JP5535047B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer for automatically performing qualitative / quantitative analysis of a biological sample such as blood, which is used in a clinical test, and particularly relates to determination of necessity of measurement of a quality control sample or calibration.

  In the automatic analyzer, a reagent bottle set (one set of reagent bottles) is set in the reagent table for each analysis item to be analyzed in the biological sample, and the standard solution is used for the set reagent before starting the analysis. Calibration for density calculation is performed and the result is stored.

  Here, in the case of an analysis item that requires only one type of reagent, the reagent bottle set means one reagent bottle containing the reagent, and in the case of an analysis item that requires a plurality of types of reagents. Means a reagent bottle in which each reagent is separately stored for each type.

  When multiple reagent bottle sets are set for the same item, a barcode or the like is attached to the reagent bottle. Information includes reagent analysis item information, reagent type (first reagent and second reagent), reagent lot information, serial number information in the reagent lot, information on the expiration date of the reagent, etc. In addition, the reagent bottle can be uniquely identified. And the function to hold | maintain a calibration result etc. for every reagent bottle set as described in Unexamined-Japanese-Patent No. 9-325150 (patent document 1) is known, for example.

  In addition, the reagent bottle containing the reagent is generally kept at about 8 ° C. on the apparatus, but the deterioration of the reagent cannot be avoided. For this reason, for example, as described in JP-A-61-38464 (Patent Document 2), it is necessary to create or correct a calibration curve using a standard solution at time intervals according to items. A function for instructing the creation of a calibration curve for each item or the execution of correction according to a set time (effective time) is used.

  These are functions related to calibration, but the automatic analyzer also has a function to hold the measurement results of quality control samples for each reagent bottle set and a function to encourage the measurement of quality control samples at time intervals set for each analysis item. It is installed.

  Further, for example, as described in JP-A-10-339732 (Patent Document 3), the status of calibration or accuracy management of a plurality of analysis units is managed in an integrated manner, and There was also technology that encouraged operators to make measurements.

JP-A-9-325150 JP-A-61-38464 JP-A-10-339732

  The analysis items to be measured by the automatic analyzer include not only items that are steadily analyzed every day, but also items that are measured steadily when necessary, for example, once a week. .

  Even if the reagent table of the automatic analyzer has a cooling function, it is inferior to a dedicated refrigerator, so the reagents used for the items to be measured irregularly are not kept in the reagent table of the device, In some cases, the system is stored in a refrigerator or the like outside the apparatus, and the reagent is set in the apparatus for analysis as necessary.

  As described above, conventionally, as a trigger for prompting an operator to measure a calibration or quality control sample, calibration or quality control is performed when the time interval of the calibration or quality control sample set for each analysis item has passed. Trigger that prompts the measurement of the sample, trigger that prompts the measurement of calibration when the calibration curve itself does not exist, trigger that prompts the measurement of calibration again if the calibration fails if the calibration result is not within the set tolerance Examples include a trigger that prompts the measurement of the quality control sample again when the measurement value of the quality control sample is not within the allowable range and the measurement value is not allowable.

  However, even if the reagent once used for the analysis is removed from the apparatus and re-installed, it does not cope with prompting the calibration or the measurement of the quality control sample.

  Therefore, an object of the present invention is to automatically reduce the burden on the operator by reducing the operation of the quality control sample and the calibration measurement even when the used reagent is stored outside the apparatus and re-installed in the apparatus. An analyzer is provided.

  The above and other objects and novel features of the present invention will be apparent from the description of this specification and the accompanying drawings.

  Of the inventions disclosed in the present application, the outline of typical ones will be briefly described as follows.

  That is, the outline of a typical one is a reagent table in which a plurality of reagent bottles containing reagents are installed, a database for storing setting information and accuracy management results for the accuracy management of reagent bottles for each reagent bottle, and a reagent to the reagent table When a reagent bottle once installed in the reagent table is removed from the reagent table and installed in the reagent table again based on the bottle installation information and the setting information related to accuracy control, And a control unit that displays a screen for prompting measurement on the display unit.

  In addition, a reagent table in which a plurality of reagent bottles for storing the reagent are installed, a database for storing setting information and calibration results for calibration of the reagent bottles for each reagent bottle, and information on the installation of the reagent bottles in the reagent table and calibration When the reagent bottle once installed in the reagent table is removed from the reagent table and installed again in the reagent table based on the setting information on the display, a screen prompting calibration for the reagent bottle is displayed on the display unit. And a control unit.

  The effects obtained by typical ones of the inventions disclosed in the present application will be briefly described as follows.

