JP2008058065A - Autoanalyzer and automatic analysis method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To detect anomalies in measurement data in the process of a reaction even without reference data. <P>SOLUTION: In a control computer 6 of this autoanalyzer, upper and lower limits of the rate of change in measurement data or the rate of change in the amount of change in measurement data between photometric points are previously set by a measurement data change-rate allowance setting part 66 or a measurement data change-amount change-rate allowance setting part 67. With respect to measurement data on the several photometric points in a prescribed zone, the rate of change in measurement data or the rate of change in the amount of change in measurement data between adjoining photometric points are calculated by a measurement data change-rate calculation part 62 or by a measurement data change-amount change-rate calculation part 63. When the calculated rate of change in the measurement data or the calculated rate of change in the amount of change in the measurement data stands outside the previously set upper and lower limits, the then measurement data are detected as anomalous measurement data by an anomalous measurement data detection part 68. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an automatic analyzer used in the field of clinical testing, and in particular, while sequentially transferring a plurality of reaction containers, samples and reagents are sequentially dispensed into each reaction container, and a liquid in the reaction container is dispensed with a predetermined amount. The present invention relates to an automatic analysis apparatus and an automatic analysis method for photometry at time intervals.

  In recent years, in automated analyzers used in the field of clinical examinations, while sequentially transferring a plurality of reaction vessels, sample dispensing, reagent dispensing, stirring, photometry, and washing are performed on each reaction vessel to react. It has become common to use containers repeatedly. In such an automatic analyzer that repeatedly uses a reaction vessel, a photometric cuvette capable of direct photometry is used as the reaction vessel. Each time the photometric cuvette containing the sample and the reagent passes through the photometric unit between the predetermined timing before the start of the reaction and the predetermined timing after the start of the reaction and before the cleaning, the light from the light source is measured. Photometry is performed through a cuvette to obtain data such as absorbance. Furthermore, in such an automatic analyzer, the entire reaction is performed using the measurement data at a specific photometry point set in advance according to the measurement item from a plurality of acquired data such as absorbance. Some use process metering.

  In such an automatic analyzer of the total reaction process photometry method, the reaction process between the reagent and the specimen can be traced continuously for each photometric cuvette at a constant time, so that it can be traced over time like an enzyme reaction. Therefore, it is possible to easily analyze the reaction process in which the absorbance changes. Furthermore, various check logics for improving the reliability of measurement data can be provided.

For example, in Patent Document 1 and Patent Document 2, measurement data obtained in the reaction process using a sample and a reagent for quality control are registered as reference data, and the measurement data is used as a reference when measuring a sample. An example of an automatic analyzer that detects an abnormality in measured data in a reaction process by comparing with data and the magnitude of the difference is disclosed.
JP 2003-57248 A JP-A-2005-181106

  However, in these conventional techniques, it is necessary to prepare reference data for the same reaction process in advance. The reference data must be prepared for each analysis item and, in some cases, for each reagent concentration. Therefore, the man-hours for preparing the reference data are man-hours that cannot be ignored in the entire analysis work.

  In view of the above problems of the prior art, the object of the present invention is to detect an abnormality in measurement data in the reaction process even without reference data, and to thereby improve the efficiency of the entire analysis work. It is an object of the present invention to provide a possible automatic analyzer and automatic analysis method.

  In order to solve the above-described problems of the prior art, the automatic analyzer according to the present invention is a measurement in which the control computer calculates the rate of change of measurement data between adjacent photometry points with respect to measurement data at each photometry point. A data change rate calculating means, a change rate allowable range setting means for setting an upper limit value and a lower limit value of the change rate of the measurement data between the photometry points, and the calculated change rate of the measured data is a change of the set measurement data. And an abnormal measurement data detecting means for detecting the measurement data at that time as abnormal measurement data when it is outside the range of the upper limit value and the lower limit value of the rate.

  According to the present invention, the measurement data change rate calculation means calculates the change rate between the measurement data of the adjacent photometry points for the measurement data of each photometry point, and the change rate of the calculated measurement data is changed. It is compared with the upper limit value and lower limit value of the rate of change of measurement data separately determined by the rate allowable range setting means. When the calculated change rate of the measurement data is outside the range of the upper limit value and the lower limit value, the measurement data is detected as abnormal measurement data. That is, in the present invention, it is determined that the measurement data is abnormal when the measurement data greatly changes from the measurement data of the adjacent photometry point. Therefore, even if the reference data is not necessary, it is possible to detect an abnormality in the measurement data.

