JPH0342429B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an automatic chemical analyzer, and particularly to an automatic chemical analyzer suitable for emergency tests in hospitals.

Automated chemical analyzers have made remarkable progress in clinical tests in hospitals and the like. In particular, devices that analyze biochemical components in blood have become widespread, such as the flow method developed by Technikon and the discrete method developed by Hitachi, Ltd., which can analyze multiple items at the same time. It is served to. However, all of these conventional devices require a skilled technician to handle them, and the disadvantage is that the initial analysis process takes time. The reasons for this are (1) when analyzing blood, it is necessary to separate serum or plasma from whole blood collected from a patient by centrifugation, and this work is done offline; (2) Color analysis takes time and requires preparation for analysis, starting up the equipment,
It also takes time to clean up afterwards. For this reason, biochemical tests in hospitals are generally processed in batches in laboratories, and test results are not available on the same day.

However, the importance of test data in diagnosis has recently been recognized, and testing of some biochemical components is now required for emergency tests such as emergency patients, and in the case of outpatients, it is difficult to obtain data immediately at the time of consultation. For example, there is a growing demand for speeding up testing because it allows for more efficient medical care without requiring patients to return to the hospital to receive test results, as is currently the case. For this purpose, it is necessary to produce results within 5 to 10 minutes after blood collection, but currently there is no device that meets this purpose.

An object of the present invention is to provide an automatic chemical analyzer that can easily and quickly analyze a plurality of desired chemical components from collected whole blood without requiring a skilled person to handle it.

In a preferred embodiment of the present invention, the configuration of the analyzer is designed to satisfy the following conditions.

In other words, (1) A device that anyone can use; specifically, a device that automatically performs the entire analysis process, from pretreatment to analysis, by simply inserting blood collected from a patient into a blood collection tube.

(2) A device that is always on standby and can accept samples at any time and quickly provide analysis results.

(3) Equipment that consumes less energy while on standby, and that does not require time to prepare for operation, start up, and clean up after operation.

(4) A device with a simple structure and highly reliable analysis.

It is to be.

The present invention includes a pretreatment section that performs centrifugation, and an analysis section that advances the reaction between the sample and reagent in a reaction coil and detects the reaction state with a detector. A sample holding tube that can aspirate the required amount of sample, a sample measuring tube that can measure the required amount of sample for each analysis item, and a reagent introduction tube that introduces the reagent according to the analysis item are connected by a flow path switching means. It is characterized by the structure in which the sample and reagent are introduced in series into the main analysis channel of the analysis section.

In a preferred embodiment according to the present invention, the following operations may be performed.

(1) A centrifuge has the function of centrifuging blood by high-speed rotation, and the function of rotating the rotor by step feeding and stopping at a desired position.When loading a sample, the rotor automatically The sample container is rotated to receive the sample container into the holding container at the predetermined numbered position, and after centrifugation, it automatically rotates again and stops the sample container at the sample introduction position where the sample is sucked into the analyzer. .

(2) When introducing a sample, the total amount required for analysis is sucked into the sample holding tube provided in the sample introduction section at once, and after sucking up the centrifuge, it immediately enters a standby state to accept the next sample.

(3) In order to analyze multiple components, the sample held in the sample holding tube is divided into multiple sections and sequentially introduced into the measuring tube provided in the sampling valve at regular time intervals. In synchronization with this, reagents prepared in the reagent reservoir corresponding to each analysis item are sequentially introduced into the reagent introduction tube provided in the reagent introduction valve in the order of the items to be analyzed.

(4) The main analysis flow path uses a liquid pump to send a carrier liquid (generally distilled water) through the reaction coil to the detector, forming a continuous, single, stable flow path that is constantly Samples are accepted and ready for immediate analysis.

(5) For analysis, the measured sample area is connected to the center of the reagent introduction tube by switching valves, and the reagent area sandwiching the sample area is further connected to form a flow path in series with the main analysis flow path. By doing so, the sample and reagent are introduced into the main analysis flow path, and multiple items of analysis are sequentially performed by sequentially introducing the sample and reagent at regular time intervals.

Examples of the present invention will be described below.

FIG. 1 shows an embodiment of the invention.

