Biochemical analysis device and biochemical analysis method

Abstract

The control device (500) performs a blank measurement on each colorimetric port (P3b). In the blank measurement, the ratio of the light quantity measured at the colorimetric port (P3b) in a state where the cuvette (100) is not configured to the light quantity measured at the reference port (P4), i.e., the light quantity ratio, is calculated. In the blank measurement, if the light quantity ratio is outside a specified range, the control device (500) determines that the colorimetric port (P3b) is erroneous. If the error number indicating the number of colorimetric ports (P3b) determined to be erroneous is smaller than a specified value, the control device (500) determines that the colorimetric port (P3b) determined to be erroneous is abnormal. If the error number is greater than the specified value, the control device (500) determines that the reference port (P4) is abnormal.

Description

Technical Field

[0001] The present invention relates to a biochemical analysis device and a biochemical analysis method. Background Art

[0002] The following biochemical analysis is known: reagents are injected into a reaction container (hereinafter referred to as a "cuvette" or "cup", etc.) containing blood components (serum or plasma), urine, and other specimens (samples), and the scattered light or transmitted light when irradiated with light is measured, thereby analyzing the coagulation function and fibrinolytic function of the specimen.

[0003] Known methods for this type of biochemical analysis include the clotting time method and the colorimetric method. The clotting time method involves irradiating a cuvette filled with a specimen and reagent with light. The clotting time of the specimen is calculated based on the intensity change of the scattered light, and the coagulation function is analyzed based on this clotting time. The colorimetric method involves irradiating a cuvette filled with a specimen and reagent with light of a specific wavelength, measuring the absorbance based on the intensity of the transmitted light, and analyzing the fibrinolytic function of the specimen based on the concentration or activity value calculated from the absorbance after a specified time or the change in absorbance within a specified time. Colorimetry is sometimes also referred to as absorptiometry.

[0004] Japanese Patent Application Publication No. 2003-520942 (Patent Document 1) describes the use of a colorimetric method for measuring an analyte (specimen). The device structure is described as including a light source, a detector for detecting transmitted light through a cuvette, an amplifier for amplifying the signal from the detector, an A / D (analog / digital) converter for converting the amplified signal into a digital signal, a processor for data processing, and a data processing / control subsystem for a reference detector. The reference detector measures a signal proportional to the power of the light source incident on the cuvette. By using this reference detector, light source fluctuations can be compensated or the power of the light source can be actively adjusted (see Patent Document 1).

[0005] Prior art literature

[0006] Patent Literature

[0007] Patent Document 1: Japanese Patent Application No. 2003-520942 Summary of the Invention

[0008] Problems to be solved by the invention

[0009] In colorimetry, the ratio of the amount of transmitted light detected through a measurement port equipped with a cuvette containing a sample and reagent is sometimes calculated to the amount of reference light detected through the reference port by a reference detector, as described above, and this ratio is used as the measurement result (absorbance). In this case, a blank measurement can be performed before the start of the analytical measurement, without a cuvette in the measurement port. The light intensity ratio during the blank measurement can be used to verify the absence of any abnormalities in the measurement system. However, this alone cannot pinpoint the location of the abnormality in the measurement system.

[0010] The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a biochemical analysis device and a biochemical analysis method capable of identifying an abnormal site in a measurement system.

[0011] Solutions for solving problems

[0012] The biochemical analysis device disclosed herein is a biochemical analysis device that performs biochemical analysis of a specimen by reacting the specimen with a reagent within a reaction vessel. The device comprises a plurality of measurement ports, a reference port, and a control device. During analysis, a plurality of reaction vessels are respectively arranged at the plurality of measurement ports. The amount of light transmitted through the reaction vessel is measured by each measurement port. The amount of light equivalent to the light irradiated onto the reaction vessel is measured by the reference port. The control device is configured to analyze the specimen within the reaction vessel based on the ratio of the light amount measured at the measurement port where the reaction vessel is arranged to the light amount measured at the reference port. The control device is configured to perform a blank measurement for each measurement port. In this blank measurement, the ratio of the light amount measured at the measurement port without a reaction vessel arranged therein to the light amount measured at the reference port, i.e., the light amount ratio, is calculated. Furthermore, if the light amount ratio falls outside a specified range during the blank measurement, the control device determines that the measurement port is faulty. The control device is configured to determine that the measurement ports determined to be erroneous are abnormal when the error count indicating the number of measurement ports determined to be erroneous is smaller than a predetermined value, and to determine that the reference ports are abnormal when the error count is greater than the predetermined value.

[0013] The biochemical analysis method disclosed herein is a method for performing biochemical analysis of a specimen by reacting a specimen with a reagent within a reaction vessel. The apparatus for performing the biochemical analysis includes multiple measurement ports and a reference port. During the analysis and measurement, multiple reaction vessels are respectively disposed at the multiple measurement ports. The amount of light transmitted through the reaction vessel is measured via each measurement port. The amount of light equivalent to the irradiation light directed at the reaction vessel is measured via the reference port. Moreover, the biochemical analysis method includes the following steps: analyzing the specimen in the reaction container based on the ratio of the amount of light measured at the measuring port configured with the reaction container to the amount of light measured at the reference port; performing a blank measurement for each measuring port, in which the ratio of the amount of light measured at the measuring port in a state where no reaction container is configured and the amount of light measured at the reference port, i.e., the light intensity ratio, is calculated; if the light intensity ratio is outside a prescribed range in the blank measurement, the measuring port is judged to be erroneous; if the error number indicating the number of measuring ports judged to be erroneous is smaller than a prescribed value, the measuring port judged to be erroneous is judged to be abnormal; and if the error number is greater than a prescribed value, the reference port is judged to be abnormal.

[0014] Effects of the Invention

[0015] In the above-described biochemical analysis device and biochemical analysis method, if the number of errors in a measurement port determined to be erroneous is less than a specified value, the error is considered to be limited to that measurement port, and the erroneous measurement port is determined to be abnormal. On the other hand, if the number of errors is greater than the specified value, the error is considered to be not limited to the measurement port, and the reference port shared by all measurements using the measurement ports is determined to be abnormal. Therefore, according to this biochemical analysis device and biochemical analysis method, it is possible to determine the abnormal location of the measurement system (whether the abnormality is in a measurement port or a reference port). BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a diagram functionally showing the overall configuration of the analysis device according to the first embodiment of the present invention.

[0017] Figure 2 It is a plan view showing a configuration example of an analysis table of an analysis device.

[0018] Figure 3 It is a diagram showing a configuration example of a light measuring unit.

[0019] Figure 4 1 is a diagram showing a configuration example of a colorimetric port and a reference port.

[0020] Figure 5 It shows Figure 4A cross-sectional view of a structural example of section VV.

[0021] Figure 6 It is a diagram showing a configuration example of an optical system of a colorimetric port and a reference port.

[0022] Figure 7 It is a plan view showing a configuration example of a filter device.

[0023] Figure 8 This is a block diagram functionally showing the configuration of a measurement system using colorimetry.

[0024] Figure 9 This is a block diagram showing an example of the system configuration of the analysis device.