  In other words, the effect obtained by a typical one is to reduce the burden on the operator by prompting the measurement of a quality control sample or calibration even when the reagent once used is stored outside the apparatus and re-installed in the apparatus. Can do.

It is a block diagram which shows the structure of the automatic analyzer which concerns on one embodiment of this invention. It is explanatory drawing for demonstrating the example of a setting regarding the measurement of the quality control sample of the automatic analyzer which concerns on one embodiment of this invention. It is explanatory drawing for demonstrating the example of a setting regarding the measurement of the calibration of the automatic analyzer which concerns on one embodiment of this invention. It is a flowchart which shows the determination process of the necessity of measurement of the quality control sample or calibration of the automatic analyzer which concerns on one embodiment of this invention. It is explanatory drawing for demonstrating the setting which gives priority to quality control / calibration in the automatic analyzer which concerns on one embodiment of this invention. It is a figure which shows an example of the screen which prompts an operator to measure the quality control sample with respect to the operator of the automatic analyzer which concerns on one embodiment of this invention. It is a figure which shows an example of the screen which prompts an operator to measure the calibration with respect to the operator of the automatic analyzer which concerns on one embodiment of this invention.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. Note that components having the same function are denoted by the same reference symbols throughout the drawings for describing the embodiment, and the repetitive description thereof will be omitted.

  With reference to FIG. 1, the configuration of an automatic analyzer according to an embodiment of the present invention will be described. FIG. 1 is a configuration diagram showing a configuration of an automatic analyzer according to an embodiment of the present invention.

  In FIG. 1, the automatic analyzer includes a sample container 1, a sample table 2 (2a, 2b), a sample dispensing mechanism 3, a reaction container 4, a reaction table 5, a reagent table 6, a reagent bottle 7, a reagent dispensing mechanism 8, The stirring mechanism 9, the photometer 10, the reaction vessel cleaning mechanism 11, the control unit 21, and the user interface 22 are configured.

  The automatic analyzer is divided into a sample erection part and a reaction part. In the sample erection part, samples such as serum and urine collected in the sample container 1, standard solutions for calibration, and quality control samples are sampled. It is built on the table 2.

  The sample table 2 is divided into two types, one having no cooling function (2a) and one having a cooling function (2b). Usually, a specimen is placed on the sample table 2a without the cold insulation function, and a sample that may be measured several times a day, such as a quality control specimen, is placed on the sample table 2b with the cold insulation function.

  In addition to the one using the disk-shaped sample table 2 (2a, 2b) shown in FIG. 1, the sample erection part may supply a sample rack erected with a sample container to the sample dispensing position.

  The sample is discharged from the sample container 1 to the reaction container 4 by the sample dispensing mechanism 3. The reaction container 4 is arranged on the circumference of the reaction table 5 in the reaction section. When the reaction table 5 rotates, the reaction container 4 into which the sample has been dispensed moves to the reagent addition position, and the reagent table 6 A reagent of a predetermined analysis item is added from the reagent bottle 7 set to the position by the reagent dispensing mechanism 8.

  A plurality of reagent bottles 7 are installed on the reagent table 6. As the reagent table 6 rotates, a predetermined reagent bottle 7 used for the item is moved to the reagent suction position of the reagent dispensing mechanism 8. The reaction vessel 4 to which the reagent has been added moves to the stirring position as the reaction table 5 rotates, and the reaction solution is stirred by the stirring mechanism 9. The reaction vessel 4 containing the reaction solution passes through the optical axis of the photometer 10 at regular intervals by the rotation of the reaction table 5, and the absorbance is measured each time.

  The concentration of the target component in the sample is calculated from the measured absorbance and the calibration curve drawn in advance, and the result is output. The used reaction vessel 4 is washed by the reaction vessel washing mechanism 11 and used for the next measurement.

  Control and processing of the entire automatic analyzer such as these operations and other processing are performed by the control unit 21. Further, the automatic analyzer performs exchanges with the operator via the user interface 22. Examples of the user interface 22 include a CRT that is a display unit, a keyboard, a mouse, and a storage medium.

  In addition, although the biochemical automatic analyzer is shown here as the automatic analyzer, in the automatic immune analyzer, the reaction container 4 is often disposable, and therefore there is no reaction container cleaning mechanism 11, The measurement is different not in measuring the absorbance of the reaction solution but in measuring the light quantity of the luminescent label.

  Here, in order to uniquely identify the reagent bottle 7, the reagent bottle 7 includes information on the reagent in the reagent bottle 7 (analysis item, reagent type (first reagent and second reagent), lot number, lot A medium (bar code or RFID) that stores serial numbers, etc.) is attached, and the reagent table 6 is a means (reagent for recognizing the information according to the storage medium attached to the reagent bottle). A barcode reader is provided if the bottle information storage medium is a barcode, and an RFID reader if the storage medium is RFID (not shown).

