JP2009036515A - Autoanalyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an autoanalyzer capable of performing the determination of necessary work content, on the basis of the measuring result of a precision management sample and to avoid the wasteful use of an expensive standard sample or reagent by reducing the load of a result determination work by an operator, while minimizing the number of times of the replacement of the reagent and of calibration. <P>SOLUTION: The autoanalyzer is constituted so as to decide the measuring results of a plurality of precision management samples by a comparative reference to indicate necessary work on the autoanalyzer or the operator. The presence of the abnormality of the precision management sample itself is decided from the measuring results of a plurality of other inspection items controlled in the same precision management sample. Alternatively, the presence of the abnormality of the precision management sample is decided, by utilizing items in particular having less data variation as a decision reference item. The abnormality of the reagent of an inspection item, performing precision management by using a plurality of the precision management of samples is decided, on the basis of the measuring results of a plurality of the precision management samples. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of a biological sample such as blood and urine, and more particularly to an automatic analyzer that measures a quality control sample for confirming the analysis accuracy of the apparatus.

  Automatic analyzers are remarkably widespread mainly in large hospitals and laboratory centers because of their rapid and quantitative measurement. The measurement principle is to use a reagent that reacts with the measurement target component and changes its color, and measures the change in color using a photometer as a change in absorbance for each wavelength (colorimetric measurement). There are those that label the substance to be bound and count the label, and those that measure the turbidity of the reaction solution with scattered light.

  In such an automatic analyzer, it is necessary to create a calibration curve for changing the measured change in absorbance, the count number of the label, and the turbidity to the concentration of the component to be measured. For example, in the case of colorimetric analysis, the calibration curve creates a relational expression between absorbance and concentration using a standard sample whose concentration is specified in advance for each reagent corresponding to each test item (referred to as calibration). Further, the validity of the calibration curve is periodically confirmed by measuring a quality control sample with a known concentration (referred to as quality control, QC, etc.).

  An accuracy control sample is a sample whose concentration of a measurement target component is known, and is used for management of measurement accuracy of an analyzer. The control value and control range of the accuracy control sample indicate the allowable range of measurement accuracy. For example, the average value and the standard deviation (SD) obtained from the results of measurements performed 20 times or more in succession for a plurality of days in advance for each facility. Is set arbitrarily. The accuracy control sample is measured at a certain number of sample intervals or at intervals of time, thereby managing the measurement accuracy during that time (or guaranteeing the measurement results of general samples measured during that time). Yes.

  The reagent of each item is generally stored at 2 to 8 ° C. on the apparatus, but deterioration of the reagent such as decomposition of the reactant and absorption of carbon dioxide in the air cannot be completely avoided. The quality of the reagent is managed by the expiration date and the expiration date after the start of use. However, the actual reagent degradation level depends on the measurement result of the quality control sample measured at regular intervals to manage the accuracy of the measurement result. Often judged. In general, when the reagent is deteriorated, there is a phenomenon in which the measurement result of the quality control sample gradually rises or falls. Even if the reagent has deteriorated, depending on the type of reagent, the calibration curve can be calibrated again by measuring the standard sample at that time, so that the measurement result of the quality control sample can be brought closer to the center value of the control range. Some reagents can be used continuously for analysis.

  Therefore, in the conventional technique, a function for enabling the effective time of a calibration curve to be set for each inspection item and automatically instructing or executing calibration curve creation and calibration at a set fixed time interval has been used. An automatic analyzer having such a function is described in Patent Document 1, for example.

JP-A-10-339732

  In the above conventional technique, the effectiveness of the calibration curve for each inspection item is managed in units of time. Therefore, when a certain time set for each item has elapsed, the actual deterioration degree of the reagent or the quality control sample Regardless of the measurement result, the calibration curve was always instructed to be calibrated. Actually, even if the calibration curve set for each item exceeds the valid time, the measurement value of the quality control sample may be within the allowable range of management.

  As another problem, some quality control samples need to be used by dissolving a freeze-dried product with water, and others have relatively low stability as a sample. Therefore, there is a possibility that the quality control sample itself used for measurement is abnormal and the measurement result may be out of the control value.

  Conventionally, even if the calibration curve calibration is instructed by the equipment from the time when the calibration curve is expired or the quality control sample measurement result is outside the control range, is there any problem with the degree of reagent deterioration or the quality control sample itself? For example, it is necessary for the operator to comprehensively determine the measurement results of multiple quality control samples and determine whether or not reagent replacement is necessary, calibration curve calibration is required, and quality control sample repreparation is required. was there. In addition, in the above case, if the setting of the apparatus automatically performs calibration of the calibration curve, or if the operator to be judged is not familiar with the work, the calibration curve that is originally unnecessary can be By exchanging the reagent, there is a possibility that an expensive standard sample and reagent are consumed excessively.

