Enzyme cleaner for automated clinical analyzers and methods of use thereof

Abstract

Methods for cleaning an electrode subsystem are provided. In some embodiments, the method for cleaning an electrode subsystem includes providing a cleaning composition comprising: (i) one or more cleaning enzymes; (ii) one or more pH adjusting agents; (iii) one or more matrix components; (iv) one or more buffer components; and (v) one or more preservatives, wherein the cleaning composition has a pH range of about 7.2 to about 7.4. The method further includes flowing the cleaning composition through the electrode subsystem, wherein the electrode subsystem comprises an inlet port, one or more sensors, an outlet port, and a fluid flow channel connecting the inlet port, the one or more sensors, and the outlet port.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 486,727, filed February 24, 2023, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to an enzymatic cleaner for an automated clinical analyzer and a method for cleaning components of an automated clinical analyzer using an enzymatic cleaning solution. [Background technology]

[0003] Immunoassay and chemistry analyzers are used to calculate the concentration of specific substances in samples of serum, plasma, urine, and / or other body fluids. Substances that can be analyzed with these instruments include specific metabolites, electrolytes, proteins, and / or drugs. Some immunoassay and chemistry analyzers can be used for in vitro diagnostic testing.

[0004] The primary purpose of chemical and biosensors (e.g., ion-selective electrodes / sensors) within chemistry analyzers (also referred to herein as clinical or Atellica® analyzers) is to rapidly process large volumes of serum, plasma, and urine samples. As samples are processed over time, deposits (e.g., proteins, lipids) may form in the system, including the manifold, tubing, and subassemblies (e.g., including the ion-selective sensor system). The deposit coating alters the sample-system interface, affecting air / liquid detection capabilities. Excessive deposits can also cause sample carryover, resulting in unstable signals, leading to detection errors and poor calibration.

[0005] Some immunoassay and clinical chemistry analyzers currently use harsh cleaners, such as bleach, to clean the analyzer. The performance of some aspects of the analyzer, such as ion-selective electrodes (ISEs), can be adversely affected by the use of harsh cleaners. It is desirable to use cleaners that are not detrimental to the performance and lifespan of the electrodes. Summary of the Invention [Problem to be solved by the invention]

[0006] The present disclosure is directed to overcoming these and other deficiencies in the art. [Means for solving the problem]

[0007] One embodiment of the present disclosure relates to a method for cleaning an electrode subsystem. The method includes providing a cleaning composition comprising: (i) one or more cleaning enzymes; (ii) one or more pH adjusters; (iii) one or more matrix components; (iv) one or more buffer components; and (v) one or more preservatives, wherein the cleaning composition has a pH range of about 7.2 to about 7.4. The method further includes flowing the cleaning composition through an electrode subsystem, the electrode subsystem including an inlet port, one or more sensors, an outlet port, and a fluid flow channel connecting the inlet port, the one or more sensors, and the outlet port.

[0008] Another aspect of the present disclosure relates to a method for cleaning an electrode subsystem. The method includes providing a cleaning composition comprising: (i) a lipase; (ii) an amylase; (iii) one or more pH adjusting agents selected from hydrochloric acid and sodium hydroxide; (iv) one or more matrix components selected from the group consisting of bovine serum albumin, zinc chloride, and magnesium chloride hexahydrate; (v) a HEPES buffer; and (vi) one or more preservatives selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, and clotrimazole, wherein the cleaning composition has a pH range of about 7.2 to about 7.4. The method further includes flowing the cleaning composition through an electrode subsystem, the electrode subsystem including an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port. [Brief explanation of the drawings]

[0009] [Figure 1A] Graphs showing the calibration stability of the K slope and air readings of standards A and B for sensors treated with pancreatin from porcine pancreas (Figure 1A), trypsin and lipase (Figure 1B), lipase (Figure 1C), and amylase (Figure 1D). [Figure 1B] Same as above. [Figure 1C] Same as above. [Figure 1D] Same as above. [Figure 2A]Graphs showing the K slope and calibration stability of air readings for Standards A and B for medium-load sensors treated every other week with A-LYTE® IMT Cleaner for a total of four treatments (FIG. 2A), medium-load sensors treated every other week with A-LYTE® IMT Cleaner starting on day 28 for a total of three treatments (FIG. 2B), high-load sensors treated approximately weekly with A-LYTE® IMT Cleaner for a total of five treatments (FIG. 2C), and ultra-high-load sensors treated every 5000 samples with A-LYTE® IMT Cleaner (FIG. 2D). [Figure 2B] Same as above. [Figure 2C] Same as above. [Figure 2D] Same as above. [Figure 3] 1 is a graph showing the calibration stability of the Na, K, and Cl sensors of one sensor cartridge before and after 10 and 50 replicates of A-LYTE® IMT Cleaner treatment. [Figure 4] 1 is a graph showing the calibration stability of the Na, K, and Cl sensors of three sensor cartridges before and after 50 replicates of A-LYTE® IMT Cleaner treatment. [Figure 5] 1 is a graph showing amylase stability in A-LYTE® IMT Cleaner. [Figure 6A] 6A and 6B are graphs showing regression plots illustrating the stability of lipase (FIG. 6A) and amylase (FIG. 6B). [Figure 6B] 6A and 6B are graphs showing regression plots illustrating the stability of lipase (FIG. 6A) and amylase (FIG. 6B). [Figure 7] FIG. 1 is a schematic diagram illustrating an integrated multi-sensor technology (IMT) manifold assembly. [Figure 8A]

[0033] Figures 8A and 8C are flow charts illustrating a method for cleaning a fluid system according to the present disclosure, comprising combining a concentrated enzymatic cleaning composition with a diluent and flowing the diluted enzymatic cleaning composition through a fluid tubing, a cartridge containing one or more ion-selective sensors, and an outlet port. Figures 8B and 8D illustrate a method for cleaning a fluid system, comprising flowing the enzymatic cleaning composition through a fluid tubing, a cartridge containing one or more ion-selective sensors, and an outlet port. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 8D] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0010] definition Unless otherwise indicated, the definitions and embodiments set forth in this section and other sections are intended to be applicable to all embodiments and aspects of the disclosure described herein for which they are suitable, as would be understood by one of skill in the art.

[0011] The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a "method" includes one or more methods, and / or steps of the type described herein and / or that will become apparent to those skilled in the art upon reading this disclosure. As another example, reference to a "compound" includes both a single compound and a plurality of different compounds.

[0012] The term "about" or "approximately" includes within a statistically significant range of values. Such a range may be within an order of magnitude, such as within 50%, or within 20%, or within 10%, or within 5% (or any amount or range within 5-50%) of a given value or range. The allowable variation encompassed by the term "about" or "approximately" may depend on the context.

[0013] As used herein, the term "and / or" means that the listed features may be present or utilized individually or in any combination. In effect, the term means that "at least one" or "one or more" of the listed features may be utilized or present.

[0014] As will be understood by those skilled in the art, for all purposes, including in terms of providing a written description, all ranges disclosed herein encompass all possible subranges and combinations of subranges, as well as any value within the range. Any recited range can be readily recognized as fully descriptive and allowing the same range to be broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be easily broken down into a lower third, middle third, upper third, etc. Additionally, as will be understood by those skilled in the art, all terms such as "up to," "at least," etc., are inclusive of the recited number and refer to a range that can be subsequently broken down into subranges or their specific values, as described above. Finally, as will be understood by those skilled in the art, a range includes each individual value, as described above.

[0015] In understanding the scope of the present disclosure, the term "comprising" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other, unstated features, elements, components, groups, integers, and / or steps. The above also applies to words of similar meaning, such as the terms "including," "involving," "having," and their derivatives. The term "consisting of" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of stated features, elements, components, groups, integers, and / or steps, but exclude the presence of other, unstated features, elements, components, groups, integers, and / or steps. The term "consisting essentially of" as used herein is intended to specify the presence of stated features, elements, components, groups, integers, and / or steps, and the presence of other features, elements, components, groups, integers, and / or steps that do not materially affect the basic and novel characteristics of the features, elements, components, groups, integers, and / or steps. In embodiments or claims where the term "comprising" (or the like) is used as a transitional phrase, such embodiments can also be envisioned by replacing the term "comprising" with the term "consisting of" or "consisting essentially of." The disclosed methods, kits, systems, and / or compositions may comprise, consist essentially of, or consist of the disclosed components.

[0016] In some embodiments that include an "additional" or "second" component, the second component, as used herein, is different from the other components or the first component. The "third" component is different from the other components, the first component, and the second component, and further listed or "additional" components are similarly different.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this invention belongs.Any method and material similar or equivalent to those described herein can also be used to implement or test this disclosure, but some embodiments of method and material are described here.All publications mentioned in this specification are incorporated herein by reference to disclose and describe the method and / or material related to which publication is cited.

[0018] Before the present disclosure is further described, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. Also, the scope of the present disclosure will be limited only by the appended claims, and it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0019] Method for cleaning an electrode subsystem One embodiment of the present disclosure relates to a method for cleaning an electrode subsystem, the method comprising: (a) providing a cleaning composition comprising: (i) one or more cleaning enzymes; (ii) one or more pH adjusting agents; (iii) one or more matrix components; (iv) one or more buffer components; and (v) one or more preservatives, wherein the cleaning composition has a pH range of about 7.2 to about 7.4. The method further comprises (b) flowing the cleaning composition through an electrode subsystem, the electrode subsystem comprising an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port.

[0020] In some embodiments, the method further comprises (c) flowing a rinsing solution through the electrode subsystem, wherein the flowing of the rinsing solution is effective to remove residual cleaning composition from the electrode subsystem.

[0021] Suitable rinse solutions that can be used include water (e.g., dd water), buffer solutions (e.g., PBS (phosphate buffered saline), HEPES free acid (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid), HEPES Na salt (2-hydroxyethyl)piperazine-N'-(2-ethanesulfonic acid) sodium salt), phosphate, TRIS (2-amino-2-(hydroxymethyl)-1,3-propanediol), TES (2-[(2-hydroxy-1,1-bis(hydroxymethyl)ethyl)amino]ethanesulfonic acid), MOPS (3-(N-morpholino)propanesulfonic acid), PIPES (1,4-piperazinediethanesulfonic acid), TAPS ([tris(hydroxymethyl)methylamino]propanesulfonic acid), bicine (N,N-bis(2-hydroxyethyl)glycine), tricine (N-[tris(hydroxymethyl)methyl]glycine), CAPSO (3-(cyclohexylamino)-2-hydroxy-1-propanesulfonic acid), cacodylate (dimepreserthylarsenic acid) acid), and MES (2-(N-morpholino)ethanesulfonic acid), preservative solutions (e.g., antibacterial or antifungal compositions), and combinations thereof.

[0022] In some embodiments, the cleaning composition is substantially free of sodium hypochlorite.

[0023] According to the present disclosure, cleaning enzymes that can be used in the cleaning compositions include, but are not limited to, amylase, lipase, trypsin, pepsin, and combinations thereof. In some embodiments, cleaning enzymes that can be used in the cleaning compositions include, but are not limited to, amylase, lipase, and combinations thereof.

[0024] The term "amylase" refers to an enzyme that catalyzes the hydrolysis of starch. Suitable exemplary amylases include, but are not limited to, alpha-amylase, beta-amylase, amyloglucosidase (glucoamylase), fungal amylase, and pullulanase.

[0025] The term "lipase" refers to an enzyme that catalyzes the hydrolysis of triglycerides. Suitable exemplary lipases include, but are not limited to, pancreatic lipase, microbial lipase, and plant lipase.

[0026] The terms "inlet port" and "input port" are used interchangeably and refer to a point of entry into a system, such as a fluid system.

