JP2007316013A - Autoanalyzer and specimen-dispensing method therefor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an autoanalyzer capable of accurately measuring the concentration of a blood corpuscle component, even if the times taken up to dispensing are different, and to provide a specimen-dispensing method therefor. <P>SOLUTION: The autoanalyzer is constituted so as to dispense a predetermined amount of a specimen, containing the blood corpuscle component housed in a specimen container by a dispenser 20 for making the same react with a reagent to perform analysis. The specimen-dispensing method for the autoanalyzer is also disclosed. The autoanalyzer 1 includes a memory part 15b for storing changes in the concentrations of the blood corpuscle components with the elapse of time, a clocking part 15a for clocking the elapse time, after the specimen has been mounted in the autoanalyzer and a position control part 15c for controlling the suction position in the vertical direction of the specimen, during dispensing by the dispenser 20. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an automatic analyzer and a sample dispensing method thereof.

  Conventionally, hemoglobin A1c (HbA1c) has been used as a diagnostic marker for diabetes. In an automatic analyzer, a certain amount of a sample (blood) containing blood cell components collected from a subject is dispensed, and a reagent, for example, It is measured as a ratio (%) to the total hemoglobin (T-Hb) from the concentration of total hemoglobin (T-Hb) and the concentration of hemoglobin A1c obtained from the absorbance of the hemolyzed sample in which the blood cell component was hemolyzed by adding the treatment solution. (For example, refer to Patent Document 1). Here, if a specimen containing a blood cell component is left after collection, the blood cell component settles and separates into a plasma component and a blood cell component. For this reason, usually, a specimen containing blood cell components avoids sedimentation of the blood cell components by performing a process such as inversion mixing until the sample is dispensed into the reaction container after collection.

JP 2000-46843 A

  By the way, an automatic analyzer for analyzing a sample (blood) containing blood cell components holds a so-called sample container made up of a blood collection tube from which a sample is collected and a tube into which blood is divided from the blood collection tube. Analyze the sample sequentially while transporting the sample. For this reason, the specimen containing the blood cell component is retained in the rack, transported to the dispensing position, and dispensed into the reaction container, so that the blood cell component settles and a concentration gradient is generated in the vertical direction. As a result, the automatic analyzer has the same position because the position at which the sample is dispensed is fixed if the time until the dispensing nozzle dispenses the sample differs after the rack holding the sample container is set. Even for a specimen, there is a problem that the concentration of blood cell components cannot be measured accurately due to the concentration gradient caused by sedimentation of blood cell components. In this case, it is conceivable to vibrate the specimen container to suppress sedimentation of blood cell components. However, if the automatic analyzer is provided with a vibration device, it is not preferable because the device becomes complicated and large.

  The present invention has been made in view of the above, and provides an automatic analyzer capable of accurately measuring the concentration of blood cell components even when the time until dispensing differs, and a sample dispensing method thereof With the goal.

  In order to achieve the above object, an automatic analyzer according to claim 1 is an automatic analyzer that dispenses a predetermined amount of a sample containing a blood cell component contained in a sample container by a dispensing device and reacts with a reagent for analysis. In the apparatus, storage means for storing the concentration change of the blood cell component with time, time measuring means for measuring the elapsed time after mounting the sample on the automatic analyzer, and the elapsed time measured by the time measuring means are also included. And a position control means for controlling the suction position of the specimen in the vertical direction when dispensing by the dispensing device.

  The automatic analyzer according to claim 2 further comprises storage means for previously storing a change in concentration of the blood cell component over time in the invention described above, and the position control means is a time measured by the time measuring means. The suction position is controlled based on time and a change in density over time stored in the storage means.

  According to a third aspect of the present invention, there is provided the automatic analyzer according to the above invention, wherein the first detection means for detecting the mounting of the sample on the automatic analyzer and outputting to the time measuring means, and the dispensing of the sample. Second detection means for detecting movement to the dispensing position by the device and outputting to the time measurement means, the time measurement means based on information input from the first and second detection means And measuring the elapsed time.

