Patent Description:
As a device for analyzing a target component contained in a biological sample (hereinafter, referred to as a specimen) such as blood, an automated analyzer is widely used which measures light intensity of transmitted light or scattered light having a single or a plurality of wavelengths obtained by emitting light from a light source to a reaction solution in which the specimen serving as an analysis target and a reagent are mixed with each other.

The automated analyzer includes a biochemical analysis device that performs quantitative and qualitative analysis of a target component contained in a biological specimen in the field of biochemical tests and hematology tests, and a blood coagulation analysis device that measures coagulation ability of blood serving as the specimen (hereinafter, referred to as a blood coagulation analysis device in some cases).

This coagulation ability of the blood includes exogenous ability by which the blood leaking out from the blood vessel coagulates and endogenous ability by which the blood in the blood vessel coagulates. Measurement items relating to the coagulation ability of the blood (blood coagulation time) include prothrombin time (PT) of an exogenous blood coagulation reaction test, activated partial thromboplastin time (APTT) of an endogenous blood coagulation reaction test, and a fibrinogen amount (Fbg) relating to overall blood coagulation reaction.

In the blood coagulation analysis device, in order to analyze any one of these measurement items, fibrin precipitated by adding a reagent for initiating the blood coagulation reaction is detected by using various methods including an optical method. In a case of using the optical method, the light is emitted to the reaction solution so as to detect a time-dependent light intensity change in the scattered light or the transmitted light from the fibrin precipitated in the reaction solution. In this manner, the blood coagulation time is calculated, based on a detected result. A blood coagulation time item requires photometric data at intervals of <NUM> seconds. Thus, the reaction is performed in a separate photometric port. If the reaction solution coagulates, a reaction container cannot be reused by cleaning. Consequently, the reaction container has to be discarded.

In addition to this blood coagulation time measurement, a blood coagulation/fibrinolysis test field also includes blood coagulation factor measurement and blood coagulation/fibrinolysis marker measurement. The latter coagulation/fibrinolysis marker is analyzed by a synthetic substrate method using a chromogenic synthetic substrate or by a latex agglutination method using a reagent containing latex particles in which an antibody is sensitized on (bound with) a surface. The blood coagulation time item includes PT, APTT, Fbg and the like. In addition to D-dimer or fibrin/fibrinogen degradation products (FDP), the blood coagulation/fibrinolysis marker item includes soluble fibrin monomer complex (SFMC) and plasmin-α2 plasmin inhibitor (PIC). The blood coagulation/fibrinolysis marker item is expected to increase in future, since there is a demand for early diagnosis/treatment of disseminated intravascular coagulation (DIC). Accordingly, it is desirable to achieve improved throughput or efficiency of the automated analyzer. The blood coagulation time measurement is usually completed within two to four minutes. In contrast, in a case where the coagulation ability of the blood is poor, the reaction time may be <NUM> minutes or longer. On the other hand, according to the synthetic substrate method and the latex agglutination method, the reaction time usually requires <NUM> minutes, and the reaction time is fixed similarly to the above-described biochemical analysis.

Incidentally, as the automated analyzer for clinical tests, a known device includes a stand-alone type that is operated as an independent device, and a modular type that is operated as a single device in which analysis units in a plurality of fields such as biochemical analysis and immunoassay analysis are connected to a specimen rack conveyance line in order to streamline laboratory work. The automated analyzer of the module type has a plurality of the analysis units that analyze the reaction solution in which the specimen and the reagent are mixed and reacted with each other. As a method of supplying the specimen to the analysis unit, a method is known in which a specimen rack accommodating a specimen container is conveyed via the conveyance line so as to be located at a specimen dispensing position of the analysis unit.

Since the plurality of analysis units are modularized and integrated with each other, advantageous effects can be expected in that a specimen management flow is improved and device management is streamlined. Therefore, various techniques have been devised in order to efficiently perform the measurement.

PTL <NUM> introduces a technique as follows. A conveyance order of specimen containers is variable by being associated with the throughput of each analysis unit, thereby obtaining an average analysis processing time in each analysis unit. In this manner, the analysis processing time is shortened as a system.

PTL <NUM> discloses a technique as follows. Based on analysis item information, a conveyance destination of a specimen rack is determined from the plurality of analysis units. The specimen rack is conveyed to the analysis unit which can quickly accept the specimen rack from the plurality of analysis units to which the same analysis item is assigned. In this manner, the analysis item is efficiently analyzed.

PTL <NUM> discloses a specimen processing system as follows. Based on each requested measurement item, an analysis unit having fewest measurement reservations is determined as the conveyance destination of the specimen rack.

Further automated analyzers are disclosed <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

Each of PTLS <NUM> to <NUM> relates to a technique for efficiently processing the specimen in a specimen conveyance system having the module type connected thereto or the plurality of analysis devices connected thereto. According to these techniques, the specimen can be efficiently processed in a case where a biochemical item whose reaction time is determined in advance is analyzed, or in a case where the plurality of analysis units capable of measuring immune items are connected to each other.

Here, as described above, with regard to the blood coagulation time measurement, the reaction time depends on the blood coagulation ability of the specimen, and is not fixed. In a case where a plurality of blood coagulation analysis units which can measure the blood coagulation time item whose reaction time differs depending on the specimen in this way are incorporated in the module type device, there may be discrepancies between the analysis units in the specimen processing, the number of measurement times, or the measurement time. Consequently, it is considered that the entire throughput of the device becomes poor. In addition, some reagents of the blood coagulation time item are derived from living bodies. Accordingly, the expiration date of the reagents is as short as one week. If there is the discrepancy between the analysis units in the number of measurement times, the reagent may not be used within the expiration date in some cases. Therefore, the reagent is unnecessarily wasted.

