JP5276470B2 - Analysis apparatus and analysis method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an analyzer capable of acquiring an analysis result with high accuracy and reliability, and to provide an analysis method of the analyzer. <P>SOLUTION: The analyzer 1 includes a storage 104 for storing a calibration curve for each predetermined environmental temperature area with an environmental temperature when the calibration curve is created; a temperature sensor 12 for measuring an environmental temperature at which the analyzer 1 is installed; a determination section 108 for determining that an environmental temperature area among predetermined environmental temperature areas corresponds to the environmental temperature and the presence of a calibration curve effective in the environmental temperature area where the environmental temperature resides; a controller 101 for controlling the practice of analysis by a measurement mechanism 9, when the determination section 108 determines that a valid calibration curve is present, and an analysis section 103 for calibrating and calculating the analysis result, based on the calibration curve with respect to photometry data measured by the measurement mechanism 9. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

Description

  The present invention relates to an analysis apparatus and an analysis method for performing a calibration process for creating a calibration curve based on a measurement result for a calibrator showing a known result to maintain analysis accuracy.

  The analyzer can perform analysis processing on a large number of specimens at the same time, and can analyze multiple components quickly and with high accuracy, so it is used for tests in various fields such as immunological tests, biochemical tests, and blood transfusion tests. ing. In order to obtain highly accurate analysis results in such an analysis, it is very important to control the analysis conditions, particularly the reaction temperature. Even if the reaction temperature is changed by various methods, Calibration methods and the like for obtaining accurate analysis results have been proposed.

  As a reaction temperature control method, an analyzer that controls the supply of a reagent while heating the reagent used for the analysis and corrects the analysis result based on the difference between the supplied reagent temperature and the optimum temperature is known ( Patent Document 1).

  On the other hand, an immunoanalyzer that measures the temperature of a reagent or cleaning solution used for analysis and corrects the analysis result based on the temperature difference between the reaction temperature and the temperature to obtain the analysis result (see Patent Document 2), near infrared In infrared spectroscopic analysis, a spectrum is measured at the same sample at different temperatures, a difference spectrum of the spectrum is obtained, and a difference spectrum obtained by multiplying a coefficient corresponding to a temperature change of the measured spectrum is added to or subtracted from the measured spectrum for calibration. Is disclosed (see Patent Document 3).

JP 2004-37161 A JP 2001-74749 A JP-A-2005-331386

  However, the analyzer described in Patent Document 1 not only costs for installing the heating means, but also requires a large apparatus.

  Moreover, the analyzer described in Patent Document 2 can correct the analysis result based on the temperature difference between the temperature of the reagent or the like and the reaction vessel temperature. However, if the temperature difference is large, the analysis accuracy can be improved by the correction. There is a limit.

  Even in the calibration method described in Patent Document 3, when the temperature difference between the reference temperature and the measured temperature is large, the accuracy of correction becomes a problem.

  The present invention has been made in view of the above, and holds, for each analysis item, a plurality of calibration curves corresponding to a predetermined environmental temperature area, and uses the appropriate calibration curve to calculate the analytical result. Accordingly, an object of the present invention is to provide an analysis apparatus and an analysis method capable of obtaining an analysis result with high accuracy and reliability.

  In order to solve the above-described problems and achieve the object, an analyzer according to the present invention is a analyzer that photometrically analyzes a reaction product between a sample and a reagent and calculates an analytical result from photometric data based on a calibration curve. Storage means for storing a calibration curve for each predetermined environmental temperature area; temperature measuring means for measuring the environmental temperature in which the analyzer is installed; and whether the environmental temperature corresponds to the predetermined environmental temperature area, And determining means for determining whether or not an effective calibration curve exists in the environmental temperature area to which the environmental temperature belongs, and analysis is performed by the measuring means when the determining means determines that an effective calibration curve exists. And control means for calibrating the analysis result based on the calibration curve for the photometric data measured by the measuring means. .

  In the analysis apparatus according to the present invention, in the above invention, the temperature measuring unit also measures an environmental temperature after the analysis is completed, calculates a temperature difference before and after the analysis, and determines whether the temperature difference is within a predetermined range. And a temperature determination unit, and an output unit that outputs the flagged data when the temperature difference is outside a predetermined range.

  In the analysis device according to the present invention, in the above invention, the control unit determines that the environmental temperature is a predetermined environment when the determination unit determines that the environmental temperature does not correspond to any of the predetermined environmental temperature areas. Control is performed so that the analysis is stopped until one of the temperature areas is met.

  Moreover, the analysis apparatus according to the present invention is characterized in that, in the above invention, the environmental temperature area section is different depending on the analysis item to be measured.

  In the analyzer according to the present invention, in the above invention, the control unit controls the calibration unit to perform a calibration process when the determination unit determines that there is no effective calibration curve. The measurement result is calibrated on the basis of the calibration curve prepared in (1).

