Patent Application
20240012019
The present invention relates to an automatic analyzer.
As an automatic analyzer, a biochemical analyzer and an immunoanalyzer that analyze a biological component contained in a sample (a specimen) such as blood and urine are known. The automatic analyzer optically measures a concentration of a mixed liquid generated by a reaction between a sample and a mixed liquid used for analysis of each inspection item, activity of an enzyme, and the like.
PTL 1 discloses an automatic analyzer in which different dispensing mechanisms are used based on a reaction process, and each dispensing mechanism dispenses both a sample and a reagent with the same dispensing nozzle, and stirs a mixed liquid of the sample and the reagent by a pipetting operation.
The inventors have examined a sequence of a dispensing operation capable of increasing throughput of the automatic analyzer as disclosed in PTL 1. Since cleaning an inner side and an outer side of a dispensing nozzle for every dispensing operation leads to a decrease in throughput and an increase in an amount of cleaning water used, it is preferable to perform a dispensing operation in which the number of cleaning is reduced as much as possible.
Therefore, after examining a sequence in which the reagent is first aspirated from a reagent container, only the outer side of the dispensing nozzle is cleaned, the sample is then aspirated from a sample container, and the aspirated reagent and sample are discharged into a reaction container and stirred, it has been found that carry-over between the reagent and the sample can occur in some test items. For example, a nephelometric reagent contains a protein. According to the sequence as described above, when the nephelometric reagent adhering to the inner side of the dispensing nozzle is mixed into the sample in the sample container, even an amount of protein mixed is fairly small, in a case of a sample having a low protein concentration such as urine, an erroneous measurement result such as a false high value may be generated due to the mixed nephelometric reagent.
An automatic analyzer according to an aspect of the invention includes: a dispensing mechanism that includes a dispensing nozzle and dispenses a sample or a reagent into a reaction container; a cleaning tank that cleans the dispensing nozzle; and a control unit that controls the dispensing mechanism and the cleaning tank to dispense the sample and the reagent into the reaction container by a first dispensing operation or a second dispensing operation.
The first dispensing operation includes a first procedure in which the dispensing mechanism aspirates the reagent accommodated in a reagent container by the dispensing nozzle, a second procedure in which the cleaning tank cleans an outer side of the dispensing nozzle after the first procedure, a third procedure in which the dispensing mechanism aspirates the sample accommodated in a sample container by the dispensing nozzle after the second procedure, and a fourth procedure in which the dispensing mechanism discharges the reagent and the sample aspirated in the first procedure and the third procedure to the reaction container after the third procedure.
The second dispensing operation includes a first procedure in which the dispensing mechanism aspirates the sample accommodated in the sample container by the dispensing nozzle, a second procedure in which the dispensing mechanism discharges the sample aspirated in the first procedure to a first reaction container after the first procedure, a third procedure in which the cleaning tank cleans an inner side and the outer side of the dispensing nozzle after the second procedure, a fourth procedure in which the dispensing mechanism aspirates the reagent accommodated in the reagent container by the dispensing nozzle after the third procedure, a fifth procedure in which the cleaning tank cleans the outer side of the dispensing nozzle after the fourth procedure, a sixth procedure in which the dispensing mechanism aspirates the sample accommodated in the first reaction container by the dispensing nozzle after the fifth procedure, and a seventh procedure in which the dispensing mechanism discharges the reagent and the sample aspirated in the fourth procedure and the sixth procedure to a second reaction container after the sixth procedure.
An automatic analyzer capable of performing a dispensing operation with high throughput while reducing a risk of carry-over of a reagent is provided.
Other problems and novel characteristics will become apparent from a description of the present specification and the accompanying drawings.
Hereinafter, an embodiment of the invention will be described with reference to the drawings. In the drawings, common components and similar components are denoted by the same reference numerals, and redundant description will be omitted as appropriate.
