JP3169598B2 - Automatic analysis method and automatic analyzer - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an automatic analysis method and an automatic analyzer,
In particular, the present invention relates to an automatic analysis method and apparatus suitable for automatically performing calibration of a calibration curve.

[0002]

[Prior art]

As described in Japanese Patent Application Laid-Open No. 63-236966, a conventional apparatus has an automatic analyzer that holds and transports a sample container in a rack and has a sample that is determined to be re-analyzed as a result of analysis. The rack is not stored in the rack storage unit, but is transported again to the sample sampling position via the retest line and automatically re-analyzed.

[0003]

[Problems to be solved by the invention]

In the above prior art, no consideration is given to the method of controlling the transfer of the rack for a specific sample to be analyzed a plurality of times, and when it is desired to repeat the analysis several times for such a specific sample, As a conventional method, each time one sampling of a specific sample is completed, the rack holding the sample is reset to the rack supply unit.In this case, time is wasted due to the resetting of the sample, and erroneous operation of the device is performed. There was a drawback to cause. As another conventional example, there is a method in which racks for holding a specific sample are prepared in advance for the number of measurements, and these racks are set together with other general sample racks in a rack supply section to perform a series of analysis. In some cases, a plurality of racks holding a specific sample are prepared, so that the amount of the sample used has increased.

An object of the present invention is to transport a rack holding a general sample to a measuring device via a rack transport path and analyze the sample.
An object of the present invention is to provide an automatic analysis method and apparatus capable of performing calibration or accuracy control periodically and repeatedly while performing an analysis operation on a general sample.

[0005]

[Means for Solving the Problems]

The automatic analysis method of the present invention measures a specific sample composed of a standard solution for preparing a calibration curve or a control sample during the execution of an analysis operation on a general sample in order to recreate a calibration curve or control the accuracy of an analyzer. In the automatic analysis method, the identification number of the specific rack holding the specific sample is registered in the control unit, the specific rack is made to stand by in the rack standby unit, and the identification number of the specific rack is identified by the rack. The specific rack is read by the device, the general sample rack is transported to the measuring device by the rack transport path while the specific rack is waiting in the rack standby unit, and the general sample on the general sample rack is sampled by the measuring device. The general sample rack after sampling should be collected in the rack storage unit via the rack transport path, and the number of processed general samples or the elapsed time When the specific sample measurement repetition timing condition is met, the specific rack is taken out from the rack standby unit to the rack transport path and transported to the measuring device, and the specific rack for which the specific sample has been sampled by the measuring device is a rack. It is stored in a rack standby section via a transport path.

Further, the automatic analyzer of the present invention transports a general sample rack holding a general sample from a rack supply unit to a sampling position of a measuring device via a rack transport path, and dispenses the sample to the measuring device. In an automatic analyzer that transports the general sample rack toward the rack storage unit, a rack standby unit that waits for a specific rack holding a specific sample composed of a standard solution or a control sample for preparing a calibration curve that requires repeated measurement, and A rack loading / unloading device that stores a specific rack from the rack transport path in the rack standby section and removes the specific rack waiting in the rack standby section to the rack transport path; Take out a specific rack from the rack standby unit to the rack transport path when the elapsed time since the measurement of the specific sample corresponds to the condition for repeated measurement And a control unit for controlling the operation of the rack loading / unloading device.

[0007]

[Action]

According to the present invention, by registering the identification number of the rack in the storage unit of the control device and having a function of taking the rack in and out between the transport line and the standby space, a general sample to be processed on the transport line is provided. According to a predetermined condition, the rack of the specific sample is sent out between the racks, sampling is performed, and after the sampling is completed, the rack can be returned to the standby space. Thereafter, the same process as described above can be repeated on the rack that has entered the standby space.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION

 Hereinafter, embodiments of the present invention will be described with reference to the drawings.

FIG. 1 shows an overall configuration of an automatic analyzer according to an embodiment of the present invention, which supplies a sample sample in a rack system.

