JP7420976B2 - Automatic analyzer and analysis method - Google Patents

Description

The present invention relates to an automatic analyzer and an analysis method for clinical testing.

Regarding automatic analyzers equipped with multiple photometers of two or more types, a patent has been granted as an example of technology that can realize suitable output from the measurement results of multiple photometers and data alarms even if there is an abnormality during measurement. Document 1 includes, for example, two types of photometers with different quantification ranges and an analysis control unit that controls analysis including measurement of a target specimen using the two types of photometers, and the analysis control unit includes two types of photometers. If two types of measurement results using a photometer are accompanied by two types of data alarms depending on abnormalities during measurement, the output will correspond to the combination of the two types of data alarms. It is described that measurement results and data alarms are selected and output to the user as analysis results.

International Publication 2019/130668

Automatic analyzers for clinical tests detect the concentration and amount of target components contained in biological samples (hereinafter referred to as specimens) such as blood and urine based on optical measurements.

As a method for detecting a target component substance, an absorption photometry method that measures the amount of light transmitted through a specimen is often used. In spectrophotometry, light from a light source is irradiated onto a sample or a reaction solution (a mixture of a sample and a reagent), and the resulting amount of transmitted light of one or more wavelengths is measured to calculate absorbance. In the spectrophotometric method, the amount of the target component substance is determined from the relationship between absorbance and concentration according to the Lambert-Beer law.

In addition, automatic analyzers for clinical tests are known to achieve high sensitivity in immunoassays, for example, by using a light scattering detection method that utilizes changes in the amount of scattered light, which makes it easier to detect larger changes in the amount of light. ing. In the light scattering detection method, an aggregate produced by an antigen-antibody reaction is irradiated with light, and at least one of the amount or intensity of the scattered light scattered by the aggregate is measured. Thereafter, the amount of the target component substance is determined from the relationship between the amount of light or light intensity and the concentration.

There are differences in characteristics between an absorption photometer that uses absorption photometry and a scattering photometer that uses light scattering detection, including the range that can be measured and quantified (hereinafter sometimes referred to as "quantification range" etc.). be. Therefore, in recent years, automatic analyzers have been developed that take advantage of the differences in the characteristics of these two types of photometers and incorporate two types of photometers into one to widen the dynamic range of measurement.

As a prior art related to the above-mentioned automatic analyzer, there is a technology described in Patent Document 1. Patent Document 1 discloses a method for realizing a suitable output from measurement results and alarm contents when measured using two or more types of photometers, and a method for realizing a suitable automatic retest control.

When measuring one test item with a device equipped with an absorption photometer and a scattering photometer, two types of reagents are used: one for the absorption photometer measurement and the other for the scattering photometer measurement. It needed to be installed. This is because the appropriate reagent concentration for each measurement is different, so there is a problem that a suitable quantitative range cannot be obtained when the same reagent is used for measurement with an absorption photometer and a scattering photometer. .

For example, consider a case where the reagent concentration is suitable for measurement with a scattering photometer, but too low for measurement with an absorption photometer. There is no problem when measuring low concentration regions using a scattering photometer, but when measuring high concentration regions using an absorption photometer, the upper limit of quantification becomes small due to the low reagent concentration, making it difficult to obtain a sufficient quantification range. There is a possibility that there is no.

In addition, if we consider that the reagent concentration is suitable for measurement with an absorption photometer but too high for measurement with a scattering photometer, the measurement sensitivity of the scattering photometer will decrease, making it difficult to quantify low concentration regions. may not be possible.

Therefore, in order to obtain a suitable quantitative range using two types of photometers, it is necessary to install two types of reagents with different concentrations for one test item. This operation has the problem of compressing the capacity of the reagent disk and reducing the number of items that can be tested using the reagents placed on the reagent disk.

The present invention solves the above-mentioned problems of the prior art and provides an automatic analyzer and analysis method that can obtain a suitable quantitative range using an absorption photometer and a scattering photometer without compressing the volume of a reagent disk. .

The present invention includes a plurality of means for solving the above-mentioned problems, and one example thereof is a reaction container containing a reaction solution produced by mixing a specimen and a reagent, and a reaction container containing the reagent. a reagent dispensing mechanism that dispenses a reagent, an absorption photometer that measures light transmitted through the reaction solution, a scattering photometer that measures light scattered within the reaction solution, and a control that controls the operation of each device. an apparatus, wherein the control apparatus controls the operation of the reagent dispensing mechanism so that analysis by the spectrophotometer and analysis by the scattering photometer are performed using the same type of reagent at different concentrations. Features.

According to the present invention, a suitable quantitative range can be obtained using an absorption photometer and a scattering photometer without compressing the volume of the reagent disk. Problems, configurations, and effects other than those described above will be made clear by the description of the following examples.

1 is a diagram showing the overall schematic configuration of an automatic analyzer according to Example 1 of the present invention. FIG. 2 is a functional block diagram showing the configuration of a computer and a control unit that control the operation of the automatic analyzer of Example 1. FIG. 3 is a configuration diagram of an analysis parameter input screen in the automatic analyzer of Example 1. FIG. 2 is a correspondence table showing the correspondence between initial measurement conditions, alarm contents, and retest conditions in the automatic analyzer of Example 1. 3 is a flowchart showing the operation of the automatic analyzer in Example 1. It is a flowchart showing the operation of the automatic analyzer in Example 2 of the present invention. It is a flowchart which shows the operation of the automatic analyzer in Example 3 of the present invention. It is a figure which shows an example of the analysis parameter setting screen of the automatic analyzer in Example 4 of this invention. It is a figure which shows an example of the analysis parameter setting screen of the automatic analyzer in Example 5 of this invention. It is a figure which shows an example of the analysis parameter setting screen of the automatic analyzer in Example 6 of this invention. It is a correspondence table showing the correspondence between initial measurement conditions, alarm contents, and retest conditions in the automatic analyzer of Example 6 of the present invention. It is a flowchart which shows the operation of the automatic analyzer in Example 6 of the present invention. It is a flowchart which shows the operation of the automatic analyzer in Example 7 of the present invention. It is a flowchart which shows the operation of the automatic analyzer in Example 8 of the present invention.

Embodiments of an automatic analyzer and an analysis method of the present invention will be described below with reference to the accompanying drawings. In the accompanying drawings, functionally identical elements may be designated by the same or similar numbering and repeated description may be omitted.

Note that although the attached drawings show specific implementation examples in accordance with the principles of the present disclosure, they are for the purpose of understanding the present disclosure, and should not be used to limit the interpretation of the present disclosure in any way. isn't it. It should also be understood that other implementations and forms are possible, and that configurations and structures can be changed and various elements can be replaced without departing from the scope and spirit of the technical idea of the present disclosure. Therefore, the following description should not be interpreted as being limited to this.

<Example 1>
Embodiment 1 of the automatic analyzer and analysis method of the present invention will be described using FIGS. 1 to 5.

First, the overall configuration of the automatic analyzer will be explained using FIG. 1. FIG. 1 is a diagram showing the overall schematic configuration of an automatic analyzer 1 of Example 1.

The automatic analyzer 1 shown in FIG. 1 includes a sample disk 4, a reaction disk 10, a reagent disk 7, a sample dispensing mechanism 11, a reagent dispensing mechanism 12, a control section 17, a measuring section 18, a computer 20, and the like.

The reaction disk 10 is placed between the sample disk 4 and the reagent disk 7. In this reaction disk 10, reaction containers 9, which are containers for accommodating a reaction liquid 8 generated by mixing the specimen 2 and the reagent 5, are arranged in parallel and spaced apart from each other along the circumferential direction of the reaction disk 10. It is maintained in the same condition. The reaction vessel 9 is made of a light-transmitting material for measurements by an absorption photometer 14 and a scattering photometer 15.

The reaction disk 10 moves the plurality of reaction containers 9 along the circumferential direction by rotating under the control of the control unit 17 . The reaction disk 10 arranges one reaction container 9 of the plurality of reaction containers 9 at a predetermined position provided along the circumferential direction by rotation of the disk. The predetermined position is, for example, a specimen discharging position by the specimen dispensing mechanism 11, a reagent discharging position by the reagent dispensing mechanism 12, or the like.