In the figure, 100 is a preprocessing section, and 200
is the analysis department. The pretreatment section 100 first performs centrifugation, and then the analysis section 200 analyzes the sample. Therefore, first, the preprocessing section 100
I will explain about it. This preprocessing section 100
It has a configuration as shown in FIGS. That is, in the figure, 101 is a centrifugal separation section, and 102 is a centrifugal rotor. The centrifugal rotor is equipped with a plurality of sample tube holding containers 103 (six in the illustrated example) into which sample tubes 104 are inserted.The sample tube holding containers are held vertically when the rotor is stationary. When rotated at high speed, it swings and rotates in a horizontal state as shown in FIG. 4, centrifuging the blood sample in the sample tube. 105 is a rotor drive device, which drives the rotor at 2000r.pm for centrifugation.
It has the function of rotating at a high speed of ~4000rpm and the function of rotating at a low speed and stopping the sample tube holding container at any position. Reference numeral 106 indicates a position detection device for this purpose. 107 is the upper lid of the centrifugal section;
Work is carried out under closed conditions at all times. Reference numeral 108 denotes a sample tube insertion port through which sample containers containing blood samples to be processed can be inserted or removed one by one. 109 is a lid of the sample insertion port;
It is automatically opened and closed by an electric motor 110. Reference numeral 111 is a sample suction port, through which the plasma that has risen from the centrifuged blood is sucked out. 112 is a nozzle for sucking up the sample, which can be moved up and down by a drive device 113.
When rotating, that is, when sucking up the sample, it passes through the suction port 111 and descends, and introduces the sample into the analysis section 200 via the suction conduit 114.
The analysis section 200 has functions necessary for chemical analysis, such as weighing a fixed amount of an introduced sample, adding a fixed amount of reagent to cause a color reaction, and performing colorimetric measurements. Each time a sample for one specimen is introduced, the nozzle 112 rises, rotates, and descends to the position of the washer 116 to perform cleaning. For cleaning, distilled water is poured from the rear of the conduit 114 to clean the conduit 114 and the nozzle 11.
Clean the channel while pushing out the analyzed sample remaining in Step 2. The analysis section 200 is equipped with necessary functions such as a washing tank and a liquid pump.

117 is a liquid level detector that descends into the sample tube together with the nozzle 112, and when it comes into contact with the sample liquid surface, it communicates with the nozzle 112 through the liquid, thereby detecting the position of the liquid level and confirming the sample amount. At the same time, the amount of suction can also be controlled by detecting the falling state of the liquid level during the suction process.

First, a case where only one sample is urgently processed will be explained. The specimen is collected using a vacuum blood collection tube containing an anticoagulant, and the blood collection tube is simplified so that it can be used as it is as the sample tube 104.

First, when you press the sample loading key (not shown), the lid 109
At this time, the rotor 102 has automatically rotated in advance so that a predetermined container (for example, FIG. 5 1) of the sample tube holding container 103 has come to the position of the sample insertion port 108, and the sample tube is inserted into the container. inserted into. The number is displayed on a display board (not shown). Next, when a start key (not shown) is pressed, the rotor 102 rotates at high speed to perform centrifugation, and then rotates at low speed to transfer a predetermined sample tube to the sample suction port 11.
The analyzer is stopped at position 1, and the separated upper plasma is guided to an analyzer for analysis, and the results are printed on a printer or the like. All work during this time is done automatically. When the centrifuge is operating, the lamp on the start key lights up to indicate that the centrifuge is in operation.When the separated sample is introduced into the analyzer and the sample container returns to its original position where the sample tube was inserted, the lamp lights up. disappears, indicating that the preprocessing is complete. When a sample tube removal key (not shown) is pressed, the lid 109 of the sample tube insertion port opens and the sample tube can be removed, and when a stop key (not shown) is pressed, the lid 109 is closed and the function of the centrifuge is stopped.

This device is designed to speed up the time required for centrifugation and analysis, as it is used for analyzes where quick results are desired, such as for emergency test specimens. That is, centrifugation is performed at 4000 rpm, and plasma can be separated in about 2 minutes, including the time required to increase speed for starting and braking and decelerating for stopping. In addition, the analyzer automatically analyzes multiple items required for urgent testing (To give one example, total protein, bilirubin, creatinine, GOT, GPT, amylase, 6 items in total) from chemical reaction to measurement in 2 to 5 minutes. It has the function of Therefore, analysis results can be obtained several minutes after inserting the sample as whole blood.

Next, a case where multiple samples are processed at once will be explained.

First, when the sample loading key is pressed, the lid 109 opens and the first sample tube is inserted in the same way as when processing one sample.Then, when the sample loading key is pressed again, the centrifugal rotor 102 rotates and the lid 109 opens as shown in Fig. 5. The sample tube holding container stops at the sample tube insertion port 108, and the next sample tube is inserted there. Similarly, press the keys one after another to insert the sample tubes in the order of 3, 4, 5, and 6 shown in FIG. This is a function in which every two sample tubes to be loaded are placed in a container on a diagonal line, so that regardless of the number of sample tubes to be loaded, at least one sample tube is always not placed in an unbalanced manner.

