JP4439024B2 - Automatic analyzer - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an automatic analyzer for analyzing a sample for a plurality of analysis items using a reagent.
[0002]
[Prior art]
Reagents used in conventional automated analyzers affect calibration by their preparation. In addition, the calibration of the prepared reagent is affected by the difference in reagent bottles for putting the reagent or the difference in shipping lots.
[0003]
In order to reduce the measurement error of the calibration of the reagent affected by such differences, when replacing the reagent used for sample analysis with the same kind of reagent in the conventional automatic analyzer, the reagent should be replaced each time. Calibration is in progress. In addition, regarding reagent replacement, multiple reagents of the same type are placed on the device, and the same type of reagent is selected based on a predetermined order of use when there are not enough reagents used for sample analysis. An automatic analyzer to be used after that is described in utility model registration number 2503751.
[0004]
In addition, in order to improve the throughput of the entire device, an automatic analyzer that eliminates the need for reagent replacement by arranging multiple reagents on the device in preparation for when there is no reagent used for sample analysis, There is also known an automatic analyzer that automatically performs calibration associated with replacement.
[0005]
[Problems to be solved by the invention]
However, in the conventional automatic analyzer described above, calibration is performed after reagent replacement, and the throughput of the entire apparatus is reduced. At this time, if there is a problem in the calibration, the operator will check and take measures during the measurement, and the throughput of the entire apparatus will be further reduced. In addition, there is a problem that the order of use of reagents must be determined in advance.
[0006]
That is, even when the reagent is automatically replaced by the apparatus itself, the operator needs to always be aware of the reagent calibration status. For this reason, there is a problem that the operator is burdened and the throughput of the entire apparatus is reduced when a problem occurs in reagent calibration.
[0007]
The present invention has been made in view of the above circumstances, and an object of the present invention is to provide the same kind of reagent as that of the reagent with a time margin before starting measurement of a patient specimen when a sample is analyzed using the reagent. By calibrating the reagent, an automatic analyzer capable of improving the throughput of the entire apparatus and reducing the burden on the operator is provided.
[0008]
[Means for Solving the Problems]
In order to solve the above problems, the automatic analyzer of the invention described in claim 1 has a plurality of reagents of the same type used for a certain inspection item, and measures a sample while exchanging these reagents. A storage means for storing a plurality of reagents, and a recognition means for recognizing that at least one of the plurality of reagents other than the reagent used for the measurement and the reagent used for the measurement is the same type of reagent. A registration means for registering, as a calibration condition, to execute calibration when the number of reagents required for one test for each of the plurality of reagents is less than a predetermined testable number, and the registration The calibration condition of the reagent used for the measurement registered in the means is read, and the remaining testable number of the reagent used for the measurement is determined by the registered calibration. A determination means for determining whether or not a condition is satisfied; and when the determination means determines that the remaining testable number of reagents used for the measurement satisfies the calibration condition, the recognition means Calibration means for calibrating at least one kind of reagent other than the reagent to be used recognized by the determination means, and the judgment means, after calibration for the at least one kind of reagent, Calculate the total remaining testable number of the reagent to be used and the at least one reagent of the same type, determine whether or not the total remaining testable number exceeds the predetermined testable number, and If it is determined that the testable number does not exceed the predetermined testable number, the calibration The stage calibrates the reagent to be used recognized by the recognition means and the same kind of reagent other than the at least one kind of reagent, and the judgment means performs calibration of the further same kind of reagent. Later, a total remaining testable number of the reagent to be used, the at least one same type of reagent and a further same type of reagent is calculated, and whether or not the total remaining testable number exceeds the predetermined testable number The calibration unit and the determination unit repeat the calibration and the determination, respectively, until it is determined that the total remaining testable number exceeds the predetermined testable number, If it is determined that the total remaining testable number exceeds the predetermined testable number, the calibration is performed. The calibration means ends the calibration .
[0014]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
[0015]
(Embodiment 1)
In the first embodiment of the present invention, when the testable number of reagents used for analyzing a sample is less than or equal to a preset testable number, calibration is performed for another reagent of the same type as that reagent. If the total testable number of the reagent used for sample analysis and the calibrated reagent exceeds the preset testable number, calibrate the reagent and analyze the sample. Like to do.
