JP3462995B2 - 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 automatic analyzer for analyzing a biological fluid sample of a patient, and in particular, a quality control sample of known concentration is measured in order to confirm the performance of the device and reagents, and the result is shown. The present invention relates to an automatic analysis device capable of managing data through a screen.

[0002]

2. Description of the Related Art Analytical examinations of patient specimens for use in diagnosing diseases are often measured by automatic analyzers because many biological specimens are handled at the same time.

For this reason, the management of the device for analysis is particularly important, and it is necessary to determine whether the device is operating normally and the patient sample is being measured correctly, and a quality control sample having a known concentration between the patient sample measurements is used. Is measured and the value is managed.

Therefore, in the unlikely event that the measurement value of the quality control sample is out of the control range, the cause should be pursued and, of course, it should be determined which patient sample should be re-measured, as well as returning to normal. It is important to process quickly.

On the other hand, the quality control of the conventional automatic analyzer is merely statistical processing of reproducibility of quality control samples measured a plurality of times and plotting each measured value on a graph such as an X control chart.

Further, two kinds of quality control samples are measured,
It has a function of plotting on a binary diagram in real time and notifying that it is out of control range such as systematic error and random error, but in any case, it was only to manage the measured value of the quality control sample. . On the other hand, even in day-to-day accuracy control, which is performed over a long period of time to maintain the performance of the equipment and analytical reagents, statistical processing of the reproducibility of quality control samples measured over multiple days and each measurement value X-R control chart, etc. There was no function to display the maintenance status and reagent status of the device, which only influences the fluctuation of the measured value, just by plotting on the graph.

[0007]

In the conventional automatic analyzer, the measured value of the quality control sample is within control, out of control, or there is no variation or drift tendency in the values measured a plurality of times, or It has many built-in functions that determine if there is a tendency to shift.

However, in addition to this, the information desired by the user is, of course, more important, especially when the measured value of the quality control sample is out of control, not only the identification of the cause of the abnormality. Is to grasp the patient sample that was not accurately measured due to its cause, and to re-measure immediately.

However, the conventional automatic analyzer does not have a function of outputting information for this purpose.

Therefore, when the measurement value of the quality control sample is out of control, the user searches for the printing location of the measurement result of the quality control sample out of control from the enormously output print results, and manages the previous time from that location. It was necessary to find out the patient sample measured up to the measurement result of the quality control sample which was within the range and the patient sample measured after out of the control.

However, even with this means, from the viewpoint of prompt result reporting, the results of samples containing only electrolyte items and samples containing analysis items with short reaction times are output in preference to the results of other samples. In some cases, the results may be printed in a different order from the analysis order of, so it was very difficult to make an accurate determination.

[0012] On the other hand, the daily difference accuracy control is performed even if the measured value is not out of control, by controlling the state of the device or the reagent depending on the variation of the trend or shift of the data over time, and more accurate measurement. The conventional automatic analyzer also has independent quality control screens, reagent information screens, and maintenance status screens.

Therefore, in order to grasp the relationship,
You can save a lot of time and extra time by copying each screen and printing it on a printer for comparison, or by preparing a separate measurement diary to fill in and manage the reagent replacement and device maintenance status. Needed.

An object of the present invention is to retrieve a patient sample requiring reconfirmation or remeasurement from measured values of quality control samples,
By notifying the operator of the information through the screen, it is possible to reduce the trouble of searching.

Another object of the present invention is to provide the information necessary for maintaining the performance in the daily difference accuracy control by simultaneously outputting the maintenance status and the condition of the reagent which influence the fluctuation of the measurement value of the quality control sample. Especially.

[0016]

In the intraday quality control of an automatic analyzer to which the present invention is applied, a quality control is provided with a storage section for storing sample measurement order and sample numbers of patient samples between quality control sample measurements. When the measured value of the sample is out of control, a control unit that outputs the information of the patient sample together with the measured value is provided.

