JP3438607B2 - Automatic analyzer - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for optically analyzing the concentration of biological material components, and more particularly to an automatic analyzer equipped with a function of operating the apparatus normally without burdening the operator.

[0002]

2. Description of the Related Art The quality control of an automatic analyzer is performed in the following way. Usually, the X-R control chart method in which a control sample is measured and the result is plotted is often used.
The principle of this control chart is based on Gaussian normal distribution theory. Generally, when multiple measurements are performed on the same sample, the measured values show a normal distribution. Mean value ± 1S. D. 68.3% of all measured values in the range of, and the average value ± 2SD is 95.4%.
% Is included. Usually, the average value ± 2SD is set as a control limit, and it is said that if the value exceeds this limit, the measurement data is incorrect and the cause should be pursued. Other devices use dye solutions to monitor sampling accuracy and other control chart methods.

Based on this idea, the automatic analyzer already has a standard sample and a sample measuring function for quality control. In JP-A-7-159411 and JP-A-8-35970, there is no need to add a standard sample or a quality control sample,
Standard samples and quality control samples can be measured at regular intervals. By measuring at random intervals, it has become possible to improve the accuracy of quality control and provide highly reliable inspection data. In JP-A-5-95744, when a plurality of automatic analyzers are connected, the correction coefficient of each device is calculated from the measurement values of the constituent samples of each device, and the data is compatible by automatically correcting the data. It is devised to enhance it.

Although various improvements have been made to the performance of the device,
It remains unchanged for the operator to control the state of the device. As usual, the operator judges the device status by displaying and printing the control chart. When it is determined that the equipment needs to be calibrated, calibration and maintenance of the mechanical system are performed. The operator is obliged to confirm that the device is normal, but the mechanical system of the device becomes more complicated, and in order to determine whether it is abnormal, normal, or in the middle, fully understand the mechanism and measurement principle of the device. There is a need. If there are many items, the quality control data will increase, and it will be difficult for a full-time operator to know where a problem occurs in the device.

In various automatic analyzers, detectors (sensors) are arranged at the required points of the mechanical system, and an alarm (warning) is generated unless the detector is in a normal detection state.

For example, Japanese Unexamined Patent Publication (Kokai) No. 7-151765 discloses a confirmation value of a sample amount and a reagent amount, a blank measurement value of a reaction cell, a reaction temperature error value, an abnormality of a light source lamp, a residual amount of washing water, and the like. The detected value of 1 is displayed on the display device, and a warning is issued when each detected value exceeds the threshold value.

The device issues an alarm buzzer to inform the operator. Check the alarm code and name, read the explanation of the countermeasure in the manual, and take action. Depending on the device, the name is displayed when an alarm occurs, the cause and countermeasure are searched for, and the operator takes action by referring to the explanation on the screen. The operator regularly performs maintenance for preventive maintenance according to the manual. Parts are replaced without deciding whether they are necessary or not.

Nowadays, hospitals are open 24 hours a day, and are often not full-time operators at night and on holidays. At this time,
Even if a problem occurs, what is wrong and how to deal with it is a problem. The patient does not wait, and the measures need speed. In addition, even if a countermeasure is taken, it is troublesome to record and notify the next operator.

In a urine component qualitative analyzer, there is a facility where quality control is performed without using control urine or the like.
Depending on the item, the ratio of negative samples to all samples per day is almost constant. From this, the negative rate is checked every day, and if the negative rate changes extremely, it is determined that some abnormality has occurred in the apparatus, and the apparatus is calibrated. In this case, the calculation and plotting of the negative rate are all done manually. It is a simple check method, but it is not automated at present.

[0010]

In order to monitor the state of the device, a control substance is automatically or arbitrarily measured and the result is displayed. However, the operator is left to judge whether the result is good or bad. Since the level of the operator also varies, appropriate processing may not be performed. This is especially true when it is used by people who are not full-time around the clock.

The operator regularly performs maintenance for preventive maintenance. However, in this case, the manufacturer decides the maintenance interval based on the average usage conditions of the device, and it often does not match the conditions of the actual facility.

The device is internally equipped with various detectors to notify an abnormality of the device as an alarm. However, the operator is also responsible for the subsequent decisions and countermeasures. It is troublesome to read the manual or see the explanation on the screen after the alarm is issued. To deal further with this, the device cannot be returned to normal unless another screen is opened, parameters are input, or several steps are taken.

The object of the present invention is to determine the state of the device inside the device.
Judgment based on judgment criteria, inform the operator of countermeasures, and
Being able to select and execute treatments improves efficiency and improves reliability
It is to plan.

At present, the quality control function is not included in a relatively inexpensive analyzer, but another data processing device is used to store or display the data. However, in this case, not only the operator is required to evaluate the state of the device, but also another data processing device is required. Then, even if quality control is performed, the countermeasure cannot be reflected in the device.