  In the analysis device according to the present invention, in the above invention, when the output unit determines that there is no effective calibration curve by the determination unit, the analysis unit notifies the user and the user performs a new calibration. In the case where the process is not selected, there is provided correction means for calibrating the analysis result with a calibration curve of the adjacent environmental temperature area and correcting the analysis result based on a correction coefficient set for each environmental temperature area.

  In addition, the analysis method according to the present invention is a first temperature for measuring an environmental temperature at which an analysis is performed in an analysis method in which a reaction product of a sample and a reagent is photometrically analyzed and an analysis result is calibrated from photometric data based on a calibration curve. A calibration curve that is effective in the measurement step, the environmental temperature measured in the first temperature measurement step corresponds to a predetermined environmental temperature area stored in the storage means, and the environmental temperature area to which the environmental temperature belongs A determination step for determining whether there is a calibration curve, a measurement step for performing analysis when it is determined by the determination step that an effective calibration curve exists, and a photometric data measured by the measurement step for the calibration curve. And a calibration step for calculating a calibration result based on the analysis result.

  Moreover, the analysis apparatus according to the present invention is the above-described invention, wherein the environmental temperature measured in the second temperature measurement step, the first temperature measurement step, and the second temperature measurement step is again measured after the analysis step. A temperature determination step for calculating a difference and determining whether or not the environmental temperature difference is within a predetermined range; and a first output step for outputting the flagged data when the environmental temperature difference is outside the predetermined range. It is characterized by.

  In the analysis apparatus according to the present invention, in the above invention, when it is determined in the determination step that the environmental temperature does not correspond to any of the predetermined environmental temperature areas, the environmental temperature is any of the predetermined environmental temperature areas. And an environmental temperature adjusting step for adjusting the environmental temperature until the above condition is satisfied.

  Moreover, the analysis apparatus according to the present invention is characterized in that, in the above-mentioned invention, the environmental temperature area section is different depending on an analysis item.

  In the above invention, the analyzer according to the present invention is created by the calibration process step for performing a calibration process when the determination step determines that there is no effective calibration curve, and the calibration process step. Storage means for storing the calibration curve for each environmental temperature area, wherein the calibration step calibrates the measurement result based on the newly created calibration curve.

  In the analysis apparatus according to the present invention, in the above invention, when it is determined that there is no effective calibration curve in the determination step, a second output step that outputs the fact to the user, and the user performs a new calibration. A correction step of detecting an analysis result with a calibration curve in an adjacent environmental temperature area when the process is not selected, and correcting the analysis result based on a correction coefficient set for each environmental temperature area.

  According to the present invention, it is possible to interrupt the analysis at an environmental temperature outside the setting range that hinders high-precision analysis, and to calculate the analysis result based on a calibration curve that is closer to the environmental temperature at the time of analysis. High analytical results can be obtained.

  Hereinafter, an analysis apparatus according to an embodiment of the present invention will be described with reference to the drawings, taking a biochemical analysis apparatus as an example. Note that the present invention is not limited to the embodiments. In the description of the drawings, the same parts are denoted by the same reference numerals.

(Embodiment 1)
First, the first embodiment will be described. In the first embodiment, a case will be described in which the presence or absence of an effective calibration curve corresponding to the environmental temperature is confirmed, and a calibration process is newly executed when there is no effective calibration curve.

  FIG. 1 is a schematic configuration diagram illustrating an analyzer 1 according to a first embodiment of the present invention. As shown in FIG. 1, the analyzer 1 controls a measurement mechanism 9 that measures light passing through a reaction product between a specimen and a reagent, and the entire analyzer 1 including the measurement mechanism 9, and also measures the measurement mechanism. 9 and a control mechanism 10 for analyzing the measurement result in FIG. The automatic analyzer 1 automatically performs analysis of a plurality of samples by cooperation of these two mechanisms.

  The measurement mechanism 9 roughly includes a sample table 2, a reaction table 3, a reagent table 4, a sample dispensing device 5, a reagent dispensing device 7, and dispensing probe cleaning devices 6 and 8.

  The sample table 2 includes a disk-shaped table, and includes a plurality of storage units 21 that are arranged at equal intervals along the circumferential direction of the table. In each storage unit 21, a sample container 22 containing a sample is detachably stored. The sample container 22 has an opening 22a that opens upward. The sample table 2 is rotated in a direction indicated by an arrow in FIG. 1 by a sample table driving unit (not shown) with a vertical line passing through the center of the sample table 2 as a rotation axis. When the sample table 2 rotates, the sample container 22 is transported to the sample aspirating position where the sample is aspirated by the sample dispensing mechanism 5.

  The sample container 22 is attached with an identification label (not shown) having sample information relating to the type of sample contained and analysis items. On the other hand, the sample table 2 includes a reading unit 23 that reads information on the identification label of the sample container 22.