The automatic analyzer 1 includes a reaction disk 2 for performing sample analysis.
Are provided, and a plurality of reaction vessels 3 are provided on the concentric circumference. Around the reaction disk 2, a sample dispenser 4 having a pipetting nozzle, reagent dispensers 5 and 6,
A stirrer 7 and 8, a washing mechanism 9, and a multi-wavelength photometer 10 are arranged, and a rack supply for moving the rack between the transport lines 11a and 11b around the measuring device configured as described above. Unit 12, rack storage unit 13, space 14 for waiting the rack
a, 14b and 14c are provided.

The transport line 11a transports the rack by a belt conveyor from a rack position 91 to a rack position 92, and when the rack detector 20 detects the rack, the rack extruding device 21 operates to move the rack position on the transport line 11b. Move the rack to 93. After being transported by the belt conveyor from the rack position 93 to the rack position 94 on the transport line 11b, the rack moving claws 54 shown in FIG. When the rack detector 24 detects the rack, the rack extruder 25 is operated, the rack for the general sample is stored in the storage unit 13, and the rack for reanalysis is moved to the rack position 91 on the transport line 11a.

The operation of each unit of these devices is performed by a computer 151, a storage device 155, a keyboard input device via the interface 30.
152, CRT output device 153, and printer output device 154 can be arbitrarily controlled.

A procedure for processing a rack for holding a sample in the automatic analyzer described above will be described. (1) Transfer the analysis sample to a container 15 having the identification number shown in FIG.
, And a plurality of containers 15 are held in a rack 16 having an identification number shown in FIG. This identification number is given to distinguish whether the rack is a rack having a general sample or a rack sample having a sample to be re-analyzed, and also indicates an individual number for each rack. (2) A rack having a general sample is set in the rack supply section 12, and a rack having a sample to be re-analyzed a plurality of times is set in the rack standby spaces 14a to 14c. To enter. (3) The rack holding the general sample is sent out onto the transport line 11a by the rack extruder 17, and the rack holding the reanalysis sample corresponds to the target rack among the rack sorting devices 52a to 52c shown in FIG. Transfer line 11
b, the rack is moved to the rack position 95 by the rack moving claws 54, and the rack detector 24 detects the rack,
The rack is moved to a position 91 on the transport line 11a by the extrusion device 25. (4) The rack moved to the transport line 11a is transported by a belt conveyor (not shown) in the direction of the sampling position 110. (5) During the transport, the barcode 100 attached to the sample container 15 shown in FIG. 4 is read by the barcode reader 19, and the row of holes 101 of the rack 16 shown in FIG. The rack identification number is read by optically identifying whether the opened hole is a closed hole or not by transmitting light.

When the identification numbers of the container 15 and the rack 16 are read, the analysis item and the number of analysis items for the sample in the sample container 15 of the rack 16 are read out from the storage device 34, and the control mechanism is configured based on this information. To control each part of the device. That is, it controls the transport lines 11a and 11b, the rack storage unit 13, the rack standby space 14, the rack supply unit 12, the sample dispenser 4, and the like.

The control mechanism includes transport lines 11a and 11b, a rack supply unit 12,
The state of the rack storage unit 13, the rack standby spaces 14a to 14c,
And it monitors the rack and the sample at which position. (6) When the rack arrives at the sampling position 110, the belt conveyor stops, the pipetting device 4 samples the sample stored in the container 15 of the rack 16 by the pipetting nozzle, and then performs the sampling of the different containers 15 on the same rack. When a sample is sampled, the belt conveyor moves so that the pipetting nozzle enters the container containing the sample, transports the rack 16 a short distance, and operates the dispenser 4. (7) The rack for which sampling has been completed is carried to the rack position 92 by the belt conveyor and stopped, and the rack detector 20 is stopped.
Detects the rack, and the rack pushing device 21 operates to push the rack to the rack position 93. Then, the belt conveyor on the transport line 11b moves and moves the rack to the rack position 94 to stop it. (8) When the rack arrives at the rack position 94, the computer 31
Determines whether the rack contains a general sample or a sample to be re-analyzed, and when the re-analysis sample is stored, stores the rack in a rack standby space. In the case of a general sample rack, the rack is transported to the rack position 95 along the transport line 11b by the rack moving claws 54 shown in FIG. It is stored in the storage unit 13. (9) The control mechanism monitors the interval condition for re-analyzing the sample at any time, and when the analysis time comes, the transfer line 11
The rack flowing over b is stopped at the rack position 94, during which the target rack stored in the standby spaces 14a to 14c is sent out onto the transport line 11b. The rack containing the re-analyzed sample sent out is transported to rack position 95 and stopped.
The rack is moved to the rack position 91 by the rack pushing device 25.
The rack moves on the transport line 11a to the sampling position 110.
It is transported in the direction, and reanalysis is performed. Rack position 94
The rack stopped by the above is transported again after the rack of the reanalysis sample starts moving on the transport line 11a.

