WO2013021646A1

WO2013021646A1 - Analytical instrument and analysis method

Info

Publication number: WO2013021646A1
Application number: PCT/JP2012/005061
Authority: WO
Inventors: 浩御子柴
Original assignee: ベックマンコールター，インコーポレイテッド
Priority date: 2011-08-09
Filing date: 2012-08-09
Publication date: 2013-02-14
Also published as: JP2013036891A

Abstract

Provided are an analytical instrument and an analysis method which can detect an abnormality in stirring. After the completion of a reaction time course, "additional stirring", which is unnecessary to the process of reaction of a reagent with a sample, is conducted. Before and after the additional stirring, an optical property (such as absorbance) of a reaction liquid in a reaction vessel is measured. Abnormality in the stirring of the reagent and the sample within the reaction time course is detected on the basis of comparison between the optical property (such as absorbance) of the reaction liquid in the reaction vessel as determined before the additional stirring and that of the reaction liquid in the reaction vessel after the additional stirring.

Description

Analysis apparatus and analysis method

The present invention relates to an analysis apparatus and an analysis method capable of detecting an abnormality in stirring.

The stirring of the reaction solution in the reaction container is performed after the sample or reagent is dispensed into the reaction container. In general, agitation makes it possible to perform the required reaction correctly by homogenizing the substances in the reaction vessel, such as dispensed specimens and reagents, or dispensed reagents and diluents. There is an effect. Such agitation is performed, for example, by automatically inserting a spatula-like or bar-like object called a stir bar into the reaction vessel into the reaction vessel and vibrating or rotating the stir bar.

In an analyzer such as an automated blood analyzer, stirring of the reaction solution in the reaction vessel is an essential element indispensable for obtaining accurate data, but a method for confirming stirring performance has not been established. Is the current situation.

In particular, a method of stirring the reaction solution in a non-contact state with respect to the reaction solution, such as using ultrasonic waves or vibrating and stirring the reaction vessel itself, has been proposed and realized. In the stirring of the reaction solution, since the stirring state cannot be visually confirmed, there is no method for confirming whether the stirring is actually performed. Even if the stirring state can be confirmed visually, there is a limit to the confirmation with the naked eye.

In Patent Document 1, it is determined whether or not a sample dispensing process for dispensing a sample into a reaction container is performed normally, and whether or not a reagent dispensing process for dispensing a reagent into a reaction container is performed normally. It is described that it is determined. However, Patent Document 1 does not describe anything about how to detect a stirring abnormality.

Patent Document 2 describes an analyzer capable of detecting an agitation abnormality. However, the analyzer described in Patent Document 2 requires the use of a dedicated solution for stirring performance evaluation in order to detect stirring abnormalities, and detection of stirring abnormalities is performed in a time zone different from the actual inspection. I need that. As described above, detection of abnormality in stirring by the analyzer described in Patent Document 2 is time consuming, expensive and labor intensive, and does not guarantee real-time inspection results.

Patent Document 3 describes an analyzer that can eliminate unnecessary stirring depending on the liquidity of a sample and a reagent. However, Patent Document 3 does not describe anything about how to detect a stirring abnormality.

JP 2007-292495 A JP 2009-150730 A JP 9-127124 A

The analyzer of the present invention comprises means for dispensing a reagent into a reaction solution, means for dispensing a specimen into a reaction container, means for stirring the reagent dispensed into the reaction container and the specimen, and the reaction A means for analyzing the reaction solution obtained by reacting the reagent and the sample dispensed in the container, and a predetermined time has elapsed since the reagent and the sample dispensed in the reaction container were stirred. After measuring the optical properties of the reaction liquid in the reaction vessel, the first measurement result is obtained, and after measuring the optical properties of the reaction liquid in the reaction vessel, Means for further stirring the reaction liquid, and means for obtaining the second measurement result by measuring the optical properties of the reaction liquid in the reaction container after further stirring the reaction liquid in the reaction container; The first Based on comparison with the results constant result and the second measurement, and means for detecting an abnormality of agitation of said reagent dispensed into the reaction vessel and the sample.

The analysis apparatus further measures the optical property of the reaction solution in the reaction container when an abnormality in stirring of the reagent and the sample dispensed in the reaction container is detected, thereby Means for obtaining a measurement result and means for outputting the analysis result of the reaction solution based on the third measurement result as reference data may be further included.

The analyzer may further include means for outputting information indicating that the agitation is abnormal when an abnormality in the agitation of the reagent and the specimen dispensed in the reaction container is detected. .

The optical property of the reaction liquid in the reaction vessel is absorbance, and the means for detecting an abnormality in stirring is the absorbance acquired as the first measurement result and the absorbance acquired as the second measurement result. May be determined to be abnormal in stirring of the reagent and the sample dispensed in the reaction container.

The optical property of the reaction liquid in the reaction vessel is the stability of absorbance, and the means for detecting an abnormality in the stirring is the stability of the absorbance obtained as the first measurement result and the second measurement. When the difference from the absorbance stability obtained as a result is larger than a predetermined threshold, it may be determined that stirring of the reagent and the sample dispensed in the reaction container is abnormal.

