (a reagent containing a labeled antibody) is added to a sample resulting from the treatment by the primary BF separation unit <NUM>. The magnetic particles and the labeled antibody having bound to the protein are attracted to a magnet of the secondary BF separation unit <NUM>, and a contaminant that has not been attracted to the magnet is removed through suction so that the R3 reagent containing an unreacted labeled antibody is removed. An R4 reagent (liquid dispersion) and an R5 reagent (a luminescent substrate that emits light in a process of a reaction with the labeled antibody) are added to a sample resulting from the treatment by the secondary BF separation unit <NUM>. Then, the amount of light generated through a reaction between the labeled antibody and the luminescent substrate is measured. Through such a process, the protein contained in the specimen is quantitatively measured. In measurements of measurement items <NUM>-<NUM> and <NUM>-<NUM> described later, a specimen diluent is used as the R1 reagent, and antibody-immobilizing particles are used as the R2 reagent.

When measurements of specimens are started, an operator causes containers T accommodating the specimens to be held on a rack R. Holding portions capable of holding a plurality of the containers T are formed on the rack R. The operator sets the rack R holding the containers T onto the specimen transport unit <NUM>.

The specimen transport unit <NUM> transports the rack R having been set by the operator to a suction position of the specimen dispensing unit <NUM>. The specimen dispensing unit <NUM> sequentially suctions, at the suction position, the specimens in the plurality of the containers T held on the rack R. In the specimen analyzer <NUM>, in order to prevent any of the specimens suctioned and discharged by the specimen dispensing unit <NUM> from being mixed with another one of the specimens, a disposable pipette tip is exchanged every time a specimen is suctioned and discharged.

The urgent specimen/tip transport unit <NUM> includes a transport rack 13a capable of being moved in the left-right direction. Container placement portions 13b and a tip placement portion 13c are formed on the transport rack 13a. A container T accommodating an urgent specimen that needs to be tested so as to take precedence over a specimen being transported by the specimen transport unit <NUM> is held in any of the container placement portions 13b. The container T held in the container placement portion 13b is transported in the right direction and positioned so as to overlap with a rotation trajectory of a pipette 12c of the specimen dispensing unit <NUM>.

The pipette tip supply device <NUM> sets supplied pipette tips into the tip placement portion 13c one by one. The pipette tip held in the tip placement portion 13c is transported in the right direction and positioned so as to overlap with the rotation trajectory of the pipette 12c of the specimen dispensing unit <NUM>. The tip detachment unit <NUM> is used to detach a pipette tip mounted to the specimen dispensing unit <NUM>.

The specimen dispensing unit <NUM> includes an arm portion 12a, a shaft 12b, and the pipette 12c. The arm portion 12a is rotated around the shaft 12b and moved in an up-down direction. The pipette 12c is located at a distal end of the arm portion 12a, and suctions and discharges each specimen. The pipette tip transported by the tip placement portion 13c is mounted at a lower end of the pipette 12c. The specimen dispensing unit <NUM> suctions each of the specimens in the containers T transported by the specimen transport unit <NUM> and the transport rack 13a.

The reagent tables <NUM> and <NUM> are composed of tables that are driven to rotate. On the reagent table <NUM>, a reagent container accommodating the R1 reagent and a reagent container accommodating the R3 reagent are placed. On the reagent table <NUM>, a reagent container accommodating the R2 reagent is placed.

The primary reaction unit <NUM> includes a primary reaction table 18a and a container transfer portion 18b. On the primary reaction table 18a, holding portions 18c for holding cuvettes C are formed.

The reagent dispensing unit <NUM> includes an arm 19a, a shaft 19b, and a pipette 19c. The arm 19a is rotated around the shaft 19b and moved in the up-down direction. The pipette 19c is located at a distal end of the arm 19a. The reagent dispensing unit <NUM> suctions the R1 reagent in the reagent container placed on the reagent table <NUM> and discharges the suctioned R1 reagent into an empty cuvette C on the primary reaction unit <NUM>. The specimen dispensing unit <NUM> dispenses any of the suctioned specimens into the cuvette C into which the R1 reagent has been discharged. Thereafter, on the primary reaction unit <NUM>, the specimen and the R1 reagent in the cuvette C are subjected, for a predetermined time, to a primary reaction treatment so as to be heated to a predetermined temperature.

The reagent dispensing unit <NUM> has the same configuration as that of the reagent dispensing unit <NUM> and includes an arm 20a, a shaft 20b, and a pipette 20c. The reagent dispensing unit <NUM> suctions the R2 reagent in the reagent container placed on the reagent table <NUM> and discharges the suctioned R2 reagent into the cuvette C which is located on the primary reaction unit <NUM> and into which the specimen and the R1 reagent have been discharged.

The primary reaction unit <NUM> drives the primary reaction table 18a so as to rotationally transfer the cuvette C on a corresponding one of the holding portions 18c and stirs the specimen, the R1 reagent, and the R2 reagent in the cuvette C. Thereafter, on the primary reaction unit <NUM>, the specimen, the R1 reagent, and the R2 reagent in the cuvette C are subjected, for a predetermined time, to a secondary reaction treatment so as to be heated to a predetermined temperature. Consequently, the R2 reagent containing the magnetic particles and the protein in the specimen react with each other in the cuvette C. The container transfer portion 18b transfers, onto the primary BF separation table <NUM>, the cuvette C having been subjected to the treatment by the primary reaction unit <NUM>.

The primary BF separation unit <NUM> performs a primary BF separation treatment in which the R1 reagent containing an unreacted capture antibody is removed from the sample in the cuvette C on the primary BF separation table <NUM>.

The transfer mechanism <NUM> includes an arm 23a, a shaft 23b, and a grip portion 23c. The arm 23a is rotated around the shaft 23b and moved in the up-down direction. The grip portion 23c is located at a distal end of the arm 23a and is configured to be capable of gripping the cuvette C. The transfer mechanism <NUM> transfers, onto the secondary reaction unit <NUM>, the cuvette C which is located on the primary BF separation table <NUM> and which has been subjected to the treatment by the primary BF separation unit <NUM>.

The secondary reaction unit <NUM> has the same configuration as that of the primary reaction unit <NUM> and includes a secondary reaction table 24a and a container transfer portion 24b. On the secondary reaction table 24a, holding portions 24c for holding cuvettes C are formed.

The reagent dispensing unit <NUM> has the same configuration as that of the reagent dispensing unit <NUM> and includes an arm portion 25a, a shaft 25b, and a pipette 25c. The reagent dispensing unit <NUM> suctions the R3 reagent in the reagent container placed on the reagent table <NUM> and discharges the suctioned R3 reagent into the cuvette C which is located on the secondary reaction unit <NUM> and into which the specimen, the R1 reagent, and the R2 reagent have been discharged. Thereafter, on the secondary reaction unit <NUM>, the specimen, the R1 reagent, the R2 reagent, and the R3 reagent in the cuvette C are subjected, for a predetermined time, to a tertiary reaction treatment so as to be heated to a predetermined temperature. The container transfer portion 24b of the secondary reaction unit <NUM> transfers, onto the secondary BF separation table <NUM>, the cuvette C into which the R3 reagent has been discharged.

The secondary BF separation unit <NUM> has the same configuration as that of the primary BF separation unit <NUM> and performs a secondary BF separation treatment in which the R3 reagent containing an unreacted labeled antibody is removed from the sample in the cuvette C on the secondary BF separation table <NUM>. The container transfer portion 24b of the secondary reaction unit <NUM> transfers, into any of the holding portions 24c of the secondary reaction unit <NUM> again, the cuvette C which is located on the secondary BF separation table <NUM> and which has been subjected to the treatment by the secondary BF separation unit <NUM>.

The R4 reagent dispensing unit <NUM> and the R5 reagent dispensing unit <NUM> move nozzle portions parallelly and upward/downward, to respectively supply the R4 reagent and the R5 reagent into the cuvette C on the secondary reaction unit <NUM>.

The secondary reaction unit <NUM> drives the secondary reaction table 24a so as to rotationally transfer the cuvette C in the holding portion 24c and stirs the specimen and the R1 to R5 reagents in the cuvette C. Thereafter, on the secondary reaction unit <NUM>, the specimen and the R1 to R5 reagents in the cuvette C are subjected, for a predetermined time, to a quaternary reaction treatment so as to be heated to a predetermined temperature. Consequently, in the cuvette C, the R3 reagent containing the labeled antibody and the protein in the specimen react with each other, and the R5 reagent containing the luminescent substrate and the labeled antibody of the R3 reagent react with each other.

The detector <NUM> includes a transfer mechanism unit 30a which transfers the cuvette C held in the holding portion 24c of the secondary reaction unit <NUM> to the detector <NUM>. The detector <NUM> detects, by a photodetector such as a photomultiplier tube, light generated through the reaction process between the luminescent substrate and the labeled antibody having bound to the protein of the specimen.

The cuvette C having been used is disposed of into the disposal hole <NUM> by the transfer mechanism unit 30a of the detector <NUM>.

The temperature sensor <NUM> is placed, near the detector <NUM>, inside the housing 2a of the measurement device <NUM>. The temperature sensor <NUM> is, for example, a thermistor. The temperature sensor <NUM> detects a temperature of the inside of the housing 2a of the measurement device <NUM>. The temperature detected by the temperature sensor <NUM> is used for determining whether or not the environmental temperature of the inside of the measurement device <NUM> is appropriate for measurement. The placement position of the temperature sensor <NUM> only has to be inside the housing 2a and is not limited to the vicinity of the detector <NUM>.

<FIG> is a block diagram schematically showing a configuration of the control device <NUM>.

The control device <NUM> includes a controller <NUM>, a storage unit <NUM>, a display unit <NUM>, an input unit <NUM>, and a communication unit <NUM>.

