WO2003107012A1 - 自動分析装置、測定装置および測定結果を管理する方法 - Google Patents
自動分析装置、測定装置および測定結果を管理する方法 Download PDFInfo
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- WO2003107012A1 WO2003107012A1 PCT/JP2003/007499 JP0307499W WO03107012A1 WO 2003107012 A1 WO2003107012 A1 WO 2003107012A1 JP 0307499 W JP0307499 W JP 0307499W WO 03107012 A1 WO03107012 A1 WO 03107012A1
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- Prior art keywords
- measurement
- error code
- abnormality
- measurement result
- primary
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00623—Quality control of instruments
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00603—Reinspection of samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
- G01N35/025—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having a carousel or turntable for reaction cells or cuvettes
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00623—Quality control of instruments
- G01N2035/00633—Quality control of instruments logging process history of individual samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
- G01N2035/00683—Quality control of consumables of detectors
Definitions
- the present invention relates to an automatic analyzer for measuring a component concentration of a specific substance contained in a sample (sample), a measuring apparatus, and a method for managing measurement results.
- An automatic analyzer qualitatively or quantitatively measures the concentration of a specific substance contained in a sample collected from a subject such as blood or urine.
- a sample collected from a subject is kept in a sample container in a sample place called a sample disk.
- the sample aspirated from the sample container is poured into the reaction cell.
- Various types of reagents are kept in reagent containers in a reagent area called a reagent disk.
- the reagent corresponding to the measurement item is aspirated from the container and poured into a specific reaction cell.
- the sample reacts with the reagent.
- the reaction solution is measured with a photometer or the like. The measurement results reflect the concentration of a particular component.
- samples collected from the same subject are dispensed into the same number of reaction cells as the specified number of measurement items.
- Reagents corresponding to the respective measurement items are poured into each reaction cell. .
- representative examples of measurement items for liver function tests include “GOT” and “GPT”.
- the blood collected from the subject includes “GOT” and “GPT”.
- the reaction solution is measured with a photometer.
- the measurement result or the analysis result of the measurement result indicates the quantitative concentration of “GOT”. Digitized or symbolized '
- the measurement result is displayed on the screen or printed on paper.
- the clinical technician creates a report for the physician based on the displayed or printed measurement results. Reports are prepared for each subject. The doctor grasps the condition of the subject based on the report.
- a measurement result is generated through a measurement process corresponding to a measurement item.
- the measurement process consists of many measurement steps: sample aspiration, sample injection, reagent aspiration, reagent injection, stirring, reaction, photometry, reaction solution disposal, detergent injection, washing, pure water injection, washing, and pure water disposal.
- sample aspiration sample injection
- reagent aspiration reagent injection
- stirring reaction
- photometry reaction solution disposal
- detergent injection washing, pure water injection, washing, and pure water disposal.
- One of the most important issues is that physicians make diagnoses by recognizing inherently error-free measurements as non-error-free measurements. When an abnormality is detected at a certain stage in the measurement process, an error code is always associated with the measurement result obtained through the measurement process. On the other hand, when no abnormality is detected at any stage during the measurement process, no error code is associated with the measurement result obtained through the measurement process.
- a physician will recognize that a measurement with an associated error code contains an error, and that a measurement without an associated error code will contain an error. And acknowledge. .
- the lab technician compares the measurement result list with the error code list, and the measurement result that is likely to contain an error even though no error code is attached.
- the task of picking up is imposed. This task places a burden on clinical laboratory technicians. In addition, differences in experience and skill among laboratory technicians make the accuracy of the work unstable.
- An object of the present invention is to improve the error management accuracy of a measurement result. .
- the device has a measuring unit.
- the measurement unit measures the measurement target and generates a plurality of measurement results for a plurality of measurement items.
- the abnormality detector detects an abnormality in the measurement process for each measurement result.
- the storage unit stores a plurality of measurement results.
- the primary error code associating unit assigns a primary error code to at least one measurement result in which an abnormality is detected in the measurement process.
- the secondary error code association unit associates the secondary error code with at least one measurement result in which no abnormality is detected in the measurement process.
- FIG. 1 is a perspective view of a measuring unit of an automatic analyzer according to an embodiment of the present invention. ⁇
- FIG. 2 is a schematic block diagram of the automatic analyzer according to the embodiment of the present invention. ⁇
- FIG. 3 shows a flowchart of the measurement procedure in the embodiment of the present invention. .