The means for obtaining the second measurement result does not use the measurement value measured at the first measurement point after further stirring the reaction solution in the reaction vessel, and further stirs the reaction solution in the reaction vessel. The second measurement result may be obtained using the measurement values measured at the second and subsequent measurement points after the measurement.

The apparatus may further include means for allowing a user of the analyzer to set a timing for further stirring the reaction liquid in the reaction vessel.

The timing for further stirring the reaction solution in the reaction vessel may be fixed.

The stirring of the reaction solution in the reaction vessel is not performed in the circulation in which the reagent and the sample dispensed in the reaction vessel react, and the circulation of the circulation is performed without washing the reaction vessel in the circulation. It may be performed in the next lap.

The analysis method of the present invention includes a step of dispensing a reagent into a reaction solution, a step of dispensing a sample into a reaction vessel, a step of stirring the reagent and the sample dispensed into the reaction vessel, and the reaction A step of analyzing a reaction solution obtained by reacting the reagent and the sample dispensed in the container, and a predetermined time has elapsed since the reagent and the sample dispensed in the reaction container were agitated After obtaining the first measurement result by measuring the optical properties of the reaction liquid in the reaction container, and after measuring the optical properties of the reaction liquid in the reaction container, A step of further stirring the reaction solution, and a step of obtaining a second measurement result by further measuring the optical properties of the reaction solution in the reaction vessel after further stirring the reaction solution in the reaction vessel. The first And detecting, based on comparison with the results constant result and the second measurement, the abnormal stirring of said reagent dispensed into the reaction vessel and the sample.

According to the present invention, after the reaction time course is completed, “additional stirring” that is not required for the reaction process between the reagent and the specimen is performed. Before and after this “additional stirring”, the optical properties (for example, absorbance) of the reaction solution in the reaction vessel are measured. Optical properties (eg, absorbance) of the reaction solution in the reaction vessel measured before “additional stirring” and optical properties (eg, absorbance) of the reaction solution in the reaction vessel measured after “additional stirring” Based on the comparison, an abnormality in stirring of the reagent and the sample within the reaction time course is detected. Thus, according to the present invention, it is possible to provide an analysis apparatus and an analysis method capable of detecting an agitation abnormality. Furthermore, in the present invention, when an abnormal stirring is detected, the optical properties (for example, absorbance) of the reaction solution in the reaction vessel are further measured, and the analysis result of the reaction solution based on this measurement result is output as reference data. You may make it do. Thus, according to the present invention, reference data for inferring correct data can be provided to a user of an analyzer when a stirring abnormality is detected.

The figure which shows an example of the fundamental structure of the analyzer 1 of this invention The figure which shows an example of a logical structure of the analyzer 1 shown by FIG. The figure which shows an example of the operation | movement flow of the analyzer 1 shown by FIG. Figure showing an example of the additional agitation setting screen Figure showing an example of the item name setting screen The figure which shows an example of the item detailed condition setting screen The figure which shows the time sequence based on the operation | movement flow of the conventional analyzer The figure which shows the time sequence based on the operation | movement flow of Embodiment 1 of this invention. The figure which shows the time sequence based on the operation | movement flow of Embodiment 3 of this invention. The figure which shows the change of the light absorbency when the stirring speed is set to a speed lower than the normal stirring speed (the stirring speed is reduced by 50%). Enlarged view of Fig. 6a Figure showing the change in absorbance when the stirring speed is set to a normal stirring speed Enlarged view of FIG. 6c

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
(Basic configuration of the analyzer 1 of the present invention)
FIG. 1 shows an example of a basic configuration of an analyzer 1 of the present invention.

The analyzer 1 includes a reagent table 2 and 3, a reaction table 4, a reagent dispensing mechanism 6 and 7, a sample container transfer mechanism 8, a sample dispensing mechanism 11, an analysis optical system 12, and a cleaning mechanism 13. The control unit 15, the input unit 6, the display unit 17, and the stirring mechanism 20 are provided.

The reagent tables 2 and 3 hold a plurality of

reagent containers

2a and 3a arranged along the circumferential direction of the reagent tables 2 and 3, respectively, and are rotated by driving means (not shown). By rotating the reagent tables 2 and 3, a plurality of

reagent containers

2 a and 3 a are transported along the circumferential direction of the reagent tables 2 and 3.

The reaction table 4 holds a plurality of reaction vessels 5 arranged along the circumferential direction of the reaction table 4, and is rotated in the positive or negative direction indicated by the arrow by a driving means (not shown). By rotating the reaction table 4, the plurality of reaction containers 5 are transported along the circumferential direction of the reaction table 4.

Reagents are dispensed into the reaction container 5 from the

reagent containers

2 a and 3 a of the reagent tables 2 and 3 by the reagent dispensing mechanisms 6 and 7 provided in the vicinity of the reaction table 4. The reagent dispensing mechanisms 6 and 7 are respectively attached to arms 6a and 7a that rotate in the direction of an arrow in a horizontal plane,

probes

6b and 7b that are attached to the arms 6a and 7a, and dispense the reagent, and probes 6b that are washed with water. , 7b for cleaning (not shown).