[0025] Figure 10 It shows Figure 9 FIG. 1 is a diagram showing an example of the hardware configuration of the control device shown.

[0026] Figure 11 This is a flowchart showing an example of the procedure of abnormality determination processing for the colorimetric port and the reference port.

[0027] Figure 12 It is shown in Figure 11 Flowchart of an example of the procedure of the blank measurement process executed in step S10.

[0028] Figure 13 This is a flowchart showing an example of the procedure of abnormality determination processing of the colorimetric port and the reference port in the second embodiment. DETAILED DESCRIPTION

[0029] Hereinafter, the embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the drawings, the same or corresponding parts are denoted by the same reference numerals, and their description will not be repeated.

[0030] [Implementation Method 1]

[0031] The biochemical analysis device disclosed herein (hereinafter referred to as the "analyzer") is configured to dispense a specimen and a reagent into a cuvette via a probe (nozzle) and optically measure the reaction state within the cuvette. The specimen is, for example, a blood component (serum or plasma), urine, or the like. Hereinafter, the specimen is sometimes referred to as a "sample" or "test specimen." In addition, in the present disclosure, a disposable cuvette (disposable cuvette) is employed as the cuvette.

[0032] Figure 1 This is a diagram functionally showing the overall configuration of an analysis device according to Embodiment 1 of the present invention. The analysis device described in Embodiment 1 is an example of a biochemical analysis device and can function as a blood coagulation (fibrinolysis) automatic analysis device.

[0033] Reference Figure 1 The present analyzing apparatus includes a cuvette supply device 110, a cuvette transfer device 120, a stirring device 200, a measuring device 300, and a cuvette waste container 400. Hereinafter, the cuvette supply device 110, the cuvette transfer device 120, and the cuvette waste container 400 will be referred to as the "supply device 110," the "transfer device 120," and the "waste container 400," respectively.

[0034] The analyzer also includes a sample dispensing port P1. The supply device 110 includes a cuvette storage unit 111 (hereinafter referred to as "the storage unit 111") and a supply mechanism 112. The storage unit 111 is configured to accommodate a large number of cuvettes (for example, a maximum of 1,000). The supply mechanism 112 supplies the cuvettes stored in the storage unit 111 to the sample dispensing port P1. Details of the storage unit 111 and the supply mechanism 112 will be described later. Figure 2 is described in .

[0035] The sample dispensing port P1 is arranged at a position where a sample can be dispensed into a cuvette by a sample dispensing device (not shown). When a cuvette is set at the sample dispensing port P1, the sample is dispensed into the cuvette by the sample dispensing device.

[0036] The transfer device 120 includes an arm 121 with a chuck (hereinafter referred to as "arm 121") and a drive device 122. The arm 121 has a chuck configured to hold the cuvette. The arm 121 is configured to hold the cuvette in a detachable manner using the chuck. The drive device 122 is configured to operate the arm 121 (chuck) to change the position of the chuck. Details of the arm 121 and the drive device 122 will be discussed later. Figure 2 is described in .

[0037] The analyzer also includes multiple ports for transferring cuvettes via a transfer device 120, specifically, a stirring port P2, a photometry port P3, and a disposal port P5. The photometry port P3 includes multiple coagulation ports P3a and multiple colorimetric ports P3b. Port sensors for detecting the presence of a missing cuvette are provided at each of the sample dispensing port P1, stirring port P2, photometry port P3, and disposal port P5.

[0038] The stirring port P2 is disposed at a stirring position of the stirring device 200. When a cuvette is set at the stirring port P2, the stirring device 200 is configured to stir the contents of the cuvette under predetermined conditions (eg, stirring speed and stirring time).

[0039] The coagulation port P3a and the colorimetric port P3b are each disposed in a photometric unit (not shown). A photodetector (not shown) is provided at each of the coagulation port P3a and the colorimetric port P3b that receives light from a light source and detects the irradiated light.

[0040] The measurement device 300 receives light intensity detection results from the photodetectors at the coagulation port P3a and the colorimetric port P3b, and performs predetermined measurements on the contents of the cuvettes located at each port. Specifically, the measurement device 300 uses the scattered light intensity detected by the photodetectors at the coagulation port P3a to perform a coagulation measurement of the specimen in the cuvette using the time-coagulation method. Furthermore, the measurement device 300 uses the transmitted light intensity detected by the photodetectors at the colorimetric port P3b to measure the absorbance of the specimen in the cuvette using the colorimetric method.

[0041] Furthermore, a light emitting diode, for example, can be used as the light source for the coagulation port P3a, and a photodiode, for example, can be used as the light detector provided at the coagulation port P3a. The light detector at the coagulation port P3a is configured to detect the amount of 90° scattered light (scattered light in a direction perpendicular to the direction of light irradiation).

[0042] Furthermore, a halogen lamp, for example, can be used as the light source for the colorimetric port P3b. As will be described later, the wavelength of the light supplied to the colorimetric port P3b can be switched using a filter according to the analysis conditions. A photodiode, for example, can be used as the light detector provided at the colorimetric port P3b. The light detector at the colorimetric port P3b is configured to detect the amount of transmitted light.

[0043] This analyzer also includes a reference port P4 for measuring the absorbance of a specimen within a cuvette located in the colorimetric port P3b. Reference port P4 has the same structure as each colorimetric port P3b, but instead of a cuvette, it is shielded from light by a cover or other means to prevent light other than that from the light source from entering reference port P4. Furthermore, based on colorimetry, the absorbance of the specimen is measured based on the ratio (light intensity ratio) of the amount of light detected by the photodetector located in the colorimetric port P3b to the amount of light detected by the photodetector located in the reference port P4, thereby performing a colorimetric analysis of the specimen. Analytical measurements based on colorimetry will be described in detail later.

[0044] In the present disclosure, “analytical measurement” refers to obtaining measurement data by placing a cuvette at the photometric port P3 , and is distinguished from “blank measurement” described later, in which measurement is performed without inserting a cuvette at the photometric port P3 (colorimetric port P3 b ).

[0045] The waste port P5 is configured to collect used cuvettes. The waste port P5 is connected to the waste container 400 via a pipe, for example. When a cuvette is inserted into the waste port P5, the cuvette is introduced into the waste container 400.

[0046] Figure 2 1 is a top view showing a structural example of an analysis workbench of an analysis device. Figure 2 The figure shows three mutually orthogonal axes (X, Y, and Z). The X and Y axes represent the width and depth of the analyzer, respectively, and the Z axis represents the vertical direction (i.e., the up-down direction). The direction indicated by the arrow on the Z axis is upward, and the opposite direction is downward (i.e., the direction of gravity).

[0047] Also refer to Figure 2 and Figure 1 The storage section 111 stores a large number of cuvettes 100. The user can add cuvettes 100 to the storage section 111 from an inlet (not shown) of the storage section 111. The cuvette 100 can be made of any material as long as it allows light to pass through it, and for example, a transparent acrylic cuvette can be used.