  In order to achieve the above object, the sample dispensing method of the automatic analyzer according to claim 4 dispenses a predetermined amount of a sample containing a blood cell component contained in a sample container with a dispensing device, A sample dispensing method for an automatic analyzer that performs reaction and analysis, the storage step storing a change in concentration of blood cell components over time, and the elapsed time after mounting the sample on the automatic analyzer And a position control step of controlling a suction position in the vertical direction of the specimen during dispensing by the dispensing device based on the elapsed time.

  According to a fifth aspect of the present invention, the sample dispensing method of the automatic analyzer further includes a storage step of previously storing a change in concentration of the blood cell component over time, in the above invention, The suction position is controlled based on time and the concentration change over time.

  In the automatic analyzer of the present invention, based on the elapsed time measured by the time measuring means, the position control means controls the suction position of the specimen in the vertical direction during dispensing by the dispensing apparatus, and the automatic analysis of the present invention. Since the dispensing method of the device controls the suction position in the vertical direction of the specimen during dispensing by the dispensing device based on the elapsed time in the position control step, even if the time to dispensing is different, The effect of providing an automatic analyzer capable of accurately measuring the concentration of a blood cell component by dispensing a sample having a predetermined concentration corresponding to the change in concentration of the blood cell component over time, and a sample dispensing method thereof. Play.

  Exemplary embodiments of an automatic analyzer and a dispensing method thereof according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a schematic configuration diagram of an automatic analyzer according to the present invention. FIG. 2 is a block diagram showing a schematic configuration of a sample dispensing apparatus used in the automatic analyzer of FIG.

  The automatic analyzer 1 is a device that automatically analyzes a sample such as blood or urine containing blood cell components. As shown in FIG. 1, the reagent tables 2 and 3, the cuvette wheel 4, the sample container transfer mechanism 8, the analysis optical system. 11, a cleaning mechanism 12, a first stirring device 13 and a second stirring device 14, a control unit 15, and a sample dispensing device 20.

  As shown in FIG. 1, each of the reagent tables 2 and 3 includes a plurality of reagent containers 2a for the first reagent and a plurality of reagent containers 3a for the second reagent arranged in the circumferential direction. The reagent containers 2a and 3a are rotated by driving means. Transport in the circumferential direction. Each of the plurality of reagent containers 2a and 3a is filled with a reagent containing a pretreatment liquid that hemolyzes blood cell components in accordance with the test item, and information on the type, lot, and expiration date of the stored reagent is recorded on the outer surface. A recording medium (not shown) is added. Here, on the outer periphery of the reagent tables 2 and 3, a reading device that reads the reagent information recorded on the information recording medium added to the reagent containers 2 a and 3 a and outputs it to the control unit 15 is installed.

  As shown in FIG. 1, the cuvette wheel 4 has a plurality of reaction vessels 5 arranged in the circumferential direction, and is rotated in a direction indicated by an arrow by a driving means different from the driving means for driving the reagent tables 2 and 3. Then, the reaction vessel 5 is moved in the circumferential direction. The cuvette wheel 4 is disposed between the light source 11a and the spectroscopic unit 11b, and has a holding unit 4a that holds the reaction vessel 5 and an optical path 4b that includes a circular opening that guides the light beam emitted from the light source 11a to the spectroscopic unit 11b. is doing. The holding portions 4a are arranged on the outer periphery of the cuvette wheel 4 at predetermined intervals along the circumferential direction, and an optical path 4b extending in the radial direction is formed on the inner peripheral side of the holding portion 4a.

  The reaction vessel 5 is an optically transparent material that transmits 80% or more of the light contained in the analysis light (340 to 800 nm) emitted from the analysis optical system 11, such as glass containing heat-resistant glass, cyclic olefin, and polystyrene. It is a container called a cuvette formed into a square cylinder shape by the like. In the reaction container 5, the reagent is dispensed from the reagent containers 2a and 3a of the reagent tables 2 and 3 by the reagent dispensing devices 6 and 7 provided in the vicinity. Here, each of the reagent dispensing devices 6 and 7 is rotated in a horizontal plane, and nozzles 6b and 7b for dispensing the reagent are provided on arms 6a and 7a that are moved up and down in the vertical direction. , 7b.

