Analysis device
By combining optical and electrical assay units in the analysis device and optimizing the overlap of sample modulation and measurement time, the problems of low red blood cell assay accuracy and insufficient flux in the prior art are solved, and more efficient and more accurate subject analysis is achieved.
Patent Information
- Application Number
- CN202411245042.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-15
- Filing Date
- 2024-09-06
- Publication Date
- 2025-03-18
AI Technical Summary
The existing analytical devices use flow cytometers based on optical assays in red blood cell assays, resulting in low measurement accuracy and insufficient flux of red blood cells.
An analysis device is designed, using a plurality of sample modulation units and a measurement unit to realize multi-stage analysis of the subject through the combination of optical and electrical measurement units, and to increase the analysis throughput by controlling the overlap time of sample modulation and measurement.
Improve the flux of subject analysis and the accuracy of red blood cell assays, achieving more efficient sample processing and more accurate results.
Smart Images

Figure CN119643417A_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an analyzing device for analyzing a subject. [Background technology]
[0002] Non-patent document 1 describes an analysis device for measuring and classifying cells in a blood test subject. This analysis device has two systems of mechanisms for mixing a test subject and a reagent to prepare a measurement sample. The two systems of mechanisms each have a container for preparing a measurement sample for red blood cell (RBC) measurement and a container for preparing a measurement sample for white blood cell (WBC) measurement. The measurement sample for red blood cell measurement and the measurement sample for white blood cell measurement are measured together using a flow cytometer. In this analysis device, by having two systems of mechanisms for modulating measurement samples, sample modulation in the other mechanism can be performed while sample modulation and measurement in one mechanism are being performed, resulting in an increase in the throughput of the analysis device.
[0003] The results of comparing the accuracy of red blood cell measurement by optical measurement and electrical measurement are disclosed in Non-Patent Document 2. Non-Patent Document 2 shows that the accuracy of red blood cell measurement is higher than that of electrical measurement.
[0004] [Prior art literature]
[0005] [Patent Literature]
[0006] [Non-patent document 1] Gabriella Lakos, "Calibration and QC Guidance for the Abbott Alinity hq Hematology Analyzer", (USA), Abbott
[0007] [Non-patent document 2] Yutaka Nagai, "Research on the Nucleated Cell Microstructure Analysis Method for Light Scattering Measuring and Analysis", October 2006
[0008] [Summary of the Invention]
[0009] [Problems to be solved by the invention]
[0010] The analysis device of Non-Patent Document 1 improves throughput by providing a two-system sample preparation mechanism. However, since a flow cytometer based on optical measurement is used for the measurement of red blood cells, the measurement accuracy of red blood cells is inferior to that of electrical measurement.
[0011] In view of the above problems, the present invention aims to provide an analysis device capable of improving the throughput of subject analysis and the measurement accuracy of red blood cells.
[0012]
Methods for solving the problem
[0013] The analyzing device (1) of the present invention relates to an analyzing device for analyzing a subject. The analyzing device (1) of the present invention comprises a first and a second sample preparing section (C21, C22) for preparing a first measurement sample from a subject using a first reagent, a third sample preparing section (C11) for preparing a second measurement sample from a subject using a second reagent, an optical measuring section (381) for measuring the first measurement sample to obtain an optical signal corresponding to white blood cells, an electrical measuring section (382) for measuring the second measurement sample to obtain an electrical signal corresponding to red blood cells, an analyzing section (851) and a control section (852) for analyzing the subject based on the optical signal and the electrical signal. The control unit (852) controls the modulation of the samples in the first and second sample modulation units (C21, C22) and the measurement by the optical measurement unit (381) in response to a plurality of measurement orders, including at least a portion of a period during which the first measurement sample is modulated by the first sample modulation unit (C21) and the first measurement sample modulated in the first sample modulation unit (C21) is measured by the optical measurement unit (381), and at least a portion of a period during which the first measurement sample is modulated by the second sample modulation unit (C22) and the first measurement sample modulated in the second sample modulation unit (C22) is measured by the optical measurement unit (381) overlaps.
[0014] The analyzer of the present invention has a plurality of sample preparation units for preparing the measurement sample to be measured by the optical measurement unit, so that at least a portion of the period for sample preparation and measurement can be repeated. This can improve the throughput of the subject analysis. Furthermore, since the electrical measurement unit is used in the measurement of red blood cells, the accuracy of the red blood cell measurement can be improved.
[0015] [Effects of the Invention]
[0016] The present invention can improve the throughput of subject analysis and the determination accuracy of red blood cells.
[0017] [Brief description of the attached drawings]
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[0047] Figure 1 1 is a perspective view showing the structure of the analyzing device 1. Figure 1 In the middle, the directions of up, down, left, right, front and back are displayed.
[0048] The analyzer 1 is a blood cell counting device that measures white blood cells, red blood cells, platelets, etc. contained in a subject and counts each blood cell. The subject is whole blood collected from a test subject. The analyzer 1 includes a measuring unit 10, a transport unit 20, and an analyzing unit 30.
[0049] The measuring unit 10 measures blood cells contained in a subject. Various components for measuring a subject are accommodated in a housing 11 of the measuring unit 10. The transport unit 20 is disposed on the front side of the measuring unit 2 and transports a sample rack 100 holding a plurality of sample containers 110.
[0050] Figure 2 It is a perspective view showing the structure of the sample rack 100 and the sample container 110.
[0051] The sample rack 100 includes ten holes 101 capable of holding sample containers 110 and a barcode label 102. The barcode label 102 is attached to the rear surface of the sample rack 100. On the barcode label 102, a barcode indicating a rack ID for individually identifying the sample rack 100 is printed.
[0052] The specimen container 110 includes a body 111, a barcode label 112, and a cover 113. The body 111 is a tubular container with an open upper end, and contains a specimen inside. The barcode label 112 is attached to the side of the body 111. A barcode indicating a specimen ID that can individually identify the specimen inside is printed on the barcode label 112. The cover 113 is provided at the upper end of the body 111 in a manner that seals the inside of the body 111. The cover 113 includes a suction tube 351 (see FIG. 1 ) provided in the measuring unit 10. Figure 4 ) Elastic material that can penetrate up and down.
[0053] return Figure 1 The transport unit 20 transports the sample rack 100 and supplies the sample container 110 held in the sample rack 100 to the measurement unit 2. The measurement unit 10 takes out the sample container 110 from the sample rack 100 and transfers the taken-out sample container 110 into the housing 11. The measurement unit 10 measures the sample in the sample container 110 and returns the sample container 110 after the measurement to the sample rack 100.
[0054] The analysis unit 30 performs analysis including blood cell counting based on the measurement results obtained by the measurement unit 10, and generates analysis results. The analysis results include, for example, numerical results based on the analysis, coordinate graphs, diagrams, and marker information given to the subject. The analysis unit 30 includes a display unit 31 and an input unit 32. The display unit 31 displays the analysis results, etc., and the input unit 32 receives input from the operator.
[0055] Figure 3 It is a plan view schematically showing the structure of the transport unit 20 .
[0056] The transport unit 20 includes a loading area 210 , a transport path 220 , a collection area 230 , and a reading mechanism 240 .
[0057] The operator sets the sample container 110 containing the sample to be analyzed in the hole 101 of the sample rack 100, and loads the sample rack 100 with the sample container 110 set in the loading area 210. The loading area 210 is provided with a conveying mechanism 211 for pushing the sample rack 100 backward. The conveying mechanism 211 includes a pair of members for pressing the front of the sample rack 100. The sample rack 100 pushed backward by the conveying mechanism 211 is located at the right end of the conveying path 220.
[0058] The conveying path 220 includes two conveyor belts 221 and 222 that move independently in the left-right direction. The conveyor belts 221 and 222 transfer the sample rack 100 located at the right end of the conveying path 220 to a designated position of the conveying path 220. The reading mechanism 240 includes a roller 241, a pair of rollers 242, a barcode reader 243, a mechanism for rotating the roller 241, and a mechanism for moving the pair of rollers 242 in the front-rear direction. The reading mechanism 240 reads the rack ID and the sample ID from the sample rack 100 and the sample container 110 on the conveying path 220. The structure of the reading mechanism 240 is similar to that of the reading mechanism 340 described later (see Figure 4 )same.
[0059] The transport path 220 is provided with a take-out position P1 for the measuring unit 10 to take out the sample container 110. When the sample container 110 is located at the take-out position P1, the measuring unit 10 takes out the sample container 110 from the sample rack 100, and takes the taken-out sample container 110 into the measuring unit 10, aspirates the sample in the sample container 110, mixes the aspirated sample with a reagent to prepare a measurement sample, measures the measurement sample, and obtains a measurement result. Thereafter, the analysis unit 30 analyzes the sample based on the measurement result. When the measuring unit 10 completes aspiration of the taken-in sample container 110, the sample container 110 is returned to the original hole 101 of the sample rack 100. When the necessary analysis of all the sample containers 110 held in the sample rack 100 is completed, the sample rack 100 is transported to the left end of the transport path 220.
[0060] The collection area 230 is provided with a conveying mechanism 231 for pushing out the sample rack 100 forward. The conveying mechanism 231 includes a member for pressing down the rear of the sample rack 100. The sample rack 100 located at the left end of the conveying path 220 is pushed out forward by the conveying mechanism 231 and collected in the collection area 230. The operator takes out the sample rack 100 collected in the collection area 230. Thus, the conveying of the sample rack 100 and the analysis of the sample held in the sample container 110 of the sample rack 100 are completed.
[0061] Figure 4 It is a plan view schematically showing the configuration inside the housing 11 of the measurement unit 10 .
[0062] The measurement unit 10 includes a holding mechanism 310 , a stirring mechanism 320 , a container transfer mechanism 330 , a reading mechanism 340 , a dispensing mechanism 350 , an RBC / PLT reaction chamber C11 , an HGB reaction chamber C12 , and a reaction chamber heating unit 400 .
[0063] The holding mechanism 310 includes a pair of holding pieces 311 for holding the sample container 110 from the front-back direction, a mechanism for moving the pair of holding pieces 311 in the direction of approaching and separating from each other, and a mechanism for moving the pair of holding pieces 311 in the vertical direction. The holding mechanism 310 is arranged on the conveying path 220 (see Figure 3 ) is located above the removal position P1. An opening 11a is formed on the lower surface of the housing 11 so that the pair of holding pieces 311 can move up and down relative to the lower surface of the housing 11.
[0064] The holding mechanism 310 holds the sample container 110 located at the removal position P1 by using the pair of holding pieces 311 , and moves the pair of holding pieces 311 upward to remove the sample container 110 from the sample rack 100 and to be located above the removal position P1 .
[0065] The stirring mechanism 320 includes a holding portion 321, a sliding portion 322, and a mechanism for driving the holding portion 321 and the sliding portion 322. The holding portion 321 includes a holding member 321a that forms a hole capable of holding the sample container 110, a roller 321b that can move in the left and right directions, and a rotating shaft 321c that extends in the front and rear directions. The sliding portion 322 is configured to support the lower portion of the holding portion 321 and can move in the left and right directions. The holding portion 321 is configured to be rotatable around the rotating shaft 321c.
[0066] When the holding mechanism 310 takes out the sample container 110 at the taking-out position P1 from the sample rack 100 and moves it upward, the stirring mechanism 320 moves the sliding part 322 in the left direction to position the holding member 321a below the sample container 110. In this state, the holding mechanism 310 moves the pair of holding pieces 311 in the downward direction to place the sample container 110 held by the holding pieces 311 in the holding member 321a. Next, the stirring mechanism 320 moves the sliding part 322 in the right direction to position the sample container 110 held in the holding member 321a at the stirring position P2. Furthermore, the stirring mechanism 320 moves the roller 321b in the left direction to make the sample container 110 stationary in the holding member 321a. In this state, the stirring mechanism 320 stirs the sample in the sample container 110 held in the holding member 321a by rotating the holding member 321 around the rotation axis 321c.
[0067] The container transfer mechanism 330 includes a holding member 331 having a hole formed therein for holding the sample container 110 , a plate member 332 extending in the front-rear direction to support the holding member 331 , and a mechanism for moving the plate member 332 in the front-rear direction.
[0068] When the stirring of the sample container 110 is completed, the stirring mechanism 320 positions the sample container 110 held by the holding member 321a above the removal position P1 again, and the gripping mechanism 310 takes the sample container 110 upward from the holding member 321a. In this state, the stirring mechanism 320 retracts the holding portion 321 and the sliding portion 322 to the right, and the container transfer mechanism 330 positions the holding member 331 below the sample container 110. Furthermore, the gripping mechanism 310 sets the sample container 110 to the holding member 331 by moving the pair of gripping pieces 311 downward. Thereafter, the container transfer mechanism 330 positions the sample container 110 held by the holding member 331 at the reading position P3 of the reading mechanism 340.
[0069] The reading mechanism 340 includes a roller 341 , a pair of rollers 342 , a barcode reader 343 , a mechanism for rotating the roller 341 , and a mechanism for moving the pair of rollers 342 in the left-right direction.
[0070] When the sample container 110 is located at the reading position P3, the reading mechanism 340 moves the pair of rollers 342 to the left, and the sample container 110 is sandwiched between the roller 341 and the pair of rollers 342. Next, the reading mechanism 340 rotates the sample container 110 by the rotation of the roller 341, and reads the sample ID from the sample container 110 by the barcode reader 343. The reading mechanism 240 provided in the conveying path 220 is also configured similarly to the reading mechanism 340. Thereafter, the container transfer mechanism 330 positions the sample container 110 held by the holding member 331 at the suction position P4 of the dispensing mechanism 350.
[0071] The dispensing mechanism 350 includes a suction tube 351 with high rigidity extending in the vertical direction, a cleaning device 352 for cleaning the suction tube 351, a transfer unit 353 for transferring the suction tube 351 in the vertical direction and the horizontal direction, and a liquid transfer unit 354 for sucking and discharging the sample through the suction tube 351 (see Figure 7 The suction tube 351 is used to suck the sample from the sample container 110 at the suction position P4 and to dispense the sucked sample.
[0072] When the sample container 110 is at the suction position P4, the lower end of the suction tube 351 of the dispensing mechanism 350 penetrates the cover 113 of the sample container 110 (see Figure 2 ) to move the suction tube 351 downward. At this time, the lower end of the suction tube 351 is located at a predetermined distance below the liquid surface in the sample container 110. In this state, the dispensing mechanism 350 sucks the sample in the sample container 110 through the suction tube 351.
[0073] The reaction chamber heating unit 400 includes WDF reaction chambers C21 and C22, a WNR reaction chamber C23, and a RET / PLT-F reaction chamber C24. In the reaction chamber heating unit 400, the WDF reaction chambers C21 and C22 are arranged adjacent to each other. The RBC / PLT reaction chamber C11 and the HGB reaction chamber C12 are arranged between the suction position P4 and the WDF reaction chamber C21. The reaction chambers C11, C12, C21, C22, C23, and C24 are arranged in the order of proximity to the suction position P4, and are arranged in a straight line in the left-right direction. For further details on the structure of the reaction chamber heating unit 400, refer to Figures 10-12 Provide explanation.
