JP4871761B2 - Biological sample analysis method and automatic analyzer - Google Patents

Description

  The present invention relates to a biological sample analysis method for analyzing components contained in a sample derived from a living body such as blood and urine, and an automatic analyzer, and in particular, a biological sample analysis method for measuring two or more measurement items, And an automatic analyzer.

  Some substances to be measured have a function of diluting a specimen before measurement. This is a case where the concentration range of the component is wide, but in a certain concentration range, a predetermined resolution is required for understanding the pathological condition. For example, like thyroid hormone, the blood concentration range is as wide as 0.005 μU / ml to 50 μU / ml. Among these, in hyperthyroidism, precise measurement is required for concentrations of 0.1 μU / ml or less, but in the range from 0.5 to 50 μU / ml in healthy individuals with hypofunction, Don't be. In such a case, a method of adjusting the detection range by prioritizing high-resolution resolution and diluting the specimen in advance when the concentration is high is used. However, when measuring an unknown sample, if the appropriate dilution conditions are unknown, it is common to measure the sample without diluting it and dilute it again if the result is overranged. . However, in this method, after the first measurement result is obtained, a retest is performed, and therefore, it takes an extra time at least for the reaction time to obtain the final result after the sample is put into the system. In other words, the worst value of the time from sample collection to result report that can be promised with confirmation to a clinician requesting a test must be shown, for example, as an amount of one hour. In order to minimize the time from the visit or the start of diagnosis to diagnosis, the test time becomes a bottleneck. Furthermore, since the reagents used for such items use materials derived from living bodies such as antibodies, and the samples used for calibration and accuracy control are also expensive, the unit price of one measurement itself increases. Therefore, it is extremely important to suppress the number of times of measurement, and for that purpose, it is very important to use an appropriate measurement condition such as a dilution rate in advance using some information. Therefore, conventionally, for example, in a computer system, the past data of the patient is stored, and the previous value of the same patient as the sample to be measured is searched. A method of automatically using the magnification has been devised. Such a method is described in Patent Document 1, for example.

JP-A-6-27117

  In the case of performing an analysis, when the factors that inhibit the analysis are known in advance, and when the analysis inhibiting factor is measured as a second measurement item by another means, the judgment criteria are clear. In this case, it is possible to appropriately select a parameter for performing the first analysis by first measuring the second measurement item and evaluating the result. For example, hyperproteinemia is a symptom in which the protein concentration in the blood increases due to a pathological cause. Generally, in heterogeneous immunoassay, a sample sample and reagents are mixed and stirred, then an immune reaction is performed, and a measurement target is adsorbed on a solid phase or the like. In these cases, in order for the analysis to be performed appropriately, it is expected that the protein concentration is within a predetermined range in the mixed and stirred solution. For example, when the reagent volume is 4 with respect to the sample volume 1, the contribution of the protein concentration contained in the sample volume is 20%. For example, in a reagent system designed to have a protein concentration of about 7 g / dl and a serum level, when a sample with a concentration of 10 g / dl is used, the final protein concentration is conveniently 9 g / dl, 30% The concentration increases to a certain extent, and accurate measurement may be difficult. In such a case, the concentration of the sample solution is generally 2 g / dl by diluting the specimen to about 1/5, for example. In this case, the final concentration is 6 g / dl. In this case, the protein concentration is reduced by about 15%. However, by preparing a protein solution of about 6 g / dl in the diluted solution in advance, the decrease in the protein concentration can be controlled, and the final protein concentration is within +/− 5%. Can be controlled. For this reason, in heterogeneous immunoassay, when serum with a high protein concentration is used as a sample, when measurement is not performed with dilution, the measurement range is exceeded, or abnormality is suspected, the sample is diluted with physiological saline containing protein, etc. The method to do is common. Protein concentration in serum is a very basic measurement item for understanding the general condition, and biochemical analysis using the Burette method is common and is measured as total protein (TP). The In addition, albumin (Alb), which is a major protein for controlling osmotic pressure in blood, is measured by biochemical analysis by the BCG method. The above-mentioned hyperproteinemia is a disease in which globulin other than albumin is secreted in the blood in large quantities due to diseases such as infection and myeloma. Total protein and albumin are measured, and these differences are used in clinical practice as the A / G ratio. Diseases can also be estimated by a method of evaluating the component composition of proteins in serum using the difference in electrophoresis speed of albumin, globulin, etc. by serum electrophoresis. In recent years, in addition to these measurements, homogenous immunoassay (immunoturbidimetric method, latex agglutination method) has been developed as a method for measuring globulin fractions in more detail using immune reactions. Measurement was possible with the same equipment as protein and albumin. Further, heterogeneous immunoassay is used for more detailed and minute measurement.

