JP5953089B2 - Method for detecting measurement data abnormality and measurement data abnormality detection device - Google Patents

Description

  The present invention relates to a method for detecting an abnormality of a measurement object based on measurement data, and an abnormality detection apparatus.

  In recent years, automatic analyzers are generally used in the field of clinical tests including biochemical tests. In the automatic analyzer, a predetermined amount of a sample and a reagent are dispensed into each reaction container and agitated and reacted, and based on the result of measuring the absorbance of the reaction solution for a certain period of time, the concentration, activity value, etc. of the measurement target substance are obtained.

  Examples of factors inside the apparatus that affect the analysis performance of such instrument analysis include a sampling mechanism, a reagent dispensing mechanism, a stirring mechanism, an optical system, a reaction vessel, and a thermostatic chamber. In addition to reagents such as automatic analyzers, in addition to reagents, calibration standard solutions, and quality control samples, there are equipment being analyzed and the status of reagents, etc. Analytical performance can be obtained.

  Therefore, when a clinical test is performed using an automatic analyzer on a daily basis, it is necessary to determine whether or not the clinical test can be normally performed after confirming the state of such factors.

  Furthermore, in order to carry out highly accurate clinical tests, in addition to the above-mentioned factor checking mechanism to maintain the good analytical performance of the automatic analyzer, the reaction process that is time series data of absorbance in daily tests There is a method of detecting an abnormality from the analysis of measurement data.

  As a method for determining the presence or absence of abnormality using measurement data in the reaction process, for example, there are methods disclosed in Patent Document 1, Patent Document 2, and Patent Document 3. In the method according to Patent Document 1, a chemical reaction model is used in advance to create and store reference time series data, and the measurement data of the sample is compared with the reference time series data. If the deviation is large, it is determined as abnormal. To do. In the method according to Patent Document 2, it is assumed that the measurement data applies to a certain approximate expression, and the reaction coefficient of the reaction approximate expression calculated from the measurement data is compared with the parameter coefficient of the reaction approximate expression at the time of normal reaction. Judgment is normal or abnormal. In the method according to Patent Document 3, a plurality of approximate expressions that accurately match the reaction curve are prepared from the measurement data, and the coefficients, intercepts, and the like of the approximate expression that the measurement data matches well with the selected approximate expression are calculated. This is a method of determining whether or not a reaction has been appropriately performed from a plurality of parameter coefficient values obtained in this way from a deviation from a value that should be originally.

JP 2004-347385 A JP 2008-058065 A JP 2010-261822 A

  However, the abnormality determination method using the measurement data in the reaction process as described above has the following problems.

In the method of Patent Document 1, it is necessary to prepare reference data for the same reaction process in advance.
It is necessary to prepare all known abnormality data such as by item and by reagent.

  In such a method, even if all known abnormal data are stored, the patterns that the apparatus can recognize as abnormal are limited, and cannot cope with newly generated abnormal patterns. In addition, the reaction process may fluctuate, and when this fluctuation occurs in the range of the reaction process used for concentration calculation, a measured value cannot be obtained accurately.

  In the method of Patent Document 2, since the upper limit value and the lower limit value of the change rate of the measurement data between the photometry points adjacent to each photometry point are out of the set value range, the change is detected as abnormal measurement data. There is a possibility that an abnormality cannot be determined in a section where the rate is large, or that the determination is sensitive in a section where the rate of change is small. In addition, regarding the comparison of judgment value setting and management, it is assumed that the rate of change is not constant in the course of the reaction, but in order to accurately detect an abnormality in the reaction, the upper and lower limit values of the judgment are set according to the rate of change. There is a problem that it is necessary to set in detail and the setting and management of the judgment reference value becomes complicated.

  In the method of Patent Document 3, in the coefficient set as the determination value, the coefficient in the normal reaction changes depending on the scale of the reaction process, that is, the difference in the absolute value of the measurement data. Therefore, it is necessary to manage the coefficient for each coefficient setting considering the scale difference of the reaction process or for each scale of the reaction process, which requires complicated work. That is, even if the data is normal, the value of the coefficient varies greatly depending on the scale of the reaction process. Therefore, in the case of data with a different scale of the reaction process, it is difficult to determine abnormality due to the difference in coefficient. .

  There is also a problem regarding the difference in coefficients depending on the coefficient calculation procedure and the initial value. Depending on the type of the approximate expression, the initial value becomes a large factor when the coefficient is obtained. Therefore, there may be a plurality of coefficients for which the approximate expression is established based on the initial value of each coefficient, and it is difficult to make a determination based on the difference in the coefficients. Further, there is a problem that the method for setting the initial value becomes complicated, such as the coefficient may not be obtained depending on the initial value.

  The present inventors diligently studied the means for solving the above problems, and found that when the measurement data in the reaction process is abnormal, the change amount does not draw a smooth curve, and the measurement data itself Instead, it was found that the determination logic (abnormality determination logic) for detecting an abnormality based on the amount of change in the measurement data is adopted, and the abnormality of the measurement data in the reaction process can be detected without reference data. It is another object of the present invention to provide a method and an abnormality detection device for detecting an abnormality in measurement data that can improve the efficiency of the entire analysis work.

  That is, the present invention relates to the following contents.

A method for detecting an abnormality in measurement data according to one aspect of the present invention includes: (a) a step of obtaining a measurement data change amount between each measurement point from a measurement start point to a measurement end point in a specified period; ) A step of calculating an approximate expression from the measured data change amount, (c) a step of setting a determination value from the approximate expression calculated in (b), and (d) of the approximate expression set in (c) And a step of determining the presence / absence of an abnormality based on the determination value.

  As another form of the method for detecting an abnormality in the measurement data according to the above aspect, the determination value in the step (c) may be calculated from a ratio to the measurement data.

As another form of the method for detecting an abnormality of the measurement data according to the above aspect, the determination value in the step (c) is determined according to the value of the determination coefficient of the approximate expression calculated from the measurement data change amount. It may be determined from the set allowable range.

  As another form of the method for detecting an abnormality of the measurement data according to the above aspect, the determination value in the step (c) is allowed to vary depending on the determination coefficient of the approximate expression calculated from the measurement data change amount. It may be a value.

  As another form of the method for detecting an abnormality of the measurement data according to the above aspect, an upper limit allowable value and / or a lower limit allowable calculated from the ratio of the determination value set in the step (c) to the entire measurement data. It may be a value.

  As another form of the method for detecting an abnormality of the measurement data according to the above aspect, the determination value set in the step (c) may be an area allowable value represented by an area.

