JP2003185672A - Automatic analysis system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an automatic analysis system that can avoid the influence of contamination due to a remaining sample in the reinspection of an immunological analysis after the completion of analysis in a biochemical analysis unit. <P>SOLUTION: In the automatic analysis system having a biochemical analysis unit 1 and an immunological analysis unit 2, a data processor section 4 inserts a probe 11 into a sample 10 for carrying out a sampling operation so that an amount S2 of insertion in sampling operation for sucking the sample 10 where a contaminated site 12 due to a remaining sample exists becomes deeper than that in a normal sampling operation for sucking the sample without any contaminated sites, thus sucking the sample 10 at a non-contaminated site, and hence preventing the contamination due to the remaining sample from affecting the reinspection of an immunological analysis. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analysis system configured to carry out biochemical and immunological analyses.

[0002]

2. Description of the Related Art Specimen tests include biochemical tests, immunological tests, blood cell counts, blood coagulations, etc., each of which is automated and popular. On the other hand, the systematization of tests is progressing in order to improve the efficiency of tests, and in particular, biochemical tests that are biochemical analyzes and immunological tests that are immunological analyzes are integrated and processed. An automatic analysis system configured as described above has been proposed.

An automatic analysis system configured to carry out a biochemical analysis and an immunological analysis includes, for example, an analyzer section including a biochemical analysis unit and an immunological analysis unit, and has a wide range of analysis. There is an automatic analysis system for specimen testing for clinical tests, which has the processing capability of items. As a conventional example of such an automatic analysis system, for example, JP-A-2000-74925, JP-A-2000-105248, and JP-A-2001-91.
There is one described in Japanese Patent No. 523. JP 2000-
In the automatic analysis system (hereinafter referred to as Conventional Examples 1 and 2) described in Japanese Patent Publication No. 74925 and Japanese Patent Application Laid-Open No. 2000-105248, a biochemical analysis unit and an immunological analysis unit are connected in series to form one analysis unit. Are configured.

[0004] Since the immunological analysis has a very wide measuring range, in particular, the influence of another sample (for example, a pre-sample which is a sample used for analysis before the analysis) by a probe for sampling the sample (specimen) It is important to avoid For that purpose, a biochemical analysis unit using a probe of the type that is washed and reused after performing an immunological analysis with an immunological analysis unit that uses a disposable probe (disposable sample chip) that is exchanged for each sample. It is configured to perform biochemical analysis in. In such a configuration, re-inspection may be necessary depending on the inspection result, so the sample is kept waiting in the standby unit until the determination of necessity of re-inspection is completed, and it is determined that re-inspection is unnecessary. If this is the case, the sample should be transferred from the immunological analysis unit to the biochemical analysis unit, and if retesting is necessary, the sample should be returned to the immunological analysis unit without being transferred to the biochemical analysis unit. I have to. Incidentally, Japanese Patent Laid-Open No. 2001-
In the automatic analysis system described in Japanese Patent Publication No. 91523 (hereinafter referred to as Conventional Example 3), a dispenser nozzle is used with a detergent solution and water as necessary in order to avoid contamination by another sample in the biochemical analysis unit. I try to wash it.

[0005]

In the above-mentioned conventional examples 1 and 2, the sample is transported to the biochemical analysis unit after the analysis in the immunological analysis unit constituting the system is completed including the case of retesting. Therefore, it is necessary to wait for the sample to wait at least until the analysis result is obtained in the immunological analysis unit regardless of whether the retest is performed or not, and the start of the analysis in the subsequent biochemical analysis unit is delayed. I will end up. This delay in the start of analysis is mainly due to the fact that contamination by another sample does not affect the measured value, but there are many test items for which you want to obtain test results quickly. Delayed start of analysis in clinical trials is not a desirable clinical test.

On the other hand, in the prior art 3 described above, in order to avoid contamination of another sample in the biochemical analysis unit, the dispensing nozzle is washed with a detergent. At present, there is no good detergent as a detergent capable of avoiding the influence of contamination in addition to the increase in running cost.