  The reaction table 3 includes an annular table, and includes a plurality of storage portions 31 that are arranged at equal intervals along the circumferential direction of the table. In each storage unit 31, a transparent reaction container 32 for storing a sample and a reagent is detachably stored in a form opening upward. The reaction table 3 is rotated in a direction indicated by an arrow in FIG. 1 by a reaction table driving unit (not shown) with a vertical line passing through the center of the reaction table 3 as a rotation axis. When the reaction table 3 rotates, the reaction container 32 is transported to the sample discharge position where the sample is discharged by the sample dispensing mechanism 5 or the reagent discharge position where the reagent is discharged by the reagent dispensing mechanism 7.

  The reagent table 4 includes a disk-shaped table, and includes a plurality of storage portions 41 arranged at equal intervals along the circumferential direction of the table. In each storage unit 41, a reagent container 42 storing a reagent is detachably stored. The reagent container 42 has an opening 42a that opens upward. The reagent table 4 is rotated in a direction indicated by an arrow in FIG. 1 by a reagent table driving unit (not shown) with a vertical line passing through the center of the reagent table 4 as a rotation axis. When the reagent table 4 rotates, the reagent container 42 is transported to the reagent suction position where the reagent is sucked by the reagent dispensing mechanism 7. Note that an identification label (not shown) having reagent information such as the type of reagent contained, reagent ID, and expiration date is affixed to the reagent container 42, and the sample table 2 has an identification label for the sample container 22. A reading unit 43 for reading the information is provided.

  The reagent container 42 is affixed with an information code (not shown) such as a barcode for recording reagent information (reagent ID) relating to the type and amount of reagent contained. On the other hand, the reagent table 4 includes a reading unit 43 that reads the information code of the reagent container 42.

  The sample dispensing device 5 has a dispensing probe (not shown) for aspirating and discharging the sample attached to the distal end, and the vertical axis passing through the vertical end of the sample dispensing apparatus 5 and the base end thereof is the central axis. An arm that freely rotates is provided. The sample dispensing mechanism 5 is provided between the sample table 2 and the reaction table 3, sucks the sample in the sample container 22 transported to a predetermined position by the sample table 2 with a dispensing probe, rotates the arm, The sample is dispensed into the reaction container 32 conveyed to a predetermined position by the reaction table 3, and the sample is transferred into the reaction container 32 on the reaction table 3 at a predetermined timing.

  The reagent dispensing device 7 has a dispensing probe (not shown) for aspirating and discharging the reagent attached to the distal end portion, and the vertical axis passing through the vertical end and the base end portion of the reagent dispensing device 7 is the central axis. An arm that freely rotates is provided. The reagent dispensing mechanism 7 is provided between the reagent table 4 and the reaction table 3. The reagent in the reagent container 42 transported to a predetermined position by the reagent table 4 is sucked by the dispensing probe, the arm is swung, The reagent is dispensed into the reaction container 32 transported to a predetermined position by the reaction table 3, and the reagent is transferred into the reaction container 32 on the reaction table 3 at a predetermined timing.

  The dispensing probe cleaning device 6 is provided between the sample table 2 and the reaction table 3 and in the middle of the trajectory of the horizontal movement of the dispensing probe in the sample dispensing device 5. These are provided between the reagent table 4 and the reaction table 3 and in the middle of the trajectory of the horizontal movement of the dispensing probe in the reagent dispensing device 7.

  The photometric device 33 includes a light source 33a and a light receiving unit 33b. The light source 33a emits analysis light having a predetermined wavelength. The light receiving unit 33b measures the light beam emitted from the light source 33a and transmitted through the reaction solution in which the sample and the reagent contained in the reaction container 32 have reacted. In the photometric device 33, the light source 33a and the light receiving portion 33b are arranged at positions where they oppose each other in the radial direction with the storage portion 31 of the reaction table 3 interposed therebetween. The reaction table 3 includes a cleaning mechanism 34 that discharges the measured reaction solution from the reaction container 32 and cleans the reaction container 32. The cleaning mechanism 34 sucks and discharges the liquid sample in the reaction vessel 32 using a suction nozzle and a discharge nozzle (not shown), and repeatedly injects and sucks a cleaning liquid such as a detergent or cleaning water, thereby completing the analysis. The reaction vessel 32 is washed.

  The analyzer 1 further includes a temperature sensor 12 that measures the environmental temperature outside the analyzer, outside the housing 11 of the analyzer 1. Since the temperature sensor 12 is intended to measure the environmental temperature outside the analyzer, it is assumed that it is installed at a position that is not easily affected by temperature-generating parts such as motors and heaters inside the apparatus.

  Next, the control mechanism 10 will be described. As shown in FIG. 1, the control mechanism 10 includes a control unit 101, an input unit 102, an analysis unit 103, a storage unit 104, an output unit 105, a transmission / reception unit 107, and a determination unit 108. Each unit included in the control mechanism 10 is electrically connected to the control unit 101. The analysis unit 103 is connected to the photometry device 33 via the control unit 101, calculates an analysis result such as a component concentration of the sample based on the amount of light received by the light receiving unit 33 b, and outputs the analysis result to the control unit 101. The analysis result is calibrated based on a calibration curve stored in the storage unit 104 described later. The analysis unit 104 plays a role as a calibration means. The input unit 102 is a part that performs an operation of inputting an inspection item or the like to the control unit 101. For example, a keyboard or a mouse is used.