[0048] The supply mechanism 112 is configured to take out the cuvettes 100 one by one from the storage portion 111 and supply them to the sample dispensing port P1. The transfer method of the cuvettes 100 in the supply mechanism 112 is arbitrary, for example, it can be any one of a slide method (self-weight method), a conveyor belt method, a roller method, and a sliding method. The supply mechanism 112 is configured to receive the detection result of the port sensor of the sample dispensing port P1, and if the sample dispensing port P1 is empty, the next cuvette 100 is supplied to the port P1. However, the present invention is not limited to this, and the supply mechanism 112 can also be configured to supply the cuvette 100 to the sample dispensing port P1 according to the instructions from the control device described later.

[0049] The arm 21 is a device (sample dispensing apparatus) for dispensing a sample drawn from the sample aspiration port P21 into the cuvette 100 provided at the sample dispensing port P1. The arm 21a includes a probe 21a and an arm body 21b. The arm body 21b is rotatable about a rotation axis 23a. Rotation of the arm body 21b allows the probe 21a, located at the distal end of the arm body 21b, to move along an arc-shaped trajectory L2 on the XY plane.

[0050] By rotating the arm body 21b, the probe 21a can be moved to each of the sample dispensing port P1, the sample aspiration port P21, the S-port P22 (more specifically, ports P22a to P22i), and the cleaning port P23, which are located on the trajectory L2. Regarding the S-port P22, for example, ports P22a and P22b are wash ports, ports P22c, P22d, and P22e are buffer ports, and ports P22f, P22g, P22h, and P22i are diluent ports.

[0051] Although not shown, a movable sample rack is located below the sample suction port P21. Multiple sample containers containing samples such as blood components and urine are placed on the sample rack. Before dispensing the sample into the cuvette 100 located at the sample dispensing port P1, the sample rack operates to position the sample container to be dispensed directly below the sample suction port P21. The CTS mechanism 24 is located near the sample suction port P21 and is configured to perforate the cover of the sample container to be dispensed using a punch.

[0052] In the photometry unit 130, multiple photometry ports P3 (multiple coagulation ports P3a and colorimetric ports P3b) are arranged in an arc shape. In this example, there are 14 coagulation ports P3a and 6 colorimetric ports P3b. The arm 11 is a device used to dispense reagents drawn from the suction port P11 into the target cuvette 100, which is located at the photometry port P3. It includes a probe 11a and an arm body 11b. The arm body 11b is configured to rotate about a rotation axis 13a. As the arm body 11b rotates, the probe 11a, located at the tip of the arm body 11b, can move so as to trace an arc-shaped trajectory L1 on the XY plane.

[0053] By rotating the arm body 11b, the probe 11a can move to each port of each coagulation port P3a, each colorimetric port P3b, suction ports P11, P12, and recovery port P13 set on the trajectory L1. In addition, although not specifically shown, in fact, the probe 11a is composed of two probes to avoid contamination between reagents, and the reagent tray 31a (described later) has an outer tray and an inner tray, and can respectively use the two probes to suck the reagent (or cleaning liquid) on the outer tray and the reagent (or cleaning liquid) on the inner tray from the suction ports P11 and P12. In addition, the recovery port P13 is a port for recovering the used cleaning liquid. Although not specifically shown, the recovery port P13 includes a water accumulation portion that accumulates water ejected from the probe 11a to clean the outer surface of the probe front end, and a waste portion for discarding the liquid.

[0054] The reference port P4 is located at a different location from the photometric port P3 (photometric unit 130). As described above, the reference port P4 has the same structure as the colorimetric ports P3b, but does not require a cuvette 100. Therefore, it is not located on the analysis workbench but rather inside the analysis device.

[0055] Below the suction ports P11 and P12, a reagent tray 31a is located within the reagent refrigerator 31. The reagent containers 1 contain different reagents, and the detergent containers 1a contain different detergents. The reagent tray 31a comprises a disc-shaped turntable. By driving the turntable, the desired reagent container 1 or detergent container 1a can be positioned directly below the suction ports P11 and P12.

[0056] The arm 121 includes a chuck 121a and an arm body 121b. The chuck 121a is configured to grip the cuvette 100. The chuck 121a can hold the cuvette 100 in any manner; the chuck 121a can be a mechanical chuck, a magnetic chuck, or a vacuum chuck. The arm body 121b is configured to rotate around the rotation axis 13a together with the rotating body 122a. As the rotating body 122a rotates, the arm body 121b rotates integrally with the rotating body 122a, and the chuck 121a, which is provided at the front end of the arm body 121b, can move so as to trace a circular arc trajectory L1 on the XY plane.

[0057] As described above, the arms 11 and 121 share the same rotational center. Along trajectory L1 are located the sample dispensing port P1, stirring port P2, disposal port P5, multiple photometric ports P3 (multiple coagulation ports P3a and multiple colorimetric ports P3b), suction ports P11 and P12, and a recovery port P13. Furthermore, the arm 121 can move the chuck 121a to the sample dispensing port P1, stirring port P2, the photometric ports P3, and the disposal port P5, while the arm 11 can move the probe 11a to the suction ports P11 and P12, the recovery port P13, the stirring port P2, and the photometric ports P3.

[0058] Figure 3 1 is a diagram showing a configuration example of the light measuring unit 130. Figure 3 In the photometry unit 130, multiple coagulation ports P3a and colorimetric ports P3b are arranged in an arcuate pattern. More specifically, the multiple coagulation ports P3a and colorimetric ports P3b are arranged so that the cuvette insertion openings of each port follow an arcuate trajectory L1. In this example, there are 14 coagulation ports P3a and 6 colorimetric ports P3b. The number and arrangement order of the coagulation ports P3a and colorimetric ports P3b are not limited to the illustrated arrangement.

[0059] Furthermore, as described above, the reference port P4 (not shown) is not provided in the photometry unit 130 provided with the coagulation port P3 a and the colorimetric port P3 b , but is disposed, for example, inside the analysis device.

[0060] Figure 4 : is a top view showing a configuration example of the colorimetric port P3b and the reference port P4. Figure 5 It shows Figure 4 4 is a cross-sectional view of the structure of section VV. Note that the structure of the reference port P4 is the same as that of the colorimetric port P3b, and therefore the colorimetric port P3b will be representatively described below.

[0061] Reference Figure 4 and Figure 5 The colorimetric port P3b includes a lens holder 310, an optical fiber cable 312, a cuvette insertion port 314, and a light detector 316. The lens holder 310 has a lens at its front end and is inserted into the socket of the colorimetric port P3b. The lens holder 310 receives light from a light source (not shown) via the optical fiber cable 312 and outputs it to the cuvette insertion port 314 through the lens.

[0062] The cuvette insertion port 314 is configured to allow the cuvette 100 transferred by the transfer device 120 (arm 121) to be loaded and unloaded. When the cuvette 100 is inserted into the cuvette insertion port 314, the insertion of the cuvette 100 is detected by a port sensor (not shown).

[0063] The photodetector 316 is disposed on the side opposite to the lens holder 310 across the cuvette insertion port 314. When measuring a specimen in the cuvette 100 inserted into the cuvette insertion port 314, the photodetector 316 detects the amount of light transmitted from the lens holder 310 to the cuvette 100 and through the cuvette 100. When performing a blank measurement without the cuvette 100 inserted into the cuvette insertion port 314, the photodetector 316 directly detects the amount of light output from the lens holder 310. The photodetector 316 is comprised of, for example, a photodiode. Furthermore, the photodetector 316 outputs a detection signal to the substrate 320 via a connecting cable 318.

