JP2002196005A - Automatic chemical analyzer with recalculation function - Google Patents

Abstract

(57) [Summary] [Problem] An inspection by simple mistake by storing a whole reaction process at the time of analysis, applying a calibration result to an arbitrary sample, and applying a recalculation function. Automatic chemistry analyzer that can reduce the delay of data analysis and speed up data submission to the laboratory and improve efficiency. In an automatic chemical analyzer, a reaction process is stored for each analysis. Calibration failed,
If the concentration of the sample for which the measurement is performed is calculated incorrectly thereafter, the result of the re-calibration is used, and the recalculated sample can be calculated for the incorrectly calculated sample.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic chemical analyzer used for clinical examination.

[0002]

2. Description of the Related Art Since a current automatic chemical analyzer can quickly and accurately analyze many samples and many items by introducing a computer, it can be used not only for biochemical tests at hospitals and test centers. It is used for tests in various fields such as immunoserologic tests, toxicity tests at pharmaceutical related research institutions.

[0003] In a laboratory at a hospital, all the measurement items are calibrated by an automatic chemical analyzer every morning by calibration, and then the patient sample is measured.

Here, an example of calibration will be described. Normally, a blank solution having a concentration of 0 and a standard solution 2 having a known concentration
By preparing a seed and measuring it, a calibration curve is drawn, and calibration by calibration is completed. As a result, the absorbance (S1AB) of the reagent blank called the calculation parameter
S) and the slope (K) of the calibration curve are calculated and used for calculating the concentration of the sample. The formula for calculating the concentration of the sample is as follows.

C = K × (Ax−S1ABS) Equation (1) where C: sample concentration, Ax: absorbance of sample When a hospital laboratory technician uses such daily calibration, calibration is performed at the time of measurement. May fail. A common example is a simple human error due to misplacement or misplacement of a standard solution, which is a common behavior among skilled laboratory technicians. The background is that the operation has become complicated due to the multifunctionality of automatic chemical analyzers, and the number of measurable items has increased due to the development of reagent manufacturers.
This is probably because the number of places where the standard solution is placed has been doubled compared to the past, and the load on the laboratory technicians working in the laboratory has increased due to the increase in facilities for performing pre-diagnosis tests in hospital operations.

In the case where the calibration has failed, if the measurement proceeds as it is, the calculation of the concentration of the sample is performed based on the wrong calibration result or the result of the previous calibration. This item requires re-calibration and then re-examination, resulting in lower efficiency and waste of reagent. This could have devastating effects in laboratories requiring quick and accurate results.

When the calibration has failed and the measurement has proceeded as described above, the reaction state (Ax) of the patient sample, which is the sample shown in the concentration calculation of the sample of equation (1), is the same. Regardless, the calculation parameter S1AB
Sample values will be inaccurate because S and K are processed with incorrect results. Carry out calibration again,
Although it was confirmed that the sample was successful, the sample which had progressed thereafter had to be retested, and the time and reagents spent for the retest were wasted.

Further, the customer can confirm the process of the reaction with respect to the measurement result, which is shown in FIG.

FIG. 2 is a graph showing a process in which the sample and the reagent are mixed and the reaction proceeds, wherein the vertical axis represents the absorbance and the horizontal axis represents the number of times of photometry. An ordinary sample follows a reaction process as shown in FIG. 9A, but some reagents contain a large amount of a surfactant, and bubbles may be generated during the reaction. In such a case, the user may encounter a poka in the reaction process as shown in FIG. 9B. Measurement points used by this POCA for concentration calculation (sample concentration calculation formula (1)
Ax) causes data failure.
Since defective measurement points cannot be deleted and cannot be recalculated due to changes such as shifting the measurement points, re-examination is required, and the time and reagents used for this are wasted. there were.

[0010]

When an automated chemical analyzer is used by a laboratory technician in a hospital, a rapid and accurate data is required every day, especially in a laboratory in which a pre-examination examination and a 30-minute examination are practiced. It depends on the skill of the laboratory technician, such as the skill, more than the performance of the device. In addition, the number of technicians who are required to simultaneously perform tasks other than biochemical tests is increasing, and simple mistakes such as misplacement of a standard solution tend to increase.