[0074] The dispensing mechanism 350 dispenses the sample sucked at the suction position P4 through the suction tube 351 into at least one of the reaction chambers C11, C12, C21 to C24 based on the measurement command of setting the sample as the sample. In each of the reaction chambers C11, C12, C21 to C24, the sample and the designated reagent are mixed to prepare the measurement sample.
[0075] When the suction of the sample in the sample container 110 is completed, the container transfer mechanism 330 places the sample container 110 held by the holding member 331 above the removal position P1, and the gripping mechanism 310 grips the sample container 110 from the holding member 331 and lifts it upward. In this state, the container transfer mechanism 330 causes the holding member 331 to retreat backward, and the gripping mechanism 310 returns the gripped sample container 110 to the original hole 101 of the sample rack 100.
[0076] Figure 5 This is a block diagram showing a configuration in which measurement samples prepared in the reaction chambers C11 , C12 , and C21 to C24 provided in the measurement unit 10 are supplied to the optical measurement unit 381 , the electrical measurement unit 382 , and the HGB measurement unit 383 .
[0077] Except for reference Figure 5 The analysis operation described above is performed by the measurement control unit 852 of the analysis unit 30 (see Fig. 20 ) controls the dispensing mechanism 350, the modulation of the measurement sample in each reaction chamber C11, C12, C21~C24 and the measurement by each measurement unit 381~383.
[0078] The sample sucked from the sample container 110 by the suction tube 351 is appropriately dispensed into the reaction chambers C11, C12, C21 to C24 based on the measurement command set for the sample. The reaction chambers C11, C12, C21 to C24 are containers with open tops. The configuration of the reaction chambers C11, C12, C21 to C24 is further described in Figure 8 , 10 Provide explanation.
[0079] In the RBC / PLT reaction chamber C11, the test body and the RBC / PLT diluent are mixed to prepare an RBC / PLT measurement sample. The RBC / PLT diluent is, for example, CELLPACK (registered trademark) DCL. The RBC / PLT measurement sample prepared in the RBC / PLT reaction chamber C11 is measured by the electrical measurement unit 382. The electrical measurement unit 382 obtains electrical signals corresponding to red blood cells and platelets. The analysis unit 851 (refer to Fig. 20 ) The measurement results of the RBC / PLT measurement sample are analyzed to obtain the red blood cell count and platelet count, etc.
[0080] In the HGB reaction chamber C12, a test object, an HGB hemolytic agent, and an HGB diluent are mixed to prepare an HGB measurement sample. The HGB hemolytic agent is, for example, SULFOLYSER (registered trademark), and the HGB diluent is, for example, CELLPACK (registered trademark) DCL. The HGB measurement sample prepared in the HGB reaction chamber C12 is measured by the HGB measurement unit 383. The HGB measurement unit 383 obtains a signal corresponding to the hemoglobin concentration. The analysis unit 851 of the analysis unit 30 analyzes the measurement result of the HGB measurement sample to obtain the hemoglobin concentration and the like.
[0081] In the WDF reaction chamber C21, a test subject, a WDF hemolytic agent, and a WDF staining solution are mixed to prepare a WDF measurement sample. The WDF hemolytic agent is, for example, LYSERCELL (registered trademark) WDFII, and the WDF staining solution is, for example, FLUOROCELL (registered trademark) WDF. The WDF measurement sample prepared in the WDF reaction chamber C21 is measured by the optical measurement unit 381. The optical measurement unit 381 obtains an optical signal corresponding to white blood cells. The analysis unit 851 of the analysis unit 30 analyzes the measurement results of the WDF measurement sample prepared in the WDF reaction chamber C21 and the measurement results of the WNR measurement sample, and performs classification of white blood cells (for example, five classifications of neutrophils, lymphocytes, monocytes, eosinophils, and basophils).
[0082] In the WDF reaction chamber C22, as in the WDF reaction chamber C21, the test body, the WDF hemolytic agent, and the WDF staining solution are mixed to prepare the WDF measurement sample. The WDF measurement sample prepared in the WDF reaction chamber C22 is measured by the optical measurement unit 381. The optical measurement unit 381 obtains an optical signal corresponding to the leukocytes. The analysis unit 851 of the analysis unit 30 analyzes the measurement results of the WDF measurement sample prepared in the WDF reaction chamber C22 and the measurement results of the WNR measurement sample, and performs classification of the leukocytes (for example, 5 classifications of neutrophils, lymphocytes, monocytes, eosinophils, and basophils).
[0083] Among them, the WDF measurement sample is prepared under the common preparation conditions in the WDF reaction chambers C21 and C22. Specifically, the WDF hemolytic agent and the WDF staining solution are supplied to each of the WDF reaction chambers C21 and C22 as reagents of the same type. The WDF hemolytic agent is supplied to each of the WDF reaction chambers C21 and C22 from a common reagent container, and the WDF staining solution is supplied from a common reagent container. In each of the WDF reaction chambers C21 and C22, the amount of the sample to be dispensed, the amount of the reagent to be supplied, the time for preparing the WDF measurement sample, the amount of the prepared WDF measurement sample, and the reaction temperature during preparation are the same.
[0084] In the WNR reaction chamber C23, the test object, the WNR hemolytic agent, and the WNR staining solution are mixed to prepare a WNR measurement sample. The WNR hemolytic agent is, for example, LYSERCELL (registered trademark) WNR, and the WNR staining solution is, for example, FLUOROCELL (registered trademark) WNR. The WNR measurement sample prepared in the WNR reaction chamber C23 is measured by the optical measurement unit 381. The optical measurement unit 381 obtains optical signals corresponding to white blood cells and nucleated red blood cells. The analysis unit 851 of the analysis unit 30 analyzes the measurement results of the WNR measurement sample and obtains the number of white blood cells and the number of nucleated red blood cells, etc.
[0085] In the RET / PLT-F reaction chamber C24, a test object, a RET diluent, and a RET staining solution are mixed to prepare a RET measurement sample. The RET diluent is, for example, CELLPACK (registered trademark) DFL, and the RET staining solution is, for example, FLUOROCELL (registered trademark) RET. The RET measurement sample prepared in the RET / PLT-F reaction chamber C24 is measured by the optical measurement unit 381. The optical measurement unit 381 obtains an optical signal corresponding to reticulocytes. The analysis unit 851 of the analysis unit 30 analyzes the measurement results of the RET measurement sample and performs classification of reticulocytes, etc.
[0086] In addition, in the RET / PLT-F reaction chamber C24, the test body, the PLT-F diluent and the PLT-F staining solution are mixed to prepare a PLT-F measurement sample. The PLT-F diluent is, for example, CELLPACK (registered trademark) DFL, and the PLT-F staining solution is, for example, FLUOROCELL (registered trademark) PLT. The PLT-F measurement sample prepared in the RET / PLT-F reaction chamber C24 is measured by the optical measurement unit 381. The optical measurement unit 381 obtains an optical signal corresponding to platelets. The analysis unit 851 of the analysis unit 30 analyzes the measurement results of the PLT-F measurement sample to obtain the platelet count and the like.
[0087] Figure 6 This is a schematic diagram for explaining the procedure of dispensing the sample sucked by the suction tube 351 into each reaction chamber.
[0088] The lower end portion 351a of the suction tube 351 has a cylindrical shape with a groove formed at the lower end thereof at a surface inclined relative to a horizontal plane. A flow path 351b through which the subject passes is formed inside the suction tube 351. The flow path 351b is formed along the vertical direction in which the suction tube 351 extends, and is open to the outside from the side surface of the suction tube 351 at the lower end portion 351a.
[0089] The amount of the sample sucked from the sample container 110 by the suction tube 351 is constant regardless of the measurement command set for the sample. Figure 6 As shown, the flow path 351b is filled with the sample. The sample filled with the flow path 351b is sequentially discharged from the lower end 351a side to the designated reaction chamber. This dispensing operation is performed continuously in response to the suction of the sample from the sample container 110 once.
[0090] Specifically, among the samples filling the flow path 351b, the specified amount of samples located at the bottom is discharged into the RBC / PLT reaction chamber C11 as a preparatory action for dispensing by the suction tube 351. The samples discharged into the RBC / PLT reaction chamber C11 as a preparatory action are discarded through the flow path for discarding described later. Next, the specified amount of samples located above the samples for preparatory action in the flow path 351b are discharged into the HGB reaction chamber C12 for preparation of the HGB measurement sample. Next, the specified amount of samples located above the samples for the HGB measurement sample in the flow path 351b are discharged into the RBC / PLT reaction chamber C11 for preparation of the RBC / PLT measurement sample. Next, the specified amount of samples located above the samples for the RBC / PLT measurement sample in the flow path 351b are discharged into the WDF reaction chamber C21 or C22 for preparation of the WDF measurement sample. Next, a specified amount of the sample located above the sample for WDF measurement sample in the flow path 351b is discharged to the WNR reaction chamber C23 for preparation of the WNR measurement sample. Next, a specified amount of the sample located above the sample for WNR measurement sample in the flow path 351b is discharged to the RET / PLT-F reaction chamber C24 for preparation of the RET measurement sample. Next, a specified amount of the sample located above the sample for RET measurement sample in the flow path 351b is discharged to the RET / PLT-F reaction chamber C24 for preparation of the PLT-F measurement sample.
[0091] In the dispensing operation as described above, the amount of the test sample discharged into each reaction chamber is determined to be a specified amount corresponding to the preparation operation and the preparation of each measurement sample. In addition, the test sample corresponding to the measurement sample that is not necessary for preparation is not used in the preparation of the measurement sample and is discarded. For example, when preparation of the RET measurement sample is necessary, when the tip of the suction tube 351 is located at the height of the cleaning device 352, the test sample for the RET measurement sample is discharged from the opening of the suction tube 351 and recovered by the cleaning device 352. The unnecessary test sample in the suction tube 351 can be discarded by discharging it into an empty reaction chamber and discharging it from the reaction chamber even if the cleaning device 352 is not used.
[0092] like Figure 6 As shown in FIG. 1 , the reason for determining the order of dispensing into each reaction chamber is that when the sample is sucked into the suction tube 351, a concentration gradient is generated in the vertical direction in the flow path 351b of the suction tube 351. Since the amount of the sample sucked into the suction tube 351 is constant, if the order of dispensing into each reaction chamber is not changed, the concentration of the sample dispensed into each reaction chamber can be set substantially constant for each measurement. Thus, the deviation of the measurement result based on the concentration gradient can be suppressed.
[0093] Figure 7 The figure schematically shows the structure of the liquid transfer unit 354 for sucking and discharging the sample through the suction tube 351.
[0094] The upper end of the suction tube 351 is connected to the syringe pump 601 via a flow path, and a valve 602 is arranged on the flow path. The syringe pump 601 includes a piston and a motor, and is configured so that a specified amount of the subject is sucked from the suction tube 351 by applying a specified pressure to the flow path, and a specified amount of the subject sucked into the suction tube 351 is dispensed. When the dispensing of the subject is completed, the syringe pump 601 draws the subject remaining in the suction tube 351 and discards it via a valve 603.
[0095] In the flow path 351b (refer to Figure 6 ), the lower end portion 351a of the suction pipe 351 (see Figure 6 ) is located in the washer 352. In this state, the syringe pump 601 transfers the cleaning liquid supplied to the syringe pump 601 to the suction tube 351. The cleaning liquid transferred to the suction tube 351 is discharged from the opening of the lower end portion 351a and is discarded through the washer 352. In addition, when cleaning the outer side surface of the suction tube 351, the suction tube 351 moves in the upward and downward directions relative to the washer 352. At this time, the cleaning liquid supplied to the washer 352 abuts against the outer side surface of the suction tube 351 and is discarded through the washer 352. In this way, the inside and outside of the suction tube 351 are cleaned.
[0096] Figure 8This is a diagram schematically showing the configuration of a fluid circuit connected to the WDF reaction chambers C21 and C22 , the WNR reaction chamber C23 , the RET / PLT-F reaction chamber C24 , and the optical measurement unit 381 .
[0097] Reaction chambers C21 to C24 have the same structure as each other and each of them includes an inlet 361 for supplying reagents and cleaning liquid, an outlet 362 for discharging the measurement sample prepared in the reaction chamber, and a waste port 363 for discharging the liquid in the reaction chamber.
[0098] In the WDF reaction chamber C21, WDF hemolytic agent, WDF staining solution and cleaning solution are supplied through the inlet 361. In the WDF reaction chamber C22, WDF hemolytic agent, WDF staining solution and cleaning solution are supplied through the inlet 361 in the same manner as in the WDF reaction chamber C21. In the WNR reaction chamber C23, WNR hemolytic agent, WNR staining solution and cleaning solution are supplied through the inlet 361. RET diluent, PLT-F diluent, RET staining solution, PLT-F staining solution and cleaning solution are supplied to the RET / PLT-F reaction chamber C24.
[0099] The WDF hemolytic agent supplied to the WDF reaction chamber C21, the WDF hemolytic agent supplied to the WDF reaction chamber C22, the WNR hemolytic agent supplied to the WNR reaction chamber C23, and the RET dilution liquid and the PLT-F dilution liquid supplied to the RET / PLT-F reaction chamber C24 are stored in the reagent storage parts 501, 502, 503, and 504 of the reagent heating unit 500 and heated. For the detailed structure of the reagent heating unit 500, refer to Figures 13-15 Provide explanation.
[0100] The outlets 362 of the reaction chambers C21 to C24 are connected to the flow path 651 via valves 611, 621, 631, and 641, respectively. The flow path 651 is connected to a syringe pump 652, a valve 653, and an optical measuring unit 381. The diaphragm pump 655 is connected to the flow path 651 via valve 653. A valve 654 is connected to the flow path between the valve 653 and the diaphragm pump 655. The waste ports 363 of the reaction chambers C21 to C24 are connected to the waste flow path via valves 612, 622, 632, and 642, respectively.
[0101] exist Figure 8 When the preparation of the measurement sample in each reaction chamber shown in FIG. 6 is completed, the diaphragm pump 655 introduces the prepared measurement sample from the corresponding reaction chamber into the flow path 651. The syringe pump 652 supplies the measurement sample stored in the flow path 651 to the optical measurement unit 381. The syringe pump 601 is configured to transfer only a specified amount of the measurement sample stored in the flow path 651 to the optical measurement unit 381 by applying a specified pressure to the flow path 651.
[0102] The optical measurement unit 381 allows the measurement sample and sheath liquid supplied from the flow path 651 to flow into the flow cell 40 (see Fig.18 The optical signal corresponding to the blood cells in the measurement sample is output based on flow cytometry. The measurement sample passing through the optical measurement unit 381 is discarded. When the measurement of one measurement sample by the optical measurement unit 381 is completed, a cleaning liquid is supplied to the reaction chamber for modulating the measurement sample. The cleaning liquid in the reaction chamber is discharged to the flow path 651 through the outlet 362 and is discarded through the discard port 363. The cleaning liquid discharged to the flow path 651 is discarded by the syringe pump 652 and the diaphragm pump 655 through the valve 654.