[0016]
FIG. 1 is a diagram showing the configuration of the automatic analyzer according to the first embodiment of the present invention. In FIG. 1, the automatic analyzer according to the first embodiment of the present invention includes a sample storage unit 10 for storing a plurality of sample bottles each containing a sample to be analyzed, and a reagent used for analyzing the sample. A reagent storage unit 20 that stores a plurality of reagent bottles, and a reagent storage unit 20 that is stored in the reagent storage unit 20 is stored in the sample storage unit 10 using the calibration and reagents of the reagents contained in the reagent bottles. An analysis unit 30 for analyzing a sample contained in a sample bottle, a sample storage unit 10, a reagent storage unit 20, a control unit 40 for controlling the operation of the analysis unit 30, a keyboard, a mouse, etc. Input unit for entering calibration conditions, reagent ID, reagent validity period, etc. 50, a display unit 60 for displaying the calibration result obtained by the calibration of the reagent by the analysis unit 30, and the calibration condition, the calibration ID inputted from the input unit 50, the reagent ID, and the validity of the reagent And a storage unit 70 for storing a period and the like.
[0017]
Next, a reagent calibration process in the automatic analyzer according to the first embodiment of the present invention will be described.
[0018]
FIG. 2 is a diagram for explaining a flow of reagent calibration processing in the automatic analyzer according to the first embodiment of the present invention, and FIG. 3 is a control unit of the automatic analyzer according to the first embodiment of the present invention. 5 is a flowchart showing a reagent calibration determination process in FIG.
[0019]
Here, for example, the same kind of reagent contained in three reagent bottles used for a certain inspection item (analysis item) is prepared in advance, and analysis (measurement) of the sample is performed while exchanging these three reagent bottles. Think about what to do. For convenience of explanation, bottle numbers are assigned to the three reagent bottles, but it is not actually necessary to assign a bottle number to each reagent bottle. In the case of analyzing a sample, it is assumed that the reagent contained in the reagent bottle of bottle number 1 is used first.
[0020]
First, three reagent bottles each containing three reagents of the same type are stored in the reagent storage unit 20, and the input unit 50 receives the same reagent ID a10001 as shown in FIG. Input from to perform the registration process. As the registration process, for example, an automatic registration process using a barcode can be performed.
[0021]
In addition, the operator enters the valid period of the reagent contained in each reagent bottle from the input unit 50 and performs registration processing. FIG. 5 shows an example of the registration processing result.
[0022]
Furthermore, the calibration process of the reagent in the inspection item, for example, the condition “content of testable number of reagents is 100 tests or less” is input from the input unit 50 by the operator, and registration processing is performed.
[0023]
The reagent ID, reagent validity period, calibration conditions, and the like are stored in the storage unit 70 by the control unit 40. Thereafter, calibration of the reagent is performed.
[0024]
First, at the start of sample analysis, a predetermined reagent (here, a reagent contained in a reagent bottle of bottle number 1) is selected (step A1). Next, the calibration condition of the selected reagent stored in the storage unit 70 is checked to determine whether this calibration condition is satisfied, that is, whether another reagent needs to be calibrated ( Step A2).
[0025]
Specifically, the amount of the reagent contained in the reagent bottle of bottle number 1 is measured using a liquid level sensor (not shown), and the measurement result and the amount of reagent necessary for one test (analysis) are used. Then, the testable number of the reagent is calculated, and it is determined whether or not the calculated testable number is 100 tests or less. The calculated testable number of reagents is stored in the storage unit 70.
[0026]
In step A2, if the reagent contained in the reagent bottle of bottle number 1 does not satisfy the calibration condition (that is, if the calculated testable number of reagents exceeds 100 tests), calibration is performed for another reagent. The sample is analyzed without doing so.
[0027]
On the other hand, in step A2, when the reagent contained in the reagent bottle of bottle number 1 satisfies the calibration condition (that is, when the calculated testable number of reagents is 100 tests or less), the reagent storage unit 20 Whether there is a reagent with the same reagent ID (another reagent of the same type) among the reagents contained in the reagent bottle (except for the reagent contained in the reagent bottle of bottle number 1) (Step A3).
[0028]
Specifically, as shown in FIG. 6, when the amount of the reagent (the number of testable items) contained in the reagent bottle of bottle number 1 is 40 tests and 100 tests or less, the above-described calibration conditions are set. Satisfied. Therefore, in this case, it is necessary to calibrate another reagent of the same type as that reagent.
[0029]
In step A3, when there is no reagent having the same reagent ID, the operator is notified that there is no reagent to be calibrated (step A8). Specifically, for example, a message indicating that there is no reagent to be calibrated is displayed on the display unit 60. As a result, the operator prepares another reagent of the same type.