If a mistake such as a calibration failure occurs, it takes a long time to deal with it, which causes a great deal of inconvenience to the laboratory and the clinic, and also causes the patient to wait longer at the hospital. Sometimes it was.

An object of the present invention is to contribute to the clinic by speeding up the submission of data to the laboratory, and to improve the efficiency and reduce the burden on the laboratory, and to respond when calibration is required or when data is defective, etc. An object of the present invention is to realize an automatic chemical analyzer having a recalculation function, which can delete a process and change a measurement point.

[0013]

In order to achieve the above object, the present invention is configured as follows.

In an automatic chemical analyzer, the reaction process at the time of analysis, preferably the entire reaction process, is stored and can be checked at any time.

In the automatic chemical analyzer, a calibration result required when calculating the concentration, that is, a calculation parameter is also stored and can be designated or edited.

In the automatic chemical analyzer, the calculation (recalculation) of the concentration of the sample under the condition of the changed calculation parameter can be executed.

In the automatic chemical analyzer, all the data of the reaction process can be deleted, and the recalculation can be executed when the measurement is performed at a measurement point different from the original parameter.

In the automatic chemical analyzer, the operator can determine whether or not to adopt the result of the recalculation, and if necessary, print the result or transfer it to the host computer.

In an automatic chemical analyzer, the reaction process can be confirmed at any time, and recalculation can be performed under designated conditions, thereby providing useful functions such as quicker result reporting in customer use. It is possible to realize an automatic chemical analyzer with the same.

[0020]

DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows an embodiment of an automatic chemical analyzer using the present invention. This apparatus comprises a sample disk 2 on which a plurality of sample cups 1 can be mounted, a sampling mechanism 4 having a sample probe 3 for collecting a predetermined amount of sample, a reagent pipetting mechanism 5a, 5b for dispensing a plurality of reagents, and a reagent disk 6a, 6b, a reaction disk 8 holding a plurality of reaction vessels 7 for direct photometry, stirring mechanisms 9a and 9b, a reaction vessel cleaning mechanism 10, a photometer 11, and a central processing unit (microcomputer) for controlling the entire mechanism system 12a, 12b, 12c and the like are mainly configured. The reaction disk 8 holding a plurality of reaction vessels is controlled by an operation of rotating the reaction vessel half a cycle + 1 and rotating the reaction vessel temporarily for each cycle. That is, at the time of stoppage for each cycle, the reaction vessel 7 of the reaction disk 8 stops in a state where it has advanced counterclockwise by one reaction vessel. Photometer 11
Uses a multi-wavelength photometer having a plurality of detectors, so that the rows of the reaction vessels 7 pass through the luminous flux 14 from the light source lamp 13 when the reaction disk 8 is in a rotating state as opposed to the light source lamp 13. It is configured. A reaction vessel cleaning mechanism 10 is provided between the position of the light beam 14 and the sample discharge position 15. Multiplexer 1 for further selecting wavelength
6, a logarithmic conversion amplifier 17, an A / D converter 18, a printer 19, a CRT 20, a reagent dispensing mechanism drive circuit 21, and the like, all of which are connected to the central processing units 12a, 12b, 12c via an interface 22. ing. This central processing unit also performs control of the entire apparatus including control of the entire mechanical system and data processing such as concentration or enzyme activity value calculation. The operation principle of the above configuration will be described below.