[0064] Regarding the reference port P4 , a light-shielding cover is provided on the cuvette insertion port 314 to prevent light from entering the cuvette insertion port 314 from the outside, and the photodetector 316 always directly detects the amount of light output from the lens holder 310 .

[0065] Figure 6 : is a diagram showing a configuration example of the optical system of the colorimetric port P3b and the reference port P4. Figure 6Light from a common light source 330 is supplied to each lens holder 310 attached to the reference port P4 and a plurality of (six in this example) colorimetric ports P3b.

[0066] Light source 330 is, for example, a halogen lamp. Light output from light source 330 passes through filter device 332 and is then supplied to an optical fiber cable 334. Filter device 332 is located near the output of light source 330 and includes an optical filter that allows light of a specific wavelength to pass through. Filter device 332 includes multiple optical filters, and is configured so that the wavelength of light passing through can be changed by switching the optical filters.

[0067] Figure 7 332 is a top view showing a configuration example of the filter device 332. Figure 7 Filter device 332 is composed of a circular drum with multiple openings arranged in the circumferential direction. In this example, four openings are arranged at equal intervals in the circumferential direction, and optical filters 340a-340c that transmit different wavelengths are installed in three of these openings. Optical filters 340a-340c are, for example, interference filters that transmit light with wavelengths of 405nm, 570nm, and 730nm, respectively.

[0068] In this manner, the analyzing apparatus is configured to switch the wavelength of light irradiated onto the specimen (cuvette), and can use light of a specific wavelength corresponding to the specimen and the test item for colorimetric analysis.

[0069] Refer again Figure 6 Light from light source 330 passes through an optical filter in filter device 332 and is then supplied to an optical fiber cable 334. Optical fiber cable 334 branches into seven optical fiber cables 312, six of which are connected to six colorimetric ports P3b, and the remaining optical fiber cable 312 is connected to reference port P4.

[0070] Next, the configuration of an analysis and measurement system based on colorimetry in the analysis device according to the first embodiment will be described.

[0071] Figure 8 This is a block diagram functionally showing the configuration of a measurement system using colorimetry. Figure 8 The light output from the light source 330 passes through the filter 340 (one of the optical filters 340 a to 340 c ) and is supplied to each colorimetric port P3 b and the reference port P4 .

[0072] The output of each colorimetric port P3b (the output of the photodetector 316) is amplified by the amplifier 350 and then input to the port selector 352. The port selector 352 is configured to output any one of the outputs from the six colorimetric ports P3b (the output of the amplifier 350) from an output port connected to the LOG converter 354. Which of the six colorimetric ports P3b outputs is output to the LOG converter 354 is appropriately switched according to the analysis schedule for colorimetric analysis using the six colorimetric ports P3b.

[0073] The output of the reference port P4 (the output of the photodetector 316 ) is amplified by the amplifier 350 and input to the LOG conversion unit 354 .

[0074] The LOG converter 354 is comprised of, for example, a LOG amplifier, and outputs the logarithmic value of the value obtained by dividing the output from the port selector 352 by the output from the reference port P4 (the output of the amplifier 350). Specifically, the LOG converter 354 calculates the ratio of the light intensity measured at the colorimetric port P3b to the light intensity measured at the reference port P4, and outputs this light intensity ratio as a logarithmic value. The output from the LOG converter 354 is then converted into a digital signal by the AD converter 356 and output as measurement data to the output unit 358.

[0075] Thus, in this embodiment 1, in the analysis and measurement based on the colorimetric method using the colorimetric port P3b, the ratio of the light amount of the transmitted light detected at the colorimetric port P3b where the cuvette 100 is provided to the light amount of the reference light detected at the reference port P4 is calculated, and this light amount ratio is used as the measurement result (absorbance).

[0076] Furthermore, in the first embodiment, before starting the analytical measurement, a blank measurement is performed in which the measurement is performed without the cuvette 100 being placed at each colorimetric port P3b. The light intensity ratio during the blank measurement is theoretically 1 if normal. Based on this light intensity ratio during the blank measurement, it is possible to detect whether the measurement system has no abnormalities.

[0077] However, this alone cannot identify the abnormal location in the measurement system. Therefore, in the analyzer according to this first embodiment, if the light intensity ratio during a blank measurement is outside a specified range (e.g., ±10% of 1.0), the colorimetric port P3b in question is determined to be erroneous. Then, if the number of colorimetric ports P3b determined to be erroneous (the number of errors) is less than a specified value, the error is determined to be limited to that colorimetric port P3b, and the colorimetric port P3b determined to be erroneous is determined to be erroneous. On the other hand, if the number of errors is greater than a specified value, the error is determined to be not limited to a specific colorimetric port P3b, and the reference port P4 shared by all colorimetric ports P3b during the blank measurement is determined to be erroneous. Thus, the analyzer according to this first embodiment can identify the abnormal location in the measurement system (whether it is an abnormality in the colorimetric port P3b or the reference port P4).

[0078] Although not specifically shown, a light source and a photodetector are provided for each coagulation port P3a. A detection signal corresponding to the amount of 90° scattered light detected by the photodetector is amplified by an amplifier, converted to a digital signal by an AD converter, and acquired as a measurement signal.

[0079] Figure 9 This is a block diagram showing an example of the system configuration of the analysis device according to the first embodiment. Figure 9 The analyzing apparatus includes a photometric unit 130 , a robot unit 150 , a measuring device 300 , a control device 500 , and an operation display unit 520 .

[0080] The photometric unit 130 includes a plurality of coagulation ports P3a, a plurality of colorimetric ports P3b, and a reference port P4. Figure 8 The light source 330, the filter 340 (filter device 332), the amplifier 350, and the port selector 352 are shown. In addition, the amplifier 350 and the port selector 352 may also be provided in the measurement device 300.

[0081] The robot unit 150 is used to generally illustrate the arms 11, 21, 121, the cuvette supply device 110, the CTS mechanism 24, the reagent refrigerator 31, and the reagent tray 31a (see above). Figure 2 ), sample holder, filter device 332 (refer to Figure 6 、 7) and other movable devices. The robot unit 150 transports samples using the arm 21, sample rack, and CTS mechanism 24; transports reagents using the arm 11, reagent cooler 31, and reagent tray 31a; transfers and transports the cuvette 100 using the supply device 110 and arm 121; and drives the filter device 332. The robot unit 150 is fully automatically controlled by the transfer control unit 376 of the measurement device 300.

[0082] The measurement device 300 includes a photometry control unit 370, a data collection unit 372, an A / D converter 374, and a transfer control unit 376. The photometry control unit 370 controls the overall photometry of the photometry unit 130 according to instructions from the data collection unit 372. For example, the photometry control unit 370 drives the filter device 332 to appropriately switch the optical filters 340a to 340c, or controls the port selector 352 to select the output from the colorimetric port P3b of the measurement target.