Further, the reaction disk 10 is equipped with a constant temperature bath 19, and each of the plurality of reaction vessels 9 arranged on the reaction disk 10 is constantly immersed in constant temperature bath water (also referred to as constant temperature fluid) in this constant temperature bath 19. ing. Thereby, the reaction liquid 8 in the reaction container 9 is maintained at a constant reaction temperature (for example, about 37° C.). The temperature and flow rate of the constant temperature bath water in the constant temperature bath 19 are controlled by the control unit 17, and the amount of heat supplied to the reaction vessel 9 is controlled.

On and near the circumference of the reaction disk 10, in addition to the sample dispensing mechanism 11 and the reagent dispensing mechanism 12, a stirring section 13, an absorption photometer 14, and a scattering photometer 15 are provided at different positions. , a cleaning tank 16a, a cleaning section 16b, etc. are arranged.

A plurality of sample cups 3 are installed and held on the sample disk 4. The sample cup 3 is a sample container that accommodates the sample 2. Each sample cup 3 is held on a sample disk 4 so as to be spaced apart from each other in the circumferential direction.

Reagent disk 7 is placed next to reaction disk 10. A plurality of reagent bottles 6 are installed and held on the reagent disk 7. The reagent bottle 6 is a reagent container that stores the reagent 5. The reagent bottle 6 contains a type of reagent 5 corresponding to the target component substance of the test item in the automatic analyzer 1. Each type of reagent 5 is contained in a separate reagent bottle 6.

The sample dispensing mechanism 11 is installed between the sample disk 4 and the reaction disk 10, and includes a movable arm and a dispensing nozzle consisting of a pipette nozzle attached to the movable arm.

The sample dispensing mechanism 11 performs a sample dispensing operation, which is an operation of inhaling the sample 2 from the sample cup 3 at the sample suction position of the sample disk 4 and discharging it into the reaction container 9 at the sample discharge position of the reaction disk 10. During the sample dispensing operation, the dispensing nozzle is moved to the sample suction position on the sample disk 4, and a predetermined amount of the sample 2 is sucked into the dispensing nozzle from the sample cup 3 placed at the sample suction position and stored. do. Thereafter, the sample dispensing mechanism 11 moves the dispensing nozzle to the sample discharge position on the reaction disk 10, and discharges the sample 2 in the dispensing nozzle into the reaction container 9 arranged at the sample discharge position.

The reagent dispensing mechanism 12 is installed between the reagent disk 7 and the reaction disk 10, and, like the sample dispensing mechanism 11, includes a movable arm and a dispensing nozzle.

The reagent dispensing mechanism 12 performs a reagent dispensing operation, which is an operation of inhaling the reagent 5 from the reagent bottle 6 at the reagent suction position of the reagent disk 7 and discharging it into the reaction container 9 at the reagent discharge position of the reaction disk 10. The reagent 5 to be dispensed is a reagent used for quantifying a target component substance, which is an analysis item (also called a test item, etc.) set corresponding to the target specimen 2.

During a reagent dispensing operation, the reagent dispensing mechanism 12 moves the dispensing nozzle to a reagent suction position on the reagent disk 7, and dispenses a predetermined amount of reagent into the dispensing nozzle from the reagent bottle 6 disposed at the reagent suction position. Inhale and contain 5. After that, the reagent dispensing mechanism 12 moves the dispensing nozzle to the reagent discharging position on the reaction disk 10 and discharging the reagent 5 in the dispensing nozzle into the reaction container 9 arranged at the reagent discharging position. The sample 2 and the reagent 5 are mixed to prepare a reaction solution 8.

The specimen dispensing mechanism 11 and the reagent dispensing mechanism 12 are each provided with a cleaning tank 16a in preparation for dispensing different types of specimens 2 or reagents 5. The cleaning tank 16a is a mechanism for cleaning the dispensing nozzle. Each dispensing mechanism cleans each dispensing nozzle in the cleaning tank 16a before and after the dispensing operation. This prevents contamination between the samples 2 or between the reagents 5.

Further, the dispensing nozzle of each dispensing mechanism is equipped with a sensor that detects the liquid level of the sample 2 or reagent 5. This makes it possible to monitor and detect measurement abnormalities due to shortage of specimen 2 or reagent 5.

In addition, the sample dispensing mechanism 11 is equipped with a pressure sensor that detects clogging of the dispensing nozzle. Thereby, it is possible to monitor and detect a dispensing abnormality that occurs when the dispensing nozzle is clogged with an insoluble substance such as fibrin contained in the specimen 2. The control unit 17 is capable of monitoring and detecting various abnormalities during measurement through a mechanism including these sensors.

In addition, the sample dispensing mechanism 11 and the reagent dispensing mechanism 12 have dispensing nozzles filled with pure water (hereinafter referred to as system water), and inhale the sample 2 and reagent 5 by driving the system water.・It is spitting out. The sample dispensing mechanism 11 and the reagent dispensing mechanism 12 can dilute the sample and reagent to a specific concentration by simultaneously discharging system water as dilution water and the sample 2 and reagent 5 into the reaction container 9. be.

The reaction container 9 into which the specimen 2 has been dispensed by the specimen dispensing mechanism 11 is moved to the reagent discharge position by the rotation of the reaction disk 10. At the same time, the reagent dispensing mechanism 12 moves the dispensing nozzle to the reagent discharge position and discharges the reagent, thereby mixing the specimen and the reagent in the reaction container 9. There are three reagent discharge timings, R1, R2, and R3, and each timing is uniquely determined. When measuring by dispensing two types of reagents for one specimen, the first reagent is dispensed at R1 timing, and the second reagent is dispensed at R2 timing or R3 timing.

The stirring part 13 is a part for stirring the mixed liquid of the specimen 2 and the reagent 5 in the reaction container 9 arranged at a stirring position which is a predetermined position on the reaction disk 10, and is, for example, a stirrer equipped with stirring blades, Alternatively, it is equipped with a stirring mechanism using ultrasonic waves. As a result, the mixed liquid in the reaction container 9 is uniformly stirred, the reaction is promoted, and a reaction liquid 8 is obtained.

The automatic analyzer 1 of this embodiment has one absorption photometer 14 as a first type photometer and one scattering photometer 15 as a second type photometer. Each of the absorption photometer 14 and the scattering photometer 15 has a light source and a light receiving section as a basic structure. The light source of each photometer is arranged, for example, on the inner circumference side of the reaction disk 10, and the light receiving section of each photometer is arranged on the outer circumference side of the reaction disk 10. Each photometer is connected to a measuring section 18.

The spectrophotometer 14 measures the reaction liquid 8 in the reaction container 9 placed at a predetermined measurement position (particularly the first measurement position) on the reaction disk 10 . The scattering photometer 15 measures the reaction liquid 8 in the reaction container 9 placed at a measurement position (particularly the second measurement position) that is a predetermined position on the reaction disk 10 .

This spectrophotometer 14 irradiates light from a light source to the reaction liquid 8 in the reaction container 9 at the first measurement position. At this time, the absorption photometer 14 detects the light that has passed through the reaction solution 8 using the light receiving section, and detects at least one of the light amount or light intensity of the transmitted light of a single or multiple wavelengths (when described as light amount/light intensity). ).

The scattering photometer 15 irradiates light from a light source onto the reaction liquid 8 in the reaction container 9 at the second measurement position. At this time, the scattering photometer 15 detects the scattered light scattered within the reaction liquid 8 using the light receiving section, and measures at least one of the amount or intensity of the scattered light (light amount/light intensity).

The cleaning section 16b cleans the reaction container 9 placed at the cleaning position on the reaction disk 10. The cleaning section 16b discharges the remaining reaction liquid 8 from the reaction vessel 9 after the measurement and analysis, and cleans the reaction vessel 9. The cleaned reaction vessel 9 can be reused. That is, the next sample 2 is dispensed from the sample dispensing mechanism 11 and the next reagent 5 is dispensed from the reagent dispensing mechanism 12 into the reaction container 9 again.