  As another form of the method for detecting an abnormality of the measurement data according to the one aspect, the area allowable value set in the step (c) is an area surrounded by the measurement data change amount and the approximate expression. It may be calculated on the basis.

  As another form of the method for detecting an abnormality of the measurement data according to the above aspect, the determination value in the step (c) is an allowable number of times obtained from a ratio of the measurement data change amount to the number of measurement points. Also good.

  As another form of the method for detecting an abnormality of the measurement data according to the one aspect, the calculation of the determination value in the step (c) is obtained from the ratio of the measurement data change amount to the number of measurement points, and the measurement data The approximate number calculated from the change amount is compared with the allowable number of times and the number of times the value of the measured data change amount is switched across the approximate expression (C), and the number of times (C) exceeds the allowable number of times. In such a case, an abnormality may be detected.

  As another form of the method for detecting an abnormality of the measurement data according to the above aspect, the measurement data may be absorbance.

Further, as another form of the method for detecting an abnormality of the measurement data according to the above aspect, the approximate expression may be expressed by (Expression 1) described later. Here, ln is a natural logarithm, x is a measurement data interval, y is a change amount of a measurement value in the measurement data interval x, and a and b are coefficients.

  In addition, as another form of the method for detecting an abnormality of the measurement data according to the above aspect, an information processing apparatus (abnormality detection apparatus) that realizes each of the above-described configurations may be used. It may be a program, or a storage medium that can be read by a computer, other devices, machines, or the like in which such a program is recorded. Here, the computer-readable recording medium is a medium that stores information such as programs by electrical, magnetic, optical, mechanical, or chemical action. Note that the information processing system may be realized by one or a plurality of information processing apparatuses.

  The method for detecting an abnormality of measurement data in the present invention employs a determination logic using the measurement data change amount instead of the measurement data itself in the reaction process. Therefore, it is possible not only to detect an abnormality in the reaction process without reference data, but also to detect a new abnormal reaction process that does not specialize in a known abnormal reaction process pattern.

  In addition, it is not necessary to compare the value calculated from the approximate expression of the change in absorbance with the change in absorbance and determine the presence or absence of abnormality from the degree of deviation. It is possible to detect abnormalities in the reaction process such as a distorted shape and an outlier without comparing them.

  Furthermore, since the approximate expression is obtained for each reaction, it can be handled even if the scale of the reaction process is different. Therefore, there are various situations in which the coefficient of the approximate expression is not affected by the difference in the absolute value of the measurement data, or the coefficient of the approximate expression is not uniquely determined, so that the presence or absence of abnormality cannot be determined. It is possible to accurately detect abnormal reactions.

  Therefore, in the automatic analysis method and the automatic analyzer used particularly in the field of clinical examination, it is possible to improve the efficiency of the entire analysis work by increasing the accuracy of detecting abnormalities in the reaction process for each measurement result. .

FIG. 1 is an example of a normal reaction process of measurement data in a reaction process by the endpoint method. The horizontal axis represents measurement points, and the vertical axis represents absorbance. FIG. 2 is a diagram illustrating the amount of change calculated from each measurement data in the normal reaction process illustrated in FIG. The horizontal axis represents measurement points, and the vertical axis represents absorbance. FIG. 3 is a diagram illustrating the transition of the amount of change calculated from the measurement data illustrated in FIG. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 4 is a diagram illustrating an approximate expression calculated from the transition of the amount of change calculated from each measurement data illustrated in FIG. 3 together with the transition of the amount of change. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 5 is an example of an abnormal reaction process of measurement data in the reaction process by the endpoint method. The horizontal axis represents measurement points, and the vertical axis represents absorbance. FIG. 6 is a diagram illustrating the amount of change calculated from each measurement data in the abnormal reaction process illustrated in FIG. The horizontal axis represents measurement points, and the vertical axis represents absorbance. FIG. 7 is a diagram illustrating changes in the amount of change calculated from each measurement data illustrated in FIG. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 8 is a diagram illustrating an approximate expression calculated from the transition of the amount of change calculated from each measurement data illustrated in FIG. 7 together with the transition of the amount of change. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 9 is a diagram exemplifying the transition of the change amount, the approximate expression calculated from the transition, and the upper and lower limits of the set approximate expression. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 10 is a diagram illustrating a region formed by the approximate expression calculated from the transition of the change amount and the change amount. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 11 illustrates an abnormal reaction process of measurement data. The horizontal axis represents measurement points, and the vertical axis represents absorbance. FIG. 12 is an example of the change amount up-and-down frequency with respect to the approximate expression of the change amount calculated from the abnormal reaction process example illustrated in FIG. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 13 is a flowchart illustrating the steps of processing for detecting an abnormality. FIG. 14 is a diagram in which an allowable range is shown together with an absorbance change amount and an approximate expression of the change amount in an example of a normal reaction process of ZTT by the endpoint method. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 15 is a diagram in which an allowable range is shown together with an absorbance change amount and an approximate expression of the change amount. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 16 is a diagram of an absorbance change amount and an approximate expression of the change amount in an abnormal reaction process example of the item ZTT test. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 17 is a diagram in which an allowable range is shown together with an absorbance change amount and an approximate expression of the change amount in an example of a normal reaction process of ChE by the rate method. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 18 is a diagram in which an allowable range is shown together with a diagram of an absorbance change amount and an approximate expression of the change amount. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 19 is a diagram of an absorbance change amount and an approximate expression of the change amount in an example of a normal reaction process of the item ChE test. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 20 is a diagram of an absorbance change amount and an approximate expression of the change amount in an abnormal reaction process example of the item ChE test. The horizontal axis represents the measurement data interval, and the vertical axis represents the amount of change in absorbance. FIG. 21 illustrates the abnormality determination device according to the embodiment.

  In the following, an embodiment of the present invention when an automatic analyzer is used will be described in detail with reference to the drawings as appropriate, but the mode of use is not limited thereto.

  The method for detecting an abnormality of the present invention (hereinafter referred to as the method of the present invention) can be used, for example, in a method for detecting an abnormality of measurement data of an automatic analyzer used in the field of clinical examination and managing the accuracy. It should be noted that an apparatus for detecting abnormality in measurement data that can implement the method of the present invention is also included in the scope of the present invention.

  An automatic analyzer is, for example, an apparatus that includes a sample dispensing mechanism, a reagent dispensing mechanism, a stirring mechanism, a photometric unit, a reaction vessel, and a thermostatic bath. Such automatic analyzers are generally sold for the purpose of clinical testing, but are not limited to such automatic measuring devices, and photometry that can be performed based on a measurement principle such as an absorption optical system or a fluorescent optical system. Any device that can acquire reaction process data by providing a unit can be used in the present invention.

