JP2011017660A - Automatic analysis device and retesting method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an automatic analysis device capable of automatically performing retesting at an appropriate dilution factor at one time, requiring no operator intervention and to provide a retesting method.SOLUTION: The automatic analysis device 1 for determining an object to be measured by measuring the amount of light emission or absorbance caused by the reaction between a specimen and a reagent includes a photometric part 31 for measuring the amount of light emission or absorbance; a computation part 48 for determining whether a measured value lies within or outside the range between a measurement upper limit and a measurement lower limit for the measurement of the measured value, for determining a ratio between the measured value and the measurement upper limit when it is determined that the measured value exceeds the measurement upper limit for the measurement of the measured value, and for computing an appropriate dilution factor on the basis of the ratio or determining a ratio between the measured value and for the measurement lower limit when it is determined that the measured value is below the measurement lower limit for the measurement of the measured value and computing an appropriate dilution factor on the basis of the ratio; and a retesting control part 50 for performing control in such a way as to perform retesting after the specimen is diluted on the basis of the appropriate dilution factor.

Description

  The present invention relates to an automatic analyzer and a retest method for measuring a light emission amount or absorbance caused by a reaction between a specimen and a reagent to quantify a measurement object.

  Conventionally, in order to quantitatively analyze a specific component in a sample, a device for optically analyzing a reaction product generated by a reaction between the sample and a reagent is known. If the concentration of a specific component is too high, analysis is performed. Since the reliability of the results is not guaranteed, the specimen is diluted and retested.

  As a method for setting the dilution factor for retesting, methods, devices, and the like for setting the dilution factor based on the measured absorbance are disclosed (see, for example, Patent Documents 1 to 4).

  Further, the sample is analyzed at the first dilution factor, and the measured value is compared with the upper and lower limit values which are threshold values. If the measured value is larger than the upper limit value, the second dilution factor larger than the first dilution factor is set next time. An analysis system is disclosed in which re-examination is performed as the dilution factor, and when the measured value is smaller than the lower limit, the third dilution factor smaller than the first dilution factor is re-examined as the next magnification. (For example, refer to Patent Document 5).

Japanese Patent Publication No. 4-37384 Japanese Patent No. 3607336 Japanese Patent Laid-Open No. 10-213546 Japanese Patent Laid-Open No. 10-282112 JP 2007-33132 A

  However, in the ones described in Patent Documents 1 to 4, although the dilution factor can be determined, the dilution to the factor can be performed manually by the user, or when diluting on the device side, the dilution conditions on the device side should be set before retesting. There is a need to register, and it does not reduce the operator's work significantly.

  Further, the method described in Patent Document 5 compares the measured value at a predetermined dilution rate with the measured value as a threshold value, and if the measured value is larger than the upper limit value, the dilution rate is increased by one step. However, if it is smaller than the lower limit, it is possible to reduce the operator's judgment and dilution work by deciding to lower the dilution factor by one step and re-examination. However, when the sample concentration is very high, etc. Since a proper dilution ratio cannot be set, the retest may not be completed once.

  The present invention has been made in view of the above, and provides an automatic analyzer and a retest method that can automatically perform a retest once at an appropriate dilution ratio without bothering an operator. With the goal.

  In order to solve the above-described problems and achieve the object, the automatic analyzer of the present invention is an automatic analyzer that measures a light emission amount or absorbance generated by a reaction between a sample and a reagent to quantify a measurement object. Measuring means for measuring the amount of luminescence or absorbance under predetermined measuring conditions, and whether the measured value measured by the measuring means is within the range of the measurement upper limit value and measurement lower limit value when measuring the measured value Determining, if it is determined that the measured value exceeds the upper limit of measurement when measuring the measured value, obtain a ratio of the measured value and the upper limit of measurement, calculate an appropriate dilution factor based on the ratio, or When the measurement value is determined to be less than the measurement lower limit when measuring the measurement value, a ratio between the measurement value and the measurement lower limit value is obtained, and a calculation means for calculating an appropriate dilution factor based on the ratio; Based on the appropriate dilution ratio After dilution of the can the analyte, characterized in that it comprises a re-examination control section for controlling to perform reinspection, the.

  Further, the automatic analyzer according to the present invention, in the above invention, determines the dilution ratio based on the storage means for storing the retest dilution ratio determination table, the appropriate dilution ratio calculated by the calculation means, and the retest dilution ratio determination table. The reexamination control means controls to perform a reexamination after diluting the sample based on the dilution ratio determined by the dilution magnification determination means.