In the automatic analyzer 1 in this embodiment, when the sample 2 or the target component of the sample 2 has a high concentration, the concentration calculated from the measurement value of the spectrophotometer 14 is used, and when the sample 2 or the target component of the sample 2 has a low concentration, the concentration calculated from the measurement value of the spectrophotometer 14 is used. The concentration calculated from the measurement value of the scattering photometer 15 can be output from the output section 32 as an analysis result, making it possible to perform measurements with a wide dynamic range.

The computer 20 includes a data storage section 21, an analysis section 22, an input section 31, an output section 32, and the like. The computer 20 is composed of, for example, a PC, but is not limited to this, and may be composed of a circuit board such as an LSI board, or a combination thereof.

FIG. 2 is a functional block diagram of the computer 20 and the control unit 17 that control the operation of the automatic analyzer 1 of this embodiment.

As shown in FIG. 2, the computer 20 includes a data storage section 21 that stores measurement request information, analysis parameters, and measurement results, and an analysis section 22 that analyzes data such as absorbance and scattered light intensity measured by the measurement section 18. and an automatic reexamination determination section 23.

The automatic analyzer 1 of this embodiment has an automatic retesting function, and the automatic retesting determination unit 23 determines whether retesting is necessary based on the analysis result of the analysis unit 22, and if retesting is necessary, the retesting request information is stored in the data storage section 21.

The computer 20 is connected to a measurement section 18 that measures the specimen 2 using an absorption photometer 14 and a scattering photometer 15, and a control section 17 that controls various mechanisms, and according to the measurement request information input from the input section 31. The analysis operation is performed and the measured results are output from the output unit 32.

In this embodiment, the computer 20 and the control unit 17 control the operation of the reagent dispensing mechanism 12 so that the analysis by the spectrophotometer 14 and the analysis by the scattering photometer 15 are performed using the same type of reagent at different concentrations. .

For example, the automatic retest determination unit 23 of the computer 20 performs a measurement using one of the absorption photometer 14 and the scattering photometer 15, and performs a retest using the other photometer based on the measurement result. It is configured such that it is possible to select whether or not. At this time, the measurement result by one photometer is compared with a preset threshold value, and based on the comparison result, it is determined whether or not to perform a retest using the other photometer.

Here, in this embodiment, measurement using the spectrophotometer 14 is performed first, but in this case, the computer 20 and the control unit 17 dispense the stock solution of the reagent into the reaction container 9 using the reagent dispensing mechanism 12. Based on the measurement result of the spectrophotometer 14, it is determined whether or not to perform the measurement using the scattering photometer 15. If the measurement using the scattering photometer 15 is to be performed, the stock solution of the reagent is diluted. The operation of the reagent dispensing mechanism 12 is controlled so that the diluted reagent is dispensed and measured.

A known method can be used to prepare the diluted reagent at this time.

Next, the structure of the analysis parameters to be referred to and the actual operation flow when making measurements using the absorption photometer 14 and the scattering photometer 15 in the automatic analyzer 1 of this embodiment will be explained using FIGS. 3 to 5.

FIG. 3 is an example of a configuration diagram of an operation unit for setting analysis parameters in the first embodiment. In the automatic analyzer 1 of this embodiment, the operation unit for setting analysis parameters is configured as an application setting screen 71 as a GUI as shown in FIG. The application setting screen 71 is displayed on a display device such as a display included in the output section 32 by a predetermined operation of an operating device such as a keyboard and a mouse included in the input section 31 . The analysis parameters are configured to be set and input via the input section 31 on this application setting screen 71.

As shown in FIG. 3, the application setting screen 71 has an item selection field 72 for application settings and a parameter setting field 73 for each selected item. In FIG. 3, a state is shown in which "Analysis" is selected in the item selection field 72 and a parameter setting field 73 for setting analysis parameters is displayed.

A parameter setting column 73 for setting analysis parameters includes a photometer common setting column 75 for setting and inputting analysis parameters common to the spectrophotometer 14 and scattering photometer 15, and a photometer common setting column 75 for setting and inputting analysis parameters only for the spectrophotometer 14. The screen is divided into a spectrophotometer-dedicated setting field 76 and a scattering photometer-dedicated setting field 77 for setting and inputting analysis parameters only for the scattering photometer 15.

In FIG. 3, in the photometer common setting column 75, "CRP (C-reactive protein)" is selected as the type of analysis item, and " The example shows a state in which "absorption analysis" is selected and "possible" is selected as the type of photometer change at re-examination. The sample amount is "5 [μl]", the "reagent dispensing amount" is "140 [μl]" for the first reagent in "R1", "0 [μl]" in "R2", and the second reagent in "R3". The reagent is set to "70 [μl]", the component amount "3" is set as the "absorption/scattering result difference check value", and the "output unit" of the component amount is set to "mg/dl". is exemplified.

In addition, in the spectrophotometer-specific setting field 76, the type of "analysis method" is a method for determining the concentration of the target component from two measured values: the measured value before the reaction or immediately after the reaction starts, and the measured value at the end of the reaction. The example shows a state in which "2 point end" is set to "800/450 [nm]" as the main/sub wavelength of two-wavelength photometry as the "measurement wavelength." Furthermore, "19" and "30" were selected or set as "photometric points" and "5 to 40" of the component amount (measured value of the concentration of the target component) was selected or set as the "quantification range" by the spectrophotometer 14. The state is illustrated.

Regarding the types of analysis methods, in addition to this "2-point end" method, for example, "1-point end" uses the same endpoint method and uses the measured value at the end of the reaction, and "1-point end" uses the same endpoint method to measure the concentration of the substance by measuring the reaction rate. The desired "rate method" can be selected using a pull-down menu.

Further, in the scattering photometer dedicated setting field 77, a state is illustrated in which "2 point end" is set as the type of analysis method and "20°" is set as the light receiving angle. Then, "21" and "30" are "photometric points", "0.1 to 10" of the component amount is "quantification range" by the scattering photometer 15, and "reagent dilution magnification" at the time of analysis by the scattering photometer 15. A state in which "2.0" is selected or input as "2.0" is illustrated.

FIG. 4 is an example of a correspondence table in which the combinations of initial measurement conditions and alarm contents and the correspondence between re-examination conditions are defined in the inspection flow of this embodiment. According to this correspondence table, the automatic reexamination determination unit 23 selects conditions such as a photometer, reagent concentration, and sample amount to be used at the time of reexamination, and requests a reexamination. In accordance with the retest request, the control section 17 and the measurement section 18 control the operations of each section including the reagent dispensing mechanism 12 so as to execute the retest operation.

In FIG. 4, No. In example 1, when the initial measurement condition on the analysis parameters is that the photometer is "absorbance" and the reagent is "undiluted solution", if an alarm of "absorbance quantification range lower limit exceeded" occurs, the photometer will be set to "scattering". , an automatic retest is performed under the conditions that the reagent is “diluted” and the sample amount is “standard”.

Here, exceeding the lower limit of the absorbance quantification range means that the result of the first measurement by the spectrophotometer 14 is below the lower limit of the "quantification range" set in the spectrophotometer-specific setting column 76 on the analysis parameters in FIG. This is an alarm that occurs when the In this case, a retest is performed using the scattering photometer 15, which can measure lower concentrations.

In FIG. 4, No. In 2, when the initial measurement conditions are the photometer is “scattering” and the reagent is “dilution,” and an alarm of “scattering quantification range upper limit exceeded” occurs, the photometer is “absorbing” and the reagent is “diluting.” , Automatic retesting is performed under conditions where the sample amount is “standard”.

Note that exceeding the lower upper limit of the scattering quantification range means that the result of the first measurement by the scattering photometer 15 exceeds the upper limit of the "quantification range" set in the scattering photometer-specific setting column 77 on the analysis parameters in FIG. This is an alarm that occurs when the In this case, a retest is performed using the spectrophotometer 14, which can measure higher concentrations.