Automation is desired for checking the ratio of negative samples in a urine component qualitative analyzer. Another object of the present invention is to provide an automatic analyzer having a check function for automatically performing a simple check method, reducing the burden on the operator, and maintaining the performance of the apparatus.

Furthermore, when an alarm is issued, the device keeps a record of the alarm. But I can't record what I did at that time. It is also troublesome to record and manage the executed contents separately, and contact mistakes also occur when going on nights and holidays. Regular maintenance is presented by the manufacturer after averaging the usage conditions of the equipment. Failure to meet the actual operating conditions of the device may result in problems.

[0017]

One of the objects of the present invention is to provide a countermeasure function for judging the state of the device by a judgment criterion specific to the device, such as the detector condition, general sample measurement result, and quality control sample measurement result. This is achieved by providing a judgment standard (algorithm) for evaluating the state of the device from the above. Further, the function of simplifying the procedure for returning the device is achieved by displaying a countermeasure menu on the screen when an alarm is issued and determining that the countermeasure is necessary based on the measurement result, and performing the procedure from the same screen.

Another function of the present invention, which is to judge the apparatus state from the negative rate, is to provide a command for requesting calculation and display of the negative rate. This is achieved by calculating and displaying the negative rate with, and judging from the rate of change at that time and the daily fluctuation rate, and displaying a screen prompting the measure when it is necessary.

Further, another optimum object of the present invention, that is, the optimum maintenance interval setting for each facility, can be achieved by adding a record of countermeasures to the judgment standard at any time. Recording the details of the measures and the date and time will automatically inform the interval until the next maintenance, and the optimal maintenance interval can be automatically presented by using the usage conditions that differ depending on the facility. Like

[0020]

BEST MODE FOR CARRYING OUT THE INVENTION An example of the configuration of an automatic analyzer of the present invention will be described with reference to FIG. This represents the configuration of the urine qualitative analyzer. This is a device in which a test piece, which is a reagent, reacts with a urine sample to measure color development with a photometer. The urine sample 101 placed on the sample rack 102 moves to the stirring position according to an instruction from the rack sampler mechanism control unit 103, and is stirred by the stirring mechanism 104. The test papers 105 are drawn out one by one from the sorter mechanism 107, rotated while being gripped by the gripping mechanism 106, and immersed in the urine sample 101. Thereafter, the test paper 108 dipped in urine is placed on the photometer 109. After a fixed time, photometry is performed by the photometer 109, the result is converted by the A / D converter 110, and the result is sent to the control unit 111. The result is displayed on the LCD display unit 112, printed on the printer 113, and if necessary, data, parameters, alarm generation information, countermeasure date and time, etc. are stored in the data storage device 114. Parameters and measurement conditions are input from the operation panel 115.

(Embodiment 1) In the automatic analyzer shown in FIG. 1, a judgment standard (algorithm) for normally operating the device is incorporated in the control unit in advance. Many automatic analyzers for measuring the reflectance of test strips having the above-mentioned structure do not use control urine for quality control but perform quality control with a negative rate. The reason is that the cost of control urine is high and there is no function to display and save the X-R control chart on the analyzer. It is said that the ratio of negative samples in the daily routine samples is almost constant. The department may change depending on the day of the week, and the ratio may change. A method for easily performing quality control using the negative rate will be described with reference to the flowchart of FIG.

First, a negative criterion is set for each item by reflectance or rank (step 201). A routine sample is measured (step 202). The order of steps 201 and 202 does not matter. After the measurement, the calculation of the negative rate is requested (step 203). In the calculation, the number of samples determined to be negative at the designated date and time is divided by all samples and multiplied by 100. The calculation timing can be requested for each sample or by a request from the operation panel. Save the negative rate calculated for each item and display the previous value, average value so far, current value, etc. on the screen. The change over time can be confirmed graphically (step 204). This is shown in FIG. 9, FIG. 10, and FIG.
Shown in.

Whether or not countermeasures are necessary is the average value up to the last time,
The current value, the previous value, and the value before a certain period of time are used to judge the rate of change.

[0024]

[Equation 1]

[0025]

[Equation 2]

[0026]

[Equation 3]

When the values of A, B, and C are greatly changed in the test items where the change in reflectance is sensitive, it is considered that the device is abnormal. Possible measures are calibration and cleaning of the reflection reference plate, and these two items are displayed in the treatment menu. When the rate of change of C is large and the rate of change of A is not large, it is considered that the change over time is present. The menu of measures is cleaning of the reflection reference plate and measures against deterioration of the light source. In this way, the treatment menu is decided based on the relationship between the item and the rate of change (step 20).
7). If no abnormality is found in the device, the countermeasure menu is not displayed (step 206). This is determined at the time of calculation or when instructed by the operation panel. The countermeasure menu is automatically displayed when it is determined that countermeasures are necessary (step 2).
08). This is shown in FIG.