  According to the present invention, there is provided an automatic analyzer and an automatic analysis method capable of detecting an abnormality of measurement data in a reaction process without reference data and thereby improving the efficiency of the entire analysis work. Can be provided.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings as appropriate.

  FIG. 1 is a diagram showing an example of the configuration of an automatic analyzer according to an embodiment of the present invention. As shown in FIG. 1, the automatic analyzer 1 includes an analyzer 5 and a control computer 6. The analyzer 5 in FIG. 1 is a schematic top view thereof.

  In FIG. 1, a reaction disk 36 in which a reaction vessel 35 is placed on the circumference is arranged on the housing of the analyzer 5, and a reagent disk 42 is disposed inside the reaction disk 36 and a reagent disk is disposed outside. A disk 41 is arranged. A plurality of reagent containers 40 are placed on the circumference of the reagent disks 41 and 42, respectively. Here, one reagent container 40 is divided into two, and usually different reagents are put therein.

  In the vicinity of the reaction disk 36, a transport mechanism 12 for placing the sample container 10 and moving the rack 11 is provided. In addition, rails 25 and 26 are provided above the reagent disks 41 and 42, and reagent probes 20 and 21 movable in a direction parallel to the rail and in the vertical direction are installed on the rail 25. Are constructed with a rail and reagent probes 22 and 23 movable in three axial directions. Reagent pumps 20, 21, 22 and 23 are connected to reagent pumps (not shown).

  Between the reaction vessel 35 and the transport mechanism 12, sample probes 15 and 16 that can rotate and move up and down are installed. A sample pump (not shown) is connected to each of the sample probes 15 and 16. Further, around the reaction disk 36, stirring devices 30 and 31, a light source 50, a photometric device 51, and a container cleaning mechanism 45 are arranged. A cleaning pump (not shown) is connected to the container cleaning mechanism 45. A cleaning port 54 is installed in the operation range of each of the sample probes 15 and 16, the reagent probes 20, 21, 22 and 23 and the stirring devices 30 and 31.

  Next, the operation of the analyzer 5 will be described. Here, the operation when performing analysis according to the analysis method of the two-reagent system (analysis method in which two types of reagents are dispensed and reacted with a sample with a time difference) will be described.

  First, a sample container 10 in which a sample to be examined such as blood is placed is placed on a rack 11 and is transported to the vicinity of sample probes 15 and 16 by a transport mechanism 12. Next, the sample probes 15 and 16 take a sample from the sample container 10 and dispense a predetermined amount into the reaction container 35 arranged on the reaction disk 36.

  Subsequently, the reagent probes 20 and 21 collect a predetermined amount of the first reagent from the reagent container 40 placed on the reagent disk 41 or 42 and dispense it into the reaction container 35. The stirring devices 30 and 31 stir the sample and the reagent in the reaction vessel 35 as appropriate. Thereafter, after a predetermined time has elapsed, the reagent probe 22 or 23 collects a predetermined amount of the second reagent from the reagent container 40 placed on the reagent disk 41 or 42 in the reaction container 35 and dispenses it into the reaction container 35. To do. The stirring devices 30 and 31 stir the sample and the reagent in the reaction vessel 35 as appropriate.

  Further, after a predetermined time has elapsed, the photometric device 51 measures the light emitted from the light source 50 through the reaction vessel 35 to obtain measurement data such as the absorbance of the sample that has reacted with the reagent, and the obtained measurement data is obtained. To the control computer 6.

  In the analyzer 5 as described above, the reaction disk 36 repeats the rotation operation and the stop operation for one rotation + 1 reaction container every predetermined time (for example, every minute). Therefore, during the repetition of the operation, the reaction vessel 35 rotates by one reaction vessel, for example, counterclockwise every time it stops. Then, when the reaction disk 36 is stopped, the sample and the reagent are respectively dispensed into the reaction container 35 at a predetermined position, and the reaction container 35 at the other position is washed or the sample therein It will be stirred up.

  Further, when the reaction disk 36 rotates by one rotation plus one reaction container, all the reaction containers 35 cross between the light source 50 and the photometry device 51. Therefore, the photometric device 51 can acquire measurement data such as absorbance of the sample in which the reagents in all the reaction containers 35 are dispensed at predetermined time intervals (for example, every minute).