[0083] The data collection unit 372 determines the wavelength of light to be supplied to the colorimetric port P3b and the colorimetric port P3b from which measurement data is to be acquired, in accordance with the data collection instruction from the control device 500, and outputs the instruction to this effect to the photometry control unit 370. The data collection unit 372 then acquires the measurement data of the light intensity ratio from the A / D converter 374 and outputs the collected data to the control device 500.

[0084] Furthermore, when performing measurement using the coagulation port P3a, the data collection unit 372 determines the coagulation port P3a from which to acquire measurement data in accordance with a data collection instruction from the control device 500, and outputs an instruction to perform measurement using the coagulation port P3a to the photometry control unit 370. The data collection unit 372 then acquires measurement data (light intensity) of scattered light detected at the coagulation port P3a from the A / D converter 374, and outputs the acquired data to the control device 500.

[0085] The AD conversion unit 374 is configured to include Figure 8 The LOG converter 354 and AD converter 356 are shown. Furthermore, the AD converter 374 converts the detection signal from the photodetector of each coagulation port P3a into a digital signal and outputs it to the data acquisition unit 372 as a measurement signal based on the time-coagulation method. The transfer control unit 376 generates commands for controlling various operations of the robot unit 150 in accordance with instructions from the data processing unit 510 of the control device 500, thereby controlling various operations of the robot unit 150.

[0086] The control device 500 includes a data processing unit 510 and a storage unit 512. The data processing unit 510 generates various instructions for performing measurements in accordance with measurement instructions issued by the user from the operation display unit 520, and outputs the generated various instructions to the data collection unit 372 and the transfer control unit 376 of the measurement device 300. Furthermore, the data processing unit 510 performs various data processing for colorimetric analysis based on various measurement data received from the data collection unit 372 of the measurement device 300, and also performs various data processing for coagulation analysis.

[0087] Furthermore, during a measurement using the colorimetric port P3b, the data processing unit 510 generates a command for executing a blank measurement and outputs the generated command to the measurement device 300. The data processing unit 510 then receives the blank measurement result from the measurement device 300. If the blank measurement result is considered abnormal, the data processing unit 510 determines whether the abnormality is at the colorimetric port P3b or at the reference port P4. The specific details of this processing will be described in detail later.

[0088] The storage unit 512 stores control programs and various information (data) for the control device 500 to execute various processes, and outputs the various control programs and information (data) to the data processing unit 510 in response to a request from the data processing unit 510 .

[0089] Figure 10 It shows Figure 9 FIG. 1 is a diagram showing an example of a hardware configuration of a control device 500. Figure 10 The control device 500 is configured to include a CPU (Central Processing Unit) 530, a RAM (Random Access Memory) 532, a storage device 534, and an input / output buffer (not shown) for inputting and outputting various signals.

[0090] The CPU 530 expands the control program stored in the storage device 534 into the RAM 532 for execution. This control program is a program that records the procedures for various processes performed by the control device 500. In addition to the control program, the storage device 534 also stores various information and data used in the various processes. The control device 500 executes the various processes in the analysis device according to this control program and various information and data. Furthermore, the processes are not limited to those implemented by software and can also be executed by dedicated hardware (electronic circuits).

[0091] In addition, in addition to recording the control program of the processing process, the storage device 534 also stores information or data such as reagent information, analysis schedule, analysis history, and judgment conditions. Figure 2 ) Information on each reagent prepared in (for example, reagent ID, reagent type, expiration date, etc.).

[0092] The analysis schedule is determined based on sample information (e.g., analysis items for each sample) and the availability of each port, allowing for efficient analysis of all scheduled samples. For example, the analysis schedule includes the times for dispensing and measurement, the sample and reagent to be dispensed, and the photometric port P3 (coagulation port P3a and / or colorimetric port P3b) to be measured. The analysis schedule is managed for each sample ID (and each sample container).

[0093] The analysis history records show the progress of the analysis, including the progress of the analysis, and are updated sequentially according to the progress of the analysis. The analysis history records include, for example, the movement path of the cuvette (including the current position), the sample and reagents dispensed into the cuvette, the photometric port P3 where the measurement was performed, and the measurement results. The analysis history records are managed for each cuvette. The control device 500 and the user can each confirm whether the analysis has been performed according to the analysis schedule (or whether the analysis is progressing according to the analysis schedule) by referring to the analysis history records.

[0094] The judgment conditions include a judgment value for determining an abnormal location when a blank measurement of colorimetric port P3b indicates an error. Specifically, in the analyzer according to Embodiment 1, the control device 500 performs a blank measurement for each colorimetric port P3b before performing the analytical measurement and determines that a colorimetric port P3b with a light intensity ratio outside a specified range is an error. Then, if the error count, which indicates the number of colorimetric ports P3b determined to be error, is less than a specified value, the control device 500 determines that the colorimetric port P3b determined to be error is abnormal. On the other hand, if the error count is greater than the specified value, the control device 500 determines that the reference port P4 is abnormal.

[0095] Furthermore, the determination conditions include the aforementioned prescribed range of the light intensity ratio when performing a blank measurement, and the aforementioned prescribed value of the error count, which represents the number of colorimetric ports P3b determined to be erroneous. Furthermore, the aforementioned prescribed range can also be set for each wavelength of light supplied to each colorimetric port P3b and reference port P4 (i.e., for each optical filter selectable in the filter device 332). Since the sensitivity of the photodetector can vary depending on the wavelength of light, the aforementioned prescribed range can be set for each wavelength.

[0096] Next, the abnormality determination process of the colorimetric port P3b and the reference port P4 using this determination condition will be described in detail.

[0097] Figure 11 This is a flowchart illustrating an example of the abnormality determination process for the colorimetric port P3b and the reference port P4. In the example shown here, the series of processes shown in the flowchart is executed upon system startup of the analyzer. However, the processes may also be executed immediately before a series of analytical measurements begins or after the analytical measurements have been completed.

[0098] Reference Figure 11 The control device 500 first performs a blank measurement process (step S10). As described above, a blank measurement is performed without inserting a cuvette 100 into each colorimetric port P3b, and the ratio of the light intensity detected at each colorimetric port P3b to the light intensity detected at the reference port P4 is checked to see if it is within a specified range.

[0099] Figure 12 It is shown in Figure 11 Flowchart of an example of the procedure of the blank measurement process executed in step S10. Figure 12 The control device 500 first sets the count value i to 1 (step S110) to select the i-th (i.e., first) colorimetric port P3b as the target for blank measurement (step S120). Hereinafter, the i-th colorimetric port P3b will also be referred to as "port i."

[0100] Next, the control device 500 sets the count value k to 1 (step S130) and controls the filter device 332 to select the kth (i.e., first) filter (e.g., optical filter 340a) (step S140). The kth filter will sometimes be referred to as "filter k" below.

[0101] Next, the control device 500 reads the prescribed range of light intensity ratios for the filter k selected in step S140 from the storage device 534 (step S150). Specifically, in this example, the prescribed range is set for each wavelength of light supplied to each colorimetric port P3b and reference port P4 (i.e., for each filter selectable in the filter device 332).