  As shown in FIG. 1, the specimen container transfer mechanism 8 transfers the plurality of arranged racks 9 while stepping one by one along the arrow direction. The rack 9 holds a plurality of sample containers 9a that store samples. Here, the sample container 9a is affixed with a bar code or the like on which information on the stored sample is affixed, and every time the advance of the rack 9 transported by the sample container transport mechanism 8 stops, Is dispensed into each reaction vessel 5.

  Here, as shown in FIG. 1, the sample container transfer mechanism 8 is configured to mount the sample container 9 a held and mounted on the rack 9 on the automatic analyzer 1 and transport the sample container 9 a to the sample dispensing apparatus 20. Reading devices 10 </ b> A and 10 </ b> B are provided as first and second detection means that read from the bar code or the like and output to the timer unit 15 a of the control unit 15.

  The analysis optical system 11 is an optical system for performing analysis by transmitting analysis light (340 to 800 nm) through the liquid sample in the reaction vessel 5 in which the reagent and the sample have reacted. As shown in FIG. , A spectroscopic unit 11b and a light receiving unit 11c. The analysis light emitted from the light source 11a passes through the liquid sample in the reaction vessel 5 and is received by the light receiving unit 11c provided at a position facing the spectroscopic unit 11b. The light receiving unit 11 c is connected to the control unit 15.

  The cleaning mechanism 12 sucks and discharges the liquid sample in the reaction vessel 5 by the nozzle 12a, and then repeatedly injects and sucks a cleaning liquid such as detergent and cleaning water by the nozzle 12a, thereby performing analysis by the analysis optical system 11. The reaction vessel 5 that has been completed is washed.

  The first stirrer 13 and the second stirrer 14 stir the dispensed specimen and reagent with the stirrers 13a and 14a and cause them to react.

  The control unit 15 includes the reagent tables 2 and 3, the reagent dispensing devices 6 and 7, the sample container transfer mechanism 8, the analysis optical system 11, the cleaning mechanism 12, the stirring devices 13 and 14, the input unit 16, the display unit 17, and the sample distribution. It is connected to the injection device 20 and the like to control the operation of these parts, and a microcomputer or the like is used. The control unit 15 obtains the absorbance for each wavelength of the liquid sample in each reaction vessel 5 based on the light amount signal for each wavelength input from the light receiving unit 11c, and analyzes the component concentration and the like of the specimen. In addition, the control unit 15, based on information read from the information recording medium added to the reagent containers 2 a and 3 a, the automatic analyzer 1 so as to stop the analysis work when the reagent lot is different or when the expiration date is out of date. Or alert the operator. And the control part 15 is provided with the time measuring part 15a, the memory | storage part 15b, and the drive mechanism control part 15c, as shown in FIG.

  The time measuring unit 15a measures the elapsed time from the information input from the reading devices 10A and 10B until the sample container 9a is mounted on the sample container transfer mechanism 8 and then conveyed to the sample dispensing device 20, and the sample container The time information for each 9a is output to the storage unit 15b. The storage unit 15b stores in advance the temporal concentration change (see FIG. 4) of the reference concentration R1 of the blood cell component, and based on the time information input from the time measuring unit 15a and the temporal concentration change, A sample suction position by the dispensing nozzle 20b is set for each sample container 9a. The storage unit 15b outputs information related to the sample aspiration position for each sample container 9a set in this way to the drive mechanism control unit 15c. In this case, the change over time of the reference concentration R1 of the blood cell component shown in FIG. 4 is measured in advance for each measurement target of the blood cell component, and is input to the storage unit 15b as an average graph. The drive mechanism control unit 15c controls the raising / lowering operation and the rotation operation of the arm 20a by the drive mechanism 22, but based on the information on the sample aspiration position for each sample container 9a input from the storage unit 15b, The vertical movement of the sample held in the sample container 9a by the dispensing nozzle 20b when the sample is dispensed by the sample dispensing device 20 is controlled by controlling the lifting operation.

  The input unit 16 is a part that performs an operation of inputting an inspection item or the like to the control unit 15, and for example, a keyboard, a mouse, or the like is used. The display unit 17 displays analysis contents, analysis results, alarms, or the like, and a display panel or the like is used.