  Moreover, in order to manage the reagent bottle 7 uniquely, in addition to the analysis item etc., the automatic analyzer manages each reagent bottle lot number and the serial number in the lot as a database of the reagent bottle 7, for example, A database is stored in a storage unit in the control unit 21 or other storage device. In addition, a mechanism (not shown) for recognizing removal / insertion of the reagent bottle 7 from the reagent table 6 is provided.

  In order to recognize this insertion / extraction, for example, a lid and a sensor as means for detecting opening / closing of the lid may be installed on the reagent table 6. As another loading / unloading recognition method, a reagent bottle installation mechanism for automatically loading / unloading the reagent bottle 7 to / from the reagent table 6 may be provided, and loading / unloading may be managed by an instruction from the user interface 22 or the like.

  Next, referring to FIG. 2, a setting example relating to the measurement of the quality control sample of the automatic analyzer according to the embodiment of the present invention will be described. FIG. 2 is an explanatory diagram for explaining a setting example related to the measurement of the quality control sample of the automatic analyzer according to the embodiment of the present invention.

  The operator sets whether or not to perform the quality control sample measurement when the reagent bottle 7 is once installed in the automatic analyzer → storage outside the apparatus → reinstalled in the automatic analyzer.

  In addition, when the quality control sample measurement is required, the storage period outside the apparatus used for the determination standard for promoting the measurement of the quality control sample and the quality control sample for promoting the measurement are set. Note that these settings in quality control sample measurement once stored outside the device can be easily set for each analysis item because the judgment criteria and the quality control sample to be measured are easily estimated to vary depending on the analysis item. Better.

  Next, referring to FIG. 3, a setting example relating to calibration measurement of the automatic analyzer according to the embodiment of the present invention will be described. FIG. 3 is an explanatory diagram for explaining a setting example regarding calibration measurement of the automatic analyzer according to the embodiment of the present invention.

  The operator sets whether or not to perform calibration measurement when the reagent bottle 7 is once installed in the automatic analyzer → storage outside the apparatus → reinstalled in the automatic analyzer. When calibration measurement is necessary, the storage period outside the apparatus used as a criterion for prompting calibration measurement and the calibration execution method are set. The execution method of calibration is selected from four types of blank, span, two points, and all points.

  Here, the blank is used when the calibration to be performed uses one type of standard solution with zero concentration, and the span is the calibration when the calibration to be performed is performed with one type of standard solution having a known concentration other than zero. Two points are when the calibration to be performed uses two types of standard solutions with known concentrations, and all the points are when the calibration to be performed uses three or more types of standard solutions with known concentrations.

  Note that these settings in the calibration measurement once stored outside the device are easily estimated that the judgment criteria and calibration execution method differ depending on the analysis item, so it should be set for each analysis item. Good.

  Next, with reference to FIG. 4 and FIG. 5, a determination process for determining whether or not the accuracy control sample or calibration measurement of the automatic analyzer according to the embodiment of the present invention is necessary will be described. FIG. 4 is a flowchart showing a determination process of whether or not the measurement is required for the quality control sample or calibration of the automatic analyzer according to the embodiment of the present invention, and FIG. 5 shows the accuracy in the automatic analyzer according to the embodiment of the present invention. It is explanatory drawing for demonstrating the setting which prioritizes management / calibration.

  First, the automatic analyzer performs a reagent bottle scan to read information on a storage medium attached to the reagent bottle 7 installed on the reagent table 6 (S100). The reagent bottle scan may be performed automatically by opening / closing the lid of the reagent table 7 as a trigger, or may be performed at a timing designated by the operator.

  When the reagent bottle scan is performed, the automatic analyzer compares the installation status of the reagent bottles on the reagent table before and after the reagent bottle scan, and the reagent bottles installed on the reagent table after the reagent bottle scan are detected. Then, it is discriminated whether it is kept on the reagent table, installed after the reagent bottle scan, or removed after the reagent bottle scan (S101). For the reagent bottle 7 determined to remain on the reagent table in S101, the measurement of the quality control sample or calibration triggered by storage outside the apparatus is not prompted (S102).

  Here, the reagent bottle 7 determined to have been installed after the reagent bottle scan in S101 is the reagent bottle 7 that has never been installed in the automatic analyzer, or once installed in the automatic analyzer → storage outside the apparatus → automatic analyzer Since the reagent bottle 7 has been re-installed, it is determined whether it is newly installed or re-installed (S103).