The controller <NUM> is implemented by, for example, a processor such as a CPU. The storage unit <NUM> is implemented by, for example, an SSD, an HDD, a RAM, or the like. The display unit <NUM> is, for example, a liquid crystal display or an organic electroluminescence display. The display unit <NUM> displays various screens in accordance with signals from the controller <NUM>. The display unit <NUM> displays screens <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> described later. The input unit <NUM> is, for example, a mouse or a keyboard. The input unit <NUM> transmits a signal based on an operation by a user to the controller <NUM>. The display unit <NUM> and the input unit <NUM> may be integrally formed as a touch-panel-type display. The communication unit <NUM> is, for example, a network card. Via the communication unit <NUM>, the controller <NUM> controls each unit of the measurement device <NUM> and receives a signal from the measurement device <NUM>.

The controller <NUM> controls each unit of the measurement device <NUM> via the communication unit <NUM> such that the operations described with reference to <FIG> are performed for each of the plurality of measurement items. Consequently, the measurement device <NUM> dispenses a specimen in one container T into cuvettes C correspondingly to the number of the measurement items that are set for the specimen. The measurement device <NUM> dispenses reagents corresponding to the measurement items into the cuvettes C, prepares a measurement sample for each of the measurement items as described above, and detects, by the detector <NUM>, light generated from the measurement sample. The controller <NUM> converts the amount of the light detected by the detector <NUM> into a measurement value that is the concentration of a measurement-target protein.

Examples of the measurement items that can be set in Embodiment <NUM> include HBsAg, HBsAb, HBeAg, TSH, FT3, FT4, PSA, AFP, CEA, HBeAb, HBcAb, HCVAb, HIVAb, HTLV-I, TPAb, CA125, CA19-<NUM>, TM, TAT, PIC, tPAI-C, FRN, insulin, HIVAg+Ab, <NUM>-<NUM>, <NUM>-<NUM>, and the like. Further, examples of calculation items that can be set in Embodiment <NUM> include AB42/<NUM>.

The measurement item <NUM>-<NUM> is an item related to amyloid beta <NUM>-<NUM>, and the measurement item <NUM>-<NUM> is an item related to the amyloid beta <NUM>-<NUM>. The calculation item AB42/<NUM> is an item related to a ratio obtained by dividing a measurement value of the measurement item <NUM>-<NUM> by a measurement value of the measurement item <NUM>-<NUM>.

Meanwhile, if a blood specimen is collected from a subject, amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM> in the collected blood specimen decrease in association with elapse of time. However, it is known that the rates of decreases in amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM> are approximately equal to each other.

Therefore, measurements related to the measurement items <NUM>-<NUM> and <NUM>-<NUM> for calculating the calculation item AB42/<NUM> are performed at as close timings as possible. For example, the measurements are performed such that a time difference therebetween is not longer than <NUM> hour at most, preferably not longer than <NUM> minutes, and more preferably not longer than <NUM> minutes. The reason for this is as follows. If measurements related to the measurement items <NUM>-<NUM> and <NUM>-<NUM> are performed at close timings, the times having elapsed from the collection from the subject become approximately equal to each other. Thus, the rates of decreases in amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM> in the specimen dispensed from the one container T into each of a cuvette C for the measurement item <NUM>-<NUM> and a cuvette C for the measurement item <NUM>-<NUM>, become approximately equal to each other. In this case, the rates of decreases in the measurement value of the measurement item <NUM>-<NUM> as a numerator and the measurement value of the measurement item <NUM>-<NUM> as a denominator offset each other in calculation of a calculation value (ratio) of the calculation item AB42/<NUM>. Therefore, if measurements of the measurement items <NUM>-<NUM> and <NUM>-<NUM> are performed at close timings, the reliability of the calculation value (ratio) of the calculation item AB42/<NUM> can be kept high.

From this viewpoint, in Embodiment <NUM>, the specimen analyzer <NUM> is controlled such that measurements of the measurement items <NUM>-<NUM> and <NUM>-<NUM> are performed at close timings. For example, processing is performed such that the time difference between a measurement of the measurement item <NUM>-<NUM> and a measurement of the measurement item <NUM>-<NUM> is equal to or shorter than a predetermined time (for example, <NUM> hour, <NUM> minutes, <NUM> minutes, or the like) as described later. Hereinafter, screens and control of the specimen analyzer <NUM> controlled from the above viewpoint will be described.

In addition, as a result of thorough research by the present inventors, it has been found that a temperature range for a measurement environment in which the reliability of the measurement value of the measurement item <NUM>-<NUM> can be kept high is narrower than a temperature range for a measurement environment in which the reliability of the measurement value of the measurement item <NUM>-<NUM> can be kept high. From this viewpoint, in Embodiment <NUM>, the specimen analyzer <NUM> is controlled such that the temperature range for an allowable measurement environment regarding the measurement item <NUM>-<NUM> is narrower than the temperature range for an allowable measurement environment regarding the measurement item <NUM>-<NUM>. For example, as described later, a temperature range of not lower than <NUM> and not higher than <NUM> is set as an appropriate temperature range for the measurement item <NUM>-<NUM>, and a temperature range of not lower than <NUM> and not higher than <NUM> is set as an appropriate temperature range for the measurement item <NUM>-<NUM>.

<FIG> schematically shows a configuration of a screen <NUM>, displaying a job list, which is displayed on the display unit <NUM>.

The screen <NUM> includes a job list display region <NUM>, a detail display region <NUM>, a specimen information display region <NUM>, a subject information display region <NUM>, and an order registration button <NUM>.

The job list display region <NUM> is a region in which various types of information such as a measurement order and a measurement value obtained as a result of each measurement, which are associated with each of specimen numbers, are displayed. The job list display region <NUM> includes: an item of progress, an item of measurement date and time, and an item of specimen number; and a plurality of measurement items and a calculation item. The item of progress indicates a state, of each of jobs, such as a state where measurements have been completed, a state where measurement values have been approved, or an error state. The specimen number is a number that enables individual identification of a specimen accommodated in a container T.

In each of the measurement items in the job list display region <NUM>, a check mark is displayed before measurement if the measurement item is scheduled to be measured. The check mark in each of the measurement items is displayed on the basis of a measurement order preset for the specimen. The measurement order is obtained from a host computer communicably connected to the control device <NUM>. Alternatively, the measurement order is manually inputted by an operator via an order-registering screen <NUM> (<FIG>), described later, which is displayed on the display unit <NUM> by selecting the order registration button <NUM> through an operation of the input unit <NUM> by the operator. In addition, regarding each of the measurement items in the job list display region <NUM>, a measurement value of the measurement item, a calculation value, or the like is displayed after measurement.

An operator performs an operation of selecting one row of the job list display region <NUM> via the input unit <NUM>, thereby being able to select information (job) corresponding to the row. In an example shown in <FIG>, a job for a specimen number "<NUM>" at a lowermost row is selected, and this row is highlighted.

The detail display region <NUM> is a region in which information, about the job selected in the job list display region <NUM>, such as measurement values of the respective measurement items and a calculation value of a calculation item is displayed. In the example shown in <FIG>, for the job on the selected row, no measurement process has yet been performed by the measurement device <NUM>, and thus the detail display region <NUM> is blank.

The specimen information display region <NUM> is a region in which the specimen number, the measurement date and time, and the like for the job selected in the job list display region <NUM> are displayed. The subject information display region <NUM> is a region in which a subject ID, a subject name, and the like for the job selected in the job list display region <NUM> are displayed.

<FIG> schematically shows a configuration of a screen <NUM>, for performing item sorting setting, which is displayed on the display unit <NUM>.

The screen <NUM> includes a sorting list display region <NUM>, an upward movement button <NUM>, a downward movement button <NUM>, an OK button <NUM>, and a cancel button <NUM>.

In the sorting list display region <NUM>, blocks 211a corresponding to all measurement items and a calculation item that can be measured and analyzed by the specimen analyzer <NUM> are arranged. On the blocks 211a, measurement item names and a calculation item name are displayed. The arrangement of the plurality of blocks 211a indicates a sequence according to which measurements related to the plurality of measurement items are performed. When measurement for one specimen is started, a measurement of a measurement item indicated on an upper left block 211a is performed earliest, and a measurement of a measurement item indicated on a lower right block 211a is performed latest. In an example shown in <FIG>, a measurement of a measurement item HBsAg is performed earliest, and a measurement of the measurement item <NUM>-<NUM> is performed latest. The screen <NUM> in <FIG> indicates an example in which blocks 211a corresponding to the measurement items <NUM>-<NUM> and <NUM>-<NUM> are arranged so as to be adjacent to each other.

An operator performs an operation of selecting any of the blocks 211a via the input unit <NUM>, thereby being able to select a measurement item corresponding to the block 211a. In the example shown in <FIG>, a block 211a for the measurement item <NUM>-<NUM> is selected, and this block 211a is highlighted. When an operator operates the upward movement button <NUM> in a state where any of the blocks 211a is selected, the selected block 211a is moved to an immediately-above measurement rank in the sorting list display region <NUM>. Meanwhile, when an operator operates the downward movement button <NUM> in this state, the selected block 211a is moved to an immediately-below measurement rank in the sorting list display region <NUM>.

As described above, measurements related to the measurement items <NUM>-<NUM> and <NUM>-<NUM> are preferably performed at close timings. From this viewpoint, in Embodiment <NUM>, when an operator operates the upward movement button <NUM> or the downward movement button <NUM> in a state where either of the two blocks 211a corresponding to the measurement items <NUM>-<NUM> and <NUM>-<NUM> is selected, the measurement ranks of these two blocks 211a (group 211b) among all the measurement items are changed with the blocks 211a being kept arranged so as to be adjacent to each other in terms of the measurement ranks thereof as shown in <FIG>.

Meanwhile, if the blocks 211a corresponding to the measurement items <NUM>-<NUM> and <NUM>-<NUM> are arranged so as not to be adjacent to each other as shown in <FIG>, when an operator operates the upward movement button <NUM> or the downward movement button <NUM> in a state where either of the two blocks 211a corresponding to the measurement items <NUM>-<NUM> and <NUM>-<NUM> is selected, the measurement ranks of these two blocks 211a (group 211b) among all the measurement items are changed with the blocks 211a being rearranged so as to be adjacent to each other in terms of the measurement ranks thereof as shown in <FIG>.