  The storage unit 104 is configured by using a hard disk that magnetically stores information and a memory that loads various programs related to the process from the hard disk and electrically stores them when the automatic analyzer 1 executes the process. Various information including the analysis result of the specimen is stored. The storage unit 104 stores a calibration curve for each environmental temperature area together with the environmental temperature at the time of creating the calibration curve. The storage unit 104 may include an auxiliary storage device that can read information stored in a storage medium such as a CD-ROM, a DVD-ROM, or a PC card.

  The output unit 105 is configured using a printer, a speaker, and the like, and outputs various information related to analysis under the control of the control unit 101. The output unit 105 includes a display unit 106 configured using a display or the like. The display unit 106 displays analysis contents, alarms, and the like, and a display panel or the like is used. The input unit 102 and the display unit 106 may be realized by a touch panel. The transmission / reception unit 107 has a function as an interface for performing transmission / reception of information according to a predetermined format via a communication network (not shown). The transmission / reception unit 107 receives analysis item information of a sample to be analyzed from a host computer (not shown).

  The determination unit 108 is connected to the temperature sensor 12 via the control unit 101, and the environmental temperature output from the temperature sensor 12 corresponds to any of the environmental temperature areas, and the calibration curve within the expiration date in the corresponding environmental temperature area. It is determined whether or not exists. The determination unit 108 also includes a temperature determination unit 109. The temperature determination unit 109 determines whether the environmental temperature before analysis is within the set range, calculates the environmental temperature difference before and after the analysis, and the environmental temperature difference is It is also determined whether the temperature is within a predetermined temperature range. When the temperature determination unit 109 determines that the environmental temperature difference before and after the analysis is outside the predetermined temperature range, the temperature determination unit 109 outputs the fact to the control unit 101, and the output unit 105 outputs the analysis result with the flag under the control of the control unit 101. To do.

  The control unit 101 is connected to the above-described units of the measurement mechanism 9 and the temperature sensor 12 installed outside the casing of the analyzer 1, and the control mechanism 10 stores various programs related to each process of the automatic analyzer 1. The operation process of each part of the measurement mechanism 9 is controlled by using it.

  In the analyzer 1 configured as described above, the reagent dispensing device 7 dispenses the reagent from the reagent container 42 into the plurality of reaction containers 32 conveyed along the circumferential direction by the rotating reaction table 3, The reaction container 32 into which the reagent has been dispensed is transported along the circumferential direction by the reaction table 3, and the specimen is dispensed from the specimen container 22 held on the specimen table 2 by the specimen dispensing apparatus 5. Thereafter, the amount of light transmitted through the reaction solution is measured by the photometric device 33, and the analysis unit 103 calculates the analysis result using the calibration curve.

  Next, a processing procedure of analysis processing by the analyzer 1 will be described. FIG. 2 is a flowchart showing a processing procedure of analysis processing by the analysis apparatus 1. First, the transmission / reception unit extracts analysis item information for a sample to be analyzed based on sample information such as a sample ID read by the reading unit 23 (step S100). Thereafter, the ambient temperature (front) outside the analyzer is measured by the temperature sensor 12 (step S101). The environmental temperature data is transmitted to the temperature determination unit 109 via the control unit 101, and the temperature determination unit 109 determines whether or not the measured environmental temperature is within a predetermined temperature range (15 ° C. to 30 ° C.) suitable for analysis. (Step S102). The environmental temperature range that can be analyzed is determined in advance and can also be set by the user. If the environmental temperature is outside the predetermined temperature range (step S102: No), the analysis is interrupted until the environmental temperature falls within the predetermined range, and the environmental temperature is adjusted (step S103). Since the internal temperature and the reaction temperature are greatly affected by the environmental temperature in which the analyzer 1 is installed, the environmental temperature is adjusted so that the environmental temperature falls within a predetermined temperature range.

  When the temperature determination unit 109 determines that the environmental temperature is within a predetermined temperature range suitable for analysis (step S102: Yes), the determination unit 108 stores a calibration curve in the environmental temperature area to which the measured environmental temperature belongs. (Step S104), and if there is a calibration curve (step S104: Yes), it is confirmed whether the calibration curve is valid, that is, whether the calibration curve creation date and time is within the expiration date. (Step S105). A predetermined temperature range to be analyzed is set and stored in the storage unit 104, and the temperature range is usually divided into environmental temperature areas every 5 ° C. In addition, a calibration curve created at the environmental temperature in the environmental temperature area is stored for each environmental temperature area. FIG. 3 is a diagram illustrating a storage state of a calibration curve for each analysis item (reagent used for analysis of the analysis item).

