Calibration and validation of cuvettes in automated chemical analyzers

Abstract

The presently claimed technology provides improved calibration and validation procedures for sample containers (e.g., cuvettes) in automated chemical analyzers. The presently claimed technology further provides a method of operating an automated analyzer that can automate the calibration and integrity tracking of individual sample containers (e.g., cuvettes) in parallel with the measurement of component samples. The method eliminates the need to alternate between diagnostic and measurement modes when performing system maintenance such as verifying cuvette integrity, calibrating absorbance baselines, and replacing cuvettes. Thus, the presently claimed technology can reduce downtime and significantly increase the productivity of clinical laboratories by allowing such system maintenance to be performed in parallel with sample analysis.

Description

Technical Field

[0001] Related Applications This patent application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 131241, filed on Dec. 28, 2020, the content of which is incorporated herein by reference in its entirety.

[0002] Field Various aspects of the technology disclosed and claimed herein relate to the calibration and verification of cuvettes in automated chemical analyzers, and more particularly to an improved method for assessing the integrity of cuvettes utilized in such analyzers.

[0003] Background Automated chemical analyzers are commonly used in clinical chemistry sampling and analysis applications. Automated analyzers, such as automated analytical chemistry workstations, can efficiently perform clinical analyses on a large number of samples by running tests in parallel or at short time intervals. Efficient results are, to some extent, due to the use of automated sample identification and sample tracking. The apparatus can automatically prepare appropriate volumes of samples and automatically set the test conditions required for the execution of scheduled tests. The test conditions can be established and tracked independently for each of the various test protocols that proceed simultaneously within a single test station, enabling the simultaneous execution of multiple different tests that require different reaction conditions based on various chemical reactions. Automated analyzers are particularly well-suited for high-volume test environments, such as those found in many hospitals and centralized testing laboratories, because automated sample handling enables more accurate sample identification and sample tracking. Automated sample handling and sample tracking significantly reduce the potential for human error or accidents that can lead to incorrect test results or unwanted contamination.

[0004] Calibration and validation of sample containers (e.g., cuvettes) are a crucial part of using automated chemical analyzers to ensure data accuracy. While tracking the integrity of individual sample containers is necessary, it can be extremely time-consuming. Therefore, current calibration and validation procedures are often limited in their use during evaluation, and may not be performed frequently enough. This can lead to data inaccuracies, inefficiencies, and increased costs.

[0005] Further limitations and shortcomings of conventional classical approaches will become apparent to those skilled in the art by comparing such systems with some aspects of the present disclosure described in other parts of this application with reference to the drawings.

[0006] overview The inventors recognized the need for improved calibration and verification procedures for sample containers (e.g., cuvettes) in automated chemical analyzers. In particular, they disclose a method that enables the automation of calibration and tracking of the integrity of individual sample containers (e.g., cuvettes).

[0007] One aspect of the technology disclosed and claimed herein is a method for operating an automated analyzer, the method comprising: preparing an automated analyzer comprising a plurality of cuvettes, a plurality of positions including at least one reagent distribution position, at least one component distribution position, at least one cuvette washing position, and at least one component measurement position, at least one cuvette transporter having a plurality of cuvette holders, at least one photometer, and a control device; moving the plurality of cuvettes between the plurality of positions using at least one cuvette transporter according to a schedule of the control device; and, when one or more of the plurality of cuvettes are at at least one component measurement position, according to a schedule of the control device, The method includes the steps of: measuring one or more cuvettes using a single photometer to determine at least one characteristic of each of the one or more cuvettes; assigning a disabled state to each of the cuvettes measured at at least one component measurement position if at least one characteristic of the cuvette is greater than a predetermined first threshold; and distributing components into the corresponding cuvette according to the schedule of the control device, unless a disabled state has been assigned to the corresponding cuvette, when a corresponding cuvette among the one or more cuvettes is at one of the distribution positions and a component test for the corresponding cuvette is scheduled at at least one component measurement position.

[0008] In a further embodiment of the technology, the method further includes measuring the components in the corresponding cuvette using at least one photometer when the corresponding cuvette is at at least one component measurement position, when the components have been distributed into the corresponding cuvette, and when a component test for the corresponding cuvette is scheduled at at least one component measurement position.

[0009] In another aspect of the technology, the method further includes a step of rescheduling component testing when a disabled state is assigned to the corresponding cuvette. In another aspect, the rescheduling step is performed in response to a previously known disabled state. In yet another aspect, the rescheduling step is performed in response to a disabled state assigned just at that moment. In yet another aspect, the rescheduling step results in the substitution of an untested component. In an additional aspect, the untested component includes a portion of the diluent. Alternatively, the untested component includes a portion of the pretreatment agent.

[0010] In at least one aspect of this technology, the component is a biological sample. In another aspect, the biological sample is selected from the group consisting of blood, plasma, serum, saliva, urine, cerebrospinal fluid, tears, sweat, gastrointestinal fluid, amniotic fluid, mucosal fluid, intrapleural fluid, and sebaceous gland fluid. In yet another aspect, the biological sample may be of mammalian origin, preferably human origin. In yet another aspect, the biological sample is in a state ready for testing.

[0011] In at least one additional aspect of this technology, before the components are measured using a photometer, the cuvette is moved to at least one reagent distribution position and the reagent is distributed. In another aspect, the step of measuring some of the cuvettes of one or more cuvettes using a photometer includes the step of measuring the absorbance of each cuvette to electromagnetic radiation of at least one predetermined wavelength. In a further aspect, the step of measuring the absorbance of each cuvette to electromagnetic radiation of at least one predetermined wavelength generates a plurality of absorbance data points for each of the electromagnetic radiations of at least one predetermined wavelength, or alternatively, at least 13 predetermined wavelengths.

[0012] In at least one further aspect of the technology, the step of measuring at least some of one or more cuvettes using a photometer includes the step of measuring the absorbance of each cuvette in electromagnetic radiation of 13 different predetermined wavelengths. In a further aspect, the electromagnetic radiation of 13 different predetermined wavelengths includes a short wavelength limit, a long wavelength limit, and 11 different wavelengths between the short wavelength limit and the long wavelength limit. In yet another aspect, at least one of the electromagnetic radiation of the predetermined wavelengths is a UV wavelength or a visible wavelength. In yet another aspect, the short wavelength limit is a UV wavelength and the long wavelength limit is a visible wavelength.

[0013] In another aspect of this technology, at least one property of each of at least several cuvettes includes at least absorbance dispersion. Furthermore, in yet another aspect, absorbance dispersion is the difference between the maximum and minimum absorbance measured for electromagnetic radiation of at least one predetermined wavelength. In yet another aspect, each of the corresponding cuvettes is assigned an enable state if at least one property of the corresponding cuvette measured at the component measurement location is within a predetermined range or below a predetermined second threshold.

[0014] In at least one aspect of the technology, the method further includes the step of applying at least one enhanced cleaning routine to a cuvette to which a disabled state has been assigned when the cuvette is in at least one cuvette cleaning position. In another aspect, the at least one enhanced cleaning routine includes the step of distributing detergent to the cuvette to which a disabled state has been assigned. In yet another aspect, after at least one enhanced cleaning routine has been applied, the method further includes the steps of measuring the corresponding cuvette when the cuvette to which a disabled state has been assigned is in a component measurement position, and reassigning the cuvette to a disabled state if at least one characteristic of the cuvette is higher than a predetermined first threshold, or assigning the cuvette to an enabled state if at least one characteristic of the cuvette is below a second threshold or within a predetermined range. In yet another aspect, if a cuvette has been reassigned to a disabled state, a subsequent enhanced cleaning routine is applied when the cuvette to which the disabled state has been assigned is in at least one cuvette cleaning position. In another embodiment, the subsequent enhanced cleaning routine is applied for a predetermined number of applications before the cuvette is assigned a decontaminated state. In yet another embodiment, the predetermined number of applications is at least 10 applications.