- FIG. 4 shows the configuration of the photometric unit in the embodiment of the present invention.
- FIG. 5 shows a configuration of the sampling monitor method in the embodiment of the present invention.
- FIG. 6 shows an error code association table stored in the table storage unit of FIG.
- Figure 7 shows how to update the error code association table in Figure 6.
- 8A and 8B show examples of the measurement result list displayed on the display unit in FIG.
- FIG. 9 shows an error association procedure by the association units 53 and 54 in FIG. ...
- the measurement results of the sample collected from the subject are obtained through the measurement process corresponding to each measurement item.
- the measurement process is sample absorption
- Reagents are used according to the measurement items.
- the step of aspirating the first sample collected from the first subject is distinguished from the step of injecting the second sample collected from the second subject. Aspirating the first reagent is distinguished from injecting the second reagent.
- the measuring section 30 has a sample section 1.
- the sample section 1 stores a plurality of samples and selectively injects a plurality of samples into a plurality of reaction cells 12.
- the reagent section 2 stores a plurality of reagents and injects the plurality of reagents into a plurality of reaction cells 1.2.
- the reaction section 3 reacts the sample with the reagent injected into the same cell and measures the reaction solution.
- the sample section 1 includes a sample disk 3, a sample arm 5, and a sample probe 6.
- the sample disk 3 holds a plurality of sample containers 4.
- the plurality of sample containers 4 contain a plurality of samples such as blood collected from a plurality of subjects.
- the plurality of sample containers 4 are typically arranged concentrically.
- the sample disk 3 is rotatably supported. The rotation of the sample disk 3 is controlled so that any sample container 4 stops at the sample suction position.
- the sample arm 5 is pivotably supported.
- the sample probe 6 is attached to the tip of the sample arm 5.
- the sample probe 6 reciprocates between the sample suction position on the sample disk 3 and the sample dispensing position on the reaction disk 11 by the rotation of the sample arm 5.
- the sample in the sample container 4 at the sample suction position is sucked from the sample probe 6.
- the aspirated sample is injected into the reaction cell 12 at the sample dispensing position.
- the reagent section 2 includes a reagent storage 7, a reagent container 8, a first reagent arm 9.1, a second reagent arm 9-2, a first reagent probe 10-1 and a second reagent. Probes 1 0 and 2
- the reagent storage 7 is provided alongside the reaction disk 11.
- the reagent storage 7 holds a plurality of reagent containers 8.
- the plurality of reagent containers 8 contain a plurality of reagents.
- the plurality of reagent containers 8 are typically arranged concentrically.
- the first and second reagent arms 911 and 912 are arranged near the center thereof.
- the first and second reagent arms-9-1, 9-2 transfer the reagent sucked from any reagent container 8 on the reagent storage 7 to the first disk with rotation on the reaction disk 11. 1 or. Discharge into the specific reaction cell 12 that has reached the second reagent dispensing position.
- the reagent storage 7 may be rotatably supported. In this case, the rotation of the reagent storage 7 is controlled so that any reagent container 8 stops at the first or second reagent suction position.
- the reagent in the reagent container 8 at the first or second reagent suction position is sucked by the first or second reagent probe 10-1 or 10-2.
- the sucked reagent is discharged to the reaction cell 12 at the first or second reagent dispensing position.
- the reaction section 3 has a reaction disk 11.
- Reaction disk 1 1 has a plurality of reaction cells 12 arranged in a ring.
- the reaction disk 11 is rotatably supported.
- a stirrer 13, a washing unit 15 and a photometric unit 14 are arranged along the outer periphery of the reaction disk 1.1. The rotation of the reaction disk 11 is intermittently rotated according to the measurement process.
- the stirrer 13 has, for example, a pair of stirrers.
- the stirrer is composed of, for example, a piezoelectric vibrator. The stirrer vibrates when an alternating voltage is applied. Due to the vibration, the sample contained in the reaction cell 12 is mixed with the reagent contained in the same reaction cell 12 and stirred.
- the cleaning unit 15 has a first cleaning nozzle, a second cleaning nozzle, and a drying nozzle.
- the first cleaning nozzle injects the detergent into the reaction cell 12 that has reached the first cleaning position on the reaction disk 11.
