JP2009008558A - Dispenser, sample inspection system, dispensing method, sample inspection method, dispensing program, and sample inspection program - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To reduce burdensome works, such as, setting and manipulation of a sample, and to avoid errors, such as forgotten measurements and implementation of the measurements with a wrong timing. <P>SOLUTION: A dispensing module 130 is constituted of a dispensing section 320, a sorting section 320, a sample storage 370; a sample vessel holding section 372, a sample vessel transferring/placing unit 374, and a control section. The sample storage 370 accommodates a standard sample for calibrating an analysis module 140, and an accuracy control sample for controlling the statistical quality of the analysis module 140. The sample vessel holding section 372 and the sample vessel transferring/placing unit 374 transfer the sample accommodated in the sample storage 370 to a sample-collecting location 321. The control section controls timing at which the sample is transferred. The dispensing section 320 collects the sample and prepares small portions of the sample. The sorting section 350 sorts the small portions of the sample from the dispensing section 320 so as to deliver them to the analysis module 140. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a dispensing device for dispensing a patient sample, a dispensing method used in the dispensing device, a sample testing system including the dispensing device, a sample testing method used in the sample testing system, and a dispensing program. And a sample testing program.

  Conventionally, in a clinical test, a test substance contained in a patient sample is chemically quantified using a sample test system equipped with an analyzer. In order to guarantee the analysis accuracy, the analyzer is known to perform calibration of the analyzer using the standard sample and statistical quality control based on the measurement result using the sample for accuracy control. (For example, see Patent Document 1 below.) As the statistical quality control, the XMean-R management method is frequently used.

  The XMean-R management method measures a plurality of quality control samples at random within this statistical management unit, that is, “true random”, and statistically evaluates the results. This statistically proves whether the measurement results within the unit have the required accuracy. Specifically, for example, in the management by the XMean-R management method, a measurement sample group is defined as a statistical management unit, and a sample for quality control is randomly selected while measuring a patient sample of the measurement test group. It is indispensable to insert at random and measure the quality control sample. The number of measurements of the quality control sample is based on the design, and differs depending on the management content and method for each inspection item. The measurement sample group (statistical management unit) is a quantity unit (for example, 1000 consecutive samples) or a time unit (for example, a time unit from 9:00 to 18:00, a daily unit such as one day, a week unit such as one week, etc.) Etc.

  On the other hand, the measurement of the standard sample for calibrating the analyzer is performed at a set predetermined interval. The measurement timing of the standard sample differs depending on the management content and method design for each test item. Specifically, for example, when the power is turned on, when the reagent is replaced, the starting point of the sample group to be measured, and further, in real time, Immediately after the measurement abnormality is detected by the accuracy control.

  The standard sample and the quality control sample are accommodated in a dedicated container or a test tube, and are arranged at predetermined positions of a disk-shaped sample container holding unit or a rack-shaped sample container holding unit provided inside the analyzer. . These standard samples and quality control samples may be mixed with patient samples in the patient sample container holding unit. These standard samples and quality control samples are collected every time they are measured, dispensed into a reaction container, mixed with a reaction reagent, and a test substance is quantified.

JP-A-8-35970

  However, in the analyzer using the XMean-R management method described above, the random and random quality control sample insertion work itself is very complicated and fine work. At present, the measurement interval is approximately constant and inserted at an artificial interval. For this reason, many of the conventional analyzers have incomplete accuracy control. For example, when an accident occurs, there is a problem that the analysis accuracy does not serve as a basis for guaranteeing the analysis accuracy.

  In addition, when a plurality of analyzers are provided, since standard samples and quality control samples are stored in each analyzer, not only the entire system is increased in size but also the standard samples used in each analyzer Since the state of the quality control sample is slightly different, there is a problem that each analysis accuracy is different.

  In addition, the standard sample and the quality control sample stored in the analyzer may be slightly concentrated due to evaporation or the like depending on the storage state. Therefore, if these standard samples and quality control samples are used without replacement for a long period of time, the analysis accuracy will deteriorate, so the operator will have to manually replace them with new ones at the appropriate time. There was a problem.

  Thus, in the prior art, it is difficult to insert a standard sample for calibration of an analyzer and a sample for accuracy control at an appropriate time, and sufficient accuracy control is performed. The current situation is not. In particular, in an analyzer that operates continuously for 24 hours and a large sample test system that includes a plurality of analyzers, there is a problem that such a problem becomes significant.

  In order to solve the above-described problems caused by the prior art, the present invention eliminates troublesome operations such as setting of a quality control sample for the analysis apparatus and operations performed on the analysis apparatus for measuring the quality control sample. Dispensing device, sample testing system, dispensing method, sample testing that can avoid errors such as forgetting measurement or wrong measurement timing, and can efficiently perform statistical quality control It is intended to provide a method, a dispensing program, and a specimen testing program.

  In order to solve the above-described problems and achieve the object, the dispensing apparatus according to the present invention is divided into a dispensing unit for collecting and subdividing a patient sample at a predetermined dispensing position, and the dispensing unit. In a dispensing device comprising a sorting means for sorting the patient sample for delivery to a predetermined analyzer for analyzing the patient sample, a standard sample for calibrating the analyzer, A storage unit that stores a quality control sample for statistical quality control of the analyzer, and a transfer unit that transfers the standard sample and the quality control sample stored in the storage unit to the dispensing position, respectively. And control means for controlling the timing of the transfer of the standard sample by the transfer means and the timing of the transfer of the quality control sample, respectively, and the dispensing means is controlled by the transfer means. The standard sample and the quality control sample transferred in this manner are collected and subdivided at the dispensing position, and the sorting means separates the standard sample and the quality control sample subdivided by the dispensing means. It is characterized by sorting for shipping to the analyzer.

  In the dispensing apparatus according to the present invention as set forth in the invention described above, the control means controls the transfer timing of the standard sample by the transfer means to a predetermined timing set in advance. The quality control sample transfer timing is controlled to a randomized timing within a statistical management unit.

  Further, in the dispensing apparatus according to the present invention, in the above-described invention, the control means performs control to interrupt the quality control sample to a patient sample conveyed to the dispensing position in the dispensing order. Features.

  The dispensing apparatus according to the present invention is the dispensing apparatus according to the above-described invention, wherein the control unit is configured to start the statistical management unit, replace the standard sample, replace the quality control sample, and start the apparatus. Alternatively, immediately after a measurement abnormality is detected by statistical quality control, control is performed to cause the transfer means to transfer the standard sample.

  Moreover, the dispensing apparatus according to the present invention is characterized in that, in the above-described invention, the storage section stores the standard sample and the quality control sample while maintaining a predetermined temperature.

  The dispensing device according to the present invention is characterized in that, in the above-described invention, the container includes an insertion port for exchanging or replenishing the standard sample and the quality control sample.

  Further, in the dispensing device according to the present invention, in the above-described invention, a plug is attached to a sample container of the standard sample and the quality control sample accommodated in the accommodating portion, and the transfer means includes: When the standard sample and the quality control sample accommodated in the accommodating part are respectively transferred to the dispensing position, sample opening means for opening the stopper is provided.

  Further, in the dispensing device according to the present invention, in the above-described invention, the standard sample and the quality control sample container accommodated in the storage unit include the standard samples and the quality control samples. An identification display for identifying a sample is provided, and further comprises reading means for reading the identification display, and the control means is configured to control the standard sample and the quality control based on the identification display read by the reading means. A sample is selected, and the selected standard sample and the quality control sample are controlled to be transferred to the transfer means.

  In the dispensing device according to the present invention, in the invention described above, the dispensing means includes a nozzle that sucks and discharges the patient specimen or sample, and a nozzle tip that is detachably attached to the tip of the nozzle. And detaching means for detaching the nozzle tip.