The movement of the rack in the vicinity of the standby space of the automatic analyzer 1 according to the embodiment will be described in detail with reference to FIG.

When the rack arrives at the rack position 94 on the transport line 11b, the control device determines whether this rack has a reanalysis sample, and if so, performs the following operation.

The control device specifies a place where a rack does not enter from the rack standby spaces 14a to 14c. The rack moving claw 54 moves to the position of the rack at the position 94, and hooks the claw on the lower portion of the rack to move the rack to a position in front of the empty space among the standby spaces 14a, 14b, 14c.
Then, the rack moving claws 54 release the claws and return to the rack position 94. The rack is then placed in a specific standby space by activating one of the rack sorting devices 53a-53c at the location where the rack is located.

When it is time to re-analyze a specific rack contained in the standby space, the other rack carried on the transport line 11b is stopped at a position 94. Of the rack sorting devices 52a to 52c, the device in the standby space in which the rack for reanalysis is stored is operated,
The rack is sent out onto the transfer line 11b. The rack moving claw 54 moves to the position where the rack is extended, and carries the rack to the hooking position 95. The rack moving claw 54 returns to the rack position 94, and the rack is detected by the rack detector and is moved to the position 91 of the transport line 11a by the rack pushing device. Thereafter, the sample is transported to the sampling position 110 and re-analyzed.

On the other hand, the rack stopped at the position 94 is carried on the carrying line 11b by the rack moving claws 54 after the rack having the reanalyzed sample is carried.

FIG. 3 shows an embodiment of the rack sorting devices 52a to 52c and 53a to 53c.

The belt 58 is rotated by a step motor 56 controlled by a computer 151, whereby the truck on the support 60 is rotated.
Rack extruding plate 52 in which 62 moves and is connected to trolley 62
Can be arbitrarily moved in the directions of arrows 63 and 64.

This makes it possible to move the rack in and out between the transport line 11b and the standby spaces 14a to 14c according to the processing of the control mechanism.

FIG. 4 shows the appearance of the sample container 15.

Each of the sample containers 15 has a bar code label 100 on which a bar code for identifying the container is printed. And this sample container 15 is rack
A plurality of, for example, five pieces are set in 16 and are carried on the transport line. At that time, the barcode reader 19 installed along the transport line 11a reads the barcode printed on the barcode label 100, and the data is sent to the control device. This enables individual identification of the plurality of sample containers 15.

FIGS. 5A and 5B show the appearance of the rack 16. The rack 16 has holes 10 on the sides to allow individual identification.
Four rows of 1 are provided with five rows as one row. The hole 101 can be closed, and the unblocked hole 101 corresponds to a binary number of 0, and the closed hole corresponds to 1. Since there are four rows, four racks in one rack 16
It is possible to assign a 4-bit hex number, which allows individual identification of the rack. While the rack 16 is being transported to the sampling position 110, the rack identification device 27 installed along the transport line 11a identifies whether the hole 101 is open or closed by transmitting light to determine whether the hole 101 is open or closed. Then, the data is converted into numerical data, the four columns of numerical values are taken, and the data is sent to the control device. This enables the control device to identify each rack.

The rack 16 has a constriction 120 at the lower part of the rack 16 so that the rack moving claw 54 can be caught.
4 enters and pushes rack 16 to move.

Next, a description will be given of a method of registering a rack holding a sample to be repeatedly analyzed in a control mechanism using an input device in the automatic analyzer of the embodiment, and further setting a timing of performing the analysis.

FIG. 6 shows a condition setting screen for re-analyzing a specific rack in the CRT output device 153. First, the identification number of the rack holding the sample to be subjected to the repeated analysis is input from the keyboard input device 152 to the setting column 35. In addition, at what timing the rack is sent from the standby space to the transport line for analysis, the apparatus performs a series of operations according to the setting method described below. (A) Repeat analysis according to the number of samples analyzed.