[0015] In a further embodiment of the present technology, the method further includes a step of notifying the operator of the need to replace at least one cuvette that has been assigned a disabled state. In another embodiment, the method further includes a step of notifying the operator of the quantity of cuvettes that have been assigned a disabled state. In yet another embodiment, the method further includes a step of notifying the operator that the capacity of the automated analyzer has been reduced due to the disabled state of at least one cuvette. In a further embodiment, the method further includes a step of notifying the operator, via a display screen, of the location of the cuvette to be replaced on the cuvette transporter.

[0016] In one aspect of this technology, the automated analyzer is an automated clinical chemistry analyzer. In another aspect, one or more cuvettes include reusable cuvettes or disposable cuvettes. In yet another aspect, one or more cuvettes are formed from glass, plastic, or optical-grade quartz.

[0017] In a further embodiment of the technology, at least one photometer includes a light source, which may be, for example, a halogen lamp. In another embodiment, the method further includes a step of monitoring the degradation of the light source. In yet another embodiment, the method further includes a step of modeling the degradation of the light source by statistical analysis in order to predict the replacement time.

[0018] In another aspect of the technology, at least some of the cuvettes among one or more cuvettes contain liquid when at least one property of the cuvettes is determined. In another aspect, at least some of the cuvettes among one or more cuvettes do not contain liquid when at least one property of the cuvettes is determined. In a further aspect, the method further includes the step of performing a statistical analysis on at least one property of the cuvettes. In yet another aspect, the statistical analysis forms a value that identifies a defect type. In yet another aspect, the defect type includes, for example, scratches and stains. In another aspect, after at least one property of at least one cuvette that does not contain liquid is determined, the cuvettes are filled with liquid and at least one property of the liquid-filled cuvettes is determined. In one aspect, the liquid is deionized water. In a further aspect, the cuvette transporter includes a wheel with a plurality of cuvette holders. In another aspect, the method further includes the step of repeatedly operating the corresponding components between a plurality of positions in one cycle of the wheel. In yet another embodiment, the cuvette transporter moves one or more cuvettes in a fixed order between multiple positions. In yet another embodiment, the fixed order corresponds to five cycles of components at the multiple positions. In yet another embodiment, each of one or more cuvettes is positioned once at at least one component measurement position every five cycles.

[0019] Details of these and other advantages, aspects and novel features of the present disclosure, as well as of exemplary embodiments thereof, will be better understood from the following description and drawings.

[0020] Embodiments of the present disclosure are described below as mere examples with reference to the accompanying drawings. [Brief explanation of the drawing]

[0021] [Figure 1A] This diagram illustrates the schematic configuration of an automated analyzer according to an exemplary embodiment of the present disclosure. [Figure 1B] A configuration diagram for explaining the schematic configuration of an automatic analyzer according to an exemplary embodiment of the present disclosure. [Figure 2] A diagram showing multiple variations of a cuvette wheel that can be used as part of an automatic analyzer according to an exemplary embodiment of the present disclosure. [Figure 3A] A diagram showing a photometer that can be used as part of an automatic analyzer according to an exemplary embodiment of the present disclosure. [Figure 3B] A diagram showing a photometer that can be used as part of an automatic analyzer according to an exemplary embodiment of the present disclosure. [Figure 4] A diagram showing a cuvette transporter having multiple cuvette holders that travel to a component measurement position according to an exemplary embodiment of the present disclosure. [Figure 5] A diagram showing the routine calibration and verification analysis of a cuvette using 16 data points according to an exemplary embodiment of the present disclosure. [Figure 6A] A diagram showing a part of one cycle of a cuvette wheel, which shows an exemplary embodiment of a cleaning cycle, according to an exemplary embodiment of the present disclosure. [Figure 6B] A diagram showing a part of one cycle of a cuvette wheel, which shows an exemplary embodiment of a cleaning cycle, according to an exemplary embodiment of the present disclosure. [Figure 6C] A diagram showing a part of one cycle of a cuvette wheel, which shows an exemplary embodiment of a cleaning cycle, according to an exemplary embodiment of the present disclosure. [Figure 6D] A diagram showing an exemplary embodiment of cycles of dispensing, mixing, and cleaning. [Figure 7] A flowchart showing the basic determination of cuvettes in an enabled state and a disabled state according to an exemplary embodiment of the present disclosure. [Figure 8] A flowchart showing the determination of cuvettes in an enabled state and a disabled state using a diagnostic mode and a measurement mode according to an exemplary embodiment of the present disclosure. [Figure 9] A diagram showing the maximum and minimum data for 179 cuvettes at one wavelength according to an exemplary embodiment of the present disclosure. [Figure 10] A diagram showing the characterization of the results of a data point group according to an exemplary embodiment of the present disclosure. [Figure 11] A diagram showing the range of baseline absorbance between two different methods according to an exemplary embodiment of the present disclosure. [Figure 12] A diagram showing the mean ± 3SD of baseline absorbance between two different methods according to an exemplary embodiment of the present disclosure. [Figure 13A] A diagram showing the cuvette positions in the layout of a cuvette wheel and each functional part according to an exemplary embodiment of the present disclosure. [Figure 13B] A diagram showing the profile of a photometer according to an exemplary embodiment of the present disclosure where real-time calibration and verification are performed. [Figure 14] A diagram showing a control device that can be used as part of an automatic analyzer according to an exemplary embodiment of the present disclosure.

[0022] Detailed Description Various embodiments will be described in detail with reference to the drawings, where like reference numerals represent similar parts and assemblies throughout the several views. It is to be understood that the present disclosure is not limited to the specific methods, protocols, and reagents described herein and is thus capable of variation in itself. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present disclosure or the appended claims.

[0023] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0024] Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art in which this disclosure pertains.

[0025] As described herein, improved calibration and verification procedures for sample containers in automated chemical analyzers are disclosed. When sample containers are used in automated analyzers, it is necessary to calibrate the measurement variations in each sample container for data accuracy. Furthermore, sample containers may deteriorate or be damaged over time, leading to biased results. Therefore, it is also necessary to verify the integrity of the sample container before using it for subsequent analysis. These procedures can be used to analyze a sample container (e.g., cuvette) and determine whether the sample container should be enabled or disabled for use in sample analysis.

[0026] Quantification in routine chemical analysis is typically based on one of two types of measurements: (1) light measurement (photometry or spectroscopy) or (2) electrochemical potential measurement (potentiometric measurement). The following examples will be based on photometry (absorbance measurement), but other analytical methods such as potentiometric measurement are also available.

[0027] The configuration of an automated analyzer according to at least one embodiment of the technology described and claimed herein will be described below with reference to Figures 1A, 1B, 2, 3, and 4. Figures 1A and 1B are schematic diagrams illustrating the general configuration of an automated analyzer 10 according to one embodiment of the technology described and claimed herein.

[0028] In the specific embodiments described below, the sample container in the automated analyzer is a cuvette 20, and this method allows for efficient calibration and verification of each cuvette, as well as measurement of the components after verification of the cuvette. The automated analyzer 10 includes at least a cuvette transporter 40 and a photometer 50, which are described in detail below. Specific embodiments for operating the automated analyzer 10 to calibrate and / or verify the integrity of the cuvettes are also described.

[0029] The automated analyzer 10 may be an automated clinical chemistry analyzer. A clinical chemistry analyzer is a medical laboratory device used to calculate the concentration of specific substances in samples of serum, plasma, urine, and / or other body fluids. Substances analyzed through the device include, for example, specific metabolites, electrolytes, proteins, and / or drugs.