  In addition, the dispensing device according to the present invention dispenses the patient sample conveyed through the conveying unit, and sends the patient sample after the dispensing to the conveying unit again in order to send the patient sample to the subsequent analyzer. In the injection apparatus, a storage section for storing a standard sample for calibrating the analysis apparatus, a quality control sample for statistical quality control of the analysis apparatus, and a timing for sending the standard sample to the transport means And control means for controlling the timing at which the quality control sample is sent to the transport means to a timing that is randomized within a statistical management unit.

  Further, the dispensing method according to the present invention comprises a dispensing step of collecting and subdividing a patient sample at a predetermined dispensing position, and analyzing the patient sample from the patient sample subdivided by the dispensing step. In a dispensing method including a sorting step for sorting for shipment to a predetermined analyzer, a standard sample for calibrating the analyzer and accuracy for statistical quality control of the analyzer A transfer step for transferring the standard sample and the quality control sample from the storage portion for storing the control sample to the dispensing position, a transfer timing of the standard sample by the transfer step, and the quality control sample, respectively. A control step for controlling the timing of the transfer of each of the standard samples and the quality control sample transferred in the transfer step. Collecting and subdividing at a position, the sorting step performs sorting for sending the standard sample and the quality control sample subdivided by the dispensing step to the analyzer. .

  Further, in the dispensing method according to the present invention, in the invention described above, the control step controls the transfer timing of the standard sample in the transfer step to a predetermined timing set in advance. The quality control sample transfer timing is controlled to a randomized timing within a statistical management unit.

  Further, in the dispensing method according to the present invention, in the invention described above, the control step performs control to interrupt the quality control sample to a patient sample that is transported to the dispensing position in the order of dispensing. Features.

  The dispensing method according to the present invention is the dispensing method according to the above-described invention, wherein the control step includes the start point of the statistical management unit, the replacement of the standard sample, the replacement of the quality control sample, and the startup of the apparatus. Alternatively, immediately after a measurement abnormality is detected by statistical quality control, control is performed such that the standard sample is transferred in the transfer step.

  Further, in the dispensing method according to the present invention, in the above-described invention, a plug is attached to a sample container of the standard sample and the quality control sample stored in the storage unit, and the transfer step includes When the standard sample and the quality control sample stored in the storage unit are respectively transferred to the dispensing position, a sample opening step of opening the plug is included.

  Further, in the dispensing method according to the present invention, in the above-described invention, the sample container of the standard sample and the quality control sample stored in the storage unit includes information on the standard sample and the quality control sample. And a reading step of reading the barcode, and the control step is configured to remove the standard sample and the quality control sample based on the barcode read by the reading step. The selection is performed, and the selected standard sample and the quality control sample are controlled to be transferred in the transfer step.

  In addition, the dispensing method according to the present invention dispenses a patient sample that has been transported through the transporting means, and sends the patient sample after the dispensing to the transporting means again in order to send it to a subsequent analyzer. In the dispensing method of the pouring device, the standard sample is transported from the housing portion containing the standard sample for calibrating the analyzing device and the quality control sample for statistical quality control of the analyzing device. And a control step of controlling the timing for sending the sample for quality control to a predetermined timing set in advance, and controlling the timing for sending the sample for quality control to the transport means to a timing randomized within a statistical management unit.

  A dispensing program according to the present invention causes a computer to execute the dispensing method described above.

  Further, the sample testing system according to the present invention includes an input unit that inputs a patient sample, a dispensing unit that dispenses the patient sample input by the input unit, and the dispenser that is dispensed by the dispensing unit. In the sample test system, comprising: an analysis unit that analyzes a patient sample; a collection unit that collects the patient sample analyzed by the analysis unit; and a transport unit that transports the patient sample to each unit. The injection means accommodates a standard sample for calibrating the analysis means and a quality control sample for statistical quality control of the analysis means, and dispenses the standard sample at a predetermined timing. The quality control sample is dispensed at a randomized timing, and the analyzing means performs calibration using the standard sample dispensed by the dispensing means, and And performing statistical quality control by using the quality control sample that has been dispensed by the Notes section.

  Further, the specimen testing method according to the present invention is the above-described invention, wherein in the above-described invention, a feeding process for feeding a patient specimen, a dispensing process for dispensing the patient specimen loaded in the loading process, and the dispensing In the sample inspection method including an analysis step of analyzing the patient sample dispensed by the step and a recovery step of collecting the patient sample analyzed by the analysis step, the dispensing step calibrates the analyzer A standard sample to be dispensed at a predetermined timing, and a quality control sample for statistical quality control of the analyzer is dispensed at a randomized timing, and the analysis step includes the dispensing step Calibration is performed using the standard sample dispensed in the process, and statistical quality control is performed using the quality control sample dispensed in the dispensing process. To.

  A sample test program according to the present invention causes a computer to execute the sample test method described above.

  According to the dispensing device and the sample inspection system according to the present invention, it is possible to save troublesome operations such as setting of a standard sample and a quality control sample for the analysis device, and operation of the analysis device for measuring the quality control sample. Thus, it is possible to avoid errors such as forgetting measurement or erroneous implementation of measurement timing, and to effectively perform statistical quality control.

  Exemplary embodiments of a dispensing device, a sample testing system, a dispensing method, a sample testing method, a dispensing program, and a sample testing program according to the present invention will be described below in detail with reference to the accompanying drawings.

(Overall configuration of specimen test system 100)
FIG. 1 is an explanatory diagram showing the overall configuration of a sample testing system provided with a dispensing device of the present invention. In the example shown in FIG. 1, the sample testing system 100 includes a loading module 110 into which a patient sample is loaded, a sample opening module 120 for opening a patient sample plug, and a parent sample by dispensing a patient sample. Dispensing module (dispensing device) 130 for creating a child sample, analysis module (analyzing device) 140 for analyzing the dispensed patient sample, parent sample after dispensing by dispensing module 130, and analysis module A recovery module 150 that recovers the child sample after analysis at 140, a transport module 160 that sequentially transports patient samples in the direction of the arrow between the modules from the input module 110 to the recovery module 150, and a transport module 160; This is a part of the patient sample transport function that is provided in the front of the analysis module 140 and temporarily stores the patient sample before analysis. A fan module 170, and a. Each part of the input module 110 to the buffer module 170 is totally controlled by the PC 180. The parent sample and the child sample are transported to each unit in a container unit such as a blood collection tube.

  For example, the input module 110 is supplied in units of racks that store a plurality of patient samples in units of containers, and the patient sample containers are taken out from the racks and transferred to the transport module 160. The sample opening module 120 opens a seal plug or a rubber plug attached to the container.

  The dispensing module 130 creates a child sample by collecting and dividing the transported patient sample. As will be described in detail later, the dispensing module 130 includes a storage unit 131 that stores a standard sample for calibrating the analysis module 140 and a quality control sample for statistical quality control of the analysis module 140. It has. There are n analysis modules 140 (three in the illustrated example). By providing a plurality of analysis modules 140, a large number of patient specimens can be measured in parallel, or different analyzes can be performed for each analysis module 140.

  The collection module 150 sorts and collects the parent sample and the child sample. The buffer module 170 is configured to circulate the patient sample container in an endless manner, and the patient sample can be overtaken by control of positioning a specific patient sample at a connection location with the transport module 160. The buffer module 170 has functions of an initial test buffer and a retest buffer. The initial test buffer temporarily waits for a patient sample so that the input module 110, the sample opening module 120, and the dispensing module 130 are not stopped when the connected analysis module 130 is occupied by the patient sample. . In FIG. 1, a line 171 corresponds to the initial test buffer. Further, the retest buffer temporarily holds the patient sample until the analysis module 130 determines whether or not the patient sample is retested. In FIG. 1, line 172 corresponds to the retest buffer. Thereby, a patient sample with a high priority is conveyed to the analysis module 140 and analyzed before a patient sample with a low priority. Further, as shown in FIG. 1, the loading module 110 and the collection module 150 are arranged adjacent to each other, thereby improving the workability of loading and collecting the patient sample.