  For example, when the analysis of the analysis item A is first ordered for the specimen and the environmental temperature is measured to be 21 ° C. in step S101, the environmental temperature 21 ° C. is determined by the temperature determination unit 109 in a predetermined temperature range (15 ° C. to 30 ° C. (Step S102: Yes). Thereafter, the determination unit 108 confirms whether an effective calibration curve is stored in the environmental temperature area 20 ° C. to 25 ° C. to which the environmental temperature 21 ° C. belongs (step S104). As shown in FIG. 3, a calibration curve is stored in the environmental temperature area 20 ° C. to 25 ° C. of the analysis item A (step S104: Yes), whereas the creation date is January 10, 2009, If the analysis date is, for example, January 26, 2009, and the expiration date of the analytical curve for analysis item A is two weeks, the determination unit 108 determines that it is not within the expiration date (step S105: No). . Since the expiration date of the calibration curve is different for each analysis item (reagent used for analysis of the analysis item), the expiration date of the calibration curve is determined for each analysis item. The expiration date of the calibration curve (reagent) is stored in the identification label affixed to the reagent container 42 and read by the reading unit 43. Thereafter, when analysis is ordered for analysis item B and the determination is made in the same manner, if the environmental temperature remains at 21 ° C., the temperature determination unit 109 determines that the temperature is within a predetermined temperature range (15 ° C. to 30 ° C.) ( (Step S102: Yes), the determination unit 108 determines that there is no calibration curve in the range of the environmental temperature area 20 ° C. to 25 ° C. (Step S104: No). In the first embodiment, the calibration process is performed at an environmental temperature that is closer to the environmental temperature at which the analysis is performed, and the analysis result is calculated based on the created calibration curve, thereby obtaining a more accurate analysis result. .

  When the determination unit 108 determines that a calibration curve is not stored in the environmental temperature area to which the measured environmental temperature belongs (step S104: No), the control unit 101 controls to perform the calibration process (step S104). S106). The calibration curve created by the calibration process is stored in the storage unit 104 in association with the environmental temperature area together with the environmental temperature and date information for which the calibration process has been performed (step S107). Moreover, although the calibration curve is preserve | saved in the environmental temperature area to which the measured environmental temperature belongs by the determination part 108 (step S104: Yes), the preserved calibration curve is not effective (step S105: No). Also when it determines, the control part 101 performs a calibration process (step S106), and controls the memory | storage part 104 to newly preserve | save corresponding to an environmental temperature area (step S107). Reagents used in the calibration process are kept refrigerated to prevent denaturation, but there may be some change in reactivity over time. Therefore, in order to obtain a highly reliable analysis result, even if a calibration curve exists in the environmental temperature area, the calibration curve should not be used if the expiration date has passed. A calibration process is performed.

  When the determination unit 108 stores a calibration curve in the environmental temperature area to which the measured environmental temperature belongs (step S104: Yes), and determines that the stored calibration curve is valid (step S105: Yes). Alternatively, when calibration processing is newly performed and a calibration curve is newly stored (steps S106 and S107), the control unit 101 controls to start analysis (step S108). After the analysis is completed, the analysis unit 103 calibrates and calculates the analysis result based on an effective calibration curve in the environmental temperature area (step S109), and the temperature temperature after the analysis is measured by the temperature sensor 12 (step S110). . The temperature determination unit 109 calculates the environmental temperature difference before and after the analysis, and determines whether the environmental temperature difference is within a predetermined temperature range, for example, within 2 ° C. (step S111). Even if the environmental temperature at the start of analysis is within the specified temperature range and the analysis result is calculated using the calibration curve of the environmental temperature area to which the environmental temperature at the time of analysis belongs, the environmental temperature may change during the analysis. The reliability of analysis results calculated due to temperature changes may be low. Therefore, when the environmental temperature difference before and after the analysis is not within the predetermined temperature range (step S111: No), the user can be alerted by attaching the flag to that effect and outputting the analysis result (step S113). It becomes possible. When the environmental temperature difference before and after the analysis is within the predetermined temperature range (step S111: Yes), the analysis result is output as it is (step S112). Thereafter, it is confirmed whether or not the analysis of all analysis items for the sample has been completed (step S114). If the analysis has not been completed (step S114: No), the process is repeated from step S101.

  Note that the reagents used for each analysis item have different effects from the environmental temperature depending on the type. Therefore, as a modification of the first embodiment, many analytical curves can be stored for an analysis item that uses a reagent that has a large influence from changes in environmental temperature by setting the environmental temperature area at every 3 ° C. instead of every 5 ° C. You may do it. Preserving a large number of calibration curves is preferable because the influence on the analysis result due to temperature change can be further reduced. When the environmental temperature areas differ depending on the analysis item, for example, as shown in FIGS. 4 and 5, the storage state of the calibration curve may be held for each analysis item in the same environmental temperature area. FIG. 4 is a diagram showing the storage status of the analytical curve for the analysis item every 5 ° C. in the environmental temperature area, and FIG. 5 is a diagram showing the storage status of the calibration curve for the analytical item every 3 ° C. in the environmental temperature area. is there.

