JP2010256260A - Automatic analyzer - Google Patents

Abstract

[PROBLEMS] A conventional automatic analyzer performs analysis of items used only for abnormality determination in advance in order to determine an abnormal specimen, and visual extraction by a clinical technologist or a doctor. There was a lot of waste in terms. Even if the sample is determined to require retesting, it is discarded outside the automatic analyzer after the analysis is completed, so it is necessary to place the sample in the device again at the time of retesting. There was sometimes.
A function for extracting an item to be recommended for reexamination from an abnormality determination result for a measurement result and highlighting the item and the sample on a display screen is provided. Furthermore, it has a function that can quickly shift to the measurement state when a re-examination is requested by maintaining the measurable state without discarding the sample in the recommended state outside the apparatus. As a result, it is possible to provide an automatic analyzer that can reduce the labor required for retesting, prevent an omission of abnormal sample extraction, and enable accurate retesting.
[Selection] Figure 1

Description

  The present invention relates to an automatic analyzer that performs qualitative / quantitative analysis of samples such as blood and urine, and more particularly to a multi-item automatic analyzer that can analyze the same specimen using a plurality of analysis items.

  Usually, in an automatic analyzer, a plurality of measurement items are requested for one patient sample, and if a measurement value of an item among them is out of a reference range, some disease is suspected.

  At the time of determination, the laboratory technician or doctor visually determines the normality / abnormality of the sample after the measurement. The sample determined to be abnormal is set again in the automatic analyzer for measurement again, and reanalysis is started.

  In this way, it takes a lot of time and labor for a person to check all the measurement results and determine the necessity of re-examination. In addition, since the sample for which the measurement has been completed is discarded outside the apparatus, it is necessary for the sample to be retested to be set in the apparatus again and restart the analysis, resulting in a remeasurement result. It was a loss of time.

  In view of this, Patent Documents 1 and 2 disclose an invention in which a measured value is compared with a predetermined reference value and a sample outside the reference value range is automatically reexamined. As a result, it is possible to reduce the time and labor required for the operator to check the measurement result and to set the retest sample again in the apparatus, and to shorten the time until the retest result is output.

  However, the reference value range used for determination is determined by a statistical method of multiple specimens and does not apply to all individuals, so it is not necessarily abnormal even if it is not within the reference value range Is not limited. Furthermore, the normal value range of an individual itself changes depending on the disease and physical condition of the individual and is not fixed. By automatically performing a reexamination on all specimens outside the reference value range, items that do not need to be measured may be measured. In addition, it is necessary to carefully select the items to be analyzed rather than mechanically analyzing the reexamination items for a small amount of samples that cannot be collected in large quantities.

  In order to accurately determine an abnormality, it is necessary to make a human decision that appropriately considers the individual patient's condition.

JP-A 63-206660 Japanese Patent Laid-Open No. 2-195260

  Patent Document 1 and Patent Document 2 disclose an invention in which additional measurement of necessary items is automatically determined and remeasured in order to clarify a suspected disease based on measurement data of multiple examination request items. Yes.

  However, a simple judgment formula is not enough to actually determine the necessity of remeasurement, and various factors such as the age of the patient, the degree of obesity, the presence or absence of smoking, the type of disease, the presence or absence of a biological variation such as genetics, etc. Factors need to be considered. For this reason, doctors and laboratory technicians visually check the measurement results and make advanced judgments to determine additional measurement items. Therefore, a great deal of labor and time is required to extract a sample to be remeasured from many samples. In addition, omission of extraction caused delays in finding serious diseases.

  In addition, with the conventional automatic analyzer, the sample that has been measured is discarded outside the automatic analyzer, so it takes time to install the remeasurement sample in the device again before starting the remeasurement. It took time to output the results.

  An object of the present invention is to provide an automatic analyzer that reduces the labor of clinical laboratory technicians and doctors, prevents extraction omission, enables accurate reexamination, and further reduces the time required for patient diagnosis. There is.