  For example, in a patient who is in a poor physical condition and has come to the hospital, when these diseases are predicted by a doctor's diagnosis, the above measurement is performed. In recent years, with the widespread use of automatic analyzers, it has become common to perform blood sampling and data output within an hour, and patients receive treatments such as diagnosis and medication based on more detailed data on the day of their visit. Can now. However, in the heterogeneous immunoassay described above, when a reaction time of about 20 minutes is required and a failure such as range over occurs in the measurement, in addition to the judgment of the clinical laboratory technician, pretreatment, etc. Therefore, there is a problem that it takes time to obtain a clinically required result.

  When there are multiple measurement items and the relationship and causal relationship are already known in the measurement results and it is possible to select an appropriate test method based on the existing knowledge, use these knowledge to A processing method can be selected. That is, in measuring the concentration of at least two components contained in a sample, measurement of one concentration component is performed, and the result is evaluated according to an evaluation scale given in advance. Prior to performing a concentration measurement of a component, an analysis method is selected.

  A measurement result can be obtained in the shortest time, and waste of reagents can be eliminated by avoiding useless measurement.

  Embodiments of the present invention will be described below in detail with reference to the drawings.

FIG. 1 schematically shows the configuration of an automatic analysis system according to the first embodiment. The automatic analysis system according to the present embodiment includes two analysis modules 101 and 102, a specimen sample transport mechanism 103, a control unit 104 that controls the whole, an operation unit 105 connected to the control unit, and the control. A display unit 106 connected to the control unit, and a recording medium 107 connected to the control unit. For example, a colorimetric analysis module can be used as the analysis module 101, and a heterogeneous immunoassay module can be used as the analysis module 102, for example.

FIG. 2 shows a screen for registering information about related items displayed on the display unit 106 in this embodiment. This screen selects a part 201 for selecting a registration number of a related item, a part 202 for selecting a measurement item to be monitored, a part 203 for inputting a monitored condition for a monitoring item, and an item to be a process change target. A part 204 for selecting the contents of the process change, a button 206 for registering the contents displayed on this screen in the recording medium 107, and registering the contents displayed on this screen in the recording medium 107. If there is a request only for the item 207 to move to another screen and the item registered as the process change target, and there is no request for the item registered as the monitoring target, the monitoring target item And a portion 208 capable of selecting whether or not to measure automatically.

  In the portion 201 for selecting the registration number of the related item, when one number is selected, the information on the related item corresponding to the number is read from the recording medium 107 and displayed on the screen. Information from 202 to 205 can be input by selecting from a list or by direct input using a keyboard. In addition, it is also possible to input a plurality of pieces of information in portions other than 203. Further, the portion 203 can be a portion that is input in a format that specifies a density range.

  FIG. 3 is a flowchart showing the flow of related item processing in the automatic analysis system according to this embodiment.

First, the user registers information about related items in the recording medium 107 in advance using the operation unit 105 or the like. For example, when registration is performed in the state of FIG. 2, “GPT (glutamic-
“If the measured value of puruvic aminase) is 400 IU / L or more, the information that“ dilutes the specimen sample 100 times in HbsAg (HBs antigen) measurement ”is registered. The content of the change such as the dilution rate can be determined by restrictions in the heterogeneous immunoassay module, a measurable concentration range of the reagent system, and the like.

  When the sample sample is loaded into the transport mechanism 103, first, in step 301, the sample sample is read by means such as reading from the ID assigned to the sample container or the sample transport rack, or manual input by the operation unit 105 from the user. The measurement request item for is registered in the recording medium 107.

  Next, in step 302, the control unit 103 collates the measurement request item with a related item registered in advance. If there is a related item among the measurement request items, the process proceeds to step 303, and if there is no related item, the process proceeds to step 304.

  In addition, when only the items that can change the measurement process are requested among the related items, the measurement items to be monitored may be automatically measured if they are designated in advance. For example, it is useful by the user to reduce retesting when items that can be changed in the measurement process are very expensive.