  As shown in FIG. 2, the sample dispensing device 20 is provided with a dispensing nozzle 20 b that dispenses a sample to an arm 20 a that is driven by a drive mechanism 22. The arm 20 a is supported by a support column 21 that is driven to rotate up and down by a drive mechanism 22. A liquid level detection electrode 23 connected to the liquid level detection unit 24 is attached to the dispensing nozzle 20b. The liquid level detection unit 24 electrically detects the liquid level of the sample S held in the sample container 9a by a current that changes when the liquid level detection electrode 23 touches the liquid level.

  In the automatic analyzer 1 configured as described above, the reagent dispensing device 6 sequentially dispenses the first reagent from the reagent container 2a to the plurality of reaction containers 5 conveyed along the circumferential direction by the rotating cuvette wheel 4. Note. In the reaction container 5 into which the first reagent has been dispensed, the specimen is sequentially dispensed from the plurality of specimen containers 9 a held in the rack 9 by the specimen dispensing apparatus 20. The reaction container 5 into which the sample has been dispensed is stirred by the first stirring device 13 each time the cuvette wheel 4 is stopped, and the first reagent reacts with the sample. The reaction container 5 in which the first reagent and the sample are stirred is sequentially stirred by the second stirring device 14 when the cuvette wheel 4 is stopped after the second reagent is sequentially dispensed from the reagent container 3a by the reagent dispensing device 7. Further reaction is promoted. Here, depending on the sample to be analyzed, both the first reagent and the second reagent are not necessarily dispensed, and either one of them may be present.

  Next, when the cuvette wheel 4 is rotated again, the reaction vessel 5 sequentially moves relative to the light source 11 a and the reaction vessel 5 passes through the analysis optical system 11. Thereby, the light receiving unit 11 c outputs an optical signal to the control unit 15. The control unit 15 obtains the absorbance for each wavelength of the liquid sample in each reaction vessel 5 based on the light amount signal for each wavelength input from the light receiving unit 11c, and analyzes the component concentration and the like of the specimen. At this time, the control unit 15 stores the analysis result such as the component concentration of the analyzed sample, and displays the analysis result on the display unit 17. Thus, after the analysis is completed, the reaction vessel 5 is washed by the washing mechanism 12 and then used again for analyzing the specimen.

  Here, in the specimen (blood) collected in the specimen container 9a, blood cell components are precipitated with time. FIG. 3 shows a state in which blood cell components of the sample S collected in the sample container 9a are sedimented. Since the specific gravity of the blood cell component is larger than that of the plasma component in the sample S, as shown in FIG. 3, even when the blood cell component is uniformly distributed in the plasma at the time of collection, the blood cell component settles with time. However, the upper layer part of the sample S has a thin blood cell component, and the lower layer part of the sample S becomes thicker.

  FIG. 4 is a schematic diagram showing the change over time of the reference concentration R1 (upper limit Lu, lower limit Ll) of the blood cell component resulting from such sedimentation of the blood cell component in the reaction vessel. In the sample (blood), as shown in FIG. 4, blood cell components settle with time. For this reason, in the blood cell component, a region having a concentration R0 lower than the reference concentration R1 expands from the upper layer to the lower layer with time, and a region having a concentration R2 higher than the reference concentration R1 expands from the lower layer to the upper layer. However, even if the concentration gradient of the blood cell component is generated in the vertical direction due to sedimentation over time, the sample S is dispensed without being affected by sedimentation if the reference concentration R1 is within the range between the upper limit Lu and the lower limit Ll. be able to. Therefore, the automatic analyzer 1 stores the elapsed time of the reference concentration R1 of the blood cell component shown in FIG. 4 in the storage unit 15b, and the elapsed time measured by the time measuring unit 15a and the storage unit 15b in advance. The sample S having the reference concentration R1 can be always dispensed by arranging the dispensing nozzle 20b at an appropriate depth based on the stored concentration change over time shown in FIG.

