Abstract:
An automatic analyzer according to the invention can execute the re-measurement of a calibration or quality control sample easily when the measured data of the quality control sample is out of the reference range having maximum and minimum values set in advance. Accordingly, the automatic analyzer can quickly execute a process for the quality control and highly reliable analysis continuously. The analyzer includes a function that the measured data of a quality control sample is compared with the reference maximum and minimum values of the measured data of a quality control sample, then when the measured data is out of the range between the reference maximum and minimum values, the re-measurement of a calibration is recommended and so a user can easily instruct to confirm on an operation screen and to request the measurement. Further, the analyzer includes a means which can easily instruct to confirm the measured data of the quality control sample being out of the range between the reference maximum and minimum values and to perform the re-measurement of the quality control sample of this analysis item.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates to an automatic analyzer which performs the qualitative and quantitative analysis of a biological sample such as blood and urine and, in particular, to an automatic analyzer which performs the quality control of analysis results and an analyzer using measured data of a quality control sample.  
       DESCRIPTION OF THE RELATED ART  
       [0002]     An automatic analyzer, which performs the qualitative and quantitative analysis of a biological sample such as blood and urine by using reagent that specifically reacts on a measurement object component within the biological sample and changes its own physical properties, has been spread mainly in large hospitals and medical laboratories due to high measurement reproducibility and a high processing ability. In such the automatic analyzer, so-called quality control, for periodically measuring a sample (quality control sample) which density is known in advance, is performed in order to determine whether or not the measured result is reliable.  
         [0003]     The conventional automatic analyzer is provided with a display function capable of easily confirming whether or not the measured data of a quality control sample is within a target range, as described in JP-A-2000-187037.  
       SUMMARY OF THE INVENTION  
       [0004]     In the conventional automatic analyzer, when the measured data of a quality control sample is out of the target range, in general, a user determines a measure from the user&#39;s past experience based on the measured data of the quality control sample and calibration results etc. However, it is supposed that an operator inexperienced in the operation of the automatic analyzer may not be able to determine the measure. Further, in the case of measuring the quality control sample, there is a problem that the setting of the measurement is troublesome.  
         [0005]     An object of the present invention is to provide an automatic analyzer which provides a means capable of executing the re-measurement of a calibration or a quality control sample easily with respect to a reagent of an analysis item as to which the measured data of a quality control sample is out of the range between reference maximum and minimum values set in advance so that even an operator inexperienced in the operation of the automatic analyzer can quickly perform a measure for the quality control and a highly reliable analysis can be realized continuously.  
         [0006]     In order to attain the aforesaid object, an automatic analyzer according to the present invention is configured in the following manner. First, there is provided with a means for setting and storing determination parameters which are used to determine the measured data of a quality control sample. The determination parameters are information for discriminating the quality control sample (for example, name of the quality control sample), a range between reference minimum and maximum values (a coefficient as to a control SD) and calibration methods (combination patterns of standard samples used in the calibration measurement). Next, a value obtained by multiplying the control SD of the quality control sample registered in the analyzer by a coefficient of the range between reference minimum and maximum values is added to/subtracted from a control means value to determine the reference minimum and maximum values used for determining the measured data of the quality control sample. The reference minimum and maximum values can be set by an operation unit and stored in a memory unit. Further, in a system where the information as to the control average value and the control SD of the quality control sample can be registered via an external input medium (for example, a bar code), the reference minimum and maximum values are automatically calculated at the time of the registration and stored in the memory means.  
         [0007]     When the quality control sample is measured and the measured data is outputted, firstly, it is determined whether or not the measured data is data to be employed as the quality control data. In this determination, alarm information of data to be outputted together with the measured data is employed. For example, as to the measured data in which an alarm such as the shortage of the sample not suitable to be employed as the quality control data, the determining processing using the reference minimum and maximum values is not executed.  
         [0008]     When the measured data to be employed as the quality control data is outputted, the determining processing using the reference minimum and maximum values described below is executed.  
         [0009]     As the determining processing, first, the determination parameters and the reference minimum and maximum values are read from the memory means. When the quality control sample is set as the determination parameter of the analysis item, the measured data of the quality control sample is compared with the reference minimum and maximum values.  
         [0010]     When the measured data of the quality control sample is out of the range between the reference minimum and maximum values, as to the reagent used in the measurement of the analysis item, the recommendation information of the calibration measurement is stored in the memory means together with the reagent information (a reagent lot No. and a sequential No. of the reagent).  
         [0011]     In contrast, when the measured data of the quality control sample is within the range between the reference minimum and maximum values, the recommendation information of the calibration measurement stored in the memory means is deleted.  
         [0012]     The measured data of the quality control sample subjected to the determination using the reference minimum and maximum values is stored in the memory unit in the order of being outputted.  
         [0013]     In the case of performing the calibration measurement, when the calibration result being outputted is within an allowable range and satisfies a calibration curve update condition, the recommendation information of the calibration measurement stored in the memory means is deleted.  