The reaction vessel 5 is configured to hold a liquid. The reaction vessel 5 is made of an optically transparent material. For example, the reaction vessel 5 is made of a material that transmits 80% or more of light included in analysis light (340 to 800 nm) emitted from an analysis optical system 12 described later, such as glass including heat-resistant glass, cyclic olefin, polystyrene, and the like. Made of synthetic resin.

The specimen container transfer mechanism 8 transfers a plurality of racks 10 arranged in the feeder 9 one by one along the arrow direction. The rack 10 holds a plurality of sample containers 10a containing samples. Each time the rack 10 transferred by the sample container transfer mechanism 8 stops, the sample in the sample container 10a is distributed to each reaction container 5 by the sample dispensing mechanism 11 having the arm 11a and the probe 11b that rotate in the horizontal direction. Noted. For this reason, the specimen dispensing mechanism 11 has a cleaning means (not shown) for cleaning the probe 11b with cleaning water.

The analysis optical system 12 optically analyzes the reaction solution obtained as a result of the reaction between the reagent and the sample. The analysis optical system 12 includes a light source 12a that emits analysis light (for example, analysis light having a wavelength of 340 nm to 800 nm) for analyzing the reaction solution, a spectroscopic unit 12b, and a light receiving unit 12c. The analysis light emitted from the light source 12a passes through the reaction solution in the reaction vessel 5 at the measurement point of the analyzer 1, and is received by the light receiving unit 12c provided at a position facing the spectroscopic unit 12b. The light receiving unit 12 c is connected to the control unit 15.

The cleaning mechanism 13 sucks and discharges the reaction liquid in the reaction vessel 5 with the nozzle 13a, and then repeatedly injects and sucks a cleaning liquid such as a detergent and cleaning water with the nozzle 13a, thereby performing analysis by the analysis optical system 12. The reaction vessel 5 that has been completed is washed.

The control unit 15 controls the operation of each unit of the analyzer 1 and measures the optical property (for example, absorbance) of the reaction liquid in the reaction vessel 5 based on the analysis light received by the light receiving unit 12c. Based on the measurement result, characteristics of the reaction solution (for example, components and concentration of the reaction solution) are analyzed. The control unit 15 can be implemented by, for example, a microcomputer. The control unit 15 includes an input unit 16 (for example, a keyboard) for inputting inputs (for example, analysis items and analysis conditions) from a user, and a display unit 17 (for example, a display panel) for displaying analysis results. And connected to.

The stirring mechanism 20 is configured to stir the reagent and the sample dispensed in the reaction vessel 5. In this way, the reagent and the sample react with each other by stirring the reagent and the sample in the reaction container 5. The stirring mechanism 20 is configured to further stir the reaction solution obtained by the reaction between the reagent and the sample in the reaction vessel 5. Here, the timing of stirring by the stirring device 20 is controlled according to a control signal from the control unit 15. As the stirring device 20, any known type of stirring device can be used. For example, the stirring mechanism 20 may use a stirring bar, may use vibration, or may use sound waves. Note that the position and number of the stirring mechanism 20 are not limited to the embodiment shown in FIG. 1 and may be any position and number.

FIG. 2 shows an example of a logical configuration of the analysis apparatus 1 shown in FIG. The control unit 15 includes the reagent tables 2 and 3, the reaction table 4, the reagent dispensing mechanisms 6 and 7, the sample container transfer mechanism 8, the sample dispensing mechanism 11, the analysis optical system 12, and the cleaning mechanism 13. These are controlled by outputting control signals to the input unit 16, the display unit 17, and the stirring mechanism 20.
(Basic operation of the analyzer 1 of the present invention)
Next, the basic operation of the analyzer 1 shown in FIG. 1 will be described.

Reagents are sequentially dispensed from the

reagent containers

2 a and 3 a by the reagent dispensing mechanisms 6 and 7 into the plurality of reaction containers 5 conveyed along the circumferential direction of the reaction table 4 by the rotating reaction table 4. Samples are sequentially dispensed from the plurality of sample containers 10 a held in the rack 10 by the sample dispensing mechanism 11 to the reaction container 5 into which the reagent has been dispensed. The reagent and the sample dispensed in the reaction container 5 are sequentially stirred by the stirring mechanism 20 every time the reaction table 4 stops between the measurement points of the analyzer 1. Thereby, a reagent and a sample react. When the reaction vessel 5 passes through the analysis optical system 12, the analysis light transmitted through the reaction solution in the reaction vessel 5 is received by the light receiving unit 12c, and the control unit 15 receives characteristics of the reaction solution (for example, components of the reaction solution and Concentration) is analyzed. Then, after the analysis is completed, the reaction vessel 5 is washed by the washing mechanism 13 and then used again for analyzing the specimen.

In addition, although an example of the structure of the analyzer 1 was demonstrated with reference to FIG. 1, the structure of the analyzer 1 is not limited to the structure mentioned above. For example, in the example shown in FIG. 1, the number of reagent tables is two, but the number of reagent tables is not limited to two. The number of reagent tables may be one, or three or more.
(Embodiment 1 of the present invention)
FIG. 3 shows an example of the operation flow of the analyzer 1 shown in FIG. This operation flow is premised on the case where the user of the analyzer 1 can set a point for performing additional stirring for each analysis item in the analyzer 1 in which the timing of stirring can be freely set. This operation flow can be achieved by the control unit 15 controlling each unit shown in FIG. 2 according to the procedure shown in FIG. The first embodiment of the present invention is preferably applied mainly to a measurement system in which a measurement value (for example, absorbance) at the final measurement point of an item does not change.

