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WO2025128481A1 - Correction de données d'étalonnage utilisées par des analyseurs de diagnostic sur la base de conditions de stockage de réactifs - Google Patents

Correction de données d'étalonnage utilisées par des analyseurs de diagnostic sur la base de conditions de stockage de réactifs Download PDF

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Publication number
WO2025128481A1
WO2025128481A1 PCT/US2024/059179 US2024059179W WO2025128481A1 WO 2025128481 A1 WO2025128481 A1 WO 2025128481A1 US 2024059179 W US2024059179 W US 2024059179W WO 2025128481 A1 WO2025128481 A1 WO 2025128481A1
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WIPO (PCT)
Prior art keywords
calibration data
reagent cartridge
computer processor
diagnostic analyzer
date
Prior art date
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Pending
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PCT/US2024/059179
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English (en)
Inventor
Murli NARAYAN
Kevin Horan
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Siemens Healthcare Diagnostics Inc
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Siemens Healthcare Diagnostics Inc
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Publication date
Application filed by Siemens Healthcare Diagnostics Inc filed Critical Siemens Healthcare Diagnostics Inc
Publication of WO2025128481A1 publication Critical patent/WO2025128481A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00693—Calibration
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00663—Quality control of consumables
    • G01N2035/00673—Quality control of consumables of reagents

Definitions

  • a “calibration reagent” is a solution with chemicals/substances added at specific target values that may be used by the diagnostic analyzer as a reference to check the validity of, and if necessary adjust, a measurement made by the diagnostic analyzer in order to maintain high analytical performance.
  • Calibration reagents may be provided with related data that indicates, e.g., quantities, concentrations, or ratios of reagent components.
  • storage conditions of the reagents before use in a diagnostic analyzer may affect those quantities, concentrations, or ratios, and thus the accuracy of the related data and subsequent assay calibration. This may, in turn, adversely affect the analytical performance of the assay. [0004] Accordingly, improved apparatus and methods for calibrating diagnostic analyzer assays are desired.
  • a method of calibrating an assay in a diagnostic analyzer for measuring an analyte in a biological sample includes a computer processor, and the method includes receiving a reagent cartridge in the diagnostic analyzer, wherein the reagent cartridge includes a temperature correction fluid, calibration data, and a date of manufacture. The method also includes determining, via the computer processor, a storage time of the reagent cartridge based on the date of manufacture; and measuring, via one or more analyte sensors of the diagnostic analyzer, pH or pO 2 (partial pressure of oxygen) of the temperature correction fluid.
  • the diagnostic analyzer includes a computer processor, an analyte sensor operative to measure the analyte in the biological sample or a quality control sample, one or more other analyte sensors operative to measure pH or pO 2 , a clock operative to indicate a current date, and a receptacle operative to receive a reagent cartridge.
  • the reagent cartridge includes a temperature correction fluid, calibration data, and a date of manufacture.
  • the computer processor is operative via programming instructions to receive the calibration data and the date of manufacture upon receipt of the reagent cartridge in the receptacle.
  • the computer processor is also operative via programming instructions to determine a storage time of the reagent cartridge based on the date of manufacture and the current date provided by the clock, and measure pH or pO 2 of the temperature correction fluid via the one or more other analyte sensors.
  • the computer processor is further operative via programming instructions to determine an average storage temperature based on measured pH or pO 2 relative to a respective pH or pO 2 value of the temperature correction fluid included in the calibration data.
  • the computer processor is still further operative to correct the calibration data in response to the determined average storage temperature and the determined storage time indicating that correction of the calibration data is needed, and calibrate an assay of the diagnostic analyzer for measuring the analyte using corrected calibration data in response to the calibration data being corrected.
  • FIG. 2A illustrates a graph of pH stability versus storage time of a temperature correction fluid stored at 25o C according to embodiments provided herein.
  • FIG. 2B illustrates a graph of pO 2 stability versus storage time of a temperature correction fluid stored at 25o C according to embodiments provided herein.
  • FIG. 3 illustrates a graph of predicted creatine concentrations versus storage time at six average storage temperatures in a calibration solution having creatine and no creatinine at time of manufacture according to embodiments provided herein.
  • FIG. 4 illustrates a graph of predicted creatine concentrations and experimentally-determined creatine concentrations versus storage time at 25o C in a calibration solution having creatine and no creatinine at time of manufacture according to embodiments provided herein.
  • a calibration reagent is a solution that includes chemicals/substances added at specific target values (e.g., levels, quantities, ratios, or concentrations) to a matrix (i.e., all components of a solution in addition to the analyte of interest) that provides a reference for the diagnostic analyzer.
  • An analyte sensor or like measurement device contacting the calibration reagent generates an electrical signal that is measured (in, e.g., mV or nA) and converted into an amount of an analyte.