  FIG. 2 is a diagram showing an example of the functional block configuration of the control computer of the automatic analyzer according to the embodiment of the present invention. As shown in FIG. 2, the control computer 6 includes an information processing device 60 including a CPU (Central Processing Unit) and a storage device (not shown), an input device 80 including a keyboard and a mouse, an LCD (Liquid Crystal Display), and the like. And a display device 90 made up of.

  In addition, the information processing apparatus 60 includes a measurement data acquisition unit 61, a measurement data change rate calculation unit 62, a measurement data change amount change rate calculation unit 63, an analysis data calculation unit 64, an analysis data display unit 65, a measurement data change rate allowable range. Processing function blocks such as a setting unit 66, a measurement data change amount change rate allowable range setting unit 67, an abnormal measurement data detection unit 68, a measurement data storage unit 71, a measurement data change rate storage unit 72, and a measurement data change amount change rate storage Unit 73, analysis data storage unit 74, measurement data change rate allowable range storage unit 75, and measurement data change amount change rate allowable range storage unit 76. However, these functional blocks are functional blocks according to the present embodiment, and the information processing apparatus 60 includes a large number of other functional blocks related to operation control of the analysis apparatus in addition to these functional blocks. The description of is omitted.

  Hereinafter, functions of the functional blocks constituting the control computer 6 will be described with reference to FIG.

The measurement data acquisition unit 61 acquires measurement data such as absorbance measured at a predetermined time interval (for example, 1 minute) by the photometry device 51 of the analyzer 5, and the measurement data storage unit 71 acquires the acquired measurement data. To store. In the measurement data storage unit 71, the measurement data is stored in the measurement data storage unit 71 as time-series data at predetermined time intervals for each reaction container 35, that is, for each sample dispensed with a reagent. In this specification, the time-series measurement data is represented by m (i) (i = 1, 2,..., N).
It expresses. Here, i is a number representing the order of time-series data, and m (i) is measurement data acquired at time t (i).

The measurement data change rate calculation unit 62 calculates a change rate (measurement data change rate) per unit time of the time-series measurement data m (i), and uses the calculated measurement data change rate as a measurement data change rate storage unit. 72. Here, the measurement data change rate v (i) can be calculated by the following equation (1).
v (i) = {m (i + 1) −m (i)} / {t (i + 1) −t (i)} Equation (1)
Where i = 1, 2,..., N−1.
That is, the measurement data change rate v (i) corresponds to a derivative of the measurement data m (i).

Moreover, since the time interval for obtaining measurement data is usually the same regardless of the value of i, t (i + 1) −t (i) = 1 in equation (1) if the time interval is a unit time. be able to. In that case, the measurement data change rate v (i) can be calculated by the following equation (1 ′).
v (i) = m (i + 1) −m (i) Equation (1 ′)
Where i = 1, 2,..., N−1.

The measurement data change amount change rate calculation unit 63 calculates a change rate of change amount per unit time of the time-series measurement data m (i) (measurement data change amount change rate), and the calculated measurement data change amount The change rate is stored in the measurement data change amount change rate storage unit 73. Here, the measurement data change amount change rate a (i) can be calculated by the following equation (2).
a (i) = {v (i + 1) −v (i)} / {t (i + 1) −t (i)} Equation (2)
However, i = 1, 2, ..., n-2
That is, the measurement data change rate change rate a (i) corresponds to a differentiation of the measurement data change rate v (i), that is, a second-order differentiation of the measurement data m (i).

Similarly to the calculation of the measurement data change rate v (i), when t (i + 1) −t (i) = 1, the measurement data change rate change rate a (i) is expressed by the following equation. (2 ′) can be calculated.
a (i) = v (i + 1) −v (i) Equation (2 ′)
However, i = 1, 2, ..., n-2

  Based on the measurement data stored in the measurement data storage unit 71, the analysis data calculation unit 64 performs a predetermined calculation according to the analysis item of the sample from which the measurement data is acquired, and calculates analysis data for the sample. The calculated analysis data is stored in the analysis data storage unit 74.

  The measurement data change rate allowable range setting unit 66 reads the upper limit value and the lower limit value of the measurement data change rate input from the input device 80, and uses the read upper limit value and lower limit value of the measurement data change rate as the measurement data. It is stored in the change rate allowable range storage unit 75. The measurement data change amount change rate allowable range setting unit 67 reads the upper limit value and lower limit value of the measurement data change amount change rate input from the input device 80, and reads the upper limit of the read measurement data change amount change rate. The value and the lower limit value are stored in the measurement data change amount change rate allowable range storage unit 76.

