Real-time cuvette monitoring

Abstract

A method of using an automated chemical analyzer includes detecting, in real-time, anomalies in a cuvette used with the analyzer, and also detecting anomalous reaction conditions present in a cuvette used with the analyzer. The baseline signal is continuously updated and compared to subsequent signal records, and data within a given subsequent signal record itself is evaluated. When evaluating and comparing the signal record data, a signal criterion is used, and in the event that a cuvette anomaly or a reaction condition anomaly is determined to be detected, the analyzer will indicate or provide an alarm.

Description

Background Art

[0001] Certain automated analyzers are used to analyze samples, such as biological samples like blood or urine. These analyzers are capable of measuring the amount of light transmitted through a reaction vessel that contains the sample and reagents. For such analyzers, the reaction vessel is located between a light source and a spectral detector.

[0002] Although various automated analyzers and methods of use for measuring analytes in samples have been made and used, it is believed that no one prior to the present inventors has made or used the invention as described herein. Brief Description of the Drawings

[0003] Although this specification concludes with claims that particularly point out and distinctly claim the invention, it is believed that the invention will be better understood from the following description of certain embodiments in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and in which:

[0004] Figure 1 An exemplary configuration of an analyzer is shown.

[0005] Figure 2 is a schematic diagram showing Figure 1 the graphical construction of the photometric measurement section of the analyzer shown.

[0006] Figure 3 is a perspective view of an exemplary reaction vessel or cuvette.

[0007] Figure 4 depicts a method of using Figure 1 the analyzer shown.

[0008] Figure 5 depicts a process for detecting anomalies and abnormal reaction conditions in a cuvette.

[0009] Figure 6 shows a process for defining a signal recording range according to Figure 5 the process shown.

[0010] Figure 7 depicts an exemplary output showing the voltage curve of a cuvette and an exemplary defined signal recording range.

[0011] Figure 8 depicts a process for defining a first baseline signal according to Figure 5 the process shown.

[0012] Figure 9 depicts a process for evaluating the integrity of a cuvette according to Figure 5 the process shown.

[0013] Figure 10Depicts an exemplary voltage curve showing the detection of a missing cuvette.

[0014] Figure 11 Depicts a process for defining a first reagent blank signal according to Figure 5 the process.

[0015] Figure 12 Depicts a process for detecting an abnormal reaction condition according to Figure 5 the process.

[0016] Figure 13 Depicts a signal record showing the detection of an abnormal reaction condition.

[0017] Figure 14 Depicts an exemplary table showing a matrix of signal record data from multiple signal records of a given cuvette.

[0018] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be implemented in various other ways, including those not necessarily depicted in the drawings. The drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it is to be understood that the invention is not limited to the precise arrangements shown. Detailed Description

[0019] The following description of certain embodiments of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is one of the best modes for carrying out the invention. As will be recognized, the invention is capable of having other different and obvious aspects, all of which do not depart from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0020] For an automated analyzer that uses spectrophotometry to detect and / or measure an analyte in a sample, the detection and / or measurement can be affected by: (1) the quality or integrity of the reaction vessel (e.g., cuvette); and (2) the quality or condition of the reaction occurring within the cuvette. For example, the detection and / or measurement can be affected by a cuvette with scratches or stains. In addition, the detection and / or measurement can be affected by a reaction that produces crystals or bubbles. The following paragraphs describe methods and devices that can detect cuvette abnormalities and abnormal reaction conditions in real time, while being able to distinguish the detected abnormal reaction conditions from cuvette quality or integrity abnormalities. The methods and devices described herein help the user know what corrective action to take without taking unnecessary steps that would take the device offline. For example, if bubbles are detected in a reaction, it may not be necessary to take the analyzer offline for enhanced cuvette cleaning.

[0021] I. Exemplary Analyzer Configuration

[0022] Figure 1 An exemplary analyzer 1 is shown. The analyzer 1 includes a measuring mechanism 2 for measuring the absorbance of a liquid contained in a reaction vessel 20 (also referred to herein as a cuvette 20). The analyzer 1 further includes a control mechanism 3 for controlling the analyzer 1, including analyzing the measurement results in the measuring mechanism 2.