  In addition to the above-described configuration, there may be provided a centrifuge module for centrifuging patient specimens or a plurality of buffer modules 170. Moreover, in the example shown in FIG. 1, each part is arrange | positioned at linear form, However, There exist various installation forms, such as L shape, U shape, and R shape, according to the magnitude | size and shape of an installation location. Further, although the transport module 160 is configured as an independent unit, a configuration may be employed in which a transport unit is formed in each module so that each unit includes a transport unit.

(Hardware configuration of PC 180 in specimen test system 100)
Next, a hardware configuration of the PC 180 in the sample test system 100 according to the present embodiment will be described with reference to FIG. FIG. 2 is a block diagram showing a hardware configuration of the PC in the sample test system according to the present embodiment.

  In FIG. 2, a PC 180 includes a CPU 201, a ROM 202, a RAM 203, an HDD (hard disk drive) 204, an HD (hard disk) 205, an FDD (flexible disk drive) 206, an FD (flexible disk) 207, and a display 208. An I / F (interface) 209, a keyboard 210, and a mouse 211. Each component is connected by a bus 212.

  The CPU 201 governs overall control of the sample testing system 100. The ROM 202 stores a program such as a boot program. The RAM 203 is used as a work area for the CPU 201. The HDD 204 controls reading / writing of data with respect to the HD 205 according to the control of the CPU 201. The HD 205 stores data written under the control of the HDD 204.

  The FDD 206 controls reading / writing of data with respect to the FD 207 according to the control of the CPU 201. The FD 207 stores data written under the control of the FDD 206 or causes the PC 180 to read data stored in the FD 207. In addition to the FD 207, the removable recording medium may be a CD-ROM (CD-R, CD-RW), MO, DVD (Digital Versatile Disk), memory card, or the like.

  The display 208 displays data such as a document, an image, and function information as well as a cursor, an icon, or a tool box. As the display 208, for example, a CRT, a TFT liquid crystal display, a plasma display, or the like can be adopted.

  The I / F 209 connects the input module 110 to the buffer module 170. The keyboard 210 includes keys for inputting characters, numbers, various instructions, and the like, and inputs data. Moreover, a touch panel type input pad or a numeric keypad may be used. The mouse 211 performs cursor movement, range selection, window movement, size change, and the like.

(Configuration of dispensing module 130)
Next, the configuration of the dispensing module 130 according to the present embodiment will be described with reference to FIGS. 3 and 4. FIG. 3 is an explanatory diagram showing the configuration of the dispensing module. FIG. 4 is an explanatory view showing a configuration of a main part of the dispensing module.

  Hereinafter, a description will be given with reference to FIG. In FIG. 3, the dispensing module 130 includes a parent container supply unit 310 that supplies a parent sample 314 that is a patient sample, a dispensing unit 320 that subdivides the parent sample 314 and creates a child sample 327, and a parent container 316. A parent container collection unit 330 that collects, a child container supply unit 340 that supplies a child container 341, a sorting unit 350 that conveys and sorts the child sample 327, and a sample storage 370 that serves as a storage unit 131 that stores a sample. It has.

  The parent container supply unit 310 includes a parent container supply unit 311 and a parent container transport unit 315. The parent container supply unit 311 includes a scroller 313, and sequentially supplies the parent container rack 312 on which the parent sample 314 is installed to the parent container transport unit 315 by the scroller 313. The parent container transport unit 315 includes a feeder (not shown), and feeds the parent container rack 312 to the dispensing unit 320 (X direction) by the feeder.

  The dispensing unit 320 includes a dispensing unit 322, and subdivides the parent sample 314 to create a child sample 327. Although the details will be described later, the dispensing unit 322 includes a dispensing nozzle (not shown) and a dispensing arm 325. The dispensing unit 322 collects a certain amount of the parent sample 314 located at the sample collection position 321 by the dispensing nozzle, and as shown in FIG. 4, the direction of the arrow 401 using the support shaft 326 of the dispensing arm 325 as a fulcrum. The patient sample collected is discharged to the child container 341 located at the dispensing position 324 on the turntable 323 by the rotation to the position.

  The parent container collection unit 330 includes a push bar (not shown) and a parent container collection unit 331. The parent container collection unit 331 includes a parent container collection tray 332 on which the parent sample 314 is placed. The parent container collection unit 330 collects the parent container rack 312 for which the dispensing operation has been completed to a parent container collection tray 332 set in the parent container collection unit 331 using a push bar.

  The child container supply unit 340 includes a child container supply unit 342 and a child container transfer unit 344. The child container supply unit 342 aligns the child containers 341 and supplies them to the child container supply position 343. Hereinafter, a description will be given based on FIG. The child container transfer unit 344 includes a grip portion 346 capable of gripping the child container 341 and a supply arm 347, and the supply arm 347 rotates in the direction of the arrow 402 with the support shaft 348 as a fulcrum. Thus, the child container 341 located at the child container supply position 343 is transferred to the transfer position 345 on the turntable 323.

  The turntable 323 is rotatable by a drive motor or the like. When the turntable 323 rotates by a predetermined amount in the direction of the arrow 403, the child container 341 located at the transfer position 345 on the turntable 323 is sent to the dispensing position 324 and the patient sample collected by the dispensing unit 322 Are to be dispensed.

  The sorting unit 350 includes a child container transfer unit 351, and sorts the dispensed child containers 341. The child container transfer unit 351 includes a slide mechanism 352, an arm 353, and a grip portion 354 that can grip the child container 341. The slide mechanism 352 can move the arm 353 in the arrow 404 direction and the arrow 405 direction.

  The child container 341 at the dispensing position 324 of the turntable 323 moves to the child container take-out position 355 by rotating the turntable 323 by a predetermined amount in the direction of the arrow 403 after the patient sample is dispensed. The child container transfer unit 351 can be moved in the direction of the arrow 404 by the slide mechanism 352, and the child container 341 located at the child container take-out position 355 is transferred to an empty rack 357 stored in the primary sorting area 356. To do. At this time, the child container transfer unit 351 moves in the direction of the arrow 405, and transfers the child container 341 to the empty rack 357 determined in advance by the item to be measured, the analysis module 140 to be used, or the like.

  Hereinafter, a description will be given based on FIG. The sorting unit 350 further includes an empty rack supply unit 359, an empty rack transfer unit 360, and a child container sorting unit 361. The empty rack supply unit 359 sets an empty rack 357 for installing the child container 341 on the empty rack supply tray 362 in advance, and supplies the empty rack transfer unit 360 using the scroller 363. The empty rack transfer unit 360 places the empty rack 357 in the primary sorting area 356.

  In the primary sorting area 356, the secondary container sorting unit 361 takes out a rack in which the secondary containers 341 are fully installed, or a rack in which a predetermined number of secondary containers 341 are installed, and outputs the secondary sorting area 364. 365 is stored in a predetermined position of a section determined in advance by an item to be measured, an analysis module 140 to be used, or the like. A plurality of sections can be set in the secondary sorting areas 364 and 365. In other words, a plurality of racks can be stored in one section. Further, the next empty rack 357 is replenished by the empty rack transfer unit 360 at the position where the rack is taken out by the child container sorting unit 361 in the primary sorting area 356.

  In the dispensing module 130, barcode labels are affixed to the parent container 316 and the child container 341, and the barcode label identification information read by a barcode reader (not shown) and the order of transport of the containers are used. Based on the position information, it is possible to grasp which container is located at which position.

  The sample storage 370 is maintained at a low temperature, and accommodates the standard sample and the sample for quality control. A plurality of housing members 370a are housed in the sample storage 370. The sample container 371 containing the standard sample and the quality control sample is held by the sample container holding part 372 fixed to the circulating belt 380 in the sample storage 370 and circulates. The sample container holding portion 372 may be a disk shape or a rack shape. A sample container transfer unit 374 is arranged in the sample storage 370. The sample container transfer unit 374 includes an arm 375, and the arm 375 moves a predetermined sample container 371 positioned at the transfer position 376 in the vicinity of the sample collection position 321 of the parent container transport unit 315 to the arrow in FIG. As indicated by 406, the sample is supplied to the sample collection position 321.