  As will be described later, the abnormal measurement data detection unit 68 stores, in the analysis using the rate analysis method, the measurement data change rate for each series of time-series measurement data of each sample. It is determined whether it is included in the range between the upper limit value and the lower limit value stored in the unit 75, and if not included in the range between the upper limit value and the lower limit value, the measurement data is abnormal. Detect as measurement data. Similarly, in the analysis using the endpoint method or the like, the measurement data change amount change rate is stored in the measurement data change amount change rate allowable range storage unit 76 for each series of time-series measurement data of each sample. It is determined whether or not it is included in the range between the stored upper limit value and lower limit value. If it is not included in the range between the upper limit value and lower limit value, the measurement data is regarded as abnormal measurement data. To detect.

  The analysis data display unit 65 displays the analysis data stored in the analysis data storage unit 74 on the display device 90. At this time, when the abnormal measurement data is detected by the abnormal measurement data detection unit 68 for the measurement data that is the basis of the analysis data, an alarm indicating that the abnormal measurement data has been detected for the analysis data Is displayed. The analysis data display unit 65 displays the measurement data stored in the measurement data storage unit 71 in the form of a graph or the like as necessary.

  The functions of the processing function blocks of the information processing apparatus 60 described above are realized by a CPU (not shown) of the information processing apparatus 60 executing a predetermined program stored in a storage device (not shown). Each storage function block of the information processing device 60 is realized by a table or file configured on the storage device.

  Next, a specific example of processing for detecting an abnormality in measurement data, that is, an abnormality in a reaction process, using the automatic analyzer 1 of the present embodiment will be described with reference to FIGS. Here, FIG. 3 is a diagram illustrating an example of a flow of processing for detecting an abnormality in measurement data after measurement data is acquired in the control computer according to the embodiment of the present invention.

  Since the process of FIG. 3 is a process executed after acquisition of measurement data, when the flow of the process is started, the measurement data is already stored in the measurement data storage unit 71 by the measurement data acquisition unit 61. The upper limit value and lower limit value of the measurement data change rate (or measurement data change amount change rate) are set by the change rate allowable range setting unit 66 (or measurement data change amount change rate allowable range setting unit 67). The data is stored in the storage unit 75 (or the measurement data change amount change rate allowable range storage unit 76).

  Therefore, here, before starting the description of FIG. 3, setting of the measurement data change rate allowable range will be described with reference to FIG. 4. Here, FIG. 4 is a diagram showing an example of an analysis parameter setting screen in the control computer according to the embodiment of the present invention.

  As shown in FIG. 4, the analysis operator sets parameters such as analysis method, measurement time, and photometry point on the analysis parameter setting screen. Here, the analysis method is information for distinguishing the rate analysis method from other analysis methods. In FIG. 4, the rate analysis method is set. The measurement time is the time required to acquire all measurement data, and the photometry point is information that specifies measurement data used for calculating analysis data among the measurement data. The number representing the photometric point here corresponds to the variable i when the measurement data is represented as m (i) (i = 1, 2,..., N).

  In addition, an absorbance change rate check setting screen is displayed in the analysis parameter setting screen of FIG. Then, using the absorbance change rate check setting screen, the analysis operator can set the calculation start point and calculation end point for calculating the absorbance change rate, and the lower limit value and upper limit value of the absorbance change rate. it can. The absorbance here corresponds to the measurement data.

  The calculation start point is a photometric point for starting the calculation for calculating the absorbance change rate and the calculation for comparing the absorbance change rate calculated by the calculation with the upper limit value and the lower limit value set on the same screen, The calculation end point is a photometric point at which the calculation ends. That is, the calculation start point and the calculation end point check whether or not the calculated absorbance change rate is within the range of the upper limit value and the lower limit value, that is, specify the photometry point section where the measurement data abnormality is detected. Information.

  The absorbance change rate check setting screen allows the analysis operator to set the calculation start point and calculation end point separately from the photometry point used for calculating the analysis data, thereby increasing the flexibility of analysis.

