Ion selective electrode module and optical module startup

Abstract

Operation of an analyzer may include performing a set of startup activities after powering the analyzer on. These activities may include automatically cleaning a module of the analyzer, such as an ion selective electrode (ISE) module, automatically calibrating that module, and checking a volume of detergent in that module. In some cases, this volume checking may be performed after the module has been the module has been cleaned and calibrated, and may even take place after a sample has been loaded into the analyzer (e.g., during a pre-wash procedure).

Description

ION SELECTIVE ELECTRODE ANALYZER MAINTENANCEBACKGROUND

[0001] Clinical analyzers are well known in the art and are generally used for automated or semiautomated analysis of patient samples, such as blood, urine, spinal fluid, and the like. So that these types of analyzers can be used effectively, before sample measurement (i.e., before a patient sample is loaded onto an analyzer for processing) an analyzer will generally be subjected to a daily startup routine in which it is inspected, cleaned, has its reagents checked, and goes through a calibration / quality control process. While this type of startup routine is necessary, it results in downtime for the analyzer. Accordingly, there is a need for technology which can improve the efficiency of, and / or otherwise decrease the time taken by, an analyzer’s daily startup routine.BRIEF DESCRIPTION OF THE DRAWINGS

[0002] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0003] FIG. 1 illustrates an exemplary analyzer which may be used in some embodiments;

[0004] FIG. 2 illustrates a set of steps which may be performed during daily start up for an analyzer such as shown in FIG. 1;

[0005] FIG. 3 illustrates an exemplary startup routine including startup activities for both an ion- selective electrode (ISE) module and an optical analysis module; and

[0006] FIG. 4 illustrates another exemplary startup routine including startup activities for both an ISE module and an optical analysis module.

[0007] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0008] Turning now to the figures, FIG. 1 illustrates an example analyzer 1 which may be used in implementing the disclosed technology. As shown in FIG. 1, such an analyzer may include various types of analytic technologies and systems for determining different properties of patient samples. For example, an analyzer 1 may include an optical analysis system 12 which uses one or more optical techniques (e.g., photometry, in which a light source 12a would shine light through a sample then be split by a separator 12b (e.g., a prism or a grating) and detected by a light sensor 12c) to determine a sample’s concentration and composition. To perform this type of optical analysis, a sample container 10a containing a sample would be loaded into a sample rack 10 in a feeder portion of the analyzer 9. A controller (e.g., a programmed microprocessor) 15 would then transfer the rack 10 containing the sample container 10a to an aspiration location using a conveyor 8, and a sample dispenser 11 would lower its probe 1 lb into the sample container 10a and aspirate a portion of the sample for analysis. The dispenser 11 would then pivot so that its arm I la would convey the aspirated sample to a reaction vessel 5 of a sample analysis wheel 4 for processing.

[0009] Simultaneously with, or in sequence with, a sample transfer procedure such as described above, an analyzer 1 such as shown in FIG. 1 may perform a similar process for transferring the reagent(s) that would be used in the optical analysis. For example, in the configuration shown in FIG. 1, the controller 15 may cause a reagent wheel (e.g., first reagent wheel 2 or second reagent wheel 3) to rotate such that a reagent container (e.g., reagent container2a or reagent container 3a) containing a reagent which would be used in the analysis is disposed at an aspiration point for a reagent dispenser (e.g., first reagent dispenser 6 or second reagent dispenser 7) used by that wheel. The reagent dispenser could then aspirate the appropriate amount of reagent for analyzing the patient sample using its probe (e.g., probe 6b or probe 7b) and the dispenser could then pivot so that its arm (e.g., arm 6a or arm 7a) would bring the aspirated reagent to a dispensing position on the analysis wheel 4. The analysis wheel 4 could move the reaction vessel 5 containing the sample to the appropriate dispensing position, and the dispenser could then dispense the previously aspirated reagent into the reaction vessel 5. The contents of the reaction vessel 5 could then be mixed using a mixer 20 (e.g., a stirring rod, a mixer that would vibrate the reaction vessel, a mixer which would subject the reaction vessel to sound waves, etc.) in preparation for the optical analysis using the optical analysis system 12.