However, any one of the configurations described in PTLS <NUM> to <NUM> does not consider a technique of incorporating the blood coagulation analysis units which measure the items whose reaction time differs depending on each specimen as in the blood coagulation time item. Therefore, there is a possibility that the entire throughput of the above-described device may become poor and the reagent may be unnecessarily wasted.

An object of the present invention is to realize highly efficient analysis in which the entire throughput of the device is satisfactorily maintained and unnecessary waste of the reagent is minimized, even in a module type configuration having the plurality of blood coagulation analysis units which measure the blood coagulation time items whose reaction time differs depending on each specimen.

According to an aspect of the present invention, in order to solve the above-described problem, there are provided an automated analyzer according to claim <NUM> and an analysis method of an automated analyzer according to claim <NUM>.

According to the above-described aspect, it is possible to realize highly efficient analysis in which the entire throughput of the device is satisfactorily maintained and unnecessary waste of the reagent is minimized by the averaged and more efficient specimen processing, even in a module type configuration having the plurality of blood coagulation analysis units which measure the blood coagulation time items whose reaction time differs depending on each specimen.

Hereinafter, examples and embodiments of the present invention will be described in detail with reference to the drawings. Throughout the description, in principle, the same reference numerals will be given to respective configuration elements having the same function in the respective drawings for describing the present embodiment, and description thereof may be omitted in some cases.

In addition, in the following description, a synthetic substrate item or a latex item in a blood coagulation test item may be referred to as a first test item, and a blood coagulation time item may be referred to as a second test item. In addition, a biochemical measurement item may be referred to as a third test item.

An example of the first test item includes D-dimer, FDP, SFMC, and PIC. An example of the second test item includes PT, APTT, and Fbg. An example of the third test item includes alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

<FIG> is a view illustrating a basic configuration of an automated analyzer including blood coagulation analysis units in two modules.

As illustrated in the drawing, an automated analyzer <NUM> of a module type has a first blood coagulation analysis unit <NUM> and a second blood coagulation analysis unit <NUM> which are a plurality of analysis units for analyzing a reaction solution serving as a mixed solution of a sample and a reagent, and includes a conveyance line <NUM> and a return line <NUM> which convey a specimen rack <NUM> on which a specimen container accommodating a specimen is mounted in order to supply the specimen to each analysis unit. As examples of configuration elements of a conveyance system for conveying the specimen rack <NUM> on which the specimen container containing the specimen such as plasma serving as an analysis target, the drawing illustrates the conveyance line <NUM> and the return line <NUM> which convey the specimen rack <NUM> to each analysis unit, a rack supply unit <NUM> that supplies the specimen rack <NUM> onto the conveyance line <NUM>, a rack accommodation unit <NUM> that accommodates the specimen rack <NUM> which completes analysis and reaches the rack accommodation unit <NUM> after moving on the return line <NUM>, a rack standby unit <NUM> that causes the specimen rack awaiting specimen dispensing to stand by, a rack handling mechanism <NUM> that transfers the specimen rack <NUM> between the conveyance line <NUM>, the return line <NUM>, and the rack standby unit <NUM>, and inside the rack standby unit <NUM>, a rack allocating mechanism <NUM> that allocates a destination of the rack on the return line <NUM>, based on information of the specimen rack <NUM>, a rack returning mechanism <NUM> that moves the allocated specimen rack <NUM> to the rack accommodation unit <NUM>, an urgent specimen rack loading unit <NUM> that loads the specimen rack <NUM> which needs urgent analysis, and a reading unit (conveyance line) <NUM> that reads information such as a bar code attached to the specimen rack <NUM> on the conveyance line <NUM>.

The conveyance system of the first blood coagulation analysis unit <NUM> disposed along the conveyance line <NUM> includes a reading unit (first blood coagulation analysis unit) <NUM> for collating analysis request information relating to the specimen accommodated in the specimen rack <NUM> from the conveyance line <NUM>, a first rack conveyance mechanism <NUM> that receives the specimen rack <NUM> from the conveyance line <NUM>, a first dispensing line <NUM> that includes a sampling area where the specimen is dispensed, and that can await the specimen rack <NUM> until the specimen starts to be dispensed, and a first rack handling mechanism <NUM> that conveys the specimen rack <NUM> to the conveyance line <NUM> or the return line <NUM> after the specimen rack <NUM> dispenses the specimen. Here, the first dispensing line <NUM> includes a specimen rack conveyance mechanism that can move the specimen rack <NUM> in both directions of a direction the same as and a direction opposite to a traveling direction of the specimen rack <NUM>.

Similarly to the configuration of the conveyance system of the first blood coagulation analysis unit <NUM>, the conveyance system of the second blood coagulation analysis unit <NUM> disposed along the conveyance line <NUM> includes a reading unit (second blood coagulation analysis unit) <NUM> for collating analysis request information relating to the specimen accommodated in the specimen rack <NUM> from the conveyance line <NUM>, a second rack conveyance mechanism <NUM> that receives the specimen rack <NUM> from the conveyance line <NUM>, a second dispensing line <NUM> that includes a sampling area where the specimen is dispensed, and that can await the specimen rack <NUM> until the specimen starts to be dispensed, and a second rack handling mechanism <NUM> that conveys the specimen rack <NUM> to the return line <NUM> after the specimen is dispensed. The second dispensing line <NUM> includes a specimen rack conveyance mechanism that can move the specimen rack <NUM> in both directions of the direction the same as and the direction opposite to the traveling direction of the specimen rack <NUM>.