Consequently, measurements of the measurement items <NUM>-<NUM> and <NUM>-<NUM> are always performed consecutively, and thus the reliability of the calculation value (ratio) of the calculation item AB42/<NUM> can be kept high.

When an operator operates the OK button <NUM>, the controller <NUM> stores, in the storage unit <NUM>, the measurement ranks of the measurement items on the basis of the arrangement sequence of the blocks 211a having been set in the sorting list display region <NUM>, and closes the screen <NUM>. When an operator operates the cancel button <NUM>, the controller <NUM> discards the content having been set in the sorting list display region <NUM> and closes the screen <NUM>.

In <FIG>, the blocks 211a may be moved by performing a drag-and-drop operation on the blocks 211a instead of using the upward movement button <NUM> and the downward movement button <NUM>. In this case as well, the blocks 211a for the measurement items <NUM>-<NUM> and <NUM>-<NUM> are moved as the group 211b.

<FIG> schematically shows a configuration of a screen <NUM>, for performing item information setting by an administrator, which is displayed on the display unit <NUM>.

The screen <NUM> includes an item list display region <NUM>, a basic setting button <NUM>, and a detail setting button <NUM>. An administrator who performs maintenance of the specimen analyzer <NUM> or the like performs, after logging in by using the authority of an administrator, a predetermined operation to display the screen <NUM>.

In the item list display region <NUM>, the blocks 221a corresponding to all the measurement items that can be measured and analyzed by the specimen analyzer <NUM> are arranged. On the blocks 221a, the measurement item names and the calculation item name are displayed. The blocks 221a are arranged in accordance with the measurement ranks having been set in the screen <NUM> in <FIG>.

The administrator performs an operation of selecting a block 221a via the input unit <NUM>, thereby being able to select a measurement item corresponding to the block 221a. In an example shown in <FIG>, the block 221a for the measurement item <NUM>-<NUM> is selected. When the administrator operates the basic setting button <NUM> in a state where a block 221a is selected, a screen for setting, for example, a displayed item name, a display range for a measurement value, a unit of the measurement value, and the like for basic setting regarding the selected measurement item is displayed on the display unit <NUM>. When the administrator operates the detail setting button <NUM> in a state where a block 221a is selected, a screen for performing additional setting on the selected measurement item is displayed on the display unit <NUM>. When the detail setting button <NUM> is operated in a state where the measurement item <NUM>-<NUM> is selected as shown in <FIG>, a screen <NUM> (shown in <FIG>) for adding a re-measurement condition is displayed on the display unit <NUM>.

<FIG> schematically shows a configuration of the screen <NUM>, for performing additional setting regarding the measurement item <NUM>-<NUM>, which is displayed on the display unit <NUM>.

The screen <NUM> includes a measurement item display region <NUM>, a time interval setting region <NUM>, and a temperature setting region <NUM>.

A measurement item name "<NUM>-<NUM>" is displayed in the measurement item display region <NUM> so as to make it understandable that the screen <NUM> is for setting related to the measurement item <NUM>-<NUM>.

The time interval setting region <NUM> includes a checkbox 232a and pull-down menus 232b and 232c. If the administrator desires to enable setting of the pull-down menus 232b and 232c, the administrator performs an operation via the input unit <NUM>, to check off the checkbox 232a. Consequently, setting of a time interval between a measurement of the measurement item <NUM>-<NUM> and a measurement of a measurement item to form a pair with the measurement item <NUM>-<NUM>, is enabled.

The pull-down menu 232b is a menu for selecting a measurement item to form a pair with the measurement item <NUM>-<NUM>. The pull-down menu 232c is a menu for selecting a maximum time interval between a measurement of the measurement item <NUM>-<NUM> and a measurement of the measurement item to form a pair with the measurement item <NUM>-<NUM>. The administrator operates the pull-down menu 232b, selects a measurement item to form a pair with the measurement item <NUM>-<NUM>, operates the pull-down menu 232c, and selects a time interval, via the input unit <NUM>. In <FIG>, the measurement item <NUM>-<NUM> is selected as a measurement item to form a pair with the measurement item <NUM>-<NUM>, and " <NUM> hour" is selected as a time interval.

If setting in the time interval setting region <NUM> is made as shown in <FIG>, when the time interval between a measurement of the measurement item <NUM>-<NUM> and a measurement of the measurement item <NUM>-<NUM> exceeds <NUM> hour, each of the measurement values of the measurement items <NUM>-<NUM> and <NUM>-<NUM> is indicated as a measurement error, and no calculation value (ratio) of the calculation item AB42/<NUM> is outputted. In this case, an order for measuring the measurement items <NUM>-<NUM> and <NUM>-<NUM> again is automatically created. Consequently, outputting of a calculation value having a low reliability can be avoided, and re-setting of a measurement order makes it possible to automatically provide an opportunity in which a calculation value having a high reliability can be obtained.

The temperature setting region <NUM> includes a checkbox 233a and pull-down menus 233b and 233c. If the administrator desires to enable setting of the pull-down menus 233b and 233c, the administrator performs an operation via the input unit <NUM>, to check off the checkbox 233a. Consequently, setting of an appropriate temperature range for measurement of the measurement item <NUM>-<NUM> is enabled.

The pull-down menus 233b and 233c are menus for respectively setting a lower limit and an upper limit of the appropriate temperature range for measurement of the measurement item <NUM>-<NUM>. The administrator operates the pull-down menus 233b and 233c and sets an appropriate temperature range for measurement of the measurement item <NUM>-<NUM>, via the input unit <NUM>. In <FIG>, a temperature range of not lower than <NUM> and not higher than <NUM> is set as an appropriate temperature range for measurement of the measurement item <NUM>-<NUM>. The temperature range is important for obtaining an appropriate measurement value in the measurement of the measurement item <NUM>-<NUM>, and thus such a temperature range is preferably set.

If setting in the temperature setting region <NUM> is made as shown in <FIG>, when the temperature in a measurement of the measurement item <NUM>-<NUM> is outside the above temperature range, not only the measurement of the measurement item <NUM>-<NUM> but also a measurement of the measurement item <NUM>-<NUM> forming a pair with the measurement item <NUM>-<NUM> is canceled. Consequently, each of the measurement values of the measurement items <NUM>-<NUM> and <NUM>-<NUM> is indicated as a measurement error, and no calculation value (ratio) of the calculation item AB42/<NUM> is outputted. In this case as well, an order for measuring the measurement items <NUM>-<NUM> and <NUM>-<NUM> again is automatically created. Consequently, outputting of a calculation value having a low reliability can be avoided, and re-setting of a measurement order makes it possible to automatically provide an opportunity in which a calculation value having a high reliability can be obtained.

When the administrator operates an OK button <NUM>, if the checkbox 232a is in a checked state, the controller <NUM> stores, in the storage unit <NUM>, the pair-forming measurement item and the time interval having been set in the time interval setting region <NUM>, and, if the checkbox 233a is in a checked state, the controller <NUM> stores, in the storage unit <NUM>, the temperature range having been set in the temperature setting region <NUM>. Thereafter, the controller <NUM> closes the screen <NUM>. When the administrator operates a cancel button <NUM>, the controller <NUM> discards the content having been set in the screen <NUM> and closes the screen <NUM>.

Meanwhile, when the detail setting button <NUM> is operated in a state where the measurement item <NUM>-<NUM> is selected in <FIG>, a screen <NUM> shown in <FIG> is displayed on the display unit <NUM>.

If the pair-forming measurement item and the time interval are set as shown in <FIG>, when the measurement item <NUM>-<NUM> is selected as a pair-forming measurement item in the pull-down menu 232b in <FIG>, the time interval in the pull-down menu 232c in <FIG> is automatically changed to the time interval having been set in <FIG>. In contrast, if the pair-forming measurement item and the time interval are set as shown in <FIG>, when the measurement item <NUM>-<NUM> is selected as a pair-forming measurement item in the pull-down menu 232b in <FIG>, the time interval in the pull-down menu 232c in <FIG> is changed to the time interval having been set in <FIG>. That is, the time intervals for the measurement items <NUM>-<NUM> and <NUM>-<NUM> can be set in either of the screens in <FIG> and <FIG>.

In the screen <NUM> related to the measurement item <NUM>-<NUM> in <FIG>, the checkbox 233a is in an unchecked state in initial setting. The reason for this is because a temperature range necessary for guaranteeing the reliability of a measurement value does not need to be individually set for measurement of the measurement item <NUM>-<NUM>. The temperature setting region <NUM> may be omitted in the screen <NUM> related to the measurement item <NUM>-<NUM>.

<FIG> schematically shows a configuration of a screen <NUM>, for allowing an operator to register a measurement order, which is displayed on the display unit <NUM>.

The screen <NUM> is displayed through operation, of the order registration button <NUM> of the screen <NUM> in <FIG>, performed by an operator via the input unit <NUM>. The screen <NUM> includes checkboxes <NUM>, item display regions <NUM>, an OK button <NUM>, and a cancel button <NUM>. The checkboxes <NUM> and the item display regions <NUM> are displayed so as to correspond to each other in a one-to-one relationship.

When an operator operates the input unit <NUM> so as to check off any of the checkboxes <NUM> and operates the OK button <NUM>, a measurement item corresponding to the checkbox <NUM> is registered in a measurement order. As for a calculation item, if all measurement items necessary for obtaining the calculation item are registered, the calculation item is automatically registered in the measurement order.

When an operator checks off the checkbox <NUM> for one of the measurement items <NUM>-<NUM> and <NUM>-<NUM> and operates the OK button <NUM>, a message that urges registration of another one of the measurement items in the measurement order is displayed on the display unit <NUM> as shown in <FIG> described later. Alternatively, when an operator checks off the checkbox <NUM> for one of the measurement items <NUM>-<NUM> and <NUM>-<NUM> and operates the OK button <NUM>, error information indicating that the measurement order has failed to be registered may be displayed on the display unit <NUM>.

<FIG> schematically shows a configuration of a modification of the screen <NUM>, for allowing an operator to register a measurement order, which is displayed on the display unit <NUM>.