A specific sample is repeatedly analyzed based on the number of samples analyzed by the measuring device. For this reason, keyboard
The number of samples is input from 152, and the number of samples is registered in the storage device 155. In the analysis process of the apparatus, the rack is sent out to the sampling position 110. The barcode reader 19 reads the identification number of the sample container on the rack, the rack identification device 27 detects the identification number of the rack, and sends those signals to the control device. The control device retrieves the number of samples held by the rack and the sample container from the storage device 155. The control unit counts the number of samples in a series and compares it with the set value of the storage device 155.When the set value is reached, the control unit sends the rack holding the sample from the standby space to the transport line so that measurement can be performed. Transport to equipment. (B) A repeated analysis method according to the number of analyzed samples for each analysis item.

Based on the number of samples analyzed for a specific analysis item by the measuring device, a repetitive analysis of the specific number of samples is performed. Therefore, the number of samples is input from the keyboard 152 to the setting column 81, and the number of samples is registered in the storage device 155. In the analysis process of the device, it is sent to the sampling position 110,
The barcode reader 19 reads the identification number of the sample container on the rack, the rack identification device 27 detects the identification number of the rack, and sends those signals to the control device. When the rack comes to the sampling position, the analysis item corresponding to the rack and the container is extracted from the storage device 155, and the sample is analyzed accordingly. The control device counts the number of samples analyzed for each analysis item, compares the number with the set value of the storage device 155, and places the rack holding the sample in a standby space so that the specified sample can be analyzed when the set value is reached. From to the transport line. (C) A repeated analysis method according to the elapsed analysis time.

The repeated analysis of the specific sample is performed based on the elapsed time when the measurement device has performed the analysis.
The elapsed time is input from 2 and this number of hours is registered in the storage device 155. In the analysis process of the device, the measuring device sends a signal to the control device when starting the analysis. The control device measures the elapsed time from that time, and sends out the rack holding the sample from the standby space to the transport line so that the specific sample can be analyzed when the set value is reached as compared with the set value in the storage device 155.

According to the above setting, the rack having the sample to be repeatedly analyzed is carried to the sampling position 110 and analyzed, and then returned to the standby space again.

A method for maintaining the analysis accuracy of the automatic analyzer in the embodiment will be described below.

In the component analysis of various sample samples using an automatic analyzer, first, a sample sample (standard solution) having a known component concentration
Must be measured, and a calibration curve representing the correspondence between the absorbance value and the component concentration must be created based on the measured absorbance. This operation is called calibration. Thereafter, absorbance measurement is performed on a general analyte sample sample, and the obtained absorbance value is compared with a previously prepared calibration curve to calculate the concentration of an arbitrary component in the sample sample. However, if the number of analyte samples is very large and the analysis time is prolonged, the correspondence between the actual component concentration and the absorbance deviates from the calibration curve initially created. Even in such a case, if the component concentration is calculated using the calibration curve created first, an accurate component analysis value cannot be obtained, and the reliability of the apparatus decreases. But,
This problem can be solved by applying the automatic analyzer of the embodiment to the calibration work.
In other words, the absorbance measurement is repeated periodically for the standard solution, and each time, a new calibration curve is created and the calibration curve is calibrated, and the component concentration of the general sample is calculated using the newly created calibration curve. Calculation is performed based on the line so that an accurate component analysis value is always obtained. This will be described below with reference to FIGS.