[0103] exist Figure 8 In the figure, reaction chambers C21 to C24 are connected to the optical measurement unit 381 by a common flow path 651. The RET / PLT-F reaction chamber C24 is arranged at a position closest to the optical measurement unit 381 among the multiple reaction chambers C21 to C24. In other words, the length of the flow path connecting the RET / PLT-F reaction chamber C24 and the optical measurement unit 381 is shorter than the length of the flow path connecting the other reaction chambers C21 to C23 and the optical measurement unit 381. This is a design that takes into account the properties of the RET dye solution used in the RET measurement. The RET dye solution has the property that its components tend to remain in the flow path more easily than other dye solutions. Therefore, in order to shorten the length of the flow path that the measurement sample containing the RET dye solution contacts as much as possible and minimize the impact on other measurement samples, Figure 8 In the configuration, the RET / PLT-F reaction chamber C24 is arranged at the position closest to the optical measurement unit 381 .
[0104] Fig. 9 This is a diagram schematically showing the configuration of a fluid circuit connected to the RBC / PLT reaction chamber C11 , the HGB reaction chamber C12 , the electrical measurement unit 382 , and the HGB measurement unit 383 .
[0105] The reaction chambers C11 and C12 have the same structure as the reaction chambers C21 to C24 described above. That is, each of the reaction chambers C11 and C12 has an inlet 361 for supplying reagents and cleaning liquids, an outlet 362 for discharging the measurement sample prepared in the reaction chamber, and a waste port 363 for discharging the liquid in the reaction chamber. However, the HGB reaction chamber C12 also has an inlet 366 for supplying reagents.
[0106] The RBC / PLT diluent and the cleaning solution are supplied to the RBC / PLT reaction chamber C11 through the inlet 361. The HGB diluent and the cleaning solution are supplied to the HGB reaction chamber C12 through the inlet 361, and the HGB hemolytic agent is supplied through the inlet 366.
[0107] The outlet 362 of the RBC / PLT reaction chamber C11 is connected to the flow path 681 via a valve 661. The syringe pump 682, valve 683, and electrical measurement unit 382 are connected to the flow path 681. The outlet 362 of the HGB reaction chamber C12 is connected to the HGB measurement unit 383 via a valve 671. The HGB measurement unit 383 is connected to the flow path 684 via a valve 672. Valves 683 and 685 are connected to the flow path 684. A diaphragm pump 687 is connected to the flow path 684 via a valve 685. A valve 686 is connected to the flow path between the valve 685 and the diaphragm pump 687. The waste ports 363 of the reaction chambers C11 and C12 are connected to the waste flow paths via valves 662 and 672, respectively.
[0108] When the preparation of the RBC / PLT measurement sample in the RBC / PLT reaction chamber C11 is completed, the diaphragm pump 687 introduces the RBC / PLT measurement sample from the RBC / PLT reaction chamber C11 into the flow path 681. The syringe pump 682 supplies the RBC / PLT measurement sample stored in the flow path 681 to the electrical measurement unit 382. The syringe pump 682 is configured to transfer only a specified amount of the measurement sample stored in the flow path 681 to the electrical measurement unit 382 by applying a specified pressure to the flow path 681.
[0109] The electrical measurement unit 382 allows the RBC / PLT measurement sample and sheath fluid supplied from the flow path 681 to flow into the flow cell 50 (see Fig.18 The RBC / PLT measurement sample passing through the electrical measurement unit 382 is discarded. When the measurement of the RBC / PLT measurement sample by the electrical measurement unit 382 is completed, a cleaning liquid is supplied to the RBC / PLT reaction chamber C11. The cleaning liquid in the RBC / PLT reaction chamber C11 is discharged to the flow path 681 through the outlet 362 and is discarded through the discard port 363. The cleaning liquid discharged to the flow path 681 is discarded by the syringe pump 682 and the diaphragm pump 687 through the valve 686.
[0110] When the preparation of the HGB measurement sample is completed in the HGB reaction chamber C12, the HGB measurement sample is supplied to the HGB measurement unit 383 through the valve 671. The HGB measurement unit 383 outputs a signal corresponding to the hemoglobin concentration by the SLS-hemoglobin method based on the HGB measurement sample. The HGB measurement sample used in the measurement by the HGB measurement unit 383 is discarded. When the measurement of the HGB measurement sample by the HGB measurement unit 383 is completed, a cleaning liquid is supplied to the HGB reaction chamber C12. The cleaning liquid in the HGB reaction chamber C12 is discharged to the HGB measurement unit 383 through the outlet 362 and is discarded through the discard port 363. The cleaning liquid discharged to the HGB measurement unit 383 is discharged to the flow path 684 through the inside of the HGB measurement unit 383. The cleaning liquid discharged to the flow path 684 is discarded by the syringe pump 682 and the diaphragm pump 687 through the valve 686.
[0111] Next, refer to Figures 10 to 17 , the structure of the heating unit 700 is described.
[0112] The heating unit 700 has Figure 4 The reaction chamber heating unit 400 and Figure 8 The reagent heating unit 500 shown in FIG. Figure 4 As shown, the reaction chamber heating unit 400 includes WDF reaction chambers C21, C22, a WNR reaction chamber C23 and a RET / PLT-F reaction chamber C24.
[0113] Fig.10 It is a perspective view showing the structure of the WDF reaction chambers C21 and C22, the WNR reaction chamber C23, and the RET / PLT-F reaction chamber C24.
[0114] The reaction chambers C21 to C24 have the same shape and are made of the same material. Each reaction chamber C21 to C24 is made of a material having heat resistance, rigidity and chemical resistance, for example, polyphenylene sulfide (PPS) resin. Each reaction chamber C21 to C24 has an inlet 361, an outlet 362, waste ports 363 and 364, and a body 365.
[0115] The trunk 365 is a cylindrical component that can accommodate liquid inside. The inlet 361, the outlet 362, and the waste ports 363 and 364 are formed in a tubular shape and are connected to the inside of the trunk 365. The waste port 363 is connected in a manner extending downward relative to the lower end of the trunk 365. The outlet 362 is connected in a manner extending in a lateral direction relative to the trunk 365 above the connection position of the waste port 363. The inlet 361 is connected in a manner extending in a lateral direction relative to the trunk 365 above the connection position of the outlet 362. The inlet 361 and the outlet 362 are connected near the lower end of the trunk 365.
[0116] The upper end of the body 365 is formed with a discharge port 365a which is open upward. The discharge port 365a has a circular shape in a plan view, and the diameter of the discharge port 365a is R. The discharge port 365a is formed at the lower end 351a of the suction tube 351 (see Figure 6 ) passes through the opening when descending to the inside of the trunk 365. The waste port 364 is connected to the vicinity of the upper end of the trunk 365 to prevent the liquid in the trunk 365 from overflowing from the discharge port 365a. The waste port 364 is connected to the waste flow path.
[0117] Furthermore, the RBC / PLT reaction chamber C11 and the HGB reaction chamber C12 also have the same shape as the reaction chambers C21 to C24, and the HGB reaction chamber C12 further has an inlet 366 (see Fig. 9). The RBC / PLT reaction chamber C11 and the HGB reaction chamber C12 are made of, for example, polyvinyl chloride (PVC) resin.
[0118] Fig.11 It is an exploded perspective view showing the structure of the reaction chamber heating unit 400.
[0119] The reaction chamber heating unit 400 includes holding blocks 401 and 402 , a frame member 413 , a pair of screws 421 , a heater 430 , a cover member 440 , and heat-insulating members 450 , 461 , 462 , and 463 .
[0120] The holding block 401 on the front side and the holding block 402 on the rear side hold the four reaction chambers C21 to C24 in a manner of clamping from the front and back. The holding blocks 401 and 402 are made of a metal with high thermal conductivity, for example, aluminum. A recessed portion along the outer shape of the four reaction chambers C21 to C24 is formed on the rear side of the holding block 401 and the front side of the holding block 402. When the holding blocks 401 and 402 are joined in a state of clamping the four reaction chambers C21 to C24, the four reaction chambers C21 to C24 are accommodated in the recessed portions of the holding blocks 401 and 402.
[0121] The inlet 361, outlet 362 and waste port 364 of the four reaction chambers C21 to C24 protrude to the front of the holding block 401 through holes provided in the holding block 401. The waste port 363 of the four reaction chambers C21 to C24 protrudes below the holding blocks 401 and 402 through holes provided in the holding blocks 401 and 402.
[0122] The frame member 413 has a rectangular shape and is provided on the outer periphery of the rear side of the holding block 402. A pair of holes 413a for fixing a pair of screws 421 and a pair of screws 721 (see FIG. 4) for fixing the pair of screws 421 are formed on the upper side of the frame member 413. Fig.16 ) is provided with a pair of holes 413b. In addition, a pair of screws 722 are formed at the lower portion of the frame member 413 for fixing (see Fig.16 ) a pair of incisions.
[0123] The heater 430 is provided at the rear of the holding block 402 from the rear of the frame member 413 through the opening in the center of the frame member 413. The heater 430 heats the four reaction chambers C21 to C24. The heater 430 is a sheet-shaped heater having a sheet shape. The heater 430 heats the rear of the holding block 402 by electric drive. The heater 430 is driven in such a manner that the liquid temperature in the four reaction chambers C21 to C24 is heated to 35° C. to 45° C., more specifically, 41° C. Thus, the measurement sample can be smoothly and appropriately modulated in the four reaction chambers C21 to C24.
[0124] The cover member 440 is provided on the upper surfaces of the holding blocks 401 and 402. The cover member 440 has an L-shape when viewed from the right direction, and has a plate portion 441 parallel to the horizontal plane and a plate portion 442 perpendicular to the horizontal plane.
[0125] Four holes 441a are formed in the plate portion 441 so as to penetrate the plate portion 441 in the vertical direction. The four holes 441a are located at the discharge ports 365a at the upper ends of the four reaction chambers C21 to C24 (see Fig.10 ) directly above. The four holes 441a have a long hole shape that is longer in the left-right direction than in the front-back direction. When dispensing the sample, the lower end 351a of the suction tube 351 (see Figure 6 ) descends through hole 441a into the interior of each reaction chamber C21~C24.
[0126] Four cutouts 441b are formed at the front end of the plate 441, and four cutouts corresponding to the four cutouts 441b are also formed at the rear end of the plate 441. A tube extending from a reagent heating unit 500 described later passes through these cutouts. Since the tube passes through the lower side of the plate 441 when passing through these cutouts, the tube can be prevented from being randomly arranged near the upper side of the plate 441 where the lower end 351a of the suction tube 351 moves.
[0127] The plate portion 442 is formed with a pair of notches 442a for fixing a pair of screws 421 and a pair of screws 721 (see Fig.16 The plate portion 442 is disposed on the upper surface of the holding blocks 401 and 402, and a pair of screws 421 are fixed to a pair of notches 442a of the plate portion 442 and a pair of holes 413a of the frame member 413. Thus, the cover member 440 is disposed relative to the holding blocks 401 and 402 and the frame member 413.
[0128] The heat-insulating member 450 has an L-shape when viewed from the left, and has a plate portion 451 perpendicular to the horizontal plane and a plate portion 452 parallel to the horizontal plane. The heat-insulating member 450 is made of a material with high heat insulation, for example, made of foamed urethane obtained by adding a foaming agent to polyurethane. The heat-insulating member 450 is provided in front of the holding block 401 and on the lower surface of the holding blocks 401 and 402. At this time, the inlet 361, the outlet 362, and the waste port 364 provided on the side of the four reaction chambers C21 to C24 protrude to the front of the heat-insulating member 450 through the holes 451a and 451b formed in the plate portion 451 of the heat-insulating member 450. In addition, the waste port 363 provided at the lower end of the four reaction chambers C21 to C24 protrudes to the lower side of the heat-insulating member 450 through the hole 452a formed in the plate portion 452 of the heat-insulating member 450.
[0129] The heat-insulating members 461, 462, and 463 have a plate shape perpendicular to the horizontal plane. The heat-insulating members 461, 462, and 463 are made of the same material as the heat-insulating member 450. The heat-insulating member 461 is provided on the left side of the holding blocks 401 and 402, and the heat-insulating member 462 is provided on the right side of the holding blocks 401 and 402. The heat-insulating member 463 is provided behind the holding blocks 402 and the heater 430 from the rear of the heater 430 through the central opening of the frame member 413. Thus, the reaction chamber heating unit 400 is completed.
[0130] Fig.12 It is a perspective view showing the structure of the reaction chamber heating unit 400 after assembly.
[0131] As described above, four holes 441a are formed in the cover member 440 for the lower end portion 351a of the suction pipe 351 to pass through. The shapes and sizes of the four holes 441a are equal to each other. The length L1 of the hole 441a in the left-right direction is longer than the length L2 of the hole 441a in the front-back direction. In addition, the length L1 of the hole 441a is equal to the diameter R (refer to FIG. 2 ) of the discharge port 365a provided at the upper end of each reaction chamber C21 to C24. Fig.10 ) is the same. That is, in a plan view, the hole 441a is located in the discharge port 365a of each reaction chamber C21 to C24. Thus, the lower end 351a of the suction pipe 351 can smoothly pass through the hole 441a, while preventing dust and the like from entering each reaction chamber C21 to C24 through the hole 441a.
[0132] like Fig.11 , 12 As shown, by covering the front, left, right and rear of the reaction chamber heating unit 400 with the heat insulating members 450, 461, 462 and 463, it becomes easy to maintain the temperature of the liquid in the four reaction chambers C21 to C24 heated by the heater 430 at 41°C.
[0133] Fig.13 It is a perspective view showing the structure of the frame portion 510 included in the reagent warming unit 500. Fig.13 The left side of FIG. 5 is a view of the frame portion 510 as viewed from the front side. Fig.13 The right side of FIG. 5 is a diagram showing the frame portion 510 as viewed from the rear side.
[0134] An opening 510a is formed in the center of the frame 510, which penetrates the frame 510 in the front-to-back direction. An inlet 511 is provided at the rear near the lower end of the frame 510, and an outlet 512 is provided at the front near the upper end of the frame 510. The inlet 511 and the outlet 512 are formed in a tubular shape. The inlet 511 is connected to the inside of the opening 510a through a hole 510b formed near the lower end of the opening 510a. The outlet 512 is connected to the inside of the opening 510a through a hole 510c formed near the upper end of the opening 510a.
[0135] Fig.14 It is an exploded perspective view showing the structure of the reagent warming unit 500.
[0136] The reagent heating unit 500 includes four frame parts 510 , sheet members 521 , 522 , plate members 523 , 524 , heaters 531 , 532 , heat-retaining members 540 , 550 , 560 , clamps 571 , 572 , 573 , 574 , and a pair of screws 581 , 582 , 583 , 584 .
[0137] The sheet members 521 and 522 are made of a material having heat resistance and chemical resistance, for example, fluororesin. The plate members 523 and 524 are made of a material having heat resistance and rigidity, for example, stainless steel. Fig.13 In the state where four frame parts 510 are arranged side by side in the left-right direction, sheet members 521 and 522 are arranged so as to sandwich the four frame parts 510 from the front-back direction of the four frame parts 510. Plate member 523 is arranged in front of sheet member 521, and plate member 524 is arranged behind sheet member 522. Furthermore, the plate members 523 and 524 are connected to each other near the periphery. Thus, four closed spaces are formed by the frame parts 510 and sheet members 521 and 522. The four closed spaces are respectively connected to Figure 8 The reagent storage parts 501, 502, 503, and 504 shown in FIG.
