JP4825442B2 - Accuracy control method of automatic analyzer for clinical examination, and automatic analyzer - Google Patents

Description

  The present invention relates to an analyzer for biological samples such as blood and urine, and more particularly to an automatic analyzer having an analysis accuracy management function and an accuracy management method thereof.

  The automated analyzer can analyze a large number of samples in parallel, and can analyze and process multiple components quickly and with high accuracy. Used in various fields such as toxicological tests at related research institutions. Especially in hospital use, the analysis target is a biological fluid sample such as blood or urine of the patient, and the analysis results determine the diagnosis and treatment policy of the disease. Is always sought. For this reason, management of the apparatus which performs analysis is important. One method for confirming whether the apparatus is operating normally and measuring correctly is to measure a quality control sample with a known concentration. This is because the sample for quality control is measured before and after the measurement of the patient sample or between measurements, and if the measured value of the quality control sample is within the allowable range (within control), the device is judged to be operating normally. This is a method of guaranteeing measurement values of patient specimens. As an example of such a quality control method using a quality control sample, for example, a method described in Patent Document 1 is known.

JP 2000-227433 A

  Conventional automatic analyzers measure quality control samples with a known concentration before, during, or during measurement of patient specimens. If within the control, it is judged that the instrument is operating normally, and patient specimen measurements are guaranteed. However, quality control samples are generally expensive, running costs increase if the measurement sense is too dense, and device management can be effectively performed if the measurement interval is too large. It affects the measurement accuracy. Furthermore, the quality control sample is manufactured by setting the concentration in the normal range or the abnormal range within the measurement range of the patient specimen, and the measurement values cannot be guaranteed for all patient measurement ranges. An object of the present invention is to provide an accuracy management method using an accuracy control sample and an accuracy management method capable of effective accuracy management without an increase in running cost in an automatic analyzer employing the management method, and the management method thereof. It is to provide an automatic analyzer employing the above.

  The configuration of the present invention for achieving the above object is as follows.

  Analyzing a predetermined analysis item for the same general sample is performed a plurality of times at a predetermined time interval, and it is determined whether the variation of the performed analysis values is within a predetermined standard, An accuracy analysis method for an automatic analyzer for clinical testing, including issuing a warning when the fluctuation is not within the standard, and an automatic analyzer having means for executing it.

  Examples of the automatic analyzer described above include a sample container that contains a patient specimen, a reagent container that contains a reagent to be added to the sample, a reaction container that reacts the sample and the reagent, and a reaction container in the reaction container. And an automatic analyzer equipped with a photometer that measures the above reaction by a change in absorbance of the reaction solution. However, sample containers, reagent containers, etc. do not necessarily exist as containers, and the analysis means does not need to measure changes in absorbance, and measures fluorescence emitted from a label that specifically binds to the target component. It may be a photodetector.

  The present invention is applicable to any automatic analyzer as long as there is a means for reacting a sample with a reagent and automatically measuring the physical properties of the reaction solution.

  ADVANTAGE OF THE INVENTION According to this invention, the precision of precision management can be improved and the reliability of a test | inspection can be improved.

  Hereinafter, the configuration and operation of an automatic analysis system according to an embodiment of the present invention will be described with reference to FIGS. First, the overall configuration of the automatic analyzer according to the present embodiment will be described with reference to FIG.