  In addition, the sample storage 370 is provided with an insertion port (not shown) that can be opened and closed, for example, and the operator of the dispensing module 130 sets the standard sample and the sample container for quality control at the sample setting position 373, so that Can be replaced or refilled at any time. In the sample storage 370, a barcode reader 377 and a sample container taking-in unit 378 are arranged. The barcode reader 377 reads the barcode label attached to the sample container 371 that is inserted from the insertion port and located at the sample setting position 373. The sample container take-in unit 378 includes an arm 379. When the sample container 371 is inserted from the insertion port by the operator, the arm 379 moves the sample container 371 from the sample setting position 373 to the sample container holding unit 372. It is like that.

  The sample container holder 372 is given a fixed number or symbol, and which standard sample or quality control sample is held at which position based on the identification information read by the barcode reader 377. Can always be grasped. The bar code reader 377 is not limited to the fixed type incorporated in the dispensing module 130. For example, the bar code reader 377 is read from the insertion port after the operator reads the bar code using a handy bar code reader. It may be set at the set position 373.

(Detailed configuration of dispensing unit 320 and sample storage 370)
Next, detailed configurations of the dispensing unit 320 and the sample storage 370 according to the present embodiment will be described with reference to FIG. FIG. 5 is a perspective view showing a dispensing unit and a sample storage.

  In FIG. 5, the dispensing unit 322 of the dispensing unit 320 includes a case 501, a dispensing arm 510, a drive motor 520, a drive transmission unit 530, and a suction / discharge unit 540. The case 501 is formed in a rectangular shape, a dispensing arm 510 and a drive motor 520 are provided at the top, and a drive transmission means 530 is provided inside.

  The dispensing arm 510 includes a dispensing arm shaft 511 and an arm 512. The dispensing arm shaft 511 has a rod shape that is erected on the upper portion of the case 501 and is connected to a drive motor 520 via a drive transmission means 530. The dispensing arm shaft 511 supports the arm 512 and rotates together with the arm 512 based on the drive of the drive motor. Further, the dispensing arm shaft 511 moves up and down by driving a drive mechanism (for example, a motor, a hydraulic cylinder, etc.) controlled by a computer (not shown).

  The arm 512 has a rod shape, and one end is pivotally supported by the dispensing arm shaft 511 and rotates together with the dispensing arm shaft 511. The arm 512 is provided with a dispensing nozzle 543 at the other end. The arm 512 is rotated together with the dispensing arm shaft 511 by the drive of the drive motor 520, whereby the dispensing nozzle 543 at the tip of the arm 512 is moved to the sample collection position 321 (inhalation position) and the dispensing position 324 (discharge position). ).

  Further, the arm 512 can move up and down the dispensing nozzle 543 held at the tip of the arm 512 by moving up and down together with the dispensing arm shaft 511 by driving of a drive mechanism controlled by a computer (not shown). . For example, in order to inhale a patient sample or sample from the parent container 316 located at the sample collection position 321, when the dispensing nozzle 543 is located at a predetermined sample collection position 321, the arm 512 and the dispensing arm shaft 511 are combined. By lowering, the tip of the dispensing nozzle 543 can be inserted into the patient specimen or sample injected into the parent container 316.

  The drive motor 520 is a motor (DC motor or AC motor) that is driven by control of a computer (not shown) to rotate the dispensing arm 510 via the drive transmission means 530. The drive transmission means 530 includes a drive shaft 531, a drive pulley 532, and a drive belt 533, and transmits the drive force of the drive motor 520 to the dispensing arm 510.

  The suction / discharge means 540 includes a syringe pump unit 541, a syringe pump pipe 542, and a dispensing nozzle 543. The syringe pump unit 541 generates a pressure (negative pressure) for inhaling a patient specimen or sample and a pressure (positive pressure) for discharging the patient specimen or sample under the control of a computer (not shown).

  The pressure (negative pressure and positive pressure) generated by the syringe pump unit 541 is transmitted to the dispensing nozzle 543 via the syringe pump pipe 542. For example, when pressure (negative pressure) is generated by the syringe pump unit 541 when the distal end of the dispensing nozzle 543 is inserted into the parent container 316, the patient injected into the parent container 316 from the distal end of the dispensing nozzle 543 The specimen or sample can be inhaled.

  On the contrary, when the tip of the dispensing nozzle 543 into which the patient specimen or sample has been inhaled is inserted into the child container 341, pressure (positive pressure) is generated by the syringe pump unit 541, whereby the dispensing nozzle 543 A patient specimen or sample can be discharged from the tip to the child container 341. As will be described later in detail, the dispensing nozzle 543 has a nozzle tip 544 detachably attached to the tip thereof, and accommodates an inhaled patient sample or sample in the nozzle tip 544.

  The sample storage 370 is a storage space including a bottom surface portion 550, a wall surface not shown surrounding the bottom surface portion 550, and a top plate portion not shown. In addition, an openable and closable supply port that is opened when the standard sample or the quality control sample is taken out by the sample container transfer unit 374 is provided on the wall surface on the specimen collection position 321 side.

  The sample storage 370 stores the standard sample and the quality control sample injected into the sample container 371. A plug 560 is attached to the sample container 371 so that the sample inside the sample container 371 can be prevented from volatilizing. The sample container 371 is held by the sample container holding part 372 fixed to the circulating belt 380 in the sample storage 370 and circulates in the arrow 570 direction.

  In addition, as described above, the sample container transfer unit 374 includes a movable arm 375 and a movement mechanism (not shown) that moves the arm 375, and the sample container 371 held by the sample container holding unit 372 includes the sample container 371. When positioned at the transfer position 376, the predetermined sample container 371 positioned at the transfer position 376 is lifted and supplied to the sample collection position 321 by the arm 375 and the moving mechanism. The sample supplied to the sample collection position 321 is dispensed by the dispensing unit 322 in the same manner as the parent sample 314, thereby being injected into the child container 341.

  In addition, a sample opening portion (not shown) is arranged in the vicinity of the sample container transfer unit 374 so that the sample stopper is opened before being supplied to the sample collection position 321. The sample container take-in unit 378 includes a movable arm 379 and a movement mechanism (not shown). When the sample container 371 is inserted from the insertion port by the operator and placed at the sample setting position 373, the arm 379 is provided. The sample container 371 is lifted by the moving mechanism and moved from the sample setting position 373 to the sample container holding portion 372.

(Configuration of nozzle tip 544)
Next, the configuration of the nozzle tip 544 according to the present embodiment will be described with reference to FIG. FIG. 6 is a perspective view showing the configuration of the nozzle tip according to the present embodiment. As shown in FIG. 6, the dispensing nozzle 543 is connected to the syringe pump pipe 542. The dispensing nozzle 543 is formed in, for example, a cylindrical shape or a conical shape that narrows toward the tip 543b. The nozzle tip 544 has the same opening diameter at one end 544a and the other end 544b. The nozzle chip 544 is molded of resin and has, for example, a length of 10 cm, an inner diameter of about 2 to 8 mm, a wall thickness of 0.1 mm, and a capacity of about 0.5 to 1 cc. The nozzle tip 544 is easily formed by simply cutting a cylindrical member having a predetermined length in units of 10 cm.

  The nozzle tip 544 is mounted by inserting one end 544a into the tip 543b of the dispensing nozzle 543 with a predetermined length from below. Conversely, the nozzle tip 544 can be pulled downward with respect to the dispensing nozzle 543 and removed. The other end 544b functions as an inlet and outlet for a patient specimen or sample. Note that the one end 544a and the other end 544b are described for convenience of explanation, and the entire nozzle tip 544 has a uniform inner diameter.

  The nozzle chip 544 is supplied from a nozzle chip supply unit (not shown) provided in the rotation direction of the arm 512 and discharged to a nozzle chip discharge unit (not shown). The nozzle tip supply unit attaches the nozzle tip to the dispensing nozzle 543 by moving the arm 512 downward while the nozzle tip 544 is held upright as shown in FIG. Similarly, the nozzle tip discharger removes the nozzle tip 544 from the dispensing nozzle 543 and discharges (discards) it. The present invention is not limited to such a configuration, and a nozzle chip discharge unit may be provided in the nozzle chip supply unit, and a new nozzle chip 544 may be supplied (replaced) immediately after the old nozzle chip 544 is discharged.