[0138] The heater 531 is provided in front of the plate member 523, and the heater 532 is provided in the rear of the plate member 524. The heater 531 is electrically driven to heat the four reagent storage sections 501 to 504 (see Figure 8 ) for heating. The heater 532 is electrically driven to heat the four reagent storage sections 501 to 504 via the plate member 524. The heaters 531 and 532 are sheet-shaped heaters having a sheet shape. The heaters 531 and 532 are driven in such a manner that the liquid temperature in the four reagent storage sections 501 to 504 is heated to 35°C to 45°C, more specifically 41°C. Thus, the measurement sample can be smoothly and appropriately prepared using the reagent in the four reaction chambers C21 to C24.
[0139] The heat-insulating members 540 and 550 have a plate shape perpendicular to the horizontal plane. The heat-insulating members 540 and 550 are made of a material with high heat insulation properties, for example, polyurethane foamed with a foaming agent added to polyurethane. The heat-insulating member 540 is set in front of the plate member 523 and the heater 531 from the front of the heater 531. At this time, the outlets 512 of the four frame parts 510 (see Fig.13The left side of the heat-insulating member 540 protrudes to the front of the heat-insulating member 540 through the hole 541 formed in the heat-insulating member 540. The heat-insulating member 550 is set behind the plate member 524 and the heater 532 from the rear of the heater 532. At this time, the inlet 511 of the four frame parts 510 (refer to Fig.13 The right side of the heat-insulating component 550 protrudes to the rear of the heat-insulating component 550 through the hole 551 formed in the heat-insulating component 550.
[0140] The heat-insulating member 560 is made of a material with high heat insulation properties, for example, polyurethane foamed by adding a foaming agent to polyurethane, and is arranged in a vertical and horizontal manner around the structure in which the four frame parts 510, the two sheet parts 521, 522, the two plate parts 523, 524, the two heaters 531, 532, and the two heat-insulating members 540, 550 are assembled.
[0141] The clamps 571, 572, 573, and 574 are components for connecting the reagent heating unit 500 to the reaction chamber heating unit 400. The clamp 571 is provided near the upper end of the rear surface of the plate member 524 by a pair of screws 581. The clamp 572 is provided on the upper surface of the clamp 571 by a pair of screws 582. A pair of screws 723 (see FIG. 5A ) is formed on the clamp 572 to fix the reagent heating unit 500 and the reaction chamber heating unit 400. Fig.16 ) is provided with a pair of holes 572a. The clamp 573 is provided near the lower end of the rear of the plate member 524 by a pair of screws 583. The clamp 574 is provided on the lower surface of the clamp 573 by a pair of screws 584. A pair of screws 724 (see Fig.16 ) is provided with a pair of holes 574a. Thus, the reagent heating unit 500 is completed.
[0142] Fig.15 It is a perspective view showing the structure of the reagent warming unit 500 after assembly.
[0143] like Fig.14 , 15 As shown, the upper, lower, left, right, front and back surfaces of the reagent heating unit 500 are covered with heat-insulating members 540, 550, 560, so that the temperature of the reagents in the four reagent storage sections 501 to 504 heated by the heaters 531, 532 is maintained at 41°C.
[0144] Fig.16 It is an exploded perspective view showing the structure of the heating unit 700.
[0145] The heating unit 700 includes a reaction chamber heating unit 400 , a reagent heating unit 500 , a clamp 710 , and a pair of screws 721 , 722 , 723 , and 724 .
[0146] A pair of screws 721 are fixed to a pair of holes 413b of the frame member 413 (see Fig.11) and a pair of holes 711 of the fixture 710. A pair of screws 722 are fixed to the cutout provided at the lower end of the frame member 413 and the holes 712 of the fixture 710. Thus, the reaction chamber heating unit 400 is set on the fixture 710.
[0147] The pair of screws 723 are fixed to the pair of holes 713 of the jig 710 and the pair of holes 572a of the heating unit 700. The pair of screws 724 are fixed to the pair of holes 714 of the jig 710 and the pair of holes 574a of the heating unit 700. Thus, the reagent heating unit 500 is installed in the jig 710.
[0148] When assembling the heating unit 700, the tubes connected to the four outlets 512 of the reagent heating unit 500 are extended through the central opening of the fixture 710 and the four cutouts 441b of the reaction chamber heating unit 400 to the front of the reaction chamber heating unit 400. Thus, the heating unit 700 is completed.
[0149] Fig.17 It is a perspective view showing the structure of the heating unit 700 after the assembly is completed.
[0150] When the heating unit 700 is installed in the measuring unit 10, the four inlets 511 (see Fig.13 The right side of the reagent heating unit 500 is connected to the tube connected to the reagent container containing the corresponding reagent. Fig.13 The pipe connected to the left side of the reaction chamber heating unit 400 is connected to the inlet 361 of the four reaction chambers C21 to C24 through the four cutouts 441b of the reaction chamber heating unit 400. The outlet 362 of the four reaction chambers C21 to C24 is connected to the valves 611, 621, 631, and 641 (see Figure 8 ) flow path connection. The waste ports 363 of the four reaction chambers C21 to C24 (see Fig.10 ) are connected to valves 612, 622, 632, 642 (refer to Figure 8 The waste ports 364 of the four reaction chambers C21 to C24 are connected to the waste flow path.
[0151] Fig.18 The diagram shows the configuration of the flow cell 40 of the optical measurement section 381 , the configuration of the flow cell 50 of the electrical measurement section 382 , and the configuration of the HGB measurement section 383 .
[0152] like Fig.18 As shown in the upper part of FIG. 3 , the flow cell 40 of the optical measurement unit 381 includes a sheath liquid supply port 41 , a sample nozzle 42 , a fine hole portion 43 , and a waste port 44 .
[0153] The sheath liquid supply port 41 supplies the sheath liquid into the flow cell 40. The sample nozzle 42 delivers the measurement sample upward in the flow cell 40. The measurement sample, in a state of being covered by the sheath liquid, passes through the flow path 43a formed in the fine hole portion 43 and enters the waste port 44. The blood cells contained in the measurement sample pass through the flow path 43a in a state of being aligned in a row. The flow path 43a is irradiated with laser light of a specified wavelength. When the measurement sample passing through the flow path 43a is irradiated with laser light, forward scattered light, side scattered light, and fluorescence are generated from the blood cells in the measurement sample. The light receiving portion of the optical measurement unit 381 outputs an optical signal corresponding to the intensity of the forward scattered light, side scattered light, and fluorescence. The intensity of the forward scattered light reflects information related to the size of the blood cells, the intensity of the side scattered light reflects the internal information of the blood cells, and the intensity of the fluorescence reflects the degree of staining of the blood cells. When the optical measurement unit 381 is cleaned, a cleaning liquid is supplied to the sheath liquid supply port 41 and the sample nozzle 42.
[0154] The optical signal may be any signal obtained as an optical response by irradiating light to the blood cells. The optical signal is not limited to the above-mentioned signal based on light scattering and signal based on fluorescence, for example, it may be a signal based on light absorption or a signal based on transmitted light.
[0155] like Fig.18 As shown in the middle section of FIG. 3 , the flow cell 50 of the electrical measurement unit 382 includes a sample nozzle 51 , a chamber 52 , a hole 53 , a recovery tube 54 , and a chamber 55 .
[0156] The sample nozzle 51 delivers the measurement sample upward. The chamber 52 has a gradually narrowing shape that becomes thinner as it goes upward. Sheath liquid is supplied to the chamber 52. The measurement sample enters the recovery tube 54 through the hole 53 while being wrapped in the sheath liquid. The blood cells contained in the measurement sample pass through the hole 53 in a state of being aligned in a row. Electrodes are provided in the hole 53. A direct current is supplied between the electrodes of the hole 53, and an electrical signal corresponding to a change in direct current resistance when the measurement sample passes through the hole 53 is detected. The RBC / PLT diluent used in the preparation of the RBC / PLT measurement sample has conductivity because it contains electrolytes. Therefore, since the direct current resistance increases when the blood cells in the RBC / PLT measurement sample pass through the hole 53, the electrical signal becomes information reflecting the blood cells passing through the hole 53.
[0157] The sheath liquid is supplied to the chamber 55 so as to flow downward through the outer region of the recovery tube 54. After the sheath liquid flowing through the outer side of the recovery tube 54 reaches the lower end of the chamber 55, it flows into the interior of the recovery tube 54. This prevents the blood cells that have passed through the hole 53 from returning to the hole 53, thereby preventing erroneous detection of blood cells. When the electrical measurement unit 382 is cleaned, the cleaning liquid is supplied to the sample nozzle 51 and the chambers 52 and 55.
[0158] like Fig.18As shown in the lower part of FIG. 3 , the HGB measurement unit 383 includes a cell 383 a , a light source unit 383 b , and a light receiving unit 383 c .
[0159] The cell 383a is made of a plastic material with high light transmittance. The light source unit 383b irradiates the cell 383a with light of a wavelength having a high light absorbance due to SLS-hemoglobin. The light receiving unit 383c is arranged facing the light source unit 383b by sandwiching the cell 383a, and receives the light transmitted through the cell 383a.
[0160] The HGB measurement sample is contained in the cell 383a. In this state, the light source unit 383b emits light, and the light receiving unit 383c receives the transmitted light. Since the cell 383a is made of a material with high light transmittance, the light receiving unit 383c receives only the transmitted light that is not absorbed by the HGB measurement sample from the light of the light source unit 383b. The light receiving unit 383c detects a signal corresponding to the intensity of the transmitted light. This signal corresponds to the absorbance.
[0161] Fig.19 It is a block diagram showing the functional configuration of the measurement unit 10 .
[0162] The measuring unit 10 includes an optical measuring unit 381, an electrical measuring unit 382, an HGB measuring unit 383, analog processing units 811, 812, 813, A / D conversion units 821, 822, 823, IF (interface) units 801, 802, a communication unit 803, a reading mechanism 340, a dispensing mechanism 350, a liquid transfer unit 830, a mechanism unit 840 and heaters 430, 531, 532.
[0163] The analog processing units 811, 812, and 813 perform processing such as noise removal or flattening on the analog signals output from the optical measurement unit 381, the electrical measurement unit 382, and the HGB measurement unit 383. The A / D conversion units 821, 822, and 823 convert the analog signals processed by the analog processing units 811, 812, and 813 into digital signals, and transmit them to the analysis unit 30 as measurement results via the IF unit 801 and the communication unit 803. The communication unit 803 is composed of a connection terminal based on the USB standard, and performs communication with the analysis unit 30.
[0164] The reading mechanism 340 includes a mechanism for driving rollers 341 and 342 and a barcode reader 343. The dispensing mechanism 350 includes a transfer unit 353 for transferring the suction tube 351 and a liquid transfer unit 354. The liquid transfer unit 830 includes a mechanism for driving the liquid in the liquid. Figure 8 , 9The mechanism section 840 includes a mechanism for driving a pair of gripping pieces 311 of the gripping mechanism 310, a mechanism for driving the roller 321b of the stirring mechanism 320, a mechanism for rotating the holding section 321 around the rotation axis 321c, a mechanism for transferring the sliding section 322, and a mechanism for transferring the plate member 332 of the container transfer mechanism 330. Each section of the measuring unit 10 is controlled by the analyzing unit 30 via the IF section 802 and the communication section 803.
[0165] Fig. 20 It is a block diagram showing the functional configuration of the transport unit 20 and the analysis unit 30 .
[0166] The transport unit 20 includes a reading mechanism 240 , a mechanism unit 251 , and a communication unit 252 .
[0167] The reading mechanism 240 includes a mechanism for driving rollers 241 and 242 and a barcode reader 243. The mechanism unit 251 includes a mechanism for driving a pair of components of the conveying mechanism 211, a mechanism for driving the conveyor belts 221 and 222 of the conveying path 220, and a mechanism for driving components of the conveying mechanism 231. The communication unit 252 is composed of a connection terminal based on the USB standard, and communicates with the analysis unit 30.
[0168] The analysis unit 30 includes a control unit 850 , a storage unit 861 , a display unit 31 , an input unit 32 , and communication units 862 and 863 .
[0169] The control unit 850 is composed of, for example, a CPU. The control unit 850 functions as an analysis unit 851 that analyzes a subject and a measurement control unit 852 that controls the measurement unit 10 by executing a computer program stored in the storage unit 861. The storage unit 861 is composed of, for example, an SSD, an HDD, a RAM, etc. The measurement results received from the measurement unit 10, the program for controlling the analysis unit 30, and the program for realizing the functions of the analysis unit 851 and the measurement control unit 852 are stored in the storage unit 861.
[0170] The display unit 31 is, for example, composed of a liquid crystal display or an organic EL display, etc. The input unit 32 is composed of a mouse or a keyboard, etc. Furthermore, the display unit 31 and the input unit 32 may be integrally formed, for example, they may be composed of a touch panel type display.
[0171] The communication unit 862 is composed of a connection terminal based on the USB standard, and performs communication between the communication unit 803 of the measurement unit 10 and the communication unit 252 of the transport unit 20 via a cable based on the USB standard. The measurement control unit 852 controls each unit of the measurement unit 10 via the communication unit 862, and receives the sample ID read by the reading mechanism 340 of the measurement unit 10 and the measurement result from the measurement unit 10. In addition, the measurement control unit 852 controls each unit of the transport unit 20 via the communication unit 862, and receives the sample ID and rack ID read by the reading mechanism 240 of the transport unit 20.
[0172] The communication unit 863 is composed of a connection terminal based on the Ethernet standard, and communicates with the host computer outside the analysis device 1 via a cable based on the Ethernet standard. The measurement control unit 852 receives the subject ID read by the reading mechanism 340 of the measurement unit 10, and inquires the host computer for the measurement command via the communication unit 863, and receives the measurement command corresponding to the subject ID from the host computer. The received measurement command for each subject is stored in the storage unit 861. In addition, the measurement control unit 852 can also receive the measurement command from the operator via the input unit 32.
[0173] The measurement order includes information indicating a predetermined analysis mode such as CBC, DIFF, RET, PLT-F, etc. For example, the measurement control unit 852 controls each unit of the measurement unit 10 so that when the measurement order is CBC, the RBC / PLT measurement sample, the HGB measurement sample, and the WNR measurement sample are modulated; when the measurement order is CBC+DIFF, the WDF measurement sample is modulated in addition to the measurement sample corresponding to CBC; when the measurement order is CBC+DIFF+RET, the RET measurement sample is modulated in addition to the measurement samples corresponding to CBC and DIFF; and when the measurement order is CBC+DIFF+RET+PLT-F, the PLT-F measurement sample is modulated in addition to the measurement samples corresponding to CBC, DIFF, and RET. Furthermore, the measurement control unit 852 causes the optical measurement unit 381, the electrical measurement unit 382, and the HGB measurement unit 383 to measure the modulated measurement samples and obtain measurement results.