(Embodiment 2)
In the first embodiment, the determination unit 108 determines whether there is a valid calibration curve that is valid, and if there is no valid calibration curve, the calibration process is executed to obtain a more reliable analysis result. Although the object is to be described, the second embodiment allows the calibration process to be performed by allowing the user to determine whether or not the calibration process can be performed for an analysis item that does not require much analysis accuracy or an analysis item that is not easily affected by temperature. Such time and cost can be reduced. Even if there is no appropriate calibration curve, if there is a calibration curve at the adjacent temperature, the analysis result can be calculated with the calibration curve, and the analysis result can be obtained more quickly by correcting the temperature. .

  FIG. 6 is a schematic configuration diagram of an analyzer 1A according to the second embodiment. As shown in FIG. 6, the analysis apparatus 1 </ b> A is different from the analysis apparatus 1 according to the first embodiment in that the analysis unit 103 </ b> A includes a correction unit 110. When there is no effective calibration curve in the analyzed environmental temperature area, the correction unit 110 calibrates the analysis result with the calibration curve in the adjacent environmental temperature area, and the environmental temperature at the time of creating the calibration curve and the A temperature difference from the environmental temperature is calculated, and the analysis result is corrected based on the environmental temperature difference.

  Next, a processing procedure of analysis processing by the analysis apparatus 1A will be described. FIG. 7 is a flowchart showing a processing procedure of analysis processing by the analysis apparatus 1. First, the transmission / reception unit extracts an analysis condition including an analysis item and an expiration date of a calibration curve based on sample information such as a sample ID read by the reading unit 23 for a sample to be analyzed (step S200). Thereafter, the ambient temperature (front) outside the analyzer is measured by the temperature sensor 12 (step S201). The environmental temperature data is transmitted to the temperature determination unit 109 via the control unit 101, and the temperature determination unit 109 determines whether or not the measured environmental temperature is within a predetermined temperature range (15 ° C. to 30 ° C.) suitable for analysis. (Step S202). The environmental temperature range that can be analyzed is determined in advance and can also be set by the user. If the environmental temperature is outside the predetermined temperature range (step S202: No), the analysis is interrupted until the environmental temperature falls within the predetermined range, and the environmental temperature is adjusted (step S203). Since the internal temperature and the reaction temperature are greatly affected by the environmental temperature in which the analyzer 1 is installed, the environmental temperature is adjusted so that the environmental temperature falls within a predetermined temperature range.

  When the temperature determination unit 109 determines that the environmental temperature is within a predetermined temperature range suitable for analysis (step S202: Yes), the determination unit 108 stores a calibration curve in the environmental temperature area to which the measured environmental temperature belongs. (Step S204), and if there is a calibration curve (step S204: Yes), it is confirmed whether the calibration curve is valid, that is, whether the calibration curve creation date is within the expiration date. (Step S205). A predetermined temperature range to be analyzed is set and stored in the storage unit 104A, and the temperature range is usually divided into environmental temperature areas every 5 ° C. In addition, a calibration curve created at the environmental temperature in the environmental temperature area is stored for each environmental temperature area (see FIG. 3).

  For example, when the analysis of the analysis item A is first ordered for the sample and the environmental temperature is measured to be 21 ° C. in step S201, the environmental temperature 21 ° C. is determined by the temperature determination unit 109 in a predetermined temperature range (15 ° C. to 30 ° C. (Step S202: Yes). Thereafter, the determination unit 108 confirms whether an effective calibration curve is stored in the environmental temperature area 20 ° C. to 25 ° C. to which the environmental temperature 21 ° C. belongs (step S204). As shown in FIG. 3, a calibration curve is stored in the environmental temperature area 20 ° C. to 25 ° C. of the analysis item A (step S204: Yes), whereas the creation date is January 10, 2009, If the analysis date is, for example, January 26, 2009, and the expiration date of the calibration curve of the analysis item A is 2 weeks, the determination unit 108 determines that it is not within the expiration date (step S205: No). . Since the expiration date of the calibration curve is different for each analysis item (reagent used for analysis of the analysis item), the expiration date of the calibration curve is determined for each analysis item. The expiration date of the calibration curve (reagent) is stored in the identification label affixed to the reagent container 42 and read by the reading unit 43. Thereafter, when analysis is ordered for analysis item B and the determination is made in the same manner, if the environmental temperature remains at 21 ° C., the temperature determination unit 109 determines that the temperature is within a predetermined temperature range (15 ° C. to 30 ° C.) ( (Step S202: Yes), the determination unit 108 determines that there is no calibration curve in the range of the environmental temperature area 20 ° C. to 25 ° C. (Step S204: No). In the second embodiment, when it is determined that there is no calibration curve in the environmental temperature area (step S204: No), or when it is determined that there is no effective calibration curve (step S205: No), this is output. (Step S206) is different from the first embodiment in that the user is notified. Even when it is determined that there is no calibration curve in the environmental temperature area (step S204: No), or when it is determined that there is no effective calibration curve (step S205: No), there is a need to perform calibration processing depending on the analysis item. Since it may be determined that the value is low, the user is allowed to execute the calibration process (step S207). If the user determines that the calibration process is not necessary (step S207: No) and continues the analysis, the analysis time and cost can be reduced.