Step S1: The operation flow of the analyzer 1 starts.

Step S2: An additional stirring setting screen is displayed. For example, as shown in FIG. 4a, a screen “Do you use additional stirring? YES NO” is displayed on the display unit 17 as an additional stirring setting screen. As used herein, “additional stirring” refers to stirring that is not required for the reaction process between the reagent and the specimen. In other words, the conventional “stirring” is stirring for the purpose of reacting the reagent and the sample within the reaction time course, whereas the “additional stirring” of the present invention is the reaction between the reagent and the sample. They are fundamentally different in that they are agitated after completion (that is, after completion of the reaction time course). When “YES” is selected on the additional stirring setting screen shown in FIG. 4A, the process proceeds to step S3. When “NO” is selected on the additional agitation setting screen shown in FIG. 4a, the additional agitation setting is not performed, and a normal analysis operation without additional agitation is executed.

Step S3: Item names to be measured before and after additional stirring are set. For example, as shown in FIG. 4B, an “item name setting screen” is displayed on the display unit 17 as a screen for setting item names. In the “item name setting screen”, only item names whose last measurement point of the item name is two points or more before the last measurement point of the analyzer 1 are displayed. The user can select one item name to be measured before and after the additional stirring from the item names displayed on the “item name setting screen”. Hereinafter, a case where the user selects item A will be described as an example.

Step S4: Timing for performing additional stirring is set. For example, as shown in FIG. 4c, an “item detailed condition setting screen” is displayed on the display unit 17 as a screen for setting a point at which additional stirring is performed. The point where the additional stirring is performed can be arbitrarily set between the final measurement point of the item and the final measurement point of the analyzer 1. Both the final measurement point of the item and the final measurement point of the analyzer 1 are predetermined. For example, when the final measurement point of the item A is the point 15 and the final measurement point of the analyzer 1 is the point 27, any point of the points 15 to 27 is used as a point where additional stirring is performed. Can be set. The user can set a point at which additional stirring is performed by inputting a number indicating the point at which additional stirring is performed in the area 40 of the “item detailed condition setting screen” via the input unit 16. . Hereinafter, the case where the user sets the point 20 as a point where the additional stirring of the item A is performed will be described as an example. When the point 20 is set as a point where the additional stirring is performed, the stirring is performed between the measurement point 19 and the measurement point 20.

Step S5: The analysis operation of the analyzer 1 starts.

Step S6: The analysis operation of item A of the analysis apparatus 1 starts.

Step S7: At the final measurement point 15 of item A, measurement data is captured. Here, the final measurement point of item A is the reagent dispensing / stirring performed before the final measurement point of item A, and the sample dispensing / stirring is performed. It is predetermined that the reaction is complete.

Step S8: At the measurement point (for example, the measurement point 19) after the final measurement point 15 of the item A and before the point 20 set to perform additional stirring (for example, the measurement point 19), The optical properties of the reaction solution are measured by the analysis optical system 12. The measurement result by the analysis optical system 12 is analyzed by the control unit 15 and acquired as the first measurement result.

Step S9: The additional stirring is performed by the stirring mechanism 20 at the point 20 set to perform the additional stirring. The timing of the additional stirring by the stirring mechanism 20 is controlled by the control unit 15.

Step S10: The optical properties of the reaction solution in the reaction vessel 5 are measured by the analysis optical system 12 at a measurement point (for example, the measurement point 21) after the point 20 set to perform additional stirring. . The measurement result obtained by the analysis optical system 12 is analyzed by the control unit 15 and acquired as the second measurement result. Here, the measurement point immediately after the point 20 set to perform additional agitation is not the measurement point 21 but the measurement point 20, but the measurement value measured at the measurement point 20 is not used and the measurement is performed. It is preferable to use a measurement value measured at the point 21 or a measurement value measured at a measurement point after the measurement point 21. The reason for this is that at the measurement point 20 immediately after the additional stirring, the shaking of the liquid due to the additional stirring is not settled, the temperature decreases due to the penetration of the stirring bar into the reaction liquid, or water is brought in when the stirring bar is washed. This is because an unstable measurement value is often obtained due to the influence of the above. These measured values are, for example, absorbance.

Step S11: The first measurement result acquired at Step S8 (for example, the measurement value measured at the measurement point 19) and the second measurement result acquired at Step S10 (for example, the measurement measured at the measurement point 21) Value).

Step S12: Based on the comparison in step S11, it is determined whether there is a stirring abnormality. For example, when the difference between the first measurement result (for example, the measurement value measured at the measurement point 19) and the second measurement result (for example, the measurement value measured at the measurement point 21) is larger than a predetermined threshold value. In addition, it may be determined that there is a stirring abnormality. Note that the predetermined threshold may be set by the user of the analysis apparatus 1 using an “item detailed condition setting screen” as shown in FIG. The details of the determination logic for the presence or absence of abnormal stirring will be described later.