[0030] As shown in Figures 1A, 1B, and 2, the automated analyzer 10 includes at least one cuvette transporter 40 equipped with a plurality of cuvette holders 41, where the plurality of cuvette holders 41 can hold one or more cuvettes 20. One or more cuvettes 20 may be reusable cuvettes. Glass, plastic, and quartz are particularly suitable as cuvette materials. In non-limiting examples, at least one of the one or more cuvettes 20 can be formed from, for example, glass, plastic, or optical-grade quartz.

[0031] The cuvette transporter 40 further includes a wheel 42 capable of moving a plurality of cuvette holders 41 through a plurality of positions on the automated analyzer 10. In one embodiment of the art, the plurality of positions include, but are not limited to, a distribution position including at least one reagent distribution position 31, at least one component distribution position 32, and at least one cuvette washing position 33. The plurality of positions also include at least one component measurement position 34. Figure 2 shows several variations of the wheel 42, in particular the cuvette wheel, that can be used as part of the automated analyzer 10. At least some cuvettes 41 within the cuvette holders 41 can be considered corresponding cuvettes. A "corresponding cuvette" is a cuvette that is positioned to receive components, reagents, water, and / or detergent when the cuvette is in a distribution position.

[0032] The automated analyzer 10 may include various units for processing components. As shown in Figure 1A, in some embodiments of the claimed technology, the automated analyzer 10 comprises, for example, a component dispensing unit 100 for dispensing biological samples for analysis, a first reagent dispensing unit 110, a second reagent dispensing unit 120, a first stirring unit 130, and a second stirring unit 140. The first reagent dispensing unit 110 may contain reagent A (in reagent bottle A'), while the second reagent dispensing unit 120 may contain reagent B (in reagent bottle B'), where each reagent may be a chemical substance required to react with a component sample before performing a component test, or it may be a material such as a solvent, calibrator, standard, or control. A barcode reader may be used to identify reagents during the automated process. The stirring units provide physical mixing within the sample container (e.g., cuvette). Those skilled in the art will understand that multiple combinations of numerous reagents are assumed in the understanding and implementation of the claimed technology.

[0033] During operation, one or more cuvettes 20 are moved between multiple locations by at least one cuvette transporter 40 according to a schedule of the control device 60. All units of the automated analyzer 10 are connected to the control device, which can perform block control of all functions of the analyzer, for example, using a microcomputer. The control device may include subunits such as a data processing unit and a communication interface. An exemplary embodiment of the control device 60 of the present technology is shown in Figure 14. In this embodiment, the control device 60 may include a data processor 60A, a non-temporary computer-readable medium 60B, and a data storage 60C connected to the data processor 60A. The non-temporary computer-readable medium 60B may include code for performing the functions described herein, which can be executed by the data processor 60A. The data processor 60A may store, for example, data for processing a sample, sample data, or data for analyzing sample data.

[0034] The data processor 60A may include any suitable data computing device or combination thereof. An exemplary data processor may include one or more microprocessors that cooperate to achieve a desired function. The data processor 60A may include a CPU that includes at least one high-speed data processor suitable for executing program components for fulfilling user-generated and / or system-generated requests. Such CPU may include microprocessors, such as AMD's Athlon, Duron and / or Opteron, IBM and / or Motorola's PowerPC, IBM and Sony's Cell processors, Intel's Celeron, Itanium, Pentium, Xeon and / or XScale, Apple's M1, and / or similar processors.

[0035] The computer-readable medium 60B and data storage 60C may be any suitable one or more devices capable of storing electronic data. Examples of memory may include, for example, one or more memory chips, disk drives, etc. Such memory may operate using any suitable electrical, optical and / or magnetic mode of operation.

[0036] The computer-readable medium 60B may contain code for performing any suitable method that can be executed by the data processor 60A. For example, the computer-readable medium 60B may contain code that can be executed by the processor 60A to cause the control device 60 to operate on a predetermined schedule. In some embodiments of the claimed technology, the predetermined schedule is a component test. In other embodiments, the computer-readable medium 60B may contain code that can be executed by the data processor 60A to cause the control device 60 to reschedule a component test when a disabled state is assigned to a corresponding cuvette.

[0037] To verify the integrity of at least some of the cuvettes 20, at least some of the cuvettes are moved to component measurement positions 34 according to the control device's schedule. When at least one of the cuvettes 20 is at component measurement position 34, at least one characteristic of each of the cuvettes 20 is determined using at least one photometer 50. The characteristic of the cuvette corresponds to the measurement of the cuvette in the absence of a sample. In some embodiments, the characteristic is, for example, the absorbance of the cuvette measured at one or more wavelengths.

[0038] The automated analyzer 10 is configured to perform cell blanking. Dry cell blanking is a baseline measurement of the cuvettes. The measured absorbance is used to subtract background during the determination of at least one property of each of one or more cuvettes 20, and / or to measure the corresponding cuvette component using the photometer 50 when the cuvette is at at least one component measurement position 34.

[0039] In some embodiments of the claimed technology, the automated analyzer 10 is configured to perform cell blanking. In one embodiment, a plurality of absorbance data points are measured per cuvette that does not contain liquid across a plurality of wavelengths of electromagnetic radiation. In an exemplary embodiment, 16 data points are measured for 13 predetermined wavelengths of electromagnetic radiation. The measured absorbance data points are averaged for each predetermined wavelength of electromagnetic radiation, and an average of the average dry cell blanks across all cuvettes (i.e., a total dry average) is obtained for each predetermined wavelength of electromagnetic radiation. In one embodiment, dry cell blanking further includes performing a statistical analysis on at least one characteristic of the cuvette. This statistical analysis can form a value that identifies damage, such as a defect type. In some embodiments, the defect type includes, for example, scratches, stains, and / or cracks. See Figure 8 for this.

[0040] According to several embodiments of the claimed technology, the automated analyzer 10 is configured to perform wet cell blanking. In one embodiment, multiple absorbance data points are measured over multiple wavelengths per cuvette containing a liquid, such as deionized water. In one exemplary embodiment, 16 data points are measured for 13 predetermined wavelengths of electromagnetic radiation. The measured absorbance data points are averaged for each predetermined wavelength of electromagnetic radiation, and an average of the dry cell blanks (i.e., a total wet average) across all cuvettes is obtained for each predetermined wavelength of electromagnetic radiation. See Figure 8 for details.

[0041] Photometry measures the concentration of various analytes by measuring the absorbance of light as a measure of light density. A monochromator or filter is used to select the desired wavelength of light for each analysis, depending on the properties of the substance being measured. A diffraction grating can be used to separate the wavelengths of light, enabling the monochromatic measurements required in an automated analyzer. Each wavelength is measured by individual detectors in a photodiode array. As shown in Figures 3A and 3B, when the cuvette is at the component measurement position 34, the photometer 50 focuses light of the appropriate wavelength onto one or more cuvettes 20 (using a lens 52). In some embodiments, the photometer 50 is equipped with a light source 51, for example, a halogen lamp. Other suitable alternatives include, for example, a tungsten lamp, a quartz lamp, or a similar light source. When the light source 51 is a halogen lamp, it can produce a usable wavelength range of about 330 nm to about 3500 nm. Light from the light source 51 passes through the components in one or more cuvettes 20. In one embodiment, the automated analyzer 10 is configured to monitor the degradation of the light source. In one embodiment, monitoring further includes modeling the degradation of the light source using statistical analysis to predict replacement time.