[0023] For the measuring unit 2, there is a sample transfer section 11 including one or more sample racks 11b, and each sample rack 11b holds one or more sample containers 11a. Each sample container 11a contains a sample such as blood or urine. There is a sample dispensing unit 12 for dispensing the sample into one or more cuvettes 20. The reaction table 13 holds the cuvettes 20 along a circumference, and the reaction table 13 is rotatable to transfer the cuvettes 20 to a predetermined position. The reagent reservoir 14 houses one or more reagent containers 15 containing reagents. The reagent dispensing unit 16 dispenses the reagents into the cuvettes 20. In addition, there is a stirring section 17 for stirring the sample and the reagents in the cuvette 20. The photometric measurement section 18 is configured to measure the absorbance of the liquid contained in the cuvette 20. Further, there is a cleaning section 19 for cleaning the cuvettes 20 to prepare them for subsequent tests or analyses.

[0024] The control mechanism 3 includes a control section 31, an input section 32, an analysis section 33, a recording section 35, an output section 36, and a sending and receiving section 37. The input section 32, the analysis section 33, the recording section 35, the output section 36, and the sending and receiving section 37 are electrically connected to the control section 31.

[0025] In some versions, the control section 31 is implemented by a CPU or the like, and the control section 31 controls the processing and operations of the respective parts of the analyzer 1. The control section 31 processes the information input from the respective parts of the analyzer 1 and outputs the processed information to the respective parts.

[0026] In some versions, the input section 32 is implemented by a keyboard, a mouse, a touch panel having input and output functions, etc., and acquires various information required for sample analysis, instruction information for analysis operations, etc.

[0027] The analysis section 33 performs component analysis of the sample, etc., based on the measurement results of the absorbance measured by the photometric measurement section 18.

[0028] In some versions, the recording unit 35 is implemented by a hard disk for magnetically storing information and a memory for loading and electrically storing various programs from the hard disk when the analyzer 1 performs processing. The recording unit 35 stores various information including the analysis results of samples, etc. The recording unit 35 may include a supplementary storage device capable of reading information stored on a storage medium such as a flash drive, an SD card, etc. Additionally, the analyzer 1 may be network-connected such that a network or a cloud drive can be used as a storage medium.

[0029] In some versions, the output unit 36 is implemented by a display, a printer, a speaker, etc., for outputting various information.

[0030] The sending and receiving unit 37 has a function as an interface for sending and receiving messages in a predetermined format via a communication network (not shown).

[0031] Figure 2 is a schematic diagram showing the graphic configuration of the photometric measurement unit 18, and Figure 3 is a perspective view of the cuvette 20. As Figure 2 shown, the photometric measurement unit 18 includes a light source 18a, a light receiving unit 18b, and an A / D converter 18c. The light source 18a and the light receiving unit 18b are placed opposite to each other, with the cuvette 20 held by the reaction table 13 placed therebetween. The light source 18a is implemented by a halogen lamp, etc., and irradiates light for analysis onto the cuvette 20. The light receiving unit 18b includes a diffraction grating such as a concave diffraction grating, and also includes a light receiving sensor, such as a light receiving element array, a CCD sensor, a CMOS sensor, etc., for measuring the light separated by the diffraction grating for each spectrum determined by the measurement category. The light receiving unit 18b outputs a signal corresponding to the amount of light measured for each spectrum. The A / D converter 18c converts the signal output from the light receiving unit 18b into a digital value and outputs the digital value to the control unit 31. In one version, the signal output is a voltage.

[0032] As Figure 3 shown, the cuvette 20 includes a liquid holding portion 20d for holding a liquid. The liquid holding portion 20d is defined by side walls, a bottom wall 20c, and an opening 20e. For the cuvette 20, a transparent material (such as glass including heat-resistant glass, or a synthetic resin including cycloolefin and polystyrene) is used to transmit the light contained in the analysis light BL (for example, analysis light with a wavelength in the range of 340 nanometers to 800 nanometers) irradiated from the light source 18a of the photometric measurement unit 18. In one example, when the cuvette 20 passes through the analysis light BL as the reaction table 13 rotates, the bottom of the side wall 20b is used as the photometric region Am through which the analysis light BL passes. The shape of the cuvette 20 can be such that it does not cause variations in the absorbance measurement at multiple points of the cuvette 20. The shape does not have to be a rectangular parallelepiped shape as Figure 3 shown.