  When the calibration curve is not stored in the environmental temperature area to which the measured environmental temperature belongs (step S204: No) and the user determines that the calibration process is necessary (step S207: Yes), the operation of the input unit 102 is performed. In step S208, the control unit 101 controls the calibration process to be performed based on the instruction. The calibration curve created by the calibration process is stored in the storage unit 104A in association with the environmental temperature area together with the environmental temperature and date / time information on which the calibration process has been performed (step S209). Moreover, although the calibration curve is preserve | saved by the determination part 108 in the environmental temperature area to which the measured environmental temperature belongs (step S204: Yes), the preserved calibration curve is not effective (step S205: No). When the determination is made and the user determines that the calibration process is necessary (step S207: Yes), the calibration process is performed in the same manner (step S208), and is newly stored in the storage unit 104A corresponding to the environmental temperature area. (Step S209). Reagents used in the calibration process are kept refrigerated to prevent denaturation, but there may be some change in reactivity over time. Therefore, in order to obtain a highly reliable analysis result, even if a calibration curve exists in the environmental temperature area, the calibration curve should not be used if the expiration date has passed. A calibration process is performed.

  When the determination unit 108 stores a calibration curve in the environmental temperature area to which the measured environmental temperature belongs (step S204: Yes), and determines that the stored calibration curve is valid (step S205: Yes). Alternatively, when calibration processing is newly performed and a calibration curve is newly stored (steps S208 and S209), the control unit 101 controls to start analysis (step S210). After the analysis is completed, based on a valid calibration curve in the environmental temperature area, the analysis unit 103A calibrates and calculates the analysis result (step S211), and the temperature sensor 12 measures the environmental temperature after the analysis is completed (step S212). . The temperature determination unit 109 calculates the environmental temperature difference before and after the analysis, and determines whether the environmental temperature difference is within a predetermined temperature range, for example, within 2 ° C. (step S213). Even if the environmental temperature at the start of analysis is within the specified temperature range and the analysis result is calculated using the calibration curve of the environmental temperature area to which the environmental temperature at the time of analysis belongs, the environmental temperature may change during the analysis. The reliability of analysis results calculated due to temperature changes may be low. Therefore, when the environmental temperature difference before and after the analysis is not within the predetermined temperature range (step S213: No), the user can be alerted by attaching a flag to that effect and outputting the analysis result (step S218). It becomes possible. If the environmental temperature difference before and after the analysis is within the predetermined temperature range (step S213: Yes), the analysis result is output as it is (step S214).

  On the other hand, when the user determines that the calibration process is not necessary (step S207: No), the analysis is started (step S215), and the analysis result is obtained from the obtained measurement data based on the calibration curve of the adjacent environmental temperature area. Calibration and calculation (step S216), the correction unit 110 corrects the analysis result based on the correction coefficient set for each environmental temperature area (step S217). It is assumed that the calibration curve used here is only one that is measured within the expiration date, and the storage unit 104A has a correction coefficient for correction for each analysis item. FIG. 8 is a correction coefficient table for each analysis item stored in the storage unit 104A, in which the vertical is the measured environmental temperature and the horizontal is the set environmental temperature area. For example, if analysis is ordered for analysis item B, the environmental temperature is 21 ° C., there is no calibration curve in the corresponding environmental temperature area 20 to 25 ° C., and there is a calibration curve in the environmental temperature area 15 to 20 ° C., the environmental temperature Calibration and calculation of the measurement data of the ambient temperature 20 to 25 ° C. with the calibration curve of the area 15 to 20 ° C. The correction unit 110 corrects the obtained analysis result, but the correction coefficient is x1.2 (see FIG. 8, the intersecting column of the environmental temperature area 15 to 20 ° C. and the environmental temperature 20 to 25 ° C.). Will be multiplied by 1.2. The corrected analysis result is output by the output unit 105 with a flag indicating correction data (step S218). Thereafter, it is confirmed whether or not the analysis of all analysis items has been completed for the sample (step S219). If the analysis has not been completed (step S219: No), the process is repeated from step S201.

1 is a schematic diagram illustrating a configuration of an analyzer according to a first embodiment. 4 is a flowchart illustrating a processing procedure of analysis processing by the analysis apparatus according to the first embodiment. It is a figure which shows the preservation | save state of the calibration curve for every analysis item (the reagent used for the analysis of this analysis item). It is a figure which shows the preservation | save state of the analytical curve of the analysis item concerning the modification 1 of Embodiment 1 (every 5 degreeC of environmental temperature areas). It is a figure which shows the preservation | save state of the analytical curve of the analysis item concerning the modification 1 of Embodiment 1 (every 3 degreeC of environmental temperature areas). FIG. 3 is a schematic diagram illustrating a configuration of an analyzer according to a second embodiment. 10 is a flowchart illustrating a processing procedure of analysis processing by the analysis apparatus according to the second embodiment. 10 is a correction coefficient table for each analysis item stored in a storage unit according to the analyzer of the second embodiment.