[0007] Similar to the immunological analysis unit, if a disposable type probe is used in the biochemical analysis unit, the influence of contamination by another sample can be avoided. It is not practical to use a disposable type probe because the sampling amount in 1 is extremely small compared to the sampling amount in the immunological analysis unit and highly accurate analysis is required. Therefore, in general, a biochemical analysis unit uses a probe of a type that is washed and repeatedly used.

The present invention enables the waiting time to be eliminated by immediately transferring the sample, which has been analyzed by the immunological analysis unit, to the biochemical analysis unit, and the biochemical analysis for re-examination. An object of the present invention is to provide an automatic analysis system capable of avoiding the influence of contamination by another sample even when returning a sample which has been analyzed by the analysis unit to the immunological analysis unit.

[0009]

In order to achieve the first object, the first invention according to claim 1 is an automatic analysis system configured to be able to perform biochemical analysis and immunological analysis. In the above, the influence of contamination can be avoided by performing a sampling operation that is different from the normal sampling operation that aspirates a sample that does not have a contaminated site with a probe during the sampling operation that aspirates a sample that has a contaminated site due to another sample It is characterized by doing so.

According to the first aspect of the invention, a sampling operation for re-examining the immunological analysis of a sample for which the biochemical analysis has been completed in an automatic analysis system configured to perform the biochemical analysis and the immunological analysis. Sometimes, a sample with a contaminated site due to another sample is aspirated by the probe.At that time, a sample is collected by performing a sampling operation different from the normal sampling operation in which a sample without a contaminated site is aspirated by the probe. Since the influence is avoided, the automatic analysis system can avoid the influence of contamination by another sample. Thereby,
Prevents delay in the start of biochemical analysis by allowing biochemical analysis to be performed immediately on a sample for which immunological analysis sampling has been completed, without waiting for completion of determination of necessity of retesting. be able to.

A second aspect of the present invention is the second aspect of the present invention, wherein when a biochemical analysis and an immunological analysis are carried out on a sample for which a test is requested, the immunological analysis is carried out, It is characterized in that the amount of probe insertion from the sample liquid surface is changed so as to aspirate a site that does not include a contaminated site by biochemical analysis.

In the second invention, the biochemical analysis and the immunological analysis are performed on the sample for which the test is requested, and then the immunological analysis is retested. In order to aspirate the sample during analysis, the liquid level of the sample is usually detected and the amount of probe insertion into the sample is controlled to be small. Focusing on the formation of the site, during the subsequent immunological analysis, the probe insertion amount from the sample liquid surface is changed so that the site that does not include the contaminated site is aspirated. It can be avoided.

A third aspect of the present invention is a case where a biochemical analysis is performed on a sample for which a biochemical analysis and an immunological analysis are requested to be inspected. When the amount is large, it is characterized in that the contaminated site in the sample is removed by sucking a larger amount of the sample than the amount required in the biochemical analysis.

In the third invention, a probe is inserted into the sample container for aspirating the sample at the time of sampling for performing the biochemical analysis on the sample for which the biochemical analysis and the immunological analysis are requested to be inspected. As a result, a contaminated site due to the biochemical analysis is formed in a site near the sample liquid surface, but in consideration of the case where the immunochemical analysis is retested after the biochemical analysis, If the amount of the contaminated site is larger than the required amount in the chemical analysis, by aspirating a larger amount of the sample than the required amount, the contaminated site in the sample will be removed. The effects of contaminated sites can be avoided when re-examination of immunological analysis is performed.

A fourth aspect of the present invention is an immunoassay in which immunoassay is performed after performing biochemical analysis on a sample for which biochemical analysis and immunological analysis are requested. It is characterized in that the sample is mixed before performing a sampling operation for biological analysis.

According to the fourth aspect of the invention, the biochemical analysis and the immunological analysis are performed on the sample for which the test is requested, and then the immunological analysis is retested. Considering that the contaminated site formed by the biochemical analysis is formed at the site near the sample liquid surface with the insertion of the probe into the sample container for aspirating the sample at the time of analysis, By mixing the sample before performing the sampling operation for, the contaminated site in the sample container is diluted with the entire sample and diluted, so that the influence of the contaminated site can be avoided.