FIG. 7 shows a screen on the CRT output device 153 for setting analysis information necessary for performing calibration cyclically. The input of the information is performed through an external input / output device. First, an analysis item whose calibration curve is to be calibrated is input in the input box 37. Next, enter the calibration method (type of calibration) in the input box 38,
The number of standard solutions to be used is entered in an input column 39, the concentration of the standard solution, the identification number of the rack in which it is set, the position of the sample in the rack is entered in an input column 40, and a printer output device for the calibration results. The presence / absence of printing on 154 is entered in the input fields 41 respectively. Also, as shown in FIG.
In the screen for setting information for performing the cyclic analysis, in the input column 35, the same number as the rack identification number set in the input column 40 for performing the cyclic calibration is set, and the input columns 80 to 80 are set. In 82, the reanalysis conditions for the cyclic calibration are set. And
After the above setting is completed, the rack in which the standard solution specified in the input field 40 is set is moved to the rack evacuation space 14a-1.
Set to 4c and start analysis. Thereby, according to the analysis operation process described above, the absorbance of the sample was measured only for the standard solution set in the designated rack for each set reanalysis condition, and the absorbance was set in the input field 37 each time. A calibration curve for the analysis item is newly created. Each time a calibration curve is newly created, the subsequent component concentration values of the general sample are calculated according to the new calibration curve, so that accurate analysis values can always be obtained. If the calibration result is set to be printed in the input field 41, the absorbance value can be printed out from the printer 154 each time the absorbance for the standard solution is newly set. FIG. 8 shows a screen for setting the conditions when the calibration curve created by the calibration is to be displayed. The analysis items for which the calibration curve is to be displayed in the input column 42 and the display range values in the input column 43 are shown. First, the calibration curve created first and its time are displayed. Next, a newly created calibration curve can be sequentially displayed. In the input field 44, output to the printer 154 can be designated. By these operations, the temporal change of the calibration curve can be visually grasped. By the above method, in the automatic analyzer of the embodiment,
Calibration can be performed appropriately.

In order to control the analysis accuracy of the automatic analyzer, a stable control sample having a clearly determined component composition ratio is used. Usually, a plurality of racks for holding the control sample are dispersed and placed between racks for general samples. However, if the present invention is applied to the control sample, And automatic quality control can be achieved. Hereinafter, a specific description will be given with reference to FIGS. 9, 10, and 11.

FIG. 9 is a screen for setting information necessary for performing accuracy management cyclically in the CRT output device 153. First, input the analysis items you want to analyze for quality control.
Enter 45. Subsequently, the type of the control sample to be used, the identification number of the rack in which the control sample is set, and the position in the rack are input to the input field 46. In the screen shown in FIG. 6 described above, the same number as the rack identification number set in the input field 46 for performing the cyclic accuracy management is set in the input field 35, and the cyclic numbers are set in the input fields 80 to 82. Set interval conditions for quality control. And
After the above setting is completed, the rack in which the control sample specified in the input field 46 is set is set in the rack evacuation spaces 14a to 14c, and the analysis is started. Then
Also, when the analysis start timing based on the control sample analysis interval conditions set in the input columns 80 to 82 comes according to the analysis operation process described above, the rack retreat space 14
The control sample rack set in a to 14c is sent out onto the transport line 11b, and a series of analysis steps is started. After that, the control sample in the control sample rack is analyzed for each interval condition set in the input fields 80 to 82, and the component concentration is calculated. In this way, the quality control of the automatic analyzer can be performed automatically. FIG. 10 is a screen showing a list of measurement data for quality control thus obtained in the CRT output device 153. Various quality control data for the analysis items cyclically measured using the sample can be obtained as a table. Further, if the printer print is designated in the input field 48, the list can be printed out from the printer 154. FIG. 11 is a screen showing a temporal change of the quality control data measured cyclically in the CRT output device 153. The analysis items and the type of the control sample are displayed in an input column 49 and an input column. By inputting the data into each of the fields 50, the transition of the measured data corresponding thereto can be obtained as a graph. By monitoring the fluctuation of this graph, the accuracy of the apparatus can be visually controlled. Also, if you specify printer printing in the input field 51,
This graph can be printed out from the printer 154. In this way, by analyzing the control sample, the deviation of the component concentration value obtained by the measurement from the actual component concentration value can be monitored, and the accuracy control ability of the device is improved. . In addition, there is only one rack for control samples
If it is set to 4c, the control sample in this rack will be re-analyzed cyclically many times, so if sufficient control samples are prepared in this rack, the conventional As described above, it is not necessary to prepare a number of control sample racks, and the sample sample can be saved. As described above, it is possible to appropriately perform quality control in the automatic analyzer according to the embodiment.

In addition, if the reanalysis according to the present invention is performed on an unstable sample whose component composition ratio gradually changes with time, it is possible to grasp the stability of the sample. .