[0027] According to the present disclosure, the one or more pH adjusting agents that can be used in the cleaning compositions include, but are not limited to, hydrochloric acid, sodium hydroxide, potassium hydroxide, calcium hydroxide, phosphoric acid, tetramethylammonium hydroxide, CAPSO free acid (3-(cyclohexylamino)-2-hydroxy-1-propanesulfonic acid), citric acid, acetic acid, CHES (2-(cyclohexylamino)ethanesulfonic acid), borate salts, and combinations thereof.

[0028] According to the present disclosure, one or more matrix components that may be used in the cleaning composition include, but are not limited to, bovine serum albumin, human serum albumin, zinc chloride, and magnesium chloride hexahydrate.

[0029] According to the present disclosure, one or more buffer components that can be used in the cleaning compositions include HEPES free acid (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid), HEPES Na salt (2-hydroxyethyl)piperazine-N'-(2-ethanesulfonic acid) sodium salt), phosphate, TRIS (2-amino-2-(hydroxymethyl)-1,3-propanediol), TES (2-[(2-hydroxy-1,1-bis(hydroxymethyl)ethyl)amino]ethanesulfonic acid), MOPS (3-(N-morpholino)propanesulfonic acid), PIPES (1,4-piperazinediethanesulfonic acid), TAPS ([tris(hydroxymethyl)methylamino]propanesulfonic acid), bicine (N,N-bis(2-hydroxyethyl)glycine), tricine (N-[tris(hydroxymethyl)methyl]glycine), CAPSO (3-(cyclohexylamino)-2-hydroxy-1-propanesulfonic acid), cacodylate (dimethylarsenate), and MES (2-(N-morpholino)ethanesulfonic acid).

[0030] According to the present disclosure, one or more preservatives that may be used in the cleaning composition include, but are not limited to, streptomycin sulfate, gentamicin sulfate, amphotericin B, chlortrimazole, chloramphenicol, ampicillin, neomycin sulfate, isothiazolinones, and sodium gallate.

[0031] According to the present disclosure, cleaning compositions have a pH range of about 7.2 to about 7.4, about 7.21 to about 7.39, about 7.22 to about 7.38, about 7.23 to about 7.37, about 7.24 to about 7.36, about 7.25 to about 7.35, about 7.26 to about 7.34, about 7.27 to about 7.33, about 7.28 to about 7.32, about 7.29 to about 7.4, about 7.3 to about 7.4, about 7.31 to about 7.39, about 7.32 to about 7.39, about 7.33 to about 7.39, about 7.34 to about 7.39, or about 7.35 to about 7.39.

[0032] In some embodiments, the cleaning composition further comprises a diluent. Any suitable diluent can be used. For example, the diluent can be selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

[0033] In some embodiments, the method further comprises (d) calibrating the sensor.

[0034] Another aspect of the present disclosure relates to a method for cleaning an electrode subsystem. The method includes: (a) providing a cleaning composition comprising: (i) a lipase; (ii) an amylase; (iii) one or more pH adjusting agents selected from hydrochloric acid and sodium hydroxide; (iv) one or more matrix components selected from the group consisting of bovine serum albumin, zinc chloride, and magnesium chloride hexahydrate; (v) a HEPES buffer; and (vi) one or more preservatives selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, and clotrimazole, wherein the cleaning composition has a pH range of about 7.2 to about 7.4. The method further includes (b) flowing the cleaning composition through an electrode subsystem, the electrode subsystem including an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port.

[0035] In some embodiments, the method further includes (c) flowing a rinse solution through the electrode subsystem, wherein the rinse solution is effective to remove residual cleaning composition from the electrode subsystem. Any of the rinse solutions described above can be used.

[0036] In some embodiments, the cleaning composition further comprises a diluent. Any suitable diluent can be used. For example, the diluent can be selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

[0037] In some embodiments, the method further comprises (d) calibrating the sensor.

[0038] In some embodiments, the lipase is at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 1100 U / L, at least about 1200 U / L, at least about 1300 U / L, at least about 1400 U / L, at least about 1500 U / L, at least about 1600 U / L, at least about 1700 U / L, at least about 1800 U / L, at least about 2000 U / L, at least about 2100 U / L, at least about 2200 U / L, at least about 2300 U / L, at least about 2400 U / L, at least about 2500 U / L, at least about 2600 U / L, at least about 2700 U / L, at least about 2800 U / L, at least about 2900 U / L, at least about 3000 U / L, at least about 3100 U / L, at least about 3200 U / L, at least about 3300 U / L, at least about 3400 U / L, at least about 3500 U / L, at least about 3600 U / L, at least about 3700 U / L, at least about 3800 U / L, at least about 3900 U / L, at least about 4000 U / L, at least about 4100 U / L, at least about 4200 U / L, at least about 4300 U / L, at least about 4400 In some embodiments, the serotonin-containing surfactant is present in the cleaning composition in an amount of at least about 1000 U / L, at least about 1900 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, at least about 7000 U / L, at least about 8000 U / L, at least about 9000 U / L, at least about 10000 U / L, at least about 11000 U / L, at least about 12000 U / L, at least about 13000 U / L, at least about 14000 U / L, at least about 15000 U / L, or at least about 16000 U / L.

[0039] The size of the 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 600U / L, 700U / L U / L、800U / L、900U / L、1000U / L、1100U / L、1200U / L、1300U / L、1400U / L、150 0U / L、1600U / L、1700U / L、1800U / L、1900U / L、2000U / L、2100U / L、2200U / L、 2300U / L、2400U / L、2500U / L、2600U / L、2700U / L、2800U / L、2900U / L、3000U / L、3100U / L、3200U / L、3300U / L、3400U / L、3500U / L、3600U / L、3700U / L、38 00U / L、3900U / L、4000U / L、4100U / L、4200U / L、4300U / L、4400U / L、4500U / L 4600U / L、4700U / L、4800U / L、4900U / L、5000U / L、6000U / L、7000U / L、8000 U / L、9000U / L、10000U / L、11000U / L、12000U / L、13000U / L、14000U / L、、よび15 000U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L 、800U / L、900U / L、1000U / L、1100U / L、1200U / L、1300U / L、1400U / L、1500U / L L、1600U / L、1700U / L、1800U / L、1900U / L、2000U / L、2100U / L、2200U / L、230 0U / L、2400U / L、2500U / L、2600U / L、2700U / L、2800U / L、2900U / L、3000U / L、3 100U / L、3200U / L、3300U / L、3400U / L、3500U / L、3600U / L、3700U / L、3800U / L L、3900U / L、4000U / L、4100U / L、4200U / L、4300U / L、4400U / L、4500U / L、460 0U / L、4700U / L、4800U / L、4900U / L、5000U / L、6000U / L、7000U / L、8000U / L、 9000U / L、10000U / L、11000U / L、12000U / L、13000U / L、14000U / L、15000U / L、and 16,000 U / L.

[0040] The content of the substance is approximately 100 U / L to 16000 U / L; approximately 100 U / L to 15000 U / L; approximately 100 U / L to 14000 U / L; approximately 100 U / L to 13000 U / L; approximately 100 U / L to 12000 U / L; approximately 100 U / L to 11000 U / L. Approximately 100 U / L to approximately 10000 U / L; approximately 100 U / L to approximately 9000 U / L; approximately 100 U / L to approximately 8000 U / L; approximately 100 U / L to approximately 7000 U / L; approximately 100 U / L to approximately 6000 U / L; approximately 100 U / L to approximately 5000 U / L; approximately 100 U / L to approximately 4000 U / L; approximately 100 U / L ~ approx. 3000 U / L; approx. 100 U / L ~ approx. 2000 U / L; approx. 100 U / L ~ approx. 1900 U / L; approx. 100 U / L ~ approx. 1800 U / L; approx. 100 U / L ~ approx. 1700 U / L; approx. 100 U / L ~ approx. 1600 U / L; approx. 100 U / L ~ approx. 1500 U / L; approx. 100 U / L ~ approx. 1400 U / L; approximately 100 U / L to approximately 1300 U / L; approximately 100 U / L to approximately 1200 U / L; approximately 100 U / L to approximately 1100 U / L; approximately 100 U / L to approximately 1000 U / L; approximately 100 U / L to approximately 900 U / L; approximately 100 U / L to approximately 800 U / L; approximately 100 U / L to approximately 700 U / L; approximately 100 U / L ~ approx. 600 U / L; approx. 100 U / L ~ approx. 500 U / L; approx. 100 U / L ~ approx. 400 U / L; approx. 100 U / L ~ approx. 300 U / L; approx. 100 U / L ~ approx. 200 U / L; approx. 150 U / L ~ approx. 2000 U / L; approx. 150 U / L ~ approx. 1800 U / L; approx. 150 U / L ~ approx. 16 0.00 U / L; Approximately 150 U / L to approximately 1400 U / L; Approximately 150 U / L to approximately 1200 U / L; Approximately 150 U / L to approximately 1000 U / L; Approximately 150 U / L to approximately 800 U / L; Approximately 150 U / L to approximately 600 U / L; Approximately 150 U / L to approximately 400 U / L; Approximately 200 U / L to approximately 15000 U / L; Approximately 300 U / L ~ approx. 14000 U / L; approx. 400 U / L ~ approx. 13000 U / L; approx. 500 U / L ~ approx. 12000 U / L; approx. 600 U / L ~ approx. 11000 U / L; approx. 700 U / L ~ approx. 10000 U / L; approx. 800 U / L ~ approx. 9000 U / L; approx. 900 U / L ~ approx. 8000 U / L; approx. 1000 U / L ~ approx. 7000 U / L; approx. 1000 U / L ~ approx. 6000 U / L; approx. 1000 U / L ~ approx. 5000 U / L; approx. 1000 U / L ~ approx. 4000 U / L; approx. 1000 U / L ~ approx. 3000 U / L; approx. 1000 U / L ~ approx. 2000 U / L; approx. 1000 U / L ~ approx. 1900 U / L;Approx. 1000U / L ~ Approx. 1800U / L; Approx. 1000U / L ~ Approx. 1700U / L; Approx. 1000U / L ~ Approx. 1600U / L; Approx. 1000U / L ~ Approx. 1500U / L; Approx. 1000U / L L ~ Approx. 1400U / L; Approx. 1000U / L ~ Approx. 1300U / L; Approx. 1000U / L ~ Approx. 1200U / L; Approx. 1000U / L ~ Approx. 1100U / L; Approx. 500U / L ~ Approx. 1900U / L; about 600 U / L to about 1800 U / L; about 700 U / L to about 1700 U / L; about 800 U / L to about 1600 U / L; about 900 U / L to about 1600 U / L; about 1000 U / L to about 1600 U / L; about 1200 U / L to about 1600 U / L; about 1300 U / L to about 1600 U / L; or about 1400 U / L to about 1600 U / L;

[0041] In some embodiments, amylase is present in the cleaning composition in an amount of at least about 50 U / L, at least about 60 U / L, at least about 70 U / L, at least about 80 U / L, at least about 90 U / L, at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, at least about 7000 U / L, or at least about 8000 U / L.

[0042] In some embodiments, the amylase is 50 U / L, 100 U / L, 200 U / L, 300 U / L, 400 U / L, 500 U / L, 600 U / L, 700 U / L, 800 U / L, 900 U / L, 1000 U / L, 1100 U / L, 1200 U / L, 1300 U / L, 1400 U / L, 1500 U / L, 1600 U / L, 1700 U / L, 1800 U / L, 1900 U / L, 2000 U / L, 2100 U / L, 2200 U / L, 2300 U / L, 2400 U / L, 2500 U / L, 2600 U / L , 2700U / L, 2800U / L, 2900U / L, 3000U / L, 3100U / L, 3200U / L, 3300U / L, 3400U / L, 3500U / L, 3600U / L, 3700U / L, 3800U / L, 3900U / L, 4000U / L, 4100U / L, 4200U / L, 4300U / L, 4400U / L, 4500U / L, 4600U / L, 4700U / L, 4800U / L, 4900U / L, 5000U / L, 6000U / L, and 7000U / L. and 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L, 800U / L, 900U / L, 1000U / L, 1100U / L, 1200U / L, 1300U / L, 1400U / L, 1500U / L, 1600U / L, 1700U / L, 1800U / L, 1900U / L, 2000U / L, 2100U / L, 2200U / L, 2300U / L, 2400U / L, 2500U / L, 2600U / L, 2700U / L, 2800U / L, 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 6000 U / L, 7000 U / L, and 8000 U / L.