A screen 240a for registering a measurement order is different from the screen <NUM> in that the calculation item AB42/<NUM> is displayed instead of the measurement items <NUM>-<NUM> and <NUM>-<NUM>. When an operator checks off the checkbox <NUM> for the calculation item AB42/<NUM> and operates the OK button <NUM>, the measurement items <NUM>-<NUM> and <NUM>-<NUM> which are measurement items necessary for obtaining the calculation item AB42/<NUM> are registered in the measurement order.

<FIG> schematically shows a configuration of another modification of the screen <NUM>, for allowing an operator to register a measurement order, which is displayed on the display unit <NUM>.

A screen 240b for registering a measurement order is different from the screen <NUM> in that a checkbox <NUM> corresponding to both the measurement items <NUM>-<NUM> and <NUM>-<NUM> is displayed. When an operator checks off the checkbox <NUM> and operates the OK button <NUM>, the measurement items <NUM>-<NUM> and <NUM>-<NUM> are registered in the measurement order.

<FIG> schematically shows a configuration of a screen <NUM>, displaying a post-measurement job list, which is displayed on the display unit <NUM>.

The screen <NUM> in <FIG> indicates a state where measurements and analyses for all the jobs having been set in the screen <NUM> in <FIG> have been ended. In measurement items that have been checked off in each of the jobs in the job list display region <NUM> in <FIG> and that have been normally measured, measurement values are displayed instead of the check marks. In the item of progress and the item of measurement date and time in the job list display region <NUM>, a state of the job and the date and time of execution of the measurement are respectively displayed. In the item of progress in <FIG>, a term "Reported" indicating that the measurement values have been outputted to a host computer, a printer for measurement value printing, or the like and that the job has been completed, a term "Validated" indicating that the measurement values have been approved, a term "Review" indicating that the measurement values need to be reviewed, a term "Error" indicating that the measurement has failed, or the like is displayed.

In an example shown in <FIG>, the job selected on the lowermost row is in a state where measurement has failed. Specifically, the measurement items other than the measurement items <NUM>-<NUM> and <NUM>-<NUM> are each in a state where: a measurement has been normally performed; and a measurement value has been obtained. However, regarding the measurement items <NUM>-<NUM> and <NUM>-<NUM>, "* * * * *. * * *" indicating a measurement error is displayed as a measurement value of each of the measurement items <NUM>-<NUM> and <NUM>-<NUM> since the time interval between measurements of the measurement items <NUM>-<NUM> and <NUM>-<NUM> exceeds the time interval (<NUM> hour) shown in <FIG> and <FIG>. In addition, "-----. ---" is displayed as a calculation value of the calculation item AB42/<NUM> since no calculation has been performed. Accordingly, in the detail display region <NUM> as well, the same measurement values and the like as those in the job list display region <NUM> are displayed. "···" displayed in each of measurement items HBsAb, HBeAg, and the like representatively indicates that the obtained measurement value is displayed as a numerical value.

As described above, if no appropriate calculation value has been obtained in the calculation item AB42/<NUM>, a measurement order for measuring the measurement items <NUM>-<NUM> and <NUM>-<NUM> again is automatically generated for the corresponding specimen as shown in <FIG>.

<FIG> schematically shows a configuration of the screen <NUM>, related to the post-measurement job list, which is displayed on the display unit <NUM>.

Since no measurement values of the measurement items <NUM>-<NUM> and <NUM>-<NUM> have been obtained, a measurement order including these two measurement items and the calculation item obtained from measurement values of these two measurement items is generated for the same specimen (specimen number "<NUM>") as that corresponding to the immediately-above job in the screen <NUM> in <FIG> in order to perform re-measurements (also referred to as "retests") of these two measurement items.

<FIG> schematically shows a configuration of a screen <NUM>, displaying a measurement order list related to the retests, which is displayed on the display unit <NUM>.

The screen <NUM> includes a measurement order list display region <NUM> and a deletion button <NUM>.

The measurement order related to the retests is displayed in the measurement order list display region <NUM>. The measurement order list display region <NUM> includes: an item of specimen number and an item of registration date and time; and the plurality of measurement items and the calculation item. The registration date and time are the date and time on which the measurement order related to the retests is set. In the measurement items and the calculation item in the measurement order list display region <NUM>, check marks are displayed if these measurement items are scheduled to be retested. An operator can ascertain, by referring to the measurement order list display region <NUM>, what retest measurement order has been generated for which specimen. Accordingly, the operator can smoothly set the rack R holding a relevant container T onto the specimen transport unit <NUM> (see <FIG>) again or can smoothly set the container T in any of the container placement portions 13b (see <FIG>).

An operator performs an operation of selecting one row of the measurement order list display region <NUM> via the input unit <NUM>, thereby being able to select a measurement order corresponding to the row. Then, the operator operates the deletion button <NUM> via the input unit <NUM>, thereby being able to delete the measurement order corresponding to the row selected in the measurement order list display region <NUM>. Consequently, if the operator determines that the specimen has degraded significantly, the operator can stop measurement in which the relevant container T is used.

Next, a process to be performed by the specimen analyzer <NUM> will be described.

In the following descriptions, the two measurement items having been set to be consecutively measured are referred to as a first measurement item and a second measurement item. An item for which a calculation value is calculated on the basis of a measurement value of the first measurement item and a measurement value of the second measurement item is simply referred to as a calculation item. In Embodiment <NUM>, the first measurement item is <NUM>-<NUM>, the second measurement item is <NUM>-<NUM>, and the calculation item is AB42/<NUM>. Alternatively, the first measurement item may be <NUM>-<NUM>, and the second measurement item may be <NUM>-<NUM>.

<FIG> is a flowchart showing a specimen analysis process.

The process shown in <FIG> is, in a state where a measurement order is registered, started by either of: setting of a rack R holding a container T accommodating a specimen corresponding to the measurement order onto the specimen transport unit <NUM> (see <FIG>) by an operator; and setting of the container T into any of the container placement portions 13b (see <FIG>) by an operator. The process shown in <FIG> is performed per container T.

When the container T is positioned at the suction position of the specimen dispensing unit <NUM>, the controller <NUM> of the control device <NUM> sequentially performs, on the basis of the measurement items having been set in the measurement order for the target specimen, determination in step S11 according to the measurement ranks having been set in the screen <NUM> in <FIG>.

In step S11, the controller <NUM> determines whether the determination-target measurement item is the first or second measurement item or is neither of the first and second measurement items. If the determination-target measurement item is the first or second measurement item, the controller <NUM> determines, in step S12, whether or not, regarding the measurement order for the target specimen, the corresponding pair-forming measurement item is set in the measurement order. That is, in step S12, if the determination target is the first measurement item, whether or not the second measurement item is scheduled to be measured is determined, and meanwhile, if the determination target is the second measurement item, whether or not the first measurement item is scheduled to be measured is determined.

If the pair-forming measurement item is present in the measurement order, the controller <NUM> determines, in step S13, whether or not the determination-target measurement item is a measurement item to be measured earlier out of the paired first and second measurement items. If the determination-target measurement item is a measurement item to be measured earlier, the controller <NUM> performs a pairing process (step S14) for consecutively performing measurements of the first and second measurement items in accordance with the measurement ranks having been set in any of <FIG>. Meanwhile, if the determination-target measurement item is a measurement item to be measured later, a measurement of the corresponding pair-forming measurement item has already been ended, and thus step S14 is skipped. The pairing process will be described later with reference to <FIG>.

If the controller <NUM> determines, in step S12, that the pair-forming measurement item is not present in the measurement order, the controller <NUM> causes, in step S15, the display unit <NUM> to display a notification screen <NUM> shown in <FIG>. As shown in <FIG>, the notification screen <NUM> includes: a notification region <NUM> for notifying an operator that the pair-forming measurement item is not set in the measurement order for the target specimen; and buttons <NUM> and <NUM>. In an example shown in <FIG>, an indication that no calculation value of the calculation item AB42/<NUM> is to be obtained since the pair-forming measurement item <NUM>-<NUM> is not scheduled to be measured, is shown in the notification region <NUM> in the case where the determination-target measurement item is <NUM>-<NUM> and the pair-forming measurement item is <NUM>-<NUM>. If the operator desires to measure the pair-forming measurement item, the operator operates the button <NUM> via the input unit <NUM>. Meanwhile, if the operator does not desire to measure the pair-forming measurement item, the operator operates the button <NUM> via the input unit <NUM>.

In step S16, the controller <NUM> determines which of the buttons has been operated in the notification screen <NUM> in <FIG>. If the button <NUM> is operated, the controller <NUM> adds, to the measurement order, the measurement item to form a pair with the determination-target measurement item and advances the process to step S14. Meanwhile, if the button <NUM> is operated, the controller <NUM> advances the process to step S17 such that only a measurement of the determination-target measurement item out of the paired two measurement items is performed.

If the controller <NUM> determines, in step S11, that the determination-target measurement item is neither of the first and second measurement items, the controller <NUM> performs a single-process in step S17 for performing a measurement of the determination-target measurement item. In the single-process in step S17, the controller <NUM> causes a measurement process (steps S301 to S314: <FIG>) described later to be executed and causes the display unit <NUM> to display a measurement value having been obtained.

In step S18, the controller <NUM> determines, on the basis of the measurement order (including a retest order described later) for the target specimen, whether or not processes for all the measurement items have been ended. If the processes for all the measurement items have not been ended, the process is returned to step S11. Consequently, each measurement item having been set in the measurement order is regarded as a determination target according to the measurement rank thereof, and a process composed of steps S11 to S17 is performed. Meanwhile, if the processes for all the measurement items have been ended, the process in <FIG> is ended. Thereafter, if there is a subsequent container T, the process in <FIG> is performed consecutively on the subsequent container T.

<FIG> is a flowchart showing the pairing process in step S14 in <FIG>.