Here, the conveyance of the specimen rack is not limited to the above-described method of the conveyance line <NUM>. As long as the rack can be moved, the conveyance is applicable to any method such as a belt conveyor method and an extruding arm method of extruding and transferring a rear end portion of the rack.

Throughout all operations, the control unit <NUM> performs control on the operation of various configurations configuring the automated analyzer and condition settings, such as the above-described conveying operation of the specimen rack <NUM>, the dispensing operation of the specimen and the reagent, the allocation of the specimen rack <NUM> based on the read information, the operation of loading and unloading, and the data processing operations including the calculation of the blood coagulation time and the concentration of the target component based on the detection result. In addition, the control unit <NUM> is connected to an input unit <NUM> such as a keyboard to which various data items relating to the analysis condition and the instructions from the operator are input, a storage unit <NUM> which stores input information, information read from the sample or the reagent, and information relating to the detection result, and a display unit <NUM> which displays the detection result and a graphical user interface (GUI) relating to various operations of the automated analyzer. In the drawing, the control unit <NUM> is connected to each configuration unit so as to control the overall automated analyzer. However, a configuration can be adopted so that each configuration unit includes each independent control unit.

Next, a configuration of the blood coagulation analysis unit described above with reference to <FIG> will be described in more detail. <FIG> is a view illustrating a basic configuration of the blood coagulation analysis unit according to the present embodiment. In the drawing, the blood coagulation analysis unit includes a specimen dispensing mechanism <NUM> that dispenses the specimen accommodated inside the specimen container on the specimen rack <NUM> to a reaction container <NUM> used for the measurement, a specimen dispensing port <NUM> in which the reaction container <NUM> serving as a target of the specimen dispensing operation can be disposed and which has a vortex stirring function for causing the first reagent dispensing mechanism <NUM> to dispense a diluent or a pretreatment solution, a standby block <NUM> that includes a plurality of standby ports <NUM> in which the reaction container <NUM> in a standby state can be disposed, and that does not have a temperature adjustment function, a reaction container magazine <NUM> in which a plurality of the reaction containers <NUM> are stocked, a reaction container transfer mechanism <NUM> that transfers the reaction container <NUM>, and that loads and unloads the reaction container <NUM> at each position if necessary, a preheat block <NUM> that includes a plurality of preheat ports <NUM> whose temperature is adjusted to <NUM> and which raise the temperature of the specimen or a pretreatment specimen subjected to dilution processing immediately before the blood coagulation time is measured, a detection block <NUM> that includes a plurality of detection ports <NUM> whose temperature is similarly adjusted to <NUM> and which measure the blood coagulation time, a reagent disc <NUM> in which reagent cassettes <NUM> internally equipped with a reagent bottle hermetically filled with the reagent are circumferentially arranged and whose temperature is adjusted to approximately <NUM>, a reagent cassette transfer mechanism <NUM> that transfers the reagent cassettes <NUM> arranged in a reagent cassette supply unit <NUM> to the reagent disc <NUM>, a reagent information reading unit <NUM> that reads reagent information from a medium such as a barcode and an RFID to which the measurement item of the reagent cassette <NUM> transferred to the reagent disc <NUM> and the expiration date are input, a reagent cassette accommodation unit <NUM> that is withdrawn from the reagent disc <NUM> by a reagent cassette transfer mechanism <NUM>, and that accommodates the used reagent cassette <NUM>, a reaction container disposal unit <NUM> that discards the used reaction container <NUM>, a specimen probe washing tank <NUM> that washes a specimen probe, a first reagent probe washing tank <NUM> that washes a reagent probe of the first reagent dispensing mechanism <NUM>, and a second reagent probe washing tank <NUM> that washes the reagent probe of a second reagent dispensing mechanism <NUM>.

Here, although not illustrated in the drawing, each of the detection ports <NUM> in the detection block <NUM> includes an optical system having a light source that emits light to the reaction solution serving as a mixed solution of the specimen and the reagent which are accommodated in the reaction container <NUM>, and a light receiving unit (detector) that detects scattered light or transmitted light of the light emitted from the light source.

The measurement of the blood coagulation time is obtained through calculation in the control unit <NUM>, based on data of the detected light.

The first blood coagulation analysis unit <NUM> and the second blood coagulation analysis unit <NUM> can perform analysis of at least the second test item.

<FIG> is a view illustrating a calculation example of the estimated measurement time of the specimen rack. The time required for the blood coagulation measurement is classified into four categories: (<NUM>) specimen temperature raising time, (<NUM>) incubation time, (<NUM>) standard measurement time, and (<NUM>) prolonged measurement time, and are used in calculating the estimated measurement time. (<NUM>) Since the temperature is raised beforehand in the preheat block <NUM>, the specimen temperature raising time does not need to be added to the measurement time in the detection block <NUM>. Accordingly, the specimen temperature raising time cannot be included therein. (<NUM>) The incubation time is a fixed time determined for each measurement item required for incubation after a pretreatment solution is added to the specimen. (<NUM>) The standard measurement time may be optionally determined from a clinical point of view (time is fixed), or may be automatically determined, based on a mean value of the past measurement results (in this case, the time may fluctuates). (<NUM>) The prolonged measurement time is the time fluctuating depending on each specimen. An example is illustrated in which the time required for the blood coagulation measurement of PT, APTT, Fbg, ATIII, and D-Dimer as a representative measurement item is classified into the above-described four times.

