JP2000105239A - Biochemical automatic analyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To simply and surely detect abnormality, and to predict a life of a replacing component, by measuring an absorbance using a colored substance after absorbance measurement using pure water to determine that a data trouble exists in any side out of a photometric system and a dispensing system. SOLUTION: Washing for reaction vessels is started, a fixed amount of water are dispensed into one specified vessel and a plurality of reaction vessels, respectively, to measure absorbances, and measured results are determined as a check (1) and a check (2) respectively. The check (1) is compared with the check (2) to judge whether a cause exists in the reaction vessel or a light source based on an allowance value. Pure water is thereafter dispensed after a fixed amount of colored substance are dispenced from a sample probe into the plural reaction vessels (group A) after washing. The fixed amounts of the colored substance and pure water are delivered at the same time into another reaction vessels (group B) with no sample dispensed, using a reagent probe. Absorbance- measured values of the groups A, B are determined as checks (4), (5), and the checks (4), (5) are compared each other to judge whether a cause exists in deterioration of sampling precision or in a reagent pipetting mechanism.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic biochemical analyzer.

[0002]

2. Description of the Related Art Automated biochemical analyzers must rapidly and accurately analyze and report samples taken from patients in order to make an accurate diagnosis. Therefore, the performance of the apparatus and the accuracy of the measured values must always be kept at the highest level. Conventionally, the most commonly used quality control method is to purify serum collected from animals (horses, cattle) and humans and create a quality control sample with a known concentration (commercially available)
Is periodically measured, and the state of the apparatus is indirectly determined from the measured value.

At present, a method used as a general quality control method is to allow a quality control sample to be interrupted at regular intervals during the measurement of a normal routine sample and to perform measurement, and to summarize the situation such as the trend and shift during the day. Daily accuracy management methods and representative values (average values) for a day are summarized for several days.
Daily accuracy management method that summarizes the situation such as shift, real-time accuracy management method that measures two types (low value and high value) of quality control samples and twin plots them on the coordinate axes to determine whether they are within the allowable range Is used.

[0004]

Usually, the operator in charge of the operation of the apparatus performs an accurate quality control.
Various types of quality control samples are used for each measurement item, and measures are taken such as narrowing the measurement interval of quality control samples. As a result, quality control samples are prepared for each item such as enzymes, proteins, lipids, and immunological substances. This not only increases the number of samples and complicates operations, but also the presence or absence of abnormal data from the huge measurement results, A lot of time was required for the analysis time, such as confirmation.

[0005] In addition, since the absolute amount of the sample is increased, the inspection cost is increased. Further, if the measured value of the quality control sample shows an abnormality, all the factors such as the photometric system and the dispensing system are included, so the operator has to check all the mechanical parts.

[0006] Also, when a part replacement operation is performed as a countermeasure, not only parts that need to be replaced but also parts that can still be used may be replaced, and the operation itself requires a lot of time, labor, and unnecessary parts. Needed cost. Therefore, it is necessary for an operator to have many years of experience in using an analyzer in order to identify an abnormal point. As a method for controlling the accuracy of an automatic biochemical analyzer that may be used by an unspecified number of laboratory technicians in a hospital, Is currently not a satisfactory method.

SUMMARY OF THE INVENTION It is an object of the present invention to more simply and accurately detect an abnormality in each mechanism, predict the life of a replacement part, and notify an operator.

[0008]

SUMMARY OF THE INVENTION Usually, data troubles caused by a hardware system include an abnormality in a photometric system and an abnormality in a dispenser system. Abnormalities in the optical system include dirt and scratches on the reaction cell and a decrease in the light intensity of the light source lamp. Abnormalities in the dispenser system include dispensing errors caused by abrasion of packings in the sample pipettor and reagent pipetter. In order to accurately and instantly identify these and notify the operator, the following means are used to make an individual determination for each mechanism in the event of a data failure originating from the hardware system.

When checking the reaction vessel among the data troubles caused by the photometric system, a fixed amount of pure water is continuously dispensed from a reagent nozzle to a plurality of reaction vessels and the absorbance is measured. From the values of absorbance measured in a plurality of reaction vessels, an average value, a standard deviation, and a coefficient of variation are determined, and it is checked whether the values are within allowable values. This operation is a check.