  FIG. 5 is a diagram showing an example in which measurement data of absorbance obtained by the rate analysis method is displayed as a graph in the control computer according to the embodiment of the present invention. In FIG. 5, since the second reagent was discharged into the reaction vessel 35 immediately after the 19th point of the photometry point, the absorbance changed rapidly by the 20th point, and then the absorbance changed at a substantially constant rate. The situation is shown. Therefore, in this case, the photometry point is set to 21 and 38, the calculation start point is set to 20, and the calculation end point is set to 38 on the screen of FIG.

  In the example of FIG. 5, although the absorbance has changed at a substantially constant rate after the 21st point, an absorbance gap is generated between the 22nd point and the 23rd point. In such a case, there are many abnormalities in the reaction process, and it is necessary to recognize the gap as abnormal.

  Therefore, the information processing apparatus 60 starts the process shown in FIG. First, the information processing apparatus 60 determines whether or not the analysis method set on the analysis parameter setting screen of FIG. 4 is a rate analysis method (step S01). As a result of the determination, if it is a rate analysis method (Yes in step S01), the information processing apparatus 60 calculates an absorbance change rate for each photometric point i from the calculation start point to the calculation end point (step S02). . At this time, the absorbance change rate can be calculated according to the above-described equation (1), for example, when the absorbance measurement data is m (i).

  FIG. 6 is a graph showing the absorbance change rate calculated for the absorbance measurement data of FIG. In general, in the rate analysis method, the rate of change in absorbance becomes a certain value depending on the analysis item, sample, and the like. However, when a gap or the like occurs as in the absorbance measurement data in FIG. As shown, an unusually large absorbance change rate appears. Therefore, the information processing apparatus 60 detects such an abnormal value of the absorbance change rate and determines that the reaction process is abnormal.

  Detection of the abnormal value of the absorbance change rate is determined by whether or not the calculated absorbance change rate is included in the range between the upper limit value and the lower limit value set on the absorbance change rate check setting screen of FIG. However, in the case of the present embodiment, as shown in FIG. 3, the information processing apparatus 60 standardizes the absorbance change rate calculated in step S02 with the value of the calculation start point before the determination (step S03). . Here, normalization means subtracting the value of the absorbance change rate at the calculation start point from the value of the absorbance change rate at each photometric point calculated in step S02.

  FIG. 7 is a graph showing the absorbance change rate graph obtained by normalizing the absorbance change rate graph of FIG. 6 with the value of the calculation start point. In this case, since the normalized value of the absorbance change rate is almost “0”, it is easy to set the upper limit value and the lower limit value. Further, even when the concentration change in the sample to be measured is large, it is possible to easily detect the point where the absorbance change rate is abnormal. Here, the absorbance change rate is normalized by the value of the calculation start point, but may be normalized by the absorbance change rate value of another photometry point. Furthermore, after obtaining the average value of the absorbance change rate in the calculation point section, the absorbance change rate may be normalized by the average value.

  Subsequently, in FIG. 3, the information processing apparatus 60 determines whether or not the normalized absorbance change rate is a value within a predetermined range (step S07). That is, it is determined whether or not the normalized absorbance change rate is included in the range between the upper limit value and the lower limit value set on the absorbance change rate check setting screen of FIG. As a result, when it is included in the range (Yes in step S07), it is assumed that there is no abnormality in the reaction process, and the process is ended as it is. On the other hand, when the normalized absorbance change rate is not included in the range (No in step S07), it is assumed that there is some abnormality in the reaction process, and the measurement data corresponding to the absorbance change rate or the measurement data An alarm is displayed on the analysis data calculated from (step S08). In addition, the case where it becomes No by determination of step S01 is mentioned later.

  FIG. 8 is a diagram showing an example of an analysis result display screen in the control computer according to the embodiment of the present invention. As shown in FIG. 8, on the analysis result display screen, sample information such as a sample number, a sample container, and a measurement time is displayed in the left region. When one of the sample information is selected by a click operation or the like (here, sample number 0006 is selected), the measurement result of the sample is displayed in the right region. In this example, AST, ALT, GGT, and TP are displayed as analysis items. Among them, an alarm indicating that there is an abnormality in the reaction process is displayed for GGT.

  Furthermore, when one of the analysis items is selected by a click operation or the like in the measurement result region (here, GGT is selected), the information processing apparatus 60 displays the analysis items in FIGS. 5 and 6. You may make it display graphs, such as measurement data like this, and an absorbance change rate. By doing so, the analysis operator can know the abnormal state of the reaction process.