  In step 303, the request item registered as the monitoring item is measured in one analysis module, and the measurement result is registered in the recording medium 107.

  In step 304, when the process change target item is measured in another analysis module, the measurement is performed in a normal process without changing the process.

  In step 305, the control unit 103 collates the measurement result of the monitoring item with the monitoring condition registered in the recording medium 107 in advance. If the measurement result of the monitoring item satisfies the monitoring condition, the process proceeds to step 306. If the measurement result of the monitoring item does not satisfy the monitoring condition, the process proceeds to step 307.

  Note that another sample or another item may be measured while the monitoring item is being measured. This does not impair the overall processing capability of the analysis system. For example, the monitoring item measurement result may be collated with the monitoring condition registered in the recording medium 107 in advance after the monitoring item result has passed 10 minutes after the start of analysis.

  In step 306, the control unit 103 applies the process change contents registered in advance in the recording medium 107 when measuring the process change target item in another analysis module.

  In step 307, when the process change target item is measured in another analysis module, the measurement is performed in a normal process without changing the process.

FIG. 4 schematically shows the configuration of the automatic analyzer according to the second embodiment. The automatic analyzer according to the present embodiment is connected to the analysis unit 401 having at least two analysis means, the control unit 402 that controls the analysis unit, the operation unit 403 connected to the control unit, and the control unit. A display unit 404 and a recording medium 405 connected to the control unit. Examples of the analysis means possessed by the analysis unit 401 include colorimetric analysis and heterogeneous immunoassay. Even an analysis unit that uses a single detection unit can perform analysis by a plurality of means. For example, a color reaction in the total protein by a reagent system and CRP (C-reactive protein) by latex agglutination method may be used.

  FIG. 5 schematically shows a screen for registering information about related items displayed on the display unit 404 in this embodiment. This screen selects a part 501 for selecting a registration number of a related item, a part 502 for selecting a measurement item to be monitored, a part 503 for inputting a monitoring condition for a monitoring item, and an item to be a process change target. A part 504, a part 505 for selecting the contents of the process change, a button 506 for registering the contents displayed on this screen in the recording medium 406, and not registering the contents displayed on this screen in the recording medium 406 If there is a request only for the item 507 that moves to another screen and the item that is registered as the process change target, and there is no request for the item that is registered as the monitoring target, the monitoring target item is And at least a portion 508 capable of selecting whether or not to measure automatically. In the portion 501 for selecting the registration number of the related item, when one number is selected, information on the related item corresponding to the number is read from the recording medium 405 and displayed on the screen.

  Information from 502 to 505 can be input by selection from a list or direct input using a keyboard. In addition, it is also possible to input a plurality of pieces of information in portions other than 503. Further, the portion 503 may be a portion that is input in a format that specifies a density range.

  FIG. 6 is a flowchart showing the flow of related item processing in the automatic analyzer according to this embodiment.

First, the user registers information about related items in the recording medium 406 in advance using the operation unit 403 or the like. For example, when registration is performed in the state of FIG. 5, information is registered that “when the measurement result of TP is 10 g / dl or more, the specimen sample is diluted 20 times in IgM (immunoglobulin) measurement”.

  When the sample sample is input to the analysis unit 401, first, in step 601, the sample sample is read by means such as reading from the ID assigned to the sample container or the sample transport rack, or manual input from the user by the operation unit 403. The measurement request item for is registered in the recording medium 405.

  Next, in step 602, the control unit 403 collates the measurement request item with a related item registered in advance. If there is a related item among the measurement request items, the process proceeds to step 603, and if there is no related item, the process proceeds to step 604.

  In addition, when only the items that can change the measurement process are requested among the related items, the measurement items to be monitored may be automatically measured if they are designated in advance. For example, it is useful by the user to reduce retesting when items that can be changed in the measurement process are very expensive.

  In step 603, the request item registered as the monitoring item is measured in one analysis means, and the measurement result is registered in the recording medium 405.

  In step 604, when the process change target item is measured by another analysis means, the measurement is performed in a normal process without changing the process.