  In addition, the method of the present invention is not limited to the following measurement method that is measured by the automatic measurement device, and can be widely applied to measurement methods that obtain measurement data.

  In addition, the measurement data that can be the target is not limited to the reaction process, but can be applied if it is represented by a two-dimensional graph using the X-axis and Y-axis and the normal pattern is known. It is.

  For example, it is possible to detect an abnormality in the intensity of the light source of the analyzer. More specifically, the present invention is applied as a mechanism for checking whether the light source of the analyzer is operating normally by using data obtained by measuring the brightness of light emitted from the light source of the analyzer for each wavelength. Is possible.

  In addition, preferably, the present invention is used in detecting abnormalities in measurement data in the clinical laboratory field. For example, a clinical test item has a reaction process represented by a two-dimensional graph using the X-axis and the Y-axis, and the normal pattern of the reaction process is known, and measurement data in the reaction process is The present invention can be used regardless of the clinical test item (such as serological test, biochemical test, and hematology test) as long as the method is obtained.

  Tests that can obtain data that changes over time as described above include tests that measure absorbance, tests that measure luminescence, tests that measure fluorescence, etc. Examples include absorptiometry, immunoturbidimetry, enzyme immunoassay, latex agglutination turbidimetry, and latex near-infrared turbidimetry. For luminescence measurement, chemiluminescence immunoassay, electrochemiluminescence immunoassay Laws are available. Tests to be targeted are not limited to these, and the present invention can be applied to clinical test items from which measurement data in various reaction processes can be obtained according to the embodiment.

The automatic analyzer generally takes the form of being controlled by a computer. The computer may be a general-purpose PC (personal computer) or a dedicated device. FIG. 21 illustrates the computer 1. The computer 1 is, for example, an information processing apparatus having a storage unit 11, a control unit 12, an input / output unit 14, and the like connected to the bus 13 as a hardware configuration.

  The storage unit 11 stores various data and programs used in processing executed by the control unit 12 (not shown). The storage unit 11 is realized by a hard disk, for example. The storage unit 11 may be realized by a recording medium such as a USB memory.

  The various data and programs stored in the storage unit 11 may be obtained from a recording medium such as a CD (Compact Disc) or a DVD (Digital Versatile Disc). The storage unit 11 may be referred to as an auxiliary storage device.

The control unit 12 includes one or a plurality of processors such as a microprocessor or a CPU (Central Processing Unit), and peripheral circuits (ROM (Read Only Memory), RAM (Random Access Memory), interface circuits) used for processing of the processor. Etc.). The control part 12 implement | achieves the process of the computer 1 in this embodiment by running the various data and program which are stored in the memory | storage part 11. FIG. ROM, RAM, and the like may be referred to as a main storage device in the sense that they are arranged in an address space handled by a processor in the control unit 12.

  The control unit 12 includes a data acquisition unit 31 and a data analysis unit 32. The data acquisition unit 31 and the data analysis unit 32 are realized by, for example, developing a program or the like stored in the storage unit 11 in a RAM or the like that is a peripheral circuit of the control unit 12 and executing the program by the processor of the control unit 12. The Here, the automatic analyzer has a reaction unit for measuring a sample for the clinical test item, and obtains measurement data from a reaction according to the state of the sample by a biochemical reaction or an immunological reaction. (Reaction process). The data acquisition unit 31 acquires the measurement data, and the data analysis unit 32 analyzes the acquired measurement data (analysis process). In the reaction process, measurement data in the reaction process is obtained.

  The input / output unit 14 is one or a plurality of interfaces for transmitting / receiving data to / from a device existing outside the computer 1. The input / output unit 14 is, for example, an interface for connecting a LAN (Local Area Network) cable, an interface for connecting to a user interface such as an input device and an output device, or an interface such as USB (Universal Serial Bus). .

For example, the input / output unit 14 may be connected to an automatic analyzer. The input / output unit 14 may be connected to a user interface (not shown) (input / output devices such as a touch panel, a numeric keypad, a keyboard, a mouse, and a display). Further, the input / output unit 14 may be connected to an input / output device such as a CD drive or a DVD drive or a removable recording medium, or a non-volatile portable recording medium such as a memory card. The input / output unit 14 may have a function as an interface (communication unit) for performing network connection.

  The method for detecting an abnormality of measurement data according to the present invention (hereinafter also simply referred to as “the method of the present invention”) is mainly implemented in the data analysis unit 32. An apparatus (for example, the computer 1) having the data analysis unit 32 that implements the method of the present invention corresponds to the abnormality detection apparatus of the present invention (hereinafter also simply referred to as “the apparatus of the present invention”). The apparatus of the present invention can be used integrally with an automatic analyzer, can be used connected to the automatic analyzer via a network, or can be used alone. Although a detailed aspect and a usage example are shown below, it is not limited to this.

  The use of the apparatus of the present invention as an integral part of an automatic analyzer includes having a data analysis unit 32 for performing the method of the present invention in the automatic analyzer. It is preferable because abnormalities occurring in each reaction process of each automatic analyzer can be detected over time.

  The use of the apparatus of the present invention connected to an automatic analyzer via a network includes the use of the automatic analyzer and the apparatus of the present invention connected via a network. Abnormalities that occur in each reaction process, etc. of multiple automatic analyzers can be detected simultaneously over time, and even in an automatic analyzer that is not equipped with the method of the present invention, abnormalities that occur in each reaction process, etc. Because it can be detected automatically.

  Using the device of the present invention alone includes using the device of the present invention independently of various automatic analyzers (devices equipped with the method of the present invention and devices not equipped). It is preferable because data acquired by the automatic analyzer can be appropriately analyzed to detect abnormalities occurring in each reaction process.

  In the following, definitions of terms are provided to facilitate the explanation of the present invention, which is considered to be well understood by those skilled in the art.

  The reaction process represents a change in reaction from the measurement start point to the measurement end point. For example, it means a collection of data measured multiple times at a constant speed. Specifically, in the measurement method of clinical laboratory items using absorbance, it was obtained at the moment when the reaction vessel crosses the optical axis of the photometer. Examples thereof include a set of intermittent absorbances and a set of fluorescence intensities obtained by measuring luminescence after a material irradiated with light once absorbs the energy.

  Measurement data is measurement data measured by a detector.

  The amount of change refers to the amount of increase or decrease in measurement data between two consecutive measurement points. For example, when the absorbance obtained by the reaction process is used as measurement data, it represents the amount of increase or decrease in absorbance between two consecutive measurement points.

The coefficient of determination (R ² ) is used as a measure of the goodness of fit of the approximate expression calculated from the amount of change, and represents the likelihood of the approximate expression.