  An object of the present invention is to provide an automatic analyzer that determines necessary work contents based on measurement results of a plurality of quality control samples.

  The configuration of the present invention for achieving the above object is as follows.

  Storage means for storing the control range of the quality control sample used for management of the measurement accuracy in the analyzer for each type of quality control sample and each inspection item, the measurement result of each quality control sample and the stored control range In the automatic analyzer comprising the comparison means for comparing the measurement results, if the measurement result of the quality control sample is out of the control range, the measurement results of the plurality of test items of the quality control sample are compared with each control range. An automatic analyzer comprising determination means for determining necessary work contents based on a result or a comparison result between measurement results of a plurality of types of quality control samples and respective control ranges.

  When the quality control sample is used to manage the measurement accuracy of multiple inspection items, in addition to the above configuration, the operator can freely select an item that is a criterion for judging the quality control sample abnormality It is also good.

  In addition to the above configuration, storage means for storing the measurement result history of the quality control sample is provided, and from the measurement result history of all test items, the test item with the smallest variation in results is selected as the criterion for judging the quality control sample abnormality. It is good also as composition to do.

  In addition to the above configuration, as a result of determination based on the measurement results of a plurality of quality control samples, the required work may be displayed as a warning so that the operator can recognize it.

  In addition to the above configuration, a standard sample required for calibration measurement is provided on the device, and if it is determined that calibration curve calibration is necessary as a result of the determination, calibration may be automatically performed. good.

  Further, the measurement result of the quality control sample may be used as a judgment judgment material by referring to the same quality control sample measured by a plurality of apparatuses and the measurement result of the same inspection item.

  According to the automatic analyzer of the present invention, the apparatus automatically determines the measurement results of a plurality of quality control samples and the determination of necessary work, which conventionally depended on the ability of the operator, so that the apparatus automatically determines the determination. It is possible to reduce the burden on the operator and reduce the consumption of useless standard samples and reagents.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  FIG. 1 is a block diagram showing an embodiment of an analyzer to which the present invention is applied.

  The analyzer 1 includes a sample disk 2 and its concentric sample container 3, a reaction disk 4 and its concentric reaction container 5, a sample dispensing mechanism 6, a reagent disk 7 and its concentric circle. And a reagent dispensing mechanism 9, a stirring mechanism 10, a light source 11, a multi-wavelength photometer 12, an A / D converter 13, and a reaction container cleaning mechanism 14.

  Analysis by the analyzer 1 is performed in the following order. First, the sample dispensing mechanism 6 dispenses the sample to be analyzed from the sample container 3 to the reaction container 5. Next, the reagent dispensing mechanism 9 dispenses a reagent used for analysis from the reagent container 8 to the reaction container 5. Subsequently, the mixed solution is stirred by the stirring mechanism 10. The light generated from the light source 11 and transmitted through the reaction vessel containing the mixed solution is measured by the multiwavelength photometer 12 and transmitted to the interface 16 via the A / D converter 13. The measurement results obtained as a result of the calculation by the computer 17 are stored in the storage means 18 and displayed on the display unit 19. The reaction vessel 5 after the reaction is washed by the reaction vessel washing mechanism 14 and repeatedly used for the next reaction. The operation mechanisms of these analyzers are all controlled by the computer 17 via the communication means 15 and the interface 16.

  The reagent for each inspection item filled in the reagent container 8 is requested to perform calibration measurement via the interface 16, and a calibration curve is created by measuring a standard sample with a known concentration placed on the sample disk 2. The Similarly, the measurement accuracy of the apparatus is managed by measuring an accuracy control sample with a known concentration placed on the sample disk 2 at regular intervals.

  From the display unit 19, a management reference value and a management range can be set for each type of quality control sample and each inspection item, and the setting is stored in the storage unit 18. FIG. 2 is an example of a screen that displays the management reference value and the management range of the quality control sample for each inspection item. In FIG. 2, inspection item A indicates that the management reference value and management range of three types of quality control samples X, Y, and Z are set. The management reference value and the management range are arbitrarily set for each facility by the method described above.

  FIG. 3 is a flowchart showing the determination process of the measurement result of the quality control sample.