In step S101, the controller <NUM> performs a process of a pre-measurement-start check. In the process of the pre-measurement-start check, the controller <NUM> determines whether or not a time difference between a measurement of the first measurement item and a measurement of the second measurement item is to be equal to or shorter than a predetermined time if measurements of the first and second measurement items are executed. If the controller <NUM> determines, in the process of the pre-measurement-start check, that the time difference is not to be equal to or shorter than the predetermined time, the controller <NUM> prohibits start of measurements of both the first measurement item and the second measurement item as described later.

<FIG> is a flowchart showing the process of the pre-measurement-start check in <FIG>.

In step S201, the controller <NUM> obtains, from the storage unit <NUM>, reagent information to be used for measurements of the first and second measurement items. Reagent information (an expiration date of each reagent, a remaining test number of the reagent, a remaining amount of the reagent, or the like) to be used for measurements of all the measurement items to be performed by the measurement device <NUM> is prestored in the storage unit <NUM>. The controller <NUM> thoroughly updates, in accordance with an exchange of the reagent containers and consumptions of the reagents, the reagent information stored in the storage unit <NUM>. Subsequently, in step S202, the controller <NUM> obtains an environmental temperature in measurement from the temperature sensor <NUM> (see <FIG>).

In step S203, the controller <NUM> determines, on the basis of the reagent information obtained in step S201, whether or not reagents to be used for measurements of the first and second measurement items have yet to reach respective expiration dates.

If the reagents have yet to reach the respective expiration dates, the controller <NUM> determines, in step S204, whether or not remaining amounts of the reagents to be used for measurements of the first and second measurement items are equal to or larger than necessary amounts for measurements of the first and second measurement items, respectively, on the basis of the reagent information obtained in step S201. In step S204, for each of the measurement items, if the remaining test number for the reagent accommodated in a target reagent container is one or more times, the controller <NUM> determines that a necessary amount of the reagent is present in the target reagent container. Alternatively, for each of the measurement items, if the remaining amount of the reagent accommodated in a target reagent container is equal to or larger than a necessary amount for one time of measurement, the controller <NUM> may determine that a necessary amount of the reagent is present in the target reagent container.

If at least necessary amounts of the reagents are present, the controller <NUM> determines, in step S205, whether or not the environmental temperature in measurement obtained in step S202 is within a predetermined temperature range. The predetermined temperature range is the temperature range having been set in the temperature setting region <NUM> in <FIG>.

If the environmental temperature is within the predetermined temperature range, the controller <NUM> permits start of measurements of the first and second measurement items in step S206. Meanwhile, if a result of the determination in any of steps S203 to S205 is NO, the controller <NUM> prohibits start of measurements of the first and second measurement items in step S207. Consequently, the process of the pre-measurement-start check is ended.

With reference back to <FIG>, the controller <NUM> determines, in step S102, whether or not start of measurements of the first and second measurement items has been permitted in the process of the pre-measurement-start check in step S101. If start of measurements of the first and second measurement items has been permitted, the controller <NUM> causes measurements of the first and second measurement items to be performed consecutively in accordance with the measurement ranks having been set in the screen <NUM> in <FIG>. In an example shown in <FIG>, a measurement of the first measurement item is performed before a measurement of the second measurement item.

In step S103, the controller <NUM> causes a measurement of the first measurement item to be started. Consequently, the controller <NUM> causes a measurement process (steps S301 to S314: see <FIG>) described later to be executed for the first measurement item concurrently with the pairing process. Subsequently, in step S104, the controller <NUM> determines whether or not it has become possible to start a measurement of the second measurement item. In other words, the controller <NUM> determines whether or not a timing of starting a measurement of the second measurement item has come. Thus, the controller <NUM> suspends the process until it becomes possible to start a measurement of the second measurement item. For example, the controller <NUM> determines, when the measurement process for the first measurement item advances to a predetermined step (for example, step S303 in <FIG>), that it has become possible to start a measurement of the second measurement item. If it has become possible to start a measurement of the second measurement item, the controller <NUM> causes a measurement of the second measurement item to be started in step S105. Consequently, the controller <NUM> causes the measurement process (steps S301 to S314: see <FIG>) described later to be executed for the second measurement item concurrently with the pairing process.

<FIG> is a flowchart showing the measurement process performed per measurement item.

The measurement process shown in <FIG> is applicable to not only each of a measurement of the first measurement item and a measurement of the second measurement item but also a measurement of another measurement item (single-process in <FIG>). Each of steps in <FIG> is performed through control of the corresponding unit of the measurement device <NUM> by the controller <NUM>.

In step S301, the R1 reagent is dispensed in a cuvette C having been set in any of the holding portions 18c. In step S302, the specimen is dispensed in the above cuvette C. In step S303, the primary reaction unit <NUM> performs the primary reaction treatment on the specimen and the R1 reagent in the above cuvette C. In step S304, the R2 reagent is dispensed in the above cuvette C. In step S305, the primary reaction unit <NUM> performs the secondary reaction treatment on the specimen and the R1 and R2 reagents in the above cuvette C. In step S306, the primary BF separation unit <NUM> performs the primary BF separation treatment in which the R1 reagent containing an unreacted capture antibody is removed from inside the above cuvette C.

In step S307, the R3 reagent is dispensed in the above cuvette C. In step S308, the secondary reaction unit <NUM> performs the tertiary reaction treatment on the specimen and the R1 to R3 reagents in the above cuvette C. In step S309, the secondary BF separation unit <NUM> performs the secondary BF separation treatment in which the R3 reagent containing an unreacted labeled antibody is removed from inside the above cuvette C.

In step S310, the R4 reagent and the R5 reagent are dispensed in the above cuvette C. In step S311, the secondary reaction unit <NUM> performs the quaternary reaction treatment on the specimen and the R1 to R5 reagents in the above cuvette C. In step S312, the detector <NUM> performs an optical detection process of detecting light generated from the specimen and the R1 to R5 reagents in the above cuvette C. In step S313, the controller <NUM> stores, in the storage unit <NUM>, a time point at which the optical detection process has been ended. Step S313 may be a step that is executed only for measurements of the first and second measurement items and that is not executed for measurements of the other measurement items. Thereafter, in step S314, a process of converting the amount of the light detected in step S312 into a measurement value (the concentration of the protein to be measured) is performed.

With reference back to <FIG>, in step S106, the controller <NUM> determines whether or not a timing of ending step S314 for each of the first and second measurement items has come. In other words, the controller <NUM> determines whether or not a timing of ending the measurements of the first and second measurement items has come. If the controller <NUM> determines that the timing of ending the measurements of the first and second measurement items has come, the controller <NUM> performs a process of a post-measurement check in step S107. In the process of the post-measurement check, the controller <NUM> determines whether or not the time difference between the measurement of the first measurement item and the measurement of the second measurement item is equal to or shorter than the predetermined time. If the controller <NUM> determines, in the process of the post-measurement check, that the time difference is not equal to or shorter than the predetermined time, the controller <NUM> prohibits outputting of a calculation value of the calculation item based on the measurement values of the first and second measurement items as described later.

<FIG> is a flowchart showing the process of the post-measurement check.

In step S401, the controller <NUM> determines whether or not the measurement values of both the first and second measurement items are present. In Embodiment <NUM>, the measurement values of both the first and second measurement items have been normally obtained before the process of the post-measurement check is executed. However, if an error in, for example, dispensing any of the specimen and the reagents occurs in either of the measurement of the first measurement item and the measurement of the second measurement item, no measurement value is obtained for the measurement item regarding which the error in dispensing has occurred. If a measurement value of at least one of the first and second measurement items fails to be obtained in this manner, a result of the determination in step S401 is NO.

If the measurement values of both the first and second measurement items are present, the controller <NUM> reads out, from the storage unit <NUM>, the detection time points stored in step S313 in <FIG> during the measurements of the first and second measurement items and calculates the difference between the two detection time points as a time difference ΔT1 between the measurement of the first measurement item and the measurement of the second measurement item in step S402.

<FIG> is a time chart showing a measurement of the first measurement item and a measurement of the second measurement item.

If the measurement rank of the second measurement item is subsequent to that of the first measurement item, a measurement of the second measurement item is suspended until it becomes possible to start a measurement of the second measurement item after a measurement of the first measurement item is started. Thus, as shown in <FIG>, the timing of starting measurement differs between the first measurement item and the second measurement item. As a result, the detection time points stored in step S313 also differ from each other. As shown in <FIG>, the time difference ΔT1 calculated in step S402 in <FIG> is the difference between the timing at which optical detection in step S312 during the measurement of the first measurement item has been ended and the timing at which optical detection in step S312 during the measurement of the second measurement item has been ended.

With reference back to <FIG>, in step S403, the controller <NUM> determines whether or not the time difference ΔT1 obtained in step S402 is equal to or shorter than the predetermined time. The predetermined time to be used for determination in step S403 is the time interval having been set with the pull-down menu 232c in <FIG> and <FIG>.

In Embodiment <NUM>,the measurements of the first and second measurement items are performed consecutively, and thus, ordinarily, the time difference ΔT1 between the measurements of the first and second measurement items is equal to or shorter than the predetermined time. However, there are cases where a measurement out of the measurements of the first and second measurement items is temporarily interrupted, and then the measurement is restarted. For example, there is a case where the environmental temperature in the above measurement device <NUM> falls outside the predetermined range during the measurement of the first measurement item. In this case, the measurement is temporarily interrupted, and an operator takes a countermeasure such as reduction of the temperature of the room in which the specimen analyzer <NUM> is installed. When the environmental temperature in the measurement device <NUM> falls within the predetermined range as a result of the countermeasure, the measurement of the first measurement item is restarted. At this time, if a measurement value of the second measurement item has already been obtained before the measurement of the first measurement item, the time difference ΔT1 between the measurements of the first and second measurement items might exceed the predetermined time. In this case, a result of the determination in step S403 is NO.

If the time difference ΔT1 is equal to or shorter than the predetermined time, the controller <NUM> permits outputting of a calculation value of the calculation item based on the measurement values of the first and second measurement items in step S404. In Embodiment <NUM>, the calculation value of the calculation item is a ratio obtained by dividing the measurement value of the second measurement item <NUM>-<NUM> by the measurement value of the first measurement item <NUM>-<NUM>. Meanwhile, if the result of the determination in either step S401 or S403 is NO, the controller <NUM> prohibits outputting of a calculation value of the calculation item based on the measurement values of the first and second measurement items in step S405. Consequently, the process of the post-measurement check is ended.