[0017]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. FIG. 1 is a diagram showing a schematic configuration of an automatic analysis system of the present invention. This automatic analysis system is commonly used in the first to third embodiments to be described later, and is configured as an automatic analysis system for clinical specimen inspection having a processing capability of a wide range of analysis items. The operation of each unit of the analyzer unit 3 including the biochemical analysis unit 1 and the immunological analysis unit 2 is controlled by one data processor unit 4.

A rack transfer line 5 is provided above the analyzer unit 3 in the figure.
It consists of a going line 5A located above the analyzer unit 3 to convey a sample container (not shown) to the left in the figure, and a return line 5B located above the going line 5A to convey the sample container to the right in the figure. .

A sampler unit 6 is provided on the right side of the analyzer unit 3 in the drawing, and the sampler unit 6 is the analyzer unit 3.
And a sample collecting section 8 located on the right side of the sample setting section 7 for collecting the sample container after the analysis is completed.

In this automatic analysis system, the sampler unit 6
The sample container (not shown) installed in the sample installation section 7 is transferred to the unit to be analyzed through the going line 5A of the rack transfer line 5 based on the control information from the data processor section 4. There are those in which both the biochemical analysis unit 1 and the immunological analysis unit 2 perform analysis, and those in which only one performs analysis. In addition,
Depending on the result of determination of necessity of retesting in the immunological analysis unit 2, the sample container after completion of biochemical analysis can be returned to the line 5A via the return line 5B of the rack transport line 5. If it is possible and re-examination is unnecessary, the sample container after completion of the biochemical analysis will be transported to the sample recovery unit 8 and recovered.

Next, the sample suction operation in the above-mentioned automatic analysis system will be described. When the sample 10 is housed in the sample container 9 shown in FIG. 2 in the illustrated state, the probe 1 is used when performing the sampling operation in each unit.
1 is inserted into the sample 10 from the liquid surface 10a. At that time, first, various known means are used to detect the liquid surface. Next, the probe 11 is lowered and stopped by an elevator mechanism (not shown) to insert the probe 11 into the sample 10 from the detected liquid surface 10a by a predetermined insertion amount S1 (for example, several mm). Then, by driving a pump (not shown) connected to the probe 11, the sample 10 having a desired sampling amount is sucked. The aspirated sample 10 is conveyed to a reaction container (not shown) and injected into it.

In the above, since the probe 11 used in the immunological analysis unit 2 has a wide measurement range, it easily affects the measurement when contamination between samples (contamination, etc.) occurs. Although a disposable probe (disposable sample chip) that is exchanged for each sample is used, the probe 11 used in the biochemical analysis unit 1 that is unlikely to affect the measurement value even if contamination occurs is a washed probe. Use a type that is repeatedly used.

Next, the sampling operation control of the first embodiment in the automatic analysis system of the present invention will be described. FIG. 4 is a flowchart showing a control program for sampling operation control according to the first embodiment of the present invention. First, in step 51 of FIG. 4, it is determined whether or not the analysis is a retest of the immunological analysis after completion of the biochemical analysis. In this determination, if the analysis is a re-examination of the immunological analysis after the completion of the biochemical analysis, the influence of contamination by another sample (for example, the previous sample used for the analysis before the analysis) is avoided. Therefore, it is necessary to perform a sampling operation different from the normal sampling operation, so the control advances to step 52. In step 52, a sampling operation is performed in which the insertion amount of the probe 11 is changed from S1 at the time of normal sampling shown in FIG. 2 to S2 shown in FIG.

When the analysis is not a reexamination of the immunological analysis after the completion of the biochemical analysis in the determination in step 51, the analysis is a biochemical analysis or the analysis is a biochemical analysis. It may be an immunological analysis before conducting a biological analysis, but if the analysis is a biochemical analysis, even if an immunological analysis using a disposable probe is performed as the immediately preceding analysis, Since the contaminated site 12 by the probe 11 does not exist and the contaminated site 12 does not exist even when the analysis is an immunological analysis other than the retest, the immunology after the biochemical analysis is completed. If it is not the re-inspection of the dynamic analysis, a sampling operation different from the normal sampling operation for avoiding the influence of the contamination by the another sample is not required, and thus the step 5
Skip 2 and end the control as it is.