         [0014]     An operation unit includes a display and input means which can confirm the reagent information of the analysis item as to which the re-measurement of the calibration is recommended and also can request the measurement of the calibration easily as to the recommended reagent. Further, there is provided with a display and input means which can confirm the measured data of the quality control sample being out of the range between the reference minimum and maximum values and also can easily perform the re-measurement of the quality control sample.  
         [0015]     According to the present invention, there is provided with a displaying and measurement requesting function for easily performing the re-measurement of a calibration or a quality control sample with respect to a reagent of an analysis item as to which the measured data of the quality control sample is out of the reference range between the reference maximum and minimum values set in advance. Thus, the analyzer is realized which can continuously realize a highly-reliable analysis and improve the measurement accuracy. Further, the analyzer according to the present invention attributes to the reduction of work load of a user.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]      FIG. 1  is a schematic diagram showing the basic configuration of an analyzer according to the embodiment of the present invention;  
         [0017]      FIG. 2  is a diagram showing an example of a screen for setting determination parameters for the measured data of quality control samples;  
         [0018]      FIG. 3  is a diagram showing an example of a screen for displaying the target values for the measured data of the quality control samples;  
         [0019]      FIG. 4  is a diagram showing an example of a screen for a calibration measurement request;  
         [0020]      FIG. 5  is a diagram showing an example of a screen for displaying quality control measured data;  
         [0021]      FIG. 6  is a flow chart showing the updating processing of calibration recommendation information at a time of measuring the quality control sample; and  
         [0022]      FIG. 7  is a flow chart showing the updating processing of calibration recommendation information at a time of executing a calibration. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0023]     The present invention is characterized by including an operation screen for setting for setting in advance reference maximum and minimum values for determining the measured data of a quality control sample and an operation screen for recommending and displaying the re-measurement of a calibration with respect to a reagent of an analysis item as to which the measured data of a quality control sample is out of a reference range. Further, the present invention preferably includes an operation screen capable of executing easily the re-measurement of a calibration or a quality control sample with respect to a reagent of the analysis item.  
         [0024]     The present invention will be explained in detail by using drawings.  
         [0025]     Hereinafter, an embodiment of the present invention will be explained with reference to the accompanying drawings.  
         [0026]      FIG. 1  is a diagram showing the configuration of an automatic analyzer according to the embodiment of the present invention. An operation unit  101  is configured by a key board or a CRT, and is arranged to display the measured data of a quality control sample, a calibration request and recommendation information and to perform an operation such as a request for measuring a quality control sample and a calibration. A memory unit  102  is configured by a hard disk driving device etc. and stores the measured data of a quality control sample, the recommendation information of calibration measurement and so on. An analysis unit  103  is arranged to pipet and measure a sample.  
         [0027]     A control unit  104  controls the memory unit  102  and performs the determining processing of the measured data and so on.  
         [0028]      FIG. 2  shows a screen arrangement for setting determination parameters for the measured data of quality control samples with respect to analysis items registered in the analyzer. A reference numeral  201  depicts a list of the analysis items registered in the analyzer. The determination parameters stored in the memory unit  102  are displayed in correspondence to the analysis item selected by the list  201 . Then, the determination parameters will be explained in detail. A reference range designation  202  is a button for selecting the validation or invalidation of the setting of the reference range of the quality control sample. The setting of the reference range is made valid only when the reference range designation  202  is selected. A calibration method  203  is a menu for selecting the combination of standard samples used upon executing the calibration. A reference range  204  is a menu for setting as to what coefficient is to be multiplied to a control SD  306  shown in  FIG. 3  so that the multiplied control SD is used as a reference range in order to determine the measured data of a quality control sample. A selection  205  is a menu for setting a quality control sample used for determining the reference range. In the example of the menu  205 , three kinds of the quality control samples can be set at the maximum. The setting contents of the button  202  and the menus  203  to  205  can be changed on the operation unit. When a store button  206  is selected, the contents of the button  202  and the menus  203  to  205  thus changed are stored in the memory unit  102 .  
         [0029]      FIG. 3  shows an example of a screen arrangement for setting a target value, reference maximum value, a reference minimum value etc. of the quality control sample registered in the analyzer. A quality control sample  301  depicts the name of the quality control sample. A lot number  302  depicts the lot No. of the quality control sample. Values set at the analysis item selected by a target value display list  303  are displayed at a target means value  305 , a target SD  306 , the reference minimum value  308  and the reference maximum value  309 . These values can be edit on the operation unit. A calculation button  307  is used to automatically calculate the reference minimum value  308  and the reference maximum value  309  in accordance with the following expressions (1) and (2) by using the target means value  305 , the target SD  306  and the reference range  204 .
 (reference minimum value 308)=(target means value 305) −(target SD 306)·(reference range 204)  (1) (reference maximum value 309)=(target means value 305) +(target SD 306)·(reference range 204)  (2) 
 For example, in the case of  FIGS. 2 and 3 , as to the analysis item ALB, the target means value  305  is 10.0, the target SD  306  is 0.5 and the reference range  204  is in a range between +2SD and −2SD. Thus, the reference minimum value  308  is 9.0 according to the expression (1) and the reference maximum value  309  is 11.0 according to the expression (2). 