  In the following, a specific embodiment of the method for detecting an abnormality based on the measurement data according to FIG. 13, that is, abnormality determination, using the method of the present invention as an example of using the absorbance value in the reaction process as the measurement data. The logic is explained.

In the abnormality determination logic of the present invention, the reaction process during a normal reaction increases or decreases smoothly, so that if the measurement data is abnormal, the non-smooth part appears prominently in the change in absorbance change amount. Is based. The following processing can be described as processing of the control unit 12 (data analysis unit 32) of the computer 1.

  In the abnormality determination logic based on the measurement data of this aspect, first, in the range specifying step (S100), the use range of the measurement data used for determining the abnormality is set. It is set so that a suitable number and frequency of measurement data can be taken in for the range of data for which abnormality determination is desired.

  The range to be set can be appropriately selected and set by those skilled in the art in consideration of the reaction process for each inspection item. For example, when a sudden change in measurement data is observed at the start of the reaction, the portion can be excluded and set.

  A larger number of measurement data used for the analysis is preferable because the abnormality can be accurately determined, but a person skilled in the art can appropriately set a suitable number. For example, in the case of a reaction process of a general test item in the clinical test field, 1 to 50 points, 26 to 48 points, etc. may be acquired between the start of measurement and the end of measurement.

  Next, in the measurement data capturing step (S101), the measurement data is captured within the designated range. The measurement data may be numerical data that can be analyzed. For example, as a type of light measured by the photometry unit, in addition to an absorptiometric method using the fact that the absorbance varies depending on the concentration of the target substance, fluorescence emitted after the substance irradiated with light once absorbs its energy A fluorescence photometry method using intensity is used, but any measurement data acquired by a photometry unit capable of performing measurement based on the above principle can be used. In the present application, the absorbance is described as an example, but the scope of the present invention is not limited to this.

  Absorbance is measured a plurality of times as time passes, but the absorbance in the specified range used in the abnormality determination specified in the previous step S100 among all the measured data is captured (S102).

  The measurement data may be acquired over time during the reaction process of the automatic analyzer, or may be acquired after the reaction process is completed or independently. The taken measurement data is analyzed for each reaction process by the abnormality detection method of the present invention. When the measurement data taken in cannot be used as it is, it can be appropriately corrected according to an embodiment and used for analysis according to an arbitrary method. For example, when the measurement data includes a negative value, a certain value is added to make all the measurement data positive values.

  Here, how to obtain an approximate expression using measurement data in a reaction process in various reaction forms will be exemplified.

  Fig. 1-4 shows an approximate expression calculated from the reaction process during normal reaction and its change in absorbance, and the change in absorbance. Fig. 5-9 shows the reaction process during abnormal reaction, its change in absorbance, and change in absorbance. The approximation formula calculated from quantity is illustrated. 1, 2, 5, and 6, the horizontal axis represents the measurement point, the vertical axis represents the absorbance, and in FIGS. 3 to 4 and 7-9, the horizontal axis represents the measurement data section, and the vertical axis represents the measurement data interval. Represents the amount of change in absorbance.

The end point method is a method of measuring a target component by measuring the total amount of change in absorbance after reacting the target component with a reagent to change everything into a product. On the other hand, the rate method is a method in which a target component is reacted with a reagent, the speed at which the reaction is progressing is measured as the amount of change in absorbance per unit time, and the target component is measured. Hereinafter, the reaction process of the endpoint method in the present application will be described as an example in which the absorbance continues to increase when the reaction process proceeds normally, but when the absorbance continues to decrease when the reaction process proceeds normally. Can be applied similarly, and the scope of the present invention is not limited to this.

  First, as shown in FIG.1 and FIG.5, the light absorbency in a reaction process is measured.

  FIG. 1 shows an example of the reaction process of the endpoint method in which the reaction process proceeds normally. As shown in FIG. 1, when the reaction proceeds normally in the end point method, the absorbance continues to increase, but the increase in absorbance is most frequently observed in the early stage of the reaction. Since the plateau state is approached as the reaction proceeds, the increase in absorbance decreases. Therefore, the absorbance at each measurement point from the start to the end of the reaction draws a smooth curve.

  FIG. 5 is an example of a reaction process of the endpoint method in which the reaction process did not proceed normally. Even when the reaction does not proceed normally, the increase in absorbance is most often observed in the early stage of the reaction. Although the absorbance tends to approach a plateau state as the reaction progresses, it is observed that the absorbance does not only increase but also decreases at each measurement point so far. Therefore, the absorbance at each measurement point from the start to the end of the reaction is not a smooth curve but an uneven shape.

  Next, in the range set in advance in the range setting step, the amount of change in measurement data in the reaction process between each measurement point is obtained. For example, when the measurement data is absorbance, the absorbance change amount is obtained. The amount of change in absorbance is calculated by, for example, y (dx) = y (x + 1) −y (x).

  As shown in FIG. 2, FIG. 3, FIG. 6, and FIG.

  FIG. 2 is a diagram showing a difference between measurement data and each measurement point, that is, a change in absorbance in the endpoint method in which the reaction process illustrated in FIG. 1 has proceeded normally. As described above, when the reaction proceeds normally, the absorbance continues to increase, and since the smooth curve is drawn, the amount of change is the largest in the initial reaction, and the amount of change decreases as the reaction proceeds.

  FIG. 3 is a graph showing the change in absorbance illustrated in FIG. 2 in the endpoint method in which the reaction process illustrated in FIG. 1 has proceeded normally. As described above, when the reaction proceeds normally, the absorbance continues to increase, and since the smooth curve is drawn, the amount of change is the largest in the initial reaction, and the amount of change decreases as the reaction proceeds. Therefore, in the case of a reaction that has progressed normally, the absorbance change amount also draws a smooth curve.

  On the other hand, FIG. 6 is a diagram showing the difference between the measurement data in the reaction process and each measurement point, that is, the amount of change in absorbance in the endpoint method in which the reaction process illustrated in FIG. 5 did not proceed normally. In this way, even when the reaction did not proceed normally, the most increase in absorbance was observed at the initial stage of the reaction, and as the reaction proceeded, the increase tended to approach a plateau state, but the absorbance only increased. A decrease is also observed. Therefore, the amount of change in absorbance between the measurement points from the start to the end of the reaction may increase or decrease.

FIG. 7 is a graph showing the change in absorbance shown in FIG. 6 in the endpoint method in which the reaction process illustrated in FIG. 5 did not proceed normally. Even when the reaction does not proceed normally, the absorbance increases most in the early stage of the reaction, and as the reaction proceeds, the increase tends to approach a plateau state, but the absorbance decreases as well as increases. Cases are also observed. Moreover, the amount of change in absorbance between the measurement points from the start to the end of the reaction may increase or decrease. Therefore, the amount of change in absorbance between the measurement points from the start to the end of the reaction does not draw a smooth curve, and is a graph in which portions that partially show an increase / decrease are mixed.