[Measures] are executed on this countermeasure menu screen. For example, when the above countermeasure menu is displayed, first, the execution button is pressed, and after the reflection reference plate is cleaned, the confirmation button is pressed. Depending on the type of action items, items that need to be prepared and then executed, items that can be automatically executed,
There are items that require confirmation and items that require parameter input. Countermeasure menus are displayed so that the required items and those that are not are indicated by marks, colors, etc. at a glance. Non-essential items can be canceled. Since there is not one countermeasure, at the time when one countermeasure is completed, the content, date and time, and time when the countermeasure is executed are stored in the storage device (step 208). Then, it is checked whether all the measures are completed (step 209). The countermeasure execution from the countermeasure menu is an interactive mode, and when all the items are finished at the end, the countermeasure menu display is erased (step 21).
0). This is shown in FIG.

(Example 2) Different from Example 1, some facilities specially measure control urine. A method for easily performing quality control using control urine using the analyzer of FIG. 1 will be described with reference to the flowchart of FIG. As initial settings, enter the control urine concentration and number of measurements from the initial settings screen. Select measurement items (step 3)
01). Then, control urine is measured (step 302). The average value X is calculated from the reflectance of the sample having the same concentration, and the range R is calculated (step 303). Data is stored as quality control sample information, and the data is displayed as necessary (step 304). This is shown in FIGS.
3, shown in FIG.

For example, the systematic error such that the results of the two types of control exceed ± 2 SD from the average value, 1
If there is a contingency error such as exceeding 3SD for one concentration only once, it is determined whether or not countermeasures are necessary (step 30).
5). If there is no need, the countermeasure menu is not displayed (step 306).

When the average value gradually increases or decreases,
The reflection reference plate may be dirty, the control urine may be changed, or the light source may be deteriorated. The light source lamp is checked against the previous replacement time and the cleaning time of the reflection reference plate to determine a countermeasure menu (step 307). Similar to the first embodiment, the treatment menu is automatically displayed (step 308). Figure 7
Shown in.

As a countermeasure, first press the execute button and then the execute button to clean the sample nozzle. After cleaning, press the confirmation button.

Since there is not one countermeasure, when one countermeasure is completed, the contents, date and time of execution of the countermeasure are stored in the storage device (step 309). Then, it is checked whether all the measures are completed (step 310).
Measure execution from the measure menu is an interactive form,
Finally, when all items are finished, the countermeasure menu display is erased (step 311).

(Embodiment 3) Next, an embodiment in which a countermeasure menu similar to those in Embodiments 1 and 2 is displayed when trouble occurs during maintenance or routine inspection will be described with reference to the flow chart of FIG.

In the apparatus configuration shown in FIG. 1, detectors are arranged at required points in the mechanical system and the electrical system, and are constantly in a monitoring state (step 401). When the detector is operating normally, measurement is ready (step 402). Judging from the state of the detector and the contents of the treatment so far, the alarm determines the countermeasure menu (steps 403 to 404). Even if an alarm is issued, if no immediate countermeasure is required for measurement, the countermeasure menu is not displayed and the measurement is continued (step 40).
5). This is shown in FIG.

If the measurement is hindered, the measurement is stopped and the countermeasure menu is automatically displayed (step 4).
06). For example, if the detector of the rack sampler mechanism becomes abnormal, first an alarm sounds and the measurement is paused. The action menu is reset (initialized) because the rack cannot be transported normally due to an error in the detection of the rack sampler mechanism.
Suppose you need. This is shown in FIG.

To perform the reset, it is necessary to visually check the rack sampler mechanism. Send a message to call attention to it. When you press the execute button, a confirmation message is displayed. Follow the instructions and take action and reset. At the same time, the content, execution date and time of the countermeasure execution are stored in the storage unit (step 407). When all the measures are completed, the device transits to the measurable state (step 408). The details of the measures taken, the date and time, and the time are coded and stored. This will be added to the countermeasure menu when it becomes a candidate for the countermeasure menu next time and is searched by the code and it almost matches the interval from the last time. The accuracy increases as the number of times increases.

[0038]

According to the automatic analyzer of the present invention, the
Abnormality, quality control sample measurement results, the ratio of negative samples in routine tests, etc. are used to judge whether the device is operating normally, and if there is an abnormality, a countermeasure menu is decided and a function to automatically notify the operator is displayed. Since the countermeasure can be executed without changing from the countermeasure menu being performed to another screen, the operator's burden on the countermeasure can be reduced.

The burden on the countermeasures means the trouble of manually assuming the failure location of the device and considering the countermeasures based on the measurement results. It is possible for the operator to take the same measures at night or on holidays even if not a full-time operator. No need to look at other screens or manuals or read the explanations, you can easily take measures and operate the equipment normally.