 
         [0030]     When an update button  310  is selected, the set values  305 ,  306 ,  308  and  309  are reflected on the target value display list  303 . When the store button  304  is selected, the set values displayed at the target value display list  303  are stored in the memory unit  102 .  
         [0031]      FIG. 4  shows an example of a screen arrangement for the calibration measurement request. In a calibration request list  407 , the setting positions of reagents are displayed at the column of a position  401 , analysis items are displayed at the column of an analysis item  402 , a calibration method recommended or requested for analysis is displayed at the column of a measurement method  403 , a reason why the calibration request is recommended (for example, a calibration has not been measured yet, a QC measurement value is out of the range between the reference maximum and minimum values) is displayed at the column of a recommendation  404 . In the example of  FIG. 4 , the reagent ALB as the analysis item is set at the setting position  1  and the full methods are set as the calibration method as to this regent. Further, as to this reagent, since the measured data of the quality control sample is out of the range between the reference maximum and minimum values, the recommendation of the calibration measurement is displayed due to the reason of the “out of the QC range”. When a store button  406  is selected, the calibration measurement request of the full methods is stored in the memory unit  102  as to the analysis item ALB of the set position  1  in which the calibration measurement is recommended. Thus, when a user merely selects the store button  406  once, all the recommended calibration measurement request is stored in the memory unit  102  with respect to all the reagents as to which the calibration measurement is recommended.  
         [0032]      FIG. 5  shows an example of a screen displaying the quality control measured data. An analyst item list  501  is a list for selecting the analysis items registered in the analyzer. According to this list, one or all of the analysis items can be designated. When one of the analysis items is selected, the data of the quality control samples as to this selected analysis item having been measured is displayed on a measured data display area  505  in a time-sequence manner. In contrast, when all of the analysis items are selected, the measured data of the quality control samples as to all the analysis items registered in the analyzer is displayed on the measured data display area  505  in a time-sequence manner. A user can select each of the respective measured data by using a cursor  504 , whereby the detailed information of the selected data is displayed on a measured data (selection data) detail information area  502 .  
         [0033]     The measured data display area  505  displays the target means value  305  and the reference line of each of the reference minimum value  308  and the reference maximum value  309 . A data lower than the reference minimum value  308  or higher than the reference maximum value  309  is displayed out of a range between these reference lines. As shown in a remark  506 , since data within the range between the reference minimum value and the reference maximum value is represented by a sign difference from that of data out of the range, a user can easily specify the measured data out of the range. Further, as shown in a remark  506 , when the background design of the measured data display area  505  is differentiated between the measured data of today and the measured data of yesterday or before yesterday, the measured data to be treated today can be easily specified. When a quality control measurement request button is pushed, the measurement request for the quality control sample is made as to the combination of the quality control sample and the reagent used for the analysis of the measured data selected by the cursor  504  and stored in the memory unit  102 .  
         [0034]      FIGS. 6 and 7  show flow charts of the updating processing of the recommendation information displayed at the column of the recommendation  404 .  
         [0035]      FIG. 6  is a flow chart showing the processing at the time of the measurement of the quality control sample. When the measured data of the quality control sample is outputted (step  601 ), it is determined whether or not the reference range designation  202  of this analysis item is effective (step  602 ). When the reference range designation  202  is effective, it is checked whether or not the reference minimum value  308  and the reference maximum value  309  are set (step  603 ). When both the reference minimum value  308  and the reference maximum value  309  are set, it is determined whether or not the measured data contains a data alarm (such as the shortage of the sample) which should not be employed as the quality control data (step  604 ). When the data alarm is not outputted, the measured data is compared with the reference minimum and maximum values (step  605 ). As a result of the determination of the step  605 , when the measured data is out of the range between the reference minimum and maximum values, the recommendation information of the calibration is set as to the reagent information of this analysis item and stored in the memory unit  102  (step  606 ). In contrast, when the measured data is within the range between the reference minimum and maximum values, the recommendation information of the calibration set as to the reagent information of this analysis item is deleted and stored in the memory unit  102  (step  607 ). These recommendation information of the calibration can be confirmed on the screen of  FIG. 4 . The re-measurement of the calibration can be requested by selecting the store button  406 . After the execution of the steps  606  and  607 , the measured data is stored in the memory unit  102  (step  608 ). The measured data can be confirmed on the screen of  FIG. 5 . The re-measurement of the quality control sample can be requested by selecting the quality control measurement request button  503 .  
         [0036]      FIG. 7  is a flow chart showing the processing at the time of the measurement of the calibration. When the calibration result is outputted (step  701 ), it is determined whether or not the calibration result is within the allowable range (step  702 ). When the calibration result is within the allowable range, the recommendation information of the calibration set as to the reagent information of this analysis item is deleted and stored in the memory unit  102  (step  703 ). The recommendation state of the calibration can be confirmed on the screen of  FIG. 4 .