  The invention of the present application is an automatic analyzer comprising an analysis unit that adds a reagent to a sample and performs analysis, and a display unit that displays a measurement result obtained by the analysis unit. A determination unit that determines whether there is a sample abnormality based on the control unit, and a control unit that controls the display unit to display an analysis item that recommends an additional test for the sample that the determination unit determines to have a sample abnormality It is characterized by.

  Here, the determination unit determines whether the measurement result is inside or outside the range with respect to a predetermined normal value range of each measurement item, and there is a possibility of some abnormality / disease in the sample to be measured. Whether or not.

  Doctors and technologists can re-examine specimens for which re-examination is recommended, i.e., specimens whose analysis results are out of the normal range and may have some abnormality or disease. The labor and time for determining the necessity of inspection can be greatly reduced.

  Further, as other features according to the present invention, the display unit collects the patient name of the sample in which the sample abnormality has occurred, sample ID, collection time, sample information, analysis item, detected abnormality content, measurement time, recommended It is characterized by displaying at least one of a re-inspection item to be performed and a reason for recommending the item.

  Here, the specimen information indicates at least one of the age of the patient, the history of the disease, the degree of obesity, the presence or absence of smoking, the type of the disease, and the presence or absence of a biological variation such as inheritance.

  With this feature, miscellaneous information related to determination of specimen abnormality can be displayed on the same screen.

  In addition, as another feature according to the present invention, in an automatic analyzer including an analysis unit that performs analysis by adding a reagent to a sample, and a display unit that displays a measurement result obtained by the analysis unit, A determination unit that determines presence / absence of a sample abnormality based on a measurement result in the analysis unit, and a control unit that controls to hold the sample determined as the sample abnormality by the determination unit in the apparatus even after the measurement is completed. It is characterized by.

  Here, the term “hold” refers to setting a position or a state where the apparatus can immediately shift to an analysis operation within the apparatus. When the sample is placed on the disk and transported, the user should not accidentally remove the sample recommended for retesting, or when the sample is placed on the rack or cassette and transported, the rack or It is conceivable to control so that the sample dispensed from the cassette is held or to prevent the rack or cassette from being collected outside the apparatus.

  With this feature, an analysis operation can be started immediately for a sample that may be an abnormal sample even after the analysis is completed.

  According to the present invention, doctors and laboratory technicians mainly check samples that are recommended for reexamination, that is, samples that have a measurement result of an analysis item that deviates from the normal value range and may have some abnormality or disease. Therefore, the labor and time for determining the necessity of re-examination can be greatly reduced. In addition, since doctors and laboratory technicians can intervene in the necessity of reexamination, an accurate reexamination request can be made.

  Further, when determining the presence or absence of additional measurement, doctors and laboratory technicians can easily confirm information related to determination of necessity of additional measurement on the same screen, so that determination can be easily performed.

  In addition, for example, when a doctor or laboratory technician requests a re-examination for a sample recommended for re-examination, the sample has not been re-installed because the sample has already been discharged out of the apparatus, and the operator It is possible to save time and to display a quick result.

It is explanatory drawing which showed the principle whole structure outline of the automatic analyzer. It is a retest recommendation screen which displays a list of retest recommended samples. It is a measurement result screen which browses the measurement result of the measured sample. It is a measurement item addition screen for adding measurement items. It is a retest recommendation screen for setting recommended conditions for retesting. It is an additional item determination screen for registering a recommended additional item determination formula. It is a reexamination recommended sample screen in a disk type automatic analyzer.

  Re-examination recommendation to set recommended conditions for automatically recommending specimens and measurement items to be re-measured, highlighting those items and specimens, and holding re-recommendation recommended specimens in a measurable state This was realized with a condition screen, a measurement result screen for viewing measurement results, and a retest recommendation screen.

  FIG. 2 is a schematic diagram of the overall structure of the automatic analyzer. In FIG. 2, reference numeral 2-1 denotes an operation unit. The operation unit includes a keyboard 2-2 for inputting data, a mouse 2-3, a display device 2-4 for displaying data, and a printer for printing data. This is a computer having peripheral devices such as a printing device 2-5, an interface 2-6 for connecting to an analysis unit, and a storage device 2-7 for storing reexamination recommended conditions and reexamination recommended information.