[0030]
On the other hand, if there is a reagent having the same reagent ID in step A3, it is in the reagent bottle stored in the reagent storage unit 20 based on the validity period of the reagent stored in the storage unit 70. A reagent with a short effective period (here, the reagent contained in the reagent bottle of bottle number 2) is selected from the same type of reagents (step A4), and the operator is notified that calibration of the selected reagent is to be performed ( Step A5). Specifically, a message indicating that calibration is performed is displayed on the display unit 60. Thus, the operator is made aware that the reagent calibration is performed.
[0031]
For the above-described message for notifying the operator, for example, a voice unit (not shown) may be provided in advance and output from this voice unit.
[0032]
In step A6, an instruction to execute calibration of the reagent selected in step A4 is issued to the analysis unit 30. Thereby, in the analysis unit 30, the reagent is calibrated. The calibration result is stored in the storage unit 70 by the control unit 40.
[0033]
In step A7, the amount of the reagent contained in the reagent bottle of bottle number 2 is measured by the liquid level sensor, and the testable number of the reagent is determined based on the measurement result and the amount of the reagent necessary for one test. calculate. Further, the testable number of reagents in the reagent bottle of bottle number 2 is added to the testable number of reagents stored in the storage unit 70 (in the reagent bottle of bottle number 1).
[0034]
After the process of step A7, the process returns to the process of step A2, and it is determined again whether or not the testable number of reagents added in step A7 is 100 tests or less.
[0035]
Specifically, for example, as shown in FIG. 6, when the amount (testable number) of reagents contained in the reagent bottle of bottle number 2 is 80 tests, the total number of testable items added is Since 40 tests + 80 tests = 120 tests, it is determined in step A2 that the calibration condition (100 tests or less) is not satisfied. Therefore, the execution of the reagent calibration is finished here, and the sample is analyzed.
[0036]
On the other hand, for example, as shown in FIG. 7, when the amount of the reagent contained in the reagent bottle of bottle number 2 is 40 tests, the total number of tests that can be added is 40 tests + 40 tests = 80 tests. In step A2, it is determined that the calibration condition (100 tests or less) is satisfied. Therefore, in this case, the above-described steps A3 to A7 are performed again. Here, calibration is performed on the reagent contained in the reagent bottle of bottle number 3.
[0037]
After that, for example, as shown in FIG. 7, when the amount of the reagent contained in the reagent bottle of the bottle number 3 is 80 tests, the total number of tests that can be added is 40 tests + 40 tests + 80 tests = 160 It becomes a test, and it is determined in step A2 that the calibration condition (100 tests or less) is not satisfied. Therefore, the execution of reagent calibration is terminated and the sample is analyzed.
[0038]
As described above, by repeating the processing from step A2 to step A7 until the reagent does not satisfy the calibration condition, the amount of the calibrated reagent is reduced to some extent (in this case, the testable number exceeding 100 tests). ) The sample is analyzed after it is secured.
[0039]
Here, a case has been described in which the above-described reagent calibration determination process is performed at the start of sample analysis. However, the determination process is performed in the same manner, for example, every predetermined time during sample analysis.
[0040]
When analyzing the sample, if the reagent being used becomes unusable for some reason, replace the reagent that can no longer be used with a reagent of the same type that has already been calibrated, and replace the replaced reagent. Use to continue analysis of the sample. When there are a plurality of reagents that are calibrated in the same type as the reagent that can no longer be used, the sample is replaced with a reagent having the shortest effective period, and the analysis of the sample is continued. At that time, the calibration result of the reagent stored in the storage unit 70 is applied. Thereafter, the calibration determination process described above is performed, and if the calibration condition is satisfied, the calibration for another reagent of the same type is further performed.
[0041]
(Embodiment 2)
In the second embodiment of the present invention, the reagent used for analyzing the sample is not calibrated until the calibration condition is not satisfied as in the first embodiment of the present invention. If the calibration condition is satisfied and calibration is not performed for another reagent of the same type as this reagent, the calibration of only one other reagent of the same type is performed and the analysis of the sample is started. Yes.
[0042]
FIG. 8 is a flowchart showing calibration determination processing in the control unit of the automatic analyzer according to the second embodiment of the present invention. Note that the automatic analyzer of the second embodiment of the present invention is configured in the same manner as the first embodiment of the present invention.