  First, in step S21, it is determined whether or not the measurement result of the inspection item A of the quality control sample X is within the control range. If it is out of the management range, it is determined in step S22 whether or not the measurement results of other inspection items for which the management range is set with the same quality control sample X are within the management range. Here, when the measurement results of other inspection items are also outside the control range, an abnormality of the quality control sample X (sample concentration / deterioration, preparation error, contamination with foreign matter, etc.) is estimated, so the quality control shown in step S24 is performed. A display for instructing preparation of the sample X is displayed on the display unit 19.

  If the determination in step S22 is within the control range, or if the control range is not set for other items of the quality control sample X, the measurement result of item A of the other quality control sample is the control range in step S23. It is determined whether it is in. Here, if the measurement results of other quality control samples are also out of the control range, the abnormality of the reagent of item A (reagent deterioration, preparation error, etc.) is estimated. Therefore, the recalibration of item A shown in step S25 is performed. Is displayed on the display unit 19.

  If the determination in step S23 is within the control range or if the control range of item A is not set for another quality control sample, it is determined that there is another abnormality, and the reaction process of the measurement shown in step S26 is confirmed. And a display for prompting maintenance of the apparatus is displayed on the display unit 19.

  In step S22, the other inspection items used as the determination criterion can be arbitrarily set from the measurement results of the other inspection items of the quality control sample X, and at least one item may be set. In this case, since it is desirable that the variation in the measurement result due to the deterioration of the reagent is a relatively small item, the test with the smallest result variation is performed from the measurement result database of the quality control sample for each test item accumulated in the storage unit 18. An item may be automatically set as an item used as a criterion for determination in step S22.

  FIG. 4 is a diagram illustrating an example of a screen for confirming the management reference value, the setting of the management range, and the measurement result of the quality control sample regarding the inspection items A to E of the quality control sample X. Inspection items A to D indicate that the management reference value and the management range in this facility are set, and the accuracy of the quality control sample X can be checked. If the variation in the measurement result of the inspection item B is relatively small compared to the other inspection items, it is determined with reference to the measurement result of the inspection item B whether the quality control sample X itself is normal. A screen function for selecting and setting the reference item for determination shown in FIG. 4 may be provided so that the setting can be made. The inspection items used for reference of determination may be selectable by a plurality of inspection items by the operator, or as shown in FIG. 4, from the coefficient of variation (CV) of the quality control sample measurement results of a plurality of times. The item with the smallest variation may be set as the inspection item that the apparatus automatically uses for reference for determination.

  In step S23, when the abnormality of the reagent of item A is estimated, it may be possible to switch for each item whether recalibration is performed or replacement of the reagent is instructed in step S25. For example, although an alkaline reagent deteriorates due to absorption of carbon dioxide in the air and the data fluctuates, there are also inspection items in which the data fluctuation is corrected by simply performing recalibration and the reagent can be used continuously. For such inspection items, rather than immediately replacing the reagent, recalibration is performed once before the reagent replacement, and it is unnecessary to determine again whether the measurement result of the quality control sample falls within the control range. The possibility of replacing the reagent can be avoided.

  FIG. 5 is an example of a screen of an automatic analyzer to which the present invention is applied, and is a chart diagram plotting quality control sample measurement results for only inspection item A. The X axis is the number of measurements of the quality control sample, and the Y axis is the standard deviation from the control reference value. When the reagent of the inspection item A is a reagent that deteriorates relatively quickly, the measurement result of the quality control sample often gradually changes as shown in FIG. When the control range is ± 2SD, the seventh measurement result of the quality control sample Y or Z is out of the control range. If the cause is the deterioration of the reagent, the measurement result of the other inspection items (judgment reference items) of the quality control sample Y or Z is usually within the management range, and the determination at step S22 is within the management range. The determination in step S23 is out of the management range, and it is determined that the reagent of the test item A is abnormal.

  Two stages of determination reference values for the measurement result of the quality control sample may be provided. Thereby, it becomes possible to issue instructions for different work contents depending on the degree of reagent deterioration. For example, if the measurement results of multiple types of quality control samples exceed 2SD for a certain item, recalibration is continued and the reagent is used, but if the measurement results exceed 3SD, the use of the reagent is stopped. It is good also as a structure which instruct | indicates replacement | exchange.

  FIG. 6 is an example of a screen of an automatic analyzer to which the present invention is applied, and is a chart diagram in which the measurement results of only the quality control sample X are plotted. When the management range is ± 2SD, the measurement results are within the management range for the inspection items A and B up to the sixth measurement. Further, it can be seen that the item B has a smaller variation in the measurement result than the item A, and is suitable as the reference item for the result determination described above. The example in FIG. 6 also shows that item B is set as a reference item for result determination. The seventh measurement result that is out of the management range is out of the management range for both inspection items A and B. The determination in step S22 is out of the management range, and it is determined that the quality control sample X itself is abnormal.