In FIG. 4, No. In 3, when the initial measurement conditions are the photometer is “scattering” and the reagent is “dilution,” and the “Scatter Prozone” alarm occurs, the photometer is “absorbing,” the reagent is “dilution,” and the sample is An automatic retest is performed under the condition that the amount is “reduced”.

The prozone alarm is a data alarm that occurs when the amount of antigen or antibody in specimen 2 in immunoassay is excessive. Methods for determining this include the known reaction rate ratio method and the antigen/antibody re-addition method.

In the reaction rate ratio method, the amount of change in absorbance (or change in scattered light intensity) per unit time at the initial stage of the reaction and the amount of change in absorbance (or change in scattered light intensity) at the end of the reaction are determined from the reaction process of the target component substance of the test item. amount) is calculated and compared with a preset threshold.

In the antigen/antibody re-addition method, an additional antigen or antibody is added after the reaction is complete, and the change in absorbance or change in scattered light intensity per unit time immediately after addition is calculated and compared with a preset threshold. do.

FIG. 5 shows a flowchart for determining whether or not to carry out measurement using the absorption photometer 14 first and then switching to the scattering photometer 15 to perform a retest in the first embodiment of the present invention. This is a flowchart in which a process for determining whether or not to calculate a dilution factor to be used at the time of re-examination is added.

First, referring to the measurement request information and analysis parameter information input from the input unit 31, if the analysis request method is “absorption analysis”, the control unit 17 and the measurement unit 18 receive a command signal from the computer 20. Based on this, measurement using the spectrophotometer 14 using the stock reagent is first performed (step S101).

In step S101, the control unit 17 causes the reagent dispensing mechanism 12 to dispense the stock reagent 5 into the reaction container 9, and the measurement unit 18 stores measurement data by the spectrophotometer 14 in the data storage unit 21.

After the analysis is completed, the analysis unit 22 analyzes the measurement data, and the automatic retest determination unit 23 compares the measurement results with the quantitative range of absorbance analysis on the analysis parameters and determines that the sample concentration is lower than the lower limit of the absorbance quantitative range. It is determined whether or not (step S102).

When it is determined that the measurement result is within the quantitative range of absorption analysis, the process proceeds to step S107, the result is output and displayed on the output unit 32 (step S107), and the process is completed.

On the other hand, if it is determined that the measurement result is below the lower limit of the quantitative range of absorption analysis, the process proceeds to step S103 for re-examination using the scattering photometer 15.

Note that if it is determined in step S102 that the sample concentration is higher than the upper limit of the absorption quantification range, it is considered that it will not fall within the quantification range even if the photometer is changed or the reagent is diluted. In such a case, after step S102 and before step S107, a step is performed in which the retest is performed under conditions in which only the sample concentration is reduced without changing the photometer and reagent concentration.

Next, the automatic retest determination unit 23 determines whether calculation of dilution concentration is necessary (step S103). For example, in this step S103, based on the analysis parameter information, (i) the reagent is diluted to a predetermined concentration; (ii) the reagent dilution ratio is not determined, and the reagent concentration is calculated from the reaction process of the first measurement. It is determined which of the two options to choose.

In the case of (i), there is no need to calculate the reagent dilution factor, so the process proceeds to step S105, whereas in the case of (ii), the process proceeds to step S104, in which the analysis unit 22 calculates the reaction process during the first measurement. A reagent dilution factor suitable for scattering analysis is calculated from (step S104), and the process proceeds to step S105.

Next, the control unit 17 and the measurement unit 18 perform a retest using the scattering photometer 15 (step S105). At this time, the control section 17 dispenses the reagent 5 diluted with system water into the reaction container 9 using the reagent dispensing mechanism 12, and the measurement section 18 stores the measurement results by the scattering photometer 15 in the data storage section 21.

After that, the output unit 32 displays the measurement result by the scattering photometer 15 (step S106), and the process is completed.

Next, the effects of this embodiment will be explained.

In the automatic analyzer 1 according to the first embodiment of the present invention described above, the computer 20 and the control unit 17 are configured to perform the analysis by the spectrophotometer 14 and the analysis by the scattering photometer 15 using the same type of reagent at different concentrations. Controls the operation of the reagent dispensing mechanism 12.

This makes it possible to use one common reagent for one test item and perform measurements at a reagent concentration suitable for each of the absorption photometer 14 and the scattering photometer 15. There is no need to install dedicated reagents for each of the scattering photometer 15. Therefore, highly accurate analysis using the spectrophotometer 14 and the scattering photometer 15 is possible without increasing the volume of the reagent disk 7.

Furthermore, the computer 20 can select whether or not to carry out a measurement using one of the absorption photometer 14 and the scattering photometer 15, and to perform a re-examination using the other photometer based on the measurement result. Therefore, measurement is performed using the other photometer only when reexamination becomes necessary, and it is possible to suppress unnecessary consumption of specimens and reagents.

Furthermore, the computer 20 compares the measurement results from one photometer with a preset threshold, and determines whether or not to perform a retest using the other photometer based on the comparison result. It is possible to determine whether or not re-examination is necessary based on accuracy.

In addition, when the measurement using the spectrophotometer 14 is carried out first, the computer 20 and the control unit 17 dispense the stock solution of the reagent into the reaction container 9 using the reagent dispensing mechanism 12 for measurement. Based on the measurement results, it is determined whether or not to carry out the measurement using the scattering photometer 15, and when carrying out the measurement using the scattering photometer 15, a diluted reagent obtained by diluting the stock solution of the reagent is dispensed and measured. By controlling the operation of the reagent dispensing mechanism 12 in this manner, it is possible to obtain the effect that scattered light analysis is possible even with a reagent suitable for absorbance measurement.

<Example 2>
An automatic analyzer and analysis method according to Example 2 of the present invention will be explained using FIG. 6. FIG. 6 is a flowchart for determining whether or not to carry out measurement with the scattering photometer 15 first and then switch to the absorption photometer 14 to perform a retest in Example 2. In addition, FIG. 3 is a flowchart in which a process for determining whether or not to change is added.

In the following, components of the second embodiment and the like that are different from the first embodiment will be explained.

In this embodiment, the computer 20 and the control unit 17 dispense a diluted reagent obtained by diluting the stock solution of the reagent with system water using the reagent dispensing mechanism 12 when performing the measurement using the scattering photometer 15 first. Based on the measurement results of the scattering photometer 15, it is determined whether or not to carry out the measurement using the absorptiometer 14, and when the measurement is to be carried out using the absorptiometer 14, the stock solution of the reagent is dispensed into the reaction container 9. The operation of the reagent dispensing mechanism 12 is controlled so that the reagent dispensing mechanism 12 is injected and measured.

Specifically, Example 1 corresponds to No. 1 in FIG. 1, but Example 2 is the re-examination flow of No. 1 in FIG. 2, No. 3 re-examination flow.

The processing flow in Example 2 shown in Figure 6 differs from the processing flow in Example 1 shown in Figure 5, in that a diluted reagent with a predetermined dilution ratio is used for the first measurement, and the undiluted reagent is used for the retest. Since this reagent is used, the flow for calculating the dilution factor is omitted. The details will be explained below.

First, the control unit 17 uses the reagent dispensing mechanism 12 to dispense the reagent 5 diluted with system water into the reaction container 9, and the measurement unit 18 stores the measurement data by the scattering photometer 15 in the data storage unit 21 (step S201). At this time, the dilution ratio of the reagent 5 diluted by the reagent dispensing mechanism 12 is set on the analysis parameters.

After the analysis is completed, the analysis unit 22 analyzes the measurement data, and the automatic retest determination unit 23 compares the measurement results with the quantitative range of absorption analysis on the analysis parameters, and determines whether the sample concentration is below the upper limit of the scattering quantitative range. It is determined whether or not it is high (step S202).

When it is determined that the measurement result is within the quantitative range of absorption analysis, the process proceeds to step S208, the result is displayed on the output unit 32 (step S208), and the process is ended. On the other hand, if the measurement result exceeds the upper limit of the quantitative range for scattering analysis, the process advances to step S203 to set conditions for absorption analysis.