  • two or more calibration reagents with known (different) concentrations may be used. The values of the two or more electrical signals generated therefrom are used to create a calibration curve against which sensor measurements can be measured.
  • the calibration data may be stored in an electronic device (e.g., a radio frequency identification (RFID) tag) provided with the reagent cartridge.
  • RFID radio frequency identification
  • the calibration data may alternatively be encoded in a barcode affixed to the reagent cartridge.
  • a temperature correction fluid has a predictable change in pH and/or pO2 from its initial manufacturing values in response to temperature over time. Also included in the calibration data is a date of manufacture of the reagent cartridge (indicating or representing a date of manufacture of the reagents and temperature correction fluid). Changes in the values of pH and/or pO 2 in the temperature correction fluid from the time of manufacture to the time of reagent cartridge installation in a diagnostic analyzer are used to determine (estimate) an average storage temperature (also known as a bulk kinetic temperature) of the reagent cartridge from time of manufacture to the time of installation.
  • an average storage temperature also known as a bulk kinetic temperature
  • the original calibration data may then be updated (i.e., replaced) with the mathematically and/or experimentally-determined new reagent component values and stored in the electronic device (e.g., RFID tag) of the reagent cartridge and/or a non-volatile memory of the diagnostic analyzer.
  • Assay calibration (or re-calibration) may then be performed using the corrected or updated calibration data. This calibration correction procedure may be repeated periodically while the reagent cartridge remains installed in the diagnostic analyzer to maintain accurate analyte measurements. If available in the diagnostic analyzer, a temperature sensor may provide the temperature input while the reagent cartridge is installed in the diagnostic analyzer.
  • Advantages of the apparatus and methods of calibrating analyte sensors according to embodiments described herein include maintaining high analyte measurement accuracy by correcting calibration data that may have been adversely affected by reagent storage conditions. Other advantages include indicating that the reagent cartridge had been stored outside of its specified range (e.g., 2o - 25o C), extending shelf-life and use-life of reagents used by the diagnostic analyzers, and/or expanding the temperature range at which reagents may be shipped and stored. [0024] In accordance with one or more embodiments, diagnostic analyzers operative to correct calibration data based on reagent storage conditions will be explained in greater detail below in connection with FIGS. 1-6. [0025] FIG.
  • Diagnostic analyzer 100 may include a controller 102, a sensor array 104, and a reagent cartridge receptacle 106. Diagnostic analyzer 100 may include other components (not shown). Diagnostic analyzer 100 may, in some embodiments, be coupled to an automated track 108 for receiving and returning sample containers 110 carried by sample carriers 112. In some embodiments, diagnostic analyzer 100 may include a waste container for disposing sample containers 110 after testing. Each sample container 110 may contain a biological sample to be tested at diagnostic analyzer 100 for presence and quantity of one or more analytes (e.g., creatinine and/or creatine).
  • analytes e.g., creatinine and/or creatine
  • Controller 102 may include a computer processor 102P, a non-transitory memory 102M, and a clock 102C.
  • Clock 102C may be operative to indicate the current date and time of day and be any suitable system or real-time clock.
  • Non- transitory memory 102M may include programming instructions 102PI (e.g., software models, programs, algorithms, and the like) that may be executed by computer processor 102P.
  • Programming instructions 102PI may additionally or alternatively be stored in another non-transitory computer readable medium.
  • Non-transitory memory 102M may also include data/information that is accessible by computer processor 102P.
  • Controller 102 may include a user interface (not shown), which may include a display, to enable a user to access a variety of control and status display screens and to enter commands and/or data into controller 102 related to the operation of the diagnostic analyzer 100. Controller 102 may alternatively or additionally include other processing devices/circuits (including microprocessors, A/D converters, amplifiers, filters, etc.), other storage devices, transceivers, interfaces, device drivers, and/or other electronics.
  • processing devices/circuits including microprocessors, A/D converters, amplifiers, filters, etc.
  • Controller 102 may be in communication with a system controller (not shown) of an automated diagnostic analysis system (also not shown), which may include multiple automated or semi-automated diagnostic analyzers of the same and/or different type as well as one or more input/output modules, centrifuges, quality check modules, decappers, aspirating/dispensing modules, heaters, storage and/or refrigeration modules, and/or other components.
  • controller 102 may be in communication with other computers, other system controllers, or other devices of, e.g., an automated diagnostic analysis system, a laboratory information system, a medical facility, etc.
  • the communication may occur either directly via wired and/or wireless connections or via a network for transmitting analysis measurement results thereto and/or for receiving biological sample related information including, e.g., one or more of patient information, time and date a sample was obtained, medical facility information, tracking and routing information, and/or any other information relevant to the biological samples to be analyzed.