Here, the information on the patient sample is defined as the patient sample number from the patient sample number after measurement of the quality control sample that was within the management to the number of patient sample before the measurement of the quality control sample that was determined to be out of control. It is a patient sample number measured after measurement of the performed quality control sample, and further is a measurement result of the instructed patient sample number.

On the other hand, in the day-to-day accuracy control, a storage unit for storing the maintenance date and time of the replacement of the device parts and the device cleaning and the date and time of the reagent input entered on the screen, and the value of the intraday accuracy control sample are used for the daily difference It is equipped with a storage unit that stores the date and time accumulated in management, and displays the content of maintenance, the date and time of maintenance, and the date and time of reagent replacement on the same screen as the measurement value of the quality control sample on the daily difference accuracy control chart. It is characterized by having a control unit for displaying at the same time.

[0019]

DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a schematic configuration of a biochemical automatic analyzer to which the present invention is applied.

This apparatus comprises a sample disc 2 for moving a sample cup 1 containing a plurality of patient specimens and a quality control sample one by one to a sample suction position, and a sample dispensing mechanism for dispensing a sample. 3. Reagent dispensing mechanism 4a, 4b for dispensing reagent according to analysis item and analysis reagent 5
reagent disks 6a and 6b in which a and 5b are arranged, a reaction disk 8 in which a plurality of permeable reaction vessels 7 are annularly arranged and function as a reaction line, stirring mechanisms 9a and 9b for stirring the reaction liquid in the reaction vessels, and a reaction It is provided with a light source 10 for measuring the absorbance of the reaction solution in the reaction container arranged on the line, a multi-wavelength photometer 11, and a cleaning mechanism 12 for cleaning the reaction container arranged along the reaction disk 8. Further, an operation panel 13 for instructing the measurement, a central processing unit 14 for controlling the entire mechanical system and converting the measured absorbance into a concentration or an enzyme activity value, a printer 15 for printing the measurement result, and a CRT screen 16 for displaying the result. , And a hard disk 17 for storing the measurement results.

The operation of storing the measurement order of the present invention using such an automatic analyzer will be described with reference to the flowchart of FIG.

First, when the power of the apparatus is turned on in S1,
The patient sample number (S. No.) and the quality control sample number (C. No.) are reset to 1 in 2 respectively, and the number (P) for managing the measurement order is reset to 1 in S3.

Next, when the user gives an instruction to start the analysis in S4, first in S5, it is judged whether or not there is a measurement request for the quality control sample. If there is a request, the quality control sample is dispensed in S6. Done. Next, in S7, the number of the quality control sample corresponding to the number for controlling the measurement order is stored in the hard disk of the storage unit, and in S8, the measurement order control number and the number of the quality control sample are respectively incremented by one. .

Next, in S9, it is judged whether or not there is a request for measurement of the patient sample, and if there is a request, the patient sample is dispensed in S10, and then in S11, the patient corresponding to the number for managing the measurement order is placed. Store the sample number.

In S12, the measurement order control number and the quality control sample number are incremented by one. After that, in S13, the apparatus further determines or the user instructs whether or not there is a measurement request for the quality control sample or the patient sample. If there is a request, the steps from S5 to S12 are repeated. If there is no request, S14
The analysis operation ends with.

As described above, in the storage unit for storing the measurement order, as shown in FIG. 3, the number of the quality control sample and the patient sample number are stored for the measurement order number, and the quality control sample measurement is performed. It becomes easy to retrieve the patient sample number.

Next, the processing operation when the measurement result of the quality control sample is judged to be out of control will be described with reference to the flowchart of FIG.

In S21, the measurement value of the quality control sample is output, and when it is determined in S22 that the value is out of control, S23 is set.
Then, the measurement order number of the quality control sample is confirmed, then the measurement order number of the quality control sample measured last time is searched in S24, and the patient number measured during that time is extracted in S25.

In the example of FIG. 3, when the quality control sample with the measurement order number 13 is judged to be out of control and the others are within control, the patient sample number extracted by the above method is S
It becomes a6 to Sa10. Further, if there is a patient sample that has already been dispensed even after the quality control sample determined to be out of control, after the determination in S26, the process proceeds to S27 and S28.
Then, the patient sample number is extracted.