[0011] Once the analysis was complete, a cleaning module 13 may remove the liquid from the reaction vessel 5, then repeatedly inject and remove cleaning liquid such as a detergent (e.g., sodium hypochlorite) and cleaning water with its nozzle 13a, thereby cleaning the reaction vessel 5 used in the analysis. Similarly, the probes used for conveying the sample and the reagent(s) to the optical analysis wheel may be washed in respective wash towers (6c, 7c, 11c), thereby ensuring that the results of any particular sample being analyzed are not impacted by carryover from previous tests.

[0012] Other types of analysis technologies and systems may also be included in an analyzer such as that shown in FIG. 1. For example, in addition to the various optical analysis components such as discussed above, an analyzer such as illustrated may also include various components for performing analysis using an ion selective electrode (referred to herein collectively as an ion selective electrode module 14). These components, which are not individually depicted in FIG. 1, may include a dilution container, a diluent supply means for supplying the dilution liquid to the dilution container, a standard liquid supply means for supplying the standard solution to the dilution container, and an ion selective electrode (for example, an electrode for measuring an electrolyte concentration of sodium ions,potassium ions, and / or chlorine ions in a sample). In such a case, a sample may be dispensed from the sample container 10a held in the rack 10 by the sample dispensing mechanism 11 to the dilution container of the ion selective electrode module. An electrode in the module would then measure the electrolyte concentration of a constituent to be measured in the sample solution by measuring the electromotive force of each of the sample solution and a standard solution. An example of a detailed configuration of an ion- selective electrode (ISE) measurement mechanism is described in, for example, Japanese Patent Application Laid-Open No. 2005-62128, which application is hereby incorporated by reference in its entirety. The ion selective electrode module 14 may also include a wash tower which could be used to wash components of that module after it had been used to analyze a sample, thereby reducing the risk of carry over in the same manner as described above with wash towers 6c 7c 11c.

[0013] It should be understood that, while FIG. 1 illustrates an exemplary analyzer which may be used in some embodiments, the disclosed technology is not limited to the above-described configuration. For example, in the example shown in FIG. 1, the number of reagent wheels is two, but the number of reagent wheels is not limited to two, and may be one or three or more. Similarly, in the example shown in FIG. 1, the light source 12a is outside the reaction wheel 4 and the spectroscopic unit 12b and the light receiving unit 12c are shown inside the reaction wheel 4. However, in some cases the arrangement may be such that the spectroscopic unit 12b and the light receiving unit 12c are outside the reaction wheel 4, or other arrangements. Other variations are also possible, and will be immediately apparent to those of skill in the art in light of this disclosure. Accordingly, the exemplary configuration illustrated in FIG. 1 should not be treated as implying limitations on the protection provided by this document or any related document.

[0014] Turning now to FIG. 2, that figure illustrates a set of steps which may be performed during daily start up for an analyzer such as shown in FIG. 1. As shown in that figure, an analyzer’s daily startup routine may include, after the analyzer is powered on 201, cleaning the ISE module 202. This may be done by, for example, using a detergent such as sodiumhypochlorite to clean tubes used to mix samples with reagents in the ISE module. Once the ISE module is cleaned 202, the startup may continue with calibrating 203 the ISE module. This calibration 203 may be done by using the ISE module to take measurements of samples having known concentrations of various types of ions to confirm that the module was able to accurately measure those ions. The startup routine may also include checking 204 the volume of detergent (e.g., sodium hypochlorite) in the ISE module. This may be done, for example, using a probe to determine the level of detergent, then comparing the volume of detergent implied by that level with an amount of detergent which could be expected to be used during operation of the analyzer until the next startup. As part of this detergent volume check 204, if the comparison indicated that the amount of detergent loaded on the machine was less than the amount that could be expected to be used, additional detergent could be added to address this shortfall.