[0102] Next, the control device 500 performs a blank measurement for port i with filter k selected, and obtains the light intensity ratio at that time (step S160). The control device 500 then determines whether the light intensity ratio obtained in the blank measurement deviates from the specified range read in step S150 (step S170).

[0103] If the light intensity ratio obtained in the blank measurement is determined to be outside the specified range ("YES" in step S170), the control device 500 determines that port i is an error (step S180) and stores the measurement result (light intensity ratio) along with the error determination (step S190). If the light intensity ratio obtained in the blank measurement is within the specified range ("NO" in step S170), step S180 is not executed, and the process proceeds to step S190, where the measurement result (light intensity ratio) is stored.

[0104] Next, the control device 500 determines whether the count value k is 3 (step S200). This value "3" corresponds to the number of filters (optical filters 340a to 340c) included in the filter device 332 in the first embodiment and is appropriately set according to the number of filters installed.

[0105] If it is determined in step S200 that the count value k has not reached 3 ("No" in step S200), the control device 500 increments the count value k by 1 (step S210) and returns the process to step S140. That is, the processes of steps S140 to S190 are executed for each filter included in the filter device 332 for port i.

[0106] If it is determined in step S200 that the count value k is 3 ("YES" in step S200), the control device 500 determines whether the count value i is 6 (step S220). This value "6" corresponds to the number of colorimetric ports P3b in the first embodiment and is appropriately set according to the number of colorimetric ports P3b provided.

[0107] If it is determined in step S220 that the count value i has not reached 6 ("No" in step S220), the control device 500 increments the count value i by 1 (step S230) and returns the process to step S120. That is, the processes of steps S120 to S210 are executed for each colorimetric port P3b. Then, if it is determined in step S220 that the count value i has reached 6 ("Yes" in step S220), the control device 500 returns the process to the default state and terminates the blank measurement process.

[0108] Refer again Figure 11 After executing the blank measurement process of step S10, the control device 500 determines whether any colorimetric port P3b has been determined to be erroneous (step S20). If no colorimetric port P3b has been determined to be erroneous ("No" in step S20), the control device 500 determines that each colorimetric port P3b and reference port P4 is normal (step S30), and executes a series of sample measurement processes including transporting the cuvette 100, dispensing the sample and reagent into the cuvette 100, and analyzing and measuring at the photometric port P3 (step S40).

[0109] On the other hand, if there is a colorimetric port P3b determined to be erroneous ("Yes" in step S20), the control device 500 determines whether the number of colorimetric ports P3b determined to be erroneous is greater than a predetermined value (step S50). The predetermined value can be, for example, "2" to indicate that the number of colorimetric ports P3b determined to be erroneous is plural. However, if the number of colorimetric ports P3b is large, the predetermined value may be greater than 2 (for example, 3).

[0110] When the number of colorimetric ports P3b determined to be erroneous is less than a predetermined value ("No" in step S50), the control device 500 determines that the colorimetric port P3b determined to be erroneous in the blank measurement process is abnormal (step S60). For a plurality of colorimetric ports P3b, if the number of colorimetric ports P3b determined to be erroneous is less than a predetermined value, it is determined that an abnormality has occurred in the colorimetric port P3b. Then, the control device 500 turns on the operation display unit 520 ( Figure 9 ) is controlled to notify the colorimetric port P3b determined to be abnormal (step S70).

[0111] The control device 500 then ends the process and seeks confirmation from the user. Alternatively, instead of ending the process, the process may proceed to step S40 to disable the abnormal colorimetric port P3b and execute the sample measurement process.

[0112] On the other hand, if it is determined in step S50 that the number of colorimetric ports P3b determined to be erroneous is greater than a predetermined value ("YES" in step S50), the control device 500 determines that the reference port P4 is abnormal (step S80). The light intensity detected at the reference port P4 is used to measure the light intensity ratio for each colorimetric port P3b. Therefore, for the plurality of colorimetric ports P3b, if the number of colorimetric ports P3b determined to be erroneous is greater than a predetermined value, it is determined that the abnormality has occurred in the reference port P4, not in the individual colorimetric ports P3b determined to be erroneous.

[0113] The control device 500 then controls the operation display unit 520 to notify the user of an abnormality in the reference port P4 (step S90). The control device 500 then terminates the process without executing step S40. If an abnormality occurs in the reference port P4, all measurement results at the colorimetric port P3b are abnormal, and therefore, the sample measurement process is not performed. Furthermore, while the measurement process using the colorimetric port P3b is disabled, the measurement process using the coagulation port P3a can be performed according to the schedule.

[0114] As described above, in this first embodiment, if the number of errors in the colorimetric port P3b determined to be erroneous is less than a predetermined value, the colorimetric port P3b determined to be erroneous is determined to be abnormal. On the other hand, if the number of errors is greater than the predetermined value, the reference port P4, which is shared by all measurement ports, is determined to be abnormal. Thus, according to this first embodiment, it is possible to identify the abnormal location in the measurement system (whether it is the colorimetric port P3b or the reference port P4).

[0115] [Implementation Method 2]

[0116] In the first embodiment described above, based on the results of blank measurements performed on all colorimetric ports P3b before the start of sample measurement, if there is a colorimetric port P3b determined to be erroneous, the abnormal site is identified (is it the colorimetric port P3b or the reference port P4 that is abnormal).

[0117] In this second embodiment, after the start of the sample measurement, a blank measurement is performed on an idle colorimetric port P3b, and if there is a colorimetric port P3b determined to be erroneous, an abnormal site is identified.

[0118] The overall structure of the analyzer in the second embodiment is the same as that of the analyzer described in the first embodiment. The abnormality determination process of the colorimetric port P3b and the reference port P4 of the analyzer in the second embodiment ( Figure 11 ) is different from implementation mode 1.

[0119] Figure 13 This is a flowchart showing an example of the procedure of abnormality determination processing for the colorimetric port P3b and the reference port P4 in Embodiment 2. The series of processing shown in this flowchart is executed when the system of the analyzer is activated.

[0120] Reference Figure 13 , the control device 500 first performs a blank measurement process (step S310). The process of the blank measurement process is as follows Figure 12 As shown, the measurement results are stored in the storage device 534. When the blank measurement process of step S310 is executed, the control device 500 starts a series of sample measurements including the transportation of the cuvette 100, the dispensing of the sample and reagent into the cuvette 100, and the analysis and measurement at the photometry port P3 (step S320).

[0121] In this example, the sample measurement is started unconditionally after the blank measurement process in step S310 is executed. However, the blank measurement process described in the first embodiment may be performed after the blank measurement process is executed. Figure 11 The processing after step S20.

[0122] When the specimen measurement begins in step S320, the control device 500 determines whether there is a colorimetric port P3b available for performing a blank measurement (step S330). Blank measurements are performed without the cuvette 100 installed. Therefore, a colorimetric port P3b that is available in the analysis schedule can be designated as the port for performing a blank measurement. In this case, to prevent excessive blank measurements, a colorimetric port P3b that is available in the analysis schedule and has been available for a predetermined time period or longer since the last blank measurement can be designated as the port for performing a blank measurement.