When the start switch on the operation panel 23 is pressed, the reaction vessel 7 is started to be washed by the reaction vessel washing mechanism 10, and the water blank is measured. This value serves as a reference for the absorbance measured in the reaction vessel 7 thereafter. One cycle of operation of the reaction disk 8, ie, anti-rotation +1
When the process proceeds to the sample discharge position 15 by repeating the operation of causing the reaction container to temporarily stop, the sample cup 1 moves to the sampling position. Similarly, two reagent disks 6
a and 6b also move to the reagent pipetting position. During this time, the sampling mechanism 4 operates, and for example, the sample amount of the analysis item A is sucked from the sample cup 1 by the sample probe 3 and then discharged to the reaction container 7. On the other hand, when the sampling mechanism is discharging the sample into the reaction vessel 7, the reagent pipetting mechanism starts operating the reagent pipetting mechanism 5a, and the first reagent of the analysis item A installed on the reagent disk 6a is moved by the reagent probe 24a. Suction. Next, the reagent probe 24a moves onto the reaction container 7 and discharges the sucked reagent. Then, the inner wall and the outer wall of the probe are washed in the probe washing tank to prepare for the next reagent B of the next analysis item B. Photometry is started after the addition of the first reagent. The photometry is performed when the reaction disk 8 rotates and the reaction container 7 crosses the light flux 14. Immediately after the addition of the first reagent,
When rotated by the amount of the reaction container, the stirring mechanism 9a operates to stir the sample and the reagent. When the reaction container 7 has moved to the second reagent dispensing position after about 5 minutes of dispensing the sample, that is, the second reagent is added from the reagent probe 24b, and then the stirring is performed by the stirring mechanism 9b. By means of the reaction disk 8, the reaction vessel 7 successively traverses the light beam 14 and the absorbance is measured each time. The absorbance is measured 34 times in total in a reaction time of 10 minutes, and the absorbance data is stored in the central processing unit 12a. After the photometry, the reaction vessel 7 is used as the reaction vessel cleaning mechanism 1.
Washed with 0 to prepare for the next sample measurement. The sample concentration is calculated by comparing the latest calibration result stored in the central processing unit 12b with the latest calibration result.
By multiplying the absorbance data of 2a by the central processing unit 12c, the result is converted into a concentration or an enzyme activity value, and the analysis result is output from the printer 19. That is, the central processing units 12a, 12b, and 12c have a series of processing means for storing the reaction process and performing recalculation using the storage.

A first embodiment of the present invention in such an automatic chemical analyzer will be described with reference to the flowchart of FIG. The first embodiment is an example of a case where the calibration has failed and the measurement of the patient sample has proceeded as it is.

In step 300 of FIG. 3, the reaction process is stored for each analysis. In step 301,
It is determined whether or not the calibration has failed, and if not, it is determined that the calibration is normal, and the process proceeds to step 309 to report the result.

If the calibration has failed in step 301, the calibration is executed again in step 302 to check the calculation parameters.

In step 303, if the calibration has not been successful, the flow returns to step 302 to execute the calibration again.

In step 303, if the calibration is successful, the process proceeds to step 304, in which the failure, that is, the reaction process of the patient sample whose concentration is calculated based on the incorrect calibration result is confirmed. In the measurement of the patient sample, the reaction body is normal, but due to the calibration failure, the concentration is calculated with wrong calculation parameters, and an incorrect measurement result is output.

In step 305, screen example 6 in FIG.
A calculation parameter, such as 01, which is a successful calibration result is designated. Here, it is also possible to input calculation parameters.

Then, the process proceeds to step 306, where a recalculation execution button is pressed as shown in a screen example 701 in FIG. 7 to execute a recalculation based on the latest calculation parameters, that is, a result of a successful calibration. Will be displayed.

In step 307, it is determined whether or not the displayed recalculation result can be adopted. If the result is not adopted, the flow advances to step 308.
And report the result.

In step 307, when the displayed recalculation result is to be adopted, the adoption button is pressed as shown in a screen example 801 in FIG. 8, and the adopted result is printed or transmitted to the host. Proceed to step 309 to report the result.

As described above, according to the first embodiment of the present invention, when an erroneous measurement result is calculated due to a calibration failure, the corresponding portion is re-created based on the succeeding calibration result thereafter. It is configured to allow calculations.

As a result, wasteful use of valuable patient samples and reagents can be prevented, and the time required for reporting the results can be shortened, thereby realizing an automatic chemical analyzer useful for a laboratory and clinical practice.

FIG. 4 shows a second embodiment of the present invention, in which a data failure is encountered while viewing the reaction process.

In step 400 of FIG. 4, the reaction process is stored for each analysis. Next, in step 401, when confirming the reaction process, it is determined whether or not a data failure has been found.
Proceed to 7 to report the result.

If a data defect is found in step 401, the process proceeds to step 402. If it is not possible to deal with the found data defect by deleting or changing the measurement point, the process proceeds to step 403 to perform a re-examination, and then a result report is made in step 407.