[0015] Other activities may also be performed as part of an analyzer’s startup routine. For example, in some cases, in addition to the analyzer cleaning 202 the ISE module as described above, there may be another, manual, cleaning step in which an operator could clean components such as probes (e.g., sample probe l ib) using alcohol or other appropriate cleaning chemical(s). Similarly, an operator could perform reagent management activities for the ISE module, such as checking the expiry date of reagents used in the ISE module’s analysis, checking that there is a sufficient amount of each reagent to handle a volume of sample analyses that could be expected for the period before next startup. Of course, it is also possible that there may be additional automated activities which could be performed as part of a startup routine, rather than just additional tasks which would be performed by an operator. For example, in some cases, the analyzer itself may be programmed (e.g., with appropriate software executed by controller 15) to perform certain reagent management activities. For instance, in some cases, an analyzer could be configured to be able to detect whether reagent bottles had been loaded into the analyzer, to use a barcode scanner to determine basic information about the reagents (e.g., expiry date, assay which would be performed using the reagent), and to determine the volume of reagent remaining (e.g., using liquid height detection as described previously in the contextof checking 204 ISE detergent volume). Accordingly, the above description of additional manual activities which may be performed as part of a startup routine should be understood as being illustrative only, and should not be treated as limiting.

[0016] Just as additional activities which may take place during a startup routine can include both manual and automatic activities, in some cases, a startup routine may include additional activities which include different modules (such as an optical analysis module), rather than only activities for the ISE module as described above. To illustrate, consider FIG. 3, which illustrates a startup routine including startup activities for both an ISE module and an optical analysis module (e.g., as shown in the exemplary analyzer of FIG. 1). As shown in that figure, it is possible that startup activities for ISE and optical analysis modules may be considered two separate workstreams which include activities which can be performed in parallel (e.g., manually cleaning the ISE module 301 and manually cleaning the optical analysis module 302) thereby reducing the total time for completing the startup routine relative to what would be necessary for performing all of the startup activities in sequence. Other types of optimizations are also possible in a startup routine such as shown in FIG. 3. For example, in some cases, checking and (potentially) refding detergent 303 may include both checking and (potentially) refdling detergent on the optical analysis module and checking and (potentially) refilling detergent on the ISE module, thereby allowing similar activities to be performed together.

[0017] In some implementations, an analyzer which is designed to undergo a startup routine such as shown in FIG. 3 may be programmed with functionality to help support such a routine. For example, in some cases, an analyzer could be programmed to maintain and update the status of the ISE and / or optical analysis modules, and use that status information to prevent either module from trying to perform inappropriate activities. For instance, in a case where checking and (potentially) refilling detergent 303 includes checking and (potentially) refilling detergent on both the ISE and optical analysis modules, then upon initiation of consumable management 304, the status of the ISE module may be updated to busy, and when the consumable management 304 was complete, the status could be updated to ready,thereby enabling ISE module cleaning 202 and ISE module calibration 203 to proceed. Similarly, in embodiments where this type of status information was maintained, it may be used to control processing of patient samples, and prevent that processing from being performed until after the startup routine was successfully completed.