  • the network may be, e.g., a local area network (LAN), wide area network (WAN), or other suitable communication network, including wired and wireless networks.
  • controller 102 may be part of an automated diagnostic analysis system, a laboratory information system, a medical facility, etc.
  • Controller 102 via computer processor 102P executing programming instructions 102PI and, optionally, accessing data stored in non-transitory memory 102M, may be considered a special purpose machine particularly suited for controlling the overall operation of diagnostic analyzer 100, thus becoming an automated or semi-automated diagnostic analyzer 100.
  • controller 102 via computer processor 102P executing programming instructions 102PI is operative to, among other things, automatically calibrate the sensors of diagnostic analyzer 100, as described in more detail below.
  • Sensor array 104 may include a plurality of sensors operative to measure, via electrical signals, one or more analytes and/or other quantities.
  • a reagent cartridge 114 for embodiments of diagnostic analyzer 100 configured and operative to measure creatinine and/or creatine may include three calibration solutions: a first calibration solution of a first reagent with creatinine and creatine in a first ratio, a second calibration solution of a second reagent with creatine and no creatinine at time of manufacture, and a third calibration solution with no creatinine and no creatine (i.e., a measurand-free zero point).
  • the three calibration solutions when used together, may effectively calibrate out the creatine influence, enabling measurement system selectivity for creatinine to determine the amount of creatinine present in a quality control sample or biological sample.
  • the first calibration solution may contain a stable ratio of creatinine-to-creatine
  • the second calibration solution may contain an unstable ratio of creatinine-to-creatine that may result in interconversion of creatinine to creatine (or vice versa) based on pH and temperature of the second calibration solution. That is, at a fixed temperature, creatine and creatinine will interconvert until equilibrium is achieved. As the solution gets closer to equilibrium, the speed of interconversion will slow.
  • the levels (e.g., amounts, ratios, concentrations, etc.) of creatinine and creatine in each of the first and second calibration solutions at time of manufacture are encoded in electronic device 114D of reagent cartridge 114.
  • Possible changes in the levels of creatinine and creatine in the unstable second calibration solution at the time of sensor calibration may be estimated/predicted in accordance with the embodiments described herein by determining an average storage temperature and storage time of the reagent cartridge 114.
  • the creatine and/or creatinine sensor and calibration solutions associated with creatine and creatinine are independent from the estimation of average storage temperature of the reagent cartridge.
  • No direct measurements of creatinine and/or creatine levels in the calibration solutions are used for estimation of the average storage temperature of the reagent cartridge.
  • pH and/or pO 2 sensors and pH and/or pO 2 measurements from a temperature correction fluid allows the creatinine sensor and the calibration solutions being corrected to be independent.
  • the flexible laminate pouches of calibration reagents and temperature correction fluid with zero-headspace are then added to a reagent cartridge.
  • the flexible laminate pouch may then include an access point (attached fitment) to connect to the reagent cartridge and then to the diagnostic analyzer.
  • the reagent cartridge is a consumable to support the diagnostic analyzer.
  • the reagent cartridge may also include the sensors, or the sensors may be a separate consumable, such as a sensor cartridge.
  • the temperature correction fluid may be used for purposes other than shelf- life correction, such as, e.g., as a quality control solution.
  • 2B illustrates pO 2 decreasing in a temperature correction fluid maintained at 25o C over a period of time (e.g., 32 weeks), wherein line 206 represents actual pO 2 data and line 208 represents modeled pO 2 data.
  • line 206 represents actual pO 2 data
  • line 208 represents modeled pO 2 data.
  • a weighted average is used (if they agree within, e.g., 10%). Confirmation that the shelf-life correction has been successful is confirmed by further assessment via quality control reagents. If the quality control assessment is determined to be out of acceptable limits, recalibrating the sensors and repeating the shelf-life correction process would be appropriate. Further failure to meet acceptable limits may be indicative of a quality issue for the overall system.
  • the software model may be based on the following equation: ⁇ ⁇ + ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ [0045] wherein: [0046] [A] is the molar concentration of creatinine at a given time in units of nM; [0047] [A] 0 is the initial molar concentration of creatinine in units of nM; [0048] k 1 is the kinetic constant of creatinine conversion to creatine in units of day -1 ; [0049] k 2 is the kinetic constant of creatine conversion to creatinine in units of day -1 ; and [0050] t is time in units of days.
  • FIG. 3 illustrates a graph 300 representing the second calibration solution (having creatine and no creatinine at time of manufacture) and shows estimated/predicted outputs of the software model for creatine concentrations (in units of mM) over a 300-day storage time for six average storage temperatures according to one or more embodiments.
  • Creatine concentration curve 304 represents estimated/predicted creatine concentrations at an average storage temperature of 4o C.