In the example of FIG. 3, the extracted patient sample numbers are Sa11 to Sa13.

The patient sample number extracted in the above steps is displayed on the same screen as shown in the example of FIG. 5 as the measurement value of the quality control sample is displayed on the CRT screen 16 in S29. (S30). When the measurement value of the quality control sample is within the control, only the measurement value of the quality control sample is displayed in S30 and the process ends (S31).

With this, the operator can immediately recognize the patient sample to be re-measured.

Next, in the day-to-day precision management, the items of the maintenance content designated by the operator from the screen and the date and time of the maintenance, or the item and the date and time of the reagent replacement are stored,
Further, the date and time when the measurement values of the quality control sample measured during the day are accumulated in the day difference are stored and displayed on the same screen in ascending order of date and time, as shown in the example of FIG. As a result, it becomes easy to understand the relationship between the device status and the reagent status and the measurement value of the quality control sample.

[0034]

According to the present invention, when the measurement value of the quality control sample is out of the control range, it is possible to immediately grasp the patient sample requiring re-measurement.

Further, in the daily difference precision control which is managed over time, the state of the apparatus, the maintenance state and the state of the reagent which influence the analytical performance are displayed together with the measurement value of the quality control sample, so the causal relationship between the two is exhibited. It becomes clear that the data can be easily maintained and managed.

[Brief description of drawings]

FIG. 1 is a diagram showing a schematic configuration of a biochemical automatic analyzer to which the present invention is applied.

FIG. 2 is an example of a flowchart for storing a measurement order.

FIG. 3 is a diagram for explaining the contents of a storage unit.

FIG. 4 is an example of a flowchart of processing for display.

FIG. 5 is a diagram showing a display example of intraday quality control.

FIG. 6 is a diagram showing a display example of daily difference accuracy management.

[Explanation of symbols]

1 ... Sample cup, 2 ... Sample disc, 3 ... Sample dispensing mechanism, 4a, 4b ... Reagent dispensing mechanism, 5a, 5b
... analytical reagent, 6a, 6b ... reagent disc, 7 ... reaction container, 8 ... reaction disc, 9a, 9b ... stirring mechanism, 10 ...
Light source, 11 ... Multi-wavelength photometer, 12 ... Cleaning mechanism, 13 ... Operation panel, 14 ... Central processing unit, 15 ... Printer, 16
… CRT screen, 17… Hard disk.

─────────────────────────────────────────────────── ─── Continuation of front page (72) Inventor Kyoko Imai 882 Ichige, Ichige, Hitachinaka City, Ibaraki Prefecture Hitachi Ltd., Measuring Instruments Division (56) Reference JP-A-4-133175 (JP, A) (58) Fields investigated (Int.Cl. ⁷ , DB name) G01N 35/02 G01N 35/00

Claims (3)

(57) [Claims] 1. A reaction part having a plurality of reaction vessels, a sample supply part for supplying a sample to the reaction container, a reagent supply part for supplying a reagent according to an analysis item to the reaction container, and the reaction container. In an automatic analyzer equipped with a measurement unit that measures the generated reaction product, a storage unit that stores the sample numbers of quality control samples and patient samples in the order of sample measurement, and the measured values of quality control samples are controlled. If the measured value of the quality control sample is determined to be out of control by the determination means, the quality control sample measured last time and the accuracy determined to be out of control this time are provided. If there is a sample number of a patient sample measured between control samples and a patient sample that has already been dispensed after the quality control sample that was determined to be out of control this time, the sample number of the patient sample is extracted and output. And a control unit that Characteristic automatic analyzer. 2. The automatic analyzer according to claim 1, wherein the control unit has a function of outputting a measurement result of a patient sample corresponding to the extracted sample number. 3. The automatic analyzer according to claim 1, further comprising a display device that displays the measurement result of the quality control sample and the sample number of the patient sample extracted by the control unit on the same screen. An automatic analyzer characterized in that