Next, when checking the light source lamp among the data troubles caused by the photometric system, a reaction vessel (one) not used for measurement such as a patient sample is determined from a plurality of reaction vessels. A certain amount of pure water is dispensed into the set reaction container using a reagent nozzle. The reaction vessel measures the absorbance every time it crosses the optical axis while rotating around the light source lamp at regular intervals during the determined reaction time. Therefore, in the reaction container into which pure water has been dispensed, the absorbance is measured a plurality of times each time the optical vessel crosses the optical axis at regular intervals. An average value, a standard deviation, and a coefficient of variation are obtained from the absorbances measured a plurality of times, and the values are checked to see if they are within allowable values.

This operation is regarded as a check. Here, the check is compared with the check. If the check is within the allowable value but the check is out of the allowable value, it can be determined that the cause of the trouble data is the reaction vessel. If both the check and the out-of-tolerance values are found, the cause of the data trouble can be determined to be the light source lamp. Next, in the case of a data trouble caused by the dispensing system, the cause is caused by deterioration of the sampling accuracy of the sample and deterioration of the reagent pipetting accuracy.

First, a method for checking the accuracy of reagent pipetting involves dispensing a fixed amount of a stable colored substance (dye) into a plurality of reaction vessels using a reagent dispensing mechanism. At this time, a certain amount of pure water filled in the reagent pipettor is simultaneously dispensed, and the absorbance is measured. The average value, standard deviation, and coefficient of variation are determined from the absorbances measured in a plurality of reaction vessels, and checked to see if the values are within allowable values. If dispensing accuracy is deteriorating,
This is because the mixing ratio of the colored substance and the pure water is not constant, and the absorbance measured in a plurality of reaction vessels varies, resulting in poor reproducibility. This operation is a check.

Next, as to the method of checking the sampling accuracy of the sample, a sampling mechanism is used for a plurality of reaction vessels, and a predetermined amount of a colored substance (dye) is dispensed into the reaction vessels. If the dispensed amount of the sampling mechanism alone is not enough for the amount of liquid that can be analyzed, then a fixed amount of pure water is dispensed into the same reaction vessel using a reagent pipetting mechanism, and the absorbance is measured. An average value, a standard deviation, and a coefficient of variation are determined from the absorbances measured in a plurality of reaction vessels, and checked to see if the values are within allowable values. This operation is a check. Here, the check is compared with the check. If the check is within the allowable value but the check is out of the allowable value, it can be said that the cause of the data trouble is deterioration of the sampling accuracy. , Are out of the allowable values, it can be determined that the cause of the data trouble is the reagent pipetting mechanism.

As described above, the accuracy abnormality of the reagent dispensing system
By confirming both the accuracy abnormalities of the sample pipettor, it can be determined whether the reagent dispensing system is abnormal or the sample dispensing system is abnormal. In addition, all measured data is stored in the hard disk, so the value measured each time is used as daily accuracy management data, and the degree of wear of each part can be confirmed according to the fluctuation, and it is possible to predict the appropriate replacement time sufficiently. It is.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows an embodiment of an automatic analyzer using the present invention. The 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, and a reagent pipetting mechanism 5 for dispensing a plurality of reagents.
a, 5b, reagent disks 6a, 6b, a reaction disk 8 holding a plurality of reaction containers 7 for direct photometry, a stirring mechanism 9
a, 9b, a reaction vessel cleaning mechanism 10, a photometer 11, a central processing unit (microcomputer) 12 for controlling the entire mechanical system, and the like.

Reaction disk 8 holding a plurality of reaction vessels
The control of the operation of rotating the reaction vessel by half a rotation + 1 and temporarily stopping the reaction vessel every cycle is performed. 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.