  Subsequently, detection of measurement data abnormality in an analysis method other than the rate analysis method will be described. Here, the endpoint method is taken as an example of the analysis method.

  FIG. 9 is a diagram showing an example of a display screen when the endpoint method is designated on the analysis parameter setting screen in the control computer according to the embodiment of the present invention. As shown in FIG. 9, the analysis parameter setting screen is for the rate analysis method except that the endpoint method is set as the analysis method and the absorbance change rate is the absorbance acceleration. This is not different from the analysis parameter setting screen (see FIG. 4). The description of the absorbance acceleration will be described later.

  FIG. 10 is a diagram showing an example in which the absorbance measurement data acquired by the endpoint method using the control computer according to the embodiment of the present invention is displayed as a graph. In the case of the endpoint method, the absorbance change rate increases rapidly immediately after the second reagent is discharged, and thereafter, the absorbance change rate gradually decreases. In this example, the absorbance has an abnormal value at the 24th photometric point, and it can be determined that an abnormal reaction has occurred at that point.

  FIG. 11 is a graph showing the absorbance change rate calculated for the absorbance measurement data of FIG. As shown in FIG. 11, the absorbance change rate (absolute value thereof) becomes larger and smaller at first. That is, the absorbance change rate does not become a constant value unlike the rate analysis method. Therefore, in this embodiment, the change rate of the absorbance, that is, the change rate of the absorbance change rate is further calculated.

  In the present specification, the change rate of the absorbance change rate is referred to as “absorbance acceleration”. This is because the absorbance change rate is an amount corresponding to the reaction rate of the sample and the reagent, and the change rate of the absorbance change rate is related to the fact that the reaction corresponds to acceleration. However, in the description of the claims and the description of FIG. 2, the expression “change rate of change rate of measurement data (absorbance)” and the expression “acceleration of measurement data” are not used. The expression “change rate of change in measured data” is used. This is because “acceleration of measurement data” cannot be said to be a general expression, and the expression “change rate of change rate of measurement data (absorbance)” is judged to be confusingly miswritten with double words.

  FIG. 12 is a graph showing the absorbance acceleration calculated for the absorbance change rate of FIG. As shown in FIG. 12, in the case of absorbance acceleration, the value is almost constant at any calculation point.

  FIG. 13 is a graph showing the absorbance acceleration graph obtained by normalizing the absorbance acceleration graph of FIG. 12 with the value of the calculation start point. Note that the standardization method and its meaning are the same as those described in FIG. Further, the upper limit value and the lower limit value shown in FIG. 13 are set on the absorbance acceleration check setting screen of FIG.

  Next, with reference to FIG. 3, a process for detecting an abnormality in measurement data for an analysis method other than the rate analysis method will be described.

  When the information processing apparatus 60 determines in step S01 that the analysis method is not the rate analysis method (No in step S01), the absorbance change rate v for each photometric point i from the calculation start point to the calculation end point. (i) is calculated (step S04). At this time, the absorbance change rate v (i) can be calculated according to the equation (1), for example, where the absorbance measurement data is m (i).

  Next, the information processing apparatus 60 calculates the absorbance acceleration a (i) based on the calculated absorbance change rate v (i) (step S05). At this time, the absorbance acceleration a (i) can be calculated, for example, according to the equation (2). Next, the information processing apparatus 60 normalizes the calculated absorbance acceleration a (i) with the value of the calculation start point (step S06).

  Further, the information processing apparatus 60 determines whether or not the normalized absorbance acceleration is a value within a predetermined range (step S07). That is, it is determined whether or not the normalized absorbance acceleration is included in the range between the upper limit value and the lower limit value set on the absorbance acceleration check setting screen of FIG. As a result, when the absorbance acceleration is included in the range (Yes in step S07), it is assumed that there is no abnormality in the reaction process, and the process is ended as it is. On the other hand, when the normalized absorbance acceleration is not included in the range (No in step S07), it is calculated from the measurement data corresponding to the absorbance acceleration or the measurement data that there is some abnormality in the reaction process. An alarm is displayed on the analyzed data (step S08). The display example of the alarm is the same as the example of FIG.

  As described above, according to the present embodiment, it is possible to detect an abnormality in measurement data, that is, an abnormality in the reaction process, without the reference data for the same reaction process. Accordingly, it is not necessary to prepare (that is, measure) reference data in advance, so that the efficiency of analysis work can be improved.