[0033] II. Exemplary Analyzer Usage Method

[0034] Figure 4 An exemplary method of using analyzer 1 is shown. In analyzer 1, during the cleaning cycle or step 401, each cuvette 20 is filled with deionized water. In the photometric measurement step 402, the photometric measurement unit 18 measures the absorbance of cuvette 20, where each cuvette 20 contains deionized water. The output of this measurement is a signal record for each cuvette 20, which is represented by a graph of voltage versus time or distance. In some cases, these signal records may be referred to as or considered DI water blank signal records. In the storage step 403, the signal records are stored.

[0035] After the deionized water is emptied from cuvette 20, there is a reagent filling cycle or step 404, where each cuvette 20 is filled with a reagent from reagent container 15. In another photometric measurement step 405, the photometric measurement unit 18 measures the absorbance of cuvette 20, where each cuvette 20 contains only the reagent. The output of this measurement is another signal record for each cuvette 20, which is again represented by a graph of voltage versus time or distance. In some cases, these signal records may be referred to as or considered reagent blank signal records. In another storage step 406, the signal records are stored.

[0036] Next, in the sample cycle step 407, the sample dispensing unit 12 dispenses the sample from sample container 11a into cuvette 20 containing the reagent. In the stirring step 408, the contents of cuvette 20 can be stirred by the stirring unit 17. Then, in another photometric measurement step 409, the photometric measurement unit 18 measures the absorbance of the reaction solution obtained by the reaction of the reagent and the sample. In the component analysis step 410, the analysis unit 33 performs analysis based on these measurement results, thereby automatically performing component analysis of the sample and the like. Then, after the measurement of the reaction solution by the photometric measurement unit 18 is completed, the process is repeated, where the cleaning unit 19 cleans cuvette 20. Thus, the same cuvette 20 can be used multiple times in analyzer 1, and over time, analyzer 1 will accumulate multiple water blank signal records and multiple reagent blank signal records for each cuvette 20.

[0037] III. Exemplary Cuvette Quality Monitoring

[0038] Figure 5Illustrated is an exemplary process for evaluating cuvette integrity and for detecting abnormal reaction conditions in an automated analyzer such as analyzer 1 or another similar analyzer. The first step 501 involves defining a signal recording range to be used when recording signals. A subsequent step 502 involves defining a water blank baseline signal (sometimes referred to herein as a first baseline signal) for each cuvette. Another subsequent step 503 involves evaluating the integrity or quality of the cuvette 20. If the cuvette 20 quality assessment fails, the test will not continue, and corrective action will be taken and then the test will start again. If the cuvette 20 quality assessment is successful or passes, step 504 involves defining a reagent blank baseline signal (sometimes referred to herein as a second baseline signal) for each cuvette 20. And another subsequent step 505 involves detecting abnormal reaction conditions. These steps will be described in more detail in the following paragraphs and with reference to additional figures.

[0039] Figure 6 Illustrated is as Figure 5 shown an exemplary method of step 501 of defining a signal recording range. In the case of analyzer 1, the light receiving portion 18b, sometimes also referred to as a detector, continuously receives signals across the width of the cuvette 20 and between the cuvettes 20. In one example, the internal width of the cuvette 20 is 4 millimeters. When defining the signal recording range, step 601 involves continuously monitoring the input signal. In this example, the monitored signal represents a voltage output obtained from the light intensity detected by the photometric measurement unit 18 of analyzer 1. The photometric measurement unit 18 may also be referred to herein as a spectrophotometer. In some versions, the voltage output may be a negative voltage value.

[0040] When defining the signal recording range, a subsequent step 602 involves defining the start or starting point of the range. In this example, this is done by identifying a predetermined starting point. In one version, the starting time point is 1 millisecond after the input signal drops below -1.0 volts. Given the teachings herein, those of ordinary skill in the art will understand that other start or starting points may be used and defined based on the input signal reaching another voltage level.