[0174] The analysis unit 851 analyzes the measurement results of the RBC / PLT measurement sample, and obtains the number of red blood cells, the number of platelets, and the mean corpuscular volume (MCV) as analysis results. The mean corpuscular volume is a measurement value of the volume of red blood cells. The analysis unit 851 analyzes the measurement results of the HGB measurement sample, and obtains the hemoglobin concentration as analysis results. The analysis unit 851 classifies the blood cells in the subject into neutrophils, lymphocytes, monocytes, eosinophils, etc. based on the measurement results of the WDF measurement sample, and classifies the blood cells in the subject into basophils, etc. based on the measurement results of the WNR measurement sample. Furthermore, the analysis unit 851 classifies the blood cells in the subject into neutrophils, lymphocytes, monocytes, eosinophils, and basophils based on the classification results of the WDF measurement sample and the WNR measurement sample, and obtains the number of neutrophils, lymphocytes, monocytes, eosinophils, and basophils as analysis results. The analysis unit 851 classifies the blood cells in the subject into white blood cells and nucleated red blood cells based on the measurement results of the WNR measurement sample, and obtains the number of white blood cells and the number of nucleated red blood cells as analysis results. The analysis unit 851 classifies the blood cells in the subject into reticulocytes based on the measurement results of the RET measurement sample, and obtains the number of reticulocytes as analysis results. The analysis unit 851 classifies the blood cells in the subject into platelets based on the PLT-F measurement sample, and obtains the number of platelets as classification results.
[0175] Furthermore, the analysis unit 851 may also be configured to perform AI analysis using an artificial intelligence (AI) algorithm on the measurement results obtained by the measurement of the subject. By AI analysis, the analysis unit 851 can classify white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils) based only on the measurement results of the WDF measurement sample. In addition, by AI analysis, the analysis unit 851 can obtain the number of white blood cells and the number of nucleated red blood cells based on the measurement results of the WDF measurement sample instead of the measurement results of the WNR measurement sample.
[0176] In addition, the measurement order is not limited to the information indicating the analysis mode as described above, but may also include information indicating the items of the analysis results individually. In this case, the measurement control unit 852 determines whether to prepare any measurement sample based on the items specified in the measurement order, and the analysis unit 851 analyzes the measurement results obtained from the prepared measurement sample to obtain the items specified in the measurement order as the analysis results.
[0177] Fig.21 It is a schematic diagram showing the configuration of a screen 900 displayed on the display unit 31 of the analysis unit 30 .
[0178] The control unit 850 of the analysis unit 30 receives a screen display instruction from the operator and displays the screen 900 on the display unit 31. The display content of the screen 900 is based on the analysis result generated by the analysis unit 851.
[0179] Screen 900 includes a plurality of display tabs 901 arranged in the horizontal direction, an item display area 910 for displaying items of analysis results, and a graph display area 920 for displaying a graph of the analysis results. Fig.21 In the example shown in FIG. 1 , the operator operates the display tab 901 corresponding to “graph” to display an item display area 910 and a graph display area 920 corresponding to a designated subject ID.
[0180] In the graph display area 920, scatter plots 921, 922, 923, and 924 generated based on the WDF measurement sample, the WNR measurement sample, the RET measurement sample, and the PLT-F measurement sample are displayed. In addition, histograms 925 and 926 generated based on the RBC / PLT measurement sample are displayed in the graph display area 920. Labels 921a to 926a indicating that the scatter plots are generated based on the WDF measurement sample, the WNR measurement sample, the RET measurement sample, and the PLT-F measurement sample are displayed in each of the scatter plots 921 to 924. Labels 925a and 926a indicating that they are histograms of red blood cells and platelets generated based on the RBC / PLT measurement sample are displayed in each of the histograms 925 and 926.
[0181] The operator passes Fig.21 By operating the display tab 901 corresponding to "Service" in the screen 900 shown in FIG. Fig. 22 The display content of screen 900 is shown.
[0182] Fig. 22 The screen 900 shown in FIG. 1 includes a plurality of display tabs 901 arranged in the horizontal direction, a plurality of display selection buttons 931 , and a service data display area 940 .
[0183] exist Fig. 22 In the example shown in FIG. 9 , the operator operates the display selection button 931 corresponding to “WDF” to display various data related to the WDF measurement sample in the service data display area 940. Fig. 22 In the service data display area 940 shown in FIG. 1 , a display area 941 is displayed, which indicates with a numerical value whether the WDF measurement sample is modulated in either the WDF reaction chambers C21 and C22. When the numerical value of the display area 941 is 0, it indicates that the WDF measurement sample is modulated in the WDF reaction chamber C21, and when the numerical value of the display area 941 is 1, it indicates that the WDF measurement sample is modulated in the WDF reaction chamber C22.
[0184] Furthermore, information indicating whether the WDF measurement sample is prepared in either of the WDF reaction chambers C21 and C22 may also be displayed on Fig.21 For example, when the WDF measurement sample is prepared in the WDF reaction chamber C21, "WDF-1" is displayed on the label 921a, and when the WDF measurement sample is prepared in the WDF reaction chamber C22, "WDF-2" may be displayed on the label 921a.
[0185] Next, refer to Figures 23 to 25 , a timetable for the actions of two subjects SP1 and SP2 that are measured continuously is described.
[0186] exist Figures 23 to 25 In the time table shown in , the right direction indicates the passage of time, and the time width of the two vertical lines adjacent to the left and right is 4 seconds. The measurement control unit 852 controls the modulation of the measurement sample in each reaction chamber and the measurement by each measurement unit as shown in the following time table. The measurement control unit 852 executes one action sequence for one subject. The action sequence stipulates the order and timing of operating the various parts of the measurement unit 10, namely the sample modulation unit (i.e., reaction chambers C11, C12, C21 to C24), each measurement unit 381 to 383, and the valves or pumps contained in the fluid circuit. When the measurement control unit 852 executes the action sequence, for example, it controls the valve to open at a specified time, and controls the valve and pump to drive the pump after the specified time. As described in detail below, the measurement control unit 852 starts the action sequence at a specified time, and partially repeats the modulation of the WDF measurement sample and the measurement by the optical measurement unit for two consecutive subjects.
[0187] exist Figures 23 to 25 In the figure, "RBC / PLT" indicates an action based on the RBC / PLT measurement sample, "WDF(1)" indicates an action based on the measurement sample prepared in the WDF reaction chamber C21, "WDF(2)" indicates an action based on the measurement sample prepared in the WDF reaction chamber C22, "WNR" indicates an action based on the WNR measurement sample, and "RET" indicates an action based on the RET measurement sample. Figures 23 to 25 The operation based on the HGB measurement sample is omitted.
[0188] The rectangular label recorded as "Modulation" shows the period during which the modulation of the measurement sample is performed. Specifically, the left end of the rectangular label "Modulation" shows the starting point of the modulation process of the measurement sample in the corresponding reaction chamber (the timing of discharging the test subject into the reaction chamber), and the right end of the rectangular label "Modulation" shows the end point of the modulation process of the measurement sample in the corresponding reaction chamber (the timing of starting the transfer of the measurement sample from the reaction chamber). The rectangular label recorded as "Measurement" shows the period during which the measurement is performed. Specifically, the left end of the rectangular label "Measurement" shows the starting point of the signal acquisition process in the corresponding measurement unit, and the right end of the rectangular label "Measurement" shows the end point of the signal acquisition process in the corresponding measurement unit.
[0189] The rectangular labels "modulation" and "measurement" arranged in the horizontal direction are the periods of modulation and measurement for one measurement sample, that is, the processing period corresponding to one measurement sample. The starting point of the processing period is the left end of the rectangular label "modulation", and the end point of the processing period is the right end of the rectangular label "measurement". The measurement sample is transferred from the reaction chamber to the measurement unit between the rectangular labels "modulation" and "measurement".
[0190] Specifically, when the measurement sample is transferred to the optical measurement section 381, the measurement sample is introduced by the diaphragm pump 655 and a specified amount of the measurement sample is transferred to the optical measurement section 381 by the syringe pump 652. When the RBC / PLT measurement sample is transferred to the electrical measurement section 382, the RBC / PLT measurement sample is introduced by the diaphragm pump 687 and a specified amount of the RBC measurement sample is transferred to the electrical measurement section 382 by the syringe pump 682. When the HGB measurement sample is transferred to the HGB measurement section 383, a specified amount of the HGB measurement sample is transferred to the HGB measurement section 383 via the valve 671.
[0191] When the processing period corresponding to one measurement sample is completed, the corresponding reaction chamber and measurement unit are cleaned for a specified time. After the cleaning for the specified time is completed, the reaction chamber and measurement unit can be used.
[0192] Fig.23 This is a timetable for setting a measurement command of CBC+DIFF for each of two subjects SP1 and SP2 to be measured continuously.
[0193] The measurement control unit 852 of the analysis unit 30 obtains a measurement command for the subject SP1, and determines an action sequence based on the obtained measurement command. The storage unit 861 of the analysis unit 30 stores an action sequence that specifies the preparation of a measurement sample in one subject and the period of measurement, corresponding to the type of measurement command. Fig.23In the example shown in the upper section, since the measurement command for the subject SP1 is CBC+DIFF, the measurement control unit 852 reads the action sequence SEQ1 from the storage unit 861 and drives the measurement unit 10 to perform measurement on the subject SP1 based on the read action sequence SEQ1.
[0194] When WDF measurement samples of a plurality of subjects are sequentially prepared, the two WDF reaction chambers C21 and C22 are used alternately. Fig.23 In the example shown in , the WDF measurement sample of the subject SP1 is prepared in the WDF reaction chamber C21, and the WDF measurement sample of the subject SP2 is prepared in the WDF reaction chamber C22.
[0195] When the measurement command is determined, the type of reaction chamber to be used and the type of measurement unit to be used are determined. In addition, the modulation start order of the measurement sample, the modulation time of each measurement sample, the measurement start order of the measurement unit, and the measurement time of each measurement unit are predetermined in a manner that the modulation and measurement of the measurement sample can be performed in accordance with the measurement command. The action sequence is predetermined based on the order, timing and required time as described above determined by the measurement command. In addition, when the measurement commands are the same, the action sequence becomes the same. As a result, the deviation of the measurement result of each measurement is suppressed, and the quality of the measurement can be maintained.
[0196] In order to analyze red blood cells with high frequency using RBC / PLT measurement samples, Fig.23 The action sequence SEQ1 shown in FIG. 1 is defined such that the preparation of the RBC / PLT measurement sample is performed before the preparation of the WDF measurement sample. In addition, since the preparation of the WDF measurement sample requires a longer time than the preparation of the WNR measurement sample, Fig.23 The action sequence SEQ1 shown in FIG. 1 is defined so that the modulation of the WDF measurement sample is performed before the modulation of the WNR measurement sample.
[0197] Next, the measurement control unit 852 of the analysis unit 30 obtains a measurement order for the subject SP2, and determines an operation sequence based on the obtained measurement order. Fig.23 In the example shown in the lower section, since the measurement command of the subject SP2 is CBC+DIFF, the measurement control unit 852 reads the action sequence SEQ1 from the storage unit 861 and drives the measurement unit 10 to perform the measurement of the subject SP2 based on the read action sequence SEQ1.
[0198] The optical measuring unit 381 is commonly used in a plurality of sample preparation units. Figure 8In the example shown in , one optical measuring section 381 provided in the measuring unit 10 is shared by a plurality of sample preparation sections (i.e., reaction chambers C21 to C24). Therefore, even if a plurality of measurement samples to be measured by the optical measuring section 381 are prepared in parallel, it is necessary that these measurement samples are measured sequentially in the optical measuring section 381. Therefore, the measuring control section 852 is configured to be able to set the start timing of the action sequence of the second subject in such a manner that the measurement of the optical measuring section 381 is performed sequentially even though the preparation and measurement periods of the measurement samples of two consecutive subjects (the first subject and the second subject) are partially overlapped. The start timing refers to the fastest timing at which the action sequence of the second subject can be started, for example, without interfering with two consecutive action sequences. The start timing is set to a specified time after the start of the action sequence of the first subject. The time for specifying the start timing is determined corresponding to the action sequence of the first subject.
[0199] Fig.23 In the example shown in , the action sequence of the first subject SP1 is determined as SEQ1, and the time that specifies the start timing of the second subject SP2 is determined as T1. Fig.24 , 25 In the case of the example described later shown in , the action sequence of the first subject SP1 is determined as SEQ2 or SEQ3, and the time for specifying the start timing of the second subject SP2 is determined as T2 or T3 respectively. The time for specifying the start timing of the second subject SP2 (for example, time T1 to T3) is pre-set to a time at which the action sequence of the second subject SP2 can be started in parallel with the action sequence of the first subject SP1 within a range that does not interfere with the action sequence of the first subject SP1.
[0200] Fig.23 In the example shown in , time T1 is, for example, (1) shorter than the time from the start to the end of the action sequence SEQ1 of the first subject SP1, and (2) independent of the type of the action sequence of the second subject SP2 (e.g., SEQ1 to SEQ3), and the measurement process of the optical measurement unit 381 used in the two action sequences is not repeated. Fig.23 In the example, after the last measurement process (i.e., the measurement process of the WDF measurement sample) of the optical measurement unit 381 using the first sample SP1 is completed, the time T1 at which the first measurement process (i.e., the measurement process of the WNR measurement sample) of the optical measurement unit 381 using the second sample SP2 is started after the designated waiting time Tw1 is left blank. The waiting time Tw1 is the time required to perform the preparatory operations including the cleaning of the optical measurement unit 381.
[0201] As described above, when the measurement command of CBC+DIFF is set for each of the two consecutively measured subjects SP1 and SP2, the measurement control unit 852 can start the action sequence of the second subject SP2 at the start timing of the time T1 from the start point of the action sequence of the first subject SP1. Fig.23 The repetition period shown in the figure repeats a part of the period for preparing and measuring the WDF measurement sample for the first sample SP1 and a part of the period for preparing and measuring the WDF measurement sample for the second sample SP2. Therefore, since the preparation and measurement of the two samples SP1 and SP2 can be performed in parallel, the throughput of the analysis device 1 can be improved.
[0202] Fig.24 This is a timetable for setting a measurement command of CBC+DIFF (without WNR) for each of the two consecutive test subjects SP1 and SP2. Fig.23 The following describes different points in different situations.
[0203] As described above, when the measurement order is DIFF, usually, the five-classification of white blood cells is performed based on the measurement results of the WDF measurement sample and the WNR measurement sample. However, for example, when the five-classification of white blood cells becomes possible by performing AI analysis on the measurement results of the WDF measurement sample, the preparation and measurement of the WNR measurement sample may not be performed. Fig.24 An example of an action sequence in such a case is shown below.
[0204] The measurement control unit 852 of the analysis unit 30 obtains a measurement order for the first subject SP1 and determines an operation sequence based on the obtained measurement order. Fig.24 In the example shown in the upper section, since the measurement command for the first subject SP1 is CBC+DIFF (without WNR), the measurement control unit 852 reads the action sequence SEQ2 from the storage unit 861, and drives the measurement unit 10 to perform the measurement of the first subject SP1 based on the read action sequence SEQ2.
[0205] The measurement control unit 852 sets the start timing of the second subject SP2 to a time T2 after the start point of the action sequence SEQ2 of the first subject SP1, corresponding to the action sequence of the first subject SP1 being determined as SEQ2. The time T2 is, for example, (1) shorter than the time from the start point to the end point of the action sequence SEQ2 of the first subject SP1, and (2) independent of the type of the action sequence of the second subject SP2 (for example, SEQ1 to SEQ3), and the measurement process of the optical measurement unit 381 used in the two action sequences is not repeated.
[0206] Next, the measurement control unit 852 of the analysis unit 30 obtains a measurement order for the second subject SP2, and determines an operation sequence based on the obtained measurement order. Fig.24 In the example shown in the lower part of , since the measurement command for the second subject SP2 is CBC+DIFF (without WNR), the measurement control unit 852 reads the action sequence SEQ2 from the storage unit 861, and drives the measurement unit 10 in such a manner as to perform the measurement of the second subject SP2 at the start timing after a time T2 has passed since the start of the action sequence for the first subject SP1 based on the read action sequence SEQ2.
[0207] exist Fig.24 From the perspective of the preparation action of the optical measurement unit 381, when the action sequence SEQ2 of the two test subjects SP1 and SP2 is to be executed in parallel, the time between the end of the measurement of the WDF measurement sample of the first test subject SP1 and the start of the measurement of the WDF measurement sample of the second test subject SP2 can be shortened to the same time as Fig.23 The same specified waiting time Tw1. However, in Fig.24 In this case, it is necessary to wait for a designated waiting time Tw2 longer than the time Tw1 between the end of the measurement of the RBC / PLT measurement sample of the first subject SP1 and the start of the measurement of the RBC / PLT measurement sample of the second subject SP2. During this waiting time Tw2, preparatory operations such as cleaning of the electrical measurement unit 382 are performed.
[0208] As described above, when the measurement command of CBC+DIFF (without WNR) is set for each of the two consecutively measured subjects SP1 and SP2, the measurement control unit 852 can start the action sequence of the second subject SP2 at the start timing of the time T2 from the start point of the action sequence of the first subject SP1. Fig.24 The repetition period shown in the figure repeats a part of the period for preparing and measuring the WDF measurement sample for the first sample SP1 and a part of the period for preparing and measuring the WDF measurement sample for the second sample SP2. Therefore, since the preparation and measurement of the two samples SP1 and SP2 can be performed in parallel, the throughput of the analysis device 1 can be improved.
[0209] Fig.25 This is a timetable for setting the measurement command of CBC+DIFF+RET for each of the two subjects SP1 and SP2 to be measured continuously. Fig.23 The following describes different points in different situations.
[0210] The measurement control unit 852 of the analysis unit 30 obtains a measurement order for the first subject SP1 and determines an operation sequence based on the obtained measurement order. Fig.25In the example shown in the upper section, since the measurement command for the first subject SP1 is CBC+DIFF+RET, the measurement control unit 852 reads the action sequence SEQ3 from the storage unit 861 and drives the measurement unit 10 to perform measurement on the first subject SP1 based on the read action sequence SEQ3.
[0211] The measurement control unit 852 sets the start timing of the second subject SP2 to a time T3 after the start point of the action sequence SEQ3 of the first subject SP1, corresponding to the action sequence of the first subject SP1 being determined as SEQ3. The time T3 is, for example, (1) shorter than the time from the start point to the end point of the action sequence SEQ3 of the first subject SP1, and (2) independent of the type of the action sequence of the second subject SP2 (for example, SEQ1 to SEQ3), and the measurement process of the optical measurement unit 381 used in the two action sequences is not repeated.
[0212] Next, the measurement control unit 852 of the analysis unit 30 obtains a measurement order for the second subject SP2, and determines an operation sequence based on the obtained measurement order. Fig.25 In the example shown in the lower part of , since the measurement command for the second subject SP2 is CBC+DIFF+RET, the measurement control unit 852 reads the action sequence SEQ3 from the storage unit 861, and drives the measurement unit 10 in such a manner as to perform the measurement of the second subject SP2 at the start timing after a time T3 has passed since the start of the action sequence for the first subject SP1, based on the read action sequence SEQ3.
[0213] exist Fig.25 Also from the perspective of the preparation action of the optical measurement unit 381, when the action sequence SEQ3 of the two subjects SP1 and SP2 is to be executed in parallel, the waiting time Tw3 between the end timing of the measurement of the RET measurement sample of the first subject SP1 and the start timing of the measurement of the WNR measurement sample of the second subject SP2 can be shortened to a specified waiting time.
[0214] As described above, when the measurement command of CBC+DIFF+RET is set for each of the two consecutively measured subjects SP1 and SP2, the measurement control unit 852 can start the action sequence of the second subject SP2 at the start timing of the time T3 from the start point of the action sequence of the first subject SP1. In this case, although the preparation and measurement periods of the WDF measurement samples for the two subjects SP1 and SP2 do not overlap with each other, the preparation and measurement of the two subjects SP1 and SP2 can be performed in parallel, so that the throughput of the analysis device 1 can be improved.
[0215] Furthermore, the combination of the action sequences of the two subjects SP1 and SP2 to be measured continuously is not limited to Figures 23 to 25The combination illustrated in the example is determined in correspondence with the measurement command of the subjects SP1 and SP2. When the action sequence of the subjects SP1 and SP2 is another combination, the start timing of the action sequence of the second subject SP2 is set in accordance with the type of the action sequence of the first subject SP1 (for example, SEQ1 to SEQ3). As described above, the start timing of the second subject SP2 determined by the action sequence of the first subject SP1 is, for example, set by time T1 to T3, and time T1 to T3 does not depend on the type of the action sequence of the second subject (for example, SEQ1 to SEQ3) but uses the time when the measurement process of the optical measurement unit 381 shared by the two action sequences does not overlap. Therefore, any combination of the action sequences of the subjects SP1 and SP2 can also be performed in the order of subjects SP1 and SP2 while sharing the optical measurement unit 381.
[0216] Fig.26 This is a flowchart showing the operation of the analyzer 1 regarding a sample accommodated in one sample container 110 .
[0217] Fig.26 The treatment is repeated for each subject. In the following description, the following will be Fig.26 The subject to be treated is called "this subject". The following subjects of this subject will be Fig.26 A subject who is the object of treatment is hereinafter referred to as "the following subject".
[0218] The sample container 110 is located at the extraction position P1. In step S11, the measurement control unit 852 of the analysis unit 30 controls the measurement unit 10 so as to extract the sample container 110 at the extraction position P1 from the sample rack 100. The sample container 110 extracted in step S11 contains the sample of this time. In step S12, the measurement control unit 852 controls the measurement unit 10 so as to stir the sample container 110 extracted in step S11. In step S13, the measurement control unit 852 controls the measurement unit 10 so as to transfer the sample container 110 after stirring to the suction position P4 via the reading position P3. The sample container 110 transferred to the suction position P4 is located at the reading position P3. In step S14, the measurement control unit 852 controls the measurement unit 10 so as to read the barcode from the barcode label 112 of the sample container 110 at the reading position P3 and obtain the sample ID of the sample of this time.
[0219] In step S15, the measurement control unit 852 controls the measurement unit 10 to measure the current sample in the sample container 110 located at the suction position P4. In step S16, the measurement unit 10 generates a measurement result from the measurement and transmits it to the analysis unit 30. The measurement control unit 852 stores the received measurement result in the storage unit 861.
[0220] In step S17, the measurement control unit 852 controls the measurement unit 10 to return the sample container 110 to the original well 101 of the original sample rack 100. In step S18, the analysis unit 851 of the analysis unit 30 performs analysis based on the measurement result obtained in step S16 to obtain the analysis result.
[0221] Fig. 27 1 is a flowchart showing the processing of the specific analysis unit 30 regarding the action sequence.
[0222] Fig. 27 The processing in Fig.26 The process starts when the subject ID of the subject of this experiment is obtained in step S14. Fig.26 In step S21, the measurement control unit 852 of the analysis unit 30 inquires the host computer based on the acquired subject ID of the subject this time, and acquires the measurement command corresponding to the subject ID from the host computer.
[0223] In step S22, the measurement control unit 852 determines the action sequence corresponding to the measurement command obtained in step S21, that is, the action sequence of the subject at this time, from among the multiple action sequences pre-stored in the storage unit 861. In step S23, the measurement control unit 852 determines the start time of the action sequence of the subject in the future based on the action sequence of the subject at this time. Specifically, the specified time corresponding to the action sequence of the subject at this time (for example, Figures 23 to 25 The time point (time T1 to T3 shown in FIG. 1 ) is determined as the starting timing of the subsequent subjects.
[0224] In step S24, the measurement control unit 852 sends the action sequence of the subject determined in step S22 and the information related to the start timing of the subsequent subjects determined in step S23 to the measurement unit 10. Thus, the measurement unit 10 performs the operation sequence of the subject based on the received action sequence of the subject. Fig.26 The subject of this time is measured in steps S15 and S16.
[0225] Furthermore, as described in the processing of step S23, the start timing of the subsequent subjects is determined based on the action sequence of the current subject. Fig.26 ,27 During the processing of step S15 for the subsequent subject (the operation sequence for the subsequent subject) starts at the start timing determined in step S23 for the current subject.
[0226] Fig.28 This is a timetable showing an example in which the action sequences of two subjects SP1 and SP2 that are measured continuously are both started at the start timing.
[0227] At timing T11, the measurement command of the subject SP1 is obtained, and the action sequence of the subject SP1 is determined based on the obtained measurement command. Furthermore, based on the determined action sequence of the subject SP1, the start timing of the action sequence of the subject SP2 is determined to be timing T22. The start timing of the subject SP1 is determined by the subject immediately before the subject SP1, which is timing T12. When the subject SP1 is at the suction position P4 at the start timing T12, the action sequence of the subject SP1 starts at timing T12.
[0228] On the one hand, at time T21, a measurement command of the specimen SP2 is received, and based on the measurement command received, the action sequence of the specimen SP2 is determined. Furthermore, based on the determined action sequence of the specimen SP2, the start timing of the action sequence of the specimen SP2 is further determined. The start timing of the specimen SP2 is determined by the specimen SP1, which is time T22. When the specimen SP2 is located at the suction position P4 at the start timing T22, the action sequence of the specimen SP2 starts at timing T22.
[0229] Furthermore, in Fig.28 In the example of , while the measurement command of the subject SP2 is obtained after the start of the operation sequence of the subject SP1, the measurement command of the subject SP2 may be obtained before the start of the operation sequence of the subject SP1.
[0230] Fig.29 Yes Display Fig.28 A timetable of an example in which the action sequence of subject SP1 does not start at the start timing.
[0231] At this time, the start timing of the sample SP1 is also determined by the sample immediately before the sample SP1, which is the timing T12. However, depending on the transfer status of the sample rack 100 in the transport unit 20, the sample SP1 may be located at the suction position P4 at the timing T13 after the start timing T12. In this case, the action sequence of the sample SP1 is quickly started at the timing T13.
[0232] Furthermore, the sample SP1 may be located at the suction position P4 before the start timing T12. For example, if the measurement command of the sample SP1 before the start timing T12 is CBC+DIFF+RET+PLT-F and the action sequence takes a long time, the sample container 110 of the sample SP1 is collected into the measurement unit 10 in succession to the sample container 110 of the sample before the start timing T12, and the sample container 110 of the sample SP1 becomes on standby at the suction position P4 until the start timing T12 arrives. At this time, the start timing T12 arrives, and the action sequence of the sample SP1 is quickly started.
[0233] <Effects of the Analyzer According to the Embodiment>
[0234] The analyzing device 1 comprises WDF reaction chambers C21 and C22 (first and second sample preparing units) for preparing a WDF measurement sample (first measurement sample) from a subject using a WDF hemolytic agent and a WDF staining solution (first reagent), an RBC / PLT reaction chamber C11 (third sample preparing unit) for preparing an RBC / PLT measurement sample (second measurement sample) from a subject using an RBC / PLT diluent (second reagent), an optical measuring unit 381 for measuring the WDF measurement sample (first measurement sample) and obtaining an optical signal corresponding to white blood cells, an electrical measuring unit 382 for measuring the RBC / PLT measurement sample (second measurement sample) and obtaining an electrical signal corresponding to red blood cells, an analyzing unit 851 and a measuring control unit 852 (control unit) for analyzing the subject based on the optical signal and the electrical signal. The measurement control unit 852 (control unit) controls the modulation of the samples in the WDF reaction chambers C21 and C22 (first and second sample modulation units) and the measurement by the optical measurement unit 381 in a manner corresponding to a plurality of measurement commands, including at least a portion of a period in which the WDF measurement sample (first measurement sample) is modulated by the WDF reaction chamber C21 (first sample modulation unit) and the WDF measurement sample (first measurement sample) modulated in the WDF reaction chamber C21 (first sample modulation unit) is measured by the optical measurement unit 381, and at least a portion of a period in which the WDF measurement sample (first measurement sample) is modulated by the WDF reaction chamber C22 (second sample modulation unit) and the WDF measurement sample (first measurement sample) modulated in the WDF reaction chamber C22 (second sample modulation unit) is measured by the optical measurement unit 381.
[0235] In this configuration, since a plurality of WDF reaction chambers are provided for preparing WDF measurement samples measured by the optical measurement unit 381, at least a portion of the period for sample preparation and measurement can be repeated. This can improve the throughput of the subject analysis. Furthermore, since the electrical measurement unit is used in the measurement of red blood cells, the accuracy of the red blood cell measurement can be improved.
[0236] like Fig.23 ,24 As shown, the measurement control unit 852 (control unit) controls the modulation of the samples in the WDF reaction chambers C21 and C22 (first and second sample modulation units) in such a manner that the WDF measurement sample (first measurement sample) is modulated from the test subject SP1 (first test subject) in the WDF reaction chamber C21 (first sample modulation unit), and the WDF measurement sample (first measurement sample) is modulated in the WDF reaction chamber C22 (second sample modulation unit) by the test subject SP2 (second test subject) measured after the test subject SP1 (first test subject).
[0237] Thus, at least a portion of the period including the preparation and measurement of the WDF measurement sample based on the subject SP1 and at least a portion of the period including the preparation and measurement of the WDF measurement sample based on the subject SP2 are separated. Fig.23 , 24 The repetition periods overlap with each other, and the analysis of subjects SP1 and SP2 can be quickly advanced.
[0238] The measurement control unit 852 (control unit) controls the modulation of the samples in the WDF reaction chambers C21, C22 (the first and second sample modulation units) by alternately performing modulation of the WDF measurement samples (the first measurement sample) in the WDF reaction chambers C21, C22 (the first and second sample modulation units) for a plurality of different test subjects.
[0239] With this configuration, WDF measurement samples can be quickly prepared from a plurality of different subjects.
[0240] It is also provided with a fourth sample preparation unit for preparing a third measurement sample from a test subject using a third reagent. The optical measurement unit 381 measures the third measurement sample and also obtains an optical signal corresponding to a designated blood cell. Among them, as a first example, the third reagent is a WNR hemolytic agent and a WNR staining solution, the third measurement sample is a WNR measurement sample, the fourth sample preparation unit is a WNR reaction chamber C23, and the designated blood cells are white blood cells and nucleated red blood cells. As a second example, the third reagent is a RET diluent and a RET staining solution, the third measurement sample is a RET measurement sample, the fourth sample preparation unit is a RET / PLT-F reaction chamber C24, and the designated blood cells are reticulocytes. As a third example, the third reagent is a PLT-F diluent and a PLT-F staining solution, the third measurement sample is a PLT-F measurement sample, the fourth sample preparation unit is a RET / PLT-F reaction chamber C24, and the designated blood cells are platelets.
[0241] With this configuration, the subject can be analyzed in further detail based on the optical signals from the specified blood cells.
[0242] like Fig.23As shown, the modulation time for the WDF measurement sample (first measurement sample) is longer than the modulation time for the WNR measurement sample (third measurement sample).