If it is requested to analyze each of these items for a specimen <NUM> to a specimen <NUM> mounted on the specimen rack <NUM> by using the content illustrated in the drawing, it is possible to obtain the total standard measurement time calculated based on (<NUM>) the incubation time and (<NUM>) the standard measurement time, and the total prolonged measurement time calculated based on (<NUM>) the incubation time, (<NUM>) the standard measurement time, and (<NUM>) the prolonged measurement time. When the total standard measurement time is calculated, (<NUM>) the standard measurement time can be automatically determined from the mean value calculated based on the past measurement result for each item which is stored in the storage unit <NUM>. According to this configuration, it is possible to set the estimated measurement time which is optimized corresponding to facilities using the automated analyzer. Therefore, it is possible to improve the accuracy of the estimated measurement time.

In addition, (<NUM>) the standard measurement time of each specimen can be determined, based on the past measurement result of a patient which is identified by patient ID information of each specimen stored in the storage unit <NUM>. As a method of determining (<NUM>) the standard measurement time from the patient ID information, it is conceivable to employ a method of using a mean value of all of the past measurement results, a mean value of a plurality of the latest measurement result, or the latest measurement result as it is. Furthermore, depending on a measurement purpose, it is conceivable to switching (<NUM>) the standard measurement time. For example, in a case of PT measurement for monitoring an anticoagulant effect such as warfarin in treatment of thrombosis, the blood coagulation time is prolonged compared to the usual case. Accordingly, the accuracy of the estimated measurement time can be improved by switching the method to a mode for setting the standard measurement time which is prolonged as much as a predetermined time compared to the normal measurement.

In addition, in a case where a high possibility of the above-described thrombosis is determined using background information (hospital or ward in charge) of the patient which is identified by the patient ID information of each specimen, the mode can be switched so as to set the standard measurement time which is similarly prolonged as much as the predetermined time compared to the normal measurement. Alternatively, the mode can be conversely switched so as to shorten and set the standard measurement time as much as the predetermined time.

Thus, the estimated measurement time (total measurement time) in each blood coagulation analysis unit is calculated, based on the total standard measurement time calculated for each specimen rack <NUM> in this way. The control unit <NUM> controls the conveying operation so as to convey the specimen rack <NUM> to the analysis unit having the shortest total estimated measurement time.

Here, with regard to each of the first blood coagulation analysis unit <NUM> and the second blood coagulation analysis unit <NUM>, each time the measurement of the specimen is completed in the specimen rack <NUM>, the control unit <NUM> can subtract the sum of the estimated measurement times, based on the measurement time required for the actual measurement, and each time new specimen rack <NUM> is supplied, the control unit <NUM> can add the sum of the estimated measurement times, based on the measurement item requested for each specimen in the supplied specimen rack <NUM>.

In addition, the estimated measurement completion time of each specimen or each specimen rack acquired based on the calculated estimated measurement time is displayed on the display unit <NUM>, thereby enabling an operator to recognize the time required until the measurement is completed.

In this case, if the estimated measurement time is displayed with a width in view of a measurement time fluctuation width which is a difference between the total prolonged measurement time and the total standard measurement time, the measurement completion time can be properly delivered to the operator.

Under the control of the conveying operation of the control unit <NUM> based on the total measurement time calculated by the above-described method, the specimen rack <NUM> is conveyed to the analysis unit having the short total measurement time via a conveyance route from the rack supply unit <NUM> as illustrated in <FIG> or a conveyance route from the rack standby unit as illustrated in <FIG>.

Here, <FIG> is a view illustrating an example of a conveyance route of the specimen rack from the rack supply unit. As illustrated in the drawing, the specimen rack <NUM> transferred from the rack supply unit <NUM> onto the conveyance line <NUM> is conveyed to the second dispensing line <NUM> of the second blood coagulation analysis unit <NUM> via the conveyance line <NUM> by the second rack conveyance mechanism <NUM>.

In addition, <FIG> is a view illustrating an example of a conveyance route of the specimen rack from the rack standby unit. As illustrated in the drawing, the specimen rack <NUM> conveyed by the standby unit handling mechanism <NUM> from the rack standby unit <NUM> and transferred onto the conveyance line <NUM> is conveyed to the second dispensing line <NUM> of the second blood coagulation analysis unit <NUM> via the conveyance line <NUM> by the second rack conveyance mechanism <NUM>.

<FIG> is a flowchart illustrating an analysis operation. If the analysis is requested by the input unit <NUM> (<FIG>), the control unit <NUM> moves the specimen rack <NUM> arrayed in the rack supply unit <NUM> to the conveyance line <NUM> (<FIG>). Thereafter, the control unit <NUM> causes the reading unit (the conveyance line) <NUM> to read an identification medium such as a barcode label affixed to the specimen rack <NUM> and the specimen container accommodated in the specimen rack <NUM>. In this manner, the specimen rack number and the specimen container number are identified. The specimen rack number and the specimen container number which are identified by the reading unit (conveyance line) <NUM> are transmitted to the control unit <NUM>, and the control unit <NUM> collates measurement request information instructed from the input unit <NUM> in advance by associating a type of the specimen rack <NUM> or a type of the analysis item instructed to each the specimen container with the specimen reception number (<FIG>). The collation result is stored in the storage unit <NUM>, and is used for the subsequent process of the specimen rack <NUM>. The control unit <NUM> calculates the total estimated measurement times of all of the specimen racks <NUM> (<FIG>). Thereafter, the control unit <NUM> confirms the total measurement time of the respective blood coagulation analysis units (<FIG>), and the conveyance destination of the specimen rack <NUM> is determined by the control unit <NUM> (<FIG>). Here, in <FIG>, the blood coagulation analysis unit having the smallest the total estimated measurement time calculated for each of the blood coagulation analysis units is determined as the conveyance destination of the specimen rack <NUM>.

The control unit <NUM> confirms whether or not there is a vacant space in the first dispensing line <NUM> of the first blood coagulation analysis unit <NUM> or the second dispensing line <NUM> of the second blood coagulation analysis unit <NUM> (<FIG>). If there is the vacant space, the specimen rack <NUM> is conveyed to the first blood coagulation analysis unit <NUM> or the second blood coagulation analysis unit <NUM>, thereby starting to dispense the specimen (<FIG>). On the other hand, in a case where there is no vacant space in the first dispensing line <NUM> or the second dispensing line <NUM>, the control unit <NUM> controls the standby unit handling mechanism <NUM>, moves the specimen rack <NUM> to the rack standby unit <NUM>, and causes the specimen rack <NUM> to stand by (<FIG>).

Here, a rack standby operation (<FIG>) will be described in more detail with reference to <FIG> is a flowchart illustrating the rack standby operation in the rack standby unit.

After the control unit <NUM> moves the specimen rack <NUM> to the rack standby unit <NUM> (<FIG>), the control unit <NUM> frequently confirms whether or not there is the vacant space in the first dispensing line <NUM> of the first blood coagulation analysis unit <NUM> or the second dispensing line <NUM> of the second blood coagulation analysis unit <NUM> (<FIG>). In a case where there is no vacant space, the control unit <NUM> causes the specimen rack <NUM> to stand by in the rack standby unit <NUM>. In a case where there is the vacant space, the control unit <NUM> moves the specimen rack <NUM> from the rack standby unit <NUM> to the conveyance line (<FIG>). That is, the specimen rack <NUM> stands by until there is the vacant space in the first dispensing line <NUM> or the second dispensing line <NUM>.

Next, the specimen dispensing (<FIG>) will be described in more detail with reference to <FIG> is a flowchart illustrating the specimen dispensing operation of the analysis unit.

The reading unit (first blood coagulation analysis unit) <NUM> collates specimen rack information of the specimen rack <NUM> (<FIG>) conveyed to the first blood coagulation analysis unit <NUM> (<FIG>) so as to confirm the analysis information. The control unit <NUM> controls the first rack conveyance mechanism <NUM>, and moves the specimen rack <NUM> from the conveyance line <NUM> to the first dispensing line <NUM> (<FIG>). The control unit <NUM> conveys the specimen rack <NUM> to a dispensing position, and inserts a dispensing nozzle of the specimen dispensing mechanism into the specimen container where the analysis is instructed at the position. The specimen is aspirated, thereby performing control so as to dispense the specimen into the reaction container included in the first blood coagulation analysis unit <NUM> (<FIG>). In a case where two or more items are instructed to be tested for the same specimen container and in a case where the test item is instructed for the other specimen container on the same specimen rack <NUM>, the specimen dispensing operation is continuously, similarly, and repeatedly performed.

The specimen rack <NUM> in which the specimen is completely dispensed for all analysis items instructed for the first blood coagulation analysis unit <NUM> is moved from the dispensing position to the corresponding position of the first rack handling mechanism <NUM> by the control unit <NUM>. Thereafter, the control unit <NUM> moves the specimen rack <NUM> from the first dispensing line <NUM> to the conveyance line <NUM> (<FIG>). Alternatively, as will be described later, the control unit <NUM> moves the specimen rack <NUM> from the first dispensing line <NUM> to the return line <NUM> (<FIG>).

The specimen rack <NUM> which completely collects the specimen relating to all of the instructed analysis items is moved to the corresponding position of the first rack handling mechanism <NUM>, and is transferred to the return line <NUM> by the first rack handling mechanism <NUM> (<FIG>). The control unit <NUM> causes the return line <NUM> to convey the specimen rack <NUM> to the rack allocating mechanism <NUM> (<FIG>). Since the specimen rack number of the specimen rack <NUM> conveyed to the rack allocating mechanism <NUM> is stored in the storage unit <NUM>, the control unit <NUM> previously determines whether the specimen rack <NUM> does not require retest as in a control specimen rack, a standard sample rack, and cleaning solution rack, or whether the specimen rack <NUM> has a possibility of the retest.

If the retest is not required based on the determination, the specimen rack <NUM> is transferred to the rack returning mechanism <NUM> by the rack allocating mechanism <NUM> which receives a control signal of the control unit <NUM>, and is accommodated in the rack accommodation unit <NUM> by the rack returning mechanism <NUM>.

On the other hand, if there is the possibility of the retest in the specimen rack <NUM>, the specimen rack <NUM> is delivered to the standby unit handling mechanism <NUM>, and is conveyed to the rack standby unit <NUM>. Thereafter, the specimen rack <NUM> stands by until it is determined whether or not the retest is required (<FIG>).