Next, the automatic retest determination unit 23 determines whether a prozone alarm has occurred based on the analysis result in step S202 (step S203). If it is determined that a prozone alarm has occurred, the process proceeds to step S204, and if it is determined that a prozone alarm has not occurred, the process proceeds to step S206.

When it is determined that a prozone alarm has occurred, the control unit 17 causes the sample dispensing mechanism 11 to reduce the amount of the sample and dispense it into the reaction container 9, and the reagent dispensing mechanism 12 causes the reagent of the stock solution to be dispensed. 5 is dispensed into the reaction container 9 (step S204). The measurement unit 18 stores the measurement data obtained by the absorption photometer 14 in the data storage unit 21, and the output unit 32 displays the measurement results of the absorption photometer 14 (step S205), and the process is completed.

On the other hand, when it is determined in step S203 that the prozone alarm has not occurred, the control unit 17 causes the specimen dispensing mechanism 11 to dispense the standard amount of specimen into the reaction container 9, and The stock reagent 5 is dispensed into the reaction container 9 by the dispensing mechanism 12 (step S206). The measurement unit 18 stores the measurement data obtained by the spectrophotometer 14 in the data storage unit 21, and the output unit 32 displays the measurement results of the spectrophotometer 14 (step S207), and the process is completed.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

As in the automatic analyzer and analysis method of Example 2 of the present invention, the computer 20 and the control unit 17 dilute the reagent stock solution using the reagent dispensing mechanism 12 when the measurement using the scattering photometer 15 is performed first. The diluted reagent is dispensed and measured, and based on the measurement results of the scattering photometer 15, it is determined whether or not to carry out the measurement with the spectrophotometer 14. If the measurement with the spectrophotometer 14 is carried out, the reaction is By controlling the operation of the reagent dispensing mechanism 12 so that the stock solution of the reagent is dispensed into the container 9 for measurement, almost the same effects as the automatic analyzer and analysis method of Example 1 described above can be obtained. .

Note that in Example 1, the measurement using the absorption photometer 14 was performed first, and in Example 2, the measurement using the scattering photometer 15 was performed first, but these can be changed in the analysis parameters. can do. Which measurement should be performed first varies depending on the tendency of the specimen to be measured, the characteristics of the test items and reagents, and the operational policy of the operator, and can be adopted arbitrarily.

It is considered that the measurement that is fundamentally important should be performed first, and if the dynamic range is important, it is desirable to perform the absorption analysis first, and if the sensitivity is important, it is desirable to perform the scattering analysis first. For example, for items such as D-dimer where the presence or absence of thrombus is important, scattering analysis with emphasis on sensitivity is performed first.

<Example 3>
An automatic analyzer and analysis method according to Example 3 of the present invention will be described using FIG. 7. FIG. 7 is a flowchart showing the operation of the automatic analyzer in the third embodiment.

In Examples 1 and 2, the first measurement was performed using one of the photometers, and the retest was performed using a different photometer based on the results, but in the automatic analyzer of this example, the absorption photometer 14 Measurement using the same type of reagent and measurement using the scattering photometer 15 are performed using different reagent concentrations.

Specifically, the computer 20 and the control unit 17 perform measurements using both the absorption photometer 14 and the scattering photometer 15, and adopt the measurement results from either photometer based on the measurement results from both photometers. Determine whether

The flow of measurement with the automatic analyzer of Example 3 will be described below with reference to FIG.

First, the control unit 17 uses the sample dispensing mechanism 11 to dispense the sample into the two reaction vessels 9, and the reagent dispensing mechanism 12 dispenses the sample into the two reaction vessels 9, respectively, using the stock reagent and the dilution ratio set by the analysis parameters. Dispense two types of diluted reagents. The reaction container 9 into which the stock reagent has been dispensed is measured by the spectrophotometer 14, and the reaction container 9 into which the diluted reagent has been dispensed is measured by the scattering photometer 15 (step S301).

After the analysis is completed, the analysis unit 22 analyzes the measurement data and determines whether the measured sample concentration is within the quantification range of the spectrophotometer 14 and within the quantification range of the scattering photometer 15. It is determined whether or not (step S302).

In step S<b>302 , when it is determined that the measurement result is within the quantitative range of the scattering photometer 15 and is in a low concentration region that is within the quantitative range of the absorption photometer 14 , the analysis unit 22 is output (step S303), and the process is completed.

Further, in step S302, when it is determined that the measurement result is in a high concentration region that is within the quantification range of the spectrophotometer 14 and outside the quantification range of the scattering photometer 15, the analysis unit 22 14 results are output (step S305), and the process is completed.

Further, in step S302, when it is determined that the measurement result falls within the quantitative range of both the absorption photometer 14 and the scattering photometer 15, the analysis unit 22 analyzes the measurement results of both the absorption photometer 14 and the scattering photometer 15. is output (step S304), and the process is completed.

Note that step S304 is not limited to outputting the measurement results of both the absorption photometer 14 and the scattering photometer 15, and may output the result closer to the middle of the quantitative range among the results of either one. Processing such as outputting the average value of the results can be performed.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

As in the automatic analyzer and analysis method of Embodiment 3 of the present invention, the computer 20 performs measurements using both the absorption photometer 14 and the scattering photometer 15, and determines which one based on the measurement results of both photometers. By determining whether to employ the measurement results by a photometer, substantially the same effects as the automatic analyzer and analysis method of Example 1 described above can be obtained.

<Example 4>
An automatic analyzer and analysis method according to Example 4 of the present invention will be explained using FIG. 8. FIG. 8 is a diagram showing an example of an analysis parameter setting screen of the automatic analyzer according to the fourth embodiment.

In the automatic analyzers of Examples 1 to 3, the reagent dispensing mechanism 12 dispenses the reagent stock solution for measurements using the spectrophotometer 14, and dispenses system water in addition to the reagent for measurements using the scattering photometer 15. It was a form in which diluted reagents were dispensed by discharging the reagents.

In contrast, in the automatic analyzer of Example 4, the first reagent, second reagent, and diluent are placed on the reagent disk 7, and the first reagent, R2 reagent is dispensed at the same time as the R1 reagent is dispensed. The computer 20 executes control to dispense the diluent at the dispensing timing and the second reagent at the dispensing timing of the R3 reagent.

In this way, by adding the diluent to the reaction solution after the reaction of the first reagent and then adding the second reagent, it is possible to obtain the same measurement results as by dispensing the diluted second reagent. can.

As shown in FIG. 8, in this example, the photometer common setting field 75A in the parameter setting field 73A of the application setting screen 71A specifies the dispensing amount of each reagent from that of Example 1 shown in FIG. It is the same except that the item has been deleted.

On the other hand, in the spectrophotometer-specific setting field 76A, the reagent dispensing amounts of the R1 reagent, R2 reagent, and R3 reagent at the time of measurement with the spectrophotometer 14, and in the scattering photometer-dedicated setting column 77A, the dispensing amounts of the R1 reagent, R2 reagent, and R3 reagent at the time of measurement with the spectrophotometer 14, and in the scattering photometer-dedicated setting column 77A, The reagent dispensing amounts for the R1 reagent, R2 reagent, and R3 reagent during measurement can be set separately.

In this example, as shown in FIG. 8, in the measurement using the spectrophotometer 14, "140 [μl]" of the first reagent was added to "R1" and "70 [μl]" of the second reagent was added to "R3". It is set to be noted. In the measurement using the scattering photometer 15, 140 [μl] of the first reagent was added to “R1”, “35 [μl]” of the diluent was added to “R2”, and “35 [μl]” of the second reagent was added to “R3”. ” is set to dispense.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

As in Embodiment 4 of the present invention, the computer 20 further includes a reagent disk 7 capable of mounting a plurality of reagent bottles 6 containing reagents or diluents, and the computer 20 stores reagent bottles 6 when performing measurement using one of the photometers. When the dispensing mechanism 12 dispenses only the reagent into the reaction vessel 9 for measurement and the other photometer performs measurement, the reagent dispensing mechanism 12 dispenses a diluent in addition to the reagent into the reaction vessel 9. The automatic analyzer and analysis method for dispensing and measuring also provide substantially the same effects as the automatic analyzer and analysis method of Example 1 described above.