If the determination result in step S12 is “YES” (that is, if it is determined that there is a stirring abnormality), the process proceeds to step S15. In step S15, the measurement data of item A is marked with a poor agitation. If the determination result in step S12 is “NO” (that is, if it is determined that there is no abnormality in stirring), the process proceeds to step S13.

Step S13: It is determined whether or not the analysis operation of the analyzer 1 is finished. When the last sample has been processed, the analysis operation of the analyzer 1 ends.

Step S14: The operation flow of the analyzer 1 ends.

FIG. 5a shows a time sequence based on the operation flow of the conventional analyzer. FIG. 5b shows a time sequence based on the operation flow of the first embodiment of the present invention. 5a and 5b, the time sequence of FIG. 5b shows that (i) additional stirring is added, (ii) measured values measured at two points before and after the additional stirring (eg, points It can be seen that the measured value measured at 19 and the measured value measured at point 21) are different from the time sequence of FIG.
<Confirmation experiment>
Hereinafter, based on Embodiment 1 of this invention, an example of the confirmation experiment for determining the presence or absence of stirring abnormality is demonstrated.

In this confirmation experiment, the measurement item was serum albumin, and the measurement method was the BCG (Bromocresol Green) method. The total reaction time was about 15 minutes, and each measurement point was set by dividing the total reaction time into 28 equal parts.

In this confirmation experiment, the following conditions were set.

Reaction end position: measurement point 3
Data acquisition position: Measurement point 5
Additional stirring position: Between measurement point 10 and measurement point 11 How to determine stirring abnormality: When the difference between the absorbance at measurement point 10 and the absorbance at measurement point 13 is 0.005 or more, the stirring is abnormal Is determined.

FIG. 6a shows the change in absorbance when the stirring speed is set to a speed lower than the normal stirring speed (50% reduction in stirring speed). FIG. 6b is an enlarged view of FIG. 6a. In the example shown in FIGS. 6a and 6b, the difference between the absorbance at the measurement point 10 and the absorbance at the measurement point 13 is 0.0356. Therefore, it is determined that the stirring is abnormal.

FIG. 6c shows the change in absorbance when the stirring speed is set to a normal stirring speed. FIG. 6d is an enlarged view of FIG. 6c. In the example shown in FIGS. 6 c and 6 d, the difference between the absorbance at the measurement point 10 and the absorbance at the measurement point 13 is 0.0006. Therefore, it is determined that there is no abnormal stirring.

Thus, according to the above confirmation experiment, when stirring was performed under the condition where the stirring speed was reduced by 50% (that is, when stirring was not sufficiently performed), it was determined that stirring was abnormal and normal. It can be seen that when stirring is performed under the condition of the stirring speed (that is, when stirring is sufficiently performed), it is determined that there is no abnormal stirring.
(Embodiment 2 of the present invention)
The second embodiment of the present invention is a modification of the first embodiment of the present invention. In Embodiment 1 of the present invention, an example has been described in which the user of the analyzer 1 can set the timing at which additional stirring is performed. In Embodiment 2 of the present invention, an example will be described in which the timing at which additional stirring is performed is fixed (that is, the user cannot set).

In the second embodiment of the present invention, step S4 'is executed instead of step S4 shown in FIG. In step S <b> 4 ′, a point where additional stirring is performed is displayed on the display unit 17. For example, when the point where the additional stirring of the item B is performed is fixed at the point 20, the point 20 is displayed on the display unit 17.

Steps other than step S4 shown in FIG. 3 are the same as the operation flow shown in FIG.
(Embodiment 3 of the present invention)
The third embodiment of the present invention is a modification of the first embodiment of the present invention. In the third embodiment of the present invention, as in the second embodiment of the present invention, an example will be described in which the timing at which the additional stirring is performed is fixed (that is, the user cannot set).

In the third embodiment of the present invention, step S3 ″ is executed instead of step S3 shown in FIG. 3. In step S3, the last measurement point of the item name is displayed on the “item name setting screen”. The display of item names is limited so that only item names two points or more before the last measurement point of the analyzer 1 are displayed. In contrast, in step S3 ″, all item names are displayed on the “item name setting screen” regardless of the final measurement point of the analyzer 1. For example, when the final measurement point of the item C is the same point 27 as the final measurement point of the analyzer 1, the item C is also displayed on the “item name setting screen”.

In the third embodiment of the present invention, step S4 ″ is executed instead of step S4 shown in FIG. 3. In step S4 ″, a point where additional stirring is performed is displayed on the display unit 17. For example, when the final measurement point of item C is the same point 27 as the final measurement point of the analyzer 1, the measurement point on the first round of the reaction table 4 (ie, from point 0 to point 27) In addition, the measurement points on the second round of the reaction table 4 (that is, points 28 to 54) are automatically displayed. For example, when the point where the additional stirring of the item C is performed is fixed at the point 28, the point 28 is displayed on the display unit 17. When the point at which additional stirring of item C is performed is fixed at point 28, stirring is performed at the last measurement point 27 of the analyzer 1 on the first round of the reaction table 4 and on the second round of the reaction table 4. This is done between the first point 28. However, in this case, the washing operation of the reaction vessel 5 that is normally performed at the end of the first round of the reaction table 4 is skipped, and the reaction vessel 5 is not washed and enters the second round of the reaction table 4.