After loading, centrifugation and sample introduction are performed. During sample introduction, the centrifugal rotor 102 rotates in the same order as when the sample tubes were inserted, and the samples are introduced and analyzed in the order in which they were inserted. When removing a sample tube by pressing the sample removal key, there is no need to consider the balance or analysis order as when loading or introducing a sample, so the centrifugal rotor 102 is moved as shown in FIG. It is designed so that the sample tube can be quickly removed by rotating one step at a time in the order of 2, 4, and 6.

The analyzer has a processing time of 2 to 5 minutes for one sample, but when analyzing multiple samples in succession, it has a function of processing one sample per minute. Therefore, when processing multiple samples with this device, 2
After a further 2 to 5 minutes of centrifugation, data for the first sample is obtained, and data for subsequent samples are output every minute thereafter.

Next, the analysis section 200 will be explained. That is, in FIG. 1, 201 is a sample holding tube, 202 is a sample switching valve, and 203 is a measuring tube. The sample holding tube 201 holds the samples necessary for analysis, for example, if four items are to be analyzed, four
The sample for each item is sucked up at once, the sucked up sample is divided according to each analysis item, and the sample for the first analysis is introduced into the measuring tube 203 when sucked up from the centrifuge for the first time. Then, samples for second and third analyzes are introduced at regular time intervals synchronized with the analysis cycle. 206 is a pump for sucking the sample.

207 is a reagent introduction valve, and a reagent introduction tube 208
is provided. 209, 210, 211, 2
12 is a reagent bottle, in which reagents are prepared corresponding to each analysis item. Each reagent bottle 209, 210, 2
11 and 212 are connected to a reagent introduction pump 213 via a reagent introduction valve 207 and pinch valves 214, 215, 216, and 217, and by switching the reagent introduction valve 207, a desired reagent can be introduced by the action of the pump 213. A predetermined amount of reagent can be introduced into the corresponding tube by inhaling into the introduction tube 208. FIG. 1 shows a state in which the reagent bottle 211 is communicated with the reagent introduction tube.

218 is a main analysis channel, in which distilled water is supplied from the distilled water tank 220 by a pump 219 to the reaction coil 22 of the reaction tank 221 via the reagent introduction valve 207.
The liquid is sent to a flow cell 224 of a two-photometer 223, forming a stable single flow path with a constant flow rate. 22
5,226 is a drain bottle.

Introduction of the sample and reagent into the main analysis channel 218 and analysis are performed in the following steps. Sample measuring tube 20
3 and the reagent introduction tube 208, respectively, with the sample for the first analysis and the reagents necessary for that analysis introduced, the sample switching valve 202 in the direction of arrow A, and the sample introduction valve 207 in the direction of arrow B. Then, the measuring tube 203 is connected to the reagent introduction tube 208, and the reagent introduction tube 208 is connected to the main analysis channel 218.
Then, the sample flows into the main analysis flow path while being sandwiched by the reagent, forming a serial flow. Reaction coil 222
is maintained at a constant temperature (e.g. 37°C) required for a color reaction, and while passing through this, the sample and reagent are mixed and a color reaction takes place, flowing into the flow cell 224, where the photometer 223 measures the analytical components. Concentration measurements are taken. As a measurement method, it is possible to use the so-called end point method, in which the end point of color development is measured while the colored sample passes through the flow cell 224. The so-called late assay method, in which the reaction rate is measured by stopping the reaction at Pinch valves 227, 228 are then valves for stopping the sample in the flow cell and for bypassing the subsequent flow. Furthermore, when the sample in the measuring tube is connected to the passage of the reagent introduction tube by switching the sample switching valve, the reagent in the passage 204 moves to the passage 205, and the reagent in this part is discharged by the pump 206. 229, 23
0 is a pinch valve that switches the flow path for this purpose.

When the sample and reagent for the first analysis have completely entered the main analysis flow path, the sample switching valve 202
is reversed and the sample for the second analysis is transferred to measuring tube 2.
At the same time, the reagent introduction valve 207 is switched to introduce the reagent for the second analysis (for example, 21
2) is introduced into the reagent introduction tube 208. Then the first
At a fixed time interval after sample introduction for the second analysis,
Valve switching is performed for the introduction of a second sample and reagent, and a second analysis is performed. The third and fourth analyzes will be performed subsequently.

After all sample introduction for the scheduled analysis is completed, the sample introduction mechanism 117 rises, rotates, and descends to immerse the nozzle 112 in the washer 116 and remove the sample holding tube 20.
1 cleaning, the pump 231 is the cleaning device 116
It is provided to replenish distilled water.