Further, since it is executed from the countermeasure menu and the record is kept, it is possible to prevent other notes and contact mistakes. By adding this execution record to the condition for countermeasure item judgment,
More accurate countermeasures can be determined. In addition, maintenance intervals can be automatically optimized for each facility.

[Brief description of drawings]

FIG. 1 is a block diagram of an automatic analyzer shown as an embodiment of the present invention.

FIG. 2 is a flowchart of a method for quality control using FIG.

FIG. 3 is a flowchart of a method for controlling the quality of control urine using FIG.

FIG. 4 is a flowchart of a method of displaying a countermeasure menu according to the first and second embodiments.

FIG. 5 is a diagram showing a countermeasure menu of the first embodiment.

FIG. 6 is a diagram showing a countermeasure menu of the first embodiment.

FIG. 7 is a diagram showing a countermeasure menu of the second embodiment.

FIG. 8 is a diagram showing a countermeasure menu of the third embodiment.

FIG. 9 is a diagram graphically showing an example of setting a negative criterion according to the first embodiment.

FIG. 10 is a diagram graphically displaying a display example of a negative rate in Example 1.

11 is a graph graphically displaying the negative rate according to the diagram of Example 1. FIG.

FIG. 12 is a diagram showing data of quality control initial setting information according to the second embodiment.

FIG. 13 is a diagram showing a display of a management table according to the second embodiment.

FIG. 14 is a diagram graphically displaying an average value X and a range R of reflectance of a sample having the same concentration in Example 2.

[Explanation of symbols]

101 ... Urine sample, 102 ... Sample rack, 103
... rack transfer mechanism control unit, 104 ... stirring mechanism, 105 ...
Test paper, 106 ... Dipping mechanism section, 107 ... Test paper supply mechanism, 108 ... Test piece, 109 ... Photometer, 110 ...
A / D converter, 111 ... Controller, 112 ... LCD
Display unit, 113 ... Printer, 114 ... Storage device, 115
…control panel.

─────────────────────────────────────────────────── ─── Continuation of front page (58) Fields surveyed (Int.Cl. ⁷ , DB name) G01N 35/00

Claims (9)

(57) [Claims] 1. A sample supply mechanism for supplying a biological sample, a reagent supply mechanism for supplying a reagent to be added to and reacted with the biological sample, a biological sample supplied from the sample supply mechanism, and a reagent supplied from the reagent supply mechanism. In an automatic analyzer equipped with a reaction part for reacting a reagent and a reaction mechanism for analyzing the reaction between a biological sample and the reagent in the reaction part, a storage part for storing the analysis result of the analysis mechanism is provided. An automatic analysis device comprising a determination mechanism for determining whether or not there is an abnormality in the automatic analysis device by comparing average values of analysis results performed on different days stored in the storage unit. 2. The automatic analyzer according to claim 1, wherein the analysis results of the different days are compared by comparing the average value of the measurement results on the day of measurement with the average value of the measurement values of the previous measurement day. , At least one of the average value of the measurement results on the measurement day and the average value of the measurement results before the measurement day, and the average value of the measurement results on the day of measurement and the average value of the measurement results on a specific day. An automatic analyzer characterized in that 3. The automatic analyzer according to claim 1, wherein the analysis results of the different days are compared by comparing the average value of the measurement results on the day of measurement with the average value of the measurement values of the previous measurement day. , The average of the measurement results on the measurement day and the average of the measurement results before the measurement day, the average of the measurement results on the measurement day and the average of the measurement results on a specific day, and these comparisons Based on the result, if there is an abnormality, an automatic analyzer characterized by having a function of estimating the cause of the abnormality. 4. The automatic analyzer according to claim 1, further comprising a countermeasure menu display function for displaying a countermeasure method when it is determined that the determination mechanism has an abnormality. . 5. The automatic analyzer according to claim 4, further comprising storage means for storing the content of the countermeasure and the date and time of the countermeasure when the countermeasure method displayed by the countermeasure menu display mechanism is executed. Automatic analyzer. 6. The automatic analyzer according to claim 5, wherein the countermeasure method displayed by the countermeasure menu display mechanism is stored in the countermeasure content storage means with a specific countermeasure content multiple times together with the countermeasure date and time. Has a function to calculate the accuracy of the countermeasure method according to the number of those countermeasure dates and times.
The automatic analysis device is characterized in that the countermeasure menu has a function of displaying the items in descending order of accuracy. The automatic analyzer according to any one of claims 7 claims 1-6, the average value of the analysis result of the different days, with a graph display function for displaying the graph plotting each measurement day An automatic analyzer characterized in that 8. The automatic analyzer according to claim 1, wherein the biological sample is urine. 9. The automatic analyzer according to claim 1, wherein an average value of the analysis results is a negative rate.