[0243] In this way, when the time for preparing the WDF measurement sample is longer than the time for preparing the WNR measurement sample, the throughput of the analysis device 1 can be effectively improved by at least partially repeating the period based on the WDF reaction chamber C21 and the period based on the WDF reaction chamber C22.
[0244] The number of WDF reaction chambers (sample preparation sections) used for preparation of the WDF measurement sample (first measurement sample) is greater than the number of WNR reaction chambers (sample preparation sections) used for preparation of the WNR measurement sample (third measurement sample).
[0245] With this configuration, WDF measurement samples corresponding to a plurality of subjects can be prepared continuously and rapidly compared to the preparation of WNR measurement samples.
[0246] like Fig.23 As shown, the measurement control unit 852 (control unit) controls the modulation of the sample in any one of the WDF reaction chambers C21, C22 (the first and second sample modulation units) and the fourth sample modulation unit in such a manner that the modulation of the WDF measurement sample (the first measurement sample) for the subject is performed before the modulation of the third measurement sample for the subject. Here, as a first example, the third measurement sample is a WNR measurement sample, and the fourth sample modulation unit is the WNR reaction chamber C23. As a second example, the third measurement sample is a RET measurement sample, and the fourth sample modulation unit is the RET / PLT-F reaction chamber C24. As a third example, the third measurement sample is a PLT-F measurement sample, and the fourth sample modulation unit is the RET / PLT-F reaction chamber C24.
[0247] With this configuration, since the WDF measurement sample, which takes time to prepare, is prepared earlier than the third measurement sample, the processing time for one sample can be shortened.
[0248] The measurement control unit 852 (control unit) controls the modulation of the sample in any one of the WDF reaction chambers C21, C22 (the first and second sample modulation units) and the fourth sample modulation unit in such a manner that the execution order of the modulation of the WDF measurement sample (the first measurement sample) and the third measurement sample becomes the same for each of a plurality of different test subjects. As a first example, the third measurement sample is a WNR measurement sample, and the fourth sample modulation unit is the WNR reaction chamber C23. As a second example, the third measurement sample is a RET measurement sample, and the fourth sample modulation unit is the RET / PLT-F reaction chamber C24. As a third example, the third measurement sample is a PLT-F measurement sample, and the fourth sample modulation unit is the RET / PLT-F reaction chamber C24.
[0249] With this configuration, since the execution order of preparation of the WDF measurement sample and the third measurement sample becomes the same in each subject, the control by the measurement control unit 852 can be simplified.
[0250] The measurement control unit 852 (control unit) controls the modulation of the sample in either of the WDF reaction chambers C21, C22 (the first and second sample modulation units) and the RBC / PLT reaction chamber C11 (the third sample modulation unit) in such a manner that the modulation of the RBC / PLT measurement sample (the second measurement sample) for the subject is performed before the modulation of the WDF measurement sample (the first measurement sample) for the subject.
[0251] In the analysis of the subject in the analyzer 1, the red blood cells are analyzed at a high frequency using the RBC / PLT measurement sample. With the above configuration, the preparation of the RBC / PLT measurement sample is performed before the preparation of the WDF measurement sample, so that the sample preparation operation for the subject can be simplified.
[0252] The analysis unit 851 generates analysis results including mean corpuscular volume (MCV, a measurement value of the volume of red blood cells) based on the electrical signal acquired by the electrical measurement unit 382 .
[0253] The analysis result of the volume of red blood cells can be more accurate by using the electric signal generated by the electric measuring unit 382 than by using the optical signal generated by the optical measuring unit 381. Therefore, the above configuration can obtain a high-precision analysis result of the volume of red blood cells.
[0254] like Fig. 22 As shown in the display area 941 of FIG. 8 , the analysis unit 851 generates the analysis result of the test subject in such a manner that the WDF reaction chamber (sample preparation unit) used for preparation of the WDF measurement sample (first measurement sample) can be identified.
[0255] With this configuration, it is possible to identify whether the generated analysis result is based on the WDF measurement sample prepared in either of the WDF reaction chambers C21 and C22. Therefore, for example, when it is determined based on the measurement result of the quality control substance that the accuracy of the analysis result based on the WDF reaction chambers C21 and C22 is problematic, measures such as invalidating the analysis result based on the sample in the WDF reaction chamber determined to have a problem can be taken.
[0256] The measurement control unit 852 (control unit) controls the preparation of the sample in the WDF reaction chambers C21 and C22 (first and second sample preparation units) so as to prepare the WDF measurement sample (first measurement sample) under common preparation conditions.
[0257] With this configuration, since the WDF measurement sample is prepared under the common preparation conditions in the WDF reaction chambers C21 and C22, the variation in the analysis result can be suppressed due to the difference in preparation conditions.
[0258] The WDF hemolytic agent and the WDF staining solution (the first reagent) are supplied from a common reagent container to the WDF reaction chambers C21 and C22 (the first and second sample preparation sections), and the third reagent is supplied from a reagent container different from the reagent container containing the WDF hemolytic agent and the WDF staining solution (the first reagent) to the fourth sample preparation section. As a first example, the fourth sample preparation section is the WNR reaction chamber C23, and the third reagent is the WNR hemolytic agent and the WNR staining solution. As a second example, the fourth sample preparation section is the RET / PLT-F reaction chamber C24, and the third reagent is the RET diluent and the RET staining solution. As a third example, the fourth sample preparation section is the RET / PLT-F reaction chamber C24, and the third reagent is the PLT-F diluent and the PLT-F staining solution.
[0259] With this configuration, WDF reaction chambers C21 and C22 use the WDF hemolytic agent in the common reagent container and the WDF staining solution in the common reagent container to prepare the WDF measurement sample, so that the preparation conditions of the WDF measurement sample can be made common. Thus, the variation of the analysis result can be suppressed by different preparation conditions.
[0260] The measurement control unit 852 (control unit) controls the dispensing mechanism 350 (dispensing unit) so as to dispense a common amount of the sample into the WDF reaction chambers C21 and C22 (first and second sample preparation units).
[0261] With this configuration, since a common amount of the test substance is dispensed into the WDF reaction chambers C21 and C22, the preparation conditions of the WDF measurement samples can be made common. Thus, the variation in the analysis results due to the different preparation conditions can be suppressed.
[0262] The reaction time between the WDF hemolytic agent and the WDF staining solution (first reagent) and the test subject in the WDF reaction chambers C21 and C22 (first and second sample preparation units) is the same.
[0263] With this configuration, since the reaction times of the WDF reaction chambers C21 and C22 are the same, the preparation conditions of the WDF measurement samples can be made the same. Thus, the variation of the analysis results can be suppressed by different preparation conditions.
[0264] The amount of the WDF measurement sample (first measurement sample) prepared in each of the WDF reaction chambers C21 and C22 (first and second sample preparation units) is the same.
[0265] With this configuration, since the amount of the WDF measurement sample prepared in each of the WDF reaction chambers C21 and C22 is the same, the preparation conditions of the WDF measurement sample can be made the same. Thus, the variation in the analysis result can be suppressed by different preparation conditions.
[0266] The reaction temperature of the WDF measurement sample (first measurement sample) prepared in each of the WDF reaction chambers C21 and C22 (first and second sample preparation units) is the same.
[0267] With this configuration, since the reaction temperature of the WDF measurement sample prepared in each of the WDF reaction chambers C21 and C22 is the same, the preparation conditions of the WDF measurement sample can be made the same. Thus, the variation in the analysis result can be suppressed by different preparation conditions.
[0268] The syringe pump 652 (syringe) supplies a designated amount of the WDF measurement sample (first measurement sample) to the optical measurement unit 381. The measurement control unit 852 (control unit) controls the sample preparation in the WDF reaction chambers C21 and C22 (first and second sample preparation units) and the measurement by the optical measurement unit 381 so that at least a portion of the period including the preparation of the WDF measurement sample (first measurement sample) by the WDF reaction chamber C21 (first sample preparation unit), the operation of the syringe pump 652 (syringe), and the measurement of the WDF measurement sample (first measurement sample) prepared in the WDF reaction chamber C21 (first sample preparation unit) by the optical measurement unit 381 overlaps with at least a portion of the period including the preparation of the WDF measurement sample (first measurement sample) by the WDF reaction chamber C22 (second sample preparation unit), the operation of the syringe pump 652 (syringe), and the measurement of the WDF measurement sample (first measurement sample) prepared in the WDF reaction chamber C22 (second sample preparation unit) by the optical measurement unit 381.
[0269] With this configuration, the amount of the WDF measurement sample supplied from the WDF reaction chamber C21 to the optical measurement unit 381 can be the same as the amount of the WDF measurement sample supplied from the WDF reaction chamber C22 to the optical measurement unit 381. Thus, the variation in the analysis result can be suppressed by different amounts supplied to the optical measurement unit 381.
[0270] The syringe pump 652 (syringe) supplies a specified amount of WDF measurement sample (first measurement sample) to the optical measurement unit 381. The WDF measurement sample (first measurement sample) prepared in the WDF reaction chambers C21 and C22 (first and second sample preparation units) is supplied to the optical measurement unit 381 by the common syringe pump 652 (syringe).
[0271] With this configuration, since the WDF measurement sample is supplied from the WDF reaction chambers C21 and C22 to the optical measurement unit 381 by the common syringe pump 652, the amount of the WDF measurement sample supplied to the optical measurement unit 381 can be made common. This can suppress the variation of the analysis result due to different measurement conditions.
[0272] The RBC / PLT reaction chamber C11 (third sample preparation unit) is dedicated to the preparation of the RBC / PLT measurement sample (second measurement sample).
[0273] With this configuration, since the RBC / PLT reaction chamber C11 is not used for preparation of other measurement samples, the RBC / PLT measurement sample can be quickly prepared.
[0274] The measurement control unit 852 (control unit) corresponds to the first action sequence corresponding to the first measurement command using the WDF reaction chamber C21 (first sample preparation unit), and sets the start timing of the second action sequence corresponding to the second measurement command using the WDF reaction chamber C22 (second sample preparation unit).
[0275] like Fig.28 As shown, the start timing of the second action sequence is set based on the first action sequence. With this configuration, since the timing of starting the second action sequence is determined at the time point when the first action sequence is determined, the second action sequence can be started before the end of the first action sequence. Therefore, at least a part of the period of preparation and measurement of the WDF measurement sample can be repeated, and the effect of improving the throughput of the subject analysis can be more significant.
[0276] The analyzing unit 851 classifies the white blood cells contained in the subject based on the optical signal obtained by the measurement of the WDF measurement sample (first measurement sample).
[0277] When the optical signal based on the WDF measurement sample is used to classify the white blood cells, if the modulation time of the WDF measurement sample is short, the optical signals of the clusters for each classification of the white blood cells will be close to each other and it will become impossible to classify them appropriately. Therefore, it is necessary to ensure a sufficient modulation time of the WDF measurement sample. Even in such a case, by repeating at least a part of the period for sample modulation and measurement as described above for a plurality of subjects, the throughput of the subject analysis can be improved.
[0278] The optical measurement unit 381 is commonly used in the measurement of the measurement sample prepared by the WDF reaction chamber C21 (first sample preparation unit) and the measurement of the measurement sample prepared by the WDF reaction chamber C22 (second sample preparation unit).
[0279] With this configuration, the WDF measurement sample prepared in the WDF reaction chamber C21 and the WDF measurement sample prepared in the WDF reaction chamber C22 cannot be measured in parallel. By repeating the above two periods, the throughput of the sample analysis can be improved. In addition, since only one optical measurement unit 381 is provided, the configuration of the analysis device 1 becomes simple, and there is no need to perform processing for determining whether the measurement results based on the optical measurement unit 381 are appropriate or not for multiple optical measurement units.
[0280] When the measurement control unit 852 (control unit) sequentially executes the first action sequence corresponding to the first measurement command using the WDF reaction chamber C21 (first sample preparation unit) and the second action sequence corresponding to the second measurement command using the WDF reaction chamber C22 (second sample preparation unit), the start timing of the second action sequence is set to be the start timing of the measurement of the measurement sample corresponding to the second action sequence by the optical measurement unit 381 after the start and before the end of the first action sequence, and after the measurement of the measurement sample corresponding to the first action sequence by the optical measurement unit 381.
[0281] Specifically, if Fig.23 As shown, by bringing the measurement end timing of the WDF measurement sample of the subject SP1 and the measurement end timing of the WNR measurement sample of the subject SP2 close to the waiting time Tw1, the start timing of the action sequence of the subject SP2 is determined to be the timing after the time T1 has passed from the start point of the action sequence of the subject SP1. With the above configuration, the measurement of the first and second action sequences can be smoothly performed using only one optical measurement unit 381.
[0282] The analysis device 1 includes only the WDF reaction chambers C21 and C22 (the first sample preparation section and the second sample preparation section) as a sample preparation section for preparing a WDF measurement sample (a first measurement sample).
[0283] With this configuration, it is possible to concurrently modulate two WDF measurement samples each requiring a long modulation time while suppressing complication of the configuration of the analysis device 1 .
[0284] The analyzing apparatus 1 includes only one RBC / PLT reaction chamber C11 (third sample preparing section) as a sample preparing section for preparing an RBC / PLT measurement sample (second measurement sample).
[0285] The time taken to prepare the RBC / PLT measurement sample is shorter than that of the WDF measurement sample. Therefore, even if only one RBC / PLT reaction chamber C11 is provided, the RBC measurement sample can be smoothly prepared. In addition, by providing only one RBC / PLT reaction chamber C11, the complexity of the structure of the analysis device 1 can be suppressed.
[0286] The analysis device 1 includes WDF reaction chambers C21 and C22 (first and second sample preparation units) for preparing WDF measurement samples (measurement samples) for leukocyte classification by using a common WDF hemolytic agent and a WDF staining solution (reagent for leukocyte classification), and a common heater 430 (first heater) for heating the WDF reaction chambers C21 and C22 (first and second sample preparation units).
[0287] With this configuration, the WDF reaction chambers C21 and C22 can be heated at substantially the same temperature by the common heater 430, compared to when separate heaters are used. Thus, the WDF measurement sample for leukocyte classification can be prepared under uniform temperature conditions in each of the WDF reaction chambers C21 and C22. Thus, changes in the analysis results due to differences in temperature conditions can be suppressed. In addition, by configuring the common heater 430, the configuration of the analysis device 1 can be simplified.
[0288] The WDF reaction chambers C21 and C22 (first and second sample preparation sections) are arranged adjacent to each other.
[0289] With this configuration, when dispensing the respective samples into the WDF reaction chambers C21 and C22, the transfer paths of the suction tube 351 for dispensing the samples can be brought close to each other, and the transfer control of the suction tube 351 can be easily performed.
[0290] The analyzer 1 further includes a WNR reaction chamber C23 (third sample preparation unit) for preparing a WNR measurement sample (measurement sample) used for obtaining the white blood cell count. The heater 430 (first heater) is provided in common in the WDF reaction chambers C21 and C22 and the WNR reaction chamber C23 (first, second, and third sample preparation units).
[0291] When the temperature conditions of the WNR measurement sample used for obtaining the number of white blood cells and the temperature conditions of the WDF measurement sample used for classifying white blood cells are the same, the WDF reaction chambers C21 and C22 and the WNR reaction chamber C23 can be heated at substantially the same temperature by the common heater 430 according to the above configuration. Thus, the measurement sample can be prepared under uniform temperature conditions in each chamber. In addition, by providing the common heater 430, the configuration of the analyzer 1 can be simplified.