  As a method of distinguishing the two in S103, for example, there is a method of storing the time taken out from the reagent table 6 in the database of the reagent bottle 7 described above.

  For those removed after the reagent bottle scan in the comparison before and after the reagent bottle scan, for example, the time of the reagent bottle scan or the like is stored in the database as the time taken out from the reagent table 6.

  By doing in this way, there is nothing for the reagent bottle that has never been installed in the automatic analyzer at the time when it was taken out from the reagent table of the reagent bottle database. Can be distinguished from reagent bottles re-installed in the automatic analyzer.

  In S103, the reagent bottle determined to have never been installed in the automatic analyzer (newly installed reagent bottle) is not prompted to measure a quality control sample or calibration triggered by storage outside the apparatus. (S102).

  In the case of the reagent bottle 7 determined to be re-installed in S103, it is taken out from the reagent table on the reagent bottle database, which is determined in advance for each analysis item, whether it is necessary to execute the quality control sample or calibration (S104). Based on the determination of the set time, the current time, and the storage period outside the apparatus (S105), the measurement of the set quality control sample or calibration is prompted (S106).

  In S101, the reagent bottle 7 determined to have been taken out from the reagent table 6 after the reagent bottle scan writes the time taken out from the reagent table 6 to the database of the reagent bottle 7 (S107).

  Here, when both the quality control sample and the calibration measurement are prompted for a certain reagent bottle 7 triggered by storage outside the apparatus, first, after the calibration measurement, the calibration curve is correct. For confirmation, the flow of quality control is performed. In other words, it is usual to prioritize the direction that prompts calibration measurement.

  Depending on the analysis item, it is necessary to deal with the case where control is preferred. However, in that case, as shown in FIG. 5, in addition to the setting contents in FIG. 2 and FIG.

  Next, an example of a screen for the operator of the automatic analyzer according to the embodiment of the present invention will be described with reference to FIGS. FIG. 6 is a diagram showing an example of a screen prompting the operator to measure the quality control sample for the operator of the automatic analyzer according to the embodiment of the present invention, and FIG. 7 is a diagram of the automatic analyzer according to the embodiment of the present invention. It is a figure which shows an example of the screen which prompts an operator to measure the calibration with respect to an operator.

  First, the reagent bottle 7 for the analysis item A set as shown in FIG. 2 is re-installed in the reagent table 6 on the storage outside the apparatus (accuracy control sample) setting screen, and the current time is indicated in the reagent table. If more than 48 hours have passed since the time taken out from 6, the control A and control B are prompted for measurement.

  In this case, as shown in FIG. 6, on the screen for requesting quality control sample measurement with the apparatus for each analysis item and quality control sample, storage outside the apparatus in the factor column and measurement in the request column are prompted. In this case, the operator can confirm that the measurement of the control in the item is prompted.

  Further, on the storage (calibration) setting screen outside the apparatus, the reagent bottle for the analysis item A set as shown in FIG. 3 is re-installed at position 2 on the reagent table 6, and the current time is displayed. When 96 hours or more have elapsed since the time when the reagent table was taken out, blank calibration measurement is prompted.

  In this case, as shown in FIG. 7, on the screen for requesting calibration in the apparatus for each analysis item and position, it is recommended in the sense that storage in the factor column is stored outside the apparatus, and measurement is prompted in the request column, By describing the calibration execution method, the operator can confirm that the calibration measurement for the item is prompted.

  As mentioned above, the invention made by the present inventor has been specifically described based on the embodiment. However, the present invention is not limited to the embodiment, and various modifications can be made without departing from the scope of the invention. Needless to say.

  The present invention relates to an automatic analyzer for automatically performing qualitative / quantitative analysis of a biological sample such as blood, which is used in a clinical test, and can be widely applied to an accuracy control sample, an apparatus or system for measuring calibration, and the like. .

  DESCRIPTION OF SYMBOLS 1 ... Sample container, 2a ... Sample table (no cooling function), 2b ... Sample table (with cooling function), 3 ... Sample dispensing mechanism, 4 ... Reaction container, 5 ... Reaction table, 6 ... Reagent table, 7 ... Reagent Bottle, 8 ... Reagent dispensing mechanism, 9 ... Stirring mechanism, 10 ... Photometer, 11 ... Reaction vessel cleaning mechanism, 21 ... Control unit, 22 ... User interface.