[0043] In some embodiments, the amylase is from about 50 U / L to about 8000 U / L; from about 50 U / L to about 7000 U / L; from about 50 U / L to about 6000 U / L; from about 50 U / L to about 5000 U / L; from about 50 U / L to about 4000 U / L; from about 50 U / L to about 3000 U / L; from about 50 U / L to about 2000 U / L; from about 50 U / L to about 5000 U / L Approx. 1000U / L; Approx. 50U / L ~ Approx. 900U / L; Approx. 50U / L ~ Approx. 800U / L; Approx. 50U / L ~ Approx. 700U / L; Approx. 50U / L ~ Approx. 600U / L ;Approx. 50U / L~Approx. 500U / L;Approx. 50U / L~Approx. 400U / L;Approx. 50U / L~Approx. 300U / L;Approx. 50U / L~Approx. 200U / L;Approx. 50U / L~Approx. 100U / L; Approx. 70U / L ~ Approx. 800U / L; Approx. 100U / L ~ Approx. 8000U / L; Approx. 200U / L ~ Approx. 7000U / L; Approx. 300U / L ~ Approx. 600 0U / L; Approx. 400U / L ~ Approx. 5000U / L; Approx. 500U / L ~ Approx. 4000U / L; Approx. 600U / L ~ Approx. 3000U / L; Approx. 700U / L ~ Approx. 2000 U / L; about 800 U / L to about 1000 U / L; about 500 U / L to about 2000 U / L; about 500 U / L to about 1500 U / L; about 500 U / L to about 1000 U / L; about 600 U / L to about 1000 U / L; about 600 U / L to about 900 U / L; or about 600 U / L to about 800 U / L.

[0044] In some embodiments, the cleaning composition comprises trypsin, which may be present in the cleaning composition in an amount of at least about 50 U / L, at least about 60 U / L, at least about 70 U / L, at least about 80 U / L, at least about 90 U / L, at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, at least about 7000 U / L, or at least about 8000 U / L.

[0045] In some embodiments, trypsin is 50 U / L, 100 U / L, 200 U / L, 300 U / L, 400 U / L, 500 U / L, 600 U / L, 700 U / L, 800 U / L, 900 U / L, 1000 U / L, 1100 U / L, 1200 U / L, 1300 U / L, 1400 U / L, 1500 U / L, 1600 U / L, 1700 U / L, 1800 U / L, 1900 U / L, 2000 U / L, 2100 U / L, 2200 U / L, 2300 U / L, 2400 U / L, 2500 U / L, 2600 U / L , 2700U / L, 2800U / L, 2900U / L, 3000U / L, 3100U / L, 3200U / L, 3300U / L, 3400U / L, 3500U / L, 3600U / L, 3700U / L, 3800U / L, 3900U / L, 4000U / L, 4100U / L, 4200U / L, 4300U / L, 4400U / L, 4500U / L, 4600U / L, 4700U / L, 4800U / L, 4900U / L, 5000U / L, 6000U / L, and 7000U / L. and 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L, 800U / L, 900U / L, 1000U / L, 1100U / L, 1200U / L, 1300U / L, 1400U / L, 1500U / L, 1600U / L, 1700U / L, 1800U / L, 1900U / L, 2000U / L, 2100U / L, 2200U / L, 2300U / L, 2400U / L, 2500U / L, 2600U / L, 2700U / L, 2800U / L, 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 6000 U / L, 7000 U / L, and 8000 U / L.

[0046] In some embodiments, trypsin is from about 50 U / L to about 8000 U / L; from about 50 U / L to about 7000 U / L; from about 50 U / L to about 6000 U / L; from about 50 U / L to about 5000 U / L; from about 50 U / L to about 4000 U / L; from about 50 U / L to about 3000 U / L; from about 50 U / L to about 2000 U / L; from about 50 U / L to about 5000 U / L Approx. 1000U / L; Approx. 50U / L ~ Approx. 900U / L; Approx. 50U / L ~ Approx. 800U / L; Approx. 50U / L ~ Approx. 700U / L; Approx. 50U / L ~ Approx. 600U / L ;Approx. 50U / L~Approx. 500U / L;Approx. 50U / L~Approx. 400U / L;Approx. 50U / L~Approx. 300U / L;Approx. 50U / L~Approx. 200U / L;Approx. 50U / L~Approx. 100U / L; Approx. 70U / L ~ Approx. 800U / L; Approx. 100U / L ~ Approx. 8000U / L; Approx. 200U / L ~ Approx. 7000U / L; Approx. 300U / L ~ Approx. 600 0U / L; Approx. 400U / L ~ Approx. 5000U / L; Approx. 500U / L ~ Approx. 4000U / L; Approx. 600U / L ~ Approx. 3000U / L; Approx. 700U / L ~ Approx. 2000 U / L; about 800 U / L to about 1000 U / L; about 500 U / L to about 2000 U / L; about 500 U / L to about 1500 U / L; about 500 U / L to about 1000 U / L; about 600 U / L to about 1000 U / L; about 600 U / L to about 900 U / L; or about 600 U / L to about 800 U / L.

[0047] In some embodiments, the cleaning composition comprises pepsin, which may be present in the cleaning composition in an amount of at least about 50 U / L, at least about 60 U / L, at least about 70 U / L, at least about 80 U / L, at least about 90 U / L, at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, at least about 7000 U / L, or at least about 8000 U / L.

[0048] In some embodiments, pepsin is 50 U / L, 100 U / L, 200 U / L, 300 U / L, 400 U / L, 500 U / L, 600 U / L, 700 U / L, 800 U / L, 900 U / L, 1000 U / L, 1100 U / L, 1200 U / L, 1300 U / L, 1400 U / L, 1500 U / L, 1600 U / L, 1700 U / L, 1800 U / L, 1900 U / L, 2000 U / L, 2100 U / L, 2200 U / L, 2300 U / L, 2400 U / L, 2500 U / L, 2600 U / L, If the lower limit is selected from 2700U / L, 2800U / L, 2900U / L, 3000U / L, 3100U / L, 3200U / L, 3300U / L, 3400U / L, 3500U / L, 3600U / L, 3700U / L, 3800U / L, 3900U / L, 4000U / L, 4100U / L, 4200U / L, 4300U / L, 4400U / L, 4500U / L, 4600U / L, 4700U / L, 4800U / L, 4900U / L, 5000U / L, 6000U / L, and 7000U / L, and 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L, 800U / L, 900U / L, 1000U / L, 1100U / L, 1200U / L, 1300U / L, 1400U / L, 1500U / L, 1600U / L, 1700U / L, 1800U / L, 1900U / L, 2000U / L, 2100U / L, 2200U / L, 2300U / L, 2400U / L, 2500U / L, 2600U / L, 2700U / L, 2800U / L, 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 6000 U / L, 7000 U / L, and 8000 U / L.

[0049] In some embodiments, pepsin is from about 50 U / L to about 8000 U / L; from about 50 U / L to about 7000 U / L; from about 50 U / L to about 6000 U / L; from about 50 U / L to about 5000 U / L; from about 50 U / L to about 4000 U / L; from about 50 U / L to about 3000 U / L; from about 50 U / L to about 2000 U / L; from about 50 U / L to about 1000U / L; about 50U / L to about 900U / L; about 50U / L to about 800U / L; about 50U / L to about 700U / L; about 50U / L to about 600U / L; Approx. 50U / L ~ Approx. 500U / L; Approx. 50U / L ~ Approx. 400U / L; Approx. 50U / L ~ Approx. 300U / L; Approx. 50U / L ~ Approx. 200U / L; Approx. 50U / L ~ Approx. 1 00U / L; Approx. 70U / L ~ Approx. 800U / L; Approx. 100U / L ~ Approx. 8000U / L; Approx. 200U / L ~ Approx. 7000U / L; Approx. 300U / L ~ Approx. 6000 U / L; Approx. 400U / L ~ Approx. 5000U / L; Approx. 500U / L ~ Approx. 4000U / L; Approx. 600U / L ~ Approx. 3000U / L; Approx. 700U / L ~ Approx. 2000 U / L; about 800 U / L to about 1000 U / L; about 500 U / L to about 2000 U / L; about 500 U / L to about 1500 U / L; about 500 U / L to about 1000 U / L; about 600 U / L to about 1000 U / L; about 600 U / L to about 900 U / L; or about 600 U / L to about 800 U / L.

[0050] In some embodiments, the cleaning composition comprises pseudocholinesterase (PCHE), which may be present in the cleaning composition in an amount of at least about 1 U / mL, at least about 10 U / mL, at least about 20 U / mL, at least about 30 U / mL, at least about 40 U / mL, at least about 50 U / mL, at least about 60 U / mL, at least about 70 U / mL, at least about 80 U / mL, at least about 90 U / mL, at least about 100 U / mL, at least about 110 U / mL, at least about 120 U / mL, at least about 130 U / mL, at least about 140 U / mL, at least about 150 U / mL, at least about 160 U / mL, at least about 170 U / mL, at least about 180 U / mL, at least about 190 U / mL, or at least about 200 U / mL.

[0051] In some embodiments, the PCHE has a lower limit selected from 1 U / mL, 10 U / mL, 20 U / mL, 30 U / mL, 40 U / mL, 50 U / mL, 60 U / mL, 70 U / mL, 80 U / mL, 90 U / mL, 100 U / mL, 110 U / mL, 120 U / mL, 130 U / mL, 140 U / mL, 150 U / mL, 160 U / mL, 170 U / mL, 180 U / mL, or 190 U / mL, and a lower limit selected from 5 U / mL, 10 U / mL, 20 U / mL, 30 U / mL, 40 U / mL, 50 U / mL, 60 U / mL, 70 U / mL, 80 U / mL, 90 U / mL, 100 U / mL, 110 U / mL, 120 U / mL, 130 U / mL, 140 U / mL, 150 U / mL, 160 U / mL, 170 U / mL, 180 U / mL, or 190 U / mL. U / mL, 10 U / mL, 20 U / mL, 30 U / mL, 40 U / mL, 50 U / mL, 60 U / mL, 70 U / mL, 80 U / mL, 90 U / mL, 100 U / mL, 110 U / mL, 120 U / mL, 130 U / mL, 140 U / mL, 150 U / mL, 160 U / mL, 170 U / mL, 180 U / mL, 190 U / mL, or 200 U / mL.

[0052] In some embodiments, PCHE is from about 1 U / mL to about 200 U / mL; from about 1 U / mL to about 190 U / mL; from about 1 U / mL to about 180 U / mL; from about 1 U / mL to about 170 U / mL; from about 1 U / mL to about 160 U / mL; from about 1 U / mL to about 150 U / mL; from about 1 U / mL to about 140 U / mL; from about 1 U / mL to about 130 U / mL; from about 1 U / mL to about 120U / mL; about 1U / mL to about 110U / mL; about 1U / mL to about 100U / mL; about 1U / mL to about 90U / mL; about 1U / mL to about 80U / mL; about 1U / m L~about 70U / mL;about 1U / mL~about 60U / mL;about 1U / mL~about 50U / mL;about 1U / mL~about 40U / mL;about 1U / mL~about 30U / mL;about 1U / mL ~20U / mL;1U / mL~10U / mL;5U / mL~170U / mL;10U / mL~160U / mL;20U / mL~150U / mL 30U / mL~Approx. 140U / mL; Approx. 40U / mL~Approx. 130U / mL; Approx. 50U / mL~Approx. 120U / mL; Approx. 60U / mL~Approx. 110U / mL; Approx. 70U / mL~Approx. It is present in the cleaning composition in an amount of 100 U / mL; about 10 U / mL to about 90 U / mL; about 10 U / mL to about 80 U / mL; about 10 U / mL to about 70 U / mL; about 10 U / mL to about 60 U / mL; about 10 U / mL to about 50 U / mL; about 10 U / mL to about 40 U / mL; about 10 U / mL to about 30 U / mL; or about 10 U / mL to about 20 U / mL.