[0042] As light passes through the cuvette, light of different frequencies is absorbed at different levels depending on the interaction between the light and the cuvette and the liquid inside. After passing through the cuvette, the light of different frequencies is spatially separated (e.g., by a prism or diffraction grating). The frequency separation by the diffraction grating causes little to no interference (compared to a prism). In some embodiments, light from a multi-frequency halogen source is focused into the cuvette using a diffraction grating 54.

[0043] The photodetector 53 measures the light density or the amount of light absorbed by a component. In some embodiments of the technology claimed herein, the photodetector includes a photodiode array. Since the photodiode array measures the intensity of a particular wavelength, several photodiode arrays are required to measure the intensity of multiple wavelengths. For example, if 13 wavelengths are to be measured, the photodiode array has 13 photodiodes.

[0044] When the photometer 50 measures the cuvette at the component measurement position 34, the amount of absorbed light and the frequency of the light may correlate with the concentration of the analyte in the sample. In some embodiments, the measurement of at least some cuvettes 21 at the component measurement position 34 includes, for example, measuring the absorbance data of each cuvette to electromagnetic radiation of at least one predetermined wavelength. In alternative embodiments, the absorbance of each cuvette is measured to electromagnetic radiation of at least two predetermined wavelengths, alternatively to at least three predetermined wavelengths, alternatively to at least four predetermined wavelengths, alternatively to at least five predetermined wavelengths, alternatively to at least six predetermined wavelengths, alternatively to at least seven predetermined wavelengths, alternatively to at least eight predetermined wavelengths, alternatively to at least nine predetermined wavelengths, alternatively to at least ten predetermined wavelengths, alternatively to at least eleven predetermined wavelengths, alternatively to at least twelve predetermined wavelengths, and alternatively to at least thirteen predetermined wavelengths.

[0045] In some embodiments of this technology, the photometer is configured to transmit and measure different wavelengths. In at least one embodiment, at least two wavelengths are transmitted by the photometer, where the longer wavelength is the long wavelength limit and the shorter wavelength is the short wavelength limit. The photodetector further includes a single detector corresponding to each wavelength transmitted by the photometer.

[0046] In some embodiments of this technology, both the long-wavelength limit and the short-wavelength limit are wavelengths in the visible spectrum. In other embodiments, the long-wavelength limit is in the visible spectrum and the short-wavelength limit is in the UV spectrum. For example, in one embodiment, the short-wavelength limit may be about 340 nm and the long-wavelength limit may be about 800 nm. However, the short-wavelength limit may be about 330 nm, alternatively about 320 nm, alternatively about 310 nm, or alternatively about 300 nm. The long-wavelength limit may be about 825 nm, alternatively about 850 nm, alternatively about 875 nm, or alternatively about 900 nm.

[0047] In some embodiments, the photometer is configured to perform a wavelength scan that allows simultaneous detection of absorbance data at several wavelengths within a range from the short wavelength limit to the long wavelength limit. In at least some embodiments, the absorbance data for each cuvette is measured for at least three wavelengths of electromagnetic radiation (i.e., the short wavelength limit, the long wavelength limit, and wavelengths between these two). In one embodiment, electromagnetic radiation at 13 different predetermined wavelengths is measured. In this embodiment, the electromagnetic radiation at 13 different predetermined wavelengths includes the short wavelength limit, the long wavelength limit, and 11 different wavelengths between the short and long wavelength limits. In such embodiments, the short wavelength limit is approximately 340 nm, the long wavelength limit is approximately 800 nm, and the 11 different wavelengths are in the range of approximately 340 nm to approximately 800 nm. In this embodiment, the electromagnetic radiation of predetermined wavelengths includes 340 nm, 380 nm, 410 nm, 450 nm, 520 nm, 540 nm, 570 nm, 600 nm, 660 nm, 700 nm, 750 nm, and 800 nm.

[0048] In one embodiment for verifying the integrity of a cuvette measured at at least one component measurement position 34, the cuvette is disabled if at least one characteristic of the cuvette is greater than a predetermined first threshold, or alternatively, if at least one characteristic of the cuvette is less than a predetermined second threshold. In one embodiment, at least one characteristic of each of one or more cuvettes 20 includes absorbance dispersion. To measure absorbance dispersion, a cuvette transporter 40 having multiple cuvette holders 41 travels to at least one component measurement position 34, as shown in Figure 4. The absorbance of one or more cuvettes 20 is measured at multiple wavelengths using a light source 51 and a photodetector 53, thereby determining at least one characteristic.

[0049] In an exemplary embodiment, the absorbance of each cuvette is measured for at least 13 predetermined wavelengths of electromagnetic radiation. In this embodiment, by measuring the absorbance data of the cuvettes for electromagnetic radiation at at least predetermined wavelengths, 56 absorbance data points are generated for each cuvette for each predetermined wavelength. The exemplary automated analyzer 10 includes more than 200 cuvette holders and a wheel 42 having 41 slot pitch shifts per cycle. The wheel 42 rotates through 41 cuvette holders in 0.893 seconds, and the cycle time is 3.6 seconds. The cuvettes rotate while decelerating at a cycle angle of 72.35°. After 5 cycles, the cuvettes are shifted by +1 slot pitch in their position on the wheel (41 × 5 = 205 = 204 + 1) and return to their original position after 12.3 minutes. Each cycle has, for example, an acceleration section, a constant speed section, a deceleration section, and a pause section.

[0050] In routine calibration and validation analysis, 16 absorbance data points are acquired for each cuvette in a separate system cycle, and the mean is used as a baseline and correction for cuvette variation. Using the same data, the right half of the cuvette (8 data points) and the left half (8 data points) can be compared to assess whether the cuvette has any damage, such as scratches or defects. See Figure 5 for details. This procedure is time-consuming and inefficient because it requires switching the automated analyzer 10 from measurement mode to diagnostic mode for calibration and validation analysis.

[0051] As described herein, on-the-fly calibration and validation analyses can be performed to overcome these drawbacks. In on-the-fly analysis, each cuvette is calibrated and validated during the normal measurement cycle, rather than in a separate cycle. According to one embodiment, the on-the-fly calibration and validation analysis is performed in parallel with the measurement of the biological sample in measurement mode. See Figure 8 for details. In addition, multiple absorbance data points are acquired instead of the 16 data points described above. In one embodiment, 56 data points are acquired during the cuvette washing sequence. See Figures 6A to 6D, where the on-the-fly calibration and validation data are acquired at the points indicated by the arrows. See also Figure 13A.

[0052] Multiple absorbance data points are collected during the rotation of the cuvette, so that each absorbance data point originates from a slightly different region of the cuvette. Table 1 shows a comparison between one embodiment of the present disclosure ("Embodiment 1") and a routine analysis ("Routine Test"). As shown, Embodiment 1 can generate 40 additional data points compared to the routine analysis.

[0053] [Table 1]

[0054] There are at least two reasons why the number of data points differs between Embodiment 1 and the routine test. In some embodiments, the increase in the number of measured absorbance data points is related to many factors, including, but not limited to, CPU speed and / or rotation speed.

[0055] The obtained data points are classified into three data groups. To establish the calibration and validation logic for the cuvettes, rules for each system should be determined using the actual data measured for each system. This is illustrated in the flowchart of Figure 7, which shows the procedure for determining whether the cuvette is enabled or disabled.

[0056] A first data set is defined as unstable if any individual data point (across all wavelengths) deviates significantly from the total wet or total dry average by a predetermined threshold. This predetermined first threshold may be a deviation of ±0.0100 between the maximum and minimum values ​​of all 13 wavelengths being evaluated. If a cuvette falls into this first data set, i.e., if its deviation is greater than the predetermined first threshold, the corresponding cuvette is assigned a disabled state.