A plurality of reagent bottles 4b and sample containers 5 can be placed on a reagent and sample common accommodating portion 3. Each of the reagent bottles 4b is a combination of a plurality of (here, three) reagent containers 4 each accommodating a reagent. In this example, the reagent bottle 4b is located on an inner periphery of the sample container 5. However, the sample container 5 may be located on an inner periphery of the reagent bottle 4b, or the reagent bottle 4b and the sample container 5 may be located separately in a circumferential direction rather than in a radial direction. Further, although an example of the reagent and sample common accommodating portion 3 is shown here, accommodating portions for a reagent and a sample may be separate.
Between the incubator 1 and the reagent and sample common accommodating portion 3, a dispensing mechanism 6 capable of arc (rotation) movement and vertical movement and including a dispensing nozzle is provided. The dispensing nozzle moves while drawing an arc around a rotation axis, and performs dispensing from the reagent bottle 4b or the sample container 5 to the reaction container 2. On a trajectory of the dispensing nozzle, there are a reagent aspiration position and a sample aspiration position on the reagent and sample common accommodating portion 3, a dispensing position on the incubator 1, and a cleaning tank 7 for cleaning the dispensing nozzle.
The sample and the reagent are aspirated by the dispensing nozzle, and the sample and the reagent are stirred and mixed by aspiration and discharge operations by the dispensing nozzle in the reaction container 2. In this way, since the sample and the reagent are stirred by a pipetting operation by the dispensing nozzle, a stirring mechanism for stirring the sample and the reagent can be no longer necessary. The reaction container 2 that accommodates a reaction solution in which the sample and the reagent are mixed is controlled to a predetermined temperature by the incubator 1, and the reaction is promoted for a predetermined time.
When the automatic analyzer is used for a biochemical test, a spectrophotometer 8 is disposed around the incubator 1. The spectrophotometer 8 includes a light source and a detector (not shown), and measures an absorbance of the reaction solution by spectroscopically detecting transmitted light obtained by irradiating the reaction solution in which the sample and the reagent are mixed with the light source. A detection principle of the automatic analyzer is not limited to the biochemical test. For example, when the automatic analyzer is used for an immunological test, the spectrophotometer 8 is not necessary, and an immunological analysis unit (for example, a unit that measures an amount of luminescence derived from a luminescence reaction of a labeling substance using electrochemical luminescence or chemical luminescence as a principle and a photomultiplier tube as a detector) is provided. Further, when the automatic analyzer is a composite type for a biochemical test and an immunological test, both the spectrophotometer 8 and the immunological analysis unit are provided.
Each mechanism of the automatic analyzer is connected to a control unit 10. The control unit 10 controls operations of various mechanisms such as rotation driving of the incubator 1, a rotation operation inside the reagent and sample common accommodating portion 3, driving and dispensing operations of the dispensing mechanism 6, and cleaning for the dispensing nozzle by the cleaning tank 7. In
The procedures (B1) to (B8) do not need to be continuously performed, and may be separately performed as a first sequence of the procedures (B1) to (B3) and a second sequence of the procedures (B4) to (B8). When two sequences are separated, the following operation is performed. In a cycle before a cycle of executing the second sequence, the first sequence is executed to dispense the sample into the first reaction container 2a located at an access point of the dispensing nozzle (procedures (B1) to (B3)). After a predetermined time has elapsed (for example, after several tens of seconds), the second sequence is executed at a timing when both the first reaction container 2a and the second reaction container 2b are located at the access point of the dispensing nozzle (procedures (B4) to (B8)).
In such a carry-over avoidance dispensing operation, since the sample transferred from the sample container 5 to the first reaction container 2a in the procedure (B2) may be mixed with the reagent after the procedure (B6), the remaining sample cannot always be used for subsequent tests. Normally, since the analysis is performed on a plurality of measurement items for the sample in the sample container 5, it is desirable to reduce the amount of the sample dispensed from the sample container 5 to the first reaction container 2a in the procedures (B1) to (B2) as much as possible in order to prevent the sample accommodated in the sample container 5 from being finally insufficient. However, when the amount of the sample accommodated in the first reaction container 2a is small, a failure may occur in the sample aspiration operation in the procedure (B6).