If it is determined in step 402 that the cause of the data failure is, for example, an obvious data poker, and the data point can be dealt with by deleting or changing the measurement point, the process proceeds to step 404.

At step 404, a screen example 90 of FIG.
For example, in the case where the 34th point is a measurement point and data poker occurs here as in 1, it is possible to input a measurement point to be deleted in a column 902 of measurement point deletion. When the measurement point is changed, the changed point is input in the column for changing the measurement point as in a screen example 1001 in FIG.

Next, at step 405, by pressing the recalculation execution button as shown at 903 in FIG. 9 and at 1002 in FIG. 10, a recalculation result C1 from which the measurement points have been deleted and a recalculation result C2 using the designated measurement points Is displayed.

In step 406, it is determined whether or not the recalculated result displayed can be adopted. If the result is not adopted, the process proceeds to step 403.
And report the result.

In step 406, when the displayed recalculation result is to be adopted, the adoption button is pressed as shown in a screen example 801 in FIG. 8, and the adopted result is printed or transmitted to the host. Proceed to step 407 to report the result.

In the second embodiment described above,
The same effect as in the first embodiment can be obtained.

In the above-described first and second embodiments, the use in a laboratory at a hospital is assumed, but the use by a reagent manufacturer or the like is assumed. FIG. 5 shows a third embodiment of the present invention, in which a customer including a reagent maker conducts a study experiment and browses the reaction process for detailed investigation of the measurement data.

In step 500 of FIG. 5, the reaction process is stored for each analysis. Next, the process proceeds to step 501, where the reaction process of the measured data is confirmed. In an examination experiment and the like, it is customary to confirm a reaction process of measured data.

Next, proceeding to step 502, the customer judges whether to delete or change the measurement point, and if not necessary, proceeds to step 503 and ends.

Here, if it is necessary to delete or change the measurement point, the process proceeds to step 504, and the point to be deleted can be input as in a screen example 902 in FIG. Also, the measurement point can be changed as in a screen example 1001 in FIG. Next, in step 505, FIG.
The recalculation results C1 and C2 are displayed by pressing the recalculation execution button as in the screen example 903 of FIG. 10 and the screen example 1002 of FIG. 10, and the process proceeds to step 503 and ends.

According to the third embodiment described above, measurement points can be deleted and changed while re-calculation can be performed while confirming the reaction process. In particular, when using a reagent maker, it is often the case that several types of measurement points are prepared with the same reagent to examine the reagent. At present, even reagents having the same composition are prepared for the number of conditions to be examined and measurement is performed, so that waste of reagents and time may occur.

As a result, the loss and time of the reagent can be minimized, more effective examination experiments can be performed, and an automatic analyzer that is useful to a wide range of customers can be realized.

Next, an example of a screen when the above recalculation is performed will be described.

First, in step 600 in FIG. 6, the reaction process of the measured data is confirmed.

At this time, in step 601, when the sample number to be confirmed and its item are selected in the columns of the screen examples 1201 and 1202 in FIG. 12, the process proceeds to step 602, where the graph and the current concentration are displayed.

If the vertical axis of the graph is to be changed in step 603, the process proceeds to step 604 by inputting the absorbance value into the column of the screen example 1203 in FIG. 12, and the changed screen is displayed.

If it is determined in step 603 that the vertical axis of the graph is not to be changed, the flow advances to step 605 to select a calculation parameter as shown in a screen example 1204 in FIG. Next, if it is necessary to delete or change the measurement points in step 606, the user inputs the points to be deleted and the points to be changed in the columns of the screen examples 1205 and 1206 in FIG. 12, and displays the screen example 1207 in FIG. Pressing this will execute recalculation. Step 606
If it is not necessary to delete or change the measurement point, the process proceeds to step 608 to execute recalculation. The recalculation result is shown in FIG.
Is displayed in the column of the screen example 1208. Then step 60
9, the button of the screen example 1209 in FIG. 12 is pressed,
The recalculation result is adopted, and the process proceeds to step 610 and ends.