[0041] In the case where the start of the signal recording range has been defined, another step 603 involves defining the end of the range. In this example, this is done by identifying a predetermined end point. In one version, the end time point is 5.5 milliseconds after the start point. In this example, based on the rotational speed of the reaction table 13, the distance covered by the defined signal recording range spans 3.6 millimeters of the 4 - millimeter internal width of the cuvette 20. Figure 7 Illustrated is an example of signal recordings 700, 702 showing the defined signal recording range 701.

[0042] Figure 8 Illustrated is as Figure 5Exemplary method of step 502 for defining a water blank baseline signal as shown. As described above, during the cleaning process or cycle within analyzer 1, the cuvette 20 is filled with deionized water for a period of time. During this time period, the reaction table 13 rotates the cuvette 20 through the photometric measurement section 18. The signal reading step 801 involves reading the signal (at 340 nanometers in this example) of each cuvette 20 when these cuvettes 20 contain deionized water. In view of the teachings herein, those of ordinary skill in the art will understand that other wavelengths may be used when reading the signal. The recording step 802 involves recording the signals from the reading step 801 according to the defined signal recording range 501 of the plurality of cuvettes 20.

[0043] The segmentation step 803 involves segmenting the recorded data points for each cuvette 20 into a plurality of segments, where the data is recorded according to the recording step 802. By way of example and not limitation, in this example, for one cuvette 20, 275 data points are collected during the recording step 802 (i.e., one data point is collected every 0.02 milliseconds), and these data points are segmented into 11 segments or portions across the signal recording range of the cuvette 20. In other words, the signal recording range 701 defined above and shown, for example, in Figure 7 will be segmented into 11 segments, where each segment contains a plurality of data points. In the case of recording data for a plurality of cuvettes 20, the compilation and recording step 804 involves grouping the segmented data in a matrix such that the data is grouped and recorded by cuvette number and segment number. For example, all the data from the first defined segment of each cuvette will be recorded, and all the data from the second defined segment of each cuvette will be recorded, and so on. Figure 14 An exemplary matrix depicting the abstract data recorded by segment for a given cuvette during multiple cycles (e.g., multiple cleaning cycles) is shown.

[0044] After the compilation and recording step 804, the storage and averaging step 805 involves storing a predetermined number of measurement data for a given cuvette 20 from the cuvette cleaning cycle. By way of example only, in this example, the most recent 10 measurement data from each cuvette 20 analyzed during the cleaning cycle are stored. In this way, as the analyzer 1 continues to analyze the cuvette 20, the water blank baseline signal of each cuvette 20 is continuously updated. The storage and averaging step 805 involves averaging the data of each cuvette 20 among the predetermined number of measurement data stored from the cuvette cleaning cycle and storing this average as the water blank baseline signal of each cuvette 20. By way of example, Figure 7 the signal recording 700 shown in

[0045] Figure 9 shows as Figure 5Exemplary method of step 503 for evaluating the integrity or quality of the cuvette 20 shown. As Figure 9 shown, there are multiple integrity or quality checks that can be performed. These include checking to verify the presence of the cuvette, checking to verify that the cuvette present is the correct size, checking for a cuvette with stains and / or checking for a cuvette with scratches.

[0046] In the presence check 900, a subsequent or current water blank signal record is obtained and compared with the previously generated water blank baseline signal. For example, in one example, the analyzer 1 has performed more than ten analyses on each cuvette 20 in the analyzer 1. As described above, the most recent 10 measurement data here are averaged and saved as the water blank baseline signal for the corresponding cuvette 20. In the subsequent step 901, during the next cleaning cycle, the photometric measurement unit 18 measures again, and the analyzer 1 generates a current water blank signal record for each cuvette 20. In the comparison step 902, the current water blank signal record of a given cuvette 20 is compared with the previously generated water blank baseline signal of that cuvette 20. In the analysis step 903, when the difference between these signals is greater than a predetermined value, the analyzer 1 will indicate a fault status to the user and may further indicate to the user that the cuvette 20 may be missing. In one example, if the current water blank signal record exceeds the water blank baseline signal by 10%, the analyzer 1 will present a fault status and a notification of a possible missing cuvette. At this time, the user will be prompted to check for the missing cuvette before continuing with further analysis of the sample.