  In the automatic analyzer according to the present invention as set forth in the invention described above, the storage unit stores a measurement condition of the measurement unit and a dilution factor correction coefficient set for each analysis item, and the calculation unit includes the measurement unit. When it is determined that the value exceeds the measurement upper limit when measuring the measurement value, the ratio between the measurement value and the measurement upper limit value is obtained, and from the ratio, the dilution factor at the time of measurement, and the correction coefficient for the measurement upper limit value It is characterized in that an appropriate dilution ratio at the time of retest is calculated.

  In the automatic analyzer according to the present invention as set forth in the invention described above, the storage unit stores a measurement condition of the measurement unit and a dilution factor correction coefficient set for each analysis item, and the calculation unit includes the measurement unit. When it is determined that the value is less than the lower limit of measurement when measuring the measured value, the ratio between the measured value and the lower limit of measurement is obtained, and the re-examination is performed from the ratio, the dilution factor at the time of measurement, and the correction coefficient of the lower limit of measurement. The proper dilution ratio is calculated.

  Moreover, the automatic analyzer of the present invention is characterized in that, in the above invention, the dilution rate determining means does not determine the dilution rate when the appropriate dilution rate calculated by the calculating unit exceeds a maximum set dilution rate.

An output means for outputting an analysis result calculated based on the measurement value measured by the measurement means;
When the dilution factor is not determined by the dilution factor determination unit and the retest control unit does not perform the retest, a flag indicating that the retest is unnecessary is attached to the output of the analysis result.

  Further, the automatic analyzer of the present invention is the above-described invention, wherein in the above-mentioned invention, an automatic dilution factor setting mode for determining a retest dilution factor by the dilution factor determining means, and any one dilution factor specified by an operator among the set dilution factors is provided. Selection means for selecting a fixed dilution rate setting mode determined as a retest dilution rate is provided.

  Further, the reanalyzing method of the automatic analyzer of the present invention is a reanalyzing method of the automatic analyzer that measures the amount of luminescence or absorbance caused by the reaction between the sample and the reagent and quantifies the measurement object. A measurement step of measuring the amount or absorbance, and determining whether the measurement value measured by the measurement step is within a range of a measurement upper limit value and a measurement lower limit value when the measurement value is measured, and the measurement value Is determined to exceed the upper limit of measurement when measuring the measured value, the ratio of the measured value and the upper limit of measurement is obtained, and an appropriate dilution ratio is calculated based on the ratio, or the measured value is When it is determined that the measured value is less than the lower limit of measurement, a ratio between the measured value and the lower limit of measurement is obtained, a calculation step for calculating an appropriate dilution ratio based on the ratio, and based on the appropriate dilution ratio in front After diluting the sample, characterized in that it comprises a re-examination control step of controlling to perform reinspection, the.

  Further, the reanalyzing method of the automatic analyzer of the present invention includes the extraction step of extracting the retest dilution rate determination table from the storage means, the appropriate dilution rate calculated by the calculation step, and the retest dilution rate determination table in the above invention. A dilution factor determination step for determining a dilution factor, and the retest control step controls to perform a retest after diluting the sample based on the dilution factor determined by the dilution factor determination step. And

  Further, in the reanalysis method of the automatic analyzer according to the present invention, in the above invention, the extraction step extracts a measurement condition of the measurement step and a correction factor of a dilution factor set for each analysis item, and the calculation step includes When it is determined that the measured value exceeds the measurement upper limit value when measuring the measured value, the ratio between the measured value and the measurement upper limit value is obtained, and the ratio and the dilution factor at the time of measurement and correction of the measurement upper limit value are obtained. An appropriate dilution ratio at the time of retest is calculated from the coefficient.

  Further, in the reanalysis method of the automatic analyzer according to the present invention, in the above invention, the extraction step extracts a measurement condition of the measuring means and a correction factor for a dilution factor set for each analysis item, and the calculation step includes When the measurement value is determined to be less than the measurement lower limit when measuring the measurement value, the ratio between the measurement value and the measurement lower limit value is obtained, and the ratio, the dilution factor at the time of measurement, and the correction coefficient for the measurement lower limit value, From the above, an appropriate dilution ratio at the time of re-examination is calculated.

  Further, the re-examination method of the automatic analyzer according to the present invention is characterized in that, in the above invention, the dilution rate determination step does not determine the dilution rate when the appropriate dilution rate calculated by the calculation step exceeds a maximum set dilution rate. And

  Further, the re-inspection method of the automatic analyzer according to the present invention includes an output step of outputting an analysis result calculated based on the measurement value measured by the measurement step in the above invention, and the dilution factor is determined by the dilution factor determination step. First, when the re-examination control step does not perform re-examination, a flag indicating that re-examination is unnecessary is attached to the output of the analysis result.