With reference back to <FIG>, in step S108, the controller <NUM> determines whether or not outputting of a calculation value of the calculation item is permitted in step S404 in <FIG>. If outputting of a calculation value is permitted, the controller <NUM> calculates a calculation value of the calculation item in step S109. Thereafter, in step S <NUM>, the controller <NUM> causes the display unit <NUM> to display the measurement values of the first and second measurement items and the calculation value of the calculation item. Consequently, for example, the measurement values of the first and second measurement items and the calculation value of the calculation item are displayed in the screen <NUM> displaying a job list in <FIG>, as shown in any of the jobs having progresses that are not indicated as errors.

Although the displaying of the screen <NUM> in step S <NUM> may be automatically executed after completion of step S109 or may be executed through input, of a display instruction, performed via the input unit <NUM> by an operator, it is preferable to automatically execute the displaying from the viewpoint of mitigating a burden of the operator.

Meanwhile, if start of measurements is prohibited in step S207 in <FIG> and if outputting of a calculation value of the calculation item is prohibited in step S405 in <FIG>, the controller <NUM> generates a retest measurement order including the first and second measurement items and the calculation item in step S111. Then, in step S112, the controller <NUM> causes the display unit <NUM> to display the retest order. Through steps S111 and S112, a retest measurement order for the first and second measurement items and the calculation item (in Embodiment <NUM>, the measurement items <NUM>-<NUM> and <NUM>-<NUM> and the calculation item AB42/<NUM>) is generated, and the screen <NUM> showing the retest order is displayed on the display unit <NUM> as shown in <FIG>.

In addition, in step S113, the controller <NUM> causes the display unit <NUM> to display, in fields of the measurement values of the first and second measurement items and the calculation value of the calculation item, an indication that no appropriate measurement values have been obtained. Specifically, as shown in the lowermost row of the job list display region <NUM> and the detail display region <NUM> in <FIG>, "*****. ***" indicating a measurement error is displayed in each of the fields of the measurement values of the measurement items <NUM>-<NUM> and <NUM>-<NUM> corresponding to the first and second measurement items, and "-----. ---" indicating inability to perform calculation is displayed in the field of the calculation value of AB42/<NUM> corresponding to the calculation item. Consequently, the pairing process shown in <FIG> is ended.

An operator can specify a retest-target specimen by referring to the retest order displayed in step S112. Thereafter, the operator sets a container T for the target specimen onto the specimen transport unit <NUM> or into any of the container placement portions 13b. Consequently, the process in <FIG> is performed again so that a measurement process for each of the measurement items having been set in the retest order is performed.

Although whether or not the environmental temperature in measurement is within the predetermined temperature range is determined in the process of the pre-measurement-start check in Embodiment <NUM>, the determination as to the environmental temperature in measurement may be performed during a measurement.

<FIG> is a flowchart showing a process for stopping a measurement in accordance with the environmental temperature, according to Modification <NUM> of Embodiment <NUM>. In an example shown in <FIG>, the first measurement item is the measurement item <NUM>-<NUM>.

In step S501, the controller <NUM> determines whether or not a measurement of the first measurement item has been started. When a measurement of the first measurement item is started, the controller <NUM> obtains an environmental temperature in measurement from the temperature sensor <NUM> (see <FIG>) in step S502. In step S503, the controller <NUM> determines whether or not the environmental temperature in measurement obtained in step S502 is within a predetermined temperature range. The predetermined temperature range is the temperature range having been set in the temperature setting region <NUM> in <FIG>.

If the environmental temperature is outside the predetermined temperature range, the controller <NUM> stops not only the measurement of the first measurement item being executed but also a measurement of the second measurement item in step S504. In this case, no measurement values of the first and second measurement items are obtained. Thus, the result of the determination in step S401 in <FIG> is NO, and outputting of a calculation value of the calculation item is prohibited.

Meanwhile, if the environmental temperature is within the predetermined temperature range, the controller <NUM> determines, in step S505, whether or not the measurement of the first measurement item has been ended. If the measurement of the first measurement item has not been ended, the controller <NUM> returns the process to step S502 and repetitively performs a process composed of steps S502 to S504 at a predetermined time interval. Meanwhile, if the measurement of the first measurement item has been ended, the controller <NUM> ends the process in <FIG>.

In this manner, if the determination as to the environmental temperature is performed during the measurement of the first measurement item, measurements can be swiftly stopped upon increase in the temperature after the measurement of the first measurement item is started. Consequently, the consumptions of reagents having been scheduled to be used can be reduced.

Although determination as to the environmental temperature in measurement is performed during a measurement in Modification <NUM> of Embodiment <NUM>, the environmental temperature obtained during a measurement may be stored, and determination as to the environmental temperature may be performed after the measurement.

<FIG> is a flowchart showing a process of obtaining an environmental temperature, according to Modification <NUM> of Embodiment <NUM>. In <FIG>, steps S503 and S504 are omitted and step S511 is added, as compared to <FIG>. Hereinafter, step S511 will be described.

In step S511, the controller <NUM> updates, on the basis of the environmental temperature obtained in immediately preceding step S502, maximum and minimum environmental temperatures stored in the storage unit <NUM>. For example, if the obtained environmental temperature is higher than the maximum environmental temperature stored in the storage unit <NUM>, the obtained environmental temperature is newly set as a maximum environmental temperature stored in the storage unit <NUM>, and meanwhile, if the obtained environmental temperature is lower than the minimum environmental temperature stored in the storage unit <NUM>, the obtained environmental temperature is newly set as a minimum environmental temperature stored in the storage unit <NUM>. The maximum and minimum environmental temperatures out of the environmental temperature changing during the measurement of the first measurement item are stored in the storage unit <NUM> through the process in <FIG>.

<FIG> is a flowchart showing a process of a post-measurement check according to Modification <NUM> of Embodiment <NUM>. In <FIG>, step S411 is added between steps S403 and S404 as compared to <FIG>. Hereinafter, step S411 will be described.

In step S411, the controller <NUM> determines whether or not the maximum and minimum environmental temperatures obtained through the process in <FIG> are within a predetermined temperature range. The predetermined temperature range is the temperature range having been set in the temperature setting region <NUM> in <FIG>. If the maximum and minimum environmental temperatures are within the predetermined temperature range, the controller <NUM> permits outputting of a calculation value of the calculation item based on the measurement values of the first and second measurement items in step S404. Meanwhile, if a result of the determination in any of steps S401, S403, and S411 is NO, the controller <NUM> prohibits outputting of a calculation value of the calculation item based on the measurement values of the first and second measurement items in step S405.

In Embodiment <NUM>, the pre-measurement-start check is executed in <FIG>. However, Embodiment <NUM> is not limited thereto, and the pre-measurement-start check does not have to be performed.

<FIG> is a flowchart showing a pairing process according to Modification <NUM> of Embodiment <NUM>. In <FIG>, steps S101 and S102 are omitted as compared to <FIG>.

In Embodiment <NUM> or Modification <NUM> of Embodiment <NUM>, reception of measurement ranks that allow the measurement items <NUM>-<NUM> and <NUM>-<NUM> to be consecutive as in the group 211b in <FIG> and <FIG> may be omitted, and the measurement items may be received according to arbitrarily-selected measurement ranks. In addition, a process composed of steps S12, S15, and S16 in <FIG> may be omitted, and notification of the pair-forming measurement item in <FIG> does not have to be performed. In addition, a process composed of steps S111 and S112 in <FIG> and <FIG> may be omitted, and a process of automatically registering the measurement items <NUM>-<NUM> and <NUM>-<NUM> in a retest order does not have to be performed. In this case, an operator causes the display unit <NUM> to display any of the screens <NUM>, 240a, and 240b (see <FIG>) for registering an order and registers a retest order by operating the input unit <NUM>.

That is, the controller <NUM> only has to execute at least one of: a process of receiving measurement items such that an interval between the two measurement items in <FIG> becomes equal to or shorter than the predetermined time; the notification process in step S15 in the case where the measurement order includes only one of the measurement items; a process of the pre-measurement-start check in step S101; a process of the post-measurement check in step S107; and a process of generating a retest order in step S111.

In Embodiment <NUM>, the time difference between a measurement of the first measurement item and a measurement of the second measurement item is the difference ΔT1 between the time points at which the optical detection processes in step S312 have been ended. Meanwhile, in Embodiment <NUM>, the time difference between a measurement of the first measurement item and a measurement of the second measurement item is a difference ΔT2 between the time points at which measurements have been started.

<FIG> is a flowchart showing a measurement process performed per measurement item, according to Embodiment <NUM>. In <FIG>, step S313 is omitted and step S321 is added before step S301, as compared to <FIG>. Hereinafter, step S321 will be described.

In step S321 immediately preceding execution of step S301, the controller <NUM> stores, in the storage unit <NUM>, a time point at which the measurement has been started. Step S321 may be a step that is executed only for measurements of the first and second measurement items and that is not executed for measurements of the other measurement items.

<FIG> is a flowchart showing a pairing process according to Embodiment <NUM>. In <FIG>, the NO side of step S104 is not returned to step S104 but is advanced to steps S131 and S132 as compared to <FIG>. Hereinafter, steps S131 and S132 will be described.

If the controller <NUM> determines, in step S104, that the timing of starting a measurement of the second measurement item has not come, the controller <NUM> determines, in step S131, whether or not the time having elapsed from the start of the measurement of the first measurement item has exceeded a predetermined time. The time point at which the measurement of the first measurement item has been started is stored in the storage unit <NUM> in step S321 in <FIG>. The predetermined time to be used for determination in step S131 is the time interval having been set with the pull-down menu 232c in <FIG> and <FIG>.