Therefore, in the present embodiment, a second operation (small-amount aspiration operation) of aspirating the liquid from the reaction container 2 is set, in which the aspiration operation can be performed even when the amount of the sample to be dispensed into the first reaction container 2a is a dispensing amount such that the height of the liquid surface is equal to or less than ε. When the amount of the sample to be dispensed into the first reaction container 2a is less than a predetermined threshold value, the small-amount aspiration operation shown in
A state (S11) is an initial state, the top end of the dispensing nozzle 201 is located at the height h1 from the bottom surface of the reaction container 2, and a height of the liquid surface from the bottom surface in the reaction container 2 is a height h2B. Subsequently, the dispensing nozzle 201 is lowered until the top end of the dispensing nozzle 201 reaches a bottom of the reaction container 2 (a state (S12)), and then the dispensing nozzle 201 is raised by a certain distance δ (δ<ε) (a state (S13)). The sample is aspirated in a state in which the top end of the dispensing nozzle 201 is located at a height of δ from the bottom surface of the reaction container 2 (a state (S14)).
The insertion length c set in the standard aspiration operation is set to enable stable aspiration assuming that a reaction solution in which a sample and a pretreatment solution are mixed or a diluted sample obtained by diluting a sample with a dilute solution is aspirated. On the other hand, since the sample itself is accommodated in the reaction container 2 in the procedure (B6), the amount of the liquid accommodated in the reaction container 2 and the amount of the liquid aspirated by the dispensing nozzle in the procedure (B6) are both remarkably smaller than the amount assumed in the standard aspiration operation. Therefore, when the sample is dispensed from the sample container 5 to the first reaction container 2a to an extent that the standard aspiration operation can be performed, an amount of the sample to be discarded increases. By setting the small-amount aspiration operation, even when only a small amount of sample is accommodated in the reaction container 2, a stable aspiration operation can be performed, and the amount of the sample to be discarded can be reduced.
The control unit 10 determines whether the dispensing operation performed by the dispensing mechanism 6 is the normal dispensing operation in
The control unit 10 has a determination table 501 for selecting a dispensing operation based on the sample type information 402 and the measurement item information 403 of the measurement request information data 401 or a combination of the sample type information 402 and the measurement item information 403.
Although the embodiment of the invention has been described above, the invention is not limited to the above embodiment, and includes various modifications. Hereinafter, modifications will be described.
When the sample dispensed into and remaining in the first reaction container 2a affects the measurement item, it is necessary to discard the sample. However, when the sample does not affect the measurement item, it is possible to continuously use the sample dispensed into and remaining in the first reaction container 2a for another measurement.
In the present embodiment, an example is described in which application of the carry-over avoidance dispensing operation is determined based on the sample type information, the measurement item information, or the combination of the sample type information and the measurement item information. However, the application of the carry-over avoidance dispensing operation may be determined based on other information, for example, a state of the automatic analyzer.
For example, when the automatic analyzer is in a state in which maintenance of the dispensing nozzle by an operator is not performed and the sample type is easily affected by the contamination by the reagent, the carry-over avoidance dispensing operation is applied. When the maintenance of the dispensing nozzle is not executed, the dispensing nozzle is in a state in which a risk of contamination is likely to occur, and thus the carry-over avoidance dispensing operation is applied such that the contamination due to dirt in the dispensing nozzle does not occur. Execution/non-execution of the maintenance of the dispensing nozzle can be determined based on an operation log of the analyzer.
Alternatively, even when a QC measurement result is out of a reference range, and the measurement is performed as it is, the carry-over avoidance dispensing operation is applied regardless of the sample type in this case. The dirt in the dispensing nozzle may be a reason why the QC measurement result is out of the reference range. Therefore, the carry-over avoidance dispensing operation is applied such that the contamination due to the dirt in the dispensing nozzle does not occur.
The above embodiment and modifications have been described in detail for easy understanding of the invention, and the invention is not necessarily limited to those including all the configurations described above. For example, although an example has been described in which the sample is temporarily dispensed into the reaction container 2b on the incubator 1 in the carry-over avoidance dispensing operation, in a case in which there is a holding portion that temporarily holds the dispensed sample, the sample may be held by the holding portion.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2020-205500 | Dec 2020 | JP | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/JP2021/038191 | 10/15/2021 | WO |