[0053]

According to the present invention, the reaction process can be confirmed at any time, and recalculation can be performed under specified conditions. An automatic chemical analyzer having useful functions such as the contribution of the above, the improvement of the efficiency of the examination room and the reduction of the burden can be realized.

[Brief description of the drawings]

FIG. 1 is a diagram showing a configuration of an automatic chemical analyzer according to the present invention.

FIG. 2 is a diagram showing an example of a reaction process of the automatic chemical analyzer.

FIG. 3 is an operation flowchart according to the first embodiment of the present invention.

FIG. 4 is an operation flowchart according to a second embodiment of the present invention.

FIG. 5 is an operation flowchart according to a third embodiment of the present invention.

FIG. 6 is a flowchart of a screen example according to the present invention.

FIG. 7 is a diagram showing an example of a reaction process monitor screen of the automatic chemical analyzer.

FIG. 8 is a view showing an example of a reaction process monitor screen of the automatic chemical analyzer.

FIG. 9 is a diagram showing an example of a reaction process monitor screen of the automatic chemical analyzer.

FIG. 10 is a view showing an example of a reaction process monitor screen of the automatic chemical analyzer.

FIG. 11 is a view showing an example of a reaction process monitor screen of the automatic chemical analyzer.

FIG. 12 is a diagram showing an example of a reaction process monitor screen of the automatic chemical analyzer.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... sample cup, 2 ... sample disk, 3 ... sample probe, 4 ... sampling mechanism, 5 ... reagent pipetting mechanism, 6 ... reagent disk, 7 ... reaction container for direct photometry, 8 ... reaction disk, 9 ... stirring mechanism, Reference numeral 10: reaction vessel cleaning mechanism, 11: photometer, 12: central processing unit (microcomputer), 13: light source lamp, 14: luminous flux,
15: sample discharge position, 16: multiplexer, 17: logarithmic conversion amplifier, 18: A / D converter, 19: printer,
20 CRT, 21 Reagent dispensing mechanism drive circuit, 22 Interface, 23 Operation panel, 24 Reagent probe, 601 Field for designating or inputting calculation parameters, 701 Field for instructing re-calculation execution command, 702 ...
A column for displaying the recalculation result, 801... A column for employing the recalculation result, 901... An example of a data defect, 902... An input column for a measurement point to be deleted, 903. Point change input field, 100
2 ... A column for instructing a recalculation execution command, a ... Example of a reaction process, b ... A case where there was a flicker in the reaction process, C1, C2 ... A column for displaying a recalculation result, 1201 ... A column for inputting a sample number 1202: a column for selecting an item; 1203: a column for changing the vertical axis of the graph; 1204: a column for specifying or inputting calculation parameters; 1205: an input column for measurement points to be deleted; 1206: a column for changing measurement points;
... A field for instructing a recalculation execution command, 1208 a field for displaying a recalculation result, 1209 a field for adopting a recalculation result.

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Taizo Yokose 1040 Ichimo Ichimo, Hitachinaka City, Ibaraki Prefecture Inside Hitachi Science Systems Co., Ltd. 2G058 CB05 CD04 CE08 EA02 EA04 ED03 FB02 GA03 GD00 GD02 GD05 GD07

Claims (4)

[Claims] In an automatic chemical analyzer, a calibration result required for calculating a concentration of a sample and a reaction process of a measurement sample are stored, and a plurality of calibration results from the past to the present for a measured sample are stored. A means for enabling recalculation of the sample concentration based on the selected result. 2. An automatic chemical analyzer according to claim 1, further comprising means for enabling a user to freely select or edit a calibration result required for calculating a concentration. 3. It is possible to delete an arbitrary point from the reaction process data stored in claim 1,
An automatic chemical analyzer comprising a means for enabling recalculation even at a measurement point different from the original parameter. 4. A screen for instructing recalculation according to claim 1, wherein a sample number, an item and a calibration result of the sample can be arbitrarily selected, and a reaction process of the sample is graphically displayed. A means for inputting a display range of absorbance, a means for displaying and deleting the absorbance data by inputting an arbitrary measurement point,
An automatic chemical analyzer comprising: means for changing a measurement point used for concentration calculation; means for instructing recalculation and displaying the result; and means for judging whether to use the recalculation result.