DESCRIPTION OF SYMBOLS 1, 1A analyzer 2 Sample table 3 Reaction table 4 Reagent table 5 Specimen dispensing device 6, 8 Dispensing probe washing device 7 Reagent dispensing device 9 Measuring mechanism 10, 10A Control mechanism 11 Housing 12 Temperature sensor 21, 31, 41 Storage Unit 22 Sample Container 22a, 42a Opening 23, 43 Reading Unit 32 Reaction Container 33 Photometric Device 33a Light Source 33b Light Receiving Unit 34 Washing Mechanism 42 Reagent Container 101 Control Unit 102 Input Unit 103, 103A Analyzing Unit 104, 104A Storage Unit 105 Output unit 106 Display unit 107 Transmission / reception unit 108 Determination unit 109 Temperature determination unit 110 Correction unit

Claims (12)

An analyzer that photometrically analyzes a reaction product between a specimen and a reagent and calculates a calibration result from photometric data based on a calibration curve ,
Storage means for storing a calibration curve for each predetermined environmental temperature area;
A temperature measuring means for measuring the environmental temperature in which the analyzing apparatus is installed,
Determining means for determining which of the predetermined environmental temperature areas the environmental temperature corresponds to, and whether a calibration curve effective in the environmental temperature area to which the environmental temperature belongs is stored in the storage means ;
Control means for controlling the photometric analysis by the measuring means when it is determined by the determining means that an effective calibration curve is stored ;
Wherein the photometric data measured by the measuring means and a calibration means for calibration calculating an analysis result based on the calibration curve, the analysis device. The temperature measuring means also measures the environmental temperature after the end of the analysis,
The temperature measuring means includes
The temperature difference is calculated the temperature difference before and after analysis and temperature determining means for determining whether or not a predetermined range,
And output means the temperature difference is output as flagged data when outside the predetermined range, the analyzer according to claim 1. It said control means stops the analysis until the environmental temperature when the judging means and does not correspond to any of said predetermined environmental temperature area is determined, the ambient temperature corresponds to one of said predetermined environmental temperature area controls to analyzer according to claim 1 or 2. It said section of the environmental temperature area varies by analysis item to be measured, analysis device according to any one of claims 1 to 3. Said control means, said determining means the calibration process is controlled so as to perform if a valid calibration curve is determined not to be stored by the calibration means, the calibration measurement results based on the newly prepared calibration curve to, analysis device according to any one of claims 1 to 4. When it is determined by the determination means that a valid calibration curve is not stored , a second output means for outputting the fact to the user ;
If the user does not select a new calibration process, calibration of the analytical results in the calibration curve of the environmental temperature area adjacent further comprises a correcting means for correcting the analysis result based on the correction coefficient set for each environmental temperature area the analyzer according to any one of claims 1 to 4. An analysis method for performing a photometric analysis of a reaction product between a specimen and a reagent and calculating a calibration result from photometric data based on a calibration curve ,
A first temperature measuring step for measuring an environmental temperature for analysis;
The environmental temperature belongs to a storage unit that stores which one of the plurality of divided environmental temperature areas the environmental temperature measured in the first temperature measurement step corresponds to, and a calibration curve for each environmental temperature area. a determination step of determining whether or not a valid calibration curve is stored in the environmental temperature area,
A measurement step for performing analysis when it is determined that an effective calibration curve is stored in the determination step;
And a calibration step of calibrating calculating the analysis result on the basis of the calibration curve for the photometric data measured by said measuring step, the analysis method. After the analysis step, again, a second temperature measurement step of measuring the environmental temperature,
To calculate the environmental temperature difference measured by the first temperature measurement step and the second temperature measurement step, the environmental temperature difference and temperature determining step of determining whether the predetermined range,
The environmental temperature difference further includes a first output step of outputting as a flagged data when outside the predetermined range, The method according to claim 7. If the said ambient temperature at the determination step determines that none of the predetermined environmental temperature area, environmental temperature adjustment the environmental temperature is adjusted environmental temperature until any of the above predetermined environmental temperature area The analysis method according to claim 7 or 8 , further comprising a step. The analysis method according to any one of claims 7 to 9 , wherein the classification of the environmental temperature area varies depending on an analysis item. A calibration process step for performing a calibration process when it is determined that a valid calibration curve is not stored in the determination step;
Said calibration curve prepared in the calibration processing steps further comprise: a storage step of storing for each environmental temperature area,
Wherein in calibration step, based on the newly created calibration curve measurement is calibrated analysis method according to any one of claims 7-10. A second output step of outputting the fact to the user when it is determined that an effective calibration curve is not stored in the determination step;
If the user does not select a new calibration process, it detects the analysis result in the calibration curve of the environmental temperature area adjacent further comprising a step of correcting an analysis result based on the correction coefficient set for each environmental temperature area , the method according to any one of claims 7-10.

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