[0292] The analysis device 1 further includes a RET / PLT-F reaction chamber C24 (fourth sample preparation unit) for preparing a RET measurement sample (measurement sample) used for classification of reticulocytes. The heater 430 (first heater) is provided in common in the WDF reaction chambers C21 and C22 and the RET / PLT-F reaction chamber C24 (first, second and fourth sample preparation units).
[0293] When the temperature conditions of the RET measurement sample used in the classification of reticulocytes and the temperature conditions of the WDF measurement sample used in the classification of leukocytes are the same, the WDF reaction chambers C21 and C22 and the RET / PLT-F reaction chamber C24 can be heated at substantially the same temperature by the common heater 430 according to the above configuration. Thus, the measurement sample can be prepared under uniform temperature conditions in each chamber. In addition, by providing the common heater 430, the configuration of the analysis device 1 can be simplified.
[0294] The analyzer 1 further includes a suction tube 351 for sucking a sample from the sample container 110 at the suction position P4 and dispensing the sucked sample. The WDF reaction chambers C21, C22 and the RET / PLT-F reaction chamber C24 (the first, second and fourth sample preparation sections) are arranged in order of proximity to the suction position P4.
[0295] The classification frequency of reticulocytes is lower than that of leukocytes. Therefore, as in the above configuration, by arranging the WDF reaction chambers C21 and C22 closer to the suction position P4 than the RET / PLT-F reaction chamber C24 (fourth sample preparation unit), the sample can be dispensed smoothly.
[0296] The heater 430 (first heater) is a sheet-shaped heater.
[0297] With this configuration, the heater 430 can be compactly arranged in the analysis device 1 .
[0298] The heater 430 (first heater) heats the liquid temperature in the WDF reaction chambers C21 and C22 (first and second sample preparation sections) to 35°C to 45°C.
[0299] With this configuration, the WDF measurement sample can be smoothly prepared in the WDF reaction chambers C21 and C22.
[0300] The WDF reaction chambers C21 and C22 (first and second sample preparation sections) are connected to the same reagent container.
[0301] With this configuration, the preparation conditions of the measurement samples can be further uniformed in the WDF reaction chambers C21 and C22.
[0302] The analysis apparatus 1 further includes common heaters 531 and 532 (second heaters) for heating the WDF hemolytic agent (reagent) supplied to the WDF reaction chambers C21 and C22 (first and second sample preparation units).
[0303] With this configuration, the WDF hemolytic agent supplied to the WDF reaction chambers C21 and C22 can be heated at substantially the same temperature by the common heaters 531 and 532, compared to when heaters are used individually for the WDF reaction chambers C21 and C22. Thus, the WDF hemolytic agent of uniform temperature can be supplied to each of the WDF reaction chambers C21 and C22. Thus, the change in the analysis result due to the difference in the temperature condition of the WDF hemolytic agent can be suppressed. In addition, by providing the common heaters 531 and 532, the configuration of the analysis device 1 can be simplified.
[0304] The analysis device 1 further includes a dispensing mechanism 350 for sucking a sample from the sample container 110 through a suction pipe 351 and discharging the sucked sample into the WDF reaction chambers C21 and C22 (the first and second sample preparation sections). The suction position P4 for sucking a sample from the sample container 110 and the discharge port 365a of the WDF reaction chambers C21 and C22 (the first and second sample preparation sections) are arranged in a straight line.
[0305] With this configuration, the configuration and control of the dispensing mechanism 350 for transferring the suction tube 351 to the suction position P4 and the discharge port 365a of the WDF reaction chambers C21 and C22 can be simplified.
[0306] The analysis device 1 further includes an RBC / PLT reaction chamber C11 (fifth sample preparation section) for preparing an RBC / PLT measurement sample (measurement sample) used for obtaining the number of red blood cells and platelets. The dispensing mechanism 350 further discharges the sample sucked from the sample container 110 through the suction tube 351 to the RBC / PLT reaction chamber C11 (fifth sample preparation section). The discharge ports 365a of the WDF reaction chambers C21, C22 and the RBC / PLT reaction chamber C11 (first, second and fifth sample preparation sections) are arranged in a straight line.
[0307] With this configuration, the configuration and control of the dispensing mechanism 350 for transferring the suction tube 351 to the discharge port 365a of the WDF reaction chambers C21 and C22 and the RBC / PLT reaction chamber C11 can be further simplified.
[0308] The analysis device 1 further includes an HGB reaction chamber C12 (sixth sample preparation section) for preparing an HGB measurement sample (measurement sample) used for obtaining the hemoglobin concentration. The dispensing mechanism 350 further discharges the sample sucked from the sample container 110 through the suction tube 351 to the HGB reaction chamber C12 (sixth sample preparation section). The discharge ports 365a of the WDF reaction chambers C21 and C22 and the HGB reaction chamber C12 (first, second, and sixth sample preparation sections) are arranged in a straight line.
[0309] With this configuration, the configuration and control of the dispensing mechanism 350 for transferring the suction pipe 351 to the discharge port 365a of the WDF reaction chambers C21 and C22 and the HGB reaction chamber C12 can be further simplified.
[0310] <Change Example>
[0311] In the above embodiment, the action sequence of the subject is determined based on the measurement command set for the subject. However, this is not limited to this. When the measurement command set for the subject is predetermined, the action sequence of the subject can also be determined in the predetermined action sequence. For example, when the analysis device 1 often uses the measurement command as CBC+DIFF to measure and analyze the subject, the action sequence of the subject is often determined in the action sequence SEQ1. In this case, Fig.23 As shown, the action sequence SEQ1 of two consecutive subjects SP1 and SP2 is executed in an overlapping manner.
[0312] In the above embodiment, the two consecutive samples SP1 and SP2 are not limited to samples collected from different subjects, but may be samples collected from the same subject at different times, or may be samples collected from the same subject at a specified time and divided into two.
[0313] In the above embodiment, two WDF reaction chambers are provided, but three or more WDF reaction chambers may be provided. In addition, the RET / PLT-F reaction chamber C24 may be divided into a RET reaction chamber for preparing a RET measurement sample and a PLT-F reaction chamber for preparing a PLT-F measurement sample.
[0314] In the above embodiment, the diaphragm pump 655 is used to introduce liquid from the reaction chambers C21 to C24 into the flow path 651, but other mechanisms may be used. The diaphragm pump 687 is used to introduce liquid from the RBC / PLT reaction chamber C11 and the HGB measurement unit 383 into the flow paths 681 and 684, but other mechanisms may be used. In addition, the syringe pump 652 may also have the function of introducing liquid from the reaction chambers C21 to C24 into the flow path 651. The syringe pump 682 may also have the function of introducing liquid from the RBC / PLT reaction chamber C11 and the HGB measurement unit 383 into the flow paths 681 and 684.
[0315] In the above embodiment, if Figure 4 As shown, the suction position P4 and the discharge ports of the reaction chambers C11, C12, C21 to C24 are arranged in a straight line, or they may be arranged in a zigzag line or a curved line. However, from the perspective of simplifying the structure and control of the dispensing mechanism 350 for transferring the suction tube 351, the suction position P4 and the discharge ports of the reaction chambers C11, C12, C21 to C24 are preferably arranged in a straight line.
[0316] In the above embodiment, if Fig.11 As shown, the intervals between reaction chambers C21 to C24 are not fixed, and the intervals between reaction chambers C23 and C24 are slightly larger than the intervals between the other chambers. However, the present invention is not limited thereto, and reaction chambers C21 to C24 may also be arranged at a certain interval. Thus, the control of the dispensing mechanism 350 that moves the suction tube 351 can be simplified.
[0317] The embodiments of the present invention can be appropriately and variously modified within the scope of the technical concept shown in the claims.
[0318]
Explanation of symbols
[0319] 1: Analytical device
[0320] 350: Dispensing mechanism (dispensing department)
[0321] 381: Optical measurement unit
[0322] 382: Electrical measurement unit
[0323] 430: Heater
[0324] 652: Syringe Pump (Syringe)
[0325] 851: Analysis Department
[0326] 852: Measurement control unit (control unit)
[0327] C11: RBC / PLT reaction chamber (3rd sample preparation section)
[0328] C21: WDF reaction chamber (1st sample preparation section)
[0329] C22: WDF reaction chamber (second sample preparation section)
[0330] C23: WNR reaction chamber (4th sample preparation section)
[0331] C24: RET / PLT-F reaction chamber (4th sample preparation section)
[0332] SEQ1: Action sequence (1st and 2nd action sequence)
[0333] SEQ2: Action sequence (1st and 2nd action sequence)
[0334] SP1: Subject (1st subject)
[0335] SP2: Subject (2nd Subject)
Claims
1. An analysis device for analyzing a subject, characterized in that: have: The first and second sample preparation units are used to prepare a first measurement sample from the test subject using a first reagent, a third sample preparation unit for preparing a second measurement sample from the subject using a second reagent, an optical measuring unit that measures the first measurement sample to obtain an optical signal corresponding to the leukocytes, an electrical measuring unit that measures the second measurement sample to obtain an electrical signal corresponding to the red blood cells, an analyzing unit that analyzes the subject based on the optical signal and the electrical signal, and Control Department, The control unit controls the sample preparation in the first and second sample preparation units and the measurement by the optical measurement unit in a manner that overlaps the following two in response to a plurality of measurement commands: at least a portion of a period during which the first sample preparation section prepares the first measurement sample and the optical measurement section measures the first measurement sample prepared in the first sample preparation section, and The method includes at least a portion of a period during which the second sample preparation section prepares the first measurement sample and the optical measurement section measures the first measurement sample prepared by the second sample preparation section.
2. The analysis device according to claim 1, characterized in that The control unit controls the preparation of the samples in the first and second sample preparation units in the following manner: preparing the first measurement sample from a first subject in the first sample preparation unit, The second sample preparation unit prepares the first measurement sample from a second sample to be measured after the first sample.
3. The analysis device according to claim 1, characterized in that The control unit controls the preparation of the samples in the first and second sample preparation units so that the preparation of the first measurement sample in the first and second sample preparation units is alternately performed on the plurality of different subjects.
4. The analysis device according to claim 1, characterized in that The analyzing device further comprises a fourth sample preparing unit for preparing a third measurement sample from the sample using a third reagent. The optical measurement unit measures the third measurement sample to further acquire an optical signal corresponding to a designated blood cell.
5. The analysis device according to claim 4, characterized in that The time for preparing the first measurement sample is longer than the time for preparing the third measurement sample.
6. The analysis device according to claim 5, characterized in that The number of sample preparation units used for preparing the first measurement sample is greater than the number of sample preparation units used for preparing the third measurement sample.
7. The analysis device according to claim 4, characterized in that The control unit controls sample preparation in one of the first and second sample preparation units and the fourth sample preparation unit so that preparation of the first measurement sample for the subject is performed prior to preparation of the third measurement sample for the subject.
8. The analysis device according to claim 4, characterized in that The control unit controls the preparation of the sample in one of the first and second sample preparation units and the fourth sample preparation unit so that the execution order of the preparation of the first and third measurement samples becomes the same for each of the plurality of different subjects.
9. The analysis device according to claim 1, characterized in that The control unit controls sample preparation in one of the first and second sample preparation units and the third sample preparation unit so that preparation of the second measurement sample for the subject is performed prior to preparation of the first measurement sample for the subject.
10. The analysis device according to claim 1, characterized in that The analysis unit generates an analysis result including a measurement value regarding the red blood cell volume based on the electrical signal.
11. The analysis device according to claim 1, characterized in that The analyzing unit generates an analysis result of the subject so that a sample preparing unit used for preparing the first measurement sample can be identified.
12. The analysis device according to claim 1, characterized in that The control unit controls preparation of the samples in the first and second sample preparation units so that the first measurement sample is prepared under a common preparation condition.
13. The analysis device according to claim 1, characterized in that supplying the first reagent from a common reagent container to the first and second sample preparation units, The third reagent is supplied to the fourth sample preparing unit from a reagent container different from the reagent container containing the first reagent.
14. The analysis device according to claim 1, characterized in that The analyzing device comprises a dispensing unit for dispensing the sample. The control unit controls the dispensing unit so as to inject a common amount of the sample into the first and second sample preparation units.
15. The analysis device according to claim 1, characterized in that The reaction time between the first reagent and the test subject in the first and second sample preparation units is the same.
16. The analysis device according to claim 1, characterized in that The amount of the first measurement sample prepared in each of the first and second sample preparation units is the same.
17. The analysis device according to claim 1, characterized in that The first measurement sample prepared in each of the first and second sample preparation units has a common reaction temperature.
18. The analysis device according to claim 1, characterized in that The analyzing device includes a syringe for supplying a predetermined amount of the first measurement sample to the optical measurement unit. The control unit controls the sample preparation in the first and second sample preparation units and the measurement by the optical measurement unit in a manner that overlaps the following two aspects: at least a portion of a period including the first sample preparation section preparing the first measurement sample, the operation of the injector, and the measurement of the first measurement sample prepared in the first sample preparation section by the optical measurement section, and The method includes at least a portion of a period during which the second sample preparation section prepares the first measurement sample, the syringe operates, and the optical measurement section measures the first measurement sample prepared in the second sample preparation section.
19. The analysis device according to claim 1, characterized in that The analyzing device includes a syringe for supplying a predetermined amount of the first measurement sample to the optical measurement unit. The first measurement sample prepared by the first and second sample preparation units is supplied to the optical measurement unit from the common syringe.
20. The analysis device according to claim 1, characterized in that The third sample preparation unit is exclusively used in preparation of the second measurement sample.
21. The analysis device according to claim 1, characterized in that The control unit sets a start timing of a second operation sequence corresponding to a second measurement command using the second sample preparation unit, corresponding to a first operation sequence corresponding to a first measurement command using the first sample preparation unit.
22. The analysis device according to claim 1, characterized in that The analyzing unit classifies white blood cells contained in the subject based on the optical signal acquired by the measurement of the first measurement sample.
23. The analysis device according to claim 1, characterized in that The optical measurement unit is commonly used in both measurement of the measurement sample prepared by the first sample preparation unit and measurement of the measurement sample prepared by the second sample preparation unit.
24. The analysis device according to claim 23, characterized in that When the control unit sequentially executes a first action sequence corresponding to a first measurement command using the first sample preparation unit and a second action sequence corresponding to a second measurement command using the second sample preparation unit, the control unit sets, as the start timing of the second action sequence, a start timing of measurement of the measurement sample corresponding to the second action sequence by the optical measurement unit after the start and before the end of the first action sequence and after the measurement of the measurement sample corresponding to the first action sequence by the optical measurement unit.
25. The analysis device according to claim 1, characterized in that As a sample preparation section for preparing the first measurement sample, only the first sample preparation section and the second sample preparation section are provided.
26. The analysis device according to claim 25, characterized in that As a sample preparation unit for preparing the second measurement sample, only one third sample preparation unit is provided.
27. The analysis device according to claim 1, characterized in that A common heater for heating the first sample preparation section and the second sample preparation section is provided.
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Sample analyzer and sample detection method
CN119959116A