Next, the operation of the sampling operation control of the first embodiment will be described. Normally, the probe 11 is lowered by the control of the data processor unit 4 to a position where a necessary amount of the sample 10 can be sucked and stopped after the detection of the liquid surface 10a, and the sample 11 is sucked at that position. In an analysis unit in which the probe 11 is repeatedly washed and used when aspirating such a sample, if the probe 11 is inserted into the sample 10 more than necessary, the washing range of the outer portion of the probe is expanded accordingly. Since the size of the cleaning tank in the system is increased and the cost is increased due to the increase in the amount of cleaning water, it is preferable to keep the probe insertion amount to a necessary minimum.

While repeating the sampling of the sample as described above a plurality of times, the biochemical analysis unit 1 cleans the inside and outside of the probe 11 after the sampling of one sample is completed. If any sample remains, it will affect the measurement if the residual sample is brought into the next sample to be analyzed. However, since the residual sample brought into the sample to be analyzed next stays in the vicinity of the liquid surface 10a to form the contaminated portion 12 as shown in FIG. 2, the vicinity of the bottom surface of the sample container 9 is not affected by contamination and is not contaminated. It becomes a part. Note that in the case of immunological analysis, the residual sample brought into the sample is likely to affect the measurement, but in the case of biochemical analysis, it is relatively low, so retesting is included in the current probe washing. Sample 1 for biochemical analysis
The presence of the contaminated part 12 in 0 does not matter.

In the present embodiment, paying attention to the formation state of the contaminated site 12 as described above, in the case where the analysis is a reexamination of the immunological analysis after the completion of the biochemical analysis, the influence of the contamination is affected. In order to avoid the
The process proceeds from ES to step 52, and the sampling operation is performed with the insertion amount of the probe 11 changed to S2 in FIG. In this case, since the immunological analysis unit 2 uses a disposable probe that has nothing to do with washing as the probe 11,
Even if it is inserted deep into the sample 10, the problem of expanding the cleaning range does not occur. Therefore, the insertion amount of the probe 11 should be S2.
The sample 10 sucked by the sampling operation
Since it becomes a sample at a non-contaminated site, the residual sample is prevented from affecting the measurement at the time of retesting of the immunological analysis.

Further, in the present embodiment, in the automatic analysis system configured so that the operation of the biochemical analysis unit 1 and the immunological analysis unit 2 is controlled by the single data processor unit 4, after the biochemical analysis is completed, the immunization is completed. Even if the re-examination of the biological analysis is required, the influence of contamination by the residual sample is not exerted. Therefore, it is not necessary to wait for the sample to wait until the analysis result in the immunological analysis unit 2 comes out, and a standby space is not required, and the sample 10 for which the immunological analysis sampling is completed is immediately transferred to the biochemical analysis unit 1. Since it becomes possible to carry out biochemical analysis by carrying out the analysis, it is possible to prevent the delay in the start of biochemical analysis and obtain the analysis result quickly. Furthermore, in the present embodiment, since detergent is not required to wash the probe 11 in the biochemical analysis unit 1, it is possible to reduce the running cost as compared with the case where detergent is used.

Next, the sampling operation control of the second embodiment in the automatic analysis system of the present invention will be described. FIG. 5 is a flowchart showing a control program for sampling operation control according to the second embodiment of the present invention. First, in step 61 of FIG. 5, it is determined whether or not the sample has been requested to undergo both biochemical analysis and immunological analysis. In this determination, if the sample has been requested for both biochemical and immunological analysis, contamination will be detected if re-examination of immunological analysis is required after completion of biochemical analysis. Since it is necessary to avoid the impact, take measures beforehand. That is, when the sample is requested to undergo both biochemical analysis and immunological analysis, the control proceeds to step 62, and the amount of the contaminated site is lower than the required amount of the biochemical analysis. If there is a large amount, a larger amount (extra) than the required amount of the sample 10 is suctioned to remove the contaminated site 12. At this time, the extra aspirated sample shall be discarded at the washing position. In addition, in the above-mentioned step 51, when the analysis is requested to perform only one of the biochemical analysis and the immunological analysis, the contamination by the residual sample does not occur.
The step 62 is skipped and the control is ended as it is.