[0047] Figure 10 An example of the signal record 1000 is shown, which shows a situation where a cuvette is detected as missing. In the illustrated example, three missing cuvettes are shown.

[0048] Referring again to Figure 9 , in the size check 910, step 911 involves generating a subsequent or current water blank signal record as mentioned above. During this process, the monitoring step 912 checks the time when the voltage output crosses a predetermined voltage. In the comparison step 913, the time taken for the current water blank signal record to cross the predetermined voltage is compared with a predetermined time. In the case where the time to cross the predetermined voltage exceeds the predetermined time, the analyzer 1 will indicate a fault status to the user and may further indicate to the user that the cuvette 20 may be the wrong size. In one example, if the current water blank signal record takes more than 8 milliseconds to cross the -1.0 voltage, the analyzer 1 will present a fault status and a notification of a possible incorrectly sized cuvette. At this time, the user will be prompted to check for the incorrectly sized cuvette before continuing with further analysis of the sample.

[0049] In the anomaly check 920, the subsequent or current water blank signal record is obtained and compared with the previously generated water blank baseline signal. For example, where the analyzer 1 has performed more than ten analyses on each cuvette 20 in the analyzer 1. As described above, the most recent 10 measurement data are averaged here and saved as the water blank baseline signal for the corresponding cuvette 20. In the subsequent step 921, during the next cleaning cycle, the photometric measurement unit 18 measures again, and the analyzer 1 generates a current water blank signal record for each cuvette 20. In the comparison step 922, the current water blank signal record of a given cuvette 20 is compared with the previously generated water blank baseline signal of that cuvette 20. In the analysis step 923, when the difference between these signals is greater than or less than a predetermined value, the analyzer 1 will indicate a fault status to the user and may further indicate to the user that the cuvette 20 may contain an anomaly. In one example, if the current water blank signal record is greater than or less than 2% of the water blank baseline signal, the analyzer 1 will present a fault status and a notification of a possible anomaly in the cuvette 20. In one example, anomalies detected in this way may include stains on the surface of the cuvette 20. The user will then be prompted to check the cuvette before proceeding with further sample analysis. In some versions, the test can be skipped and enhanced cleaning performed before resuming.

[0050] In another anomaly check 930, step 931 involves generating a subsequent or current water blank signal record for each cuvette, and the process is similar to that of the above anomaly check 920. In the comparison step 932, the data of the current water blank signal record from a given cuvette 20 are segmented into a predetermined number of segments, and then the average value of each segmented data set is used to detect anomalies in the cuvette 20. For example, in the analysis step 933, the absolute value of the difference between the segment with the minimum average value (SegMin) and the segment with the maximum average value (SegMax) is determined. Then this determined value is compared with the average value (SegAvg) of all segments. The following formula is representative, where PV represents the predetermined value:

[0051] |SegMin - SegMax| > PV * SegAvg.

[0052] In the case where the absolute value of the difference between SegMin and SegMax exceeds a predetermined value of SegAvg, the analyzer 1 will indicate a fault condition to the user and may further indicate to the user that the cuvette 20 may contain an anomaly. In one example, the predetermined value is 5%, such that if the absolute value of the difference between SegMin and SegMax exceeds 5% of SegAvg, the analyzer 1 will present a fault condition and a notification that the cuvette 20 may be anomalous. In one example, anomalies detected in this manner may include scratches on the surface of the cuvette 20. The user will be prompted to check the cuvette before proceeding with further analysis of the sample. In some versions, the test may be skipped and enhanced cleaning may be performed before resuming.

[0053] IV. Exemplary Cuvette Reaction Condition Monitoring

[0054] Figure 11 An exemplary method of step 504 for defining a reagent blank baseline signal as Figure 5 shown is presented. During the method of step 504, the reagent filling step 1101 involves filling the cuvette 20 with only the reagent from the reagent container 15. At this time, no sample from the sampling container 11a is included or dispensed into the cuvette 20. After filling, the reaction table 13 rotates the cuvette 20 through the photometric measurement unit 18, thereby performing absorbance measurement as described above. The signal reading step 1102 involves reading the signal from the photometric measurement output (in this example, 340 nanometers) when the cuvette 20 contains only the reagent. The recording step 1103 involves recording the signal from the reading step 1102 according to the defined signal recording range 501 to generate a reagent blank signal record for each cuvette 20.