  On the premise of the relationship between the sedimentation of the blood cell component and the reference concentration, the control unit 15 uses the automatic analyzer 1 to analyze the hemoglobin A1c (HbA1c) of the blood cell component contained in the blood collected from the subject. A dispensing method according to the present invention, in which the suction position of the specimen in the vertical direction by the dispensing nozzle 20b is controlled by controlling the raising / lowering operation of the arm 20a by the drive mechanism 22, will be described below. FIG. 5 is a flowchart showing the control operation of the control unit 15.

  First, when the switch of the automatic analyzer 1 is turned on and the specimen (blood) analysis mode is set, the control unit 15 causes the tip of the dispensing nozzle 20b to enter from the liquid surface of the specimen (blood) to perform dispensing. The aspiration position of the sample to be performed is initially set (step S101). In this case, the initial setting of the sample aspiration position is based on the average time until the sample is dispensed by the sample dispensing device 20 after the rack 9 is mounted on the sample container transfer mechanism 8. 15b is set from the change in density over time shown in FIG.

  Next, when the rack 9 is mounted on the sample container transfer mechanism 8, the control unit 15 causes the time measuring unit 15a to measure time for each sample container 9a according to information input from the reading device 10A that reads the barcode of the sample container 9a. Is started (step S102). At this time, the rack 9 mounted on the sample container transfer mechanism 8 reads the barcode of the sample container 9a, holds the sample container 9a, and is sequentially transported to the sample dispensing apparatus 20 side.

  Next, according to information input from the reading device 10B that reads the barcode of each sample container 9a held in the transported rack 9, the control unit 15 causes each sample container 9a to be automatically analyzed via the rack 9. The time elapsed after being attached to 1 and being read by the reading device 10B is measured by the timer unit 15a (step S103). At this time, the control unit 15 may count the elapsed time by measuring the time when the sample dispensing apparatus 20 dispenses the sample in the sample container 9a into the reaction container 5 by the time measuring unit 15a. If the time is counted, the elapsed time can be timed more accurately.

  Thereafter, the control unit 15 starts the tip of the dispensing nozzle 20b from the liquid level of the sample (blood) from the elapsed time measured for each sample container 9a based on the change in concentration over time shown in FIG. The aspiration position of the specimen is read (step S104). At this time, if the read-out position of the sample coincides with the initially set position, the control unit 15 causes dispensing to be performed at this position. On the other hand, when the sample suction position read by the storage unit 15b does not coincide with the initially set position, the control unit 15 corrects the position of the dispensing nozzle 20b (step S105). When correcting the position of the dispensing nozzle 20b, there are a case where the position is changed above the initially set specimen suction position and a case where the position is changed below the initially set specimen suction position.

  That is, when the elapsed time after mounting the sample container 9a to the sample container transfer mechanism 8 via the rack 9 is long, the sedimentation amount of the blood cell component is large, so that the blood cell component is below the reference concentration R1 at the initial setting position. It has become. Therefore, the control unit 15 lowers the dispensing nozzle 20b to the sample aspiration position read by the storage unit 15b by the drive mechanism unit 15c. On the other hand, when the elapsed time is short, the sedimentation amount of the blood cell component is small, so that the blood cell component is equal to or higher than the reference concentration R1 at the initial position. For this reason, the control part 15 raises the dispensing nozzle 20b to the suction position of the sample which the memory | storage part 15b read by the drive mechanism part 15c.

  Then, after correcting the sample aspiration position, the control unit 15 dispenses the sample at the corrected aspiration position (step S106), and the sample dispensing method of the present invention ends.

  In the sample dispensing method of the automatic analyzer 1, the control unit 15 controls the suction position of the sample in the vertical direction based on the elapsed time after the sample is mounted on the sample container transfer mechanism 8 in this way. For this reason, the automatic analyzer 1 can dispense the reference concentration sample in consideration of the concentration gradient of the blood cell component even if the elapsed time after the sample is mounted on the sample container transfer mechanism 8 is different. It becomes possible to accurately measure the concentration of blood cell components. For this reason, the automatic analyzer 1 can stabilize the measurement accuracy of the blood cell component and increase the reliability of the measurement result. Further, the automatic analyzer 1 can continuously analyze a large number of samples (blood) because the operator does not need to mix the samples (blood) manually even when the sedimentation of blood cell components has started. .