  The present invention calculates the appropriate dilution ratio at the time of retest based on the measurement results measured by the measuring means and the upper and lower limits of the measurement range, and determines the dilution ratio that can be handled on the device side based on the calculated appropriate dilution ratio. By automatically diluting and retesting the specimen, the probability of retesting is reduced, reducing the consumption of reagents, washing water, etc. used for analysis and saving time. The operator's work can be reduced.

FIG. 1 is a schematic diagram showing a configuration of an automatic analyzer according to the present embodiment. FIG. 2 is a flowchart of the re-examination process according to the embodiment of the present invention. FIG. 3 is an example of a measurement condition parameter screen for each analysis item. FIG. 4 is a flowchart of the dilution factor determination process. FIG. 5 shows an example of a retest dilution factor determination table.

  Hereinafter, preferred embodiments of an automatic analyzer and a retest method according to the present invention will be described in detail with reference to the drawings. In addition, this invention is not limited to these embodiment, A various change is possible in the range which does not deviate from the summary of this invention. In the description of the drawings, the same parts are denoted by the same reference numerals.

  FIG. 1 is a schematic diagram showing a configuration of an automatic analyzer according to an embodiment of the present invention. As shown in FIG. 1, an automatic analyzer 1 according to an embodiment includes a measurement mechanism 20 that measures the amount of luminescence of a luminescent substrate due to the action of a reactant between a sample and a reagent, and an automatic analysis that includes the measurement mechanism 20. A control mechanism 40 that controls the entire apparatus 1 and analyzes a measurement result in the measurement mechanism 20 is provided. The analyzer 1 automatically performs immunological analysis of a plurality of specimens by cooperation of these two mechanisms.

  First, the measurement mechanism 20 will be described. The measurement mechanism 20 is roughly divided into a sample transfer unit 21, a chip storage unit 22, a sample dispensing unit 23, an immune reaction table 24, a BF table 25, a first reagent store 26, a second reagent store 27, and a first reagent dispensing unit. 28, a second reagent dispensing unit 29, an enzyme reaction table 30, a photometric unit 31, a first reaction vessel transfer unit 32, and a second reaction vessel transfer unit 33. Each component of the measurement mechanism 2 includes one or a plurality of units that perform predetermined operation processing.

  The sample transfer section 21 includes a plurality of sample racks 21b that hold a plurality of sample containers 21a containing samples and are sequentially transferred in the direction of the arrows in the figure. The sample stored in the sample container 21a is blood or urine collected from the sample provider.

  The chip storage unit 22 is provided with a chip case in which a plurality of chips are aligned, and chips are supplied from this case. This tip is a disposable sample tip that is attached to the tip of the nozzle of the specimen dispensing unit 23 and is exchanged for each specimen dispensing in order to prevent carryover when measuring an infectious disease item.

  The sample dispensing unit 23 has an arm that has a probe for aspirating and discharging the sample attached to the distal end, and that can freely move up and down in the vertical direction and rotate around a vertical line passing through its proximal end as a central axis. Prepare. The sample dispensing unit 23 sucks the sample in the sample container 21a moved to the predetermined position by the sample transfer unit 21 with the probe, rotates the arm, and distributes the sample to the reaction container 10 conveyed to the predetermined position by the BF table 25. The sample is poured and transferred into the reaction container 10 on the BF table 25 at a predetermined timing.

  The immune reaction table 24 has a reaction line for reacting a specimen with a predetermined reagent corresponding to an analysis item in each reaction container 10 arranged. The immune reaction table 24 is rotatable for each reaction line with a vertical line passing through the center of the immune reaction table 24 as a rotation axis, and the reaction container 10 disposed on the immune reaction table 24 is transferred to a predetermined position at a predetermined timing. . In the immune reaction table 24, as shown in FIG. 1, an outer peripheral line 24a for pretreatment and predilution, an intermediate peripheral line 24b for immune reaction between the specimen and the solid phase carrier reagent, and an immune reaction between the specimen and the labeling reagent. A triple reaction line structure having an inner peripheral line 24c may be formed.

  The BF table 25 performs a BF cleaning process for performing BF (bound-free) separation that separates unreacted substances in the specimen or reagent by sucking and discharging a predetermined cleaning liquid. The BF table 25 is rotatable in the direction of the arrow in FIG. 1 with a vertical line passing through the center of the BF table 25 as a rotation axis, and transfers the reaction vessel 10 disposed on the BF table 25 to a predetermined position at a predetermined timing. . The BF table 25 includes a magnetic flux collecting mechanism for collecting magnetic particles necessary for BF separation, a BF washing unit 251 having a BF washing probe for performing BF separation by discharging and sucking BF liquid into a reaction container, And a stirring mechanism for dispersing magnetized magnetic particles. As the BF cleaning process in the BF table 25, a first BF cleaning process and a second BF cleaning process are performed. The BF cleaning unit 251 includes a plurality of BF liquid discharge probes and a plurality of BF liquid suction probes corresponding to the BF liquid discharge probes.