Here, the diluting solution used in Example 4 is assumed to be a buffer solution that does not take part in the reaction of the specimen or reagent and whose salt concentration is adjusted for diluting the reagent.

When system water is mixed with the reaction solution as in Examples 1 to 3, not only dilution of the reagent but also changes in salt concentration may affect the reaction. Therefore, in the case of analysis items where salt concentration is thought to affect the reaction, by executing analysis control using a diluent as in this example, a suitable quantitative range can be determined without affecting the reaction due to changes in salt concentration. By obtaining this information, it is possible to increase the number of cases in which analytical performance can be improved.

<Example 5>
An automatic analyzer and analysis method according to Example 5 of the present invention will be described using FIG. 9. FIG. 9 is a diagram showing an example of an analysis parameter setting screen of the automatic analyzer according to the fifth embodiment.

The automatic analyzer of Example 5 differs from the automatic analyzer of Example 4 in the measurement using the spectrophotometer 14 and the reagent dispensing of the first reagent and the second reagent in the measurement using the scattering photometer 15. The liquid volume of the first reagent and the second reagent has been changed, and the computer 20 and the control unit 17 are configured so that the reagent volume ratio of the first reagent and the second reagent is different between the measurement using one photometer and the measurement using the other photometer. The operation of the reagent dispensing mechanism 12 is controlled.

As shown in FIG. 9, in the spectrophotometer-dedicated setting field 76B of the parameter setting field 73B of the application setting screen 71B of this embodiment, in the measurement by the spectrophotometer 14, the first reagent is added to "R1" at "140 [μl"]. ]", the setting is such that "70 [μl]" of the second reagent is dispensed into "R3". In addition, in the scattering photometer-dedicated setting field 77B, in the measurement using the scattering photometer 15, "175 [μl]" of the first reagent is dispensed into "R1" and "35 [μl]" of the second reagent is dispensed into "R3". It is set.

This example assumes a case where increasing the amount of the first reagent does not affect the reaction and a suitable quantitative range can be obtained by diluting the second reagent during measurement with the scattering photometer 15. At this time, in the measurement using the scattering photometer 15, a suitable quantitative range can be obtained by increasing the amount of the first reagent and decreasing the amount of the second reagent.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

As in the fifth embodiment of the present invention, the reagent dispensing mechanism 12 is configured to be able to dispense a first reagent and a second reagent different in type from the first reagent into the reaction container 9, and the computer 20 and The control unit 17 is an automatic analyzer that controls the operation of the reagent dispensing mechanism 12 so that the reagent amount ratio of the first reagent and the second reagent is different between measurements by one photometer and measurements by the other photometer. Also in the analysis method, almost the same effects as the automatic analyzer and analysis method of Example 1 described above can be obtained.

Further, in this example, unlike Examples 1 to 3, system water is not used, so there is no possibility that the salt concentration of the reaction solution will change. Further, since a diluent is not used as in Example 4, it is possible to dilute the second reagent without increasing the number of reagents installed on the reagent disk 7. Furthermore, according to this configuration, the operation of the reagent dispensing mechanism 12 is not increased compared to the fourth embodiment, and the dilution process can be executed with the same number of steps as dilution with system water, so that processing capacity is improved. be able to.

<Example 6>
An automatic analyzer and analysis method according to Example 6 of the present invention will be explained using FIGS. 10 to 12. Examples 1 to 5 show an example in which the reagent concentration is suitable for measurement with an absorption photometer but too high for measurement with a scattering photometer, in which case the reagent is diluted and scattered light is analyzed. .

Example 6 shows an example in which the reagent is concentrated for absorption analysis when the reagent concentration is suitable for measurement with a scattering photometer but too low for measurement with an absorption photometer. Concentration of the reagent is made possible by controlling the operation of the reagent dispensing mechanism 12 so that the reagent liquid volume ratio of the first reagent and the second reagent is different between measurement using a scattering photometer and measurement using an absorption photometer. do. Specifically, when measuring with an absorption photometer, the concentration of the reagent is made possible by increasing the ratio of the second reagent to the total amount of reaction liquid compared to when measuring with a scattering photometer.

FIG. 10 is a diagram showing an example of an analysis parameter setting screen of the automatic analyzer according to the sixth embodiment. The screen configuration example in FIG. 10 is the same as in Example 1 shown in FIG. 3, except that the reagent dilution ratio in the scattering photometer-specific setting field 77 is deleted, and the reagent concentration ratio is added in the spectrophotometer-specific setting field 76C. are the same. A state in which "1.5" is selected or input as the "reagent concentration magnification" during analysis by the spectrophotometer 14 is illustrated.

FIG. 11 is an example of a correspondence table in which combinations of initial measurement conditions and alarm contents, and correspondences between retest conditions are defined in the inspection flow of this embodiment. According to this correspondence table, the automatic reexamination determination unit 23 selects conditions such as a photometer, reagent concentration, and sample amount to be used at the time of reexamination, and requests a reexamination. In accordance with the retest request, the control section 17 and the measurement section 18 control the operations of each section including the reagent dispensing mechanism 12 so as to execute the retest operation.

In FIG. 11, No. In 1, when the initial measurement condition is that the photometer is set to "scattering" and the reagent is a "undiluted solution" of a reagent suitable for measurement with a scattering photometer, if an alarm of "scattering quantification range upper limit exceeded" occurs, Automatic retesting is performed under the conditions that the photometer is set to "absorption", the reagent is set to "concentration", and the amount of sample is set to "standard".

Here, exceeding the upper limit of the scattering quantification range means that the result of the first measurement by the scattering photometer 15 exceeds the upper limit of the "quantification range" set in the scattering photometer-specific setting column 77C on the analysis parameters in FIG. This is an alarm that occurs when the In this case, a retest is performed using the spectrophotometer 14, which can measure higher concentrations.

In FIG. 11, No. In 2, when the initial measurement condition is that the photometer is "absorbance" and the reagent is "concentration" which is suitable for measurement with a scattering photometer, when the alarm "exceeding the lower limit of the absorbance quantification range" occurs, Automatic retesting is performed with the photometer set to "scattering", the reagent to "undiluted solution", and the sample amount to "standard".

Here, exceeding the lower limit of the absorbance quantification range means that the result of the first measurement by the spectrophotometer 14 is below the lower limit of the "quantification range" set in the spectrophotometer-specific setting field 76C on the analysis parameters in FIG. This is an alarm that occurs when the In this case, a retest is performed using the scattering photometer 15, which can measure lower concentrations.

FIG. 12 shows a flowchart for determining whether or not to carry out the measurement with the scattering photometer 15 first and then switch to the absorption photometer 14 to perform the re-examination in Example 6. 12 is a flowchart in which a process for determining whether to calculate a concentration factor to be used at a certain time is added. Example 6 is No. 1 in FIG. This is the re-examination flow of No. 1.

First, referring to the measurement request information and analysis parameter information (FIG. 10) input from the input unit 31, if the analysis request method is “scattering analysis”, the control unit 17 and the measurement unit 18 control the computer 20. Based on a command signal from the scattering photometer 15, first, measurement using the scattering photometer 15 is performed using a stock reagent suitable for measurement with the scattering photometer (step S401).

In step S401, the control unit 17 causes the reagent dispensing mechanism 12 to dispense the stock reagent 5 into the reaction container 9, and the measurement unit 18 stores measurement data by the scattering photometer 15 in the data storage unit 21.

After the analysis is completed, the analysis unit 22 analyzes the measurement data, and the automatic retest determination unit 23 compares the measurement results with the scattering analysis quantitative range on the analysis parameters and determines that the sample concentration is higher than the upper limit of the scattering quantitative range. It is determined whether or not (step S402).

When it is determined that the measurement result is within the quantitative range of scattering analysis, the process proceeds to step S407, the result is output and displayed on the output unit 32 (step S407), and the process is completed.

On the other hand, if it is determined that the measurement result exceeds the upper limit of the quantitative range of scattering analysis, the process advances to step S403 for re-examination using the spectrophotometer 14.