  FIG. 7 and FIG. 8 are radar chart diagrams showing an example of a screen listing measurement results for a plurality of inspection items of the quality control sample X in the automatic analyzer to which the present invention is applied. Each axis in the chart corresponds to each inspection item managed by the quality control sample X, and the measurement result for each inspection item is plotted by the standard deviation from the management reference value. When the management range is ± 2SD, in FIG. 7, only the result of item A is outside the management range, and it is estimated that the reagent of item A is the cause. Similarly, in FIG. 8, the measurement results of a plurality of items are out of the management range regardless of the items, and it is estimated that the quality control sample X itself is the cause.

  In facilities using a plurality of analyzers, the same quality control sample is often used to control the quality of a plurality of apparatuses. The measurement result of the quality control sample used as the basis of the determination of the present invention may take a form in which a plurality of apparatuses refer to the result of the same inspection item obtained using the same quality control sample. .

It is the block diagram which showed one Embodiment of the automatic analyzer to which this invention is applied. It is a figure which shows the example of a screen which displays the management reference value and management range for every quality control sample of a certain measurement item with the automatic analyzer to which the present invention is applied. It is a flowchart figure which shows the determination process of the measurement result of the quality control sample of the automatic analyzer to which this invention is applied. It is the figure which showed an example of the screen which confirms the management reference value for every quality control sample of the automatic analyzer to which this invention is applied, the setting of a management range, and the measurement result of a quality control sample. It is the chart figure which plotted the quality control sample measurement result of only inspection item A in the automatic analysis device to which the present invention is applied. It is the chart figure which plotted the measurement result of only the quality control sample X in the automatic analyzer to which the present invention is applied. FIG. 6 is a radar chart showing an example of a screen listing measurement results for a plurality of inspection items of a quality control sample X in an automatic analyzer to which the present invention is applied. FIG. 6 is a radar chart showing an example of a screen listing measurement results for a plurality of inspection items of a quality control sample X in an automatic analyzer to which the present invention is applied.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Analyzer 2 Sample disk 3 Sample container 4 Reaction disk 5 Reaction container 6 Sample dispensing mechanism 7 Reagent disk 8 Reagent container 9 Reagent dispensing mechanism 10 Stirring mechanism 11 Light source 12 Multiwavelength photometer 13 A / D converter 14 Reaction container washing Mechanism 15 Communication means 16 Interface 17 Computer 18 Storage means 19 Display section

Claims (9)

  When the measurement result of the quality control sample for one analysis item is out of the control range, the measurement result of the quality control sample different from the quality control sample for the same analysis item and the control range of the quality control An automatic analyzer comprising a determination means for determining whether or not the cause of the measurement result being out of the control range is due to an abnormality of the quality control sample. The automatic analyzer according to claim 1,
The determination by the determination means is a determination based on a comparison between measurement results of a plurality of inspection items of the quality control sample and a management range of the plurality of items. The automatic analyzer according to claim 1,
The automatic analyzer according to claim 1, wherein the determination by the determination means is a determination based on a comparison between a measurement result of the plurality of types of quality control samples and a control range of the plurality of types of quality control samples. The automatic analyzer according to claim 2,
An automatic analyzer comprising selection means for selecting an inspection item as a reference for determination by the determination means. The automatic analyzer according to claim 2,
Comprising storage means for storing measurement result histories of the plurality of quality control samples,
An automatic analyzer characterized in that, among the measurement result histories of all the inspection items stored in the storage means, the inspection item having the smallest fluctuation is used as a reference for determination by the determination means. The automatic analyzer according to claim 1,
Display means for displaying the result of the determination,
An automatic analyzer which displays necessary work contents as a warning on the display unit according to the determination by the determination unit. The automatic analyzer according to claim 1,
An automatic analyzer that automatically instructs calibration measurement to the apparatus when it is determined in the determination by the determination means that calibration of a calibration curve is necessary by calibration. The automatic analyzer according to claim 1,
A standard sample used for calibration of the device is provided in the device,
An automatic analyzer that automatically calibrates an apparatus when it is determined in the determination by the determination means that calibration curve calibration is necessary. The automatic analyzer according to claim 1,
An automatic analyzer characterized in that a measurement result of a quality control sample used in the determination means is shared among a plurality of apparatuses as a determination material.

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