[0018] It should be understood that, while FIG. 3 illustrates a potential startup routine including startup activities for both an ISE module and an optical analysis module, other startup routines could be performed in analyzers which include these module types. As an example of this type of alternative startup routine, consider FIG. 4, which illustrates another startup routine including startup activities for both an ISE module and an optical analysis module. In that startup routine, in a workflow for the optical module, there is an optical consumable management 401 step, in which the optical reagents (i.e., reagents used by the optical module) would be checked and (potentially) replaced 402, and optical detergent (i.e., detergent that would be used by the optical module) is checked and (potentially) refilled 403. Because the optical consumable management 401 does not involve the ISE module, in the workflow of FIG. 4, it is possible that the ISE cleaning 202 and / or ISE calibration could be performed in parallel with the optical consumable management 401 or its constituent steps, avoiding the need to update the status of the ISE module to busy on initiation of optical consumable management 401. Similarly, the step of checking ISE detergent volume may also be performed in parallel with activities included in the optical consumable management 401, such as checking and (potentially) replacing optical reagents. ISE detergent checking may also be performed at other times as may be appropriate for particular cases. For example, in some cases, before an analyzer processes a sample, it may be programmed to perform a pre-wash which includes dipping the sample probe in, and using it to aspirate, detergent. In such a case, an analyzer may be programmed to combine the checking of detergent on the ISE module with the pre-wash, by using the probe to detect the level of detergent when it comes into contact with the detergent to aspirate it. In this way, the analyzer could still address any issues with the detergent (e.g., by providing an alert to the operator on a display 17, and then rerunning the volume check once the operator indicated that the detergent had been refdled using a keyboard or otherinput 16), even without performing a separate volume check of ISE detergent during the startup routine.

[0019] Other variations and alternative embodiments are also possible, and could be implemented by those of ordinary skill in the art based on this disclosure without undue experimentation. To further illustrate some of these variations and embodiments, the following examples are provided showing methods, analyzers and computer readable media which may be implemented based on this disclosure.

[0020] Example 1

[0021] A method comprising: a) powering on an analyzer, wherein the analyzer comprises an ion selective electrode (ISE) module and an optical analysis module; b) perform a set of ISE module startup activities, wherein the set of ISE module startup activities comprises: i) automatically cleaning the ISE module; ii) automatically calibrating the ISE module; and iii) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module; and c) perform a set of optical analysis module startup activities, wherein the set of optical analysis module startup activities comprises checking volumes of one or more reagents in the optical analysis module.

[0022] Example 2

[0023] The method of example 1, wherein: a) automatically cleaning the ISE module and automatically calibrating the ISE module take place during a first time period; b) checking volumes of one or more regents in the optical analysis module takes place during a second time period; and c) the first time period and the second time period overlap.

[0024] Example 3

[0025] The method of any of examples 1-2, wherein checking the volume of detergent in the ISE module takes place after checking volumes of one or more reagents in the optical analysis module is complete.

[0026] Example 4

[0027] The method of any of examples 1-3, wherein: a) the optical analysis module comprises: i) one or more reagent wheels; ii) a reaction wheel; iii) a spectroscopic optical analysis system; and iv) one or more optical module wash towers; and b) the ISE module comprises: i) a dilution container; ii) an ion selective electrode; and iii) one or more ISE module wash towers.

[0028] Example 5

[0029] The method of any of examples 1-4, wherein: a) the analyzer is programmed to maintain and update a status of the ISE module based on completion of the set of ISE module startup activities and the set of optical analysis module startup activities; b) the set of optical module startup activities comprises checking a volume of detergent in the optical analysis module; and c) the analyzer is not programmed to update the status of the ISE module out of a ready state based on initiation of checking the volume of detergent in the optical analysis module.

[0030] Example 6

[0031] The method of any of examples 1-5, wherein: a) the method comprises loading a sample onto the analyzer; and b) checking the volume of detergent in the ISE module is performed after the sample is loaded onto the analyzer.

[0032] Example 7

[0033] The method of any of examples 1-6, wherein: a) the analyzer is programmed to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; and b) the volume of detergent in the ISE module is checked during the pre-wash procedure by detecting a height of detergent using the sample probe.

[0034] Example 8

[0035] An analyzer comprising: a) an ion selective electrode (ISE) module; b) an optical analysis module; and c) a controller, wherein the controller is programmed to perform a set of startup activities following the analyzer being powered on, wherein the set of startupactivities comprises: i) automatically cleaning the ISE module; ii) checking volumes of one or more reagents in the optical analysis module; iii)automatically calibrating the ISE module; and iv) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module.