1 includes a sample disk 2 on which a plurality of sample cups 1 can be installed, 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. Central processing unit for controlling the disks 6a and 6b, the reaction disk 8 holding a plurality of reaction vessels 7 for direct photometry, the stirring mechanisms 9a and 9b, the reaction vessel cleaning mechanism 10, the photometer 11, and the entire mechanism system ( Microcomputer) 12 and the like are mainly configured. The reaction disk 8 holding a plurality of reaction vessels controls the operation of rotating and temporarily stopping the half rotation + 1 reaction vessel every cycle. That is, at the time of stopping every cycle, the reaction vessel 7 of the reaction disk 8 stops in the form of proceeding by one reaction vessel in the counterclockwise direction. As the photometer 11, a multi-wavelength photometer having a plurality of detectors is used. When the reaction disk 8 is in a rotating state as opposed to the light source lamp 13, the row of reaction vessels 7 passes the light beam 14 from the light source lamp 13. Is configured to do. A reaction container cleaning mechanism 10 is disposed between the position of the light beam 14 and the sample discharge position 15. Further, it comprises a multiplexer 16 for selecting a wavelength, a logarithmic conversion amplifier 17, an A / D converter 18, a printer 19, a CRT 20, a reagent dispensing mechanism drive circuit 21, etc., all of which are connected to the central processing unit 12 via an interface 22. It is connected. This central processing unit performs control of the entire device including control of the entire mechanical system and data processing such as calculation of concentration or enzyme activity value. The operation principle in the above configuration will be described below. When the start switch on the operation panel 23 is pressed, the reaction vessel 7 starts to be washed by the reaction vessel washing mechanism 10, and the water blank is further measured. This value is a reference for the absorbance measured in the reaction vessel 7 thereafter. When the reaction disk 8 advances to the sample discharge position 15 by repeating the operation of one cycle of the reaction disk 8, that is, the operation of temporarily stopping the counter-rotation + 1 reaction container, the sample cup 1 moves to the sampling position. Similarly, the two reagent disks 6a and 6b are also moved to the reagent pipetting position. During this time, the sampling mechanism 4 operates, and the sample amount of, for example, 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, in the reagent pipetting mechanism, when the sampling mechanism is discharging the sample to the reaction vessel 7, the reagent pipetting mechanism 5a starts operating, and the first reagent of the analysis item A constructed on the reagent disk 6a is moved by the reagent probe 24a. Suction. Next, the reagent probe 24a moves onto the reaction vessel 7 and discharges the sucked reagent, and then the inner wall and outer wall of the probe are washed in the probe washing tank to prepare for the first reagent dispensing of the next analysis item B. Photometry is started after the first reagent is added. Photometry is performed when the reaction vessel 7 crosses the light beam 14 when the reaction disk 8 rotates. When the reaction disk rotates twice by two reaction vessels after the first reagent is added, the stirring mechanism 8a is activated to stir the sample and the reagent. When the reaction container 7 moves from the sample dispensing position to the position rotated by 25 rotations + 25 reaction containers, that is, to the second reagent dispensing position, the second reagent is added from the reagent probe 24b, and then stirred by the stirring mechanism 8b. By the reaction disk 8, the reaction vessel 7 successively traverses the luminous flux 14, and the absorbance is measured each time. These absorbances are measured 34 times in total for a reaction time of 10 minutes. After completion of photometry, the reaction vessel 7 is washed by the reaction vessel washing mechanism 10 to prepare for the next sample analysis. The measured absorbance is converted into a concentration or enzyme activity value by the central processing unit 12 and the analysis result is output from the printer 19.

Next, one embodiment of the present invention applied to the analyzer of FIG. 1 will be described. First, after turning on the power of the apparatus, the operator performs a preparatory operation and the like, first sets a standard solution of necessary analysis items in the apparatus, and performs calibration (creation of a calibration curve). Thereafter, in order to determine whether the calibration result is good or bad, the standard solution and the sample for checking accuracy are measured and confirmed. If there is no problem, measurement of the patient sample is started (operation start). In an embodiment of the present invention, the same patient sample is arbitrarily measured twice during patient sample measurement in order to confirm the accuracy (reproducibility) of the analysis during operation of the apparatus. A difference (RANGE) and a ratio (RATE) are calculated from the obtained measurement results by the following equations (1) and (2).

RANGE = X1-X2 (1)
RATE = X1 / X2 (2)
At this time, the patient sample to be measured twice is selected by the operator through the operation panel 23, and the measurement item and the measurement interval are selected by the operator's instruction on the condition setting screen as shown in FIG. In the condition setting screen 25 shown in FIG. 2, the measurement item and the measurement interval can be selected, and the measurement interval can be selected depending on the number of samples or the time. In addition, although not shown in the figure, depending on the facility, there are many times when analysis of in-patient specimens and analysis of out-patient specimens are frequent, so the items to be analyzed often change in units of hours. The measurement interval can be selected by combining the number of samples and time in units of time. In the condition setting screen 25, an allowable range of difference and ratio is also displayed on the same screen.