Therefore, in the approximate expression calculation step (S103), the approximate expression is calculated based on the measurement data change amount (for example, the absorbance change amount), and the approximate expression determination coefficient (R ² ) and various parameter coefficients are acquired.

  4 and 8 show the approximate expression calculated from the change in absorbance and the change in absorbance.

  FIG. 4 also shows an approximate expression calculated from the amount of change in absorbance between the measurement points for the amount of change in absorbance between the measurement points shown in FIG. 3 in the end point method in which the reaction process proceeds normally. FIG. When the reaction proceeds normally, the shape of the calculated approximate equation graph shows a shape close to the shape of the absorbance change graph.

  On the other hand, FIG. 8 shows an approximate expression calculated from the amount of change in absorbance between the measurement points for the amount of change in absorbance between the measurement points shown in FIG. 7 in the endpoint method in which the reaction process did not proceed normally. It is the figure which described these graphs collectively. When the measurement reaction does not proceed normally, the shape of the calculated approximate expression graph includes a portion where the shape is partially different from the shape of the absorbance change amount graph.

  Here, the approximate expression means an expression that can be used to detect abnormality in the measurement data within the specified range, and within the specified range, the measurement data change amount (for example, reaction process data change amount, preferably Is a formula that calculates a value close to the value of the change in absorbance). As a method for calculating the approximate expression, a person skilled in the art can appropriately select and implement an interpolation polynomial, a least square method, or the like. It is particularly preferable that the approximate expression is calculated using the least square method.

  An example of obtaining an approximate expression is shown below, but the calculation method of the approximate expression is not limited to this as described above.

Here, x is the measurement data interval, ln is the natural logarithm, y is the amount of change in the measurement value in the measurement data interval x, a and b are coefficients, respectively, and these coefficients a and b and the approximation of the equation A coefficient of determination (R ² ) representing the certainty of is calculated. Further, when an expression is shown in the text, “*” is used as a symbol representing multiplication instead of “x”.

  Since the normal reaction process increases or decreases smoothly, the amount of change simply increases or decreases, which is considered to match (Equation 1). On the other hand, in an abnormal reaction process, the amount of change in absorbance deviates from the tendency to simply increase or decrease, so a portion that does not match the approximate expression is found.

  Here, the reaction process in which the absorbance continues to increase in the endpoint method has been described as an example, but the reaction process in the rate method as well as the reaction process in which the absorbance decreases has been described above without excessive trial and error. It is possible to apply the method.

  Next, in a determination value calculation step (S104), a determination value used for abnormality determination is calculated. In the abnormality determination step (S105), it is determined whether or not the measurement data is abnormal based on the calculated determination value. The presence or absence of abnormality in the measurement data is determined based on the degree of deviation between the measurement data change amount and the approximate expression obtained from the measurement data change amount. A person skilled in the art can appropriately select and implement a suitable determination method. Details will be described later.

  Next, the determination result is notified based on the result of the abnormality determination step (S106). As a specific determination result notification step, the normal and abnormal determination results obtained in the abnormality determination step are output from the analysis unit. The notification content includes at least a number that can identify a specimen having an abnormality in the reaction process, and further includes information such as a test item, a date, a measurement point at which an abnormality has occurred, and an item indicating determination accuracy. . A person skilled in the art can implement the notification contents as appropriate according to the embodiment. For example, the notification contents described in each embodiment 1-4 are included.

  As a means for outputting, a known method can be used. For example, when displaying on a computer screen, outputting with a paper medium and notifying abnormality may be mentioned. The means for notifying is not particularly limited as long as it can indicate the content of notification, and those skilled in the art can appropriately select and implement it.

  As the determination result output method, various methods can be used depending on the type of abnormality to be detected.

  Examples of the method for determining the presence or absence of abnormality of the measurement data of the present invention and the notification method of the determination result are listed below as examples using the amount of change in absorbance, but these may be implemented alone or in combination as much as possible. The scope of the present invention is not limited to these.

Embodiment 1
In the first embodiment, an example is shown in which an abnormality is determined based on the deviation of the change amount from the upper and lower limit values based on the approximate expression of the change amount.

  An approximate expression is calculated based on the amount of change in absorbance, and an allowable range surrounded by the upper limit value and / or lower limit value is set as a determination value in consideration of the allowable value for the approximate expression. For example, the change amount is within the allowable range If it exceeds, it is judged as abnormal. As an example of the allowable value, a ratio to the measurement data can be considered, and for example, it is represented by an average value of measurement data × a constant value for each item. A person skilled in the art can appropriately determine the constant value according to each item without excessive trial and error from the measurement data in the reaction process showing a normal reaction and the reaction process showing an abnormal reaction obtained using a clinical sample. can do. For example, ChE (Cholinesterase) is 1.00%, ZTT (zinc sulfate turbidity test) is 3.00%, and γ-GT (Gamma-glutamyltransferase) is 0.50 to 5. 00% can be used.

Next, based on the result of the abnormality determination step, (1) a number identifying measurement data determined to be abnormal, (2) coefficients (a, b) of the approximate expression, and determination coefficients (R ² ), ( 3) Upper and lower limit values between each measurement point, (4) Where it was determined that there was an abnormality (at what point the abnormality occurred), or (5) Upper limit or lower limit (over the upper limit or below the lower limit) (6) The number of times it is determined that there is an abnormality, etc. are notified.

  FIG. 8 shows the change in absorbance and its approximate expression in an abnormal reaction process. FIG. 9 also shows an upper limit value and a lower limit value that are set when the presence / absence of abnormality is determined according to the present invention.

(Embodiment 2)
In the second embodiment, an example in which an abnormality of measurement data is determined based on the size of a region surrounded by the approximate expression of the change amount and the change amount will be described.

  The method according to Embodiment 2 calculates an approximate expression based on the absorbance change amount, calculates the change amount of the absorbance and the region value (S) surrounded by the approximate equation, and calculates the region value (S). On the other hand, this is a method for determining an abnormality when the permissible value (allowable area value) set as a judgment value exceeds the permissible area value (S). The region value (S) can be obtained according to an integration method or the like.

  As an example of the allowable region value, a ratio to the measurement data can be considered. A person skilled in the art can appropriately determine the constant value according to each item without excessive trial and error from the measurement data in the reaction process showing a normal reaction and the reaction process showing an abnormal reaction obtained using a clinical sample. can do. For example, 0.70% can be used for ChE, 4.00 to 5.00% for ZTT, and 0.65 to 9.00% for γ-GT.