[0057] A second set of data points is defined as extremely stable if each individual data point (across all wavelengths) deviates from the total wet or total dry average by a predetermined threshold. This predetermined second threshold may be a deviation of ±0.0050 between the maximum and minimum values ​​of all 13 wavelengths being evaluated. If a cuvette falls into this second set of data points, i.e., if its deviation is less than the predetermined second threshold, the corresponding cuvette is assigned an enable state.

[0058] A third data set is defined as stable if each individual data point (across all wavelengths) falls between a predetermined minimum and maximum value from the total wet average or total dry average. This predetermined range may have a predetermined minimum value where the deviation of all 13 wavelengths being evaluated is ±0.0050, and a predetermined maximum value where the deviation is ±0.0100. If a cuvette falls within this third data set, i.e., within the predetermined range, the corresponding cuvette is assigned an enable state.

[0059] According to some embodiments, the control device 60 is configured to schedule the automated analyzer 10 to operate in diagnostic mode or measurement mode. See Figure 8 for details.

[0060] If the control device is scheduled to operate in diagnostic mode, that is, in a mode which includes but is not limited to scheduling one or more cuvettes 20 for dilution operations, pretreatment operations and / or other non-photometric test operations, then if the corresponding cuvette is at the component distribution position 32, components can be distributed into one or more cuvettes 20 whether the cuvette is assigned an enabled state or a disabled state. According to one embodiment, the components distributed to a cuvette in the disabled state may include a portion of the diluent or a portion of the pretreatment agent.

[0061] The components include, but are not limited to, quality control (QC) agents, calibrators, pretreatment solutions, diluents, deionized water, and biological samples. Exemplary biological samples include, but are not limited to, blood, plasma, serum, saliva, urine, cerebrospinal fluid, tears, sweat, gastrointestinal fluid, amniotic fluid, mucosal fluid, intrapleural fluid, and sebaceous gland fluid. In some embodiments, the biological samples are derived from vertebrates. In some embodiments, the biological samples are derived from mammals, preferably humans. In some embodiments, the biological samples are derived from birds, fish, reptiles, or amphibians. In some embodiments, the components are subjected to component testing. In some embodiments, the properties of the components, such as concentration, are measured.

[0062] In some embodiments, the component is in a test-ready state. A test-ready component is one that is ready to be distributed into the corresponding cuvette at the component distribution location, and indicates that the component in the corresponding cuvette will be tested using a photometer when the cuvette corresponding to the component measurement location reaches it, and also indicates that the component distribution location does not have an empty cycle or dilution cycle (or another cycle in which no measurement by the photometer is performed) at that time. In these embodiments, the component may be a biological sample.

[0063] An empty cycle indicates that the automated analyzer 10 is operating below capacity and / or has some inefficiency that hinders the ready-to-distribute state. Therefore, during an empty cycle, the component distribution position is kept idle. A dilution cycle indicates that the component distribution position is planned to perform dilution. Components distributed into one or more cuvettes 20 during a dilution cycle are not subsequently measured at the component measurement position.

[0064] When the control device 60 is scheduled to operate in a measurement mode that includes, but is not limited to, scheduling one or more cuvettes 20 for photometric operations (e.g., testing, calibration, or quality control), components become available for distribution into one or more cuvettes 20 when the corresponding cuvette is at a component distribution position 32 assigned to the enabled state. However, if one or more cuvettes 20 is assigned to the disabled state, the components are not distributed into the cuvette. In this embodiment, when a corresponding cuvette contains components, and a component test is scheduled for the corresponding cuvette, and the corresponding cuvette is at a component measurement position 34, the components of the corresponding cuvette are measured using the photometer 50. In some embodiments, before the components of the corresponding cuvette are measured, the cuvette containing the components is moved to at least one reagent distribution position 31 and the reagents are distributed. In some embodiments, there are at least a first reagent distribution position and a second reagent distribution position. In some embodiments, two types of reagents are distributed. In other embodiments, multiple reagents are distributed. In some embodiments, the control device 60 can schedule when the reagents should be dispensed.

[0065] In one embodiment, if a disabled state is assigned to a corresponding cuvette, the component testing of that cuvette is rescheduled. Rescheduling can be performed in response to a previously known disabled state, for example, in response to a disabled state assigned when the automated analyzer 10 was in diagnostic mode, or in response to a disabled state assigned at that very moment. Rescheduling may result in the substitution of untested components in the corresponding cuvette. Such untested components may include, but are not limited to, a portion of the diluent or a portion of the pretreatment agent.

[0066] In one embodiment, the automated analyzer 10 is configured to wash the cuvettes before assay measurement. As shown in Figures 6A to 6D, the washing has three steps: washing with detergent / washing solution 33, rinsing with water 73, and drying 83. In Figure 6A, the cuvettes are washed with detergent or other suitable washing solution at two consecutive cuvette washing positions 33a, 33b and rinsed with deionized water at four consecutive cuvette washing positions 73a, 73b, 73c, 73d. The integrity of the cuvettes is inspected before the water is drawn from them, and then the cuvettes are dried at two consecutive cuvette drying positions 83a, 83b. In Figure 6B, the cuvettes are rinsed with deionized water at cuvette rinsing position 73a, washed with detergent or other suitable washing solution at cuvette washing position 33a and rinsed with deionized water at four consecutive cuvette rinsing positions 73b, 73c, 73d, 73e. The integrity of the cuvette is inspected before water is drawn from it, and then the cuvette is dried at two consecutive cuvette drying positions 83a, 83b. In Figure 6C, the cuvette is rinsed with deionized water at cuvette rinsing position 73a, washed with detergent or other suitable cleaning solution at two consecutive cuvette washing positions 33a, 33b, and rinsed with deionized water at three consecutive cuvette rinsing positions 73b, 73c, 73d. The integrity of the cuvette is inspected before water is drawn from it, and then the cuvette is dried at two consecutive cuvette drying positions 83a, 83b. The detergent or other suitable cleaning solution may be a mild detergent or concentrated solution. In some embodiments, the detergent may be highly concentrated. Suitable examples of detergents or cleaning solutions, not limited to the following, include, in particular, alkaline cleaning concentrates, such as a mixture of tripotassium orthophosphate and ethanol.

[0067] In one embodiment, the automated analyzer 10 is configured to apply at least one enhanced cleaning routine when a cuvette assigned a disabled state is in at least one cuvette cleaning position 33. In this embodiment, at least one enhanced cleaning routine includes distributing detergent or other suitable cleaning solution to the cuvette assigned a disabled state. After the enhanced cleaning routine has been applied, the cuvette assigned a disabled state is measured using a photometer when the cuvette is in a component measurement position 34. If at least one characteristic measured for the corresponding cuvette is greater than a predetermined first threshold, the corresponding cuvette is reassigned a disabled state. Alternatively, if at least one characteristic measured for the corresponding cuvette is less than a predetermined second threshold or within a predetermined range, the corresponding cuvette is assigned an enabled state. When the corresponding cuvette is assigned an enabled state, the cuvette can be used for any purpose (e.g., dilution, pretreatment, other test operations other than photometry, and / or photometric testing in particular). In one embodiment, a cuvette that has been assigned or reassigned a disabled state will not be assigned an enabled state unless at least one characteristic measured for that cuvette is below a predetermined second threshold or falls within a predetermined range after three subsequent measurements.