[0053] In some embodiments, the cleaning composition comprises gamma-glutamyl transpeptidase (GGT). GGT may be present in the cleaning composition in an amount of at least about 50 U / L, at least about 60 U / L, at least about 70 U / L, at least about 80 U / L, at least about 90 U / L, at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, at least about 7000 U / L, at least about 8000 U / L, or at least about 9000 U / L.

[0054] In some embodiments, GGT is 50 U / L, 100 U / L, 200 U / L, 300 U / L, 400 U / L, 500 U / L, 600 U / L, 700 U / L, 800 U / L, 900 U / L, 1000 U / L, 1100 U / L, 1200 U / L, 1300 U / L, 1400 U / L, 1500 U / L, 1600 U / L, 1700 U / L, 1800 U / L, 1900 U / L, 2000 U / L, 2100 U / L, 2200 U / L, 2300 U / L, 2400 U / L, 2500 U / L, 2600 U / L, 2700 U / L, 2800 U / L, 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 5100 U / L, 5200 U / L, 5300 U / L, 5400 U / L, 5500 U / L, 5600 U / L, 5 / L, 2800U / L, 2900U / L, 3000U / L, 3100U / L, 3200U / L, 3300U / L, 3400U / L, 3500U / L, 3600U / L, 3700U / L, 3800U / L, 3900U / L, 4000U / L, 4100U / L, 4200U / L, 4300U / L, 4400U / L, 4500U / L, 4600U / L, 4700U / L, 4800U / L, 4900U / L, 5000U / L, 6000U / L, 7000U / L, and 8000U / L, if the lower limit is selected from and 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L, 800U / L, 900U / L, 1000U / L, 1100U / L, 1200U / L, 1300U / L, 1400U / L, 1500U / L , 1600U / L, 1700U / L, 1800U / L, 1900U / L, 2000U / L, 2100U / L, 2200U / L, 2300U / L, 2400U / L, 2500U / L, 2600U / L, 2700U / L, 2800U / L, 2900U / L, and 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 6000 U / L, 7000 U / L, 8000 U / L, and 9000 U / L.

[0055] In some embodiments, GGT is between about 50 U / L and about 9000 U / L; 50 U / L and about 8000 U / L; between about 50 U / L and about 7000 U / L; between about 50 U / L and about 6000 U / L; between about 50 U / L and about 5000 U / L; between about 50 U / L and about 4000 U / L; between about 50 U / L and about 3000 U / L; between about 50 U / L and about 2000 U / L; between about 50 U / L and about 1000 U / L ;Approx. 50U / L~Approx. 900U / L;Approx. 80U / L~Approx. 875U / L;Approx. 50U / L~Approx. 800U / L;Approx. 50U / L~Approx. 700U / L;Approx. 50U / L~Approx. 600U / L;Approx. 5 0U / L~Approx. 500U / L; Approx. 50U / L~Approx. 400U / L; Approx. 50U / L~Approx. 300U / L; Approx. 50U / L~Approx. 200U / L; Approx. 50U / L~Approx. 100U / L; 100U / L ~Approx. 8000U / L; Approx. 200U / L ~ Approx. 7000U / L; Approx. 300U / L ~ Approx. 6000U / L; Approx. 400U / L ~ Approx. 5000U / L; Approx. 500U / L ~ Approx. 4000U / L; Approx. 600U / L ~ Approx. 3000U / L; Approx. 700U / L ~ Approx. 2000U / L; Approx. 800U / L ~ Approx. 1000U / L; Approx. 500U / L ~ Approx. 9000U / L; Approx. 500U / L ~ Approx. 80 about 500 U / L to about 7000 U / L; about 500 U / L to about 6000 U / L; about 500 U / L to about 5000 U / L; about 500 U / L to about 4000 U / L; about 500 U / L to about 3000 U / L; about 500 U / L to about 2000 U / L; about 500 U / L to about 1000 U / L; or about 600 U / L to about 900 U / L.

[0056] In some embodiments, the cleaning composition includes lactate dehydrogenase (LDH), which may be present in the cleaning composition in an amount of at least about 50 U / L, at least about 60 U / L, at least about 70 U / L, at least about 80 U / L, at least about 90 U / L, at least about 100 U / L, at least about 200 U / L, at least about 300 U / L, at least about 400 U / L, at least about 500 U / L, at least about 600 U / L, at least about 700 U / L, at least about 800 U / L, at least about 900 U / L, at least about 1000 U / L, at least about 2000 U / L, at least about 3000 U / L, at least about 4000 U / L, at least about 5000 U / L, at least about 6000 U / L, or at least about 7000 U / L.

[0057] In some embodiments, LDH is 50 U / L, 100 U / L, 200 U / L, 300 U / L, 400 U / L, 500 U / L, 600 U / L, 700 U / L, 800 U / L, 900 U / L, 1000 U / L, 1100 U / L, 1200 U / L, 1300 U / L, 1400 U / L, 1500 U / L, 1600 U / L, 1700 U / L, 1800 U / L, 1900 U / L, 2000 U / L, 2100 U / L, 2200 U / L, 2300 U / L, 2400 U / L, 2500 U / L, 2600 U / L, 2700 U / L, 2800 U / L, 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 5100 U / L, 5200 U / L, 5300 U / L, 5400 U / L, 5500 U / L, 5600 U / L, 5 / L, 2700U / L, 2800U / L, 2900U / L, 3000U / L, 3100U / L, 3200U / L, 3300U / L, 3400U / L, 3500U / L, 3600U / L, 3700U / L, 3800U / L, 3900U / L, 4000U / L, 4100U / L, 4200U / L, 4300U / L, 4400U / L, 4500U / L, 4600U / L, 4700U / L, 4800U / L, 4900U / L, 5000U / L, and 6000U / L, if and 100U / L, 200U / L, 300U / L, 400U / L, 500U / L, 600U / L, 700U / L, 800U / L, 900U / L, 1000U / L, 1100U / L, 1200U / L, 1300U / L, 1400U / L, 150 0U / L, 1600U / L, 1700U / L, 1800U / L, 1900U / L, 2000U / L, 2100U / L, 2200U / L, 2300U / L, 2400U / L, 2500U / L, 2600U / L, 2700U / L, 2800U / L, and present in an amount within a range having an upper limit selected from 2900 U / L, 3000 U / L, 3100 U / L, 3200 U / L, 3300 U / L, 3400 U / L, 3500 U / L, 3600 U / L, 3700 U / L, 3800 U / L, 3900 U / L, 4000 U / L, 4100 U / L, 4200 U / L, 4300 U / L, 4400 U / L, 4500 U / L, 4600 U / L, 4700 U / L, 4800 U / L, 4900 U / L, 5000 U / L, 6000 U / L, and 7000 U / L.

[0058] In some embodiments, the LDH is about 50 U / L to about 7000 U / L; about 50 U / L to about 6000 U / L; about 50 U / L to about 5000 U / L; about 50 U / L to about 3000 U / L; U / L~about 1000U / L;about 50U / L~about 900U / L;about 50U / L~about 800U / L;about 50U / L~about 700U / L;about 60U / L~about 700U / L;about 50U / L~about 600U / L;about 50U / L~about 500U / L;about 50U / L~about 400U / L; about 50U / L to about 300U / L; about 50U / L to about 200U / L; about 50U / L to about 100U / L; 100U / L to about 7000U / L; about 200U / L to about 6000U / L; about 300U / L to about 5000U / L; about 400U / L to about 4000U / L; about 500U / L to about 3000U / L; about 500U / L to about 2000U / L; about 500U / L to about 1000U / L; about 600U / L to about 900U / L; about 600U / L to about 800U / L; or about 600U / L to about 700U / L.

[0059] In some embodiments, the cleaning composition comprises:

[0060] [Table 1]

[0061] In some embodiments, the cleaning composition includes magnesium chloride hexahydrate. Magnesium chloride hexahydrate is available in concentrations of 0.001 g / L, 0.002 g / L, 0.003 g / L, 0.004 g / L, 0.005 g / L, 0.006 g / L, 0.007 g / L, 0.008 g / L, 0.009 g / L, 0.01 g / L, 0.02 g / L, 0.03 g / L, 0.04 g / L, 0.05 g / L, 0.06 g / L, a lower limit selected from 0.07g / L, 0.08g / L, 0.09g / L, 0.1g / L, 0.2g / L, 0.3g / L, 0.4g / L, 0.5g / L, 0.6g / L, 0.7g / L, 0.8g / L, 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L, and 5.0g / L, and 002g / L, 0.003g / L, 0.004g / L, 0.005g / L, 0.006g / L, 0.007g / L, 0.008g / L, 0.009g / L, 0 .01g / L, 0.02g / L, 0.03g / L, 0.04g / L, 0.05g / L, 0.06g / L, 0.07g / L, 0.08g / L, 0.09g / L, It may be present in the cleaning composition in an amount within a range having an upper limit selected from 0.1 g / L, 0.2 g / L, 0.3 g / L, 0.4 g / L, 0.5 g / L, 0.6 g / L, 0.7 g / L, 0.8 g / L, 0.9 g / L, 1.0 g / L, 2.0 g / L, 3.0 g / L, 4.0 g / L, 5.0 g / L, and 6.0 g / L. For example, in some embodiments, magnesium chloride hexahydrate may be present in an amount of from about 0.0001 g / L to about 6.0 g / L; from about 0.001 g / L to about 6.0 g / L; from about 0.01 g / L to about 6.0 g / L; from about 0.1 g / L to about 6.0 g / L; from about 0.1 g / L to about 5.0 g / L; from about 0.1 g / L to about 4.0 g / L; from about 0.1 g / L to about 3.0 g / L; from about 0.1 g / L to about 2.0 g / L; from about 0.1 g / L to about 1.0 g / L; from about 0.1 g / L to about 0.9g / L; about 0.2g / L~about 0.8g / L;about 0.3g / L~about 0.7g / L;about 0.4g / L~about 0.6g / L;about 0.4g / L~about 0.5g / L;about 0.04g / L~about 0.1g / L;about 0.04g / L to about 0.95 g / L; about 0.04 g / L to about 0.85 g / L; about 0.04 g / L to about 0.75 g / L; about 0.04 g / L to about 0.65 g / L; or about 0.04 g / L to about 0.55 g / L.