Next, based on the result of the abnormality determination step, (1) a number specifying data determined to be abnormal, (2) coefficients (a, b) of the approximate expression, and determination coefficients (R ² ), (3 ) Notify the region (S) and the region allowable value.

  FIG. 8 shows the change in absorbance and its approximate expression in an abnormal reaction process. FIG. 10 is a conceptual diagram showing an area surrounded by an approximate expression for determining the presence or absence of an abnormality and the amount of change according to the present invention. 8 and 10, the horizontal axis represents the measurement data section, and the vertical axis represents the change in absorbance.

(Embodiment 3)
In the third embodiment, an example in which an abnormality of measurement data is determined based on an allowable value set on the basis of a determination coefficient (probability) of an approximate expression of variation is shown.

By using the coefficient of determination (R ² ) of the approximate expression that represents the certainty of the approximate expression for the amount of change in absorbance, it is possible to use the allowable value dynamically changed according to the characteristics of each reaction as the judgment value. It is.

That is, when the determination coefficient (R ² ) of the approximate expression is poor, it is considered that the change in absorbance does not increase or decrease smoothly throughout the reaction. Therefore, by setting a large allowable value in accordance with the determination coefficient (R ² ), it becomes possible to determine that there is no more abnormality than necessary, and recognize that there is an abnormality only for data that has an abnormality throughout. it can.

In addition, when the determination coefficient (R ² ) of the approximate expression is good, it is considered that the amount of change smoothly increases or decreases throughout the reaction. Therefore, it is possible to determine a finer abnormality by setting the allowable value small according to the determination coefficient (R ² ).

An approximate expression and a coefficient of determination (R ² ) are calculated based on the amount of change in absorbance, and the allowable range surrounded by the upper limit value and / or the lower limit value in consideration of the allowable value for the approximate expression, as in the first embodiment. And an allowable value (referred to as a primary allowable value here) are set. Next, the primary allowable value is adjusted in accordance with the determination coefficient (R ² ) to obtain a secondary allowable value used for the determination. For example, when the coefficient of determination (R ² ) = 0.7, which is generally determined to have a good correlation, exceeds 0.7, the difference from the coefficient of determination (R ² ) (1−decision coefficient) ) Is multiplied or lower, the inverse of the coefficient of determination (R ² ) is multiplied. An allowable range obtained from the adjusted primary allowable value (secondary allowable value) is determined to be abnormal, for example, when the amount of change exceeds.

Next, based on the result of the abnormality determination step, (1) a number identifying measurement data determined to be abnormal, (2) coefficients (a, b) of the approximate expression, and determination coefficients (R ² ), ( 3) Upper and lower limit values between each measurement point, (4) Where it was determined that there was an abnormality (at what point the abnormality occurred), or (5) Upper limit or lower limit (over the upper limit or below the lower limit) (6) The number of times it is determined that there is an abnormality, etc. are notified.

Embodiment 4
In the fourth embodiment, an example of abnormality determination using the upper and lower replacement frequencies based on the approximate expression of the change amount is shown.

  An approximate expression is calculated based on the amount of change in absorbance, and an allowable number of times is set as a determination value with respect to the frequency at which the amount of change in absorbance moves upward or downward across the approximate expression in the reaction process. As an example of the allowable number of times, a ratio to the number of points for which the absorbance change amount is obtained can be considered. When the movement frequency of the absorbance change amount exceeds the allowable number of times, it is determined that the measurement data is abnormal.

For example, the allowable number of times can be calculated as follows. First, the number of times (C) that the amount of change in absorbance straddles the approximate expression in the reaction process is calculated. Next, the determination coefficient (R ²
) Etc. are taken into account, and the allowable number of times is calculated. The allowable number of times is set by the number of points at which the amount of change in absorbance is obtained × constant × decision coefficient (R ² ). The constant value is determined by each person skilled in the art according to each item.
It can be appropriately determined without excessive trial and error from measurement data in a reaction process showing a normal reaction and a reaction process showing an abnormal reaction obtained using a clinical sample.

Next, based on the result of the abnormality determination step, (1) a number specifying data determined to be abnormal, (2) coefficients (a, b) of the approximate expression, and determination coefficients (R ² ), (3 ) Notify the number of times (C) and the allowable number of times.

  FIG. 11 shows an example of an abnormal reaction process. FIG. 12 is an example of up and down frequency of the absorbance change amount with respect to the absorbance change amount calculated from the abnormal reaction process shown in FIG. 11 and its approximate expression. In FIG. 11, the horizontal axis represents the measurement point, the vertical axis represents the absorbance, the horizontal axis in FIG. 12 represents the measurement data section, and the vertical axis represents the change in absorbance.

  EXAMPLES The present invention will be described in more detail below with reference to examples. However, the present examples are merely illustrative of the present invention, and the scope of the present invention is not limited to these examples. It will be apparent to those skilled in the art that any changes, improvements, or modifications can be made without departing from the spirit of the invention.

[Example 1: Determination using deviation of variation from upper and lower limit values based on approximate equation of variation (endpoint method)]
In order to verify the effect of the present invention, the end point method was used for the zinc sulfate turbidity test (ZTT). ZTT-HR Wako (Wako Pure Chemical Industries, Ltd.), which is a reagent for measuring ZTT, is used as a measuring reagent, a 7700 type Hitachi automatic analyzer (Hitachi High-Technologies Corporation) is used as an automatic analyzer, and a patient is used as a sample. Measurements were performed using the collected serum samples. An example in which no abnormality was detected (normal example) and an example in which an abnormality was detected are shown.

(1-1) Normal Reaction Process Example After the measurement of the specimen, photometric points 3 to 3, which are ranges set in advance for the ZTT item,
Twenty-four measurement data were acquired. As an absorbance change amount in this range, y (dx) = y (x + 1) −y (x) between points in the specified range was calculated. Next, when the parameter coefficient of the approximate expression y = a * ln (x) + b is calculated based on the calculated absorbance change amount,
The approximate expression was y = −17.284ln (x) +56.589, and the coefficient of determination (R ² ) was R ² = 0.9847. FIG. 14 shows the change in absorbance calculated from the measurement data and an approximate expression for the change along with the allowable range. Note that “Δ” in FIG. 14 indicates the upper limit value at each point. Further, “□” in FIG. 14 indicates the lower limit value at each point. The same applies to FIGS. 15, 17 and 18. In FIG. 14, the horizontal axis represents the measurement data interval, and the vertical axis represents the absorbance change amount. Moreover, the whole was plotted by setting the amount of change in absorbance in the preset photometric points 3 to 4 as the start point (section 1) of the measurement data interval. The constant was set to 3.00%. The allowable value was calculated from the ratio to the measurement data, and the average value of the measurement data was multiplied by a constant of 3.00%. Furthermore, since the coefficient of determination ZTT item (R ²⁾ is determined to be a correlation greater than 0.7, the difference (1- coefficient of determination (R ²⁾⁾ of the coefficient of determination (R ²⁾ a multiplied by allowable width Was calculated to be ± 16.767. As a result, the change in absorbance calculated from the measurement data did not exceed the upper and lower limits of the allowable range in any measurement data, and thus no abnormality in the reaction process was detected.