[0068] In some embodiments, when a cuvette is reassigned to a disabled state, a subsequent enhanced cleaning routine is applied when the cuvette with the reassigned disabled state is in at least one cuvette cleaning position 33. During or before the enhanced cleaning routine, the cuvette with the reassigned disabled state is considered temporarily disabled. As a result, when the automated analyzer 10 is used for diagnostic mode purposes (e.g., for purposes related to dilution, pretreatment, or other operations other than photometry), a cuvette in a temporarily disabled state can be used. If a cuvette in a temporarily disabled state is not assigned a diagnostic mode purpose, cleaning using the enhanced cleaning routine described herein continues for the cuvette in a temporarily disabled state.

[0069] The automated analyzer 10 is configured to continue the enhanced cleaning routine for a predetermined number of applications. In some embodiments, the predetermined number of applications is at least 10 applications. In other embodiments, the predetermined number of applications is at least 5 applications. In other embodiments, the predetermined number of applications is at least 15 applications. At the end of the enhanced cleaning routine, if there is no reassignment of the enable state for a cuvette that has been assigned or reassigned the disabled state, the cuvette is assigned the deremoved state. A cuvette assigned the deremoved state remains usable if the automated analyzer 10 is in diagnostic mode for diagnostic purposes, but the operator receives notification that the deremoved cuvette needs to be replaced. The notification may be, for example, a system notification, a display screen notification, a push notification, a text notification, and / or an email notification.

[0070] In some embodiments, the operator receives a notification when at least a predetermined number of cuvettes are assigned a de-eating state. In one embodiment, this is when at least about 10% of the cuvettes are assigned a de-eating state. In another embodiment, the notification is received when at least about 5% of the cuvettes are assigned a de-eating state. In yet another embodiment, the notification is received when at least about 15% of the cuvettes are assigned a de-eating state.

[0071] In some embodiments, the automated analyzer 10 is configured to notify the operator of the need to replace cuvettes that have been assigned a disabled state. When at least a predetermined number of cuvettes have been assigned a disabled state, the operator is notified of the negative impact that the disabled cuvettes may have on the throughput of the automated analyzer 10. This includes notifying the operator of the reduction in the capacity of the automated analyzer 10 due to the disabled state of at least one cuvette, and / or notifying the operator via a display screen of the location of the cuvette to be replaced on each cuvette transporter 40. In one embodiment, the predetermined number may be at least about 20% of the total number of cuvettes. In alternative embodiments, the predetermined number may be at least about 15% of the total number of cuvettes, or alternatively, at least about 25% of the total number of cuvettes.

[0072] Further examples are shown below.

[0073] Example 1: Cuvette Calibration and Cuvette Verification Logic Using conventional chemical analyzers, we analyzed the trends in low absorbance data (56 absorbance data points for each cuvette and each wavelength) for 179 cuvettes. The obtained data points were classified as "very stable," "stable," and "unstable."

[0074] To compare the results for all cuvettes, the absorbance data points for each cuvette were corrected to the baseline absorbance, which is considered to be the wet cell blank of the cuvette. Figure 9 shows the maximum and minimum data for each of the 179 cuvettes for each point at 340 nm. When the maximum and minimum absorbance data points are close to 0, this means that the absorbance data for that point is very close to the wet cell blank of the cuvette. When the variation between the maximum and minimum absorbance data points is small, the results correlate with small cuvette variations.

[0075] The 56 data points were classified into three groups using the following rule (see Figure 10 for the results of the data point groups). (a) "Unstable" data points: For these data points, the difference between the maximum and minimum values ​​is greater than 0.0100 for all 13 wavelengths. Data points #40 to #56 were classified into this group. (b) "Extremely stable" data points: For these data points, the difference between the maximum and minimum values ​​is 0.0100 or less for all 13 wavelengths. Also, the minimum value is -0.0035 or greater for all 13 wavelengths. Data points #10 to #29 were classified into this group. (c) "Stable" data points: Data points that were not classified as "unstable" or "very stable" were classified as "stable". Data points #1 to #9 and #30 to #39 were classified into this group.

[0076] Example 2: Results of cuvette calibration Figure 11 shows the baseline absorbance ranges measured by the routine method and the method of Embodiment 1. In both the routine test method and the method of Embodiment 1, 29 absorbance data points were measured for 179 cuvettes. In both methods, the range of the 29 measured absorbance data points was calculated for each wavelength for each cuvette and plotted as one dot in Figure 11. The left half of Figure 11 shows the routine test, and the right half shows the method of Embodiment 1. As shown in Figure 11, the baseline absorbance range measured by the method of Embodiment 1 tends to be smaller than the range measured by the routine test. Therefore, Embodiment 1 can measure additionally stable baseline absorbance data compared to the routine test.

[0077] Figure 12 shows the difference in baseline absorbance between Embodiment 1 and the routine test for each wavelength. Figure 12 shows the mean +3SD and mean -3SD for 5191 data absorbance points, and the mean ±3SD is within ±0.0020 for all 13 wavelengths. Therefore, the baseline absorbance measured in Embodiment 1 was very close to the baseline absorbance measured in the routine test.

[0078] Example 3: Results of cuvette verification using the method of Embodiment 1 Table 2 shows the results of cuvette verification determined by the method of Embodiment 1. In this method, new cuvettes and soiled / scratched cuvettes are set up in a conventional chemical analyzer. Initially, the cuvettes were verified using a routine method for 10 separate analyses. The cuvettes were classified into the following two groups, according to the rules below.

[0079] Group 1: Cuvettes judged as "passing" Cuvettes that passed all 10 routine tests were classified into Group 1 (judged as "pass"). 231 cuvettes were classified into this group.

[0080] Group 2: Cuvettes judged as "failure" Cuvettes that failed all 10 routine tests were classified into Group 2 ("failed"). 113 cuvettes were classified into this group.

[0081] Cuvettes that were not classified into Group 1 or Group 2 were excluded from these results because it was unclear how to classify them.

[0082] Next, the cuvettes classified as either Group 1 or Group 2 were validated for another 10 analyses using the method of Embodiment 1 with the logic described in Example 1. As shown in Table 2, all 231 cuvettes classified as Group 1 were judged as "pass" in all 10 analyses, and all 113 cuvettes classified as Group 2 were judged as "fail" in all 10 analyses. This demonstrates that cuvettes can be validated by the method of Embodiment 1 instead of routine testing.

[0083] [Table 2]

[0084] Example 4: Cuvette position and functional unit layout Figure 13A shows an exemplary cuvette position layout and corresponding functional units for the on-the-fly calibration and verification process. In this example, the photometric position is fixed. Focusing on one cuvette, the cuvette passes in front of the photometric position every 5 cycles. Since the wheel rotates through 41 positions in one cycle, the total number of cuvettes in one line (inner or outer) is 204 (41 positions × 5 cycles = 204 (1 rotation) + 1). The cycle has an acceleration section, a constant speed section, a deceleration section, and a pause section. On-the-fly tracking, including the measurement of absorbance data, is performed in the non-constant speed section of the cycle. This allows more time to be used to collect multiple data points. In this example, 56 absorbance data points were collected. Figure 13B shows a profile of photometry according to Example 4.