  Next, when the obtained difference RANGE and ratio RATE are compared with the permissible range and there is an abnormality in the measurement result, display is made so as to display the abnormality.

The flow up to here will be described with reference to the flowchart of FIG. First, measurement of the first patient sample is started (S1), then the second time of the same patient sample is measured (S2) according to the operator's instruction, and the measurement result is stored (S3). Next, a difference and a ratio are calculated from the obtained measurement results (S4), and it is determined whether or not they are within an allowable range (S5). Based on this determination, it is determined that it is normal if it is within the allowable range, and is determined to be abnormal if it is outside the allowable range, and that the abnormality is displayed on the screen (S6), the user is notified with an alarm or the like (S7), The analysis of the corresponding analysis item is stopped (S8). At this time, as shown in the example of the QC abnormality monitor 26 of FIG. 4 on the operation screen, the operator is informed that the analysis is to be stopped.

  Subsequently, after the measurement is completed, the difference or ratio measured twice is displayed in time series on the operation screen as shown in the example shown in the time series monitor 27 of FIG. 5 so that the operator can confirm. Although not shown, as a summary of the quality control data for the day after the completion of the measurement for one day, the average value of the first patient sample, the average value of the second patient sample, and the difference between the first and second measurement values Statistical data such as standard deviation and regression equation are calculated, displayed on the screen, and output to a printer or the like.

  As described above, during the operation of the apparatus, by comparing the difference and ratio from the results of the patient sample measured twice using the patient sample, it is possible to improve the accuracy of accuracy management and improve the reliability of the examination.

The figure which shows schematic structure of the automatic analyzer to which this invention is applied. The figure which shows an example of the condition setting screen in this invention. The figure which shows an example of the operation flow of Claim 1 in this invention. The figure which shows an example determined with abnormality in the quality control method in this invention. The figure which shows an example of a time series display on a screen for the difference and ratio in this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Sample cup, 2 ... Sample disc, 3 ... Sample probe, 4 ... Sampling mechanism, 5 ... Reagent pipetting mechanism, 6 ... Reagent disc, 7 ... Reaction container for direct photometry, 8 ... Reaction disc, 9 ... Stirring mechanism, DESCRIPTION OF SYMBOLS 10 ... Reaction container washing | cleaning mechanism, 11 ... Photometer, 12 ... Central processing unit, 13 ... Light source lamp, 14 ... Light beam, 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, 24a ... First reagent probe, 24b ... Second reagent probe, 25 ... Condition setting screen, 26 ... QC Abnormality monitor screen, 27 ... time series monitor screen.

Claims (6)

Analyzing the same analysis items in advance for the same general sample
Run multiple times at measurement intervals based on the number of samples or time,
Determine whether the fluctuation of the obtained analysis value is within the predetermined criteria,
Warn if the fluctuation is not within the standard,
The quality control method of the automatic analyzer for clinical examinations including this. An analysis mechanism for analyzing the specimen;
A storage mechanism for storing a predetermined analysis item and a measurement interval determined based on the number of samples or time;
A control mechanism for controlling the analysis mechanism to perform analysis on the same general sample a plurality of times based on the analysis items and measurement intervals stored in the storage mechanism;
A determination mechanism for determining whether the analysis value variation of the analysis performed by the analysis mechanism is within a predetermined reference range;
An alarm generation mechanism that issues an alarm when the determination mechanism determines that the analysis value variation is not within a predetermined reference range;
An automatic analyzer characterized by comprising: The automatic analyzer according to claim 2,
An automatic analyzer comprising: a setting mechanism for setting the predetermined analysis item and a predetermined measurement interval. The automatic analyzer according to claim 2 or 3,
An automatic analysis comprising a control mechanism for controlling the analysis mechanism so that the analysis of the corresponding analysis item is stopped when the determination mechanism determines that the analysis value fluctuation is not within a predetermined reference range. apparatus. In the automatic analyzer in any one of Claims 2-4,
An automatic analyzer comprising a display mechanism for displaying the analysis value variation on a screen in time series. In the automatic analyzer according to any one of claims 2 to 5,
The automatic analysis apparatus characterized in that the determination mechanism determines whether or not it is within a reference range based on a difference between analysis values of a plurality of analyzes and a ratio value.

Images