[0123] When it is determined in step S330 that there is a colorimetric port P3b capable of performing blank measurement (YES in step S330), the control device 500 performs blank measurement on the colorimetric port P3b (step S340).

[0124] When a blank measurement is performed, the control device 500 obtains the blank measurement result (light intensity ratio) performed at system startup (before the start of sample measurement) in step S310 for the colorimetric port P3b where the blank measurement was performed (step S350). The control device 500 then determines whether the difference between the blank measurement result (light intensity ratio) performed in step S340 and the blank measurement result (light intensity ratio) obtained at system startup in step S350 is greater than a threshold value (step S360). This threshold value can be set appropriately, for example, to ±10% of the blank measurement result (light intensity ratio) obtained at system startup.

[0125] Then, when it is determined that the deviation amount of the light intensity ratio compared to the time of system startup is larger than the threshold value (YES in step S360 ), the control device 500 determines that the colorimetry port P3 b is an error (step S370 ).

[0126] On the other hand, if the deviation in the light intensity ratio is below the threshold ("No" in step S360), the colorimetric port P3b is determined to be normal, the process of step S370 is not performed, and the process proceeds to step S380. In addition, if it is determined in step S330 that there is no colorimetric port P3b capable of performing a blank measurement ("No" in step S330), the process also proceeds to step S380.

[0127] The processing of steps S380 to SS430 is respectively Figure 11The processes of step S20, and steps S50 to S90 are the same. Specifically, if there are colorimetric ports P3b determined to be erroneous (i.e., ports with a larger deviation in light intensity ratio than at system startup), if the number of colorimetric ports P3b determined to be erroneous is less than a specified value ("No" in step S390), the colorimetric ports P3b determined to be erroneous are determined to be abnormal (step S400). If the number of colorimetric ports P3b determined to be erroneous is greater than a specified value ("Yes" in step S390), the reference port P4 is determined to be abnormal (step S420).

[0128] Then, if a port abnormality is notified in step S410 or S430, the control device 500 determines whether to terminate the series of sample measurements (step S430). For example, if the number of colorimetric ports P3b determined to be abnormal is less than a specified value, the control device 500 determines to continue the series of sample measurements ("No" in step S440), returning the process to step S330. On the other hand, if the number of colorimetric ports P3b determined to be abnormal is greater than the specified value, the control device 500 determines to terminate the sample measurements ("Yes" in step S440), transitioning the process to the end.

[0129] As described above, according to the second embodiment, a blank measurement can be performed on the idle colorimetric port P3b even after the specimen measurement starts. If there is a colorimetric port P3b that is judged to be erroneous, the abnormal part of the measurement system can be determined (whether it is the colorimetric port P3b that is abnormal or the reference port P4 that is abnormal).

[0130] [Way]

[0131] Those skilled in the art will appreciate that the above-described multiple exemplary embodiments are specific examples of the following aspects.

[0132] (Item 1) A biochemical analysis device according to one embodiment is a biochemical analysis device that performs biochemical analysis of a specimen by reacting the specimen with a reagent in a reaction vessel, and includes a plurality of measurement ports, a reference port, and a control device. During the analysis, the plurality of reaction vessels are respectively arranged at the plurality of measurement ports. The amount of light transmitted through the reaction vessel is measured by each measurement port. The amount of light equivalent to the irradiated light irradiated onto the reaction vessel is measured by the reference port. The control device is configured to analyze the specimen in the reaction vessel based on the ratio of the amount of light measured at the measurement port in which the reaction vessel is arranged to the amount of light measured at the reference port. The control device performs a blank measurement on each measurement port, in which the ratio of the amount of light measured at the measurement port in a state where no reaction vessel is arranged to the amount of light measured at the reference port, i.e., the light intensity ratio, is calculated. Furthermore, in the blank measurement, if the light intensity ratio is outside a specified range, the control device determines that the measurement port is erroneous. The control device is configured to determine that the measurement ports determined to be erroneous are abnormal when the error count indicating the number of measurement ports determined to be erroneous is smaller than a specified value, and to determine that the reference ports are abnormal when the error count is greater than the specified value.

[0133] In the biochemical analyzer described in Item 1, if the number of errors in a measurement port determined to be erroneous is less than a predetermined value, the error is determined to be limited to the measurement port in question and the erroneous measurement port is determined to be abnormal. On the other hand, if the number of errors is greater than the predetermined value, the error is determined to be not limited to the measurement port and the reference port, which is shared by all measurement ports, is determined to be abnormal. Thus, this biochemical analyzer can identify the location of the erroneous measurement system (whether the erroneous measurement port or the reference port is abnormal).

[0134] (Item 2) In the biochemical analysis device described in Item 1, one reference port is provided for the plurality of measurement ports.

[0135] With this configuration, when the error count indicating the number of measurement ports determined to be erroneous is equal to or greater than a predetermined value, it can be determined that the reference port is abnormal.

[0136] (Item 3) In the biochemical analysis device described in Item 1 or Item 2, the biochemical analysis device further includes a common light source that supplies light to each of the plurality of measurement ports and reference ports.

[0137] With this configuration, when the number of errors is smaller than a predetermined value, it can be determined that the measurement port determined as an error is abnormal, and when the number of errors is greater than the predetermined value, it can be determined that the reference port is abnormal.

[0138] (Item 4) The biochemical analyzer according to any one of Items 1 to 3 further comprises a filter device configured to switch the wavelength of light supplied to each of the plurality of measurement ports and the reference port according to analysis conditions. The predetermined range is set based on the wavelength selected by the filter device.

[0139] Since the sensitivity of the photodetector can be changed according to the wavelength of the irradiation light, the biochemical analysis apparatus according to item 4 can ensure the accuracy of abnormality determination even if the wavelength of the irradiation light is switched according to the analysis conditions.

[0140] (Item 5) In the biochemical analyzer described in any one of Items 1 to 4, the control device performs a first process of performing a blank measurement on each of the plurality of measurement ports before the start of the analysis and measurement, and performs a second process of performing a blank measurement on the measurement port not configured with a reaction vessel after the start of the analysis. The control device determines that a measurement port subjected to the second process is erroneous if the difference between the light intensity ratio obtained in the first process and the light intensity ratio obtained in the second process is greater than a threshold value. The control device is configured such that, for a measurement port subjected to the second process, if the number of errors is less than a specified value, the measurement port determined to be erroneous is determined to be abnormal, and if the number of errors is greater than the specified value, the reference port is determined to be abnormal.

[0141] According to the biochemical analyzer of item 5, blank measurement can be performed on an idle measurement port even after the start of sample measurement, and if there is a measurement port determined to be erroneous, the abnormal part of the measurement system (whether it is a measurement port abnormality or a reference port abnormality) can be determined.