  The first reagent storage 26 can store a plurality of first reagent containers 26 a in which the first reagent to be dispensed in the reaction container 10 arranged on the BF table 25 is stored. The second reagent storage 27 can store a plurality of second reagent containers 27a in which the second reagent dispensed in the reaction container 10 arranged on the BF table 25 is stored. The first reagent store 26 and the second reagent store 27 can be rotated clockwise or counterclockwise by driving a drive mechanism (not shown), and a desired reagent container can be placed in the first reagent dispensing unit 28 or the first reagent store 28. 2. Transfer to the reagent suction position by the reagent dispensing unit 29. The first reagent is a reagent containing magnetic particles that are insoluble carriers in which a reactant that specifically binds to an antigen or antibody in a sample to be analyzed is solid-phased. The second reagent is a reagent containing a labeling substance (for example, an enzyme) that specifically binds to an antigen or antibody bound to magnetic particles. The second reagent store 27 stores a substrate solution container 27b containing a substrate solution containing a substrate that emits light by an enzyme reaction with a labeling substance, and rotates clockwise or counterclockwise to obtain a predetermined substrate solution. The container 27b is transported to the substrate liquid suction position by the first reagent dispensing unit 28.

  The first reagent dispensing unit 28 has a probe for aspirating and discharging the first reagent attached to the distal end, and can freely move up and down in the vertical direction and rotate around a vertical line passing through its base end. An arm is provided. The first reagent dispensing unit 28 sucks the reagent in the first reagent container 26a moved to the predetermined position by the first reagent storage 26 with the probe, rotates the arm, and moves the arm to the first reagent discharge position by the BF table 25. Dispense into the conveyed reaction container 10. Further, the first reagent dispensing unit 28 sucks the substrate liquid in the substrate liquid container 27b moved to the predetermined position by the second reagent storage 27 with the probe, rotates the arm, and the substrate liquid discharge position by the BF table 25. To the reaction vessel 10 transported to the reactor.

  The second reagent dispensing unit 29 has the same configuration as the first reagent dispensing unit, sucks the reagent in the reagent container moved to the predetermined position by the second reagent storage 27 with the probe, and rotates the arm. Then, the BF table 25 is dispensed into the reaction container 10 which is transported to a predetermined position.

  The enzyme reaction table 30 is a reaction line for performing an enzyme reaction process in which the substrate in the substrate solution injected into the reaction vessel 10 can emit light.

  The photometric unit 31 measures luminescence emitted from the substrate in the reaction solution in the reaction vessel 10. The photometry unit 31 has, for example, a photomultiplier tube that detects weak light emission generated by chemiluminescence, and measures the amount of light emission using a counting method. The photometry unit 31 holds an optical filter, and calculates the true light emission intensity based on the measurement value dimmed by the optical filter according to the light emission intensity.

  The first reaction container transfer unit 32 freely moves up and down in the vertical direction and rotates around the vertical line passing through its base end as a central axis, and causes the reaction container 10 containing the liquid to undergo an immune reaction at a predetermined timing. The table 24, the BF table 25, the enzyme reaction table 30, an arm for transferring to a predetermined position of a reaction container supply unit (not shown) and a reaction container disposal unit (not shown) are provided. The second reaction container transfer unit 33 freely moves up and down in the vertical direction and rotates around the vertical line passing through its base end as a central axis, and the reaction container 10 containing the liquid is at a predetermined timing. The enzyme reaction table 30, the photometry unit 31, and an arm for transferring to a predetermined position of a reaction container discarding unit (not shown) are provided.

  Next, the control mechanism 40 will be described. The control mechanism 40 includes a control unit 41, an input unit 42, an analysis unit 43, a storage unit 44, an output unit 45, and a transmission / reception unit 47. These units included in the measurement mechanism 20 and the control mechanism 40 are electrically connected to the control unit 41. The control mechanism 40 is realized using one or a plurality of computer systems and is connected to the measurement mechanism 20. The control mechanism 40 controls the operation process of the measurement mechanism 20 and analyzes the measurement result in the measurement mechanism 20 using various programs related to each process of the analyzer 1.

  The control unit 41 is configured using a CPU or the like having a control function, and controls processing and operation of each component of the automatic analyzer 1. The control unit 41 performs predetermined input / output control on information input / output to / from each of these components, and performs predetermined information processing on this information. The control unit 41 controls the analyzer 1 by reading out the program stored in the storage unit 44 from the memory.

  The control unit 41 includes a calculation unit 48, a dilution rate determination unit 49, and a retest control unit 50. The calculation unit 48 determines whether or not the measurement value measured by the photometry unit 31 is within the range of the measurement upper limit value and the measurement lower limit value when the measurement value is measured, and the measurement value determines the measurement value. If it is determined that the measurement upper limit value is greater than or equal to the measurement upper limit value, the ratio between the measurement value and the measurement upper limit value is obtained, and the appropriate dilution ratio at the time of retest is determined from the ratio, the dilution ratio at the time of measurement, and the correction coefficient for the measurement upper limit value. When calculating or determining that the measured value is less than the lower limit of measurement when measuring the measured value, the ratio of the measured value to the lower limit of measurement is obtained, and the ratio, the dilution factor at the time of measurement, and the lower limit of measurement Calculate the appropriate dilution ratio at the time of retest from the correction factor. The correction coefficient for the measurement upper limit value and the measurement lower limit value is extracted from the storage unit 44 described later. The correction coefficient is set for each analysis item. The dilution rate determination unit 49 determines the dilution rate based on a retest dilution rate determination table for determining a set dilution rate that can be selected by the automatic analyzer 1 from the appropriate dilution rate. The retest dilution factor determination table is also stored in the storage unit 44. The reexamination control unit 50 controls to perform the reexamination after diluting the specimen at the dilution rate determined by the dilution rate determination unit 49.

  The input unit 42 is configured using a keyboard for inputting various information, a mouse for designating an arbitrary position on the display screen constituting the output unit 45, and the like. Information, instruction information of analysis operation, etc. are acquired from the outside. The analysis unit 43 performs an analysis process on the sample based on the measurement result acquired from the measurement mechanism 20.

  The storage unit 44 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 45 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. Further, the storage unit 44 stores the measurement conditions of the photometry unit 31, the dilution factor correction coefficient set for each analysis item, and the retest dilution factor determination table.

  The output unit 45 is configured using a printer, a speaker, and the like, and outputs various information related to analysis under the control of the control unit 41. The output unit 45 includes a display unit 46 configured using a display or the like. The transmission / reception unit 47 has a function as an interface for performing transmission / reception of information according to a predetermined format via a communication network (not shown).

  In the automatic analyzer 1 that performs this immunoassay, the first reagent dispensing process in which the first reagent containing magnetic particles is dispensed into the reaction container 10 by the first reagent dispensing unit 28, from the chip storage unit 22. A sample dispensing process in which the sample is dispensed into the reaction container 10 on the BF table 25 by the sample dispensing unit 23 to which the supplied chip is attached, and the reaction container 10 is in a state where the reactants are collected in the BF table 25. First BF washing process for removing unreacted substances from the inside, second reagent dispensing process for dispensing the labeling reagent into the reaction container 10 by the second reagent dispensing unit 29, and collecting the immune complex in the BF table 25 The second BF washing process for removing the unbound labeled antibody from the reaction container 10 in the state in which the reaction is performed, the substrate liquid dispensing process for dispensing the substrate liquid into the reaction container 10, and the measurement process for measuring the luminescence from the substrate And Analysis processing is performed to determine the amount of antigen to be detected and measured quantity of light based.

  Next, reexamination processing according to the embodiment of the present invention will be described with reference to FIGS. FIG. 2 is a flowchart of the re-examination process according to the embodiment of the present invention. FIG. 3 is an example of a measurement condition parameter screen for each analysis item. FIG. 4 is a flowchart of the dilution factor determination process. FIG. 5 shows an example of a retest dilution factor determination table.

As shown in FIG. 2, first, the measurement value N of the analysis item for which the re-examination process is determined, the measurement condition at the time of performing the analysis, additional information, and the correction factor a for the dilution factor set for each analysis item, b is acquired (step S101). Here, the measurement conditions to be acquired are the sample dilution rate D _n and the measurement upper limit value R ₂ and the measurement lower limit value R ₁ of the measurement dynamic range, and the sample dilution rate D _n is usually 1 in the initial test analysis. However, when the analysis is periodically performed from the same subject, the set dilution factor D _n is stored together with the analysis result, and the dilution factor D _n may be larger than 1. The additional information is trouble information added from the apparatus side at the time of analysis. The measurement upper limit value R ₂ and the measurement lower limit value R ₁ of the measurement dynamic range are used to calculate the appropriate dilution ratio for retesting. The dilution factor correction coefficients a and b are set for each analysis item, stored in the storage unit 44, and extracted from the storage unit 44 when calculating the appropriate dilution factor.

Subsequently, based on the additional information and the measured value N, it is determined whether reexamination is necessary (step S102). If the measurement value N is not less than the measurement lower limit value R _{1 and not} more than the measurement upper limit value R ₂ and there is no additional information, it is determined that retesting is not necessary (No in step S102), and the retesting process ends. On the other hand, if the measured value N exceeds the measurement limit value R ₁ or less than measured upper limit value R _2, or if there is additional information, it is determined that the retest is necessary (Step S102, Yes).

When it is determined that reexamination is necessary (step S102, Yes), it is determined whether it is necessary to reexamine by changing the dilution factor (step S103). Measured value N, in the case of measuring the upper limit value R ₂ or less measured lower limit R ₁ above, it is determined that it is not necessary to retest by changing the dilution ratio (step S103, No), the same dilution ratio, i.e., dilution ratio A retest analysis is performed with D _n (step S104). On the other hand, the measurement value N, if it exceeds the measurement limit value R ₁ or less than measured upper limit value R ₂ is determined that it is necessary to retest by changing the dilution ratio (step S103, Yes).

  If the dilution factor is changed and retested (step S103, Yes), it is confirmed whether or not the dilution factor setting mode is set to automatic (step S105). The dilution factor setting mode includes an automatic dilution factor setting mode in which the dilution factor determination unit 50 automatically determines the retest dilution factor, and the retest dilution factor among the set dilution factors that the automatic analyzer 1 can adopt as the dilution factor. There is a fixed dilution ratio setting mode in which any one of the dilution ratios specified by the operator is set, and the automatic dilution ratio setting mode or the fixed dilution ratio setting mode is set by the measurement condition parameter screen for each analysis item shown in FIG. .

  FIG. 3 shows an example of the measurement condition parameter screen of the analysis item TSH, but the display column 103 for displaying the retest dilution ratio is set to automatic. This indicates that the automatic dilution factor setting mode is selected. When the fixed dilution factor setting mode is selected, the dilution factor x1, x10, or x100 shown in the display field 103 is displayed. , X200, or x1000 is selected.

  If the dilution factor setting mode is set to automatic (step S105, Yes), a dilution factor determination process is performed (step S106). On the other hand, when the dilution factor setting mode is set to the fixed dilution factor (No at Step S105), the retest analysis is performed at the fixed dilution factor set by the operator (Step S109).

Dilution determination process, first, as shown in FIG. 4, by comparison with the measured values N and measuring the upper limit value _{R 2} (step S201), if the measured value N exceeds the measurement upper limit value _{R 2} (step S201, Yes), the calculation unit 48 obtains the ratio N / R ₂ between the measurement value N and the measurement upper limit value R ₂ (step S202), and uses the dilution factor D _n and the correction coefficients a ₂ and b ₂ of the measurement upper limit value R _2. An appropriate dilution ratio D is calculated (step S204). The calculation formula is as shown in the following formula (1).
D = N / R ₂ × D _n × a ₂ + b ₂ ... (1)

When the measurement value N is less than the measurement lower limit value R ₁ (No at Step S201), the calculation unit 48 obtains the ratio N / R ₁ between the measurement value N and the measurement lower limit value R ₁ (Step S203). The appropriate dilution factor D is calculated from D _n−1, which is one step dilution factor lower than the dilution factor D _n , and correction coefficients a ₁ and b ₁ of the measurement lower limit R ₁ (step S204). The calculation formula is as shown in the following formula (2). When the dilution factor D _n is 1, the appropriate dilution factor D using the measurement lower limit R ₁ is not calculated.
D = N / R ₁ × D _n−1 × a ₁ + b ₁ (2)

After calculating the appropriate dilution factor D by the calculation unit 48, the dilution factor determining unit 49 determines whether or not the appropriate dilution factor D is equal to or less than the maximum setting dilution factor of the automatic analyzer 1 (step S205), and then the dilution factor in the retest. Is determined (step S206). When the appropriate dilution ratio D exceeds the maximum set dilution ratio and when the appropriate dilution ratio D is less than 1 (No in step S205), the dilution ratio determination unit 49 determines that the re-examination of the analysis item is unnecessary, and the dilution ratio is Not set (step S207). In order to calculate an appropriate dilution factor, it is preferable to set correction coefficients a ₁ , b ₁ and a ₂ , b ₂ individually, but a ₁ = a ₂ = 1, b ₁ = b ₂ = It is possible to calculate the dilution factor even when 0 is set.