[0055] The segmentation step 1004 involves segmenting the recorded data points into multiple segments for each cuvette 20, where the data is recorded according to the recording step 1103. By way of example and not limitation, in this example, for one cuvette 20, 275 data points are collected during the recording step 1103 (i.e., one data point is collected every 0.02 milliseconds), and these data points are segmented into 11 segments or portions spanning the signal recording range of the cuvette 20. In the case of recording data for multiple cuvettes 20, the compilation and recording step 1105 involves grouping the segmented data in a matrix such that the data is grouped and recorded by cuvette number and segment number. For example, all data from the first defined segment of each cuvette will be recorded, and all data from the second defined segment of each cuvette will be recorded, and so on.

[0056] After the compilation and recording step 1105, the storing and averaging step 1106 involves storing a predetermined number of collected measurement data. By way of example only, in this example, for each cuvette 20, the last 100 measurement data from the cuvette filled only with reagent are stored. The storing and averaging step 1106 also involves averaging the data of the predetermined number of measurement data stored from each cuvette 20, and storing this average value as the baseline of each cuvette 20, which represents the reagent blank baseline signal of this cuvette. By way of example and not limitation, in this example, the data of 11 segments of the most recent 100 measurements from each cuvette 20 are averaged, and this average value is stored as the reagent blank baseline signal of a given cuvette 20. In addition, when the analyzer 1 continues to analyze and generate new reagent blank signal records for each cuvette 20, this average value representing the reagent blank baseline signal is continuously updated based on the most recent measurements.

[0057] Figure 12 illustrates an exemplary method of step 505 for detecting an abnormal reaction condition within the cuvette 20 as Figure 5 shown. As Figure 12 shown, the abnormal reaction condition check 1200 includes step 1201, in which a subsequent or current reagent blank signal record is generated for the cuvette 20 containing only reagent. Step 1202 involves comparing the current reagent blank signal record with the reagent blank baseline signal and the water blank baseline signal. Step 1203 involves: if the current reagent blank signal record is greater than or less than a predetermined value multiplied by the water blank baseline signal multiplied by the assay factor multiplied by the reagent blank baseline signal, indicating a possible abnormal reaction condition. This can be represented by the following two equations:

[0058] (1) NewRgtBlank > PV * WtrBlankBaseSig * F * RgtBlankBaseSig, and

[0059] (2) NewRgtBlank < PV * WtrBlankBaseSig * F * RgtBlankBaseSig.

[0060] NewRgtBlank represents the subsequent or current reagent blank signal record.

[0061] PV represents the predetermined value.

[0062] WtrBlankBaseSig represents the water blank baseline signal.

[0063] F represents the assay factor specific to a given reagent.

[0064] RgtBlankBaseSig represents the reagent blank baseline signal.

[0065] By way of example and not limitation, in one version, the predetermined value PV is 2%. When an abnormal reaction condition is detected in this way, the analyzer 1 will present a notification of the fault condition and the possible abnormal reaction condition in the cuvette 20. In one example, the abnormal reaction condition detected in this way may include bubbles or crystals formed or being formed in the cuvette 20. At this time, the user will be prompted to check the cuvette before proceeding with further analysis of the sample. In some versions, the test can be skipped and enhanced cleaning can be performed before resuming, or the test can be skipped and the cuvette 20 can proceed to the cleaning cycle for the next test.

[0066] Figure 12 Another abnormal reaction condition check 1210 is also depicted, which includes step 1211, in which a current reagent blank signal record is generated for the cuvette 20 containing only the reagent. Step 1212 involves segmenting the data of the current reagent blank signal record from a given cuvette 20 into a predetermined number of segments, and then using the average value of the segmented data set to detect an abnormal reaction condition in the cuvette 20. For example, step 1233 involves calculating the absolute value of the difference between the segment with the minimum average value (SegMin) and the segment with the maximum average value (SegMax). Then this determined or calculated value is compared with the average value (SegAvg) of all segments of the current reagent blank signal record. The following formula is representative, where PV represents the predetermined value:

[0067] |SegMin - SegMax| > PV * SegAvg.