Claims

1. A method for operating an automated analyzer (10), wherein the method is Multiple cuvettes, At least one reagent distribution position (31), At least one component distribution position (32), At least one cuvette washing position (33, 33a, 33b), Cuvette rinsing positions (73a, 73b, 73c, 73d), cuvette drying positions (83a, 83b), and At least one component measurement location (34) Multiple locations, including A cuvette transporter (40) having multiple cuvette holders (41), At least one photometer (50) and Control device (60) and The steps include preparing an automated analyzer (10) equipped with, The steps include moving the plurality of cuvettes between the plurality of positions using the at least one cuvette transporter (40) in accordance with the schedule of the control device (60), In a sequence in which one or more cuvettes (20) from the plurality of cuvettes are moved from the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d) to the cuvette drying position (83a, 83b), each of the one or more cuvettes (20) after the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d), and the cuvette drying position ( Steps include: when at the at least one component measurement position (34) scheduled before 83a, 83b), measuring the integrity of one or more cuvettes (20) in the sequence using the at least one photometer (50) according to the schedule of the control device (60), thereby determining the absorbance variance, which is the difference between the maximum absorbance and the minimum absorbance measured for electromagnetic radiation of at least one predetermined wavelength for each of the one or more cuvettes (20); For each of the one or more cuvettes (20) measured at the at least one component measurement position (34), if the absorbance dispersion of the cuvette is greater than a predetermined first threshold, a disabled state is assigned; When a corresponding cuvette among the plurality of cuvettes is at one of the distribution positions, and a component test for the corresponding cuvette is scheduled at at least one component measurement position (34), the control device (60) performs the step of distributing the components into the corresponding cuvette, unless the disabled state is assigned to the corresponding cuvette, according to the schedule of the control device (60). Methods that include...

2. The method according to claim 1, further comprising the step of measuring the components in the corresponding cuvette using the at least one photometer (50) when the corresponding cuvette is at the at least one component measurement position (34), and when the components have been distributed into the corresponding cuvette, and when a component test for the corresponding cuvette has been scheduled at the at least one component measurement position (34).

3. The method according to claim 1, further comprising the step of rescheduling the component test when the disabled state is assigned to the corresponding cuvette.

4. The method according to claim 3, wherein the rescheduling step is performed in response to a previously known disabled state.

5. The method according to claim 3, wherein the rescheduling step is performed in response to the disabled state assigned at that time.

6. The method according to any one of claims 3 to 5, wherein the rescheduling step results in the substitution of an untested component.

7. The method according to claim 6, wherein the untested component includes a portion of the diluent.

8. The method according to claim 6, wherein the aforementioned untested component includes a portion of the pretreatment agent.

9. The method according to any one of claims 1 to 8, wherein the aforementioned component is a biological sample.

10. The method according to claim 9, wherein the biological sample is selected from the group consisting of blood, plasma, serum, saliva, urine, cerebrospinal fluid, tears, sweat, gastrointestinal fluid, amniotic fluid, mucosal fluid, intrapleural fluid, and sebaceous gland fluid.

11. The method according to claim 9 or 10, wherein the biological sample is derived from a mammal, preferably from a human.

12. The method according to any one of claims 9 to 11, wherein the biological sample is in a state ready for testing.

13. The method according to any one of claims 9 to 12, wherein the corresponding cuvette is moved to the at least one reagent distribution position (31) and the reagent is distributed before the component is measured using the at least one photometer (50).

14. The method according to any one of claims 1 to 13, wherein the step of measuring one or more cuvettes (20) of the plurality of cuvettes using the at least one photometer (50) includes the step of measuring the absorbance of each of the cuvettes to electromagnetic radiation of at least one predetermined wavelength.

15. The method according to claim 14, wherein the step of measuring the absorbance of each of the cuvettes for electromagnetic radiation of at least one predetermined wavelength generates a plurality of absorbance data points for each of the cuvettes for each of the electromagnetic radiation of at least one predetermined wavelength.

16. The method according to claim 14 or 15, wherein the absorbance of each cuvette is measured with respect to electromagnetic radiation of at least two predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least three predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least four predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least five predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least six predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least seven predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least eight predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least nine predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least ten predetermined wavelengths, alternatively with respect to electromagnetic radiation of at least eleven predetermined wavelengths, and alternatively with respect to electromagnetic radiation of at least twelve predetermined wavelengths.

17. The method according to any one of claims 1 to 16, wherein the step of measuring one or more cuvettes (20) of the plurality of cuvettes using the photometer (50) includes the step of measuring the absorbance of each of the cuvettes in electromagnetic radiation of 13 different predetermined wavelengths.

18. The method according to claim 17, wherein the 13 different predetermined wavelengths of electromagnetic radiation include a short wavelength limit, a long wavelength limit, and 11 different wavelengths between the short wavelength limit and the long wavelength limit.

19. The method according to any one of claims 14 to 18, wherein at least one of the electromagnetic radiations of the predetermined wavelengths is a UV wavelength or a visible wavelength.

20. The method according to claim 18, wherein the short wavelength limit is a UV wavelength and the long wavelength limit is a visible wavelength.

21. The method according to any one of claims 1 to 20, further comprising the step of assigning an enable state to each of the corresponding cuvettes if the absorbance dispersion of the corresponding cuvettes measured at the component measurement position (34) is within a predetermined range or below a predetermined second threshold.

22. The method according to any one of claims 1 to 21, further comprising the step of applying at least one enhanced cleaning routine to the corresponding cuvette to which the disabled state has been assigned when the corresponding cuvette to which the disabled state has been assigned is in at least one cuvette cleaning position (33, 33a, 33b).

23. The method according to claim 22, wherein the at least one enhanced cleaning routine includes the step of distributing detergent to the corresponding cuvette to which the disabled state has been assigned.

24. After the at least one enhanced cleaning routine has been applied, The above method further, When the corresponding cuvette to which the disabled state has been assigned is located at the component measurement position (34), the step of measuring the corresponding cuvette to which the disabled state has been assigned, The steps include: reassigning the disabled state if the absorbance dispersion of the corresponding cuvette is greater than the predetermined first threshold, or assigning the enabled state if the absorbance dispersion of the corresponding cuvette is less than the predetermined second threshold or within a predetermined range; The method according to claim 22 or 23, including the method described in claim 22 or 23.

25. The method according to claim 24, wherein if the disabled state is reassigned to the corresponding cuvette, the subsequent enhanced cleaning routine is applied when the corresponding cuvette to which the disabled state has been reassigned is in at least one cuvette cleaning position (33, 33a, 33b).

26. The method according to claim 25, wherein the subsequent enhanced cleaning routine is applied over a predetermined number of applications before a decontamination state is assigned to the cuvette.

27. The method according to claim 26, wherein the predetermined number of applications is at least 10 applications.

28. The method according to any one of claims 1 to 27, further comprising the step of notifying the operator of the need to replace at least one corresponding cuvette to which the disabled state has been assigned.

29. The method according to claim 28, further comprising the step of notifying the operator of the amount of the corresponding cuvette to which the disabled state has been assigned.

30. The method according to claim 28 or 29, further comprising the step of notifying the operator that the capacity of the automated analyzer (10) has been reduced due to the disabled state of at least one of the corresponding cuvettes.

31. The method according to any one of claims 28 to 30, further comprising the step of notifying the operator via a display screen of the location of each corresponding cuvette to be replaced on the cuvette transporter (40).

32. The method according to any one of claims 1 to 31, wherein the automated analyzer (10) is an automated clinical chemistry analyzer.

33. The method according to any one of claims 1 to 32, wherein the plurality of cuvettes include reusable cuvettes or disposable cuvettes.

34. The method according to any one of claims 1 to 33, wherein the plurality of cuvettes include glass, plastic, or optical-grade quartz.

35. The method according to any one of claims 1 to 34, wherein the at least one photometer (50) includes a light source (51).

36. The method according to claim 35, further comprising the step of monitoring the deterioration of the light source (51).

37. The method according to claim 36, further comprising the step of modeling the degradation of the light source (51) by statistical analysis in order to predict the replacement time.

38. The method according to any one of claims 35 to 37, wherein the light source (51) is a halogen lamp.

39. The method according to any one of claims 1 to 38, wherein one or more of the cuvettes (20) among the plurality of cuvettes contain a liquid when the absorbance dispersion of the cuvette is determined.