(Functional configuration of dispensing module 130)
Next, a functional configuration of the dispensing module 130 according to the present embodiment will be described. FIG. 7 is an explanatory diagram showing a functional configuration of the dispensing module according to the present embodiment.

  In FIG. 7, the barcode reader 377 reads the barcode label attached to the sample container 371. The recording unit 705 records the identification information read by the barcode reader 377 in association with the positional information such as a fixed number or symbol attached to the sample container holding unit 372. Therefore, it is possible to always grasp which standard sample or quality control sample is held at which position of the sample container holding portion 372.

  The control unit 701 includes a temperature control unit 702, a timing control unit 703, and an acquisition control unit 704. The temperature control unit 702 manages the temperature of the sample storage 370 at a preset temperature, for example, about 5 to 10 ° C. The timing control unit 703 controls the transfer timing of the sample container 371. Here, as described above, in the recording unit 705, the identification information read by the barcode reader 377 and the positional information of the sample container holding unit 372 are recorded in association with each other. The timing control unit 703 selects the sample container 371 to be transferred based on the identification information and the position information recorded in the recording unit 705, and causes the sample container holding unit 372 (circulation belt 380) to rotate and the distance to move. To control.

  In this case, the recording unit 705 records information such as the storage start date and time of each sample and the effective period of the sample that differs for each sample, based on the identification information read by the barcode reader 377. Therefore, the storage period of the sample is also managed based on the information related to these periods recorded in the recording unit 705, and an expired sample is not taken out.

  The timing of the transfer of the standard sample by the timing control unit 703 is a predetermined timing such as when there is an abnormality in the measurement of the starting point in the sample group to be measured or the quality control sample in addition to when the power is turned on or when the sample is exchanged. This is the timing recorded in the recording unit 705. On the other hand, the timing of transferring the quality control sample by the timing control unit 703 is a timing that is randomized within the measurement sample group. Further, the timing control unit 703 controls the sample opening unit 720 to open the plug attached to the sample. The timing control unit 703 controls the sample container transfer unit 374 to move a predetermined sample to the sample collection position 321. The timing control unit 703 sequentially controls the sample container holding unit 372, the sample opening unit 720, and the sample container transfer unit 374 in this order.

  The take-in control unit 704 controls the sample container taking-in unit 378 to take the sample put in from the insertion port into a predetermined position of the sample container holding unit 372 when the sample is inserted from the insertion port. To do. In this case, for example, a sensor that detects a sample inserted from the insertion port is arranged, and the capture control unit 704 controls the sample container capture unit 378 when the sensor detects the sample. Do it.

  In addition, the control unit 701 controls a nozzle chip supply unit 710 and a nozzle chip discharge unit 711 as desorption means. The timing for replacing the nozzle tip 544 is a predetermined timing such as when the sample is replaced or when the sample is replaced. Further, the control unit 701 controls each unit of the sorting unit 350 and causes the sorting unit 350 to perform sorting for shipping various containers to a predetermined analysis module 140.

  The configuration described above is a configuration in which the dispensing module 130 includes the control unit 701, and the control by the control unit 701 is performed together with the control by the PC 180. However, the configuration is not limited thereto, and the control unit 701 is provided in the PC 180. That is, a configuration in which centralized control is performed by the PC 180 may be adopted.

(Example of specimen test processing of specimen test system 100)
Next, an example of a sample test process performed by the sample test system 100 according to the present embodiment will be described with reference to FIG. FIG. 8 is a flowchart showing an example of the sample test process of the sample test system according to the present embodiment.

  In FIG. 8, the specimen testing system 100 is in a standby state until the PC 180 receives an input for starting a test (step S801: No loop). When an input for starting a test is received (step S801: Yes), the input module 110 A patient sample is input (step S802). Then, the patient sample is opened by the sample opening module 120 (step S803).

  Thereafter, the patient specimen or sample is dispensed by the dispensing module 130 (step S804). As a result, the patient specimen or sample is subdivided into the child container 341. Then, the patient specimen or sample is sent to the analysis module 140 according to the priority via the buffer module 170 (step S805). The buffer module 170 temporarily stores patient specimens or samples as necessary. Thereafter, analysis of the patient sample or measurement of the sample is performed by the analysis module 140 (step S806). The measurement of the sample is the configuration of the analysis module 140 based on the measurement using the standard sample or the quality confirmation based on the measurement of the quality control sample. Then, the collection module 150 collects the containers of the parent container 316 and the child container 341 (step S807), and the series of processing ends.

(Example of dispensing process performed by dispensing module 130)
Next, an example of a dispensing process performed by the dispensing module 130 according to the present embodiment will be described with reference to FIG. FIG. 9 is a flowchart showing an example of a dispensing process performed by the dispensing module according to the present embodiment. The flowchart shown in FIG. 9 is processing that is appropriately performed in step S804 of the flowchart shown in FIG. In the following description, processing for dispensing a quality control sample will be described.

  In FIG. 9, the dispensing module 130 supplies a patient sample by the parent container supply unit 310 (step S901) (see FIG. 5). Then, the control unit 701 determines whether it is time to transfer the quality control sample (step S902). As described above, the timing of transferring the quality control sample is a timing that is randomized within the measurement sample population.

  If it is determined in step S902 that it is time to transfer the quality control sample (step S902: Yes), the quality control sample (sample container 371) to be transferred is selected based on the identification information and position information (step S902). In step S903, the sample container holding portion 372 (circulating belt 380) is moved to the transfer position 376 (step S904). Then, the sample opening part 720 opens the quality control sample (step S905). Thereafter, the sample container transfer unit 374 transfers the sample to the sample collection position 321, and interrupts the quality control sample to the patient sample conveyed in the dispensing order (step S906). Details of the point of allowing the patient specimen to interrupt the quality control sample will be described later. At this time, when the patient sample is being dispensed, that is, when the patient sample is located at the sample collection position 321, the patient sample is temporarily retracted, and the dispensing operation of the quality control sample is completed. Later, it returns to its original position and resumes dispensing of patient samples.

  Then, the dispensing unit 320 subdivides the quality control sample (step S907). In this case, the quality control sample in the sample container 371 supplied to the sample collection position 321 is collected by the dispensing unit 322 in the same manner as the patient sample, and the child at the dispensing position 324 on the turntable 323 is collected. It is dispensed into a container 341. Thereafter, the sorting unit 350 sorts the quality control sample (step S908), and the series of processing ends.

  In step S906, the dispensed sample is sorted in the same manner as in the case of the patient sample, in which the child container 341 into which a predetermined sample has been dispensed is transferred from the child container removal position 355 of the turntable 323 to the child container transfer unit. This is performed by being transferred to the empty rack 357 stored in the primary sorting area 356 by 351 (see FIG. 3). At this stage, the child container 341 into which the standard sample or the quality control sample has been dispensed is a predetermined timing set in advance in the empty rack 357 determined in advance by the item to be measured, the analysis module 140 to be used, or the like It is installed at a position corresponding to the randomized timing. The rack in which the child container 341 is installed in the primary sorting area 356 is stored in predetermined sections of the secondary sorting areas 364 and 365 as in the case of the patient sample.

  On the other hand, if it is determined in step S902 that it is not time to transfer the sample (step S902: No), the patient sample is subdivided (step S909). Then, the subdivided patient specimens are sorted (step S910), and the series of processes is terminated.

  In the normal dispensing process for the standard sample, the timing for transferring the standard sample is a predetermined timing set in advance, such as when the power is turned on or the starting point in the measurement sample group, and the quality control sample is interrupted to the patient sample in step S906. The processing is the same as the processing described above except that the processing to be performed is not performed.