- the second cleaning nozzle injects pure water into the reaction cell 12 that has been washed with the detergent that has come off at the second cleaning position on the reaction disk 11.
- the drying nozzle dries the reaction cell 12 that has been washed with pure water that has reached the drying position on the reaction disk 11.
- the photometric unit 14 has a light emitting unit 61.
- the light emitting unit 61 irradiates the reaction liquid 62 of the reaction cell 12 that has reached the photometry position on the reaction disk 11 with light.
- the amount of light transmitted through the reaction solution 62 is measured at the light receiving part 64 via the spectroscopic part 63.
- the signal processing section 65 amplifies the output signal of the light receiving section 64 and converts it into digital data (measurement result data).
- the control unit 31 shown in FIG. 2 controls the measurement unit 30.
- the control section 31 drives the sample disk mechanism section 4 4 that drives the rotation of the sample disk 3 and the swivel and up and down movement of the sample arm 5
- a sample arm mechanism 45 that drives the sample probe 6,
- a sample probe mechanism 46 that drives the suction and discharge of the sample probe 6, and
- a sample mechanism control circuit 41 that controls the mechanisms 44 to 46.
- the sample probe mechanism 46 has a sampling pump.
- the control section 31 includes a reaction disk mechanism section 48 for driving the rotation of the reaction disk 11, a stirring mechanism section 47 for driving the stirrer, and a washing unit for driving the washing unit 15. It has a mechanism section 49 and a reaction section mechanism control circuit 42 for controlling the mechanism sections 47 to 49.
- the control unit 3 1, first, One 1 second reagent arm 9, 9 one second pivot and the reagent arm mechanism 5 1 which drives the elevator, first, second reagent probe 1 0 one 1 1 0 — 2 includes a reagent pump mechanism 52 for driving suction and discharge of No. 2 and a reagent mechanism control circuit 43 for controlling the mechanism.
- the sample section mechanism control circuit 41, the reaction section mechanism control circuit 42, and the reagent section mechanism control circuit 43 are controlled by the CPU 36.
- the CPU 36 stores a data (measurement result data) output from the signal processing unit 65 together with a patient identification number (sample identification number) and a measurement step identification number.
- an analysis unit 32 that analyzes stored data (measurement result data) and outputs analysis result data such as a concentration and a component ratio.
- the analysis result data is stored in the data storage unit 35 together with the patient identification number (sample identification number) and the measurement step identification number.
- a plurality of sensors 39 are connected to the CPU 36. Multiple sensors 39 can individually detect the occurrence of multiple types of abnormalities in the measurement process. To detect.
- the measurement process includes multiple measurement steps such as sample aspiration, sample injection, reagent aspiration, reagent injection, agitation, reaction, photometry, reaction liquid disposal, detergent injection, washing, pure water injection, washing, and pure water disposal. I have.
- the plurality of sensors 39 detect operation abnormalities in a plurality of measurement stages, respectively. More specifically, multiple sensors 39 may have abnormal sample suction, abnormal sample injection, abnormal reagent suction, abnormal reagent injection, expired reagent, agitation, abnormal temperature, constant temperature water temperature drop, luminous intensity drop, and reaction liquid discard.
- Data relating to the abnormality detected by the plurality of sensors 39 is stored in the error storage unit 56 via the CP'U'36.
- the data related to the abnormality includes a time code indicating the time when the abnormality was detected, a code identifying the measurement process in which the abnormality was detected, a code identifying the measurement stage in which the abnormality was detected, and the type of abnormality. Contains the identifying code. ⁇ ⁇
- the primary error code associating unit 53 associates the primary error code with the data of the measurement result generated through the measurement process in which the abnormality specified by the abnormality data is detected.
- the data of the measurement result associated with the primary error code is stored in the data storage unit 35.
- the primary data may be associated with the analysis data instead of the measurement data. Multiple types of primary error codes are selected according to the type of anomaly or the measurement stage in which the anomaly occurred.
- the primary error code indicates that the associated measurement result has a relatively high probability of error due to anomalies during the measurement process. Exchange In other words, the measurement result associated with the primary error code includes an error caused by at least one abnormality that occurred during the measurement process. .
- the secondary error code associating unit 54 converts the data of the specific measurement result selected based on the abnormality data from the plurality of measurement results generated through the measurement process in which no abnormality is detected, into the secondary error code associating unit. Associate the error code.