40. The method according to any one of claims 1 to 38, wherein one or more of the cuvettes (20) among the plurality of cuvettes does not contain liquid when the absorbance dispersion of the cuvette is determined.

41. The method according to claim 40, further comprising the step of performing a statistical analysis relating to the absorbance dispersion of the cuvette.

42. The method according to claim 41, wherein a value for identifying the defect type is formed by the statistical analysis.

43. The method according to claim 42, wherein the type of defect includes scratches and stains.

44. The method according to claim 40, wherein after the absorbance dispersion of at least one cuvette not containing liquid is determined, the cuvette is filled with liquid, and the absorbance dispersion of the liquid-filled cuvette is determined.

45. The method according to claim 39 or 44, wherein the liquid is deionized water.

46. The method according to any one of claims 1 to 45, wherein the cuvette transporter (40) includes a wheel (42) having a plurality of cuvette holders (41).

47. The method according to claim 46, wherein the cuvette transporter (40) moves a plurality of cuvettes in a fixed order between the plurality of positions.

48. A method for operating an automated analyzer (10), wherein the method is Multiple cuvettes, At least one reagent distribution position (31), At least one component distribution position (32), At least one cuvette washing position (33, 33a, 33b), Cuvette rinsing positions (73a, 73b, 73c, 73d), cuvette drying positions (83a, 83b), and At least one component measurement location (34) Multiple locations, including A cuvette transporter (40) having multiple cuvette holders (41), At least one photometer (50) and Control device (60) and The steps include preparing an automated analyzer (10) equipped with, The steps include moving the plurality of cuvettes between the plurality of positions using the at least one cuvette transporter (40) in accordance with the schedule of the control device (60), In a sequence in which one or more cuvettes (20) from the plurality of cuvettes are moved from the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d) to the cuvette drying position (83a, 83b), each of the one or more cuvettes (20) after the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d) and before the cuvette drying position (83a, 83b) The steps include: when at the scheduled at least one component measurement position (34), measuring the absorbance of each of the one or more cuvettes (20) in the sequence with respect to electromagnetic radiation of at least one predetermined wavelength using the at least one photometer (50) in accordance with the schedule of the control device (60), thereby determining the absorbance variance, which is the difference between the maximum absorbance and the minimum absorbance measured for each of the one or more cuvettes (20) in respect to electromagnetic radiation of at least one predetermined wavelength; For each of the one or more cuvettes (20) measured at the at least one component measurement position (34), if the absorbance dispersion of the cuvette is greater than a predetermined first threshold, a disabled state is assigned; When a corresponding cuvette among the plurality of cuvettes is in one of the distribution positions, and a component test for the corresponding cuvette is scheduled at at least one component measurement position (34), the control device (60) distributes the components into the corresponding cuvette according to the schedule, unless the disabled state is assigned to the corresponding cuvette. When the corresponding cuvette is at the at least one component measurement position (34), and the components have been distributed into the corresponding cuvette, and a component test for the corresponding cuvette has been scheduled at the at least one component measurement position (34), the steps include measuring the components of the corresponding cuvette using the at least one photometer (50), If the disabled state is assigned to the corresponding cuvette, the step of rescheduling the component test is as follows: Methods that include...

49. A method for operating an automated analyzer (10), wherein the method is Multiple cuvettes, At least one reagent distribution position (31), At least one component distribution position (32), At least one cuvette washing position (33, 33a, 33b), Cuvette rinsing positions (73a, 73b, 73c, 73d), cuvette drying positions (83a, 83b), and At least one component measurement location (34) Multiple locations, including A cuvette transporter (40) having multiple cuvette holders (41), At least one photometer (50) and Control device (60) and The steps include preparing an automated analyzer (10) equipped with, The steps include moving the plurality of cuvettes between the plurality of positions by the at least one cuvette transporter (40) according to the schedule of the control device (60), In a sequence in which one or more cuvettes (20) from the plurality of cuvettes are moved from the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d) to the cuvette drying position (83a, 83b), each of the one or more cuvettes (20) after the cuvette washing position (33, 33a, 33b) and the cuvette rinsing position (73a, 73b, 73c, 73d), and the cuvette drying position ( Steps include: when at the at least one component measurement position (34) scheduled before 83a, 83b), measuring the integrity of one or more cuvettes (20) in the sequence using the at least one photometer (50) according to the schedule of the control device (60), thereby determining the absorbance variance, which is the difference between the maximum absorbance and the minimum absorbance measured for electromagnetic radiation of at least one predetermined wavelength for each of the one or more cuvettes (20); For each of the one or more cuvettes (20) measured at the at least one component measurement position (34), if the absorbance dispersion of the cuvette is greater than a predetermined first threshold, a disabled state is assigned. When a corresponding cuvette among the plurality of cuvettes is in one of the distribution positions, and a component test for the corresponding cuvette is scheduled at at least one component measurement position (34), the control device (60) distributes the components into the corresponding cuvette according to the schedule, unless the disabled state is assigned to the corresponding cuvette. The steps include: applying at least one enhanced cleaning routine to the cuvette when the cuvette assigned the disabled state is at the at least one cuvette cleaning position (33, 33a, 33b); further measuring the cuvette using at least one photometer (50) when the cuvette assigned the disabled state is at the component measurement position (34); and reassigning the disabled state if the absorbance dispersion of the cuvette is greater than a predetermined first threshold, or assigning the enabled state if the absorbance dispersion of the cuvette is less than a predetermined second threshold or within a predetermined range. Methods that include...

50. A method for operating an automated analyzer (10), wherein the method is Multiple cuvettes, At least one reagent distribution position (31), At least one component distribution position (32), At least one cuvette washing position (33, 33a, 33b), Cuvette rinsing positions (73a, 73b, 73c, 73d), cuvette drying positions (83a, 83b), and At least one component measurement location (34) Multiple locations, including A cuvette transporter (40) having multiple cuvette holders (41), At least one photometer (50) and Control device (60) and The steps include preparing an automated analyzer (10) equipped with, The steps include moving the plurality of cuvettes between the plurality of positions using the at least one cuvette transporter (40) in accordance with the schedule of the control device (60), The step of distributing liquid into one or more cuvettes (20) when one or more of the cuvettes are in the at least one cuvette washing position (33, 33a, 33b), In a sequence in which one or more cuvettes (20) from the plurality of cuvettes are moved from the cuvette washing positions (33, 33a, 33b) and the cuvette rinsing positions (73a, 73b, 73c, 73d) to the cuvette drying positions (83a, 83b), each of the one or more cuvettes (20) moves after the cuvette washing positions (33, 33a, 33b) and the cuvette rinsing positions (73a, 73b, 73c, 73d) and the cuvette drying position The steps include: when at the at least one component measurement position (34) scheduled before (83a, 83b), measuring the integrity of one or more cuvettes (20) in the sequence using the at least one photometer (50) in accordance with the schedule of the control device (60), thereby determining the absorbance variance, which is the difference between the maximum absorbance and the minimum absorbance measured for electromagnetic radiation of at least one predetermined wavelength for each of the one or more cuvettes (20); For each of the one or more cuvettes (20) measured at the at least one component measurement position (34), if the absorbance dispersion of the cuvette is greater than a predetermined first threshold, a disabled state is assigned. A step of cleaning one or more cuvettes (20) when one or more of the cuvettes (20) are in the at least one cuvette cleaning position (33, 33a, 33b), When a corresponding cuvette among the plurality of cuvettes is at one of the distribution positions, and a component test for the corresponding cuvette is scheduled at at least one component measurement position (34), the control device (60) performs the steps of distributing the components into the corresponding cuvette, unless the disabled state is assigned to the corresponding cuvette, according to the schedule of the control device (60). Methods that include...

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