An example of an analysis sequence using this system is shown in the sixth section.
As shown in the figure. This is an example in which four items are analyzed. In this example, after the sample tube is inserted, plasma separation by centrifugation and suction into the sample holding tube are completed in 2 minutes, and then the sample and reagent are metered into the main analysis channel at 30 second intervals. The processing time required for each analysis item in the analysis section is 2 minutes, including the reaction progress time in the reaction coil and the time (20 seconds) for stopping the sample in the flow cell and performing reaction measurement. Therefore, according to this example, the total time required from the insertion of the sample tube into the pretreatment section to the completion of all four analysis operations is 5.5 minutes.
After a few minutes, analysis of the next sample can be subsequently started.

Items that can be analyzed by this system include blood biochemical components, total protein, blood sugar, GOT, GPT,
Covers most items necessary for clinical tests, such as creatinine and cholesterol. It is convenient to use the same vacuum blood collection tube used for blood collection as the sample tube. Although this system is suitable for analyzing one sample at a time, a centrifuge can usually be loaded with multiple samples (for example, 12 samples) and centrifuged, so it can also be used for routine analysis where multiple samples are processed simultaneously. I can do it.

FIG. 7 shows another embodiment of the automatic chemical analysis system according to the present invention. In contrast to the single reagent introduction valve in the system shown in FIG.
switching the reagent to the main analysis flow path 218 together with the sample;
The pinch valve 21 of the system shown in FIG.
The feature is that 4,215,216,217 are unnecessary. The flow path switching valve 240 connects to the reagent bottles 209, 210, 211, and 212 by switching two steps in the direction shown by arrow C, and connects to the distilled water supply path 260 at the intermediate point, that is, every step, and switches the introduction flow path. Clean the area. The system shown in FIG. 7 is more suitable for analysis of a large number of reagents, that is, for analysis of a large number of items, compared to the system shown in FIG.

As explained above, according to the present invention, a plurality of desired chemical components can be analyzed from collected whole blood easily and quickly without requiring a skilled person to handle it.

[Brief explanation of drawings]

FIG. 1 is a block diagram showing an embodiment of the automatic chemical analyzer according to the present invention, FIG. 2 is a detailed block diagram of the pretreatment section shown in FIG. 1, FIG. 3 is a plan view of FIG. 2, and FIG. is a plan view of the internal structure of the centrifugal tank, FIG. 5 is a diagram explaining the operation of the centrifugal rotor, and FIG. 6 is a diagram showing the analysis sequence.
FIG. 7 is a configuration diagram showing another embodiment of the present invention. 101...Centrifugal separation unit, 102...Centrifugal rotor, 103...Sample tube holding container, 104...Sample tube, 105...Rotor drive device, 106...Position detection device, 107...Top lid, 108...Sample Pipe insertion port, 109...Lid, 110...Electric motor, 11
1...Sample suction port, 112...Nozzle, 11
3... Drive device, 114... Conduit, 115... Analyzer, 116... Cleaner, 117... Liquid level detector, 202... Sample switching valve, 207... Reagent introduction valve, 218... Main analysis Channel, 221...
Reaction tank, 223...Photometer, 224...Flow cell, 240...Flow path switching valve, 250...Reagent switching valve.

Claims (1)

[Scope of Claims] 1. A main analysis flow path in which a carrier liquid is sent to a detector via a reaction coil by a liquid sending pump to form a continuous stable flow, and a loaded sample is centrifuged and, after the separation, a carrier liquid is sent to a detector on a rotor. a preprocessing section consisting of a centrifuge that has the function of stopping the sample at a predetermined sample introduction position; and a reagent introduction tube having a predetermined internal volume, and the reagent introduction tube is connected to the main analysis flow path by switching the flow path. a reagent introduction switching section that sequentially introduces reagents corresponding to analysis items into the reagent introduction tube at predetermined time intervals; and a sample measuring tube, the sample measuring tube being arranged so that the front and back are sandwiched by the reagent introduction tube. a sample switching unit that is interposed in the reagent introduction tube and connects the sample measuring tube to the reagent introduction tube by switching the flow path; a sample introduction section configured to suck up the reagent into the sample holding tube at once, and then sequentially divide and introduce the sample from the sample holding tube into the sample measuring tube at regular time intervals, the reagent introduction switching section and the sample. The switching unit connects the reagent introduction tube and the sample measuring tube to the main analysis flow path by switching the flow paths to form a flow of carrier liquid-reagent-sample-reagent-carrier liquid toward the reaction coil. An automatic chemical analyzer characterized in that: