JPH07110333A - Automatic analyzer - Google Patents

Abstract

PURPOSE:To reduce error of analysis by a method wherein a working curve determined on the basis of a measured value of a physical amount of a reference sample for correction and the concentration of a specific component is corrected when a correction factor of the working curve is within a prescribed range, while the working curve is determined afresh when the factor is outside the range, and then the concentration of the specific component of each sample to be analyzed is determined. CONSTITUTION:A known concentration of an antigen of a reference sample for correction is inputted and the amount of emission of each sample is measured. Next, working curve data are taken in and a one-point correction factor is calculated. It is determined at this time whether the correction factor is within a prescribed range or not, and when the factor is within the range, a working curve is corrected thereby. Next, the amounts of emission of all samples to be analyzed are measured and converted into concentrations of a specific antigen by the corrected working curve. When the correction factor is outside the prescribed range, the working curve is prepared afresh, calculation of the one-point correction factor and determination that the factor is within the range are executed again and then the amounts of emission are converted into the concentrations of the specific antigen by the working curve corrected afresh. In this way, waste of a measuring time and the sample is avoided even when abnormality occurs, and the result of measurement having dew errors is obtained.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analyzer, and more particularly to an automatic analyzer for analyzing a sample to be analyzed by automatically measuring the concentration of a specific component in the sample to be analyzed.

[0002]

2. Description of the Related Art Conventionally, diagnosis in the field of medical treatment,
To reduce the work of inspections, etc., automatically measure the concentration of a specific component related to the diagnostic item among the various components contained in blood, urine, etc. samples collected from the subject. There is known an automatic analyzer that analyzes a sample by doing so. In this automatic analyzer, when an antigen is taken as an example of a specific component in a sample, the measurement is performed as follows.

That is, antibody-immobilized magnetic microbeads in which an antibody that specifically reacts with a specific antigen in a sample is bound to magnetic microbeads are put into a sample, and unreacted antibody-immobilized magnetic microbeads are removed by a magnet. After that, a labeled antibody in which a labeling substance is bound is added to the specifically reactive antibody, and the unreacted labeled antibody is removed. In this state, the sample contains the labeling substance at a concentration proportional to the concentration of the specific antigen, and the physical quantity representing the concentration of the labeling substance is measured (for example, when the labeling substance is an enzyme). Is charged with a luminescent substance that emits light using the enzyme as a catalyst to measure the amount of luminescence), and the concentration of the specific antigen is measured by converting the measured value of the physical quantity into the concentration of the antigen.

Thereby, for example, reagents such as antibody-immobilized magnetic microbeads and labeled antibodies prepared by using an antibody that specifically reacts with a specific antigen related to a diagnostic item are set in an automatic analyzer, Furthermore, if the sample to be analyzed collected from the subject is set in the automatic analyzer and the measurement is instructed, the concentration of the specific antigen is measured by performing the above-mentioned measurement process, which saves labor for diagnosis, inspection, etc. Can be realized.

[0007] By the way, the automatic analyzer is designed to measure the physical quantities of a plurality of standard samples, each of which has a known concentration of the specific antigen and a different concentration of the specific antigen, respectively. A calibration curve representing the relationship with the concentration is stored in advance, and the measured value of the physical quantity of the sample to be analyzed is converted into the concentration of the specific antigen using the calibration curve. However, the state of the reagent varies depending on the surrounding environment and the like, and accordingly, the relationship between the physical quantity of the sample and the concentration of the specific antigen may deviate from the relationship represented by the calibration curve.

Therefore, in the case of measuring the sample to be analyzed, prior to the measurement of the sample to be analyzed, a standard sample whose antigen concentration is known is set in an automatic analyzer, and the physical quantity of the standard sample is measured. , The calibration curve is corrected by calculating the correction coefficient of the calibration curve based on the measured value of this physical quantity, the concentration of the known antigen and the calibration curve stored in advance, and the sample to be analyzed using the corrected calibration curve The measured value of the physical quantity of is converted into the concentration of the antigen.

Further, since the automatic analyzer uses the chemical reaction to perform the measurement as described above, it takes a long time (for example, about 1 hour) to complete the measurement for a single sample. Therefore, a standard sample for determining the correction coefficient and one or a plurality of samples to be analyzed are set in advance, measurements are performed in parallel in order from the standard sample, and the physical quantity of the standard sample is measured. The concentration of the specific antigen of the sample to be analyzed is determined based on the calibration curve corrected by the correction coefficient and the measured value of the physical quantity of the sample to be analyzed that is measured later.

[0008]

However, when an abnormality such as a power failure occurs and a large change occurs in the state of various reagents stored in the automatic analyzer, or for some reason, the standard sample and the sample to be analyzed are to be solved. When a large error is added to the measured value of the physical quantity of 1, the value of the correction coefficient obtained by measuring the physical quantity of the standard sample may be greatly deviated from the appropriate range. If a calibration curve corrected with a correction coefficient whose value largely deviates from the proper range is used, a large error is included in the obtained antigen concentration. On the other hand, conventionally, regardless of the value of the correction coefficient, the concentration of the specific antigen of the sample to be analyzed is determined, or when the value of the correction coefficient is largely outside the proper range, the measurement itself is invalidated and the re-measurement is performed. I was going. For this reason,
In the former case, there is a problem that the output concentration may contain a large error, and in the latter case, it is necessary to perform the measurement again, so a longer time is required for the re-measurement. Not only is it necessary, but there is also the disadvantage that the sample taken from the subject is wasted.

In order to solve this, first, only the standard sample is set and it is judged whether the value of the correction coefficient is normal, and then the sample to be analyzed is set to measure the concentration of the specific antigen in the sample to be analyzed. Could be configured to start
As described above, since it takes a long time to complete the measurement for a single sample, there is a problem that the measurement takes a long time and the work efficiency decreases.

The present invention has been made in consideration of the above facts, and provides an automatic analyzer capable of obtaining an appropriate measurement result with a small error without wasting a sample even when an abnormality occurs. Is the purpose.

[0011]

In order to achieve the above object, an automatic analyzer according to the present invention measures a physical quantity associated with the concentration of a specific component of a standard sample and a sample to be analyzed in which the concentration of the specific component is known. Based on the measured value of the physical quantity of each of the plurality of first standard samples and the concentration of each specific component of the first standard sample, the concentration of the specific component measured by the measuring means being different from each other. Calibration curve calculating means for obtaining a calibration curve representing the relationship between the physical quantity of the sample and the concentration of the specific component, the measured value of the physical quantity of the second standard sample measured by the measuring means, and the second standard sample. Correction coefficient calculating means for calculating a correction coefficient for correcting the calibration curve based on the concentration of the specific component and the calibration curve, and the measurement of the physical quantities of the second standard sample and the analyte sample measured by the measuring means. The value If the value of the correction coefficient calculated by the correction coefficient calculating means is within a predetermined range, the calibration curve is corrected by the correction coefficient, and the corrected calibration curve and the measuring means are used. When the concentration of the specific component of the analyzed sample is calculated based on the measured value of the measured physical quantity of the analyzed sample, and the value of the correction coefficient calculated by the correction coefficient calculation means is outside the predetermined range, The measured values of the physical quantities of the second standard sample and the sample to be analyzed measured by the measuring means are stored in the storage means, and the calibration curve calculating means is instructed to newly obtain the calibration curve, and the new calibration curve is obtained. Control means for calculating the concentration of the specific component of the analyzed sample based on the obtained calibration curve and the measured values of the physical quantities of the second standard sample and the analyzed sample stored in the storage means. It is.

Further, in the invention according to claim 1, the second
The standard sample and the sample to be analyzed are stored in different cartridges among a plurality of cartridges, and the physical quantity of each sample can be sequentially measured by sequentially transferring the plurality of cartridges to the measuring means.

[0013]

In the present invention, the measuring means measures the physical quantity associated with the concentration of the specific component in the standard sample and the sample to be analyzed in which the concentration of the specific component is known. The calibration curve calculating means is based on the measured values of the physical quantities of the plurality of first standard samples in which the concentrations of the specific components measured by the measuring means are different, and the concentrations of the specific components in the first standard sample. Then, a calibration curve representing the relationship between the physical quantity of the sample and the concentration of the specific component is calculated. Further, since the relationship represented by this calibration curve fluctuates due to changes in the surrounding environment and the like, the correction coefficient computing means measures the physical quantity of the second standard sample measured by the measuring means and the second standard sample. A correction coefficient for correcting the calibration curve is calculated based on the concentration of the specific component and the calibration curve.

In the control means, when the value of the calculated correction coefficient is within a predetermined range, the calibration curve is corrected by the calculated correction coefficient, and the corrected calibration curve and the analyzed object measured by the measuring means are analyzed. The concentration of the specific component of the sample to be analyzed is calculated based on the measured value of the physical quantity of the sample. As a result, the influence of changes in the surrounding environment is eliminated and an accurate concentration of the specific component of the sample to be analyzed can be obtained. On the other hand, when the value of the calculated correction coefficient is out of the predetermined range, an abnormality occurs such that the measurement by the measuring means is not performed normally, or the state of the reagent used for the measurement by the measuring means changes significantly. There is a possibility that

Therefore, when the correction coefficient is outside the predetermined range, the measured values of the physical quantities of the second standard sample and the sample to be analyzed measured by the measuring means are stored in the storing means, and the calibration curve calculating means newly stores them. To instruct to obtain the calibration curve, and the concentration of the specific component of the analyte sample based on the newly obtained calibration curve and the measured values of the physical quantities of the second standard sample and the analyte sample stored in the storage means. Is calculated.
Therefore, when the above-mentioned abnormality occurs, the correction coefficient whose value is out of the predetermined range is used, so that a result including a large error is not output as the concentration of the specific component in the analyzed sample. . Further, since the measured values of the physical quantities of the second standard sample and the sample to be analyzed are once stored in the storage means, they are used when a new calibration curve is obtained and the concentration of the specific component is recalculated. Not only does not need time for measurement, it does not waste the sample to be analyzed,
It is possible to efficiently obtain an appropriate measurement result with a small error.

[0016]

Embodiments of the present invention will now be described in detail with reference to the drawings. FIG. 1 shows an automatic analyzer 10 according to this embodiment.
Is shown. The automatic analyzer 10 includes a casing 12, and on the right front side of the casing 12 when viewed from the front (direction of arrow A in FIG. 1), a loading for loading a cartridge 14 (see FIG. 3) storing a sample therein is provided. Mouth 2
6 is provided. As shown in FIG. 3, the cartridge 14 includes a sample tank 16 for storing a sample, a diluting tank 18 used for diluting the sample, and a reaction tank 20 for performing different reactions depending on inspection items. 22, 24,
Are integrally formed. The loading port 26 is a lid 26A.
It can be opened and closed by.

A floppy disk drive 88 is provided above the loading port 26, and a keyboard 90 for an operator to input data and the like, and a liquid crystal display 92 for displaying inspection results and the like are provided above the floppy disk drive 88. Has been. Further, inside the left front side of the casing 12 when viewed from the front, a reagent storage (not shown) for storing reagents such as antibody-immobilized magnetic microbeads and a luminescent substance described later in a constant environment is provided. A printer 94 for printing the inspection result is provided above the reagent storage.

A measuring section 28 (see FIG. 2) corresponding to the measuring means of the present invention is provided inside the casing 12 when viewed from the front. The measurement unit 28 measures the amount of luminescence as described later as a physical quantity related to the concentration of the specific component (specific antigen). Cartridge 14 is loading port 2
It is loaded into the cartridge standby unit 30 via 6. The cartridge standby unit 30 can be loaded with a large number of cartridges 14, and the loaded cartridges 14 are sent to the transport line 32 one by one. The transfer line 32 is provided with a transfer unit (not shown),
The cartridge 14 sent from the cartridge standby unit 30 is conveyed toward the measuring unit 28 in the direction of arrow B in FIG.

The measuring unit 28 is provided with a transporting means (not shown), and transports the cartridge 14 transported in the transporting line 32 in the direction of arrow C in FIG. In the measuring unit 28, a carrying line 34, a first reagent dispensing unit 36, a first reaction path 38, a second reagent dispensing unit 4 along the carrying direction of the cartridge 14.
0, the second reaction path 42, the unreacted component removing part 44, the luminescent reagent dispensing part 46, the hydrogen peroxide dispensing part 48, and the photometric part 50 are sequentially formed. A transport line 52 is connected to the downstream side of the photometry unit 50 in the transport direction of the cartridge 14, and the transport line 52 is connected to a cartridge discharge unit 54 for accommodating the cartridge 14 that has passed through the measurement unit 28.

On the other hand, a sample dispensing section 56 is provided on the side of the transfer line 34. The sample dispensing unit 56 includes a nozzle (not shown) that is movable in a direction orthogonal to the carrying direction of the cartridge 14 (direction of arrow C in FIG. 2). Further, the first reagent dispensing unit 36 is provided with a reagent dispensing unit 58. The reagent dispensing unit 58 is rotatable in the direction of arrow D in FIG. 2 and corresponds to the cartridge 14 located in the first reagent dispensing section 36 in a rotated state. The reagent dispensing unit 58 is provided with three nozzles (not shown). The three nozzles have three reaction tanks 20, 22, 24 of the cartridge 14 with the reagent dispensing unit 58 corresponding to the cartridge 14. It corresponds to. The first reagent is supplied to the three nozzles from the reagent storage described above.

The second reagent dispensing unit 40 is also provided with a reagent dispensing unit 60 having the same structure as the reagent dispensing unit 58. The second reagent solution is supplied from the reagent storage to three nozzles (not shown) of the reagent dispensing unit 60. Further, the second reagent dispensing section 40 is provided with an unreacted component removing unit 62. The unreacted component removing unit 62 includes a magnet (not shown) and a nozzle having the same configuration as the nozzles of the reagent dispensing units 58 and 60. Further, the unreacted component removal unit 44 is also provided with an unreacted component removal unit 64 having the same configuration as the unreacted component removal unit 62.

The luminescent reagent dispensing section 46 includes a reagent dispensing unit 66 having the same configuration as the reagent dispensing units 58 and 60, and an unreacted component removing unit 68 having the same configuration as the unreacted component removing units 62 and 64. Is provided. A luminescent reagent is supplied from a reagent storage to three nozzles (not shown) of the reagent dispensing unit 66. The hydrogen peroxide dispensing unit 48 is also provided with a reagent dispensing unit 70 having the same configuration as the above reagent dispensing unit. Hydrogen peroxide solution is supplied from a reagent storage to three nozzles (not shown) of the reagent dispensing unit 70.

The photometric unit 50 is provided with a photometric unit 72. The photometric unit 72 is rotatable in the direction of arrow D in FIG. 2 similarly to the reagent dispensing unit 58, and corresponds to the cartridge 14 located in the photometric unit 50 in the rotated state. As shown in FIG. 4, the photometric unit 72 is provided with three nozzles 74, and each nozzle is in communication with a flow cell 78 arranged in the light shielding portion 76. A light receiving element 80 is provided in each light shielding portion 76, and the amount of light emitted from the liquid sucked into the flow cell 78 can be measured.

As shown in FIG. 5, the light receiving element 80 is connected to the input / output port 84D of the control section 84 via the analog-digital converter (A / D converter) 82. Control unit 8
Reference numeral 4 includes a CPU 84A, a ROM 84B, a RAM 84C, and an input / output port 84D, which are connected to each other via a bus 86. The reagent dispensing units 58, 60, 66, 70 and the photometric unit 7 are connected to the input / output port 84D.
2. Unreacted component removing units 62, 64, 68 are connected, and the operation of each unit is controlled by the control unit 84. Further, the above-mentioned printer 94, liquid crystal display 92, keyboard 90 and floppy disk drive 88 are connected to the input / output port 84D.

Next, as the operation of this embodiment, the measurement process in the measuring section 28 will be described first. The sample to be measured by the measuring unit of the automatic analyzer 10 is dispensed into the sample tank 16 of the cartridge 14. The cartridge 14 into which the sample has been dispensed in the sample tank 16 is loaded into the cartridge standby unit 30 via the loading port 26, and then is transported in the direction of arrow B in FIG. The arrow C in FIG.
Transported along the direction.

When the cartridge 14 is conveyed to the site where the sample dispensing unit 56 is disposed, the sample dispensing unit 56 sucks the sample from the sample tank 16 of the cartridge 14 by the nozzle and sucks it into the reaction tanks 20, 22, 24. Dispense the sample. In this state, the sample in each reaction tank contains a wide variety of antigens as shown in FIG. 6 (A). In the automatic analyzer 10 of the present embodiment, different reactions are carried out in the respective reaction tanks so that the concentrations of three kinds of antigens can be measured at the same time. Antigen (Fig. 6
The measurement of the physical quantity (the amount of luminescence described later) for obtaining the concentration of the diamond) will be described.

The cartridge 14 that has reached the first reagent dispensing section 36 is dispensed with the first reagent into each reaction tank by the reagent dispensing unit 58. Here, as the first reagent, antibody-immobilized magnetic microbeads in which an antibody that specifically reacts with a specific antigen is bound to magnetic microbeads are dispensed. For the dispensed first reagent, the cartridge 14 has the first reaction path 38
While being transported, it reacts with and binds to a specific antigen (see FIG. 6 (B)).

When the cartridge 14 reaches the second reagent dispensing section 40, the magnet of the unreacted component removing unit 62 first contacts each reaction tank, and in this state, the nozzle sucks the reaction solution in each reaction tank. . As a result, FIG.
As shown in (1), the magnetic microbeads are attracted to the magnet, so that the specific antigen remains in the reaction tank and other antigens are removed together with the reaction solution (so-called B / F separation). Next, the reagent dispensing unit 60 dispenses the second reagent into each reaction tank. Here, as the second reagent, a labeled antibody in which a labeling enzyme is bound to an antibody that specifically reacts with a specific antigen is dispensed. The second reagent dispensed is stored in the second cartridge 14
While being transported through the reaction path 42, it reacts with and binds to a specific antigen (see FIG. 6D).

The cartridge 14 has an unreacted component removing section 44.
When it reaches, the B / F separation is performed by the unreacted component removing unit 64 in the same manner as described above. Next, the cartridge 14 is conveyed to the luminescent reagent dispensing unit 46, and B / F separation is performed again by the unreacted component removing unit 68. The unreacted second reagent is removed from these (see FIG. 6E). Next, the reagent dispensing unit 66 dispenses the luminescent reagent. Here, as the luminescent reagent, a luminescent reagent that emits light using the labeling enzyme of the second reagent as a catalyst is dispensed.

Further, in the hydrogen peroxide dispensing section 48, the reagent dispensing unit 70 dispenses hydrogen peroxide solution into each reaction tank. As a result, the dispensed luminescent reagent emits light (see FIG. 6 (F)). This luminescence amount depends on the amount of the labeling enzyme in the reaction tank, that is, the amount (concentration) of the specific antigen. Therefore, a luminescence amount corresponding to the concentration of the specific antigen in the sample can be obtained. When the cartridge 14 reaches the photometric unit 50, the light receiving element 80 of the photometric unit 72 measures the light emission amount of the reaction liquid in each reaction tank. The measured value of luminescence is A
It is taken into the control unit 84 via the / D converter 82.

Next, the operation of the control section 84 will be described with reference to the flowchart of FIG. The processing shown in FIG. 7 is performed by the control unit 84 when the power of the automatic analyzer 10 is turned on.
Executed by In step 100, it is determined whether or not the calibration for creating the calibration curve is executed. The calibration is performed when the automatic analyzer 10 is newly installed, when the reagent lot is switched, or when it becomes necessary to perform the calibration as described later, and the operator knows the concentration of the specific antigen. A plurality of standard samples (corresponding to the first standard sample of the present invention) having different specific antigen concentrations and different cartridges 1
The cartridge 14 in which the standard sample is dispensed is loaded into the automatic analyzer 10 and then the execution of the calibration is instructed.

As a result, the determination in step 100 is affirmed, and the concentrations of the specific antigens in the plurality of standard samples to be measured in step 102 are loaded. Specifically, a message requesting the operator to input the concentration of the specific antigen in the standard sample is displayed on the liquid crystal display 92, and the concentration is input. As a result, the operator respectively inputs the concentrations of the specific antigens in the plurality of standard samples via the keyboard 90, and the control unit 84 stores the input concentration values (c ₁ , c ₂ , ..., C _n ) in the RAM 84C. .

In the next step 104, the measurement of the luminescence amount of the standard sample is started. Thus, each concentration of the specific antigen is transported to a plurality of cartridges 14 are sequentially measuring unit 28 a standard sample has been dispensed different, each through the above process, the light emission amount _{(r 1, r 2, ...} , r n ) Is measured. In step 106, it is determined whether or not the measurement of the luminescence amount of each standard sample is completed, and the process waits until the measurement is completed. When the measurement is completed, the determination in step 106 is affirmative, and in step 108, a calibration curve (see FIG. 8) representing the relationship between the concentration of the specific antigen and the luminescence amount is created.

In this calibration curve, as shown in FIG. 8, the horizontal axis represents the concentration of the specific antigen and the vertical axis represents the luminescence amount, and the concentration of the specific antigen in each standard sample and the measured luminescence amount were plotted and plotted. It can be obtained by interpolating between the points. In step 108, the calibration curve data representing the created calibration curve is stored in the floppy disk loaded in the floppy disk drive 88. If a calibration curve has already been created and calibration curve data has been stored in the past, this is updated.

In the next step 109, it is determined whether or not the unconverted and unoutput light emission amount data is stored in the floppy disk. The unconverted / unoutput light emission amount data will be described later, but it is assumed that the data is not stored here, and the process proceeds to step 118.

After step 118, the analysis sample collected from the subject is measured. In a normal operation, the sample to be analyzed is collected from each of a plurality of subjects, and the operator inserts each sample to be analyzed into a sample tank 16 of a different cartridge 14.
And a standard sample in which the concentration of the specific antigen is known (this standard sample is for one-point correction described later and corresponds to the second standard sample of the present invention).
A single or a plurality (for example, three) cartridges 14
After dispensing into each of the sample tanks 16 and loading in the automatic analyzer 10 so that the standard sample is measured first, the measurement is instructed.

In step 118, the operator is requested to input the concentration of the specific antigen in the standard sample to be measured,
The density C ₀ input by the operator is captured and stored. In step 120, the measurement of the standard sample for one-point correction and the sample to be analyzed is started. As a result, first, the plurality of cartridges 14 into which the standard sample for one-point correction is dispensed are sequentially transported to the measurement unit 28, and then the plurality of cartridges 14 into which the sample to be analyzed is dispensed are sequentially transported to the measurement unit 28. Then, the amount of light emission is measured through each of the processes described above.

In step 122, it is judged whether or not the measurement of the luminescence amount of the standard sample is completed, and the process waits until the measurement is completed. When the measurement of the light emission amount of the standard sample is completed, the determination at step 122 is affirmative, and at step 124, the calibration curve data is taken from the floppy disk. Step 1
At 26, the one-point correction coefficient α is calculated. First, the average value R ₀ of the luminescence amount of the standard sample measured by each of the plurality of cartridges 14 is calculated, and then the concentration C ₀ is calculated from the calibration curve data.
The amount of light emission r ₀ corresponding to is taken in. The one-point correction coefficient α is calculated by the following equation.

Α = R ₀ ÷ r _{0 At the} next step 128, it is determined whether the value of the one-point correction coefficient α is within a predetermined range, that is, whether the value is larger than 0.8 and smaller than 1.2. If the determination in step 128 is affirmative, it is determined that there is no problem in using the calculated one-point correction coefficient α, and in step 130, the calibration curve is corrected using the one-point correction coefficient α. In this correction, the one-point correction coefficient α is used as the emission amount of the calibration curve data (r ₁ , r ₂ , ..., R _n ).
It is done by multiplying each of. That is, (r ₁ ′, r ₂ ′, ..., R _n ′) = α × (r ₁ , r ₂ , ..., R
_n ) As a result, when α> 1 (for example, R ₀ is R1 in FIG. 8), the calibration curve is corrected as shown by L ₁ in FIG. 8, and α <
1 (as an example, R ₀ is R ₂ in FIG. 8), L _{2 in} FIG.
The calibration curve will be corrected as shown by. In the next step 132, it is determined whether or not the measurement of the luminescence amount of all the analyzed samples has been completed. When the luminescence amounts of all the samples to be analyzed are measured, in step 134, the measured luminescence amount is converted into the concentration of the specific antigen using the calibration curve corrected above.
By using the corrected calibration curve, even if the state of the reagent has changed since the time when the calibration curve was created due to the surrounding environment or the like, a concentration value with this change corrected can be obtained. In the next step 136, the obtained concentration of the specific antigen is printed by the printer 94, and the process ends.

On the other hand, when the value of the one-point correction coefficient α calculated in step 126 is out of the predetermined range, there is a possibility that an abnormality such as a large change in the state of the reagent has occurred due to a power failure or the like, The calibration curve corrected using this one-point correction coefficient α falls within the range shown by hatching in FIG. 8, and is largely deviated from the original calibration curve. In such a case, the determination in step 128 is denied, and the luminescence amount data R ₀ of the standard sample for one-point correction and the luminescence amount data of all the analyzed samples measured by the measuring unit 28 in step 138 are
The data is stored in the floppy disk without converting the concentration of the specific antigen and outputting the converted concentration. In the next step 140, the printer 94 prints "RECAL" (indicating that it is necessary to perform a calibration for newly obtaining a calibration curve), and the process ends.

As a result, the operator recognizes that it is necessary to calibrate, and causes the above-mentioned steps 102 to 108 to be calibrated. At this time, since the unconverted / non-output luminescence amount data is stored in the floppy disk, the determination in step 109 is affirmative, and in step 110, the unconverted / non-output luminescence amount data and the standard sample for one-point correction are stored. Light emission data R
Read ₀ from the floppy disk. Next step 1
12, the light emission amount data R ₀ and steps 102 to 10
Based on the light emission amount r ₀ corresponding to the density C ₀ of the calibration curve data newly obtained in 8, the one-point correction coefficient α is calculated in the same manner as in step 126 described above, and in step 113, the same as in step 128 described above. It is determined whether the value of the one-point correction coefficient α is within a predetermined range.

When the determination in step 113 is positive, the calibration curve is corrected using the one-point correction coefficient in step 114, and in the next step 115, the luminescence amount data of the specific antigen is calculated using the corrected calibration curve. The density value is converted into a density value, and in step 116, the density value converted by the printer 94 is output. This prevents the sample to be analyzed from being wasted, saves time for re-measurement, and uses the newly prepared calibration curve to obtain an appropriate concentration value with less error. If the determination in step 113 is negative, "RECAL" is printed by the printer 94 in step 117, recalibration is requested, and the process ends.

In the above description, the case where one-point correction is performed has been described as an example. However, the present invention is not limited to this, and the calibration curve is obtained by measuring the luminescence amounts of two standard samples having different concentrations. The present invention can also be applied to the case of performing two-point correction. The present invention can also be applied to the case where the calibration curves are corrected by measuring the luminescence amounts of three or more standard samples having different concentrations.

Further, in the above, the fact that the calibration for newly obtaining the calibration curve needs to be performed is printed by printing "RECAL", but instead of this, a buzzer sounds or a message is issued. May be displayed on a display or the like.

Further, in the above, the value of the one-point correction coefficient α is 0.
It was determined whether it was outside the predetermined range by determining whether it was larger than 8 and smaller than 1.2, that is, whether the variation of the value with respect to the calibration curve data was 20% or more. It is not limited to the above numerical value, and for example, it may be determined whether or not it is out of the predetermined range by determining whether or not the variation of the value is 50% or more.

The measuring method in the measuring section 28 is only an example, and the measuring method is not limited to the above. For example, although the amount of luminescence of the luminescent reagent that emits light using the labeling enzyme as a catalyst is measured in the above, for example, when a radioisotope is used as the labeling substance, the radiation dose can be measured. Although the calibration curve is shown as a straight line in FIG. 8 for convenience, the calibration curve is not limited to a straight line.

[0047]

As described above, according to the present invention, when the value of the correction coefficient for correcting the calibration curve calculated by measuring the physical quantity of the second standard sample is within the predetermined range, the calibration curve is obtained. Is corrected by the correction coefficient, the concentration of the specific component of the analyzed sample is calculated based on the corrected calibration curve and the measured value of the physical quantity of the analyzed sample, and the value of the calculated correction coefficient is within a predetermined range. In other cases, the measured values of the physical quantities of the second standard sample and the sample to be analyzed are stored in the storage means, and
It is instructed to newly obtain a calibration curve, and when a new calibration curve is obtained, the analytical sample is analyzed based on the newly obtained calibration curve and the measured value of the physical quantity stored in the storage means. Since the concentration of the specific component is calculated, it is possible to obtain an excellent effect that an appropriate measurement result with less error can be obtained without wasting the sample and the measurement time even when an abnormality occurs.

[Brief description of drawings]

FIG. 1 is a perspective view showing the appearance of an automatic analyzer according to this embodiment.

FIG. 2 is a schematic configuration diagram of the inside of an automatic analyzer.

FIG. 3 is a perspective view showing a cartridge.

FIG. 4 is a schematic configuration diagram of a measurement unit.

FIG. 5 is a schematic block diagram around a control unit.

6A to 6F are explanatory views for explaining a process of measuring the light emission amount in the measurement unit.

FIG. 7 is a flowchart illustrating a process in a control unit.

FIG. 8 is a diagram showing a calibration curve.

[Explanation of symbols]

 10 automatic analyzer 14 cartridge 28 measuring unit 84 control unit 94 printer

Claims (2)

[Claims] 1. A measuring means for measuring a physical quantity related to the concentration of the specific component of a standard sample and a sample to be analyzed, in which the concentration of the specific component is known, and a plurality of different concentrations of the specific component measured by the measuring means. A calibration curve representing the relationship between the physical quantity of the sample and the concentration of the specific component is obtained based on the measured value of the physical quantity of each of the first standard samples and the concentration of the specific component of each of the first standard samples. Calibration curve calculating means, for correcting the calibration curve based on the measured value of the physical quantity of the second standard sample measured by the measuring means, the concentration of the specific component of the second standard sample, and the calibration curve Correction coefficient calculation means for calculating the correction coefficient, storage means for storing the measured values of the physical quantities of the second standard sample and the analyzed sample measured by the measurement means, and the correction coefficient calculation means When the value of the positive coefficient is within the predetermined range, the calibration curve is corrected by the correction coefficient, and the calibration curve and the measured value of the physical quantity of the sample to be analyzed measured by the measuring means are used to correct the calibration curve. When the concentration of the specific component of the analytical sample is calculated and the value of the correction coefficient calculated by the correction coefficient calculating means is out of the predetermined range, the physical quantities of the second standard sample and the analyzed sample measured by the measuring means The second standard sample stored in the storage means while instructing the calibration curve calculation means to newly obtain a calibration curve And a control means for calculating the concentration of the specific component of the sample to be analyzed based on the measured value of the physical quantity of the sample to be analyzed. 2. The second standard sample and the sample to be analyzed are stored in different cartridges of a plurality of cartridges, and the physical quantities of the respective samples are sequentially transferred by sequentially transferring the plurality of cartridges to the measuring means. The automatic analyzer according to claim 1, which is measured.