[0068] If the absolute value of the difference between SegMin and SegMax exceeds the predetermined value multiplied by SegAvg, the analyzer 1 will indicate a fault condition to the user, and may further indicate to the user that the cuvette 20 may contain an abnormal reaction condition. In one example, the predetermined value is 5%, such that if the absolute value of the difference between SegMin and SegMax exceeds 5% of SegAvg, the analyzer 1 will present a notification of the fault condition and the possible abnormal reaction condition in the cuvette 20. In one example, the abnormal reaction condition detected in this way may include bubbles or crystals formed or being formed in the cuvette 20. At this time, the user will be prompted to check the cuvette before proceeding with further analysis of the sample. In some versions, the test can be skipped and enhanced cleaning can be performed before resuming, or the test can be skipped and the cuvette 20 can proceed to the cleaning cycle for the next test.

[0069] Figure 13Examples of signal recordings 1300 and 1301 are shown, where signal recording 1300 shows the case where bubbles were detected during the reaction within cuvette 20, and signal recording 1301 shows the case where no bubbles were detected during the reaction within cuvette 20.

[0070] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from one another. Given the teachings herein, various suitable ways of combining the teachings herein will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0071] Various embodiments of the present invention have been shown and described. Without departing from the scope of the present invention, those of ordinary skill in the art can further adapt the methods and systems described herein through appropriate modifications. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the appended claims and should be understood to be not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A method for monitoring a condition associated with a cuvette among a plurality of cuvettes used with an autoanalyzer, the autoanalyzer being configured to measure an analyte in a sample using a spectrophotometer, the method comprising: a. Defining a signal recording range for the cuvette by monitoring an input signal representing a voltage output derived from a light intensity detected by the spectrophotometer; b. When the cuvette contains fluid, generating, for each of the cuvettes, a first baseline signal based on input signals from a plurality of wash cycles, the first baseline signal representing an average of a plurality of data points recorded from a plurality of segments of the defined signal recording range; c. Evaluating the condition of the cuvette by performing at least one of the following steps: i. Monitoring the duration of a voltage curve, ii. Comparing the first baseline signal with a first subsequent signal recording generated based on the input signal during a subsequent wash cycle of the cuvette when the cuvette contains the fluid, the first subsequent signal recording representing a plurality of data points recorded from a plurality of segments of the defined signal recording range, and iii. Comparing the first subsequent signal recording with at least some of the plurality of data points of the first subsequent signal recording.

2. The method according to claim 1, wherein Comparing the first subsequent signal recording with the first baseline signal verifies whether the cuvette is present in the autoanalyzer.

3. The method according to claim 2, wherein, If the first subsequent signal recording is greater than a predetermined value of the first baseline signal, the cuvette is considered absent.

4. The method according to claim 3, wherein The predetermined value is 10%.

5. The method according to claim 1, wherein, Monitoring the duration of the voltage curve verifies whether the cuvette matches a desired size.

6. The method according to claim 5, wherein If the time for the input signal to cross a predetermined voltage downward exceeds a predetermined time, the cuvette is considered not to match the desired size.

7. The method according to claim 6, wherein The predetermined voltage is -1.0 volts and the predetermined time is greater than 8.0 milliseconds.

8. The method according to claim 1, wherein, Comparing the first subsequent signal recording with the first baseline signal verifies whether the cuvette contains an abnormality.

9. The method according to claim 8, wherein, If the first subsequent signal recording is greater than or less than a predetermined amount of the first baseline signal, the cuvette is considered to contain the abnormality.

10. The method according to claim 9, wherein, The predetermined amount is 2%.

11. The method according to claim 1, wherein, Comparing the first subsequent signal recording with at least some of the plurality of data points of the first subsequent signal recording verifies whether the cuvette contains an abnormality.

12. The method according to claim 11, wherein, If the first subsequent signal recording has a predetermined value of |SegMin - SegMax| > SegAvg, the cuvette is considered to contain an abnormality, where SegMin is the minimum average voltage reading of the segment, SegMax is the maximum average voltage reading of the segment, and SegAvg is the average voltage reading of the segment of the first subsequent signal recording.