[0062] In some embodiments, the cleaning composition includes zinc chloride. Zinc chloride may be present in the range of 0.001 mg / L, 0.002 mg / L, 0.003 mg / L, 0.004 mg / L, 0.005 mg / L, 0.006 mg / L, 0.007 mg / L, 0.008 mg / L, 0.009 mg / L, 0.01 mg / L, 0.02 mg / L, 0.03 mg / L, 0.04 mg / L, 0.05 mg / L, 0.06 mg / L, 0.07 mg / L, 0.08 mg / L, 0.09 mg / L, 0.1 mg / L, 0.2 mg / L, 0.3 mg / L, 0.4 mg / L, 0.5 mg / L, 0.6 mg / L, 0. a lower limit selected from 0.7mg / L, 0.8mg / L, 0.9mg / L, 1.0mg / L, 2.0mg / L, 3.0mg / L, 4.0mg / L, 5.0mg / L, 10mg / L, 20mg / L, 30mg / L, 40mg / L, 50mg / L, 60mg / L, 70mg / L, 80mg / L, 90mg / L, 100mg / L, 110mg / L, 120mg / L, 130mg / L, 140mg / L, 150mg / L, 160mg / L, 170mg / L, 180mg / L and 190mg / L, and 0.002m g / L, 0.003mg / L, 0.004mg / L, 0.005mg / L, 0.006mg / L, 0.007mg / L, 0.008mg / L, 0.009mg / L, 0.01mg / L, 0.02mg / L, 0.03mg / L, 0.04mg / L, 0.0 5mg / L, 0.06mg / L, 0.07mg / L, 0.08mg / L, 0.09mg / L, 0.1mg / L, 0.2mg / L, 0.3mg / L, 0.4mg / L, 0.5mg / L, 0.6mg / L, 0.7mg / L, 0.8mg / L, 0.9mg / L, It may be present in the cleaning composition in an amount within a range having an upper limit selected from 1.0 mg / L, 2.0 mg / L, 3.0 mg / L, 4.0 mg / L, 5.0 mg / L, 10 mg / L, 20 mg / L, 30 mg / L, 40 mg / L, 50 mg / L, 60 mg / L, 70 mg / L, 80 mg / L, 90 mg / L, 100 mg / L, 110 mg / L, 120 mg / L, 130 mg / L, 140 mg / L, 150 mg / L, 160 mg / L, 170 mg / L, 180 mg / L, 190 mg / L and 200 mg / L.For example, in some embodiments, zinc chloride may be present in an amount of from about 0.001 mg / L to about 200.0 mg / L; from about 0.01 mg / L to about 200.0 mg / L; from about 0.1 g / L to about 200.0 mg / L; from about 1.0 mg / L to about 200 mg / L; from about 1.0 mg / L to about 100 mg / L; from about 1.0 mg / L to about 80 mg / L; from about 1.0 mg / L to about 60 mg / L; from about 1.0 mg / L to about 40 mg / L; from about 1.0 mg / L to about 20 mg / L; It may be present in an amount of from 2.0 mg / L to about 19 mg / L; from about 3.0 mg / L to about 18 mg / L; from about 4.0 mg / L to about 17 mg / L; from about 5.0 mg / L to about 16 mg / L; from about 10.0 mg / L to about 20 mg / L; from about 11.0 mg / L to about 20 mg / L; from about 12.0 mg / L to about 20 mg / L; from about 13.0 mg / L to about 20 mg / L; from about 14.0 mg / L to about 20 mg / L; or from about 15.0 mg / L to about 20 mg / L.

[0063] In some embodiments, the cleaning composition includes HEPES (acid). HEPES (acid) is available in the following concentrations: 0.001 g / L, 0.002 g / L, 0.003 g / L, 0.004 g / L, 0.005 g / L, 0.006 g / L, 0.007 g / L, 0.008 g / L, 0.009 g / L, 0.01 g / L, 0.02 g / L, 0.03 g / L, 0.04 g / L, 0.05 g / L, 0.06 g / L, 0.07 g / L, 0.08 g / L, 0.09 g / L, 0.1 g / L, 0.2 g / L, 0.3 g / L, 0.4 g / L, 0.5 g / L, 0.6 g / L, 0. ... a lower limit selected from 0.8g / L, 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L, 5.0g / L, 6.0g / L, 7.0g / L, 8.0g / L, 9.0g / L, 10.0g / L, 20.0g / L, 30.0g / L, 40.0g / L, 50.0g / L, 60.0g / L, 70.0g / L, 80.0g / L, 90.0g / L, 100.0g / L, 110.0g / L, 120.0g / L, 130.0g / L and 140.0g / L, and g / L, 0.003g / L, 0.004g / L, 0.005g / L, 0.006g / L, 0.007g / L, 0.008g / L, 0.009g / L, 0.01g / L, 0.02g / L, 0.03g / L, 0.04g / L, 0.05g / L , 0.06g / L, 0.07g / L, 0.08g / L, 0.09g / L, 0.1g / L, 0.2g / L, 0.3g / L, 0.4g / L, 0.5g / L, 0.6g / L, 0.7g / L, 0.8g / L, 0.9g / L, 1.0g / L, 2.0g 10.0g / L, 110.0g / L, 120.0g / L, 130.0g / L, 140.0g / L and 150.0g / L.For example, in some embodiments, HEPES (acid) may be present in a concentration of about 0.0001 g / L to about 150.0 g / L; about 0.001 g / L to about 150.0 g / L; about 0.01 g / L to about 150.0 g / L; about 0.1 g / L to about 150.0 g / L; about 1.0 g / L to about 150.0 g / L, about 1.0 g / L to about 140.0 g / L; about 1.0 g / L to about 120.0 g / L; about 1.0 g / L to about 100.0 g / L; about 1.0 g / L to about 80.0 g / L; about 1.0 g / L to about 60.0 g / L; about 1.0 g / L to about 40.0 g / L; about 1.0 g / L to about 20.0 g / L; about 1. about 1.0g / L to about 19.0g / L; about 1.0g / L to about 18.0g / L; about 1.0g / L to about 17.0g / L; about 1.0g / L to about 16.0g / L; about 1.0g / L to about 14.0g / L; about 1.0g / L to about 13.0g / L; about 1.0g / L to about 12.0g / L; about 1.0g / L to about 11.0g / L; about 10.0g / L to about 20.0g / L; about 10.0g / L to about 15.0g / L, about 10.0g / L to about 14.0g / L; about 10.0g / L to about 13.0g / L; about 10.0g / L to about 12.0g / L; or about 10g / L to about 11g / L.

[0064] In some embodiments, the cleaning composition comprises sodium HEPES. Sodium HEPES is present in the following concentrations: 0.001 g / L, 0.002 g / L, 0.003 g / L, 0.004 g / L, 0.005 g / L, 0.006 g / L, 0.007 g / L, 0.008 g / L, 0.009 g / L, 0.01 g / L, 0.02 g / L, 0.03 g / L, 0.04 g / L, 0.05 g / L, 0.06 g / L, 0.07 g / L, 0.08 g / L, 0.09 g / L, 0.1 g / L , a lower limit selected from 0.2g / L, 0.3g / L, 0.4g / L, 0.5g / L, 0.6g / L, 0.7g / L, 0.8g / L, 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L, 5.0g / L, 6.0g / L, 7.0g / L, 8.0g / L, 9.0g / L, 10.0g / L, 20.0g / L, 30.0g / L and 40.0g / L, and 0.00 2g / L, 0.003g / L, 0.004g / L, 0.005g / L, 0.006g / L, 0.007g / L, 0.008g / L, 0.009g / L, 0.01g / L, 0.02g / L, 0 .03g / L, 0.04g / L, 0.05g / L, 0.06g / L, 0.07g / L, 0.08g / L, 0.09g / L, 0.1g / L, 0.2g / L, 0.3g / L, 0.4g / L, 0.5 g / L, 0.6 g / L, 0.7 g / L, 0.8 g / L, 0.9 g / L, 1.0 g / L, 2.0 g / L, 3.0 g / L, 4.0 g / L, 5.0 g / L, 6.0 g / L, 7.0 g / L, 8.0 g / L, 9.0 g / L, 10.0 g / L, 20.0 g / L, 30.0 g / L, 40.0 g / L and 50.0 g / L.For example, in some embodiments, HEPES sodium is present in an amount of from about 0.0001 g / L to about 50.0 g / L; from about 0.001 g / L to about 50.0 g / L; from about 0.01 g / L to about 50.0 g / L; from about 0.1 g / L to about 50.0 g / L; from about 0.1 g / L to about 40.0 g / L; from about 0.1 g / L to about 30.0 g / L; from about 0.1 g / L to about 20.0 g / L; from about 0.1 g / L to about 15.0 g / L; from about 0.1 g / L to about 10.0 g / L L; from about 0.1 g / L to about 5.0 g / L; from about 0.25 g / L to about 5.0 g / L; from about 0.25 g / L to about 4.5 g / L; from about 0.25 g / L to about 4.0 g / L; from about 0.25 g / L to about 3.5 g / L; from about 0.25 g / L to about 3.0 g / L; from about 1.0 g / L to about 10.0 g / L; from about 1.0 g / L to about 5.0 g / L; from about 1.0 g / L to about 4.0 g / L, or from about 1.0 g / L to about 3.5 g / L.

[0065] In some embodiments, the cleaning composition includes streptomycin sulfate and / or gentamicin sulfate at concentrations of 0.01 g / L, 0.02 g / L, 0.03 g / L, 0.04 g / L, 0.05 g / L, 0.06 g / L, 0.07 g / L, 0.08 g / L, 0.09 g / L, 0.1 g / L, 0.2 g / L, 0.3 g / L, 0.4 g / L, 0.5 g / L, 0.6 g / L, 0.7 g / L, 0.8 g / L, Lower limit selected from 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L, 5.0g / L, 6.0g / L, 7.0g / L, 8.0g / L, 9.0g / L, 10.0g / L, 11.0g / L, 12.0g / L, 13.0g / L, 14.0g / L, 15.0g / L, 16.0g / L, 17.0g / L, 18.0g / L and 19.0g / L , and 0.02g / L, 0.03g / L, 0.04g / L, 0.05g / L, 0.06g / L, 0.07g / L, 0.08g / L, 0.09g / L, 0.1g / L, 0.2 g / L, 0.3g / L, 0.4g / L, 0.5g / L, 0.6g / L, 0.7g / L, 0.8g / L, 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L , 5.0g / L, 6.0g / L, 7.0g / L, 8.0g / L, 9.0g / L, 10.0g / L, 11.0g / L, 12.0g / L, 13.0g / L, 14.0g / L, 15.0g / L, 16.0g / L, 17.0g / L, 18.0g / L, 19.0g / L and 20.0g / L.For example, in some embodiments, streptomycin sulfate and / or gentamicin sulfate are present at concentrations of about 0.01 g / L to about 20.0 g / L; about 0.01 g / L to about 10.0 g / L; about 0.01 g / L to about 9.0 g / L; about 0.01 g / L to about 8.0 g / L; about 0.01 g / L to about 7.0 g / L; about 0.01 g / L to about 6.0 g / L; about 0.01 g / L to about 5.0 g / L; about 0.01 g / L to about 4.0 g / L; about 0.01 g / L to about 3.0 g / L; about 0.01 g / L to about 2.0 g / L; about 0.01 g / L to about 1.0 g / L; or about 0.01 g / L to about 0. 9g / L; from about 0.01g / L to about 0.8g / L; from about 0.01g / L to about 0.7g / L; from about 0.01g / L to about 0.6g / L; from about 0.01g / L to about 0.5g / L; from about 0.01g / L to about 0.4g / L; from about 0.01g / L to about 0.3g / L; from about 0.01g / L to about 0.2g / L; from about 0.01g / L to about 0.15g / L; from about 0.10g / L to about 0.15g / L; from about 0.11g / L to about 0.15g / L; from about 0.11g / L to about 0.14g / L; from about 0.11g / L to about 0.13g / L; or from about 0.11g / L to about 0.12g / L.