- the specific measurement result is selected according to the error code association template stored in the storage unit 55.
- FIG. 6 shows an error code association table relating to the measurement item T3.
- the error code association table for the measurement item 'T3' shows the measurement items (Tl, ⁇ 2, ⁇ ⁇ : ⁇ ⁇ 7) that relate the secondary error code to the type of error (A to F). ) And.
- Tl, ⁇ 2, ⁇ ⁇ : ⁇ ⁇ 7 the measurement items that relate the secondary error code to the type of error (A to F).
- the secondary error code has an error in the measurement result to which it is associated without anomalies occurring during the measurement process, but with errors occurring during other measurement processes. It indicates that there is a possibility that the error is included with a relatively low probability.
- the output section 33 has a display section 38 and a printing section 37.
- the display unit 38 displays a list of measurement results along with the primary error code and the secondary error code under the control of the CPU 36. To be displayed.
- the secondary error code is displayed in a different color from the primary error code.
- the printing unit 37 prints the measurement result list on paper together with the primary error code and the secondary error code under the control of the CPU 36.
- the secondary error code is printed in a different color from the primary error code.
- the input unit 34 is used to create and update the above-mentioned error code association table together with various inputs such as patient ID, sample number, and test start command performed by the operator. Used for traction input. ⁇ '
- FIG. 3 shows a measurement procedure in this example.
- the operator sets the sample container 4 containing a sample such as blood at a predetermined position on the sample disk 3 (step S1).
- a command for starting the measurement is input (steps S2 to S3).
- the CPU 36 receives this data, reads out the measurement items required for this sample from the storage unit 35 (Step S4), the sample unit mechanism control circuit 41, and the reaction unit mechanism control circuit. 4 2. Send data on mechanism control to the reagent section mechanism control circuit 4 3.
- the sample section mechanism control circuit 41 sends a control signal to the sample disk mechanism section 44 according to the instruction of the CPU 36, and the sample disk mechanism section 44 places the sample container 4 in a predetermined position based on this signal. Control the rotation of sample disk 3 so that it is installed.
- a sample arm 5 is provided in the vicinity of the section, and a sample probe 6 is attached to the tip of the sample arm 5.
- the sample mechanism control circuit 41 sends a control signal to the sample arm mechanism 45 and the sample probe mechanism 46, and the sample arm mechanism 45 receives a sample signal based on this signal.
- the sample arm 6 mounted on the tip of the arm 5 is moved to the sample container 4 placed on the sample disk 3 (step S5). Further, the sample arm / mechanism part 45 lowers the sample probe 6 to the sample container 4, aspirates a predetermined amount of the sample, and then raises it (step).
- Step S 6 the sample is sucked by the sample probe mechanism 46.
- the sample arm mechanism 45 rotates the sample arm 5 to move the sample probe 6 to the sample dispensing position on the reaction disk 11. Then, the sample probe 6 is lowered into the inside of the reaction cell 12 installed at this position (step S7).
- the sample probe mechanism 4.6 dispenses a predetermined amount of the sample into the reaction cell 12 using the sample probe 6 (step S8).
- reagent dispensing operation When sample dispensing is completed, the operation shifts to reagent dispensing operation.
- a reagent container 8 containing a reagent predetermined for a measurement item of a sample is arranged in a circumferential shape.
- the reagent section mechanism control circuit 43 is a reagent container designated by the CPU 36 from the reagent containers 8 set in the reagent storage 7. Rotation control is performed so that the reagent arms 9 1 and 9-2 move.
- the first reagent arm 9-1 and the second reagent arm 9-1-2 installed near the reagent storage 7 have reagent probes 10-1 and 10-2 attached to their tips, respectively.
- the control circuit 43 uses these two reagent arms 911 and 912 to transfer the reagent probes 10-1 and 10-2 to the reagent container 8 installed at a predetermined position of the reagent storage 7. Move to the position (step S9). -Next, the reagent probe 10 is lowered into the reagent bin 8 to aspirate a predetermined amount of the reagent (Step S10), and then lifted. When the raising of the reagent probe 10 is completed, the reagent probe 10 is moved to the reaction cell 12 placed at a predetermined position of the reaction disk 11 by rotating the reagent arm 9 (step S1). Step_S 11), a reagent is dispensed into the reaction cell 12 by a predetermined amount (Step S 12). The suction in the reagent container 8 and the dispensing into the reaction cell 12 are performed by the reagent probe mechanism 52.
- the reaction mechanism control circuit 42 performs a rotation operation using the reaction disk mechanism 48 to move the reaction cell 12 into which the sample and the reagent have been dispensed to a position for stirring (step).
- Step S 13. The reaction section mechanism control circuit 42 uses the stirring mechanism section 47 to descend the stirrer 13 provided near or beside the outer periphery of the reaction disk 11, and the stirrer attached to the tip of the stirrer 13.
- the mixture of the sample and the reagent in the reaction cell 12 is stirred (step S14).
- the temperature of the reaction cell 12 is maintained at a preset temperature by a constant temperature control circuit (not shown).
- the photometric unit 14 provided on the reaction disk 11 emits light from the light emitting unit 61 according to the instruction signal of the CPU 36.
- the reaction cell 12 placed at the photometry position of the disk 11 is irradiated, and the amount of transmitted light is measured to measure the amount of change in the sample of the reaction cell 12 due to the reagent (step S 15). ).
- This measurement result is converted into a digital signal by an AZD converter (not shown) of the photometry unit 14 and sent to the CPU 36.
- the CPU 36 reads this value and sends it to the analysis unit 32.
- the analysis unit 32 performs a quantitative component analysis of the sample based on the measured value (step S16).
- the analysis unit 32 further adds a data-error code to the value of the above-described component analysis, if necessary, according to a method described later, and the CPU 36 transmits these results from the analysis unit 32.
- the data is read out and stored in the storage unit 35 (step S17).
- the reaction mechanism control circuit 42 rotates the reaction disk 11 to move the reaction cell 12 used for the above inspection to the predetermined cleaning position, and prepares for this cleaning position.
- the washing unit 15 thus washed and dried the reaction cell 12 with the washing nozzle and the drying nozzle, and completes the inspection for one item (step S18).
- each operation of sample dispensing, reagent dispensing, stirring, reaction, and measurement is repeated according to the above procedure, and the obtained test results (measured values) are sequentially It is sent to the analysis unit 32.
- the details of the data / error code addition procedure shown in step S17 will be described later.
- FIG. 4 is a configuration diagram of a spectrophotometer used for the photometric unit 14 and includes a light emitting unit 61, a spectroscopic unit 63, a light receiving unit 64, and a signal processing unit 6'5. '
- the sample 62 is irradiated with light from the light emitting section 61 composed of a halogen lamp and the like.
- a so-called light absorption phenomenon in which light of a specific wavelength is absorbed, occurs due to changes in chemical reactions and the like.
- the transmitted light is split by the spectroscopy unit 63 and the light intensity change of a specific wavelength is measured by the light receiving unit 64. Therefore, the state of the sample 62 can be quantitatively grasped by measuring the ratio (transmission percentage) of the magnitude of the incident light to the specimen and the magnitude of the transmitted light with light of a specific wavelength. And can be.
- the light transmitted through the sample 62 is converted into an electric signal by the light receiving unit 64, and amplification and A / D conversion are performed by the signal processing units 6 and 5.
- the CPU 36 sequentially reads the value of the transmitted light having a specific wavelength and sends it to the analyzer 32.
- the analyzer 32 calculates the transmittance and absorbance for each wavelength based on the transmitted light intensity value I ( ⁇ ) and the transmitted light intensity value I ⁇ () Then, the CPU 36 temporarily stores the result in the storage unit 35. At this time, items that can be recorded are: 1) name of measurement item, 2) measurement result, 'data' error 'code, etc.
- FIG. 5 is a diagram showing the configuration of the sampling monitor method. Detecting the pressure inside the pipe connecting the sampling probe mechanism 46 equipped with a sampling pump and the sampling probe 6 in the middle of the pipe Pressure sensor 16 to be installed. When the sample in the sampling container 4 is sucked by the sampling probe, the pressure sensor 16 detects the pressure in the tube, and further converts the value to A / D. The CPU 36 reads the pressure value converted into the digital signal, determines whether or not the suction operation is normal. Add a data 'error code indicating suction abnormality to the value.
- the sampling monitor method for detecting the suction abnormality of the sampling probe was described.
- Use various sensors for items that affect measurement results such as the remaining amount of samples and reagents, the supply state of pure water used for washing, the remaining amount of detergent, and the temperature of constant temperature water in which the reaction tube is immersed. It is possible to monitor. For example, if the temperature of the reaction tube is significantly different from the specified temperature (37 ° C), the measurement result is greatly affected, and the temperature of the reagent storage 7 is also determined. If not kept below the specified temperature (for example, 10 ° C), a problem will occur. ⁇
- the operating state of the motor that causes the agitation failure is also detected by the dedicated sensor, and the result is sent to the CPU 36 via the I / F to check for abnormalities.
- the high viscosity of the solution (sample and reagent), which was mentioned as a cause of suction abnormality in the sampling probe, may also cause poor stirring. . ⁇
- the lamp used in the light emitting section 61 in FIG. 4 has a service life. If the lamp is used beyond this service time, the light quantity will decrease and fluctuate, causing measurement errors. Can be. Therefore, a measurement result using a lamp whose lamp life has passed the preset time is associated with the expired primary or secondary lamp of the lamp. The same applies to the association of primary or secondary error codes with measurement results for expired reagents and probes. It is necessary to monitor the usage time of such parts, consumables, or reagents that are used repeatedly, and if the life time is exceeded, a primary or secondary error will occur. Code association is desirable.
- Figure 6 shows the relationship between the measurement items and the error mixing factors (abnormality types) '.
- the table shown in Fig. 6 measures a certain sample. If an abnormality occurs during the measurement process corresponding to measurement item T3, the abnormality indicates an error in the measurement results of other measurement items. Is built based on the possibility of mixing .
- the secondary error code "cJ" is used for the measurement results of other measurement items for which no abnormality has actually been detected, but which may have errors associated with the abnormality.
- two types of error codes are used to distinguish between the measurement item that actually caused the abnormality and the measurement item that is expected to contain errors due to the abnormality.
- the primary error code and the secondary error code are selectively associated with the measurement item, the primary error code is written in upper case ⁇ CJ, and the secondary error code is written in lower case ⁇ cj To be distinguished.
- Figure 7 shows the graphical user interface provided by CPU 36 when creating or updating an error code association table.
- the CPU 36 receiving this command displays the input screen of FIG. 7 on the display unit 38.
- the operator uses the mouse of the input unit 34 to click, for example, "abnormal suction" of an abnormality (.priority error code c) to display the next input screen. Click “Relate to other items” on this screen to select it, set the secondary error code to be associated to “c”, and then click the associated measurement item selection button. Click.
- FIG. 8A and FIG. 8B show display examples of the measurement result list.
- measurement item T1 (GOT. (Glutamic acid oxalacetic acid transaminase).)
- Measurement item T2 (GPT (glutamate birubic acid )
- Measurement item T3 (LDH (serum lactate dehydrogenase)
- measurement item T4 (TP (total protein)
- measurement item T5 (ALB (albumin)
- the figure shows the case where the measurement steps are performed sequentially. 'In these measurements, the absorbance at a predetermined wavelength is stored in the storage unit 35 as a measurement result. .
- FIG. 8A shows a case where a suction abnormality was found from the information of the pressure sensor 16 in the first GOT inspection.
- the measurement result at this time includes a primary error code “C Is added.
- C Is primary error code
- Fig. 8B shows the case where the suction pressure abnormality was not detected in each of the G, ⁇ T, and GPT tests, and the suction pressure abnormality was detected for the first time in the third LDH test.
- the primary error code “C” is appended to the LDH measurement result. You.
- secondary error code “c” is also added to the measurement results of GOT and GPT that have already been measured.
- the measurement result showed an abnormal value, and the value was out of the normal range due to the range check.Therefore, the data was neither a primary error code nor a secondary error code.
- a third error code “U.” indicating an abnormality is appended to the GPT measurement result. It is not known at this stage whether this abnormal value is due to the condition of the disease or due to an abnormality in the reagents, etc., but it is not possible to obtain data from various sensors placed in the device. If there is no data error information, there may be a data error specific to this measurement item. Therefore, add this error code “U” only to this measurement item.
- the error code “c” or “U” is associated only with the item where the measurement process abnormality or data abnormal value was detected. For this reason, the cause of the GPT error code “U” was difficult to understand.
- the GPT since the GPT is appended with the secondary code “c”, the operator can easily know that this sample may be clogged. Can be done. Error code "It can be inferred that the cause of UJ is caused by clogging of the sample. Therefore, there is an advantage that it is easy to judge the re-test. in if you want to "re-examination” is, if the "re-examination” specified for-error code ".
- FIG. Figure 9 shows the procedure for N measurement items from T1 to TN.
- the abnormality detection signal is generated based on the stored abnormality data.
- the CPU 36 detects whether or not the signal is generated from one sensor 39 corresponding to the type of measurement or its measurement stage. If no abnormality detection signal is output, the CPU 36 measures the next measurement item T n + 1. Transition.
- Step 3 the CPU 36 stores The table stored in advance in section 55 is compared with the above-mentioned abnormality type (or measurement stage) to determine the type of primary error code (step S32). 35 Read out the inspection result of inspection item ⁇ ⁇ stored in 5 and associate the primary error code “C” corresponding to the type of abnormality (or the measurement stage in which the abnormality occurred) (Step S33) 0
- CP monument 3-6 whether or not the abnormal measurement items T n measurement E enough to stop or even Ru of 'the. Or the judges on the basis of the error code associated with the table (Step-up S 3 4), If there is no measurement item to which the secondary error code is related, proceed to the next measurement item T n + 1.
- this abnormality affects the measurement results of other measurement items
- the table it is searched whether or not the measurement item corresponding to the secondary error code is executed before Tn (step S35). Is interrupted (step S37).
- the secondary error code “ c ” is associated with the specific inspection result stored in the storage unit 35 and stored in the playback storage unit 3.5.
- Step S36 After (Step S36), the measurement is interrupted (Step S37)-. -'
- the detected abnormality affects the measurement process of other measurement items, that is, there is a measurement item that associates a secondary error code with the detected abnormality.
- the measurement is interrupted at the point determined.
- the measurement is continued.
- the determination as to whether to suspend or continue this measurement may be made in more detail based on the content of the error. For example, if an abnormality is caused due to a probe clogging at the time of aspirating or discharging the sample, it is not necessary to continue the subsequent measurement, and the measurement is stopped when the abnormality is detected.
- the CPU 36 reads the measurement results of the measurement items T1 to Tn stored in the storage circuit 35 and the associated primary error code. And output it on the display unit 38 or the printing unit 37. (Step S38). .
- this item is marked with a capital "C” and other relevant items that may be affected by the suction error, in order to clarify the measurement item that actually caused the suction error.
- 'A lowercase letter “c” is associated with the measurement item to distinguish it.
- a primary error code is associated with the measurement result generated by the measurement process in which an error was detected, and a secondary result was found in some measurement results that could contain errors due to non-detection of errors.
- Associate an error code By selectively using two types of error codes in this way, for example, if the sample contains a factor that significantly deteriorates the measurement accuracy as described above, the measurement Error codes can be prevented, and sample reconfirmation and reinspection work can be performed without omission. That is, according to the present embodiment, when one abnormal phenomenon occurs, an error code (secondary error) is given to the measurement result of another measurement item that is considered to be affected by the abnormal phenomenon. By associating the code, a warning can be issued for a test result that was conventionally mistaken as being correct and that could lead to a misdiagnosis. 'Therefore, the reliability of the test results obtained by the automatic analyzer is greatly improved. .
- the past measurement results (measurement history) for the same subject sample are stored and stored in advance in the storage circuit of the device, and the comparison between the measurement results and the newly obtained measurement results is performed. By doing so, the credibility of the measured data can be known. That is, if the difference between the two at this time exceeds a predetermined value, there is a high possibility that a data error has occurred, and the fifth error code may be associated with the inspection result. This will provide valuable information to encourage re-examination. '' In the middle of the measurement process (during measurement), if an abnormality occurs in the measurement operation of the device, such as the probe being clogged during suction or discharge, the measurement result is displayed for the measurement item being measured at that time.
- the primary and secondary error codes are automatically associated with the measurement item and other measurement items. Is also good. In this way, measurement errors can be identified in real time, so it is possible to respond quickly to retests.
- Bas, 6 in which the this Ru can be improved error management accuracy of the measurement results.