  In step 605, the control unit 403 collates the measurement result of the monitoring item with the monitoring condition registered in the recording medium 405 in advance. If the measurement result of the monitoring item satisfies the monitoring condition, the process proceeds to step 606. If the measurement result of the monitoring item does not satisfy the monitoring condition, the process proceeds to step 607.

  Note that another sample or another item may be measured while the monitoring item is being measured. This does not impair the overall processing capability of the analysis system. For example, the monitoring item measurement result may be collated with the monitoring condition registered in the recording medium 107 in advance after the monitoring item result has passed 10 minutes after the start of analysis.

  In step 606, the control unit 403 applies the process change content registered in advance in the recording medium 405 when measuring the process change target item in another analysis unit.

  In step 607, when the process change target item is measured by another analysis means, the measurement is performed in a normal process without changing the process.

  FIG. 7 schematically shows the configuration of an information system according to the third embodiment. The information analysis system according to this embodiment includes at least two analysis devices 701 and 702, an information system control unit 703 that controls them, an operation unit 704 connected to the control unit, and a control unit connected to the control unit. A display unit 705 and a recording medium 706 connected to the control unit are provided. As the analyzers 701 and 702, for example, an electrophoretic analyzer and a heterogeneous immune analyzer, a combination of a blood cell analyzer and a biochemical analyzer, or the like can be considered.

  FIG. 8 schematically shows a screen for registering information about related items displayed on the display unit 705 in the present embodiment. This screen selects a part 801 for selecting a registration number of a related item, a part 802 for selecting a measurement item to be monitored, a part 803 for inputting a monitoring condition for the monitoring item, and an item to be a process change target. A part 804, a part 805 for selecting the contents of the process change, a button 806 for registering the contents displayed on this screen in the recording medium 706, and the contents displayed on this screen are not registered in the recording medium 706. If there is a request only for the item 807 that moves to another screen and the item that is registered as the process change target, and there is no request for the item that is registered as the monitoring target, the monitoring target item is And at least a portion 808 capable of selecting whether or not to measure automatically. In the portion 801 for selecting the registration number of the related item, when one number is selected, information on the related item corresponding to the number is read from the recording medium 706 and displayed on the screen.

  Information can be input to the portions 802 to 805 by selection from a list or direct input using a keyboard. In addition, it is also possible to input a plurality of pieces of information in portions other than 803. Further, the portion 803 may be a portion that is input in a format that specifies a density range.

  FIG. 3 is a flowchart showing the flow of related item processing in the information system according to this embodiment.

  First, the user registers information about related items in the recording medium 706 in advance using the operation unit 704 or the like. For example, when registration is performed in the state of FIG. 8, information is registered that “if the white blood cell count is 11000 / μl or more, the specimen sample is diluted five times in the CRP measurement”.

  When the sample sample is put into one analyzer 701, first, in step 901, by reading from the ID given to the sample container or the sample transport rack, or by manual input from the user via the operation unit 704, etc. Measurement request items for the specimen are registered in the recording medium 706.

  Next, in step 902, the control unit 703 collates the measurement request item with a related item registered in advance. If there is a related item among the measurement request items, the process proceeds to step 903, and if there is no related item, the process proceeds to step 904.

  In addition, when only the items that can change the measurement process are requested among the related items, the measurement items to be monitored may be automatically measured if they are designated in advance. For example, it is useful by the user to reduce retesting when items that can be changed in the measurement process are very expensive.

  In step 903, the request item registered as the monitoring item is measured in one analyzer, and the measurement result is registered in the recording medium 706.

  In step 904, when the process change target item is measured in another analyzer, the measurement is performed in a normal process without changing the process.

  In step 905, the control unit 703 collates the measurement result of the monitoring item with the monitoring condition registered in advance in the recording medium 706. If the measurement result of the monitoring item satisfies the monitoring condition, the process proceeds to step 906. If the measurement result of the monitoring item does not satisfy the monitoring condition, the process proceeds to step 907.

  Note that another sample or another item may be measured while the monitoring item is being measured. This does not impair the overall processing capability of the analysis system. For example, the monitoring item measurement result may be collated with the monitoring condition registered in the recording medium 107 in advance after the monitoring item result has passed 10 minutes after the start of analysis.

  In step 906, the control unit 703 applies the process change content registered in advance in the recording medium 706 when measuring the process change target item in another analysis apparatus.

  In step 907, when the process change target item is measured in another analyzer, the measurement is performed in a normal process without changing the process.