  Reference numeral 2-8 denotes an analysis unit, which is connected to the operation unit 2-1 through an interface 2-6.

  In the analysis unit, 2-9 is a reaction disk, and a plurality of reaction vessels 2-10 are installed on the concentric circumference thereof. 2-11 is a reagent disk, and a plurality of reagent bottles 2-12 containing various reagents are installed on the concentric circle. Around the reaction disk 2-9, a sample dispensing probe 2-13, a stirring device 2-14, a cleaning device 2-15, a light source 2-16, and a multi-wavelength photometer 2-17 are arranged respectively. Has been. A reagent dispensing probe 2-18 is disposed between the reaction disk 2-9 and the reagent disk 2-11. In addition, a dispensing sample disk 2-19 is provided on the rotation circumference of the sample dispensing probe 2-13 and next to the reagent disk 2-11. A plurality of dispensing sample containers 2-20 containing dispensing samples are installed in a dispensing sample disk 2-19. Further, a rack transport belt 2-24 is installed next to the dispensing sample disk 2-19. The rack 2-22 moves on the rack transport belt 2-24. A plurality of original sample containers 2-23 containing original samples are installed in a rack 2-22. An original sample dispensing probe 2-21 is disposed between the dispensing sample disk 2-19 and the rack transport belt 2-24. All of these mechanism operations are controlled by the computer 2-26 via the interface 2-25.

  The operator uses the display device 2-4 of the operation unit 2-1, the keyboard 2-2, or the mouse 2-3 to request a measurement item and give a measurement instruction to the analyzer. The measurement instruction is transmitted to the analysis unit 2-8 via the interface 2-6. The analysis unit 2-8 performs the measurement operation as follows in accordance with the received measurement instruction.

  The original sample dispensing probe 2-21 dispenses a predetermined amount of the original sample contained in the original sample container 2-23 into the dispensing sample container 2-20. When the dispensing for one original sample container 2-23 is completed, the rack transport belt 2-24 moves the rack 2-22 so that the next original sample container 2-23 is directly below the original sample dispensing probe 2-21. Moving. When the dispensing of all the original sample containers 2-23 on the rack 2-22 is completed, the rack 2-22 is carried out by the rack transport belt 2-24. Meanwhile, the diluent in the reagent bottle 2-12 is dispensed to the sample in the dispensing sample container 2-20 by the reagent dispensing probe 2-18. The sample dispensing probe 2-13 dispenses a predetermined amount of the dispensed sample contained in the dispensed sample container 2-20 into the reaction container 2-10 for the number of requested items. When the dispensing for one dispensing sample container 2-20 is completed, the dispensing sample disk 2-19 rotates so that the next dispensing sample container 2-20 is directly below the sample dispensing probe 2-13. The reaction container 2-10 into which the dispensed sample has been dispensed rotates on the reaction disk 2-9 by the rotation of the reaction disk 2-9. Meanwhile, with respect to the sample in the reaction container 2-10, the reagent in the reagent bottle 2-12 is dispensed by the reagent dispensing probe 2-18, the reaction liquid is stirred by the stirring device 2-14, the light source 2-16, Then, the absorbance is measured by the multiwavelength photometer 2-17, and the reaction vessel 2-10 for which the measurement has been completed is subsequently cleaned by the cleaning device 2-15. The measured absorbance signal enters the computer 2-26 via the interface 2-25 via the A / D converter 2-27. From this absorbance signal, based on the analytical method set for each measurement item, calibration curve data is calculated from the set concentration data in the case of standard solution samples, and measurement of standard solution samples in the case of patient samples and control samples Concentration data is calculated from the calibration curve data obtained in (1). These data are transmitted as measurement results to the operation unit 2-1 via the interface 2-6 after adding information symbolizing the type of the sample. The operation unit 2-1 recommends reexamination according to the reexamination recommended conditions stored in the storage device 2-7, and displays it on the display device 2-4. The laboratory technician decides whether or not reexamination is necessary for the reexamination recommended sample, but in some cases, a doctor's judgment is required. In this case, reexamination recommendation information is sent to the doctor's computer terminal 2-28 via the interface 2-32. The doctor determines whether reexamination is necessary using the display device 2-31, the keyboard 2-29, or the mouse 2-30.