The sampling operation control of FIG. 5 is to completely aspirate and remove the contaminated site caused by the aspiration of the sample for biochemical analysis each time, but instead of FIG. The sampling operation control may be performed. The sampling operation control shown in FIG. 6 is for completely aspirating and removing the contaminated site in a single operation when the sample is aspirated multiple times for biochemical analysis. When the number of samples is small (that is, when the number of times the sample 10 is sucked is small), it is configured to be able to handle it.

The control of the sampling operation of FIG. 6 is a step of sucking and removing the contaminated site 12 if necessary according to the generation state of the contaminated site when the biochemical analysis unit 1 sucks the sample a plurality of times. If the sample is requested to undergo both biochemical analysis and immunological analysis in the determination in step 71 of FIG. 6, in step 72, biochemical analysis is performed. Unit 1
It is determined whether or not the contaminated portion 12 is present after the suction is performed a plurality of times in 1., and if the contaminated portion 12 is present, the contaminated portion 12 is sucked and removed in the next step 73. At that time, the determination as to whether or not the contaminated portion 12 is present after the suction is performed experimentally in advance in the data processor unit 4 based on the inner diameter of the sample container and the probe insertion amount after the liquid level detection. By comparing the volume of the contaminated site with the volume actually aspirated by the above-described plural times of sample suction, if the volume of the contaminated site is larger, it can be determined that the contaminated site 12 still exists. Assumed to be performed.

In the present embodiment, in order to avoid the influence of contamination by the residual sample when the re-examination of the immunological analysis becomes necessary after the completion of the biochemical analysis, the step 62 of FIG. 5 or the step of FIG. Since the contaminated portion 12 is suctioned and removed by executing YES-73 of step 72, the sample 10 sucked by the sampling operation when the re-examination of the immunological analysis is performed after the biochemical analysis is completed is the uncontaminated portion. Therefore, the residual sample is prevented from affecting the measurement when the retest of the immunological analysis is performed. In addition, in the present embodiment, as in the first embodiment, a biochemical analysis unit 1 and an immunological analysis unit 2 are operated in an automatic analysis system configured to be controlled by one data processor unit 4. Even if the re-examination of the immunological analysis is required after the completion of the chemical analysis, the influence of the contamination by the residual sample is prevented so that the sample can be collected until the analysis result in the immunological analysis unit 2 appears. Since there is no need to wait, a standby space is not needed, and it becomes possible to immediately transport the sample 10 for which the immunological analysis sampling has been completed to the biochemical analysis unit 1 to perform biochemical analysis. Therefore, it is possible to prevent the delay in the start of the biochemical analysis and obtain the analysis result quickly. Furthermore, in the present embodiment, since detergent is not required to wash the probe 11 in the biochemical analysis unit 1, it is possible to reduce the running cost as compared with the case where detergent is used.

Next, the sampling operation control of the third embodiment in the automatic analysis system of the present invention will be described. FIG. 7 is a flow chart showing a control program for sampling operation control according to the third embodiment of the present invention. First, in step 81 of FIG. 7, it is determined whether or not the analysis is a retest of the immunological analysis after completion of the biochemical analysis. In this determination, in order to avoid the effect of contamination by residual sample only in the case where the analysis is a re-examination of the immunological analysis after completion of the biochemical analysis, the following step 82 is performed.
Then, control is performed to mix the contaminated portion 12 and the non-contaminated portion of the sample 10.

Prior to the mixing, control is carried out to reduce contamination by the residual sample by washing the probe 11 in the biochemical analysis unit 1, and the contamination site 12 diffuses throughout the sample 10 by the mixing. Therefore, after mixing, the sample as a whole is in a diluted state. For example, when the residual volume of the sample 10 in the sample container 9 after the biochemical analysis in the biochemical analysis unit 1 is 1 mL and the contamination site 12 due to the residual sample is 0.001 μL, the mixture is mixed. The concentration of the remaining sample after is 1/100 of that before mixing
The amount becomes 0000 or less, which is a trace amount that does not affect the immunological analysis.