On the other hand, the specimen collected in the reaction container of each analysis unit is caused to react with the reagent dispensed by the reagent dispensing mechanism, and data corresponding to each measured analysis item is output to the control unit <NUM>. The control unit <NUM> collates preset determination criteria and analysis test data. In a case where the measurement data is not suitable, information indicating that the specimen require the retest is stored in the storage unit <NUM> in association with the specimen rack number and the specimen container number, thereby performing the retest (<FIG>).

Here, for example, the case where the measurement data is not suitable means a case where the measurement data exceeds or falls below the preset determination criteria. The specimen rack <NUM> which completes the retest is transferred from the rack standby unit <NUM> to the return line <NUM> by the standby unit handling mechanism <NUM> (<FIG>), and is conveyed to the rack returning mechanism <NUM> by the return line <NUM>. Thereafter, the specimen rack is accommodated in the rack accommodation unit <NUM> by the rack returning mechanism <NUM> (<FIG>). The first analysis test data and the retest analysis test data are merged by the control unit <NUM> (<FIG>), and is displayed on the display unit <NUM> (<FIG>), thereby completing the analysis (<FIG>).

The first dispensing line <NUM> includes a specimen rack conveyance mechanism capable of moving the specimen rack <NUM> forward and rearward in the traveling direction. In random order, the specimen dispensing mechanism <NUM> can have access to the specimen on the specimen rack <NUM>. Therefore, the specimen can be retested in random order in the clogging time items whose the reaction time varies depending on the specimen. For example, if specimen containers A, B, C, D, and E are arrayed from the front in the traveling direction of the specimen rack <NUM>, in the automated analyzer in the related art, the specimen dispensing mechanism <NUM> has access to the specimen containers A, B, C, D, and E in this order. However, without being limited to this order, the random order means that a sampling mechanism can have access to the specimen container in various orders such as an order of the specimen containers C, B, A, E, and D. For example, the control unit <NUM> can cause the specimen rack conveyance mechanism of the first dispensing line <NUM> to move the specimen rack <NUM> rearward in the direction opposite to the traveling direction. The sampling mechanism can have access to the specimen container in the order of the specimen containers C and B, or E and D. The analysis operation in the second blood coagulation analysis unit <NUM> is the same as that of the first blood coagulation analysis unit <NUM>, and thus, description thereof will be omitted.

Hereinafter, control performed in a case of the retest will be described with reference to <FIG> is a flowchart illustrating a system operation of the retest. Based on the measurement result of the first blood coagulation analysis unit <NUM> or the second blood coagulation analysis unit <NUM>, in a case where the item determined to require the retest by the control unit <NUM> is present in the specimen of the specimen rack <NUM> (<FIG>), the control unit <NUM> calculates the total measurement time of the specimen rack <NUM> (<FIG>). Thereafter, the control unit <NUM> confirms the total measurement time of each blood coagulation analysis unit (<FIG>), and the conveyance destination of the specimen rack <NUM> is determined by the control unit <NUM> (<FIG>). Here, a conveyance destination analysis unit is selected using the total measurement time in the retest. However, the control may be performed so that the first analysis unit performs the retest.

The control unit <NUM> confirms whether or not there is a vacant space in the first dispensing line <NUM> of the first blood coagulation analysis unit <NUM> or the second dispensing line <NUM> of the second blood coagulation analysis unit <NUM> (<FIG>). If there is the vacant space, the specimen rack <NUM> is conveyed to the first blood coagulation analysis unit <NUM> or the second blood coagulation analysis unit <NUM> (<FIG>), thereby starting to dispense the specimen (<FIG>). In a case where there is no vacant space in the first dispensing line <NUM> or the second dispensing line <NUM>, the specimen rack <NUM> stands by in the rack standby unit <NUM> until the dispensing line is vacant (<FIG>).

The control unit <NUM> causes the return line <NUM> to convey the specimen rack <NUM> which completely dispenses the specimen for retesting all items to the rack allocating mechanism <NUM> (<FIG>), and the specimen rack <NUM> is delivered to the standby unit handling mechanism <NUM>, thereby conveying the specimen rack <NUM> to the rack standby unit <NUM> (<FIG>). The control unit <NUM> confirms whether or not it is determined that all of the items require the retest (<FIG>). In a case where the control unit <NUM> confirms that all of the items are not determined to require the retest, the specimen rack <NUM> stands by in the rack standby unit <NUM> (<FIG>).

Hereinafter, a system operation in the urgent specimen analysis will be described with reference to <FIG>. Here, <FIG> is a view illustrating a basic configuration of a sampling area and a rack retracting area on the dispensing line of the blood coagulation analysis unit. As illustrated in the drawing, the first blood coagulation analysis unit <NUM> or the second blood coagulation analysis unit <NUM> has a sampling area <NUM> where the specimen is dispensed on the first dispensing line <NUM> or the second dispensing line <NUM>, and a rack retracting area <NUM> located on an upstream side of the sampling area <NUM> (here, the upstream side means a side close to the rack supply unit <NUM>).

<FIG> is a flowchart illustrating the system operation of analyzing the urgent specimen.

If the urgent specimen analysis is requested by the input unit <NUM>, the analysis starts. If the specimen rack <NUM> is installed in the urgent specimen rack loading unit <NUM>, the specimen rack <NUM> in the urgent specimen rack loading unit <NUM> is transferred to the conveyance line <NUM> in preference to the specimen rack <NUM> present in the rack supply unit <NUM> (<FIG>).