  On the other hand, when the appropriate dilution ratio D is less than or equal to the maximum set dilution ratio (step S205, Yes), after determining whether the appropriate dilution ratio D is less than or equal to the maximum set dilution ratio of 1 (step S205), the dilution ratio determining unit 49 Determines the dilution factor based on the retest dilution factor determination table shown in FIG. 5 (step S206). It is optimal to dilute the sample at the appropriate dilution factor D calculated by the calculation unit 48 and perform a retest. However, setting the dilution factor of the automatic analyzer 1 to the calculated appropriate dilution factor is a burden on the operator. In order to dilute to the appropriate dilution ratio D, it is not preferable from the viewpoint of apparatus cost. Therefore, the dilution rate determination unit 49 uses the retest dilution rate determination table of FIG. 5 to determine a set dilution rate that can be selected in the automatic analyzer 1 based on the appropriate dilution rate D.

  For example, as shown in FIG. 5, when the appropriate dilution ratio D is calculated as 14, the set dilution ratio is x100, and when the appropriate dilution ratio D exceeds 1000, the maximum setting dilution ratio of the automatic analyzer 1 is maximum. Reexamination for dilution is not performed.

  The dilution rate determination process ends at steps S206 and S207 (step S106), and the dilution control unit 50 determines whether the dilution rate is determined by the dilution rate determination process (step S107). When the dilution factor is determined (step S107, Yes), the dilution control unit 50 controls to perform retest analysis at the determined dilution factor (step S109). If the dilution factor is not determined and reexamination is not required (No at step S107), a flag indicating that reexamination is not necessary is added to the analysis result and output via the output unit 45 or the display unit 46, and the reexamination process is terminated ( Step S108).

  As described above, the present invention can automatically perform a retest at an appropriate dilution factor, and can reduce the probability of performing a retest. In addition, this reduces the consumption of reagents, washing water, etc. used for analysis, and also saves the time required for analysis. Furthermore, since the dilution factor is set and retested automatically, the operator's work can be greatly reduced.

  In the above-described embodiment, the automatic analysis device and the retesting method mainly targeting the immunological analysis items are described as examples. However, the present invention is also applied to the automatic analysis device and the retesting method targeting the biochemical analysis items. Applicable. In an automatic analyzer for biochemical items, an appropriate dilution ratio is calculated based on the absorbance obtained by measurement, the measurement upper limit value, and the measurement lower limit value. The calculation method is performed in the same manner as the appropriate dilution ratio determined in the above immunological analysis items. In the automatic analyzer for biochemical items, if the appropriate dilution ratio D is less than 1, the sample can be concentrated (increase) and retested. For example, when the appropriate dilution ratio D is 0.1 ≦ D <0.5, the sample amount is concentrated (increased) twice, and when D <0.1, the sample amount is concentrated 10 times (increased). ) And performing a retest, it is possible to obtain an accurate analysis result.

  As described above, the automatic analyzer and the retest method according to the present invention are useful for an analyzer that requires high-speed and large-scale analysis processing.

DESCRIPTION OF SYMBOLS 1 Automatic analyzer 20 Measurement mechanism 10 Reaction container 21 Specimen transfer part 21a Specimen container 21b Specimen rack 22 Chip storage part 23 Specimen dispensing part 24 Immune reaction table 24a Outer peripheral line 24b Middle peripheral line 24c Inner peripheral line 25 BF table 26 First Reagent storage 26a First reagent container 27 Second reagent storage 27a Second reagent container 27b Substrate liquid container 28 First reagent dispensing part 29 Second reagent dispensing part 30 Enzyme reaction table 31 Photometric part 32 First reaction container transfer part 33 2nd reaction container transfer part 40 Control mechanism 41 Control part 42 Input part 43 Analysis part 44 Storage part 45 Output part 46 Display part 47 Transmission / reception part 48 Calculation part 49 Dilution factor determination part 50 Retest control part 251 BF washing | cleaning part

Claims (13)