Note that steps other than steps S3 and S4 shown in FIG. 3 are the same as the operation flow shown in FIG.

FIG. 5c shows a time sequence based on the operation flow of the third embodiment of the present invention. Comparing FIG. 5a and FIG. 5c, the time sequence of FIG. 5c is that (i) the last cleaning operation in the first round is skipped, and (ii) additional stirring is added in the second round. , (Iii) measured values measured at two points before and after additional stirring (for example, measured value measured at point 27 on the first round and measured value measured at point 1 (point 29) on the second round) ) Is used for the determination of agitation abnormality, which is different from the time sequence of FIG. 5a.
(Embodiment 4 of the present invention)
The fourth embodiment of the present invention is a modification of the first embodiment of the present invention. The difference from the first embodiment of the present invention is the part of the determination logic for the presence or absence of abnormal stirring.

In the fourth embodiment of the present invention, step S8 'is executed instead of step S8 shown in FIG. In step S8 ', the optical properties of the reaction liquid in the reaction vessel 5 are measured by the analysis optical system 12 at each of the measurement points 16 to 19. The measurement result by the analysis optical system 12 is analyzed by the control unit 15 and the average value of the measurement values measured at the measurement points 16 to 19 is calculated. The average value of the measurement values measured at the measurement points 16 to 19 is taken as the first measurement result.

In the fourth embodiment of the present invention, step S10 'is executed instead of step S10 shown in FIG. In step S10 ', the optical properties of the reaction liquid in the reaction vessel 5 are measured by the analysis optical system 12 at each of the measurement points 20 to 23. The measurement result by the analysis optical system 12 is analyzed by the control unit 15 and the average value of the measurement values measured at the measurement points 20 to 23 is calculated. The average value of the measurement values measured at the measurement points 20 to 23 is the second measurement result.

In addition, steps other than steps S8 and S10 shown in FIG. 3 are the same as the operation flow shown in FIG.

As described above, according to the fourth embodiment of the present invention, the presence or absence of abnormal stirring is determined based on the comparison of the average values of the measurement values measured at a plurality of measurement points.
(Embodiment 5 of the present invention)
The fifth embodiment of the present invention is a modification of the first embodiment of the present invention. The difference from the first embodiment of the present invention is the part of the determination logic for the presence or absence of abnormal stirring. The fifth embodiment of the present invention is preferably applied mainly to a measurement system in which a measurement value (for example, absorbance) fluctuates (increases or decreases) at an item measurement point.

In the fifth embodiment of the present invention, step S8 ″ is executed instead of step S8 shown in FIG. 3. In step S8 ″, the reaction liquid in the reaction vessel 5 is measured at each of the measurement points 18 and 19. Optical properties are measured by analytical optics 12. The measurement result by the analysis optical system 12 is analyzed by the control unit 15 and measured at the measurement point 21 from the measurement value (P18) measured at the measurement point 18 and the measurement value (P19) measured at the measurement point 19. The measured value is predicted. For example, the predicted value (P21) of the measurement value measured at the measurement point 21 is calculated by the equation P21 = P19 + (P19−P18) × 2. The predicted value (P21) calculated in this way is compared with the measured value actually measured at the measurement point 21 in step S11.

Note that steps other than step S8 shown in FIG. 3 are the same as the operation flow shown in FIG.

As described above, according to the fifth embodiment of the present invention, the presence or absence of abnormal stirring is determined based on the comparison between the predicted value calculated from the measured values measured at a plurality of measurement points and the actual measured value. The
(Embodiment 6 of the present invention)
The sixth embodiment of the present invention is a modification of the first embodiment of the present invention.

In the sixth embodiment of the present invention, step S15 'is executed instead of step S15 shown in FIG. In step S15 ′, the measurement data of item A is output in place of the remark of poor stirring in addition to the measurement data of item A, or in addition to the remark of poor stirring in the measurement data of item A. Is prevented. Thereby, the output of an inaccurate detection result can be prevented.

Alternatively, in the sixth embodiment of the present invention, step S15 ″ may be executed instead of step S15 shown in FIG. 3. In step S15 ″, a remark of poor stirring is added to the measurement data of item A. In addition to being attached, or in addition to adding a remark of poor stirring to the measurement data of item A, at the measurement point (for example, measurement point 23) after it is determined that there is abnormal stirring, the reaction vessel 5 The optical properties of the reaction solution are further measured by the analysis optical system 12. The measurement result by the analysis optical system 12 is analyzed by the control unit 15 and acquired as the third measurement result. The analysis result of the reaction liquid based on the third measurement result is output as reference data in a manner that can be recognized by the user of the analyzer 1 (for example, the analysis result is used to infer correct data). It is displayed on the display unit 17 as reference data). Thus, when an abnormality in stirring is detected, not only the user of the analyzer 1 is informed that the abnormality in stirring is detected, but the measurement data after the additional stirring is analyzed as reference data for inferring correct data. It can be provided to the user of the device 1.