After the specimen rack <NUM> is transferred to the conveyance line <NUM>, the reading unit (conveyance line) <NUM> reads an identification medium such as a barcode label affixed to the specimen rack <NUM> and the specimen container accommodated in the specimen rack <NUM>, thereby identifying the specimen rack number and the specimen container number (<FIG>). The specimen rack number and the specimen container number which are identified by the reading unit (the conveyance line) <NUM> are transmitted to the control unit <NUM>. A type of the specimen rack <NUM> or a type of the analysis item instructed for each specimen container is associated with the specimen reception number, and is collated with the analysis information previously instructed from the input unit <NUM>. Based on the collation result, the conveyance destination of the specimen rack <NUM> is determined by the control unit <NUM>. Here, the analysis information relating to the type of the analysis items or the conveyance destination information of the specimen rack <NUM> is stored in the storage unit <NUM>, and is used for the subsequent process of the specimen rack <NUM>.

After calculating the total measurement time of the specimen rack <NUM> (<FIG>), the control unit <NUM> confirms the total measurement time of the items under measurement in each blood coagulation analysis unit (<FIG>), and the conveyance destination of the specimen rack <NUM> is determined by the control unit <NUM> (<FIG>). The total measurement time of the item under measurement is calculated using the measurement time of the item under measurement on the detection port <NUM> and the preheat port <NUM>. In addition, if a port for the urgent specimen is secured in the detection port <NUM>, the preheat port <NUM>, or the standby port <NUM>, the urgent specimen can be more quickly analyzed.

<FIG> is a flowchart illustrating a dispensing operation of the urgent specimen in the analysis unit.

The specimen rack <NUM> is conveyed to the reading unit of the conveyance destination analysis unit, and analysis information is collated by the reading unit (<FIG>). It is confirmed whether the specimen rack <NUM> which dispenses the specimen is present in the sampling area <NUM> (<FIG>). In a case where the specimen rack <NUM> is not present, the specimen rack <NUM> is conveyed to the corresponding position of the rack conveyance mechanism by conveyance line <NUM> (<FIG>). The specimen rack <NUM> stopped on the conveyance line <NUM> is transferred to the dispensing line by the rack conveyance mechanism (<FIG>), and the transferred specimen rack <NUM> is moved to the sampling area <NUM> (<FIG>). The dispensing nozzle of the specimen dispensing mechanism is inserted into the specimen container whose analysis is instructed, thereby dispensing the specimen to the reaction container (<FIG>).

In a case where the specimen rack <NUM> is present in the sampling area <NUM>, the specimen rack <NUM> in the sampling area <NUM> is retracted to the rack retracting area <NUM> so as to cause the sampling area <NUM> to be vacant (<FIG>). The specimen rack <NUM> having the urgent specimen mounted thereon is conveyed to the rack handling mechanism by the conveyance line <NUM> (<FIG>), and is transferred to the sampling area <NUM> by the rack handling mechanism (<FIG>). The dispensing nozzle of the specimen dispensing mechanism is inserted into the specimen container whose analysis is instructed, thereby dispensing the specimen into the reaction container (<FIG>).

The specimen rack <NUM> under sampling and the specimen rack <NUM> having the urgent specimen mounted thereon may be respectively transferred. Alternatively, after the specimen rack <NUM> having the urgent specimen mounted thereon is transferred to the dispensing line, both the specimen racks <NUM> may be simultaneously moved to the dispensing line.

The specimen rack <NUM> which completely dispenses the specimen for all of the instructed analysis items is moved to the corresponding position of the rack handling mechanism (<FIG>), and is transferred to the conveyance line <NUM> by the rack handling mechanism (<FIG>). Furthermore, the specimen rack <NUM> is transferred to the return line <NUM> by the rack handling mechanism (<FIG>), and is conveyed to the rack allocating mechanism <NUM> by the return line <NUM>.

If the retest is not required, the conveyed specimen rack <NUM> is transferred to the rack returning mechanism <NUM> by the rack allocating mechanism <NUM> which receives a control signal of the control unit <NUM>, and is accommodated in the rack accommodation unit <NUM> by the rack returning mechanism <NUM>. If there is a possibility of the retest in the specimen rack <NUM>, the specimen rack <NUM> is delivered to the standby unit handling mechanism <NUM>, and is conveyed to the rack standby unit <NUM>. Thereafter, the specimen rack <NUM> stands by until it is determined whether or not the retest is required (<FIG>). The control unit <NUM> collates the preset determination criteria and the analysis test data. In a case where the measurement data is not suitable, the information indicating that the specimen requires the retest is associated with the specimen rack number and the specimen container number, and is stored in the storage unit <NUM> (<FIG>). The specimen rack <NUM> whose the retest is determined to be not required is transferred from the rack standby unit <NUM> to the return line <NUM> by the standby unit handling mechanism <NUM>, the specimen rack <NUM> is conveyed to the rack returning mechanism <NUM> by the return line <NUM>. Thereafter, the specimen rack <NUM> is accommodated in the rack accommodation unit <NUM> by the rack returning mechanism <NUM>. The first analysis test data and the retest analysis test data are displayed on the display unit <NUM> (<FIG>).

In addition, the operation the same as the operation in the above-described urgent specimen analysis is used for all of the retests. In this manner, it is possible to shorten the time required until the test result including the retest is reported.

<FIG> is a view illustrating a basic configuration of the automated analyzer including a plurality of blood coagulation analysis units and a biochemical analysis unit according to the embodiment of the present invention.