[0036] Example 9

[0037] The analyzer of example 8, wherein the controller is programmed to automatically clean the ISE module and automatically calibrate the ISE module take place during a time period which overlaps a time period during which the volumes of the one or more reagents in the optical analysis module are checked.

[0038] Example 10

[0039] The analyzer of any of examples 8-9, wherein checking the volume of detergent in the ISE module takes place after checking volumes of one or more reagents in the optical analysis module is complete.

[0040] Example 11

[0041] The analyzer of any of examples 8-10, wherein: a) the optical analysis module comprises: i) one or more reagent wheels; ii) a reaction wheel; iii) a spectroscopic optical analysis system; and iv) one or more optical module wash towers; and b) the ISE module comprises: i) a dilution container; ii) an ion selective electrode; and iii) one or more ISE module wash towers.

[0042] Example 12

[0043] The analyzer of any of examples 8-11, wherein: a) the controller is programmed to maintain and update a status of the ISE module based on completion of the set of startup activities; b) the set of startup activities comprises checking a volume of detergent in the optical analysis module; and c) the analyzer is not programmed to update the status of the ISE module out of a ready state based on initiation of checking the volume of detergent in the optical analysis module.

[0044] Example 13

[0045] The analyzer of an of examples 8-12, wherein the controller is programmed to check the volume of detergent in the ISE module after the sample is loaded onto the analyzer.

[0046] Example 14

[0047] The analyzer of any of examples 8-13, wherein: a) the controller is programmed to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; and b) the controller is programed to check the volume of detergent in the ISE module during the pre-wash procedure by detecting a height of detergent using the sample probe.

[0048] Example 15

[0049] A non-transitory computer readable medium having stored thereon instructions for programming a controller of an analyzer to perform a set of startup activities comprising: a) automatically cleaning an ion selective electrode (ISE) module of the analyzer; b) checking volumes of one or more reagents in an optical analysis module of the analyzer; c) automatically calibrating the ISE module; and d) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module.

[0050] Example 16

[0051] The non-transitory computer readable medium of example 15, wherein instructions stored on the medium comprise instructions to check volumes of one or more reagents in the optical analysis module during a time period which overlaps checking the volume of detergent in the ISE module.

[0052] Example 17

[0053] The non-transitory computer readable medium of an of examples 15-16, wherein the instructions stored on the medium comprises instructions for programming the controller to check the volume of detergent in the ISE module after a sample is loaded onto the analyzer.

[0054] Example 18

[0055] The non-transitory computer readable medium of any of examples 15-17, wherein: a) the medium comprises instructions for programming the controller to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; and b) the medium comprises instructions for programming the controller to check the volume of detergent in the ISE module during the pre-wash procedure by detecting a height of detergent using the sample probe.

[0056] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

I / We claim:

1. A method comprising: a) powering on an analyzer, wherein the analyzer comprises an ion selective electrode (ISE) module and an optical analysis module; b) performing a set of ISE module startup activities, wherein the set of ISE module startup activities comprises: i) automatically cleaning the ISE module; ii) automatically calibrating the ISE module; and iii) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module; and c) performing a set of optical analysis module startup activities, wherein the set of optical analysis module startup activities comprises checking volumes of one or more reagents in the optical analysis module.

2. The method of claim 1, wherein: a) automatically cleaning the ISE module and automatically calibrating the ISE module take place during a first time period; b) checking volumes of one or more regents in the optical analysis module takes place during a second time period; and c) the first time period and the second time period overlap.

3. The method of claim 1, wherein checking the volume of detergent in the ISE module takes place after checking volumes of one or more reagents in the optical analysis module is complete.

4. The method of claim 1, wherein: a) the optical analysis module comprises:i) one or more reagent wheels; ii) a reaction wheel; iii) a spectroscopic optical analysis system; and iv) one or more optical module wash towers; and b) the ISE module comprises: i) a dilution container; ii) an ion selective electrode; and iii) one or more ISE module wash towers.