  In the above operations and operations, setting of the judgment items for additional items for which re-measurement is recommended, setting of re-inspection conditions, and request for re-inspection are performed by the display device 2-4, the keyboard 2-2, or the mouse 2- 3 is used.

  1, 3 and 4 are examples of screens displayed on the display device 2-4 from the measurement result until a reexamination is requested.

  FIG. 3 is a measurement result screen displaying the measurement result of the specimen.

  The sample list 3-1 displays a list of all measurement samples. In this sample list 3-1, in addition to sample information such as sample ID, patient name, measurement date and time, a status column indicating a retest status is set. For samples recommended to be retested, a retest is recommended in the status column. Is displayed. Furthermore, it may be emphasized by a display that draws attention from the operator, such as coloring or bold characters.

  In the data list 3-2, the measurement result of the sample selected in the sample list 3-1 and the items recommended for additional measurement are highlighted.

  In the reexamination recommended comment 3-3, a comment for an item for which additional measurement is recommended is displayed.

  If an additional recommended item is selected in the data list 3-2 and a request button 3-4 is selected, a measurement request is made. If not, select cancel button 3-5 to cancel the recommendation.

  Specimen attribute button 3-7 displays a patient attribute screen for inputting patient-specific information such as age, obesity level, smoking status, disease type, genetic status, etc. used as a comment to determine whether to request or cancel. Can be displayed.

  When the retest recommendation button 3-6 is selected, a retest recommendation screen (shown in FIG. 1) for displaying a list of samples recommended for retesting is displayed.

  FIG. 1 is a retest recommendation screen that displays a list of samples recommended for retesting.

  Samples recommended for reexamination can be confirmed in the reexamination recommended sample list 1-1. A status column for displaying the elapsed time after the re-examination recommendation and whether the re-examination recommendation is in the canceled / requested state / measurement state is set together with the ID and patient name which are information for specifying the specimen.

  Further, as a process for re-examination recommendation, a re-examination recommendation column for displaying whether the status is unprocessed / answered / inquiry is set.

  The retest recommended item list 1-2 displays the measurement items and recommended items of the sample selected in the retest recommended sample list 1-1. The displayed contents are the measured item name and measured value, the re-examination recommended factor (setting based on the recommended judgment formula or manual setting), the reason for recommendation, and the recommended item.

  When the patient attribute button 1-3 is selected, a patient attribute screen is displayed in which related information such as the patient's age, obesity level, smoking status, disease type, genetic status, etc. can be input as a comment. The laboratory technician, who is the operator, grasps the patient's condition from this screen, and determines whether or not to make a retest request together with the measurement result and the reason for recommendation.

  When it cannot be determined only by the inspection engineer, the inquiry button 1-4 is selected. As a result, the information on the sample is transmitted to the doctor, and it is possible to determine whether or not to perform the reexamination and the measurement additional item based on the judgment of the doctor.

  The request button 1-5 is used to request a measurement of the recommended item displayed in the reexamination recommended item list 1-2. A cancel button 1-6 cancels the recommendation of the item displayed in the reexamination recommended item list 1-2.

  Selecting the close button 1-8 closes the retest recommendation screen.

  The item addition button 1-7 is used to recommend the measurement of items not displayed in the reexamination recommended item list 1-2. When the item addition button 1-7 is selected, a measurement item addition screen shown in FIG. 4 is displayed. Is done.

  On the measurement item addition screen, an additional item is selected in the additional item selection combo box 4-1. The reason for adding the item is entered in the comment edit box 4-2. The input contents here are also reflected in the comment string of the reexamination recommended item list 1-2 in FIG. 1, the reexamination recommended comment 3-3 in FIG. 3, and the inquiry information to the doctor by the inquiry button 1-4 in FIG. Is done.

  A cancel button 4-3 cancels the input contents and closes the measurement addition screen.

  A registration button 4-4 registers input contents and closes the measurement addition screen.

  FIG. 5 and FIG. 6 are screen displays for setting a retest recommendation.

  FIG. 5 is a retest recommendation condition screen for performing various settings for retest recommendation.