As the photometer 11, a multi-wavelength photometer having a plurality of detectors is used, and when the reaction disk 8 is in a rotating state as opposed to the light source lamp 13, the rows of the reaction vessels 7 emit light beams from the light source lamp 13. 14. 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 a 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 unit 12 via an interface 22. 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 washing of the reaction vessel 7 is started by the reaction vessel washing mechanism 10, and the water blank is measured. The measured value serves as a reference for the absorbance measured in the reaction vessel 7 thereafter. After the water blank measurement, when the operation proceeds to the sample discharge position 15 by repeating the operation of one cycle of the reaction disk 8, that is, the operation of making the reaction vessel half-turn +1 and temporarily stopping the reaction vessel,
The sample cup 1 moves to the sampling position.

Similarly, the two reagent disks 6a and 6b 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 thereafter,
Discharge into the reaction vessel 7. On the other hand, the reagent pipetting mechanism starts the operation of the reagent pipetting mechanism 5a when the sampling mechanism is discharging the sample into the reaction vessel 7,
The first reagent of the analysis item A installed on the reagent disk 6a is sucked by the reagent probe 24a. 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. When the reaction disk rotates by 2 rotations + 2 reaction vessels after the addition of the first reagent, the stirring mechanism 8a operates to stir the sample and the reagent. When the reaction container 7 advances from the sample dispensing position 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 the stirring is performed by the stirring mechanism 8b. Reaction vessel 7 by reaction disk 8
Traverses the light beam 14 one after another and the absorbance is measured each time.

The absorbance is measured 50 times in total in a reaction time of 10 minutes. Reaction vessel 7 after photometry
Are washed by the reaction vessel washing mechanism 10 and are ready for the next sample measurement. The measured absorbance is converted into a concentration or an enzyme activity value by the central processing unit 12, and the analysis result is output from the printer 19.

Next, an embodiment in which the present invention incorporates the operation flow shown in FIG. 1 will be described.

When the start button for the check function on the operation panel 23 is pressed, the cleaning of the reaction vessel 7 is started by the reaction vessel cleaning mechanism 10. Thereafter, the reagent nozzle 2 is inserted into a plurality of reaction vessels 7 and a predetermined specific reaction vessel (one piece).
Dispense a certain amount of pure water continuously from 4. Further, while the reaction vessel 7 rotates in a cycle of a half rotation plus one reaction vessel for one cycle, the absorbance is measured each time the light flux 14 is traversed.

Predetermined specific reaction vessel (1)
Is used in the calculation by using the values of all (50 times) absorbances that cross the light flux 14 every fixed time during the reaction time.
For a plurality of reaction vessels, the measured absorbance at the last photometric point within the reaction time is used for calculation. The average value, standard deviation, and coefficient of variation are determined from the values of the absorbance measured in the specific reaction vessel (one) and the plurality of reaction vessels, and checked to see if the values are within allowable values.

The value obtained from the result of the specific reaction vessel (one piece) by the above operation is used as a check. Also, a value obtained by using a plurality of reaction vessel measurements is used as a check. Here, the check is compared with the check. If the check is within the allowable value but the check is out of the allowable value, it can be said that the cause of the trouble data is the reaction vessel. If both the check and the out-of-tolerance values are exceeded, it can be determined that the cause of the data trouble is the light source lamp. After the measurement, the reaction vessel enters a washing operation by the washing mechanism 10 and proceeds to the next step.

A fixed amount of a stable colored substance (dye) provided on the sample disk 2 is dispensed into the plurality of reaction vessels 7 after washing by the sample probe 3 in a predetermined amount (this is referred to as group A). Subsequently, no samples are dispensed for another plurality of reaction vessels (this is referred to as group B). At a position where the reaction container 7 is rotated by a half rotation + 1 reaction container, a certain amount of pure water is dispensed using the reagent probe 24 for the reaction container of the group A.

For group B, reagent disk 6
Colored substance (pigment) installed in a special bottle installed inside
Is aspirated using the reagent probe 24 and discharged into the reaction vessel. At this time, a fixed amount of pure water filled in the probe is simultaneously discharged together with the sucked colored reaction.

While the container 7 rotates in a cycle of a half rotation plus a reaction container for one cycle, the absorbance is measured each time it crosses the light flux 14. Of the absorbances measured within a certain time, the measured absorbance at the last photometry point is used for calculation. The average value, standard deviation, and coefficient of variation are determined from the absorbance values at the final photometric points measured in a plurality of reaction vessels, and checked to see if the values are within allowable values.