FIG. 1 is a diagram schematically illustrating a configuration of an automatic analysis system according to a first embodiment. The figure explaining the screen which registers the information with respect to the related item displayed on the display part of the automatic analysis system by Example 1. FIG. The figure explaining the flow of the process with respect to a related item in the automatic analysis system by Example 1 with the flowchart. FIG. 5 is a diagram schematically illustrating a configuration of an automatic analyzer according to a second embodiment. The figure explaining the screen which registers the information with respect to a related item displayed on the display part of the automatic analyzer by Example 2. FIG. The figure explaining the flow of the process with respect to a related item in the automatic analyzer by Example 2 with the flowchart. FIG. 6 is a diagram schematically illustrating a configuration of an information system according to a third embodiment. The figure explaining the screen which registers the information with respect to the related item displayed on the display part of the information system by Example 3. FIG. The figure explaining the flow of the process with respect to a related item in the information system by Example 3 with the flowchart.

Explanation of symbols

101, 102 Analysis module 103 Sample specimen transport mechanism 104, 402, 703 Control unit 105, 403, 704 Operation unit 106, 404, 705 Display unit 107, 405, 706 Recording medium 201, 501, 801 Registration number selection unit 202, 502, 802 Monitoring target item selection unit 203, 503, 803 Monitored condition selection unit 204, 504, 804 Change target item selection unit 205, 505, 805 Change content selection unit 206, 506, 806 Registration buttons 207, 507, 807 Buttons 208, 508, 808 Automatic measurement function selection unit 401 Analysis unit 701, 702 Analysis device

Claims (7)

In an automatic analyzer that executes multiple measurement items with different components in a sample as the measurement target,
Among the plurality of measurement items, a specific measurement item and a measurement item whose measurement target is a component different from the specific measurement item, the possibility of re-examination based on the measurement result of the specific measurement item Registration means for registering other measurement items capable of determining the presence or absence as related items;
An automatic analyzer comprising: determination means for determining whether or not the related item is included in a requested measurement item requested for a sample sample put in the automatic analyzer. The automatic analyzer according to claim 1, wherein
With at least two analytical tools,
The analysis means is
When it is determined by the determination means that the related measurement item is included in the requested measurement item, a first analysis means for analyzing a predetermined specific measurement item among the related items;
A second analysis means for analyzing a related item other than the specific measurement item,
A control unit that performs measurement by changing the measurement process of the measurement item measured by the second analysis means when the measurement result obtained by the first analysis means is outside a predetermined range; An automatic analyzer characterized by comprising. The automatic analyzer according to claim 1 , wherein
At least two analysis modules;
A transfer means for transferring a specimen sample between the analysis modules,
The analysis module includes:
When it is determined by the determination means that the related measurement item is included in the requested measurement item, a first analysis module that analyzes a predetermined specific measurement item among the related items;
A second analysis module for analyzing related items other than the specific measurement item,
A controller that performs measurement by changing a measurement process of a measurement item measured by the second analysis module when the measurement result obtained by the first analysis module is outside a predetermined range; An automatic analyzer characterized by comprising. In the automatic analyzer in any one of Claims 1-3 ,
A screen including at least one of means for registering monitoring items and process change items as related items, means for setting monitoring conditions for the monitoring items, and means for registering process change contents of process change items is displayed. An automatic analyzer characterized by comprising display means. In a sample sample analysis method using an automatic analyzer having a plurality of analysis means,
A first step of registering, as related items, a plurality of measurement items that measure different components and related to the measurement results;
A second step of collating the measurement request item for the sample with the related item registered in the step;
If a related item is included in the measurement request item as a result of the verification in the second step, a predetermined specific measurement item among the related items is measured by one of the plurality of analysis means. The third step,
When the measurement result obtained by the third step does not satisfy the check condition, the measurement process of the related item other than the specific measurement item is measured by the analysis means other than the measurement performed in the third step. The fourth step to change,
An analysis method characterized by comprising: The biological sample analysis method according to claim 5, wherein
The analysis method characterized in that the plurality of analysis items registered as the related items are any one of GPT and HBsAg, TP and IgM, white blood cell count and CRP. A biological sample analysis method according to claim 5 or 6,
The related item is analyzed by a different analyzer, and the analysis result is communicated via a communication line.

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