5. The method of claim 1, wherein: a) the analyzer is programmed to maintain and update a status of the ISE module based on completion of the set of ISE module startup activities and the set of optical analysis module startup activities; b) the set of optical module startup activities comprises checking a volume of detergent in the optical analysis module; and c) the analyzer is not programmed to update the status of the ISE module out of a ready state based on initiation of checking the volume of detergent in the optical analysis module.

6. The method of claim 1, wherein: a) the method comprises loading a sample onto the analyzer; and b) checking the volume of detergent in the ISE module is performed after the sample is loaded onto the analyzer.

7. The method of claim 1, wherein: a) the analyzer is programmed to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; andb) the volume of detergent in the ISE module is checked during the pre-wash procedure by detecting a height of detergent using the sample probe.

8. An analyzer comprising: a) an ion selective electrode (ISE) module; b) an optical analysis module; and c) a controller, wherein the controller is programmed to perform a set of startup activities following the analyzer being powered on, wherein the set of startup activities comprises: i) automatically cleaning the ISE module; ii) checking volumes of one or more reagents in the optical analysis module; iii) automatically calibrating the ISE module; and iv) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module.

9. The analyzer of claim 8, wherein the controller is programmed to automatically clean the ISE module and automatically calibrate the ISE module take place during a time period which overlaps a time period during which the volumes of the one or more reagents in the optical analysis module are checked.

10. The analyzer of claim 8, wherein checking the volume of detergent in the ISE module takes place after checking volumes of one or more reagents in the optical analysis module is complete.

11. The analyzer of claim 8, wherein: a) the optical analysis module comprises: i) one or more reagent wheels; ii) a reaction wheel;0133788.0791273 4892-9922-6067v2 15iii) a spectroscopic optical analysis system; and iv) one or more optical module wash towers; and b) the ISE module comprises: i) a dilution container; ii) an ion selective electrode; and iii) one or more ISE module wash towers.

12. The analyzer of claim 8, wherein: a) the controller is programmed to maintain and update a status of the ISE module based on completion of the set of startup activities; b) the set of startup activities comprises checking a volume of detergent in the optical analysis module; and c) the analyzer is not programmed to update the status of the ISE module out of a ready state based on initiation of checking the volume of detergent in the optical analysis module.

13. The analyzer of claim 8, wherein the controller is programmed to check the volume of detergent in the ISE module after the sample is loaded onto the analyzer.

14. The analyzer of claim 8, wherein: a) the controller is programmed to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; and b) the controller is programed to check the volume of detergent in the ISE module during the pre- wash procedure by detecting a height of detergent using the sample probe.

15. A non-transitory computer readable medium having stored thereon instructions for programming a controller of an analyzer to perform a set of startup activities comprising:a) automatically cleaning an ion selective electrode (ISE) module of the analyzer; b) checking volumes of one or more reagents in an optical analysis module of the analyzer; c) automatically calibrating the ISE module; and d) after automatically cleaning and calibrating the ISE module, checking a volume of detergent in the ISE module.

16. The non-transitory computer readable medium of claim 15, wherein instructions stored on the medium comprise instructions to check volumes of one or more reagents in the optical analysis module during a time period which overlaps checking the volume of detergent in the ISE module.

17. The non-transitory computer readable medium of claim 15, wherein the instructions stored on the medium comprises instructions for programming the controller to check the volume of detergent in the ISE module after a sample is loaded onto the analyzer.

18. The non-transitory computer readable medium of claim 15, wherein: a) the medium comprises instructions for programming the controller to, prior to analyzing a sample using the ISE module, perform a pre-wash procedure using a sample probe; and b) the medium comprises instructions for programming the controller to check the volume of detergent in the ISE module during the pre-wash procedure by detecting a height of detergent using the sample probe.

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