  If the “not recommended” radio button 5-1 is selected for reexamination, reexamination recommendation is not performed.

  When the “Recommend” radio button 5-2 is selected, re-examination is recommended.

  When the “Continue operation if recommended” check box 5-3 is selected, the analyzer continues the analysis operation state as long as there is a sample recommended for retesting. As a result, when a re-examination request is made for a sample recommended for re-examination, it is possible to quickly move to an analysis operation.

  Selecting the “Retain recommended samples in the apparatus” check box 5-4 holds the samples recommended for retesting in the apparatus.

  For example, a dispensed sample container 2-20 containing a sample that has been analyzed is usually washed after removing the sample contained by a sample container washing mechanism (not shown). For example, it may be possible to control the dispensing sample container 2-20 containing the so as not to perform the washing operation.

  Further, control is performed so that the rack 2-22 for transporting the sample recommended for retesting is retracted to a retested sample retracting unit (not shown), or is continuously transported to a transport lane (not shown) so that the rack 2-22 is not collected. I think that.

  As a result, when a measurement request is made, rapid reexamination can be performed without re-installing the specimen. The time designation edit box 5-5 sets a time for which the recommended specimen is held in the apparatus.

  When the “Start measurement automatically when requesting recommendation” check box 5-6 is selected, the re-recommended specimen is automatically analyzed. Thereby, even when a doctor requests a measurement item at the doctor's computer terminal 2-28, the analysis is started.

  When the “Automatically request recommended items” check box 5-7 is selected, recommended measurement items are automatically registered as requests and analyzed.

  When the “Measure recommended sample in urgent treatment” check box 5-8 is selected, when a measurement recommendation item is requested, measurement is started with priority over other analysis items.

  When the “Check with host” check box 5-9 is selected, an inquiry is automatically made to the doctor's computer terminal 2-28 when a recommended measurement sample is generated.

  A cancel button 5-13 cancels the setting contents and closes the reexamination recommended condition screen.

  A registration button 5-12 registers the setting contents and closes the reexamination recommended condition screen.

  FIG. 6 is an additional item determination screen for setting a plurality of conditions for recommending reexamination as determination formulas.

  In the determination formula list 6-1, additional measurement items, recommended determination formulas, and comments regarding the determination are displayed.

  When the edit button 6-2 is selected, the contents selected in the judgment formula list 6-1 can be edited.

  When the delete button 6-3 is selected, the contents selected in the determination formula list 6-1 can be deleted.

  A cancel button 6-7 cancels the edited determination formula and closes the additional item determination screen.

  The registration button 6-6 registers the determination formula and closes the additional item determination screen.

  FIG. 7 is a retest recommended specimen screen.

  This screen is displayed in the case of a disk-type automatic analyzer, and highlights a sample that is recommended for reexamination at position 7-2 in which the sample disk is arranged as shown in FIG. When the position 7-2 recommended for reexamination is selected, the relevant sample is selected in the reexamination recommended list 7-3 displaying a list of information and positions related to the reexamination recommended sample.

  When the close button 7-5 is selected, the reexamination recommended sample screen is closed.

1-1 Retest Recommended Sample List 1-2 Retest Recommended Item List 1-3 Patient Attribute Button 1-4 Inquiry Button 1-5, 3-4 Request Button 1-6, 3-5, 4-3, 5-13, 6-7 Cancel button 1-7 Item addition button 1-8 Close button 2-1 Operation unit 2-2, 2-29 Keyboard 2-3, 2-30 Mouse 2-4, 2-31 Display device 2-5 Print Devices 2-6, 2-25, 2-32 Interface 2-7 Storage device 2-8 Analysis unit 2-9 Reaction disk 2-10 Reaction vessel 2-11 Reagent disk 2-12 Reagent bottle 2-13 Sample dispensing probe 2-14 Stirring device 2-15 Cleaning device 2-16 Light source 2-17 Multi-wavelength photometer 2-18 Reagent dispensing probe 2-19 Dispensing sample disk 2-20 Dispensing sample container 2-21 Original sample dispensing probe 2-22 Rack 2-23 Original Sample Volume Device 2-24 Rack transport belt 2-26 Computer 2-27 A / D converter 2-28 Doctor's computer terminal 3-1 Specimen list 3-2 Data list 3-3 Retest recommendation comment 3-6 Retest recommendation button 4-1 Additional item selection combo box 4-2 Comment edit box 4-4, 5-12, 6-6 Register button 5-1 Not recommended radio button 5-2 Recommended radio button 5-3 Check to continue operation if recommended Box 5-4 Check box for holding recommended samples in the device 5-5 Time specification edit box 5-6 Automatically start measurement upon request for recommendation 5-7 Automatically request recommended items Check box 5-8 Check box 5-9 for measuring recommended specimens in an emergency Check box 6-1 determination formula to match list 6-2 editing button 6-3 delete button