  When the sample is dispensed at the new sample suction position with the position of the dispensing nozzle 20b corrected, when the concentration R of the hemolyzed sample deviates from the reference concentration R1, the control unit 15 again The sample may be dispensed by correcting the position of the dispensing nozzle 20b by the sample dispensing method described above, and the concentration R of the hemolyzed sample may be measured again.

  Moreover, although the above-mentioned embodiment demonstrated the case where hemoglobin A1c was measured as a blood cell component, if it is a measurement of the blood cell component which receives the influence of the sedimentation resulting from the difference in time to dispensing, it will be other than hemoglobin A1c. For example, it can be applied to the measurement of red blood cells (including hemoglobins A1a and A1b), white blood cells or platelets.

  On the other hand, although the automatic analyzer of the present invention has been described with respect to the case where two reagent dispensing devices are provided, the number of reagent dispensing devices may be one. Moreover, the automatic analyzer of the present invention may be configured by combining a plurality of units with the automatic analyzer 1 as one unit.

It is a schematic block diagram of the automatic analyzer of this invention. It is a block diagram which shows schematic structure of the sample dispensing apparatus used with the automatic analyzer of FIG. It is a schematic diagram which shows a mode that the blood cell component contained in the sample (blood) extract | collected in the sample container precipitates. It is a schematic diagram which shows the time change of the reference | standard density | concentration resulting from sedimentation of the blood cell component contained in a test substance (blood). It is a flowchart which shows the procedure of the dispensing operation | movement concerning embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 2,3 Reagent table 4 Cuvette wheel 5 Reaction container 6,7 Reagent dispensing apparatus 8 Specimen container transfer mechanism 9 Rack 9a Specimen container 10A Reading apparatus 10B Reading apparatus 11 Analytical optical system 12 Washing mechanism 13,14 Stirring apparatus DESCRIPTION OF SYMBOLS 15 Control part 15a Time measuring part 15b Memory | storage part 15c Drive mechanism control part 16 Input part 17 Display part 20 Sample dispensing apparatus 21 Support | pillar 22 Drive mechanism 23 Liquid level detection electrode 24 Liquid level detection part

Claims (5)

In an automatic analyzer that dispenses a predetermined amount of a specimen containing blood cell components contained in a specimen container with a dispensing apparatus and reacts with a reagent for analysis,
Storage means for storing concentration change of the blood cell component over time;
A time measuring means for measuring the elapsed time after mounting the sample on the automatic analyzer;
Position control means for controlling the suction position in the vertical direction of the specimen during dispensing by the dispensing device, based on the elapsed time counted by the timing means;
An automatic analyzer characterized by comprising: Furthermore, the storage means for storing in advance the concentration change over time of the blood cell component,
The said position control means controls the said suction position based on the elapsed time which the said time measuring means time-measured, and the time-dependent density | concentration change which the said memory | storage means memorize | stored. Automatic analyzer. First detecting means for detecting the mounting of the sample on the automatic analyzer and outputting to the time measuring means;
Second detection means for detecting movement of the specimen to the dispensing position by the dispensing device and outputting to the timing means;
With
2. The automatic analyzer according to claim 1, wherein the time measuring unit measures the elapsed time based on information input from the first and second detection units. A sample dispensing method for an automatic analyzer that dispenses a predetermined amount of a sample containing blood cell components contained in a sample container with a dispensing device and reacts with a reagent for analysis.
A storage step of storing a change in concentration of the blood cell component over time;
A time measuring step for measuring an elapsed time after mounting the sample on the automatic analyzer;
Based on the elapsed time, a position control step for controlling the suction position in the vertical direction of the specimen at the time of dispensing by the dispensing device;
A sample dispensing method for an automatic analyzer characterized by comprising: Furthermore, a storage step of storing in advance the concentration change over time of the blood cell component,
5. The sample dispensing method for an automatic analyzer according to claim 4, wherein the position control step controls the suction position based on the elapsed time and the concentration change with time.

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