[0142] (Item 6) In addition, a biochemical analysis method according to one embodiment is a biochemical analysis method in which a sample is reacted with a reagent within a reaction vessel to perform biochemical analysis of the sample. The device for performing the biochemical analysis includes multiple measurement ports and a reference port. During the analysis, the multiple reaction vessels are respectively arranged at the multiple measurement ports. The amount of light transmitted through the reaction vessel is measured by each measurement port. The amount of light equivalent to the irradiation light irradiated into the reaction vessel is measured by the reference port. Moreover, the biochemical analysis method includes the following steps: analyzing the specimen in the reaction container based on the ratio of the amount of light measured at the measuring port configured with the reaction container to the amount of light measured at the reference port; performing a blank measurement on each of the multiple measuring ports, in which the ratio of the amount of light measured at the measuring port in a state where no reaction container is configured and the amount of light measured at the reference port, i.e., the light intensity ratio, is calculated; in the blank measurement, if the light intensity ratio is outside a prescribed range, the measuring port is judged to be erroneous; if the error number indicating the number of measuring ports judged to be erroneous is smaller than a prescribed value, the measuring port judged to be erroneous is judged to be abnormal; and if the error number is greater than a prescribed value, the reference port is judged to be abnormal.

[0143] According to the biochemical analysis method of item 6, it is possible to identify the abnormal part of the measurement system (whether the abnormality lies in the measurement port or the reference port).

[0144] The various embodiments disclosed herein are intended to be implemented in appropriate combinations within the scope of technical non-inconsistency. Furthermore, it should be understood that the embodiments disclosed herein are illustrative in all respects and are not restrictive. The scope of the present invention is not determined by the above description of the embodiments but by the claims, and is intended to encompass all modifications within the meaning and scope equivalent to the claims.

[0145] Description of Reference Numerals

[0146] 1: Reagent container; 1a: Lotion container; 11, 21, 121: Arm; 11a, 21a: Probe; 11b, 21b, 121b: Arm body; 13a, 23a: Rotating axis; 24: CTS mechanism; 31: Reagent refrigerator; 31a: Reagent tray; 100: Cuvette; 110: Cuvette supply device; 111: Cuvette storage unit; 112: Supply mechanism; 120: Cuvette transfer device; 121a: Chuck; 122: Drive device; 122a: Rotating body; 130: Photometric unit; 150: Robot unit; 200: Stirring device; 300: Measuring device; 310: Lens holder; 312, 334: Optical fiber cable; 314: Cuvette mounting port; 316: Photodetector; 318: Connecting cable; 320: Substrate; 330: Light source; 332: Filter device ;340a~340c: optical filter; 350: amplifier; 352: port selection unit; 354: LOG conversion unit; 356, 374: AD conversion unit; 358: output unit; 370: photometry control unit; 372: data collection unit; 376: transfer control unit; 400: cuvette waste container; 500: control device; 510: data processing unit; 512: storage unit; 520: operation display unit; 530: CPU; 532: RAM; 534: storage device; P1: sample dispensing port; P11, P12: suction ports; P13: recovery port; P2: stirring port; P21: sample suction port; P22: S port; P23: cleaning port; P3: photometry port; P3a: coagulation port; P3b: colorimetric port; P4: reference port; P5: waste port.

Claims

1. A biochemical analysis device for performing biochemical analysis of a sample by reacting the sample with a reagent in a reaction container, the biochemical analysis device comprising: a plurality of measurement ports, wherein during analysis and measurement, the plurality of reaction containers are respectively arranged at the plurality of measurement ports, and the amount of light transmitted through the reaction container is measured at each of the measurement ports; a reference port commonly used in measurements performed by the respective measurement ports, for measuring the amount of light corresponding to the irradiation light directed to the reaction container; a common light source for supplying light to each of the plurality of measurement ports and the reference port; and a control device configured to analyze the sample in the reaction container based on a ratio of the amount of light measured at the measurement port where the reaction container is disposed and the amount of light measured at the reference port; in, The control device is composed of: A blank measurement is performed for each of the plurality of measurement ports, wherein in the blank measurement, a light intensity ratio is obtained, which is a ratio of the light intensity measured at the measurement port in a state where no reaction container is placed to the light intensity measured at the reference port. In the blank measurement, if the light intensity ratio is outside a predetermined range, the measurement port is determined to be an error. If the error count indicating the number of measurement ports determined to be erroneous is smaller than a predetermined value, the measurement ports determined to be erroneous are determined to be abnormal. When the number of errors is equal to or greater than the predetermined value, the reference port is determined to be abnormal.

2. The biochemical analysis device according to claim 1, wherein One reference port is provided for the plurality of measurement ports.

3. The biochemical analysis device according to claim 1 or 2, wherein: further comprising a filter device configured to switch the wavelength of light supplied to each of the plurality of measurement ports and the reference port according to analysis conditions, The predetermined range is set according to the wavelength selected by the filter device.

4. The biochemical analysis device according to claim 1 or 2, wherein: The control device is composed of: Before starting the analytical measurement, a first process of performing the blank measurement on each of the plurality of measurement ports is executed; After the analytical measurement is started, a second process of performing the blank measurement on the measurement port where the reaction container is not arranged is executed. For the measurement port on which the second processing is executed, if the difference between the light intensity ratio obtained in the first processing and the light intensity ratio obtained in the second processing is larger than a threshold value, the measurement port is determined to be an error; For the measurement port on which the second process is executed, if the number of errors is smaller than the predetermined value, the measurement port determined to be erroneous is determined to be abnormal; if the number of errors is greater than the predetermined value, the reference port is determined to be abnormal.

5. The biochemical analysis device according to claim 3, wherein The control device is composed of: Before starting the analytical measurement, a first process of performing the blank measurement on each of the plurality of measurement ports is executed; After the analytical measurement is started, a second process of performing the blank measurement on the measurement port where the reaction container is not arranged is executed. For the measurement port on which the second processing is executed, if the difference between the light intensity ratio obtained in the first processing and the light intensity ratio obtained in the second processing is larger than a threshold value, the measurement port is determined to be an error; For the measurement port on which the second process is executed, if the number of errors is smaller than the predetermined value, the measurement port determined to be erroneous is determined to be abnormal; if the number of errors is greater than the predetermined value, the reference port is determined to be abnormal.

6. A biochemical analysis method for performing biochemical analysis of a sample by reacting the sample with a reagent in a reaction container. The device for performing the biochemical analysis comprises: a plurality of measurement ports, wherein during analysis and measurement, the plurality of reaction containers are respectively arranged at the plurality of measurement ports, and the amount of light transmitted through the reaction container is measured at each of the measurement ports; a reference port commonly used in measurements performed by the respective measurement ports, for measuring the amount of light corresponding to the irradiation light directed to the reaction container; as well as a common light source for supplying light to each of the plurality of measurement ports and the reference port; The biochemical analysis method comprises the following steps: analyzing the sample in the reaction container based on a ratio of the amount of light measured at the measurement port where the reaction container is disposed to the amount of light measured at the reference port; performing a blank measurement for each of the plurality of measurement ports, wherein in the blank measurement, a light intensity ratio is obtained, which is a ratio of the light intensity measured at the measurement port in a state where no reaction container is placed therein to the light intensity measured at the reference port; In the blank measurement, if the light intensity ratio is outside a predetermined range, determining the measurement port as an error; If the error count indicating the number of measurement ports determined to be erroneous is smaller than a predetermined value, determining that the measurement ports determined to be erroneous are abnormal; and When the number of errors is equal to or greater than the predetermined value, the reference port is determined to be abnormal.

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