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- General Physics & Mathematics (AREA)
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Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03736187.0A EP1512974B1 (en) | 2002-06-12 | 2003-06-12 | Automatic analysis device, measurement device, and measurement result management method |
US10/864,534 US20040224351A1 (en) | 2002-06-12 | 2004-06-10 | Automatic analyzer, measuring device, and method for controlling measurements |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002170821A JP3901587B2 (ja) | 2002-06-12 | 2002-06-12 | 自動分析装置および自動分析装置におけるデータ管理方法 |
JP2002-170821 | 2002-06-12 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/864,534 Continuation US20040224351A1 (en) | 2002-06-12 | 2004-06-10 | Automatic analyzer, measuring device, and method for controlling measurements |
Publications (1)
Publication Number | Publication Date |
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WO2003107012A1 true WO2003107012A1 (ja) | 2003-12-24 |
Family
ID=29727777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2003/007499 WO2003107012A1 (ja) | 2002-06-12 | 2003-06-12 | 自動分析装置、測定装置および測定結果を管理する方法 |
Country Status (5)
Country | Link |
---|---|
US (1) | US20040224351A1 (ja) |
EP (1) | EP1512974B1 (ja) |
JP (1) | JP3901587B2 (ja) |
CN (1) | CN1613014A (ja) |
WO (1) | WO2003107012A1 (ja) |
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Families Citing this family (33)
Publication number | Priority date | Publication date | Assignee | Title |
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JP7185743B2 (ja) * | 2017-05-31 | 2022-12-07 | シスメックス株式会社 | 試料調製装置、及び試料調製方法 |
JP6434114B1 (ja) * | 2017-11-30 | 2018-12-05 | シスメックス株式会社 | 測定方法および測定装置 |
DE102018126078A1 (de) * | 2018-10-19 | 2020-04-23 | Endress+Hauser Conducta Gmbh+Co. Kg | Verfahren zur Behandlung von Ausnahmezuständen eines Messsystems |
JP7342122B2 (ja) * | 2019-07-03 | 2023-09-11 | 株式会社日立ハイテク | 自動分析装置および自動分析装置の表示装置の表示方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5730939A (en) * | 1995-03-17 | 1998-03-24 | Hitachi, Ltd. | Automatic analyzer having fluid abnormalities detection device |
JP3052020B2 (ja) * | 1992-06-11 | 2000-06-12 | 本田技研工業株式会社 | 自動車の組立方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4980292A (en) * | 1984-10-01 | 1990-12-25 | Baxter International Inc. | Tablet dispensing |
JPH01219564A (ja) * | 1988-02-26 | 1989-09-01 | Toshiba Corp | 自動化学分析装置 |
EP1965326A3 (en) * | 1999-11-30 | 2008-12-31 | Sysmex Corporation | Support method, quality control method, and device therefor |
WO2002073504A1 (en) * | 2001-03-14 | 2002-09-19 | Gene Logic, Inc. | A system and method for retrieving and using gene expression data from multiple sources |
-
2002
- 2002-06-12 JP JP2002170821A patent/JP3901587B2/ja not_active Expired - Lifetime
-
2003
- 2003-06-12 WO PCT/JP2003/007499 patent/WO2003107012A1/ja active Application Filing
- 2003-06-12 EP EP03736187.0A patent/EP1512974B1/en not_active Expired - Lifetime
- 2003-06-12 CN CNA03801890XA patent/CN1613014A/zh active Pending
-
2004
- 2004-06-10 US US10/864,534 patent/US20040224351A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP3052020B2 (ja) * | 1992-06-11 | 2000-06-12 | 本田技研工業株式会社 | 自動車の組立方法 |
US5730939A (en) * | 1995-03-17 | 1998-03-24 | Hitachi, Ltd. | Automatic analyzer having fluid abnormalities detection device |
Non-Patent Citations (1)
Title |
---|
See also references of EP1512974A4 * |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105842201A (zh) * | 2016-03-25 | 2016-08-10 | 丁鸿 | 半自动凝血分析仪的检测方法 |
CN105866072A (zh) * | 2016-03-25 | 2016-08-17 | 丁鸿 | 基于冷光源的凝血检测方法以及装置 |
Also Published As
Publication number | Publication date |
---|---|
CN1613014A (zh) | 2005-05-04 |
JP2004012442A (ja) | 2004-01-15 |
EP1512974A1 (en) | 2005-03-09 |
EP1512974A4 (en) | 2010-03-31 |
JP3901587B2 (ja) | 2007-04-04 |
EP1512974B1 (en) | 2013-10-23 |
US20040224351A1 (en) | 2004-11-11 |
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