In an automatic analyzer that measures the amount of luminescence or absorbance generated by the reaction between the sample and the reagent to quantify the measurement object,
Measuring means for measuring the amount of luminescence or absorbance under predetermined measuring conditions;
It is determined whether or not the measurement value measured by the measurement means is within the range of the measurement upper limit value and the measurement lower limit value when measuring the measurement value, and the measurement value is a measurement when measuring the measurement value. When it is determined that the upper limit value is exceeded, the ratio between the measured value and the measured upper limit value is obtained, and an appropriate dilution ratio is calculated based on the ratio, or the measured value is less than the lower measurement limit when measuring the measured value. A calculation means for obtaining a ratio between the measurement value and the measurement lower limit value, and calculating an appropriate dilution factor based on the ratio;
A retest control means for controlling to perform a retest after diluting the sample based on the appropriate dilution factor;
An automatic analyzer characterized by comprising. Storage means for storing a retest dilution factor determination table;
A dilution ratio determination means for determining a dilution ratio based on the appropriate dilution ratio calculated by the calculation means and the retest dilution ratio determination table;
2. The automatic analyzer according to claim 1, wherein the retest control unit controls to perform a retest after diluting the specimen based on the dilution rate determined by the dilution rate determining unit. The storage means stores a measurement condition of the measurement means and a dilution factor correction coefficient set for each analysis item,
When the calculation means determines that the measurement value exceeds the measurement upper limit value when the measurement value is measured, the calculation means obtains a ratio between the measurement value and the measurement upper limit value, and calculates the ratio and the dilution factor and measurement at the time of measurement. The automatic analyzer according to claim 1 or 2, wherein an appropriate dilution ratio at the time of re-examination is calculated from a correction coefficient for the upper limit value. The storage means stores a measurement condition of the measurement means and a dilution factor correction coefficient set for each analysis item,
When the calculation means determines that the measurement value is less than the measurement lower limit when measuring the measurement value, the calculation means obtains a ratio between the measurement value and the measurement lower limit value, and calculates the ratio, the dilution rate at the time of measurement, and the measurement lower limit value. The automatic analyzer according to claim 1 or 2, wherein an appropriate dilution ratio at the time of retesting is calculated from the correction coefficient.   The automatic analyzer according to claim 2, wherein the dilution rate determination unit does not determine the dilution rate when the appropriate dilution rate calculated by the calculation unit exceeds a maximum setting dilution rate. An output means for outputting an analysis result calculated based on the measurement value measured by the measurement means;
6. The flag indicating that the reexamination is unnecessary is attached to the output of the analysis result when the diluting rate is not determined by the diluting rate determining unit and the reexamination control unit does not perform the reexamination. The automatic analyzer described.   An automatic dilution ratio setting mode for determining the retest dilution ratio by the dilution ratio determination means and a fixed dilution ratio setting mode for determining any one of the above set dilution ratios as the retest dilution ratio is selected. The automatic analyzer according to any one of claims 2 to 6, further comprising selection means for performing the selection. In the re-examination method of the automatic analyzer that measures the amount of luminescence or absorbance generated by the reaction between the sample and the reagent to quantify the measurement object,
A measurement step for measuring the amount of luminescence or absorbance under predetermined measurement conditions;
It is determined whether the measurement value measured by the measurement step is within the range of the measurement upper limit value and the measurement lower limit value when measuring the measurement value, and the measurement value is a measurement when measuring the measurement value. When it is determined that the upper limit value is exceeded, the ratio between the measured value and the measured upper limit value is obtained, and an appropriate dilution ratio is calculated based on the ratio, or the measured value is less than the lower measurement limit when measuring the measured value. If it is determined that the ratio of the measurement value and the measurement lower limit, a calculation step of calculating an appropriate dilution factor based on the ratio;
A retest control step for controlling to perform a retest after diluting the sample based on the appropriate dilution factor;
A re-examination method for an automatic analyzer characterized by comprising: An extraction step of extracting a retest dilution factor determination table from the storage means;
A dilution factor determination step for determining a dilution factor based on the appropriate dilution factor calculated by the calculation step and the retest dilution factor determination table;
9. The re-inspection method for an automatic analyzer according to claim 8, wherein the re-inspection control step controls to perform a re-inspection after the sample is diluted based on the dilution rate determined in the dilution rate determination step. The extraction step extracts the measurement conditions of the measurement step and the correction factor for the dilution factor set for each analysis item,
In the calculation step, when it is determined that the measurement value exceeds the measurement upper limit value when the measurement value is measured, a ratio between the measurement value and the measurement upper limit value is obtained, and the ratio and the dilution factor and measurement at the time of measurement are obtained. 10. The automatic analyzer re-inspection method according to claim 8, wherein an appropriate dilution ratio at the time of re-inspection is calculated from an upper limit correction coefficient. The extraction step extracts the measurement condition of the measuring means and the dilution factor correction coefficient set for each analysis item,
In the calculation step, when the measurement value is determined to be less than the measurement lower limit when the measurement value is measured, a ratio between the measurement value and the measurement lower limit value is obtained, and the ratio, the dilution rate at the time of measurement, and the measurement lower limit value are obtained. 10. The automatic analyzer re-inspection method according to claim 8 or 9, wherein an appropriate dilution ratio at the time of re-inspection is calculated from the correction coefficient.   10. The automatic analyzer re-examination method according to claim 9, wherein the dilution rate determination step does not determine the dilution rate when the appropriate dilution rate calculated by the calculation step exceeds a maximum setting dilution rate. An output step of outputting an analysis result calculated based on the measurement value measured by the measurement step;
The flag indicating that the reexamination is not necessary is attached to the output of the analysis result when the dilution rate is not determined by the dilution rate determining step and the reexamination control step does not perform the reexamination. A method for re-examination of the described automatic analyzer.

Images