  Further, in the dispensing unit 322, the nozzle tip 544 after the dispensing is removed from the dispensing nozzle 543 by the nozzle tip discharge unit 711 and discarded. Then, a new nozzle tip 544 is supplied from the nozzle tip supply unit 710 and attached to the dispensing nozzle 543.

  As described above, the operation of the dispensing unit 322 for the quality control sample in steps S907 and S908 and the operation of the dispensing unit 322 for the patient sample in steps S909 and S910 are the same operations. Therefore, the quality control sample and the standard sample can be subdivided by the dispensing unit 322 conventionally used without providing a new mechanism or the like.

  As a result of the above processing, the predetermined number of racks 366 and 367 stored in the predetermined sections of the secondary sorting areas 364 and 365 are stored in the patient samples (sorted by the items to be measured, the analysis module 140 to be used, etc.). A group of (sub-samples) is constructed, and a standard sample at a position corresponding to a predetermined timing set in advance or a quality control sample at a position corresponding to a randomized timing is arranged between them. .

(An example of analysis processing performed by the analysis module 140)
Next, an example of analysis processing performed by the analysis module 140 according to the present embodiment will be described with reference to FIG. FIG. 10 is a flowchart illustrating an example of analysis processing performed by the analysis module according to the present embodiment. In the following description, for the sake of convenience, the analysis module 140 is the main component, that is, the analysis module 140 is configured to include a control unit, and the processing based on the control of the control unit will be described.

  In FIG. 10, the analysis module 140 acquires the identification information given to the child container 341 (each patient sample, standard sample, or quality control sample) transported to the analysis module 140 (step S1001). Based on the identification information, it is determined whether or not the injection in the child container 341 is a patient sample (step S1002). If it is determined in step S1002 that the sample is not a patient sample (step S1002: No), it is determined whether or not the injection in the child container 341 is a standard sample (step S1003).

  In step S1003, when it is determined that the injection in the child container 341 is not a standard sample (step S1003: No), it is determined that the injection in the child container 341 is a quality control sample, and the quality control sample is determined. Is measured (step S1004). The quality is confirmed by measuring the quality control sample. Thereafter, the result is transmitted to the PC (step S1005), and the series of processes is terminated. On the other hand, if it is determined in step S1002 that the injection in the child container 341 is a patient sample (step S1002: Yes), the patient sample is analyzed (step S1006), and the process proceeds to step S1005.

  If it is determined in step S1003 that the injection in the child container 341 is a standard sample (step S1003: Yes), the standard sample is measured (step S1007), and the process proceeds to step S1005. Calibration is performed by measuring a standard sample. Note that the above-described process is described as a process based on the control of the control unit with the analysis module 140 having a control unit, but the same applies to the process based on the control of the PC 180.

(Example of processing of PC 180 based on measurement results of quality control sample)
Next, an example of processing of the PC 180 based on the measurement result of the quality control sample in the sample test system 100 according to the present embodiment will be described with reference to FIG. FIG. 11 is a flowchart showing an example of processing of the PC based on the measurement result of the quality control sample in the sample test system according to the present embodiment.

  In FIG. 11, the PC 180 acquires the measurement result of the quality control sample (step S1101). Then, it is determined whether or not the measurement result of the quality control sample is an appropriate value (step S1102). If it is determined in step S1102 that the measurement result of the quality control sample is not an appropriate value (step S1102: No), for example, the quality control sample is measured again (step S1103). When the measurement of the quality control sample in step S1103 is performed again, the quality control sample may be remeasured as it is or according to the setting of the PC 180, or may be first calibrated with the standard sample. When calibration with a standard sample is performed first, the standard sample is interrupted to the patient sample conveyed in the dispensing order, and after the analysis module 140 is calibrated, the quality control sample is similarly interrupted. A control sample is measured.

  Then, it is determined whether or not the measurement result of the quality control sample is an appropriate value (step S1104). When it is determined in step S1104 that the measurement result of the quality control sample is not an appropriate value (step S1104: No), the display 208 notifies the measurement value of the quality control sample that the reliability is inappropriate (step S1105). . Then, the analysis of the patient sample in the analysis module 140 is stopped (step S1106), and the series of processes is terminated. The patient sample may be analyzed by the analysis module 140 that can be substituted among other analysis modules 140 (for example, analysis modules 2 to n in FIG. 1).

  On the other hand, if it is determined in step S1102 that the measurement result of the quality control sample is an appropriate value (step S1102: Yes), the series of processes is terminated. If it is determined in step S1104 that the measurement result of the quality control sample is an appropriate value (step S1104: Yes), the series of processes is terminated. When it is determined in step S1104 that the measurement result of the quality control sample is an appropriate value (step S1104: Yes), for example, a process of reducing the management unit of the measurement sample population may be performed.

  For example, when the management unit is 1000 samples, the management unit is reduced to 500 samples, and when the management unit is 9 hours, the management unit is reduced to 5 hours. It is. This is because if the measurement result of the sample for quality control is not an appropriate value, the analysis result of the measurement sample population itself becomes unreliable. In particular, if the management unit of the measurement sample population is large, the analysis result is correspondingly reduced. This is based on the fact that the number of unreliable specimens increases. Therefore, the process to reduce the management unit of the sample group to be measured is a process to minimize the number of invalid analysis results when the measurement results become inappropriate the next time the quality control sample is measured. It is. In addition to the process of reducing the management unit of the measurement specimen group, the management unit of the measurement specimen group can be reduced and, for example, the process of increasing the number of measurements of the quality control sample can be performed in a short span. You can check the quality.

  In addition to the case where an appropriate value cannot be obtained for the measurement of the quality control sample as described above, a case where an appropriate value cannot be obtained even in the calibration using the standard sample can be assumed. In such a case, the operator is notified by an alarm and the analysis is stopped. If the used standard sample is appropriate without any deterioration, calibration is performed again after necessary measures such as replacement or repair of the consumables of the analysis module 140 are taken. In addition to the measure to stop the analysis, the patient sample can be analyzed by another analysis module 140 that can be substituted.

(An example of interrupting a quality control sample to a patient sample)
Next, an example of interrupting a quality control sample to a patient sample in the sample test system 100 according to the present embodiment will be described with reference to FIG. FIG. 12 is an explanatory diagram showing an example of interruption of a quality control sample to a patient sample in the sample test system according to the present embodiment.

  In FIG. 12, for example, if the measurement sample group 1200 is 1000 samples, the patient samples 1201 (1202, 1203...) Based on the identification information and position information of the patient samples transported in the dispensing order are transported in the transport direction (X direction). 1000 pieces are lined up. Similarly, 1000 pieces of data recorded on the PC are arranged. When an interrupt position 1210 of the control management sample is determined at a randomized position (timing) of the measurement sample group 1200 arranged in this way, for example, a position between the patient sample 1202 and the patient sample 1203, the patient The patient samples 1204 after the sample 1203 are shifted backward by one sample. Then, the quality control sample 1220 is interrupted at the interrupt position 1210.

  In the case of the standard sample, for example, when the measurement of the standard sample is performed at the starting point of the measurement sample group, the standard sample is arranged at the head of the measurement sample group, that is, before the patient sample 1201. Further, in the re-measurement of the quality control sample when the measurement result of the quality control sample is not an appropriate value, for example, the standard sample is placed behind the quality control sample 1220, and the re-measurement sample is placed behind the standard sample. Samples for quality control are arranged. Similarly, an interrupt is performed for data recorded in the PC.

  As described above, the dispensing module 130 according to the present embodiment includes the sample storage 370 that stores the standard sample and the quality control sample, and the timing of the transfer of each sample stored in the sample storage 370. The standard sample and the quality control sample were respectively dispensed, and sorting was performed for shipping the dispensed sample to the analysis module 140. According to such a configuration, it is possible to save troublesome operations such as setting a standard sample and a quality control sample for the analysis module 140 and an operation for the analysis module 140 for measuring the quality control sample. And errors such as incorrect measurement timing can be avoided, and statistical quality control can be performed efficiently. In particular, in the analysis module 140 that continuously moves for 24 hours and the large sample test system 100 including the plurality of analysis modules 140, troublesome troubles at night and troublesome for each analysis module 140 can be saved. Is effective.