Claims (4)

An automatic analyzer that analyzes the components of the biological sample by dispensing the biological sample and the reagent into a reaction vessel and analyzing the reaction solution,
A reagent table in which a plurality of reagent bottles containing the reagents are installed;
A database that stores setting information and accuracy management results for accuracy management of the reagent bottles for each reagent bottle;
When the reagent bottle once installed in the reagent table is removed from the reagent table, the time information removed from the reagent table is stored in the database, and the reagent bottle is installed in the reagent table. based on the information, the setting information for the previous SL quality control, and the time information, when the reagent bottle once installed in the reagent table is removed from the reagent table, which is installed in the reagent table again, A control unit that displays a screen for prompting measurement of the quality control sample on the reagent bottle on a display unit ,
The setting information related to the quality control is information set for each analysis item,
In the setting information regarding the accuracy management, an allowable time during which the reagent bottle is not installed in the reagent table is set for each analysis item,
The control unit displays a setting screen for setting the allowable time on the display unit, and sets the allowable time in the setting information related to the accuracy management based on the information on the allowable time input based on the setting screen. When the reagent bottle that has been set and removed from the reagent table is placed in the reagent table again, the allowable time set in the setting information related to the accuracy management and the reagent bottle are placed in the reagent table. An automatic analyzer that compares the time periods that are not used and displays on the display unit a screen that prompts the reagent bottle to measure the quality control sample based on the comparison information . An automatic analyzer that analyzes the components of the biological sample by dispensing the biological sample and the reagent into a reaction vessel and analyzing the reaction solution,
A reagent table in which a plurality of reagent bottles containing the reagents are installed;
A database for storing setting information and calibration results for calibration of the reagent bottles for each reagent bottle;
When the reagent bottle once installed in the reagent table is removed from the reagent table, the time information removed from the reagent table is stored in the database, and the reagent bottle is installed in the reagent table. based on the information, the setting information for the previous SL calibration and the time information, when the reagent bottle once installed in the reagent table is removed from the reagent table, which is installed in the reagent table again, A control unit that displays a screen for prompting calibration on the reagent bottle on a display unit ,
The setting information related to the calibration is information set for each analysis item,
In the setting information related to the calibration, an allowable time during which the reagent bottle is not installed in the reagent table is set for each analysis item,
The control unit displays a setting screen for setting the allowable time on the display unit, and sets the allowable time in the setting information related to the accuracy management based on the information on the allowable time input based on the setting screen. When the reagent bottle that has been set and removed from the reagent table is placed in the reagent table again, the allowable time set in the setting information related to the calibration and the reagent bottle are placed in the reagent table. An automatic analyzer characterized in that a time for not calibrating is compared and a screen for prompting the calibration for the reagent bottle is displayed on the display unit based on the comparison information . An automatic analyzer that analyzes the components of the biological sample by dispensing the biological sample and the reagent into a reaction vessel and analyzing the reaction solution,
A reagent table in which a plurality of reagent bottles containing the reagents are installed;
Database for storing setting information regarding accuracy management of the reagent bottle, accuracy management result, setting information regarding calibration, and calibration result for each reagent bottle;
When the reagent bottle once installed in the reagent table is removed from the reagent table, the time information removed from the reagent table is stored in the database, and the reagent bottle is installed in the reagent table. Based on the information, the setting information related to the accuracy management, the accuracy management result, the setting information related to the calibration, and the calibration result, the reagent bottle once installed in the reagent table is removed from the reagent table, A controller for displaying on the display unit at least one of a screen for prompting measurement of the quality control sample for the reagent bottle and a screen for prompting calibration when the reagent table is installed again;
The setting information related to the accuracy management and the setting information related to the calibration are information set for each analysis item,
In the setting information related to the accuracy management and the setting information related to the calibration, an allowable time during which the reagent bottle is not installed in the reagent table is set for each analysis item,
The control unit displays a setting screen for setting the allowable time on the display unit, and based on the information on the allowable time input based on the setting screen, setting information related to the accuracy management, and the calibration The allowable time is set in the setting information related to, and when the reagent bottle once removed from the reagent table is installed in the reagent table again, the allowable time set in the setting information related to the accuracy management, and the A screen that compares the allowable time set in the setting information related to calibration and the time when the reagent bottle is not installed in the reagent table, and prompts the reagent bottle to measure the quality control sample based on the comparison information , and in particular the at least one screen of a screen prompting the calibration be displayed on the display unit Automatic analyzer to. The automatic analyzer according to claim 3,
The control unit causes the display unit to display a setting screen for setting priority information indicating which measurement should be prioritized for the accuracy management and the calibration, and the priority information input based on the setting screen is displayed. And storing the priority information in the database, and controlling the display order of the screen for prompting the measurement of the quality control sample and the screen for prompting the calibration based on the priority information. .

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