  The present invention is not limited to the embodiments described above, and various modifications can be made. For example, in the embodiment described above, the calculated absorbance change rate or absorbance acceleration is normalized, but the normalization may be omitted as long as the upper limit value and the lower limit value are appropriately set. I do not care. In that case, the information processing apparatus 60 does not need to execute the processes of steps S03 and S06 in FIG.

  In the embodiment described above, the analysis operator sets the upper limit value and the lower limit value for detecting an abnormality in the measurement data on the setting screen of FIG. 4 or FIG. 60 can also be set based on the measurement data itself. In that case, for example, the average value A and the standard deviation σ are obtained based on the absorbance change rate and absorbance acceleration value distribution (histogram) obtained from the measured absorbance, for example, A + 3σ is the upper limit value. A-3σ may be the lower limit. In this case, it is not necessary for the analysis operator to set the upper limit value and the lower limit value, so that the efficiency of the analysis work is further improved.

It is the figure which showed the example of the structure of the automatic analyzer which concerns on embodiment of this invention. It is the figure which showed the example of the structure of the functional block of the control computer which concerns on embodiment of this invention. It is the figure which showed the example of the flow of a process which detects abnormality of the measurement data after measurement data acquisition in the control computer which concerns on embodiment of this invention. It is the figure which showed the example of the analysis parameter setting screen in the control computer which concerns on embodiment of this invention. It is the figure which showed the example which displayed the measurement data of the light absorbency acquired by the rate analysis method as a graph in the control computer which concerns on embodiment of this invention. It is the figure which showed the graph of the light absorbency change rate computed about the measurement data of the light absorbency of FIG. It is the figure which showed the graph of the absorbance change rate which normalized the graph of the absorbance change rate of FIG. 6 with the value of the calculation start point. It is the figure which showed the example of the analysis result display screen in the control computer which concerns on embodiment of this invention. It is the figure which showed the example of the display screen when the end point method is designated on the analysis parameter setting screen in the control computer which concerns on embodiment of this invention. It is the figure which showed the example which displayed the measurement data of the light absorbency acquired by the endpoint method using the control computer which concerns on embodiment of this invention as a graph. It is the figure which showed the graph of the light absorbency change rate computed about the measurement data of the light absorbency of FIG. It is the figure which showed the graph of the light-absorbency acceleration calculated about the light-absorbency change rate of FIG. It is the figure which showed the graph of the absorbance acceleration which normalized the graph of the absorbance acceleration of FIG. 12 with the value of the calculation start point.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 5 Analyzer 6 Control computer 10 Sample container 11 Rack 12 Conveyance mechanism 15 Sample probe 20, 21, 22, 23 Reagent probe 25, 26 Rail 30, 31 Stirrer 35 Reaction container 36 Reaction disk 40 Reagent container 41, 42 Reagent disk 45 Container cleaning mechanism 50 Light source 51 Photometric device 54 Washing port 60 Information processing device 61 Measurement data acquisition unit 62 Measurement data change rate calculation unit 63 Measurement data change rate change rate calculation unit 64 Analysis data calculation unit 65 Analysis data display unit 66 Measurement data change rate allowable range setting unit 67 Measurement data change rate change rate allowable range setting unit 68 Abnormal measurement data detection unit 71 Measurement data storage unit 72 Measurement data change rate storage unit 73 Measurement data change rate change rate storage unit 74 Analysis data Storage unit 75 Measurement data Data change rate tolerance range storage unit 76 measurement data change amount change rate tolerance range storage unit 80 input unit 90 display unit

Claims (8)