The mixing in step 82 may be carried out at any time before the re-examination of the immunological analysis is actually carried out. The mixing method is not particularly limited, and the mixing may be performed by repeating the suction operation and the discharge operation, for example.

In the present embodiment, when the analysis is a retest of the immunological analysis after completion of the biochemical analysis,
Since the influence of contamination by the residual sample is not exerted by executing step 82 of FIG. 7 in advance, it is possible to obtain the same effect as that of the first embodiment.

In each of the above embodiments, the automatic analysis system shown in FIG. 1 was used, but instead, the automatic analysis system shown in FIG. 8 may be used. In the automatic analysis system shown in FIG. 8, the biochemical analysis unit 1 and the immunological analysis unit 2 are interchanged so that the arrangement is reversed, and the operation is the same as that of the automatic analysis system shown in FIG. is there.

Further, in the automatic analysis system shown in FIG. 1, the biochemical analysis unit 1 and the immunological analysis unit 2 are independently installed, but the biochemical analysis and immunological analysis are performed in one analysis unit. In addition to using an analysis unit capable of analysis, a probe of the type that is washed and repeatedly used may be used for biochemical analysis.

In each of the above-described embodiments, the disposable probe is used in the immunological analysis unit 2, but the operation cycle is long, and a probe that is washed and repeatedly used during the operation cycle is used. However, if a sufficiently clean state can be maintained, a probe of the type repeatedly used may be used.

Further, a configuration in which the first and second embodiments are combined or the second and third house configurations are combined is also possible and effective.

[Brief description of drawings]

FIG. 1 is a diagram showing a schematic configuration of an automatic analysis system of the present invention.

FIG. 2 is a diagram for explaining a sampling operation of sucking a sample with a probe in the automatic analysis system of the present invention.

FIG. 3 is a diagram for explaining the operation of the first embodiment of the automatic analysis system of the present invention during sampling operation control.

FIG. 4 is a flowchart showing a control program for sampling operation control according to the first embodiment of the present invention.

FIG. 5 is a flowchart showing a control program for sampling operation control according to a second embodiment of the present invention.

FIG. 6 is a flowchart showing a control program of a modified example of the sampling operation control according to the second embodiment of the present invention.

FIG. 7 is a flowchart showing a control program for sampling operation control according to a third embodiment of the present invention.

FIG. 8 is a diagram showing another schematic configuration of the automatic analysis system of the present invention.

[Explanation of symbols]

1 Biochemical analysis unit 2 Immunological analysis unit 3 Analyzer section 4 Data processor section 5 rack transfer line Line for 5A 5B Return line 6 sampler section 7 Sample setting section 8 Sample collection section 9 Sample container 10 samples 10a liquid level 11 probes 12 Contamination site

Claims (4)

[Claims] 1. In an automatic analysis system configured to perform biochemical analysis and immunological analysis, there is no contaminated site during a sampling operation in which a sample that has a contaminated site with another sample is aspirated by a probe. By performing a sampling operation different from the normal sampling operation in which the sample is sucked by the probe,
An automatic analysis system characterized by avoiding the influence of pollution. 2. When the immunochemical analysis is performed after the biochemical analysis is performed on the sample for which the biochemical analysis and the immunological analysis are requested, the contaminated site due to the biochemical analysis is included. The automatic analysis system according to claim 1, wherein the amount of probe insertion from the surface of the sample liquid is changed so as to suck a non-existing portion. 3. When performing a biochemical analysis on a sample for which a biochemical analysis and an immunological analysis are requested, and the amount of the contaminated site is larger than the required amount, the biochemical analysis is performed. The automatic analysis system according to claim 1, wherein a contaminated portion in the sample is removed by sucking a larger amount of the sample than a necessary amount in the analysis. 4. When the immunochemical analysis is performed after the biochemical analysis is performed on a sample for which a biochemical analysis and an immunological analysis are requested to be performed, a sampling operation for the immunological analysis is performed. The automatic analysis system according to claim 1, wherein the sample is mixed before performing.