A biochemical analysis unit <NUM> has a known configuration, and mainly includes a specimen dispensing mechanism that aspirates the specimen from the specimen rack <NUM>, a reaction cell that discharges the aspirated specimen, a reaction disc <NUM> in which a plurality of reaction cells can be arranged on the circumference thereof, and which is a disk-shaped unit rotatable clockwise or counterclockwise, a reagent disc <NUM> which is a reagent storage for holding the reagent to be mixed with the specimen inside the reaction cell, which is a disk-shaped unit rotatable clockwise or counterclockwise, and in which a plurality of the reagent containers for accommodating the reagent can be arranged on the circumference thereof, a reagent dispensing mechanism that discharges the reagent to the reaction cell, a detector that measures the absorbance by emitting light to a mixed solution of the specimen and the reagent inside the reaction cell, an optical system having a light source, and a calculation unit that calculates predetermined component concentration included in the mixed solution, based on data obtained from the detector.

The biochemical analysis unit <NUM> can analyze at least a third test item. In order to suppress congestion of the specimen rack <NUM>, it is generally desirable to dispose the biochemical analysis unit <NUM> having the higher specimen throughput on the upstream side of the blood coagulation analysis units <NUM> and <NUM>. In addition, the reaction time of the first test item or the third test item is determined by the item different from the second test item. Accordingly, from a viewpoint that measurement scheduling is facilitated, it is desirable to dispose the biochemical analysis unit <NUM> on the upstream side of blood coagulation analysis units <NUM> and <NUM>.

According to the embodiment of the present invention, in a case where the measurement of the first test item and the second test item is requested in the same specimen rack, the control unit determines a conveyance route of the specimen rack so that the biochemical analysis unit measures the first test item and the coagulation time analysis unit measures the second test item, and control the conveyance line. In this manner, it is possible to provide the automated analyzer which realizes the improved throughput.

In addition, in a case where the measurement of the first test item and the second test item is requested in the same specimen rack, the control unit causes the biochemical analysis unit to aspirate the specimen. Thereafter, the control unit determines a conveyance route of the specimen rack so that the blood coagulation time analysis unit aspirates the specimen, and controls the conveyance line. In this manner, it is possible to provide the automated analyzer which realizes the improved throughput. However, with regard to the arrangement of the analysis unit, the blood coagulation time analysis units <NUM> and <NUM> do not need to be arranged on the downstream side of the biochemical analysis unit <NUM>. It is also possible to adopt a configuration in which the blood coagulation analysis units <NUM> and <NUM> are arranged on the upstream side of the biochemical analysis unit <NUM>.

In addition, in a case where the measurement of the first test item and the second test item is requested in the same specimen rack, the control unit causes the biochemical analysis unit <NUM> to aspirate the specimen. Thereafter, the control unit controls the conveyance line <NUM> so as to convey the specimen rack to the dispensing line in a case where there is a vacant space in the first dispensing line <NUM> or the second dispensing line <NUM>, and so as to convey the specimen rack <NUM> to the rack standby unit <NUM> in a case where there is no vacant space in the dispensing line. After the dispensing line is vacant, the control unit conveys the specimen rack <NUM> to the first dispensing line <NUM> or the second dispensing line <NUM> from the rack standby unit <NUM>. In this manner, it is possible to provide the automated analyzer which realizes the improved throughput.

In addition, the plurality of specimen containers are mounted on the specimen rack <NUM>, and the control unit controls the position of the specimen rack <NUM> in the dispensing line so as to dispense the specimen from the specimen container in the order of determining that the retest is required for the second test item in the plurality of specimen containers. In this manner, it is possible to provide the automated analyzer which realizes the improved throughput.

Claim 1:
An automated analyzer comprising:
a conveyance line (<NUM>) that conveys a specimen rack (<NUM>) accommodating a specimen container holding a specimen;
a first dispensing line (<NUM>) that is disposed along the conveyance line (<NUM>), and that is capable of causing a plurality of the specimen racks (<NUM>) which await specimen dispensing to stand by;
a second dispensing line (<NUM>) that is disposed along the conveyance line (<NUM>), and that is capable of causing a plurality of the specimen racks (<NUM>) which await specimen dispensing to stand by;
at least one biochemical analysis unit (<NUM>) capable of analyzing biochemical analysis items whose reaction times between the specimen dispensed on the second dispensing line and a reagent are fixed;
a reading unit (<NUM>) configured to read analysis request information relating to the specimen; and
a control unit (<NUM>) configured to control an operation for conveying the specimen rack (<NUM>), based on the read information,
characterized in that the apparatus further comprises:
a plurality of blood coagulation analysis units (<NUM>, <NUM>) that are capable of analysing blood coagulation time items whose reaction times between the specimen dispensed on the first dispensing line and a reagent are different from each other depending on the specimen;
and wherein in a case where the measurement of the blood coagulation time item and the biochemical analysis item is requested in the same specimen rack (<NUM>), the control unit (<NUM>) is configured to determine a conveyance route of the specimen rack (<NUM>) so that the biochemical analysis unit (<NUM>) measures the biochemical analysis item and thereafter the coagulation time analysis unit measures the coagulation time item; and
wherein the control unit (<NUM>) is configured to calculate a sum of estimated measurement times of measurement items requested for the specimen under analysis and the specimen on standby in each of the plurality of blood coagulation analysis units (<NUM>, <NUM>), and determines a conveyance destination of the specimen rack (<NUM>), based on the calculated sum of the estimated measurement times.