The washing mechanism 10 is removed from the reaction vessel after the measurement.
The washing operation is started sequentially using. Here, the result of group A is checked, and the result of group B is checked. Here, the check is compared with the check. If the check is within the allowable value but the check is out of the allowable value, it can be said that the cause of the data trouble is deterioration of the sampling accuracy. , Can be determined to be due to the reagent pipetting mechanism.

Because the accuracy of the reagent pipetting mechanism can be checked by the operation of the reagent pipetter alone, the sampling accuracy is checked by using both the sample and reagent dispensing mechanisms. Since it is necessary to confirm the sampling accuracy after performing the above, it is necessary to confirm by performing such a comparison. All the analysis results are displayed on the alarm display screen of the CRT on the reaction vessel, light source lamp, sample pipettor,
The name of the reagent pipettor or the like is displayed, and an alarm is notified to the operator.

Further, the measured data are all stored in the hard disk as daily accuracy management data, and it is checked whether the measured value is within the allowable range every time. From this, the degree of wear of each part can be confirmed based on the degree of fluctuation of the measurement data, and it is possible to predict an appropriate replacement time.

[0033]

According to the present invention, the photometric system and the dispensing system of the apparatus can be checked separately and independently. Identification is simple and quick, which leads to more efficient repair work. Further, the measured data is accumulated as daily difference accuracy management data, and the degree of daily fluctuation can be confirmed, which serves as a guide for the next part replacement time.

Therefore, it is possible to sufficiently understand the state of wear and deterioration of parts such as cells, lamps, and packings inside the pipettor which affect the performance of the photometric system and the dispensing system. Therefore, only the parts that need to be replaced can be selected, so that compared to the current situation in which usable parts are also replaced at the same time, the cost of parts can be saved, and the cost and work efficiency can be sufficiently increased.

[Brief description of the drawings]

FIG. 1 is a flowchart of a program to which an automatic analyzer according to the present invention is applied.

FIG. 2 is a configuration perspective view showing an example of an automatic analyzer applicable to the present invention.

[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 vessel for direct photometry, 8 ... reaction disk, 9 ... stirring mechanism, Reference Signs List 10: reaction vessel washing mechanism, 11: photometer, 12: central processing unit (microcomputer), 13: light source lamp, 14: luminous flux, 1
5: sample discharge position, 16: multiplexer, 17: logarithmic conversion amplifier, 18: A / D converter, 19: printer, 2
0: CRT, 21: reagent dispensing mechanism drive circuit, 22: interface, 23: operation panel, 24: reagent probe, 25: hard disk.

 ──────────────────────────────────────────────────続 き Continuing from the front page (72) Inventor Kiyotaka Saito 832 Nagakubo, Horiguchi, Hitachinaka-shi, Ibaraki Prefecture Within Hitachi Measurement Engineering Co., Ltd. (72) Inventor Taizo Yokose 832 Nagakubo, Horiguchi-Hitaguchi, Hitachinaka-city, Ibaraki 2 Hitachi Measurement Engineering Incorporated (72) Inventor Kyoko Imai 882, Ichimo, Hitachinaka-shi, Ibaraki F-term (Reference) 2M045 AA13 CA25 FA11 FA29 FB11 GC10 JA01 JA04 JA07 2G058 CB05 CD04 CE08 ED21 FB21 GA02 GD01 GD07 GE09 2G059 AA01 BB12 EE01 KK10 MM19 NN05 NN06 PP04 PP10

Claims (2)

[Claims] The present invention is characterized in that there is provided means for measuring absorbance using pure water and determining data trouble in a photometric system + means for measuring absorbance using a colored substance to determine data trouble in a dispensing system. Biochemical automatic analyzer. 2. The apparatus according to claim 1, further comprising a function of observing the performance of the apparatus by accumulating the data obtained in claim 1, predicting a replacement time of a next maintenance point, and informing an operator from a CRT display. Biochemical automatic analyzer.