Claims (10)

An analysis unit for performing analysis by adding a reagent to a sample;
In an automatic analyzer comprising a display unit for displaying the measurement result obtained by the analysis unit on a screen,
A determination unit that determines the presence or absence of a specimen abnormality based on a measurement result in the analysis unit,
An automatic analyzer comprising: a control unit that controls to display an analysis item that recommends an additional test on the display unit for a sample that is determined to be abnormal by the determination unit. The automatic analyzer according to claim 1, wherein
An automatic analyzer comprising: a control unit configured to control the analysis result of the analysis item in which the specimen abnormality has occurred and the recommended additional analysis item to be displayed on the same screen. The automatic analyzer according to claim 2,
The automatic analysis apparatus, wherein the control unit performs control to identify and display the recommended additional analysis item. The automatic analyzer according to claim 1, wherein
The display unit collects the name of the patient from whom the sample abnormality occurred, the sample ID, the collection time, the sample information, the analysis item, the detected abnormality content, the measurement time, the recommended reexamination item, the reason why the item is recommended An automatic analyzer comprising a control unit that controls to display at least one of the above. An analysis unit for performing analysis by adding a reagent to a sample;
In an automatic analyzer comprising a display unit for displaying the measurement result obtained by the analysis unit,
A determination unit for determining the presence or absence of a specimen abnormality based on a measurement result in the analysis unit;
An automatic analyzer comprising: a control unit configured to control a sample determined by the determination unit to be abnormal in the apparatus even after the measurement is completed. The automatic analyzer according to claim 5, wherein
A storage unit that stores a maximum holding time in which the specimen recommended for the additional examination by the determination unit can be held in the automatic analyzer, and a holding state is released for a sample that is held beyond the maximum holding time. An automatic analyzer characterized by including a control unit for controlling the operation. The automatic analyzer according to claim 6,
The automatic analyzer is characterized in that an operator can specify the maximum hold time. The automatic analyzer according to claim 5, wherein
A sample disk for laying a plurality of parent samples for analysis on the circumference,
An analysis disk provided on the circumference with an analysis cell for mixing a child sample collected from a parent sample on the sample input unit with a reagent;
A display unit that associates and displays position information of a parent sample installed on the sample disk, an analysis status of the sample on the analysis disk, and an analysis result;
The control unit controls the sample recommended for the additional measurement by the determination unit so as to describe that the additional measurement is recommended for display on the display unit corresponding to the parent sample. An automatic analyzer. The automatic analyzer according to claim 5, wherein
A pretreatment disk in which a plurality of pretreatment cells for pretreating a specimen are arranged on the circumference;
A pretreatment cleaning mechanism for aspirating the specimen on the pretreatment disk and discharging it to the specimen waste drain in order to wash the pretreatment cell whose measurement has been completed,
The control unit controls the specimen on the pretreatment disk recommended for additional measurement by the determination unit so that the pretreatment cleaning mechanism does not suck and discharge to the waste drain. apparatus. The automatic analyzer according to claim 5, wherein
A sample transport mechanism for transporting a rack in which one or more samples are installed;
A sample collection unit that collects a rack in which a sample that has been analyzed is installed outside the automatic analyzer, and
The automatic analyzer according to claim 1, wherein the control unit controls the rack in which the sample recommended for the additional measurement by the determination unit is not transported to the sample collection mechanism.

Images