(1-2) Example of Abnormal Reaction Process On the other hand, in the measurement data showing the abnormal reaction process of ZTT, the presence or absence of abnormality was determined in the same manner as (1-1). When the approximate expression and the coefficient of determination (R ² ) are calculated, the approximate expression is y = −9.
It was 8577ln (x) +35.35, and the coefficient of determination (R ² ) was R ² = 0.286. Furthermore, since the coefficient of determination (R ² ) was less than 0.7 and the correlation was judged to be poor, the average value of the measurement data multiplied by a constant of 3.00% was further added to the coefficient of determination (R ² ). The allowable range was calculated to be 40.475 by multiplying the reciprocal. FIG. 15 shows the change in absorbance calculated from the measurement data and an approximate expression for the change along with the allowable range. In FIG. 15, the horizontal axis represents the measurement data section, and the vertical axis represents the absorbance change amount. In addition, regardless of the preset photometric points 3 to 24, the start point of the measurement data interval is set to 1 and used for abnormality determination. As a result, in the vicinity of the photometric point 21 in the latter half of the designated range, the amount of change in absorbance calculated from the measurement data exceeded the allowable value range, so an abnormality in the reaction process was detected.

[Embodiment 2: Determination using the size of the area surrounded by the approximate expression of the change amount and the change amount (endpoint method)]
In order to verify the effect of the present invention, the zinc sulfate turbidity test (ZTT) was measured by the endpoint method. The step of obtaining measurement data was performed in the same manner as in Example 1.
(2-1) Example of Normal Reaction Process In the same manner as in Example 1, the measurement data of the photometric points 3 to 24, which is a range set in advance for the ZTT item, were taken. As an absorbance change amount in this range, y (dx) = y (x + 1) −y (x) between points in the specified range was calculated. Next, when the parameter coefficient of the approximate expression y = a * ln (x) + b is calculated based on the calculated change in absorbance, the approximate expression is y = −17.284ln (x) +56.589, Coefficient of determination (R ²
) Was R ² = 0.9847. FIG. 14 is a diagram in which an allowable range is shown together with an absorbance change amount calculated from measurement data and an approximate expression of the change amount. At this time, the region value (S) surrounded by the absorbance change amount and the approximate expression was calculated according to a known method to be 25.869. The constant (%) was 5.00%. Here, the allowable range value was calculated by multiplying the maximum absolute value of the measurement data by a constant of 5.00%, and was 118.290. As a result, the region value (S) calculated from the measurement data did not exceed the allowable region value, so no abnormality in the reaction process was detected.

(2-2) Example of abnormal reaction process On the other hand, in the measurement data showing the abnormal reaction process of ZTT, the presence or absence of abnormality was determined in the same manner as (2-1). First, when an approximate expression and a determination coefficient were calculated, the approximate expression was y = −18.861ln (x) +51.615, and the determination coefficient (R ² ) was R ² = 0.5431. FIG. 16 shows an absorbance change amount calculated from the measurement data and an approximate expression of the change amount. In FIG. 16, the horizontal axis represents the measurement data interval, and the vertical axis represents the absorbance change amount. In addition, regardless of the preset photometric points 3 to 24, the start point of the measurement data interval is set to 1 and used for abnormality determination. At this time, the region value (S) surrounded by the absorbance change amount and the approximate expression was calculated according to a known method to be 173.501. Further, the allowable region value was calculated by multiplying the maximum absolute value of the measurement data by a constant of 5.00%, and 106.150 was calculated. As a result, since the region value (S) calculated from the measurement data exceeded the allowable region value, an abnormality in the reaction process was detected.

[Example 3: Determination using deviation of variation from upper and lower limit values based on approximate equation of variation (rate method)]
In order to verify the effect of the present invention in the reaction process by the rate method, cholinesterase (ChE) was measured. For the measurement reagent, ChE-CL (Cerotech Co., Ltd.)
The same procedure as in Example 1 was carried out except that was used.

(3-1) Example of normal reaction process After the measurement of the sample was completed, measurement data of photometric points 26 to 50, which was a range set in advance for the item of ChE, were captured. As an absorbance change amount in this range, y (dx) = y (x + 1) −y (x) between points in the specified range was calculated. Next, when the parameter coefficient of the approximate expression y = a * ln (x) + b is calculated based on the calculated change in absorbance, the approximate expression in the reaction process is y = −4.7606ln (x) −96. And the determination coefficient (R ² ) was R ² = 0.6704. In FIG. 17, the absorbance change amount obtained from the measurement data and an approximate expression of the change amount are shown together with the allowable range. In FIG. 17, the horizontal axis represents the measurement data interval, and the vertical axis represents the absorbance change amount. Further, the start point of the measurement data section was set to 1 and used for abnormality determination regardless of the section of photometry points 26 to 50 set in advance. The constant was set to 1.00%. The allowable value was calculated from the ratio to the measurement data, and the allowable value width was calculated as ± 54.557 by multiplying the average value of the measurement data by a constant 1.0. As a result, the change in absorbance calculated from the measurement data did not exceed the upper and lower limits of the allowable range in any measurement data, so no abnormality in the reaction process was detected.

(3-2) Example of abnormal reaction process On the other hand, in the measurement data showing the abnormal reaction process of ChE, the presence or absence of abnormality was determined in the same manner as (3-1). First, when the approximate expression and the coefficient of determination (R ² ) were calculated, the approximate expression is y =
It was -5.4134ln (x) -90.393, and the coefficient of determination (R ² ) was R ² = 0.0491. FIG. 18 shows the change in absorbance obtained from the measurement data and an approximate expression for the change along with the allowable range. In FIG. 18, the horizontal axis represents the measurement data interval, and the vertical axis represents the absorbance change amount. Further, the start point of the measurement data section was set to 1 and used for abnormality determination regardless of the section of photometry points 26 to 50 set in advance. The allowable value was calculated from the ratio to the measurement data, and the allowable value width was calculated to be ± 55.589 by multiplying the average value of the measurement data by a constant of 1.00%. As a result, in the vicinity of the photometric point 39, the change in absorbance calculated from the measurement data exceeded the lower limit of the allowable range, so an abnormality in the reaction process was detected.