In addition, when an abnormal stirring is detected, the user may be shown in advance the option of whether to use the measurement data after the additional stirring, or which measurement is used when the measurement data after the additional stirring is used. The user may be allowed to set whether to use point measurement data. Such a thing can be easily realized by adding a setting item in the “item detailed condition setting screen” shown in FIG.
(Judgment logic for abnormal stirring)
The following various determination logics can be adopted as the determination logic for the presence or absence of abnormal stirring in step S12 shown in FIG. Of these, the user may be able to set the determination logic.

Decision logic 1: point additional stirring is carried out (P _n) 1 previous measurement point (P _n-1) measured values and additional points that stirring is carried out at (P _n) 1 one after measurement points of the ( Whether the difference from the measured value at P _{n + 1} ) is greater than a predetermined threshold value.

Decision logic 2: Calculated from measured values at several measurement points (P _n−1 , P _n−2 , P _n−3 ,...) Before the point (P _n ) where additional agitation is performed Measured values calculated from measured values at several measurement points (P _{n + 1} , P _{n + 2} , P _{n + 3} ,...) After the average value of the measured values and the point at which additional stirring is performed (P _n ) Whether or not the difference from the average value is greater than a predetermined threshold value.

Decision logic 3: Calculated from measured values at several measurement points (P _n−1 , P _n−2 , P _n−3 ,...) Before the point (P _n ) where additional stirring is performed Measured values calculated from measured values at several measurement points (P _{n + 1} , P _{n + 2} , P _{n + 3} ,...) After the standard deviation of the measured values and the point (P _n ) where additional stirring is performed. Whether the difference from the standard deviation is greater than a predetermined threshold value.

Decision logic 4: Calculated from measured values at several measurement points (P _n−1 , P _n−2 , P _n−3 ,...) Before the point (P _n ) where additional stirring is performed that, one after the measurement points of the point where the predicted value and the additional agitation of measure points additional stirring is carried out (P _n) one after the measurement point of (P n _{+ 1)} is performed _{_{(P n) (P n +}} 1 ) Whether the difference from the actual measured value is larger than a predetermined threshold value.

Decision logic 5: calculated from measured values at several measurement points (P _n−1 , P _n−2 , P _n−3 ,...) Before the point (P _n ) where additional stirring is performed It is calculated from the measured value at some measurement points (P _{n + 1} , P _{n + 2} , P _{n + 3} ,...) After the average change in absorbance before additional stirring and the point (P _n ) at which additional stirring is performed. Whether the difference from the average change in absorbance after additional stirring is greater than a predetermined threshold value.

The determination logics 1 to 3 described above are mainly determination logics suitable for items (for example, measurement systems for blood metal components such as magnesium) whose measurement values (for example, absorbance) at measurement points are already stable. . In particular, since the determination logic 3 has an advantage that a strict evaluation is possible because the variation of the measurement value is averaged, it requires measurement at several measurement points even after additional stirring. There is a drawback that the setting range of the point where the additional stirring is performed is narrowed. The determination logic 1 has an advantage that the setting range of the point where the additional agitation is performed is wide. On the other hand, the evaluation logic 1 evaluates the measurement value at one measurement point before and after the point where the additional agitation is performed. Have the disadvantage of being susceptible to variations in

The determination logics 4 to 5 described above are suitable mainly for items in which the measurement value (for example, absorbance) at the measurement point does not converge but is still rising or falling (for example, antibody protein-related items such as immunoglobulin). Judgment logic. The calculation formula of the predicted value in the determination logic 4 is the same as the calculation formula described in (Embodiment 5 of the present invention). The advantage of the determination logic 4 is that the setting range of the point where additional stirring is performed is wide. The advantage of the determination logic 5 is that the influence of the variation in the measurement value is reduced.

As described above in Embodiments 1 to 6 of the present invention, according to the present invention, it is possible to detect an abnormality in stirring that could not be detected by a conventional analyzer. In particular, it is possible to detect a stirring abnormality that could not be detected by a conventional analyzer that employs a non-contact type stirring mechanism. Further, it is possible to detect an abnormality in stirring that could not be substantially detected even by a conventional analyzer that employs a contact type stirring function such as a stirring bar. When a stirring abnormality is detected, the user of the analyzer can check the stirring mechanism of the analyzer and contact the service department if necessary to repair the stirring mechanism of the analyzer.

Furthermore, according to the present invention, output of measurement data can be prevented when a stirring abnormality is detected. Thereby, the output of an inaccurate detection result can be prevented. As a result, misjudgment and misdiagnosis on the clinical side do not occur, which can contribute to the health of the subject.

Furthermore, conventionally, the reaction solution in the reaction vessel after completion of the reaction has only been waited for to be discharged by the cleaning mechanism, but according to the present invention, the reaction solution in the reaction vessel after completion of the reaction is measured. It can be used to ensure that the value is correct.

Furthermore, in the conventional method of setting a new test solution for stirring evaluation after the daily inspection and checking whether the stirring function is normal, it takes time, money and labor. According to the present invention, since the stirring function can be evaluated in real time, it is possible to prevent time, cost, and labor of an operator from being taken.

Furthermore, according to the present invention, after the inspection is finished (after the inspection data is taken in), the reaction liquid in the reaction vessel is additionally stirred, so that there is no influence on the inspection data when there is no abnormality in stirring. It is possible not to reach.