13. The method according to claim 12, wherein, The predetermined value is 5%.

14. The method according to any one of claims 8 to 13, wherein, The abnormality includes one or both of a stain on the cuvette and a scratch on the cuvette.

15. The method according to claim 1, further comprising detecting an abnormal reaction condition.

16. The method according to claim 15, further comprising generating a second baseline signal during a reagent filling cycle when the cuvette contains the reagent but no sample, the second baseline signal representing an average value of the input signal for the cuvette containing the reagent but no the sample.

17. The method according to claim 16, further comprising generating a second subsequent signal record during a subsequent reagent filling cycle of the cuvette, the second subsequent signal record representing the input signal for the cuvette containing the reagent but no sample, the second subsequent signal record representing a plurality of data points recorded from a plurality of sections across a defined signal record range.

18. The method according to claim 16, wherein If the second subsequent signal record is greater than or less than a predetermined value of the first baseline signal multiplied by a determination factor multiplied by the second baseline signal, the cuvette is considered to have the abnormal condition.

19. The method according to claim 18, wherein The predetermined value is 2%.

20. The method according to claim 16, wherein, If the second subsequent signal record has a predetermined value of |SegMin - SegMax| > SegAvg, the cuvette is considered to have the abnormal condition, where SegMin is the minimum average voltage reading of the section, SegMax is the maximum average voltage reading of the section, and SegAvg is the average voltage reading of the section of the second subsequent signal record.

21. The method according to claim 20, wherein, The predetermined value is 5%.

22. The method according to any one of claims 15 to 21, wherein Detecting the abnormal reaction condition includes detecting one or more of bubbles and crystals after adding the reagent to the cuvette.

23. The method according to claim 1, wherein, The input signal is a negative voltage converted from the light intensity.

24. The method according to claim 1, wherein Generating the first baseline signal includes continuously updating the first baseline signal and storing the continuously updated first baseline signal.

25. The method according to claim 16, wherein Generating the second baseline signal includes continuously updating the second baseline signal and storing the continuously updated second baseline signal.

26. The method according to claim 1, wherein, Recording the plurality of data points from each of the plurality of sections.

27. The method according to claim 1, wherein, Generating the first baseline signal includes storing an average value of the plurality of data points for each section for a plurality of cuvettes to generate a matrix of the input signal by cuvette and section.

28. The method according to claim 1 further includes applying a signal recording rule to the defined signal recording range, wherein, The signal recording rule defines the total number of the plurality of data points and the total number of the plurality of sections from which the plurality of data points are recorded.

29. The method according to claim 28, wherein, According to the signal recording rule, recording of the data points is triggered by the voltage reaching a specified condition.

30. The method according to claim 1, wherein, The signal record range starts at a time of 1 millisecond after the input signal crosses below -1.0 volts, and wherein, the signal record range ends 5.5 milliseconds after the start.

31. The method according to claim 1, wherein The signal record range starts at a time of 1 millisecond after the input signal crosses below -1.0 volts, and wherein, the signal record range ends after 3.6 millimeters of the width of the cuvette.

32. The method according to claim 1, wherein, The plurality of sections includes 11 sections.

33. The method according to claim 1, wherein The fluid is deionized water.

34. The method according to claim 1, wherein, The first baseline signal includes an average value of ten data points from ten past cleaning cycles.

35. A system for monitoring a condition associated with a cuvette, the system comprising an autoanalyzer, the cuvette, and a fluid optionally contained within the cuvette, the autoanalyzer being configured to measure an analyte in a sample using a spectrophotometer, the system being configured to: a. Define a signal recording range of the cuvette by monitoring an input signal representative of a voltage output derived from a light intensity detected by the spectrophotometer; b. When the cuvette contains the fluid, generate a first baseline signal for the cuvette based on input signals obtained from a plurality of wash cycles in accordance with the signal recording range, the first baseline signal being continuously updated from the plurality of wash cycles of the cuvette; c. Evaluate the condition of the cuvette by performing at least one of the following steps: i. Monitor a duration of a voltage curve, ii. Compare the first baseline signal with a first subsequent signal recording generated based on the input signal during a subsequent wash cycle of the cuvette when the cuvette contains the fluid, and iii. Compare the first subsequent signal recording with at least a portion of the data of the first subsequent signal recording.

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