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US 12,730,098 B2Granted
Calibration fluid comprising pyrogallol for the calibration of blood gas, electrolyte, and/or metabolite instrument oxygen sensor(s)
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsKevin Horan, Murli Narayan
Life of this patent
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Abstract
Compositions, devices, kits, and methods for calibrating at least one oxygen sensor in a blood gas, electrolyte, and/or metabolite instrument utilizing a calibration fluid comprising a pyrogallol oxygen scavenger.
Claims19
A method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system, the method comprising the steps of:
- (i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument, the sensor cartridge comprising:
- an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor;
- at least one calibration and/or quality control reagent;
- and
- aqueous pyrogallol;
- (ii) activating the sensor cartridge to add aqueous pyrogallol to the at least one calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form at least one calibration and/or quality control fluid having a desired oxygen level, wherein the aqueous pyrogallol is added to the at least one calibration and/or quality control reagent in an amount that provides a concentration in a range of from about 0.05% to about 1% of the at least one calibration and/or quality control fluid;
- and
- (iii) contacting the at least one calibration and/or quality control fluid with the at least one electrode and the at least one sensor of the amperometric sensor array, wherein:
- the at least one calibration and/or quality control fluid is contacted with the at least one electrode to directly determine a concentration of oxygen present therein based on an electrochemical current generated between the at least one electrode and oxygen present in the at least one calibration and/or quality control fluid, whereby the concentration of oxygen is directly proportional to the electrochemical current generated;
- and
- the at least one calibration and/or quality control fluid is contacted with the at least one sensor of the amperometric sensor array for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument.
8 more elements
A method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system, the method comprising the steps of:
- (i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument, the sensor cartridge comprising:
- (a) an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor;
- (b) a first calibration and/or quality control reagent;
- (c) a second calibration and/or quality control reagent having a pO2 value above zero millimeters of mercury (mmHg);
- (d) aqueous pyrogallol;
- and
- wherein each of (b), (c), and (d) is separately disposed in a substantially air tight environment in the sensor cartridge until activation of the sensor cartridge;
- (ii) activating the sensor cartridge to add aqueous pyrogallol to the first calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a first calibration and/or quality control fluid having a desired oxygen level;
- (iii) contacting the first calibration and/or quality control fluid with the amperometric sensor array, wherein an electrochemical current is generated between the at least one electrode of the amperometric sensor array and oxygen present in the calibration and/or quality control fluid, whereby the concentration of oxygen is directly proportional to the electrochemical current generated, and wherein the first calibration and/or quality control fluid sets a floor calibration measurement of the at least one pO2 sensor;
- and
- (iv) contacting the second calibration and/or quality control reagent with the amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor.
8 more elements
A method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system, the method comprising the steps of:
- (i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument, the sensor cartridge comprising:
- an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor;
- a first calibration and/or quality control reagent;
- a second calibration and/or quality control reagent having a pO2 value above zero millimeters of mercury (mmHg);
- a third calibration and/or quality control reagent having a pO2 value above zero mmHg;
- and
- aqueous pyrogallol;
- and
- (ii) activating the sensor cartridge to add aqueous pyrogallol to the first calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a first calibration and/or quality control fluid having a pO2 value of about 0 mmHg;
- (iii) activating the sensor cartridge to add aqueous pyrogallol to the third calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a third calibration and/or quality control fluid having a pO2 value between 0 mmHg and the pO2 value of the second calibration and/or quality control reagent;
- (iv) contacting the first calibration and/or quality control fluid with the amperometric sensor array, wherein an electrochemical current is generated between the at least one electrode of the amperometric sensor array and oxygen present in the calibration and/or quality control fluid, whereby the concentration of oxygen is directly proportional to the electrochemical current generated, and wherein the first calibration and/or quality control fluid sets a floor calibration measurement of the at least one pO2 sensor;
- (v) contacting the second calibration and/or quality control reagent with the amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor;
- and
- (vi) contacting the third calibration and/or quality control fluid with the amperometric sensor array, wherein the third calibration and/or quality control fluid sets a calibration measurement of the at least one pO2 sensor between the floor and ceiling measurements.
11 more elements
Dependencies are inferred from the claim text.