[0040]

According to the present invention, a general sample rack for holding a general sample and a specific rack for holding a specific sample which needs to be repeatedly measured are transported to a measuring apparatus via a rack transport path. On the other hand, it becomes possible to automatically execute periodic calibration or quality control.

[Brief description of the drawings]

FIG. 1 is a schematic diagram of a configuration of an automatic analyzer according to one embodiment of the present invention.

FIG. 2 is a configuration diagram near a standby space of the apparatus in FIG. 1;

FIG. 3 is a configuration diagram of a rack sorting device.

FIG. 4 is a sample container used in the embodiment of FIG.

5 (A) is a plan view of a rack used in the embodiment of FIG. 1, and FIG. 5 (B) is a side view of the rack of FIG. 5 (A).

FIG. 6 is an example of a condition setting screen on a CRT for analyzing a specific sample a plurality of times.

FIG. 7 is an example of a condition setting screen on the CRT for performing accuracy management of the apparatus of the embodiment of FIG. 1 on the CRT.

8 shows an example of an output screen on a CRT as a result of performing quality control of the apparatus of the embodiment of FIG.

FIG. 9 is an example of a condition setting screen on the CRT for performing accuracy management of the apparatus of the embodiment of FIG. 1 on the CRT.

FIG. 10 shows an example of an output screen on a CRT as a result of performing quality control of the apparatus of the embodiment of FIG. 1;

11 shows an example of an output screen on a CRT as a result of performing quality control of the apparatus of the embodiment of FIG.

[Explanation of symbols]

1 ... automatic analyzer, 11a, 11b ... transport line, 12 ...
Rack supply unit, 13 Rack storage unit, 14a to 14c Rack standby space, 15 Sample container, 16 Rack, 52a
~ 52c, 53a ~ 53c ... Rack sorting device.

Claims (3)

(57) [Claims] An automatic analysis method in which the measurement of a specific sample comprising a standard solution for preparing a calibration curve or a control sample is repeated at predetermined intervals during execution of an analysis operation on a general sample, wherein the specific rack holding the specific sample is provided. The identification number of the specific rack is registered in the control unit, the specific rack is made to stand by in a rack standby unit, the identification number of the specific rack is read by a rack identification device, and the specific rack is identified. The general sample rack is transported to the measurement device by the rack transport path while waiting in the standby section, and the general sample on the general sample rack is sampled by the measurement device. The number of samples processed or the elapsed time of the general sample through the measurement Be transported from the rack standby unit when true grayed condition to the measuring device takes out the specific rack to the rack transport path,
And the specific rack after the specific sample has been sampled by the measuring device is stored in the rack standby section via the rack transport path. 2. A general sample rack for holding a general sample is transported from a rack supply unit to a sampling position of a measuring device via a rack transport path, and the general sample rack after dispensing the sample to the measuring device is stored in a rack. A rack standby unit for holding a specific rack holding a standard sample or a control sample for a calibration curve for which repeated measurement is required, and A rack loading / unloading device that stores the specific rack in the rack standby unit and takes out the specific rack waiting in the rack standby unit to the rack transport path; When the elapsed time from the measurement of the specific sample satisfies the condition of the measurement repetition, the specific rack is transferred from the rack standby section to the rack transport path. A control unit for controlling the operation of the rack loading / unloading device so as to take out the rack, and the rack transport path further has a function of transporting the specific rack taken out of the rack loading / unloading device to the sampling position of the measuring device again. An automatic analyzer characterized by comprising: 3. A general sample rack holding a general sample is transported from a rack supply section to a sampling position of a measuring device via a rack transport path, and the general sample rack after dispensing the sample to the measuring device is stored in a rack. A rack standby unit for holding a specific rack holding a standard sample or a control sample for a calibration curve for which repeated measurement is required, and A rack loading / unloading device that stores the specific rack in the rack standby unit and takes out the specific rack waiting in the rack standby unit to the rack transport path; a rack identification device that reads an identification number of the specific rack; The status of the rack standby unit is monitored based on the data read by the rack identification device, and the status accompanying the transport of the general sample rack is monitored. During the processing of the general sample, the specific rack is transported in the rack transport path in accordance with the analysis repetition conditions of the specific sample, and the rack loading / unloading device is configured so that the specific sample is re-analyzed by the measurement device. An automatic analyzer, comprising: a control unit that controls the transport path.