[0066] In some embodiments, the cleaning composition comprises amphotericin B. Amphotericin B may be present in the cleaning composition in an amount within a range having a lower limit selected from 2.5 mg / L, 3.0 mg / L, 4.0 mg / L, 5.0 mg / L, 10 mg / L, 20 mg / L, 30 mg / L, 40 mg / L, 50 mg / L, 60 mg / L, 70 mg / L, 80 mg / L, 90 mg / L, 100 mg / L, 150 mg / L, 200 mg / L and 250 mg / L and an upper limit selected from 3.0 mg / L, 4.0 mg / L, 5.0 mg / L, 10 mg / L, 20 mg / L, 30 mg / L, 40 mg / L, 50 mg / L, 60 mg / L, 70 mg / L, 80 mg / L, 90 mg / L, 100 mg / L, 150 mg / L, 200 mg / L, 250 mg / L and 300 mg / L. For example, in some embodiments, amphotericin B is present in an amount ranging from about 2.5 mg / L to about 300.0 mg / L; from about 2.5 mg / L to about 250.0 mg / L; from about 2.5 mg / L to about 200.0 mg / L; from about 2.5 mg / L to about 150.0 mg / L; from about 2.5 mg / L to about 100.0 mg / L; from about 2.5 mg / L to about 50.0 mg / L; from about 2.5 mg / L to about 40.0 mg / L; from about 2.5 mg / L to about 30.0 mg / L; from about 5 mg / L to about 200.0 mg / L; from about 5 mg / L to about 150.0 mg / L; from about 5 mg / L to about 100.0 mg / L; or from about 5 mg / L to about 200.0 mg / L. from about 10 mg / L to about 50.0 mg / L; from about 5 mg / L to about 40.0 mg / L; from about 5 mg / L to about 30.0 mg / L; from about 10 mg / L to about 200.0 mg / L; from about 10 mg / L to about 150.0 mg / L; from about 10 mg / L to about 100.0 mg / L; from about 10 mg / L to about 50.0 mg / L; from about 10 mg / L to about 40.0 mg / L; from about 10 mg / L to about 30.0 mg / L; from about 5 mg / L to about 90.0 mg / L; from about 5 mg / L to about 80.0 mg / L; from about 5 mg / L to about 70.0 mg / L; or from about 5 mg / L to about 60.0 mg / L.

[0067] In some embodiments, the cleaning composition comprises clotrimazole. Clotrimazole may be present in the cleaning composition in an amount within a range having a lower limit selected from 1.5 mg / L, 2.0 mg / L, 3.0 mg / L, 4.0 mg / L, 5.0 mg / L, 10 mg / L, 20 mg / L, 30 mg / L, 40 mg / L, 50 mg / L, 60 mg / L, 70 mg / L, 80 mg / L, 90 mg / L, 100 mg / L, 150 mg / L and 190 mg / L and an upper limit selected from 2.0 mg / L, 3.0 mg / L, 4.0 mg / L, 5.0 mg / L, 10 mg / L, 20 mg / L, 30 mg / L, 40 mg / L, 50 mg / L, 60 mg / L, 70 mg / L, 80 mg / L, 90 mg / L, 100 mg / L, 150 mg / L and 190 mg / L, and 200 mg / L. For example, in some embodiments, clotrimazole is present in an amount ranging from about 1.5 mg / L to about 200.0 mg / L; from about 1.5 mg / L to about 150.0 mg / L; from about 1.5 mg / L to about 100.0 mg / L; from about 1.5 mg / L to about 80.0 mg / L; from about 1.5 mg / L to about 60.0 mg / L; from about 1.5 mg / L to about 40.0 mg / L; from about 1.5 mg / L to about 20.0 mg / L; from about 5.0 mg / L to about 150.0 mg / L; from about 5.0 mg / L to about 100.0 mg / L; from about 5.0 mg / L to about 80.0 mg / L; from about 5.0 mg / L to about 60 0.0mg / L; about 5.0mg / L to about 40.0mg / L; about 10.0mg / L to about 100.0mg / L; about 10.0mg / L to about 80.0mg / L; about 10.0mg / L to about 60.0mg / L; about 10.0mg / L to about 40.0mg / L; about 10.0mg / L to about 20.0mg / L; about 15mg / L to about 20.0mg / L; about 16mg / L to about 20.0mg / L; about 17mg / L to about 20.0mg / L; about 17mg / L to about 19.0mg / L; or about 17mg / L to about 18.0mg / L.

[0068] In some embodiments, the cleaning composition comprises bovine albumin. Bovine albumin may be present in concentrations of 0.001 g / L, 0.002 g / L, 0.003 g / L, 0.004 g / L, 0.005 g / L, 0.006 g / L, 0.007 g / L, 0.008 g / L, 0.009 g / L, 0.01 g / L, 0.02 g / L, 0.03 g / L, 0.04 g / L, 0.05 g / L, 0.06 g / L, 0.07 g / L, 0.08 g / L, 0.09 g / L, 0.1 g / L, 0.2 g / L, 0.3 g / L, 0.4 g / L, 0.5 g / L, 0.6 g / L, 0.7 g / L, 0.8 g / L, 0.9 g / L, L, 1.0g / L, 2.0g / L, 3.0g / L, 4.0g / L, 5.0g / L, 10g / L, 20g / L, 30g / L, 40g / L, 50g / L, 60g / L, 70g / L, 80g / L, 90g / L, 100g / L, 110g / L, 120g / L, 130g / L, 140g / L, 150g / L, 160g / L, 170g / L, 180g / L, 190g / L, 200g / L, 300g / L, 400g / L, 500g / L, 600g / L and 700g / L, and a lower limit selected from 0.002g / L, 0.003g / L, 0.004g / L, 0.005g / L, 0.006g / L, 0.007mg / L, 0.008g / L, 0.009g / L, 0.01g / L, 0.02g / L, 0.03g / L, 0.04g / L, 0.05g / L, 0.06g / L, 0.07g / L, 0.08g / L, 0.09g / L, 0.1g / L, 0.2g / L, 0.3g / L, 0.4g / L, 0.5g / L, 0.6mg / L, 0.7g / L, 0.8g / L, 0.9g / L, 1.0g / L, 2.0g / L, 3.0g / L, It may be present in the cleaning composition in an amount within a range having an upper limit selected from 4.0g / L, 5.0g / L, 10g / L, 20g / L, 30g / L, 40g / L, 50g / L, 60g / L, 70g / L, 80g / L, 90g / L, 100g / L, 110g / L, 120g / L, 130g / L, 140g / L, 150g / L, 160g / L, 170g / L, 180g / L, 190g / L, 200g / L, 300g / L, 400g / L, 500g / L, 600g / L, 700g / L and 800g / L.For example, in some embodiments, bovine albumin may be present in concentrations ranging from about 0.001 g / L to about 800.0 g / L; from about 0.01 g / L to about 800.0 g / L; from about 0.1 g / L to about 800.0 g / L; from about 0.1 g / L to about 500.0 g / L; from about 1 g / L to about 500.0 g / L; from about 1 g / L to about 250.0 g / L; from about 1.0 g / L to about 100.0 g / L; from about 6 g / L to about 500.0 g / L; from about 6 g / L to about 2 50.0g / L; about 6.0g / L to about 100.0g / L; about 6.0g / L to about 95.0g / L; about 6.0g / L to about 90.0g / L; about 6.0g / L to about 85.0g / L; about 6.0g / L to about 80.0g / L; about 6.0g / L to about 75.0g / L; about 6.0g / L to about 70.0g / L; about 6.0g / L to about 65.0g / L; about 6.0g / L to about 60.0g / L; about 6.0g / L to about 50 .0g / L; Approx. 10g / L~Approx. 500.0g / L; Approx. 10g / L~Approx. 250.0g / L; Approx. 10.0g / L~Approx. 100.0g / L; Approx. 10.0g / L~Approx. 90.0g / L; Approx. 10.0g / L~ Approx. 80.0g / L; Approx. 10.0g / L ~ Approx. 70.0g / L; Approx. 10.0g / L ~ Approx. 60.0g / L; Approx. 10.0g / L ~ Approx. 50.0g / L; Approx. 20.0g / L ~ Approx. 100.0g / L; Approx. 30.0 g / L to about 100.0 g / L; about 40.0 g / L to about 100.0 g / L; about 50.0 g / L to about 100.0 g / L; about 60.0 g / L to about 100.0 g / L; about 50.0 g / L to about 90.0 g / L; about 60.0 g / L to about 90.0 g / L; about 60.0 g / L to about 80.0 g / L; about 60.0 g / L to about 70.0 g / L; or about 60.0 g / L to 75 g / L.

[0069] In some embodiments, the cleaning composition comprises:

[0070] [Table 2]

[0071] In some embodiments, the cleaning composition comprises:

[0072] [Table 3]

[0073] In some embodiments, the cleaning composition comprises:

[0074] [Table 4]

[0075] In some embodiments, the electrode subsystem is positioned within a clinical analyzer or a chemistry analyzer.

[0076] According to the present disclosure, an electrode subsystem can include one or more sensors. For example, an electrode subsystem can include one sensor, two sensors, three sensors, four sensors, or five sensors. When more than one sensor is present in an electrode subsystem, the sensors can be the same or different.

[0077] Suitable sensors that may be present in the electrode subsystem include, but are not limited to, electrolyte sensors, gas sensors, metabolite sensors, potentiometric sensors, amperometric sensors, optical sensors, conductivity sensors, and biosensors comprised of biomolecules such as enzymes, antibodies, peptides, nucleic acids, etc., independent of the analyte or substance being measured. In one embodiment, the sensor detects potassium ions (K + ), sodium ions (Na + ), chloride ions (Cl - ), bicarbonate ion (HCO3 - ), calcium ions (Ca 2+ ), magnesium ions (Mg 2+ ), ammonium (NH4 + ), and / or ion-selective sensors for sensing other species, including but not limited to pH levels.

[0078] The Integrated Multi-Sensor Technology (IMT) system creates a pattern of fluid and air slugs in the IMT manifold whenever it processes a sample or IMT Standards A and B during calibration. Each multi-sensor cartridge has an air pad to generate an air slug signal. The air reading signal is based on a conductivity measurement.

[0079] As samples are processed over time, deposits (proteins, lipids, etc.) may form on the IMT system, including the manifold, tubing, and / or sensor cartridge. This coating of deposits alters the surface of the air pads and affects conductivity measurements. Calibration failures related to IMT cleanliness are often observed with a significant reduction in air readings and a significant decrease in K slope, e.g., a K slope below 50 mV / dec.

[0080] All sensors have a useful life (sensor in-use life) during which the sensor calibration remains within acceptable standards (the sensor is functioning without calibration failures). Towards the end of the sensor's useful life, a significant reduction in air readings and / or a significant drop in K slope is observed.

[0081] In some embodiments, the use of the cleaning composition to clean the electrode subsystem extends the service life of the sensor. In some embodiments, the use of the cleaning composition to clean the electrode subsystem returns the air reading to baseline. In some embodiments, the use of the cleaning composition to clean the electrode subsystem results in an increase in the K slope.

[0082] In some embodiments, the sensor is used for at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 7 days, at least 8 days, at least 9 days, at least 10 days, at least 11 days, at least 12 days, at least 13 days, at least 14 days, at least 15 days, at least 16 days, at least 17 days, at least 18 days, at least 19 days, at least 20 days, at least 21 days, at least 22 days, at least 23 days, at least 24 days, at least 25 days, at least 26 days, at least 27 days, at least 28 days, at least 29 days, at least 30 days, at least 2 months, at least 3 months, at least 4 months, or more.

[0083] In some embodiments, the fluid flow channel comprises one or more of the tubes or passages of a manifold.

[0084] In some examples, the techniques described and illustrated herein include a method for cleaning an electrode subsystem in a chemical analyzer system. In some examples, the subsystem includes an inlet port, one or more sensors, an outlet port, and / or a fluid flow channel connecting the inlet port, one or more sensors, and the outlet port, although in other examples, the subsystem can include other components. The subsystem is also referred to herein as an integrated multisensor technology (IMT) system. Cleaning can include generating or providing a cleaning composition or solution that includes one or more cleaning enzymes (e.g., amylase and / or lipase), one or more pH adjusters, one or more matrix components, one or more buffer components, and / or one or more preservatives. In some examples, the sensor is an ion-selective sensor. The cleaning composition, also referred to herein as A-LYTE® IMT Cleaner, can have a pH range of about 7.2 to about 7.4, although other pHs can be used in other examples. In some examples, cleaning is performed as shown in Figures 8A-8D.