  In addition, the dispensing module 130 according to the present embodiment controls the transfer timing of the standard sample to a predetermined timing, and controls the transfer timing of the quality control sample to a timing that is randomized in the measurement sample population. A timing control unit 703 is provided. According to such a configuration, the standard sample or the quality control sample can be transferred at an appropriate time, the statistical quality control of the analysis module 140 can be made appropriate, and the reliability of the inspection data can be improved. Can do.

  In addition, the dispensing module 130 according to the present embodiment controls the timing control unit 703 to interrupt the quality control sample to the patient sample. This configuration embodies the insertion of the quality control sample into the patient specimen when the quality control sample is transferred. According to such a configuration, the quality control sample can be inserted at an arbitrary position, the statistical quality control of the analysis module 140 can be made appropriate, and the reliability of the inspection data can be improved.

  Further, in the dispensing module 130 according to the present embodiment, the timing control unit 703 has the start point of the measurement sample group, the exchange of the standard sample, the exchange of the quality control sample, the startup of the apparatus, or the statistical Immediately after a measurement abnormality was detected by quality control, control to transfer the standard sample was performed. According to such a configuration, calibration can be performed at an appropriate time, and a normal quality control sample can be appropriately measured. In particular, in such a configuration, in the re-measurement of the quality control sample when the measurement result of the quality control sample is not an appropriate value, the quality control sample 1220 is interrupted at a randomized timing with respect to the patient sample. A standard sample is arranged behind the. Therefore, according to such a configuration, it is possible to appropriately measure the normal quality control sample, and also in the remeasurement using the quality control sample, the accuracy transferred at the randomized timing. The standard sample can be transferred along with the control sample, and the re-measurement of the quality control sample can be appropriately performed by calibration.

  In addition, in the dispensing module 130 according to the present embodiment, the sample storage 370 is provided with an insertion port for exchanging or supplementing the standard sample and the quality control sample. According to such a configuration, the user can easily replace or replenish the sample at any time. Therefore, it is not necessary to replace or replenish the sample with respect to the analysis module 140, and the sample can be replaced or replenished only at the insertion port of the dispensing module 130, which is effective for centrally managing the sample. is there.

  Further, in the dispensing module 130 according to the present embodiment, the sample storage 370 accommodates the standard sample and the quality control sample in a state where the temperature control unit 702 maintains a predetermined temperature. According to such a configuration, deterioration of the sample can be prevented. Therefore, not only the reliability of accuracy management can be improved, but also the reliability of inspection data can be greatly improved.

  In addition, the dispensing module 130 according to the present embodiment is configured so that a stopper is attached to the sample container of the standard sample and the quality control sample accommodated in the sample storage 370, and each sample is transferred to the specimen collection position 321. In the previous stage, a sample opening part for opening the stopper was provided. According to such a configuration, deterioration of the sample can be prevented. Therefore, not only the reliability of accuracy management can be improved, but also the ability to prove the reliability of inspection data can be greatly improved.

  In the dispensing module 130 according to the present embodiment, a barcode label for identifying each standard sample and each quality control sample is displayed on the sample container 371, and a barcode reader for reading the barcode label. The control unit 701 selects the standard sample and the quality control sample based on the barcode read by the barcode reader 377, and controls the selected sample to be transferred. According to such a configuration, the storage period of the sample can be managed, so that the reliability of the inspection data can be improved without the sample having passed the effective period being subjected to analysis.

  Further, the dispensing module 130 according to the present embodiment includes a dispensing nozzle 543 that sucks and discharges a patient specimen or sample in a dispensing unit 322, and a nozzle tip 544 that is detachably attached to the tip of the dispensing nozzle 543. And a nozzle chip supply unit 710 for detaching the nozzle chip 544 and a nozzle chip discharge unit 711. According to such a configuration, the dispensing nozzle 543 is not deteriorated without adhering to the dispensing nozzle 543 with a minute amount of patient specimen or reaction reagent, or a minute amount of detergent remaining when the dispensing nozzle 543 is washed. Can be prevented. Further, since the nozzle tip 544 is a disposable type, it can be kept clean, can prevent deterioration of the original standard sample and the accuracy control sample, and can improve the analysis accuracy of the analysis module 140.

  Further, in the sample inspection system 100 according to the present embodiment, the dispensing module 130 accommodates the standard sample and the quality control sample, dispenses the standard sample at a predetermined timing, and randomizes the quality control sample. The analysis module 140 calibrates using the standard sample dispensed by the dispensing module 130 and uses the quality control sample dispensed by the dispensing module 130. Statistical quality control was performed. According to such a configuration, it is possible to save troublesome work such as setting a standard sample and a quality control sample for the analysis module 140 and an operation for the analysis module 140 for measuring the quality control sample. Errors such as forgetting and incorrect measurement timing can be avoided.

  Further, the standard sample or the quality control sample can be transferred at an appropriate time, the statistical quality control of the analysis module 140 can be made appropriate, and the reliability of the inspection data can be improved. In particular, when a plurality of analysis modules 140 are provided, it is possible to save time and labor for setting standard samples and quality control samples in each analysis module 140 and for performing measurement operations. It is effective. Further, if the measurement interval of the standard sample and the quality control sample of the analysis module 140 is set in advance by the PC 180, the standard sample and the quality control sample are dispensed at the set measurement interval, and the sample is analyzed. Can be supplied to. Similarly, when a plurality of analysis modules 140 are provided, standard samples and quality control samples can be supplied to the respective analysis modules 140 at set intervals.

  As described above, according to the dispensing apparatus, the specimen inspection system, the dispensing method, and the dispensing program, the standard module and the quality control sample are set to the analysis module 140 and the quality control sample is measured. Troublesome operations such as an operation on the analysis module 140 can be saved, errors such as forgetting measurement or incorrect measurement timing can be avoided, and statistical quality control can be performed efficiently.

  The dispensing method described in this embodiment can be realized by executing a program prepared in advance on a computer such as a personal computer or a workstation. This program is recorded on a computer-readable recording medium such as a hard disk, a flexible disk, a CD-ROM, an MO, and a DVD, and is executed by being read from the recording medium by the computer. Further, this program may be a transmission medium that can be distributed via a network such as the Internet.

  As described above, the dispensing device, the specimen testing system, the dispensing method, the specimen testing method, the dispensing program, and the specimen testing program according to the present invention are useful for automatic analysis of clinical tests performed in hospitals and clinical laboratories. In particular, it is suitable for a dispensing device that is used in combination with an analyzer that is calibrated with a standard sample and performs statistical quality control based on the measurement results of a sample for quality control.

It is explanatory drawing which shows the whole structure of the sample test system provided with the dispensing apparatus of this invention. It is a block diagram which shows the hardware constitutions of PC in the sample test system concerning this Embodiment. It is explanatory drawing which shows the structure of a dispensing module. It is explanatory drawing which shows the structure of the principal part of a dispensing module. It is a perspective view which shows a dispensing part and a sample storage. It is a perspective view which shows the structure of the nozzle chip concerning this Embodiment. It is explanatory drawing which shows the functional structure of the dispensing module concerning this Embodiment. It is a flowchart which shows an example of the sample test process of the sample test system concerning this Embodiment. It is a flowchart which shows an example of the dispensing process which the dispensing module concerning this Embodiment performs. It is a flowchart which shows an example of the analysis process which the analysis module concerning this Embodiment performs. It is a flowchart which shows an example of the process of PC based on the measurement result of the sample for quality control in the sample inspection system concerning this Embodiment. It is explanatory drawing which shows an example of the interruption to the patient sample of the sample for quality control in the sample test system concerning this Embodiment.