[0043]
Here, as in the first embodiment of the present invention, for example, the same kind of reagents contained in two reagent bottles used for a certain inspection item (analysis item) are prepared in advance, and the two Consider the case where a sample is analyzed while changing reagent bottles. Further, in the case where the bottle number is assigned to each of the two reagent bottles and the sample is analyzed, it is assumed that the reagent contained in the reagent bottle of bottle number 1 is used first.
[0044]
Furthermore, the same reagent ID for each reagent bottle, the validity period of the reagent contained in each reagent bottle, and the calibration condition of the reagent in the inspection item, for example, “the number of testable reagents can be 100 tests or less” The conditions are entered from the input unit 50 by the operator, registered, and stored in the storage unit 70 by the control unit 40, and then the reagent is calibrated.
[0045]
First, at the start of sample analysis, a predetermined reagent (here, a reagent contained in a reagent bottle of bottle number 1) is selected (step B1). Next, the calibration condition of the selected reagent stored in the storage unit 70 is checked to determine whether this calibration condition is satisfied, that is, whether another reagent needs to be calibrated ( Step B2).
[0046]
Specifically, the amount of reagent contained in the bottle No. 1 reagent bottle is measured using a liquid level sensor or the like, and based on the measurement result and the amount of reagent necessary for one test (analysis). The testable number of the reagent is calculated, and it is determined whether or not the calculated testable number is 100 tests or less. The calculated testable number of reagents is stored in the storage unit 70.
[0047]
In step B2, if the reagent in the reagent bottle of bottle number 1 does not satisfy the calibration condition (that is, if the calculated testable number of reagents exceeds 100 tests), calibration is performed for another reagent. The sample is analyzed without doing so.
[0048]
On the other hand, in step B2, if the reagent contained in the reagent bottle of bottle number 1 satisfies the calibration condition (that is, if the calculated number of testable reagents is 100 tests or less), the reagent storage unit 20 Whether there is a reagent with the same reagent ID (another reagent of the same type) among the reagents contained in the reagent bottle (except for the reagent contained in the reagent bottle of bottle number 1) (Step A3).
[0049]
Specifically, as shown in FIG. 9, when the amount of reagent (number of testable items) contained in the reagent bottle of bottle number 1 is 40 tests and 100 tests or less, the calibration condition described above is set. Satisfied. Therefore, in this case, it is necessary to calibrate another reagent of the same type as that reagent.
[0050]
In step B3, if there is no reagent having the same reagent ID, the operator is notified that there is no reagent to be calibrated (step B7). Specifically, for example, a message indicating that there is no reagent to be calibrated is displayed on the display unit 60. As a result, the operator prepares another reagent of the same type.
[0051]
On the other hand, if there is a reagent having the same reagent ID in step B3, the same type contained in the reagent bottle stored in the reagent storage unit 20 based on the effective period stored in the storage unit 70 is used. A reagent having a short effective period (here, a reagent contained in the reagent bottle of the bottle number 2) is selected from the reagents (step B4), and the operator is notified that the selected reagent is to be calibrated (step B5). ). Specifically, a message indicating that calibration is performed is displayed on the display unit 60. Thus, the operator is made aware that the reagent calibration is performed.
[0052]
As in the first embodiment of the present invention, for the above-described message for notifying the operator, for example, a voice unit (not shown) is provided in advance and is output from this voice unit. Is also possible.
[0053]
In step B6, the analysis unit 30 is instructed to execute calibration of the reagent selected in step B4. Thereby, in the analysis unit 30, the reagent is calibrated. The calibration result is stored in the storage unit 70 by the control unit 40.
[0054]
In addition, as shown in FIG. 9, when the amount of the reagent contained in the reagent bottle with the bottle number 2 (the number of testable items) is 40 tests, the total testable number is 40 tests + 40 tests = 80 tests, and calibration Will satisfy the following conditions (100 tests or less). However, in the second embodiment of the present invention, the sample analysis is started without performing the reagent calibration again as in the first embodiment of the present invention.
[0055]
Here, a case has been described in which the above-described reagent calibration determination process is performed at the start of sample analysis. However, the determination process is performed in the same manner, for example, every predetermined time during sample analysis.
[0056]
When analyzing the sample, if the reagent being used becomes unusable for some reason, replace the reagent that can no longer be used with a reagent of the same type that has already been calibrated, and replace the replaced reagent. Use to continue analysis of the sample. At that time, the calibration result of the reagent stored in the storage unit 70 is applied. Thereafter, the calibration determination process described above is performed, and calibration is performed only for another one reagent.