[0085] Cleaning can further include flowing a cleaning composition through the subsystem and / or flowing a rinse solution through the subsystem. Flowing a rinse solution is effective to remove residual cleaning composition from the subsystem. In addition, cleaning can also include calibrating a sensor to prepare for subsequent sample analysis. The following examples are presented to illustrate various aspects of the present technology, but are not intended to limit the scope of the claimed technology.

[0086] The following is a list of non-limiting exemplary embodiments disclosed herein.

[0087] Exemplary Embodiment 1. A method of cleaning an electrode subsystem, comprising: (a) providing a cleaning composition comprising: (i) one or more cleaning enzymes; (ii) one or more pH adjusters; (iii) one or more matrix components; (iv) one or more buffer components; and (v) one or more preservatives, wherein the cleaning composition has a pH range of about 7.2 to about 7.4; and (b) flowing the cleaning composition through an electrode subsystem, wherein the electrode subsystem comprises an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port.

[0088] Exemplary Embodiment 2. The method of Exemplary Embodiment 1, further comprising: (c) flowing a rinsing solution through the electrode subsystem, wherein the flowing of the rinsing solution is effective to remove residual cleaning composition from the electrode subsystem.

[0089] Exemplary Embodiment 3. The method of any one of Exemplary Embodiments 1-2, wherein the cleaning composition is substantially free of sodium hypochlorite.

[0090] Exemplary Embodiment 4. The method of any one of Exemplary Embodiments 1-3, wherein the one or more cleaning enzymes are selected from the group consisting of amylases, lipases, and combinations thereof.

[0091] Exemplary Embodiment 5. The method of any one of Exemplary Embodiments 1-4, wherein the one or more pH adjusters are selected from the group consisting of hydrochloric acid, sodium hydroxide, potassium hydroxide, calcium hydroxide, phosphoric acid, tetramethylammonium hydroxide, CAPSO free acid, citric acid, acetic acid, CHES, borate salts, and combinations thereof.

[0092] Exemplary Embodiment 6 The method of any one of Exemplary Embodiments 1-5, wherein the one or more matrix components are selected from the group consisting of bovine serum albumin, human serum albumin, zinc chloride, and magnesium chloride hexahydrate.

[0093] Exemplary Embodiment 7. The method of any one of Exemplary Embodiments 1-6, wherein the one or more buffer components are selected from the group consisting of HEPES free acid, HEPES Na salt, phosphate, Tris, TES, MOPS, PIPES, TAPS, bicine, tricine, CAPSO, cacodylate, and MES.

[0094] Exemplary Embodiment 8 The method of any one of Exemplary Embodiments 1-7, wherein the one or more preservatives are selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, chlortrimazole, chloramphenicol, ampicillin, neomycin sulfate, isothiazolinones, and sodium gallate.

[0095] Exemplary Embodiment 9. The method of any one of Exemplary Embodiments 1-8, wherein the cleaning composition further comprises a diluent.

[0096] Exemplary Embodiment 10 The method of Exemplary Embodiment 9, wherein the diluent is selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

[0097] Exemplary Embodiment 11. The method of any one of Exemplary Embodiments 1-10, further comprising: (d) calibrating the sensor.

[0098] Exemplary Embodiment 12. A method of cleaning an electrode subsystem, comprising: (a) providing a cleaning composition comprising: (i) a lipase; (ii) an amylase; (iii) one or more pH adjusting agents selected from hydrochloric acid and sodium hydroxide; (iv) one or more matrix components selected from the group consisting of bovine serum albumin, zinc chloride, and magnesium chloride hexahydrate; (v) a HEPES buffer; and (vi) one or more preservatives selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, and clotrimazole, wherein the cleaning composition has a pH range of about 7.2 to about 7.4; and (b) flowing the cleaning composition through an electrode subsystem, wherein the electrode subsystem comprises an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port.

[0099] Exemplary Embodiment 13. The method of Exemplary Embodiment 12, further comprising: (c) flowing a rinsing solution through the electrode subsystem, wherein the flowing of the rinsing solution is effective to remove residual cleaning composition from the electrode subsystem.

[0100] Exemplary Embodiment 14 The method of any one of Exemplary Embodiments 12-13, wherein the cleaning composition further comprises a diluent.

[0101] Exemplary Embodiment 15 The method of Exemplary Embodiment 14, wherein the diluent is selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

[0102] Exemplary Embodiment 16. The method of any one of Exemplary Embodiments 12-15, further comprising: (d) calibrating the sensor.

[0103] Exemplary Embodiment 17 The method of any one of Exemplary Embodiments 1-16, wherein the amylase is present in the cleaning composition in an amount of at least 60 U / L.

[0104] Exemplary Embodiment 18 The method of any one of Exemplary Embodiments 1-17, wherein the lipase is present in the cleaning composition in an amount of at least 100 U / L.

[0105] Exemplary embodiment 19. A cleaning composition comprising: [Table 5] 17. The method according to any one of exemplary embodiments 12 to 16, comprising:

[0106] Exemplary embodiment 20. A cleaning composition comprising: [Table 6] 17. The method according to any one of exemplary embodiments 12 to 16, comprising:

[0107] Exemplary embodiment 21. A cleaning composition comprising: [Table 7] 17. The method according to any one of exemplary embodiments 12 to 16, comprising:

[0108] Exemplary Embodiment 22. The method of any one of Exemplary Embodiments 1-21, wherein the electrode subsystem is positioned within a clinical analyzer or a chemical analyzer.

[0109] Exemplary Embodiment 23. The method of any one of Exemplary Embodiments 1-22, wherein each of the one or more sensors present in the electrode subsystem has a useful life, and wherein use of the cleaning composition to clean the electrode subsystem extends the useful life of the sensors.

[0110] Exemplary Embodiment 24 The method of any one of Exemplary Embodiments 1 to 23, wherein the sensor is an ion-selective sensor.

[0111] Exemplary Embodiment 25. The method of any one of Exemplary Embodiments 1-24, wherein the fluid flow channel comprises one or more of the tubes or passages of a manifold. [Example]

[0112] material A-LYTE® Integrated Multisensor (IMT Na K Cl), A-LYTE® IMT Standard A, A-LYTE® IMT Standard B + salt bridge solution, and A-LYTE® IMT Diluent.

[0113] The composition of the A-LYTE® IMT Cleaner product is shown in Table 1 below.

[0114] [Table 8]

[0115] The Atellica® CH system consisted of either a direct load (DL) or sample handler (SH) connected to a clinical chemistry (CH) module. [Example]

[0116] IMT system cleanliness and calibration stability The IMT system creates a pattern of fluid and air slugs in the IMT manifold whenever it processes samples or IMT Standards A and B during calibration. Each multi-sensor cartridge has an air pad to generate an air slug signal. The air reading signal is based on a conductivity measurement.

[0117] As samples are processed over time, deposits (proteins, lipids, etc.) may form in the IMT system, including the manifold, tubing, and sensor cartridge. The deposit coating alters the surface of the air pad and affects conductivity measurements. It should be noted that calibration failures related to IMT cleanliness are always observed with a significant reduction in air readings and, in some cases, a significant drop in the K slope. [Example]

[0118] Enzyme cleaning effect Reagents: A-LYTE® Integrated Multisensor (IMT Na K Cl).

[0119] Sensor in-service life was tested with the sensor installed for 14 days or 5000 samples. Calibration was performed automatically every 4 hours or every 250 samples, whichever came first. Good in-service life was indicated by calibration remaining within acceptable standards over the test period: Na slope: 50~63mV / dec; K slope: 50~63mV / dec; Cl slope: (-40)~(-60)mV / dec; and Air reading for Standard A and Standard B: 0.45V or greater.

[0120] Currently, some immunoassay and clinical chemistry analyzers, such as Atellica® CH Analyzers, are cleaned using harsh cleaners (e.g., sodium hypochlorite or bleach). These harsh cleaners are known to have adverse effects on IMT sensors. Therefore, to find an alternative cleaning solution for IMT sensors, the effectiveness of enzymes for cleaning IMT sensors and chemistry analyzers was tested.

[0121] We found that pancreatin from porcine pancreas can effectively return air readings to baseline and, if there is carryover, may increase the K slope. As shown in Figure 1A, the air readings for both Standard A and Standard B continued to decrease with a steep drop pattern. The K slope decreased with the air reading, inducing K drift error on day 8. By running 10 replicate samples, both the air reading and K slope returned to higher levels after processing a 17 mg / mL pancreatin solution. To identify effective enzymes in the pancreatin-enzyme mixture, we selected trypsin, lipase, and amylase from porcine pancreas. Figures 1B-1D show that, when tested individually, both lipase and amylase showed similar effects on cleaning the IMT system, but trypsin was not as effective as the other two. [Example]

[0122] A-LYTE® IMT Cleaner Reagents: A-LYTE® Integrated Multisensor (IMT Na K Cl). Samples: Bio-Rad Liquid Assayed Multiqual (86901, 86903) and Bio-Rad Liquicheck Urine Chemistry Control (68561, 68562).

[0123] Sensor in-service life was tested with sensors loaded for 14 days or 5000 samples. A-LYTE® IMT Cleaner was used to clean the instrument, demonstrating long-term on-board stability of some sensors (greater than 14 days or 5000 samples). Good in-service life was indicated by calibration remaining within acceptable standards over the test period: Na slope: 50~63mV / dec; K slope: 50~63mV / dec; Cl slope: (-40)~(-60)mV / dec; and Air reading for Standard A and Standard B: 0.45V or greater.

[0124] The in-service lifetime stability of the sensor was evaluated. One run was performed on each test day, with N=5 replicates collected for each test sample. Quality control (QC) materials were used as samples during testing. A new aliquot was thawed each test day. Plasma and serum samples were loaded onto the instrument to increase the overall number of total tests performed by the sensor over the test period. QC materials were handled according to the manufacturer's instructions. Mean results were evaluated for statistically significant drift over the service life using linear regression (results vs. time) in Minitab 18. For linear regression, a slope with a p-value of 0.05 or greater was considered a "pass" result, meaning there was no significant drift. For linear regression slopes with a p-value less than 0.05, the achieved service life was estimated from the bisection of the confidence interval of the linear regression fit and the time beyond the acceptable bias.

[0125] Figures 2A-2B show the calibration stability of the air readings and K slopes for two sensors using a medium-volume test in which A-LYTE® IMT Cleaner acted as an enzyme cleaner over the course of approximately two months of the sensor's life. The sensor in Figure 2A was cleaned approximately every two weeks and showed stable air readings over the sensor's lifespan. The sensor in Figure 2B underwent its first enzyme cleaning on day 28, with a slight deterioration in the air reading observed before the first cleaning. After the first enzyme cleaning, the air readings improved slightly. Subsequent periodic enzyme cleaning events further improved the air readings, bringing them closer to their original values ​​at the beginning of the sensor's lifespan.

[0126] In both tests, the A-LYTE® IMT Cleaner was run as a sample with either 10 or 20 replicates. There was no significant difference with increasing the number of replicates from 10 to 20. Figure 2C shows the calibration stability of the sensor's air reading and K slope with a high-volume test that performed enzyme cleaning approximately weekly and demonstrated 28 loading days and more than 8,000 samples. The A-LYTE® IMT Cleaner was run as a sample with 10 replicates each time. Figure 2D shows the calibration stability of the sensor's air reading and K slope with an ultra-high-volume test that ran plasma samples overnight. The enzyme cleaning was performed after 5,000 samples, and nearly 10,000 samples were tested, allowing for maintaining a clean IMT system for longer sensor loading. The A-LYTE® IMT Cleaner was run as a sample with 10 replicates. Table 2 summarizes several additional sensors tested with different loading days and sample volumes, with different frequencies of enzyme cleaning activity. Both demonstrated long-term sensor mounting stability in terms of both the number of days mounted and the number of test samples.