Explanation of symbols

100 Sample Inspection System 110 Input Module 120 Sample Opening Module 130 Dispensing Module 140 Analysis Module 150 Collection Module 160 Transport Module 170 Buffer Module 180 PC
310 Parent Container Supply Unit 314 Parent Sample 316 Parent Container 320 Dispensing Unit 322 Dispensing Unit 327 Child Sample 330 Parent Container Recovery Unit 340 Child Container Supply Unit 341 Child Container 350 Sorting Unit 370 Sample Storage Unit 374 Sample Container Transfer Unit 377 Bar Code reader 543 Dispensing nozzle 544 Nozzle tip 701 Control unit 702 Temperature control unit 703 Timing control unit 704 Capture control unit 710 Nozzle tip supply unit 711 Nozzle tip discharge unit

Claims (21)

Dispensing means for collecting and subdividing patient specimens at predetermined dispensing positions;
Sorting means for sorting the patient specimen subdivided by the dispensing means for shipping to a predetermined analyzer for analyzing the patient specimen;
In a dispensing device with
A storage unit for storing a standard sample for calibrating the analyzer and a quality control sample for statistical quality control of the analyzer;
Transfer means for transferring each of the standard sample and the quality control sample stored in the storage unit to the dispensing position;
Control means for controlling the transfer timing of the standard sample by the transfer means and the transfer timing of the quality control sample;
With
The dispensing means collects and subdivides the standard sample and the quality control sample transferred by the transfer means at the dispensing position,
The dispensing device performs sorting for shipping the standard sample and the quality control sample subdivided by the dispensing device to the analyzer.   The control means controls the transfer timing of the standard sample by the transfer means to a predetermined timing set in advance, and the timing of randomizing the transfer timing of the quality control sample by the transfer means within a statistical management unit The dispensing apparatus according to claim 1, wherein the dispensing apparatus is controlled as follows.   The dispensing apparatus according to claim 2, wherein the control unit performs control for interrupting the quality control sample into a patient sample transported to the dispensing position in the order of dispensing.   The control means includes the starting point of the statistical management unit, the replacement of the standard sample, the replacement of the quality control sample, the startup of the apparatus, or immediately after a measurement abnormality is detected by statistical quality control. The dispensing apparatus according to any one of claims 1 to 3, wherein the control unit controls the transfer unit to transfer the standard sample.   The dispensing device according to any one of claims 1 to 4, wherein the storage unit stores the standard sample and the quality control sample while maintaining a predetermined temperature.   The dispensing apparatus according to claim 1, wherein the container includes an insertion port for replacing or replenishing the standard sample and the quality control sample. A plug is attached to the sample container of the standard sample and the quality control sample stored in the storage unit,
The transfer means includes sample opening means for opening the stopper when transferring the standard sample and the quality control sample accommodated in the accommodating portion to the dispensing position, respectively. The dispensing device according to any one of claims 1 to 6. In the sample container of the standard sample and the quality control sample accommodated in the accommodating portion, an identification display for identifying the standard sample and the quality control sample is provided,
Further comprising reading means for reading the identification display,
The control means selects the standard sample and the quality control sample based on the identification display read by the reading means, and transfers the selected standard sample and the quality control sample to the transfer means. The dispensing apparatus according to any one of claims 1 to 7, wherein the dispensing apparatus is controlled so as to be controlled.   The dispensing means includes a nozzle that sucks and discharges the patient specimen or sample, a nozzle tip that is detachably attached to a tip of the nozzle, and a detaching means that detaches the nozzle tip. Item 9. The dispensing device according to any one of Items 1 to 8. In a dispensing device that dispenses a patient sample conveyed through a conveying means, and sends the patient sample after dispensing to the conveying means again in order to send the patient sample to a subsequent analyzer,
A storage unit for storing a standard sample for calibrating the analyzer and a quality control sample for statistical quality control of the analyzer;
Control means for controlling the timing for sending the standard sample to the transport means at a predetermined timing set in advance, and for controlling the timing for sending the quality control sample to the transport means to a timing that is randomized within a statistical management unit;
A dispensing device characterized by comprising: A dispensing step of collecting and subdividing patient specimens at predetermined dispensing positions;
A sorting step for sorting the patient sample subdivided in the dispensing step for shipping to a predetermined analyzer for analyzing the patient sample;
In a dispensing method including
The standard sample and the quality control sample are respectively dispensed from a storage unit that stores a standard sample for calibrating the analysis device and a quality control sample for statistical quality control of the analysis device. A transfer process for transferring to a position;
A control step for controlling the timing of the transfer of the standard sample by the transfer step and the timing of the transfer of the quality control sample, respectively;
Including
In the dispensing step, the standard sample and the quality control sample transferred in the transfer step are collected and subdivided at the dispensing position,
The dispensing method is characterized in that sorting is performed for shipping the standard sample and the quality control sample subdivided in the dispensing step to the analyzer.   The control step controls the transfer timing of the standard sample by the transfer step to a predetermined timing set in advance, and the timing of randomizing the transfer timing of the quality control sample by the transfer step within a statistical management unit The dispensing method according to claim 11, wherein the dispensing method is controlled as follows.   The dispensing method according to claim 12, wherein the control step performs a control to interrupt the sample for quality control into a patient sample that is transported to the dispensing position in the order of dispensing.   The control step includes the starting point of the statistical management unit, the replacement of the standard sample, the replacement of the quality control sample, the startup of the apparatus, or immediately after a measurement abnormality is detected by statistical quality control. The dispensing method according to claim 11, wherein the standard sample is controlled to be transferred in a transfer step. A plug is attached to the sample container of the standard sample and the quality control sample stored in the storage unit,
The transfer step includes a sample opening step of opening the stopper when the standard sample and the quality control sample stored in the storage portion are respectively transferred to the dispensing position. The dispensing method according to any one of claims 11 to 14. A barcode for identifying information related to the standard sample and the quality control sample is displayed on a sample container of the standard sample and the quality control sample stored in the storage unit,
Further comprising a reading step of reading the barcode;
The control step selects the standard sample and the quality control sample based on the barcode read by the reading step, and the selected standard sample and the quality control sample are selected in the transfer step. The dispensing method according to claim 11, wherein the dispensing method is controlled so as to be transferred. In the dispensing method of the dispensing device, which dispenses the patient sample conveyed through the conveying means, and sends the patient sample after dispensing to the conveying means again in order to send the patient sample to the subsequent analyzer,
The timing at which the standard sample is sent to the transport means from a storage unit that stores a standard sample for calibrating the analyzer and a quality control sample for statistical quality control of the analyzer is preset. And a control step of controlling the timing at which the quality control sample is sent to the transport means to a timing that is randomized within a statistical management unit.   A dispensing program that causes a computer to execute the dispensing method according to any one of claims 11 to 17. An input means for inputting a patient sample;
Dispensing means for dispensing the patient sample introduced by the introduction means;
Analyzing means for analyzing the patient sample dispensed by the dispensing means;
A collecting means for collecting the patient specimen analyzed by the analyzing means;
Transport means for transporting the patient specimen to each means;
In the specimen testing system equipped with
The dispensing means contains a standard sample for calibrating the analyzing means and a quality control sample for statistical quality control of the analyzing means, and dispenses the standard sample at a predetermined timing. And dispensing at the timing when the quality control sample is randomized,
The analysis means calibrates using the standard sample dispensed by the dispensing means and performs statistical quality control using the quality control sample dispensed by the dispensing means. Specimen testing system characterized by A loading process for loading patient specimens;
A dispensing step of dispensing the patient sample introduced in the loading step;
An analysis step of analyzing the patient specimen dispensed by the dispensing step;
A recovery step of recovering the patient specimen analyzed by the analysis step;
In the specimen testing method including
In the dispensing step, a standard sample for calibrating the analyzer is dispensed at a predetermined timing, and a quality control sample for statistical quality control of the analyzer is dispensed at a randomized timing. And
In the analysis step, calibration is performed using the standard sample dispensed in the dispensing step, and statistical quality control is performed using the quality control sample dispensed in the dispensing step. Specimen testing method characterized by performing.   A sample test program for causing a computer to execute the sample test method according to claim 20.

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