If the measurement rank of the second measurement item is subsequent to that of the first measurement item, a measurement of the second measurement item is suspended until it becomes possible to start a measurement of the second measurement item after a measurement of the first measurement item is started. Thus, as shown in <FIG>, the timing of starting measurement differs between the first measurement item and the second measurement item. As a result, the start time points stored in step S321 also differ from each other. As shown in <FIG>, the time difference ΔT2, as to which determination is performed in step S131 in <FIG>, is the difference between the timing at which the measurement of the first measurement item has been started and the timing at which the measurement of the second measurement item has been started.

With reference back to <FIG>, if the time difference ΔT2 does not exceed the predetermined time, the controller <NUM> returns the process to step S104 and determines again whether or not the timing of starting a measurement of the second measurement item has come. Meanwhile, if the time difference ΔT2 exceeds the predetermined time, the controller <NUM> stops measurements of the first and second measurement items and prohibits outputting of a calculation value of the calculation item in step S132. Then, the controller <NUM> advances the process to step S111. When the measurements of the first and second measurement items are stopped in step S132, no calculation value of the calculation item is obtained.

As described above, measurements of the first and second measurement items are preferably performed at as close timings as possible. Considering this, a process related to a time difference between a measurement of the first measurement item and a measurement of the second measurement item is executed in Embodiments <NUM> and <NUM>.

As the process related to the time difference between a measurement of the first measurement item and a measurement of the second measurement item, for example, a process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time is executed. As the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, for example, processes are performed as shown in <FIG>, <FIG>, <FIG>, and <FIG>, <FIG>, and <FIG>. The processes are: a process of receiving measurement ranks such that an interval between the two measurement items becomes equal to or shorter than the predetermined time; a process of registering a measurement order such that the two measurement items are registered; the notification process in step S15 in the case where the measurement order includes only one of the measurement items; a process of the pre-measurement-start check in step S101; a process of the post-measurement check in step S107; a process of generating a retest order in step S111; and a process of stopping measurements at elapse of the predetermined time in steps S131 and S132.

In addition, as the process related to the time difference between a measurement of the first measurement item and a measurement of the second measurement item, for example, a process of determining whether or not the time difference between a measurement of the first measurement item and a measurement of the second measurement item is equal to or shorter than the predetermined time is executed as in step S403 in <FIG> and <FIG>. If the time difference is equal to or shorter than the predetermined time, a calculation value of the calculation item AB42/<NUM> is outputted. Meanwhile, if the time difference is not equal to or shorter than the predetermined time, outputting of a calculation value of the calculation item AB42/<NUM> is prohibited. Alternatively, a calculation value and information indicating that the reliability of the calculation value is low, may be outputted. Consequently, the reliability of the calculation value of the calculation item obtained from the measurement value of the first measurement item and the measurement value of the second measurement item can be kept high.

In Embodiments <NUM> and <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, a process of the pre-measurement-start check in step S101 in <FIG> and <FIG> is performed. In this process, if the time difference between a measurement of the first measurement item and a measurement of the second measurement item is not to be equal to or shorter than the predetermined time, start of the steps of measuring the first measurement item and the second measurement item is prohibited in step S207 in <FIG>. Accordingly, an operator exchanges the reagents or lowers the temperature of the room in which the specimen analyzer <NUM> is installed. Consequently, the measurement environment can be adjusted before measurements. Thus, measurements can be started in an environment that allows the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time. In addition, measurements of the first and second measurement items can be prevented from being performed in a state where the time difference could exceed the predetermined time. Therefore, the consumption of each reagent can be reduced, and the process can be made efficient.

In Embodiments <NUM> and <NUM>, whether or not the remaining amounts of the reagents to be used for measurements of the first measurement item and the second measurement item are equal to or larger than the necessary amounts for measurements of the first measurement item and the second measurement item, respectively, is determined in step S204 in <FIG>. If either of measurements of the first and second measurement items is interrupted owing to shortage of a corresponding one of the reagents, the time difference becomes more likely to exceed the predetermined time. Considering this, measurements of the first and second measurement items are performed when it is determined that the remaining amounts of the reagents to be used for the first and second measurement items are equal to or larger than the necessary amounts for measurements of the first and second measurement items, respectively, whereby it becomes easy for the time difference to be made equal to or shorter than the predetermined time. Therefore, a highly reliable calculation value of the calculation item can be obtained.

In Embodiments <NUM> and <NUM>, whether or not the reagents to be used for measurements of the first measurement item and the second measurement item have yet to reach the respective expiration dates, is determined in step S203 in <FIG>. If either of measurements of the first and second measurement items is interrupted owing to arrival of the expiration date of a corresponding one of the reagents, the time difference becomes more likely to exceed the predetermined time. Considering this, measurements of the first and second measurement items are performed when it is determined that the reagents to be used for the first and second measurement items have yet to reach the respective expiration dates, whereby it becomes easy for the time difference to be made equal to or shorter than the predetermined time. Therefore, a highly reliable calculation value of the calculation item can be obtained.

In Embodiments <NUM> and <NUM>, whether or not the environmental temperature in measurement is within the predetermined temperature range is determined in step S205 in <FIG>. If the environmental temperature in measurement is not within the temperature range suitable for measurement, a measurement is kept interrupted until the environmental temperature falls within this temperature range. Thus, if the environmental temperature is not within the predetermined temperature range, the time difference becomes more likely to exceed the predetermined time. Considering this, measurements of the first and second measurement items are performed when it is determined that the environmental temperature is within the predetermined temperature range, whereby it becomes easy for the time difference to be made equal to or shorter than the predetermined time. Therefore, a highly reliable calculation value of the calculation item can be obtained.

In Embodiments <NUM> and <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, reception of measurement ranks for measurement items is performed such that the interval between measurements of the first measurement item and the second measurement item becomes equal to or shorter than the predetermined time. Specifically, at the time of moving the blocks 211a for the first and second measurement items, the blocks 211a for the first or second measurement items are moved such that the blocks 211a for the first and second measurement items are kept in an adjacent state in the arrangement sequence or such that the blocks 211a are rearranged so as to be adjacent to each other, as shown in <FIG>. Consequently, it becomes easy for the time difference between measurements of the first and second measurement items to be made equal to or shorter than the predetermined time. Therefore, a highly reliable calculation value of the calculation item can be outputted.

In Embodiment <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, measurements of the first and second measurement items are performed such that the time difference between the measurements becomes equal to or shorter than the predetermined time. Consequently, it becomes easy for the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be made equal to or shorter than the predetermined time. Therefore, a highly reliable calculation value of the calculation item can be outputted.

Specifically, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, determination is performed in step S131 in <FIG> as to whether or not the predetermined time has elapsed after start of a measurement of one of the first measurement item and the second measurement item and before start of a measurement of another one of the measurement items, i.e., whether or not the time difference ΔT2 between the starts has exceeded the predetermined time. If the predetermined time has elapsed, the measurement of the other one of the measurement items is stopped in step S132. Consequently, measurements of the first and second measurement items can be restarted after an operator ascertains the cause of the elapse of the predetermined time and solves the problem. Therefore, a highly reliable calculation value of the calculation item can be outputted. In addition, since a measurement of the other one of the measurement items is stopped at elapse of the predetermined time, the consumption of each reagent can be reduced.

In Embodiment <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, determination is performed in step S403 in <FIG> and <FIG> as to whether or not the time difference between the measurement of the first measurement item and the measurement of the second measurement item is equal to or shorter than the predetermined time. If the time difference exceeds the predetermined time, outputting of a calculation value of the calculation item is prohibited in step S405. Consequently, measurements of the first and second measurement items can be restarted after an operator ascertains the cause of the elapse of the predetermined time and solves the problem. Therefore, a highly reliable calculation value of the calculation item can be outputted.

In Embodiments <NUM> and <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, generation of a measurement order including the first and second measurement items is performed in step S111 in <FIG>, <FIG>, and <FIG> if the time difference between the measurements of the first and second measurement items has exceeded the predetermined time. Consequently, if the measurement steps of measuring the first and second measurement items are performed again on the basis of the newly generated measurement order, a possibility that the time difference ΔT1 becomes equal to or shorter than the predetermined time through the measurement steps arises. Therefore, a highly reliable calculation value of the calculation item can be obtained.

In Embodiments <NUM> and <NUM>, if the time difference ΔT1, ΔT2 between the measurements of the first and second measurement items is equal to or shorter than the predetermined time, a calculation value of the calculation item is outputted to the display unit <NUM> in step S <NUM> in <FIG>, <FIG>, and <FIG>. Consequently, a highly reliable calculation value of the calculation item can be outputted.

In Embodiments <NUM> and <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, a process of, if it is determined in step S12 in <FIG> that the measurement order includes only one of the first and second measurement items, notifying a user of a result of the determination is executed in step S15. Consequently, if, after the one of the first and second measurement items is measured, a measurement order including the other one of the measurement items is registered and the other one of the measurement items is measured, the time difference can be prevented from increasing. Therefore, the time difference between a measurement of the first measurement item and a measurement of the second measurement item can be set to be equal to or shorter than the predetermined time. In addition, if a user forgets to register either of the measurement items in an order, the user can be notified as to necessity of obtaining a calculation value of the calculation item. Therefore, a calculation value of the calculation item can be appropriately presented to the user.

In Embodiments <NUM> and <NUM>, the first measurement item is one of amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM>, and the second measurement item is another one of the amyloid beta <NUM>-<NUM> and the amyloid beta <NUM>-<NUM> in the descriptions made with reference to <FIG>. In other words, the pair of the first and second measurement items is composed of amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM>. However, the pair of the first and second measurement items is not limited to the above pair. The pair of the first and second measurement items only has to be composed of measurement items such that the reliability of a calculation value of a calculation item obtained from measurement values of the first and second measurement items is increased when the time difference between measurements of the first and second measurement items is equal to or shorter than a predetermined time.

For example, the first measurement item may be a first type of amyloid beta or amyloid beta precursor protein, and the second measurement item may be a second type of amyloid beta or amyloid beta precursor protein different from the first type, as long as such a condition is satisfied. The first and second measurement items may each be an amyloid beta or an amyloid beta precursor protein.