[0127] [Table 9]

[0128] QC regression analysis was performed to assess whether periodic enzyme cleaning had any effect on sample results. QC recovery was stable over the 28-day lifetime (Table 3), confirming that enzyme cleaning can be used as a preventative treatment to extend the useful life of sensors.

[0129] [Table 10] [Example]

[0130] Stress and carryover testing Reagents: A-LYTE® Integrated Multisensor (IMT Na K Cl). Samples: Bio-Rad Liquid Assayed Multiqual (86901, 86903) and Bio-Rad Liquicheck Urine Chemistry Control (68561, 68562).

[0131] To assess potential adverse effects on the sensors, stress tests were performed by running an extensive A-LYTE® IMT Cleaner. Figure 3 shows stable calibration slopes for Na, K, and Cl using the enzyme cleaner for a total of 90 replicates within 3 hours. Tests of three additional sensor cartridges were performed with 50 replicates for each sensor cartridge, and Na, K, and Cl all remained stable and showed healthy slopes after the stressful enzyme cleaning (Figure 4).

[0132] To assess whether the wash could cause carryover issues, QC samples were run immediately after the enzyme wash. Five replicates of each QC sample were run after the wash. The results of the first replicate were compared to the average of the remaining four replicates. The first replicate for each level of each analyte was well within 3 SD of the data set (Table 4), suggesting that no carryover was observed immediately after the enzyme wash.

[0133] [Table 11]

[0134] This disclosure provides data supporting the use of enzymes as cleaning agents in IMT systems. When tested individually, lipase and amylase from porcine pancreatin demonstrated superior cleaning efficacy. [Example]

[0135] Storage Temperature and Storage Stability of A-LYTE® IMT Cleaner Amylase catalyzes the hydrolysis of carbohydrates into simple sugars. Lipase catalyzes the hydrolysis of fats into fatty acids and glycerol. The active enzymes in A-LYTE® IMT Cleaner include amylase and lipase.

[0136] Shelf-life stability testing was performed to determine the expiration date of the product in the final customer package. Shelf-life encompasses the period from product manufacture, through storage under recommended conditions, to the date of final use. In this analysis, shelf-life stability was determined by calculating a linear regression for each analyte; if the p-value for the regression slope was not significant (>0.05), stability was determined to be two days from the end of the study. If the p-value for the regression slope was significant (<0.05), the observed drift was compared to an acceptance criterion.

[0137] The Dimension Amylase and Dimension Lipase assays were calibrated using calibrators stored at -70°C to ensure that drift in the test calibrators (refrigerated at 2-8°C) was isolated from drift in the analytical system. Lots 5DD073 (Table 5), 5KD042 (Table 6), and 6GD078 (Table 7) represent the final formulation of this calibrator and are being used to establish real-time shelf life. Data generated for the three validation lots was sufficient to support a 12-month shelf life for A-LYTE® IMT Cleaner.

[0138] [Table 12]

[0139] [Table 13]

[0140] [Table 14]

[0141] Because the p-value was less than 0.05 for the amylase samples from lot 6GD078, the drift over the study period was analyzed. The linear regression in Figure 5 indicates that the drift was less than 5% of the initial recovery, and therefore, the amylase from lot 6GD078 meets the requirements.

[0142] Shelf-life stability results performed on amylase and lipase all met the acceptance criteria and support a 12-month shelf life for the A-LYTE® IMT Cleaner product when stored at 2-8°C. [Example]

[0143] In-use shelf life open vial stability Stability studies were performed to determine the length of time a product will remain suitable for its intended use under specified storage and handling conditions. Products may exhibit more than one type of stability behavior. In-use shelf life stability is the length of time a product will remain useful after it has been used.

[0144] Open-vial stability was verified by measuring amylase and lipase activity in opened and restoppered vials of A-LYTE® IMT Cleaner stored at 2-8°C, normalized to a freshly opened vial stored at 2-8°C on each test day. For this analysis, stability was determined by calculating a linear regression for each analyte; if the p-value for the regression slope was not significant (>0.05), stability was determined to be the second day from the final day of testing. If the p-value for the regression slope was significant (≤0.05), the observed drift was compared to the acceptance criteria. Acceptance criteria were ≥30 days after opening when restoppered and stored at 2-8°C, with acceptable drift of 3% or less for amylase and 5% or less for lipase.

[0145] Reagents: Dimension Vista AMY, Dimension Vista LIPL, and A-LYTE® IMT Cleaner. Sample: A-LYTE® IMT Cleaner. Acceptance Criteria: The product shall be stable for at least 30 days after opening when resealed and stored at 2-8°C. Acceptable drift is ≤3% for amylase and ≤5% for lipase.

[0146] The results obtained support a 30-day in-use life open vial stability of the A-LYTE® IMT Cleaner product after opening when resealed and stored at 2-8°C. [Example]

[0147] Bioburden Bioburden testing was used to determine the extent of microbial contamination in the samples. A-LYTE® IMT Cleaner is composed of multiple antimicrobial agents to limit bioburden, including streptomycin sulfate, gentamicin sulfate, amphotericin B, and clotrimazole solution.

[0148] Bioburden testing was performed on filled vials from random sampling across the entire lot. A sample size of 35 vials per level was used. Each of the seven samples submitted was a pooled mixture of five vials of A-LYTE® IMT Cleaner, Level B. Samples were plated on Resene agar plates and incubated as follows: half of the plates were incubated at 23-27°C for at least two days and then transferred to 33-37°C for at least one day. The other half was maintained at 23-27°C for at least three days. Bacterial colonies were counted on plates incubated at 33-37°C, and fungal counts were counted on plates incubated at 23-27°C. Final results were reported as bacterial and fungal counts per milliliter or gram of product. If no colonies were observed on the plates, the count was reported as less than 10 CFU / mL. The results are shown in Tables 8-10 below.

[0149] [Table 15]

[0150] [Table 16]

[0151] [Table 17]

[0152] The bioburden of all samples across all three lots tested reported less than 10 CFU / mL of bacteria and fungi. Therefore, the bioburden testing met the acceptance criteria of less than 100 CFU / mL of microbial growth. [Example]

[0153] Atellica sample handler installed Reagents: Atellica® CH Amylase, Atellica CH Lipase, Atellica CH SPCL CHEM CAL Lot 58103, and Atellica CH ENZ 1 Cal Lot 1MD033. Sample: A-LYTE® IMT Cleaner.

[0154] The stability of A-LYTE® IMT Cleaner when stored onboard the Atellica sample handler was verified by measuring amylase and lipase activity after newly opening vials and placing the material in the Atellica sample handler for refrigerated storage. Data were normalized to newly opened vials stored at 2-8°C on each test day. For this analysis, stability was determined by calculating a linear regression for each analyte; if the p-value for the regression slope was not significant (>0.05), stability was determined as the last day of testing minus 1 day. If the p-value for the regression slope was significant (≤0.05), the observed drift was compared to the acceptance criteria.

[0155] Stability shall be greater than or equal to 7 days as determined by an acceptable drift of + / - 15% for amylase activity and + / - 15% for lipase activity after the vial is newly opened and the material is placed in the Atellica sample handler for refrigerated storage.

[0156] [Table 18]

[0157] [Table 19]

[0158] Results met the acceptance criteria and supported a 30-day stability period after newly opening the vial and placing the material in the Atellica sample handler for the A-LYTE® IMT Cleaner product (Figures 6A-6B).

[0159] While preferred embodiments have been illustrated and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions, and the like may be made therein without departing from the spirit of the invention, and therefore are deemed to be within the scope of the invention as defined in the following claims.

Claims

1. 1. A method for cleaning an electrode subsystem, comprising: (a) (i) one or more cleaning enzymes; (ii) one or more pH adjusting agents; (iii) one or more matrix components; (iv) one or more buffer components; and (v) one or more preservatives wherein the cleaning composition has a pH range of about 7.2 to about 7.4; (b) flowing a cleaning composition through an electrode subsystem, the electrode subsystem including an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port; A method comprising:

2. (c) flowing a rinse solution through the electrode subsystem, the rinse solution being effective to remove residual cleaning composition from the electrode subsystem; The method of claim 1 further comprising:

3. 3. The method of claim 1 or 2, wherein the cleaning composition is substantially free of sodium hypochlorite.

4. The method of any one of claims 1 to 3, wherein the one or more cleaning enzymes are selected from the group consisting of amylases, lipases, and combinations thereof.

5. 5. The method of any one of claims 1 to 4, wherein the one or more pH adjusters are selected from the group consisting of hydrochloric acid, sodium hydroxide, potassium hydroxide, calcium hydroxide, phosphoric acid, tetramethylammonium hydroxide, CAPSO free acid, citric acid, acetic acid, CHES, borate salts, and combinations thereof.

6. 6. The method of any one of claims 1 to 5, wherein the one or more matrix components are selected from the group consisting of bovine serum albumin, human serum albumin, zinc chloride, and magnesium chloride hexahydrate.

7. 7. The method of any one of claims 1 to 6, wherein the one or more buffer components are selected from the group consisting of HEPES free acid, HEPES Na salt, phosphate, Tris, TES, MOPS, PIPES, TAPS, bicine, tricine, CAPSO, cacodylate, and MES.

8. 8. The method of any one of claims 1 to 7, wherein the one or more preservatives are selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, chlortrimazole, chloramphenicol, ampicillin, neomycin sulfate, isothiazolinones, and sodium gallate.

9. The method of any one of claims 1 to 8, wherein the cleaning composition further comprises a diluent.

10. 10. The method of claim 9, wherein the diluent is selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

11. (d) Calibrating the sensor The method of claim 1 further comprising:

12. 1. A method for cleaning an electrode subsystem, comprising: (a) (i) lipase; (ii) amylase; (iii) one or more pH adjusters selected from hydrochloric acid and sodium hydroxide; (iv) one or more matrix components selected from the group consisting of bovine serum albumin, zinc chloride, and magnesium chloride hexahydrate; (v) HEPES buffer; and (vi) one or more preservatives selected from the group consisting of streptomycin sulfate, gentamicin sulfate, amphotericin B, and clotrimazole. wherein the cleaning composition has a pH range of about 7.2 to about 7.4; (b) flowing a cleaning composition through an electrode subsystem, the electrode subsystem including an inlet port, one or more sensors, an outlet port, and fluid flow channels connecting the inlet port, the one or more sensors, and the outlet port; A method comprising:

13. (c) flowing a rinse solution through the electrode subsystem, the rinse solution being effective to remove residual cleaning composition from the electrode subsystem; 13. The method of claim 12, further comprising:

14. The method of claim 12 or 13, wherein the cleaning composition further comprises a diluent.

15. 15. The method of claim 14, wherein the diluent is selected from the group consisting of water, a buffer, a saline-based solution, a preservative, a pH adjuster, and albumin.

16. (d) Calibrating the sensor 13. The method of claim 12, further comprising:

17. The method of any one of claims 1 to 16, wherein the amylase is present in the cleaning composition in an amount of at least 60 U / L.

18. The method of any one of claims 1 to 17, wherein the lipase is present in the cleaning composition in an amount of at least 100 U / L.

19. The cleaning composition comprises Table 1 The method according to any one of claims 12 to 16, comprising:

20. The cleaning composition comprises Table 2 The method according to any one of claims 12 to 16, comprising:

21. The cleaning composition comprises Table 3 The method according to any one of claims 12 to 16, comprising:

22. The method of any one of claims 1 to 21, wherein the electrode subsystem is positioned within a clinical analyzer or a chemical analyzer.

23. 23. The method of any one of claims 1 to 22, wherein each of the one or more sensors present in the electrode subsystem has a useful life, and wherein use of the cleaning composition to clean the electrode subsystem extends the useful life of the sensors.

24. The method of any one of claims 1 to 23, wherein the sensor is an ion-selective sensor.

25. The method of any preceding claim, wherein the fluid flow channel comprises one or more of the tubes or passages of a manifold.

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