Note that if it is determined in step S402 that the sample concentration is lower than the lower limit of the scattering quantification range, it is considered that it will not fall within the quantification range even if the photometer is changed or the reagent is concentrated. In such a case, after step S402 and before step S407, a step is performed to perform a retest under conditions where only the sample concentration is increased without changing the photometer and reagent concentration.

Next, the automatic retest determination unit 23 determines whether or not calculation of the concentration concentration (concentration rate) is necessary (step S403). For example, in step S403, based on the analysis parameter information, (i) the reagent is concentrated to a predetermined concentration; (ii) the reagent concentration ratio is not determined, and the reagent concentration is calculated from the reaction process of the first measurement. It is determined which of the two options to choose.

In the case of (i), there is no need to calculate the reagent concentration factor, so the process proceeds to step S405, whereas in the case of (ii), the process proceeds to step S404, in which the analysis unit 22 calculates the reaction process during the first measurement. A reagent concentration ratio suitable for absorption analysis is calculated from (step S404), and the process proceeds to step S405.

Next, the control unit 17 and the measurement unit 18 perform a retest using the spectrophotometer 14 (step S405). At this time, the computer 20 calculates the reagent dispensing amount according to the reagent concentration ratio in the spectrophotometer-specific setting column 76C of the analysis parameter information (FIG. 10) or the concentration ratio calculated in step S404, and the control unit 17 The reagent dispensing mechanism 12 dispenses the reagent 5 into the reaction container 9 according to the calculated dispensing amount, and the measuring section 18 stores the measurement results by the spectrophotometer 14 in the data storage section 21 . For example, in the screen example shown in Figure 10, the "reagent concentration ratio" is "1.5", so the amount of the first reagent to be dispensed in the re-examination by absorption analysis is "105 μL", and the amount of the second reagent is "105 μL". It becomes "105 μL".

After that, the output unit 32 displays the measurement result by the spectrophotometer 14 (step S406), and the process is completed.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

Next, the effects of this embodiment will be explained.

In the automatic analyzer 1 of the sixth embodiment of the present invention described above, the computer 20 and the control unit 17 are configured to perform the analysis by the scattering photometer 15 and the analysis by the absorption photometer 14 using the same type of reagent at different concentrations. Controls the operation of the reagent dispensing mechanism 12.

This makes it possible to use one common reagent for one test item and perform measurements at a reagent concentration suitable for each measurement by the scattering photometer 15 and the absorption photometer 14. There is no need to install dedicated reagents for the absorption photometer 14 and the absorption photometer 14 respectively. Therefore, highly accurate analysis using the scattering photometer 15 and the spectrophotometer 14 is possible without increasing the volume of the reagent disk 7.

Furthermore, the computer 20 can select whether or not to carry out a measurement using one of the scattering photometer 15 and the absorption photometer 14 and perform a re-examination using the other photometer based on the measurement result. Therefore, measurement is performed using the other photometer only when reexamination becomes necessary, and it is possible to suppress unnecessary consumption of specimens and reagents.

Furthermore, the computer 20 compares the measurement results from one photometer with a preset threshold, and determines whether or not to perform a retest using the other photometer based on the comparison result. It is possible to determine whether or not re-examination is necessary based on accuracy.

In addition, when the measurement using the scattering photometer 15 is carried out first, the computer 20 and the control unit 17 dispense the stock solution of the reagent into the reaction container 9 using the reagent dispensing mechanism 12 and perform the measurement using the scattering photometer 15. It is determined whether or not to perform the measurement using the spectrophotometer 14 based on the measurement results of By controlling the operation of the reagent dispensing mechanism 12 to dispense the reagent by changing the liquid volume ratio of the reagent, absorption analysis becomes possible even with a reagent suitable for measurement with a scattering photometer. The effect of , can be obtained.

<Example 7>
An automatic analyzer and analysis method according to Example 7 of the present invention will be described using FIG. 13. FIG. 13 is a flowchart in Example 7 for determining whether or not to perform measurement using the absorption photometer 14 first and then switch to the scattering photometer 15 for re-examination. Example 7 is No. 1 in FIG. This is the re-examination flow of step 2.

Similarly to Example 6, Example 7 is an example in which the reagent concentration is suitable for measurement with a scattering photometer but too low for measurement with an absorptiometer, and the reagent is concentrated for absorption analysis. Concentration of the reagent is made possible by controlling the operation of the reagent dispensing mechanism 12 so that the reagent liquid volume ratio of the first reagent and the second reagent is different between measurement using a scattering photometer and measurement using an absorption photometer. do. Specifically, when measuring with an absorption photometer, the concentration of the reagent is made possible by increasing the ratio of the second reagent to the total amount of reaction liquid compared to when measuring with a scattering photometer.

The computer 20 and the control unit 17 of the seventh embodiment scatter the first reagent and the second reagent so that the second reagent is concentrated by the reagent dispensing mechanism 12 when the measurement using the spectrophotometer 14 is performed first. Measurement is performed by dispensing a different amount from the analysis with the photometer 15, and based on the measurement results of the absorption photometer 14, it is determined whether or not to carry out the measurement with the scattering photometer 15. When carrying out a measurement, the operation of the reagent dispensing mechanism 12 is controlled so that a stock solution of the reagent (an amount of liquid suitable for measurement with the scattering photometer 15) is dispensed into the reaction container 9 for measurement.

The processing flow in Example 7 shown in Figure 13 differs from the processing flow in Example 6 shown in Figure 12, in that a concentrated reagent with a predetermined concentration ratio is used in the first measurement, and the undiluted reagent is used in the retest. Since this reagent is used, the flow for calculating the concentration factor is omitted. The details will be explained below.

First, the control unit 17 uses the reagent dispensing mechanism 12 to dispense the first reagent and the second reagent into the reaction container 9 in amounts different from those for analysis by the scattering photometer 15 so that the second reagent is concentrated, and performs measurement. The unit 18 stores measurement data obtained by the spectrophotometer 14 in the data storage unit 21 (step S501). At this time, the concentration ratio of the reagent dispensed by the reagent dispensing mechanism 12 is set based on the analysis parameters.

After the analysis is completed, the analysis unit 22 analyzes the measurement data, and the automatic retest determination unit 23 compares the measurement results with the quantitative range of absorbance analysis on the analysis parameters and determines whether the sample concentration is below the lower limit of the quantitative range of absorbance. It is determined whether or not it is low (step S502).

When it is determined that the measurement result is within the quantitative range of absorption analysis, the process proceeds to step S505, the result is displayed on the output unit 32 (step S505), and the process is ended. On the other hand, if the measurement result is below the lower limit of the quantitative range for absorption analysis, the process advances to step S503 to set conditions for scattering analysis.

Next, the control unit 17 uses the sample dispensing mechanism 11 to dispense the standard amount of the sample into the reaction container 9, and uses the reagent dispensing mechanism 12 to dispense the stock reagent 5 into the reaction container 9 (step S503). The measurement unit 18 stores the measurement data obtained by the scattering photometer 15 in the data storage unit 21, and the output unit 32 displays the measurement results of the scattering photometer 15 (step S504), and the process is completed.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

In the seventh embodiment, almost the same effects as the automatic analyzer and analysis method of the sixth embodiment described above can be obtained.

In addition, in Example 6, the measurement by the scattering photometer 15 was carried out first, and in Example 7, the measurement by the absorption photometer 14 was carried out first, but these can be changed in the analysis parameters. can do. Which measurement should be performed first varies depending on the tendency of the specimen to be measured, the characteristics of the test items and reagents, and the operational policy of the operator, and can be adopted arbitrarily.

<Example 8>
An automatic analyzer and analysis method according to Example 8 of the present invention will be explained using FIG. 14. FIG. 14 is a flowchart showing the operation of the automatic analyzer in Example 8.

In Examples 6 and 7, the measurement was performed using one of the photometers for the first time, and the retest was performed using a different photometer based on the results, but in the automatic analyzer of this example, the absorption photometer 14 Measurement using the same type of reagent and measurement using the scattering photometer 15 are performed using different reagent concentrations.