[Embodiment 4: Determination using the size of the region surrounded by the approximate expression of the change amount and the change amount (rate method)]
In order to verify the effect of the present invention, cholinesterase (ChE) was measured. The step of obtaining the measured value was performed in the same manner as in Example 1.

(4-1) Example of normal reaction process After the measurement of the specimen was completed, measurement data of photometry points 26 to 50, which was a range set in advance for the item of ChE, were captured. As an absorbance change amount in this range, y (dx) = y (x + 1) −y (x) between points in the specified range was calculated. Next, when the parameter coefficient of the approximate expression y = a * ln (x) + b is calculated based on the calculated change in absorbance, the approximate expression is y = 1.6435ln (x) −16.627, The coefficient of determination (R ² ) was R ² = 0.3927. FIG. 19 shows an absorbance change amount calculated from the measurement data and an approximate expression of the change amount. In FIG. 19, the horizontal axis represents the measurement data interval, and the vertical axis represents the change in absorbance. Further, the start point of the measurement data section was set to 1 and used for abnormality determination regardless of the section of photometry points 26 to 50 set in advance. The constant was set to 0.70%. The region value (S) surrounded by the amount of change in absorbance and the approximate expression was calculated according to a known method to be 24.340. The allowable area value calculated by multiplying the maximum absolute value of the measurement data by a constant (%) 0.70 was 216.1139. As a result, the region value (S) calculated from the measurement data did not exceed the allowable region value, so no abnormality in the reaction process was detected.

(4-2) Example of abnormal reaction process On the other hand, in the measurement data showing the abnormal reaction process of ChE, the presence or absence of abnormality was determined in the same manner as (3-1). First, when an approximate expression and a determination coefficient were calculated in the same manner, the approximate expression was y = 0.1258ln (x) −0.3288, and the determination coefficient (R ² ) was R ² = 0.0062. The region value (S) enclosed by the absorbance change amount and the approximate expression was calculated to be 18.590. FIG. 20 shows an absorbance change amount obtained from the measurement data and an approximate expression of the change amount. In FIG. 20, the horizontal axis represents the measurement data section, and the vertical axis represents the absorbance change amount. Further, the start point of the measurement data section was set to 1 and used for abnormality determination regardless of the section of photometry points 26 to 50 set in advance. The allowable region value calculated by multiplying the maximum absolute value of the measurement data by a constant of 0.70% was 14.848. As a result, since the region value (S) calculated from the measurement data exceeded the allowable region value, an abnormality in the reaction process was detected.

  The present invention can be used mainly in the field of clinical tests, and can be a new evaluation standard that gives reliability to the measurement result for each specimen, which is impossible with the conventional evaluation method. Therefore, it is possible to provide clinical test results with higher accuracy. In addition, the efficiency of the entire analysis work can be improved by the present invention.

1 ... computer,
DESCRIPTION OF SYMBOLS 11 ... Memory | storage part, 12 ... Control part, 13 ... Bus, 14 ... Input-output part 31 ... Data acquisition part, 32 ... Data analysis part

Claims (11)

(A) a step of obtaining a measurement data change amount between each measurement point from a measurement start point to a measurement end point in a specified period;
(B) a step of calculating the measurement data amount of change in the approximate expression,
(C) a step of setting a determination value calculated from the approximate expression calculated in (b) and a ratio to a value based on measurement data; and
(D) determining whether there is an abnormality based on the determination value of the approximate expression set in (c);
Only including,
The determination value in the step (c) is determined from an allowable width set according to a value of a determination coefficient of the approximate expression calculated from a measurement data change amount.
A method for detecting abnormalities in measurement data. The method according to claim 1 , wherein the determination value in the step (c) is an allowable value that varies depending on a determination coefficient of the approximate expression calculated from a measurement data change amount. The method according to claim 2 , wherein the determination value set in the step (c) is an upper limit allowable value and / or a lower limit allowable value calculated from a ratio to the entire measurement data. The method for detecting an abnormality in measurement data according to claim 3 , wherein the determination value set in the step (c) is an area allowable value represented by an area. 5. The method for detecting an abnormality in measurement data according to claim 4 , wherein the area allowable value set in the step (c) is calculated based on an area surrounded by a measurement data change amount and an approximate expression. . The method according to claim 2 , wherein the determination value in the step (c) is an allowable number of times obtained from a ratio of the measurement data change amount to the number of measurement points. The calculation of the determination value in the step (c) is obtained from the ratio of the measurement data change amount to the number of measurement points,
Compared to the approximate expression calculated from the measurement data change amount, the allowable number of times and the number of times (C) the value of the measurement data change amount is switched across the approximate expression are compared, and the number of times (C) is the allowable number of times Detect an abnormality when exceeding
The method for detecting an abnormality in measurement data according to claim 6 . The method for detecting an abnormality in measurement data according to any one of claims 1 to 7 , wherein the measurement data is absorbance. The method for detecting an abnormality in measurement data according to any one of claims 1 to 8 , wherein the approximate expression is expressed by the following expression (1).

Here, x is a measurement data interval, ln is a natural logarithm, y is a change amount of a measurement value in the measurement data interval x, and a and b are coefficients. (A) means for obtaining measurement data;
(B) means for obtaining a measurement data change amount between each measurement point from a measurement start point to a measurement end point in a specified period;
(C) means for calculating the measurement data amount of change in the approximate expression,
(D) means for setting a determination value calculated from the approximate expression calculated in (b) and a ratio to a value based on measurement data; and
(E) means for determining the presence or absence of an abnormality based on the determination value of the approximate expression calculated in (c);
Equipped with a,
The determination value in the means (c) is determined from an allowable range set in accordance with a value of a determination coefficient of the approximate expression calculated from a measurement data change amount.
Measurement data abnormality detection device. (A) means for obtaining a measurement data change amount between each measurement point from the measurement start point to the measurement end point in a specified period;
(B) means for calculating the measurement data amount of change in the approximate expression,
(C) means for setting a determination value calculated from the approximate expression calculated in (b) and a ratio to a value based on measurement data; and
(D) (c) means for determining the presence or absence of an abnormality based on the determination value of the approximate expression calculated in the above step;
Equipped with a,
The determination value in the means (c) is determined from an allowable range set in accordance with a value of a determination coefficient of the approximate expression calculated from a measurement data change amount.
Measurement data abnormality detection device.

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