Specifically, the first measurement item may be one of amyloid beta <NUM>-<NUM> and amyloid beta precursor protein <NUM>-<NUM>, and the second measurement item may be another one of the amyloid beta <NUM>-<NUM> and the amyloid beta precursor protein <NUM>-<NUM>. In other words, the pair of the first and second measurement items may be composed of amyloid beta <NUM>-<NUM> and amyloid beta precursor protein <NUM>-<NUM>. In this case, as a calculation value of the calculation item, a ratio between measurement values of amyloid beta <NUM>-<NUM> and amyloid beta precursor protein <NUM>-<NUM> can be used, for example.

Although the calculation value of the calculation item is a ratio obtained by dividing a measurement value of the second measurement item by a measurement value of the first measurement item in Embodiments <NUM> and <NUM>, the calculation value may be a ratio obtained by dividing a measurement value of the first measurement item by a measurement value of the second measurement item. Alternatively, the calculation value of the calculation item may be a value obtained by subtracting a value obtained by multiplying a measurement value of the first measurement item by a predetermined value from a value obtained by multiplying a measurement value of the second measurement item by a predetermined value.

Although the calculation value of the calculation item is a calculation value obtained from a measurement value of the first measurement item and a measurement value of the second measurement item in Embodiments <NUM> and <NUM>, the calculation value may be a calculation value obtained from three or more measurement values including a measurement value of the first measurement item and a measurement value of the second measurement item.

For example, the measurement items may be amyloid beta <NUM>-<NUM>, amyloid beta <NUM>-<NUM>, and amyloid beta precursor protein <NUM>-<NUM>, and a calculation value of the calculation item may be obtained from measurement values of the respective measurement items. In this case, the controller <NUM> may obtain a calculation value by using, for example, an arithmetic expression including a ratio between amyloid beta <NUM>-<NUM> and amyloid beta <NUM>-<NUM> and a ratio between amyloid beta <NUM>-<NUM> and amyloid beta precursor protein <NUM>-<NUM>. In addition, the controller <NUM> may execute at least one process out of: a process for setting the time difference between a measurement of amyloid beta <NUM>-<NUM> and a measurement of amyloid beta <NUM>-<NUM> to be equal to or shorter than the predetermined time; and a process for setting the time difference between a measurement of amyloid beta <NUM>-<NUM> and a measurement of amyloid beta precursor protein <NUM>-<NUM> to be equal to or shorter than a predetermined time.

In Embodiments <NUM> and <NUM>, the administrator who performs maintenance of the specimen analyzer <NUM> or the like operates the screens <NUM> in <FIG> and <FIG>, to input a condition regarding the time difference between measurements and a condition regarding the temperature inside the measurement device <NUM>. However, the condition regarding the time difference and the condition regarding the temperature may be set by a user other than the administrator (for example, an operator who ordinarily operates the specimen analyzer <NUM>). In this case, other screens corresponding to the screens <NUM> and <NUM> and capable of being operated with the authority of an operator may be displayed on the display unit <NUM>, and the other screens may be configured to be able to receive conditions stricter than the conditions that are set by the administrator.

In Embodiments <NUM> and <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, if no pair-forming measurement item is set in the measurement order (step S12: NO) in <FIG>, a measurement of the pair-forming measurement item is performed when a measurement instruction for the pair-forming measurement item is inputted by an operator (step S16: YES). However, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, if no pair-forming measurement item is set in the measurement order, a measurement of the pair-forming measurement item may be automatically performed without any instruction from the operator. In this case, for example, if a result of the determination in step S12 is NO in <FIG>, the controller <NUM> sets the pair-forming measurement item in the measurement order and advances the process to step S <NUM>. Consequently, a measurement of the pair-forming measurement item is automatically performed.

Although measurements of the first and second measurement items are performed consecutively in Embodiments <NUM> and <NUM>, these two measurements do not necessarily have to be performed consecutively. For example, in setting of measurement ranks shown in <FIG>, the controller <NUM> may receive input made such that the blocks 211a for the first and second measurement items are not adjacent to each other.

In this case, if a block 211a for another measurement item other than a calculation item is positioned between the blocks 211a for the first and second measurement items, the controller <NUM> may determine, on the basis of a time that is ordinarily taken to measure the other measurement item, whether or not the time difference between measurements of the first and second measurement items is to be equal to or shorter than the predetermined time. The controller <NUM> may be configured not to receive, upon determining that the time difference between the first and second measurement items is not to be equal to or shorter than the predetermined time, input made so as to move the block 211a for the other measurement item to the position between the blocks 211a for the first and second measurement items. Consequently, the time difference between measurements of the first and second measurement items is set to be equal to or shorter than the predetermined time.

In addition, in the screen <NUM> in <FIG>, the controller <NUM> may, instead of performing control such that the blocks 211a for the first and second measurement items and the calculation item are adjacent to each other, automatically set a sequence of measurements of measurement items, having been set in a measurement order, such that the time difference between measurements of the first and second measurement items becomes equal to or shorter than the predetermined time. For example, measurements of the first and second measurement items may be performed consecutively in the pairing process shown in <FIG> even if measurements of the first and second measurement items are set in the screen <NUM> so as not to be performed consecutively. Consequently, the time difference between measurements of the first and second measurement items can be set to be equal to or shorter than the predetermined time.

Although the time difference ΔT1 in <FIG> and the time difference ΔT2 in <FIG> are obtained as time differences between a measurement of the first measurement item and a measurement of the second measurement item in Embodiments <NUM> and <NUM>, time differences are not limited thereto, and a time difference between processing timings in the same type of step for the two measurement items may be obtained. For example, a time difference between a processing timing of step S302 in <FIG> for the first measurement item and a processing timing of step S302 in <FIG> for the second measurement item may be obtained.

Although a calculation value of the calculation item is outputted to the display unit <NUM> in step S110 in <FIG>, <FIG>, and <FIG> in Embodiments <NUM> and <NUM>, the output destination is not limited thereto, and the calculation value of the calculation item may be outputted to another computer or the like via the communication unit <NUM>.

In Embodiment <NUM>, as the process for setting the time difference between a measurement of the first measurement item and a measurement of the second measurement item to be equal to or shorter than the predetermined time, the controller <NUM> executes the pre-measurement-start check in step S101 in <FIG> during the pairing process in step S14 in <FIG>. However, the controller <NUM> may be configured to execute the pre-measurement-start check in step S101 upon registration of a measurement order and, if a result of the determination in any of steps S203, S204, and S205 in <FIG> is NO, prohibit the measurement items <NUM>-<NUM> and <NUM>-<NUM> from being registered in the measurement order or cause the display unit <NUM> to display an indication that the measurement items <NUM>-<NUM> and <NUM>-<NUM> cannot be registered.

In Embodiments <NUM> and <NUM>, if a result of the determination as to permissibility of outputting of a calculation value in step S108 in any of <FIG>, <FIG>, and <FIG> is NO, the controller <NUM> prohibits outputting of the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> and a calculation value of the calculation item AB42/<NUM>. However, when the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> have been obtained, the controller <NUM> may output the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> and prohibit outputting of a calculation value of the calculation item AB42/<NUM>. In this case, the controller <NUM> may output, together with the calculation value of the calculation item AB42/<NUM>, information indicating that the reliability of the calculation value is low. Alternatively, the controller <NUM> may output the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> and a calculation value of the calculation item AB42/<NUM>. In this case, the controller <NUM> may output, together with the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> and the calculation value of the calculation item AB42/<NUM>, information indicating that the reliability of each of the measurement values and the calculation value is low.

<FIG> schematically shows a state where information indicating that the reliability is low is displayed in the screen <NUM> displayed on the display unit <NUM>.

The job on the lowermost row in <FIG> indicates a state where, although measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> have been obtained, a result of the determination as to permissibility of outputting of a calculation value in step S108 is NO. In this case, in addition to the measurement values of the respective measurement items <NUM>-<NUM> and <NUM>-<NUM> and a calculation value of the calculation item AB42/<NUM>, icons 201a and 202a are displayed as information indicating that the reliability of the calculation value of the calculation item AB42/<NUM> is low. An operator can ascertain that the reliability of the displayed calculation value is low, by referring to the icons 201a and 202a.

Although the controller <NUM> automatically generates a measurement order including the measurement items <NUM>-<NUM> and <NUM>-<NUM> in step S111 in <FIG>, <FIG>, and <FIG> in Embodiments <NUM> and <NUM>, the controller <NUM> may cause, in step S111, the display unit <NUM> to display any of the screens <NUM>, 240a, and 240b (see <FIG>) for registering a measurement order so that input of a measurement item can be received from an operator. In this case, when an operator registers a measurement order including only one of the measurement items <NUM>-<NUM> and <NUM>-<NUM>, the controller <NUM> may cause the display unit <NUM> to display a message that urges registration of another one of the measurement items as in the notification screen <NUM> in <FIG>. Alternatively, when an operator registers a measurement order including only one of the measurement items <NUM>-<NUM> and <NUM>-<NUM>, the controller <NUM> may automatically add the other one of the measurement items to the measurement order.

Although measurement values of the measurement items <NUM>-<NUM> and <NUM>-<NUM> are displayed on the display unit <NUM> in the specimen analyzer <NUM> according to each of Embodiments <NUM> and <NUM>, the specimen analyzer <NUM> may be configured such that: measurements of the measurement items <NUM>-<NUM> and <NUM>-<NUM> are executed only for obtaining a calculation value of the calculation item AB42/<NUM>; and the obtained measurement values are not outputted.

Claim 1:
A specimen analysis method for analyzing a specimen regarding a plurality of measurement items, the specimen analysis method comprising:
measuring a first measurement item and a second measurement item on the basis of a measurement order;
executing a process related to a time difference between a measurement of the first measurement item and a measurement of the second measurement item; and
obtaining a calculation value from a measurement value of the first measurement item and a measurement value of the second measurement item, wherein
the first measurement item is a first type of amyloid beta or amyloid beta precursor protein,
the second measurement item is a second type of amyloid beta or amyloid beta precursor protein different from the first type, and
the process related to the time difference is a setting process for setting the time difference to be equal to or shorter than a predetermined time.