In Example 3, which shows similar implementation details, when the reagent concentration is suitable for measurement with an absorption photometer but too high for measurement with a scattering photometer, the reagent is diluted and scattered light is analyzed. showed that. Example 8 shows an example in which the reagent concentration is suitable for measurement with a scattering photometer but too low for measurement with an absorptiometer, in which case the reagent is concentrated for absorption analysis.

Concentration of the reagent is made possible by controlling the operation of the reagent dispensing mechanism 12 so that the reagent liquid volume ratio of the first reagent and the second reagent is different between measurement using a scattering photometer and measurement using an absorption photometer. do. Specifically, when measuring with an absorption photometer, the concentration of the reagent is made possible by increasing the ratio of the second reagent to the total amount of reaction liquid compared to when measuring with a scattering photometer.

Specifically, the computer 20 and the control unit 17 perform measurements using both the absorption photometer 14 and the scattering photometer 15, and adopt the measurement results from either photometer based on the measurement results from both photometers. Determine whether

The flow of measurement in the automatic analyzer of Example 8 will be described below with reference to FIG.

First, the control unit 17 uses the sample dispensing mechanism 11 to dispense the sample into the two reaction vessels 9, and the reagent dispensing mechanism 12 dispenses the sample into the two reaction vessels 9, respectively, using the stock reagent and the concentration magnification set by the analysis parameters. Dispense two types of concentrated reagents. The reaction container 9 into which the stock reagent has been dispensed is measured by the scattering photometer 15, and the reaction container 9 into which the concentrated reagent has been dispensed is measured by the spectrophotometer 14 (step S601).

After the analysis is completed, the analysis unit 22 analyzes the measurement data and determines whether the measured sample concentration is within the quantification range of the scattering photometer 15 and within the quantification range of the absorption photometer 14. It is determined whether or not (step S602).

In step S602, when it is determined that the measurement result is within the quantification range of the scattering photometer 15 and is in a low concentration region outside the quantification range of the absorption photometer 14, the analysis unit 22 The result is output (step S603) and the process is completed.

Further, in step S602, when it is determined that the measurement result is in a high concentration region that is within the quantification range of the spectrophotometer 14 and outside the quantification range of the scattering photometer 15, the analysis unit 22 14 results are output (step S605), and the process is completed.

Further, in step S602, when it is determined that the measurement result falls within the quantitative range of both the absorption photometer 14 and the scattering photometer 15, the analysis unit 22 analyzes the measurement results of both the absorption photometer 14 and the scattering photometer 15. is output (step S604), and the process is completed.

Note that step S604 is not limited to the case where the measurement results of both the absorption photometer 14 and the scattering photometer 15 are output, and the case where the result of either one of the results closer to the middle of the quantification range is output. Processing such as outputting the average value of the results can be performed.

The other configurations and operations are substantially the same as those of the automatic analyzer and analysis method of Example 1 described above, and the details will be omitted.

As in the automatic analyzer and analysis method of Example 8 of the present invention, the computer 20 performs measurements using both the absorption photometer 14 and the scattering photometer 15, and determines which one based on the measurement results of both photometers. By determining whether to employ the measurement results by a photometer, substantially the same effects as the automatic analyzer and analysis method of Example 6 described above can be obtained.

1...Automatic analyzer 2...Sample 3...Sample cup 4...Sample disk 5...Reagent 6...Reagent bottle 7...Reagent disk (reagent holding part)
8... Reaction liquid 9... Reaction container 10... Reaction disk 11... Sample dispensing mechanism 12... Reagent dispensing mechanism 13... Stirring section 14... Absorption photometer 15... Scattering photometer 16a... Washing tank 16b... Washing section 17... Control section (Control device)
18...Measuring unit 19...Thermostatic chamber 20...Computer (control device)
21...Data storage unit 22...Analysis unit 23...Automatic retest determination unit 31...Input unit 32...Output unit 71, 71A, 71B, 71C...Application setting screen 72...Item selection field 73, 73A, 73B, 73C...Parameter setting field 75, 75A, 75B, 75C... Common setting field for photometer 76, 76A, 76B, 76C... Setting field for spectrophotometer only 77, 77A, 77B, 77C... Setting field for scattering photometer only

Claims (11)

a reaction container containing a reaction solution generated by mixing a specimen and a reagent;
a reagent dispensing mechanism that dispenses the reagent into the reaction container;
an absorption photometer that measures the light transmitted through the reaction solution;
a scattering photometer that measures light scattered within the reaction solution;
Equipped with a control device that controls the operation of each device,
The automatic analyzer is characterized in that the control device controls the operation of the reagent dispensing mechanism so that analysis by the spectrophotometer and analysis by the scattering photometer are performed using the same type of reagent at different concentrations. . The automatic analyzer according to claim 1,
The control device is configured to perform measurement using one of the absorption photometer and the scattering photometer, and to select whether or not to perform re-examination using the other photometer based on the measurement result. An automatic analyzer characterized by comprising: The automatic analyzer according to claim 2,
The control device compares the measurement result by one photometer with a preset threshold value, and determines whether to perform a retest using the other photometer based on the comparison result. Analysis equipment. The automatic analyzer according to claim 2,
When the measurement by the spectrophotometer is performed first, the control device dispenses and measures the stock solution of the reagent into the reaction container using the reagent dispensing mechanism, and applies the measurement result of the spectrophotometer to the measurement result of the spectrophotometer. Based on the above, it is determined whether or not to carry out the measurement using the scattering photometer, and when carrying out the measurement using the scattering photometer, a diluted reagent obtained by diluting the stock solution of the reagent is dispensed and measured. An automatic analyzer characterized by controlling the operation of a reagent dispensing mechanism. The automatic analyzer according to claim 2,
When the measurement by the scattering photometer is performed first, the control device dispenses and measures a diluted reagent obtained by diluting the stock solution of the reagent using the reagent dispensing mechanism, and applies the measurement result to the scattering photometer. Based on the spectrophotometer, it is determined whether or not to perform the measurement using the spectrophotometer, and when the measurement is performed using the spectrophotometer, the stock solution of the reagent is dispensed into the reaction container and the measurement is performed. An automatic analyzer characterized by controlling the operation of a reagent dispensing mechanism. The automatic analyzer according to claim 1,
The control device carries out measurements using both the absorption photometer and the scattering photometer, and determines which photometer to adopt the measurement results based on the measurement results from both photometers. automatic analyzer. The automatic analyzer according to claim 1,
Further comprising a reagent holding unit capable of mounting a plurality of reagent bottles containing the reagent or diluent,
The control device includes:
When performing measurement using one of the photometers, only the reagent is dispensed into the reaction container by the reagent dispensing mechanism and measured;
When performing measurement using the other photometer, the automatic analyzer is characterized in that the reagent dispensing mechanism dispenses a diluent in addition to the reagent into the reaction container. The automatic analyzer according to claim 1,
The reagent dispensing mechanism is configured to be able to dispense a first reagent and a second reagent different in type from the first reagent into the reaction container,
The control device controls the operation of the reagent dispensing mechanism so that the reagent amount ratio of the first reagent and the second reagent is different between measurements by one photometer and measurements by the other photometer. An automatic analyzer featuring: A reaction container that contains a reaction solution produced by mixing a sample and a reagent, a reagent dispensing mechanism that dispenses the reagent into the reaction container, and an absorption photometer that measures light transmitted through the reaction solution. , a scattering photometer that measures light scattered within the reaction solution, and a control device that controls the operation of each device.
An automatic analysis method characterized by controlling the operation of the reagent dispensing mechanism so that the analysis by the spectrophotometer and the analysis by the scattering photometer are performed using the same type of reagent at different concentrations. The automatic analysis method according to claim 9,
An automatic method characterized by: carrying out a measurement using one of the absorption photometer and the scattering photometer, and selecting whether or not to carry out re-examination using the other photometer based on the measurement result. Analysis method. The automatic analysis method according to claim 9,
An automatic analysis method characterized by carrying out measurements using both the absorption photometer and the scattering photometer, and determining which photometer to adopt the measurement results based on the measurement results from both photometers.

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