Furthermore, according to the present invention, it is possible to guarantee a real-time inspection in a daily inspection and to detect an abnormality in stirring in real time. For this reason, the operator can quickly perform re-examination and handling of abnormality.

Furthermore, according to the present invention, for an emergency sample that cannot wait for accurate data by retesting, a result closer to the true value can be obtained by setting an additional measurement point after additional stirring. Is possible.

As described above, the present invention has been exemplified by using the preferred embodiment of the present invention, but the present invention should not be construed as being limited to this embodiment. It is understood that the scope of the present invention should be construed only by the claims. It is understood that those skilled in the art can implement an equivalent range based on the description of the present invention and the common general technical knowledge from the description of specific preferred embodiments of the present invention.

DESCRIPTION OF SYMBOLS 1

Analyzer

2, 3 Reagent table 2a, 3a Reagent container 4 Reaction table 5 Reaction container 6, 7 Reagent dispensing mechanism 6a,

7a Arm

6b, 7b Probe 8 Specimen container transfer mechanism 9 Feeder 10 Rack 10a Specimen container 11 Specimen dispensing Mechanism 11a arm 11b probe 12 analysis optical system 12a light source 12b spectroscopic unit 12c light receiving unit 13 cleaning mechanism 13a nozzle 15 control unit 16 input unit 17 display unit 20 stirring mechanism

Claims

Means for dispensing reagents into the reaction solution;
Means for dispensing the sample into the reaction vessel;
Means for stirring the reagent and the specimen dispensed in the reaction vessel;
Means for analyzing a reaction solution obtained by reacting the reagent and the sample dispensed in the reaction container;
The first measurement result is obtained by measuring the optical properties of the reaction solution in the reaction container after a predetermined time has elapsed after stirring the reagent and the specimen dispensed in the reaction container. Means to
Means for further stirring the reaction solution in the reaction vessel after measuring the optical properties of the reaction solution in the reaction vessel;
Means for obtaining a second measurement result by further measuring the optical properties of the reaction liquid in the reaction container after further stirring the reaction liquid in the reaction container;
An analyzer comprising: means for detecting an abnormality in stirring of the reagent and the sample dispensed in the reaction container based on a comparison between the first measurement result and the second measurement result.
A third measurement result is obtained by further measuring the optical properties of the reaction solution in the reaction container when an abnormality in stirring of the reagent and the sample dispensed in the reaction container is detected. Means,
The analyzer according to claim 1, further comprising: means for outputting the analysis result of the reaction solution based on the third measurement result as reference data.
The analyzer according to claim 1, further comprising means for outputting information indicating that the stirring is abnormal when an abnormality in stirring of the reagent dispensed in the reaction container and the specimen is detected. .
The optical property of the reaction solution in the reaction vessel is absorbance,
The means for detecting an abnormality in stirring is distributed to the reaction container when the difference between the absorbance acquired as the first measurement result and the absorbance acquired as the second measurement result is larger than a predetermined threshold. The analyzer according to claim 1, wherein stirring of the poured reagent and the specimen is determined to be abnormal.
The optical property of the reaction solution in the reaction vessel is the stability of absorbance,
The means for detecting an abnormality in stirring is when the difference between the stability of the absorbance acquired as the first measurement result and the stability of the absorbance acquired as the second measurement result is greater than a predetermined threshold. The analyzer according to claim 1, wherein the stirring of the reagent and the sample dispensed in the reaction container is determined to be abnormal.
The means for obtaining the second measurement result does not use the measurement value measured at the first measurement point after further stirring the reaction solution in the reaction vessel, and further stirs the reaction solution in the reaction vessel. The analyzer according to claim 1, wherein the second measurement result is acquired using measurement values measured at the second and subsequent measurement points after the measurement.
The analyzer according to claim 1, further comprising means for allowing a user of the analyzer to set a timing for further stirring the reaction liquid in the reaction vessel.
The analyzer according to claim 1, wherein the timing of further stirring the reaction solution in the reaction vessel is fixed.
The stirring of the reaction solution in the reaction vessel is not performed in the circulation in which the reagent and the sample dispensed in the reaction vessel react, and the circulation of the circulation is performed without washing the reaction vessel in the circulation. The analyzer according to claim 8, which is performed in the next round.
Dispensing a reagent into the reaction solution;
Dispensing the sample into a reaction vessel;
Agitating the reagent and the sample dispensed in the reaction vessel;
Analyzing the reaction solution obtained by reacting the reagent dispensed into the reaction container and the specimen;
The first measurement result is obtained by measuring the optical properties of the reaction solution in the reaction container after a predetermined time has elapsed after stirring the reagent and the specimen dispensed in the reaction container. And a process of
A step of further stirring the reaction solution in the reaction vessel after measuring the optical properties of the reaction solution in the reaction vessel;
A step of obtaining a second measurement result by further measuring the optical properties of the reaction liquid in the reaction container after further stirring the reaction liquid in the reaction container;
And a step of detecting an abnormality in stirring of the reagent and the sample dispensed in the reaction container based on a comparison between the first measurement result and the second measurement result.