Samples and reagents are sequentially dispensed and reacted in multiple reaction vessels, and the reaction process of the reacted liquid is measured continuously at each photometric point at a predetermined time interval to obtain measurement data based on the photometry. An automatic analyzer configured to include an analyzer and a control computer that controls the operation of the analyzer and processes measurement data acquired by the analyzer,
The control computer is
Analysis data calculation means for calculating predetermined analysis data using measurement data included in a predetermined photometry point section of the photometry points;
Measurement data change rate calculation means for calculating a change rate of measurement data between adjacent photometry points for the measurement data at each of the photometry points,
Change rate allowable range setting means for setting an upper limit value and a lower limit value of the change rate of the measurement data between the photometric points;
When the calculated change rate of the measurement data is outside the range of the upper limit value and the lower limit value of the set change rate of the measurement data, abnormal measurement data detection means for detecting the measurement data at that time as abnormal measurement data;
An automatic analyzer characterized by comprising: Samples and reagents are sequentially dispensed and reacted in multiple reaction vessels, and the reaction process of the reacted liquid is measured continuously at each photometric point at a predetermined time interval to obtain measurement data based on the photometry. An automatic analyzer configured to include an analyzer and a control computer that controls the operation of the analyzer and processes measurement data acquired by the analyzer,
The control computer is
Analysis data calculation means for calculating predetermined analysis data using measurement data included in a predetermined photometry point section of the photometry points;
For the measurement data at each of the photometry points, a measurement data change amount change rate calculating means for calculating the change rate of the change amount of the measurement data between adjacent photometry points;
A change rate change rate allowable range setting means for setting an upper limit value and a lower limit value of the change rate of the measurement data change amount between the photometry points;
When the calculated change rate of the change amount of the measurement data is outside the range of the upper limit value and the lower limit value of the change rate of the set change amount of the measurement data, the abnormality is detected as the abnormal measurement data at that time Measurement data detection means;
An automatic analyzer characterized by comprising: The control computer is
In addition to the predetermined photometry point interval used when the analysis data calculation means calculates analysis data, a photometry point interval for designating a detection target interval of the abnormal measurement data by the abnormal measurement data detection means is set. The automatic analyzer according to claim 1, further comprising an abnormality measurement data detection target section setting unit. The control computer is
When abnormal measurement data is detected by the abnormal measurement data detection means, an alarm indicating that there is an abnormality in the measurement data of the reaction process is attached to the analysis data calculated by the analysis data calculation means, and the analysis is performed. The automatic analysis apparatus according to any one of claims 1 to 3, further comprising analysis data display means for displaying data. Samples and reagents are sequentially dispensed and reacted in multiple reaction vessels, and the reaction process of the reacted liquid is measured continuously at each photometric point at a predetermined time interval to obtain measurement data based on the photometry. A control computer connected to the analyzer to control the operation of the analyzer and process the measurement data acquired by the analyzer,
An analysis data calculation step of calculating predetermined analysis data using measurement data included in a predetermined photometry point section of the photometry points;
For the measurement data at each of the photometry points, a measurement data change rate calculation step for calculating a change rate of measurement data between adjacent photometry points;
A change rate allowable range setting step for setting an upper limit value and a lower limit value of a change rate of measurement data between the photometric points;
When the calculated change rate of the measurement data is outside the upper limit value and lower limit value of the set change rate of the measurement data, an abnormal measurement data detection step of detecting the measurement data at that time as abnormal measurement data;
The automatic analysis method characterized by performing. Samples and reagents are sequentially dispensed and reacted in multiple reaction vessels, and the reaction process of the reacted liquid is measured continuously at each photometric point at a predetermined time interval to obtain measurement data based on the photometry. A control computer connected to the analyzer to control the operation of the analyzer and process the measurement data acquired by the analyzer,
An analysis data calculation step of calculating predetermined analysis data using measurement data included in a predetermined photometry point section of the photometry points;
For the measurement data at each of the photometry points, a measurement data change amount change rate calculation step for calculating the change rate of the change amount of the measurement data between adjacent photometry points;
A change rate change rate allowable range setting step for setting an upper limit value and a lower limit value of the change rate of the measurement data change amount between the photometry points;
When the calculated change rate of the change amount of the measurement data is outside the range of the upper limit value and the lower limit value of the change rate of the set change amount of the measurement data, the abnormality is detected as the abnormal measurement data at that time A measurement data detection step;
The automatic analysis method characterized by performing. The control computer is
In addition to the predetermined photometry point interval used when calculating analysis data in the analysis data calculation step, a photometry point interval for designating a detection target interval of the abnormal measurement data in the abnormal measurement data detection step is set. The automatic analysis method according to claim 5 or 6, further comprising executing an abnormal measurement data detection target section setting step. The control computer is
When abnormal measurement data is detected in the abnormal measurement data detection step, an alarm is added to the analysis data calculated in the analysis data calculation step to indicate that there is an abnormality in the measurement data of the reaction process, and the analysis is performed. The automatic analysis method according to any one of claims 5 to 7, further comprising executing an analysis data display step of displaying data.

Images