[0057]
As described above, since the reagent is calibrated with sufficient time before using the reagent, the operator can check the calibration result. Therefore, if there is a problem with the calibration result, it can be calibrated again to solve the problem, so that it is possible to prevent re-analysis of the sample due to the problem of the calibration result. Throughput can be improved.
[0058]
In addition, since the same reagent ID is assigned to the same type of reagent, the operator can easily recognize the same type of reagent, and the operator needs to instruct which reagent is the same type. Therefore, the burden on the operator can be reduced.
[0059]
In addition, by registering the effective period of the reagent, the reagents are used in order from the reagent having the short effective period, so that it is not necessary to set the order of using the reagents in advance, and the reagents can be used efficiently.
[0060]
In addition, even when the reagent is replaced, the operator does not need to be constantly aware of the calibration status of the reagent, so the burden on the operator can be reduced.
[0061]
Furthermore, if the reagent used during measurement becomes unavailable for any reason, the reagent with the same ID and the result of calibration performed with that reagent can be used immediately. A new reagent is automatically selected without being conscious of re-measurement of calibration due to change, and the burden on the operator can be reduced.
[0062]
【The invention's effect】
As described above, according to the present invention, by calibrating a reagent of the same type as that used for measurement at the start of measurement of a patient sample, the throughput of the entire apparatus can be improved and the burden on the operator can be reduced.
[Brief description of the drawings]
FIG. 1 is a block diagram showing a configuration of an automatic analyzer according to a first embodiment of the present invention.
FIG. 2 is a diagram for explaining a flow of reagent calibration processing in the automatic analyzer according to the first embodiment of the present invention;
FIG. 3 is a flowchart showing a reagent calibration determination process in the control unit of the automatic analyzer according to the first embodiment of the present invention;
FIG. 4 is a diagram showing reagent IDs stored in the storage unit of the automatic analyzer according to the first embodiment of the present invention.
FIG. 5 is a diagram showing a reagent ID and a reagent validity period stored in the storage unit of the automatic analyzer according to the first embodiment of the present invention.
FIG. 6 is a diagram for explaining a reagent calibration determination process in the automatic analyzer according to the first embodiment of the present invention;
FIG. 7 is a diagram for explaining a reagent calibration determination process in the automatic analyzer according to the first embodiment of the present invention;
FIG. 8 is a flowchart showing a reagent calibration determination process in the control unit of the automatic analyzer according to the second embodiment of the present invention;
FIG. 9 is a diagram for explaining a reagent calibration determination process in the automatic analyzer according to the second embodiment of the present invention;
[Explanation of symbols]
10 Sample storage unit 20 Reagent storage unit 30 Analysis unit 40 Control unit 50 Input unit 60 Display unit 70 Storage unit

Claims (1)

It has multiple reagents of the same type used for a certain inspection item, and measures a sample while exchanging these reagents.
Storage means for storing a plurality of reagents;
Recognizing means for recognizing that at least one of the plurality of reagents other than the reagent used for the measurement and the reagent used for the measurement is the same type of reagent;
Registration means for registering as a calibration condition performing calibration when the number of reagents required for one test for each of the plurality of reagents is equal to or less than a predetermined testable number;
The calibration condition of the reagent used for the measurement registered in the registration unit is read, and it is determined whether or not the remaining testable number of the reagent used for the measurement satisfies the registered calibration condition. Judgment means,
When the determination means determines that the remaining testable number of reagents used for the measurement satisfies the calibration condition, at least one same kind other than the reagent used is recognized by the recognition means. Calibration means for calibrating the reagent of
With
The determination means calculates a total remaining testable number of the reagent to be used and the at least one same type of reagent after calibration for the at least one same type of reagent, and calculates the total remaining testable number. Determines whether or not the predetermined testable number is exceeded,
When it is determined that the total remaining testable number does not exceed the predetermined testable number, the calibration unit is not the reagent used and the at least one similar reagent recognized by the recognition unit Calibrate additional reagents of the same type
The determination means calculates a remaining testable number of the sum of the reagent to be used, the at least one same kind of reagent and the further same kind of reagent after the calibration of the further same kind of reagent, Determine whether the testable number exceeds the predetermined testable number,
The calibration unit and the determination unit repeat the calibration and the determination, respectively, until it is determined that the total remaining testable number exceeds the predetermined testable number,
When it is determined that the total remaining testable number exceeds the predetermined testable number, the calibration unit ends the calibration.
An automatic analyzer characterized by that .

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