  • Creatine concentration curve 320 represents estimated/predicted creatine concentrations at an average storage temperature of 20o C.
  • Creatine concentration curve 325 represents estimated/predicted creatine concentrations at an average storage temperature of 25o C.
  • Creatine concentration curve 330 represents estimated/predicted creatine concentrations at an average storage temperature of 30o C.
  • Creatine concentration curve 332 represents estimated/predicted creatine concentrations at an average storage temperature of 32o C.
  • creatine concentration curve 337 represents estimated/predicted creatine concentrations at an average storage temperature of 37o C.
  • FIG. 4 illustrates a graph 400 representing the second calibration solution (having creatine and no creatinine at time of manufacture) and shows a comparison of estimated/predicted creatine concentrations and experimentally-determined creatine concentrations versus a 100-day storage time at 25o C according to one or more embodiments.
  • method 600 may include measuring, via one or more analyte sensors of the diagnostic analyzer, pH and/or pO 2 of the temperature correction fluid included with the reagent cartridge.
  • method 600 may include determining, via the computer processor, an average storage temperature of the reagent cartridge based on the measured pH and/or pO 2 relative to respective pH and/or pO 2 values included in the calibration data. For example, a first software model executing on computer processor 102P may determine an average storage temperature at which the reagent cartridge had been kept based on measured changes in pH and/or pO 2 values and the determined storage time. The first software model may be stored in non-transitory memory 102M.
  • Method 600 may include at process block 610 correcting, via the computer processor, the calibration data in response to the determined average storage temperature and the determined storage time indicating that correction of the calibration data is needed.
  • the determined average storage temperature and the determined storage time may be input to a second software model executing on computer processor 102P.
  • the second software model which may be stored in non-transitory memory 102M determines how average storage temperature and storage time affect reagent calibration data, and if the reagent calibration data has changed by more than a predetermined amount or percentage, computer processor 102P may correct the reagent calibration data.
  • method 600 may include at process block 612 calibrating the analyte sensor using corrected calibration data.
  • Example Embodiment 1 A method of calibrating an assay in a diagnostic analyzer for measuring an analyte in a biological sample, the diagnostic analyzer including a computer processor, the method comprising: [0066] receiving a reagent cartridge in the diagnostic analyzer, the reagent cartridge including a temperature correction fluid, calibration data, and a date of manufacture; [0067] determining, via the computer processor, a storage time of the reagent cartridge based on the date of manufacture; [0068] measuring, via one or more analyte sensors of the diagnostic analyzer, pH or pO 2 of the temperature correction fluid; [0069] determining, via the computer processor, an average storage temperature of the reagent cartridge based on the measured pH or pO 2 relative to a respective pH or pO 2 value of the temperature correction fluid included in the calibration data; [0066] receiving a reagent cartridge in the diagnostic analyzer, the reagent cartridge including a temperature correction fluid, calibration data, and a date of manufacture; [0067] determining,
  • Example Embodiment 2 The method of Example Embodiment 1, wherein: [0073] the measuring further comprises measuring, via the one or more analyte sensors of the diagnostic analyzer, pH and pO 2 of the temperature correction fluid; and [0074] the determining, via the computer processor, the average storage temperature further comprises determining, via the computer processor, the average storage temperature of the reagent cartridge based on the measured pH and pO 2 relative to respective pH and pO 2 values of the temperature correction fluid included in the calibration data.
  • Example Embodiment 3 The method of any one of the previous Example Embodiments, wherein the determining, via the computer processor, the average storage temperature of the reagent cartridge comprises determining a difference between the measured pH or pO 2 and the respective pH or pO 2 value of the temperature correction fluid included in the calibration data, and providing the difference to a software model operative to determine the average storage temperature, the software model executed by the computer processor.
  • Example Embodiment 4 The method of any one of the previous Example Embodiments, further comprising, prior to the determining via the computer processor the average storage temperature, determining experimentally a change in pH in the temperature correction fluid over a range of temperatures and time periods.
  • Example Embodiment 5 The method of any one of the previous Example Embodiments, further comprising, prior to the determining via the computer processor the average storage temperature, determining experimentally a change in pO 2 in the temperature correction fluid over a range of temperatures and time periods.
  • Example Embodiment 6 The method of any one of the previous Example Embodiments, wherein the reagent cartridge includes an electronic device storing the calibration data and the date of manufacture, and the method further comprises receiving, via the computer processor, the calibration data and the date of manufacture stored in the electronic device in response to the receiving the reagent cartridge in the diagnostic analyzer.
  • Example Embodiment 7 The method of any one of the previous Example Embodiments, wherein the electronic device comprises a radio frequency identification (RFID) tag.
  • Example Embodiment 8 The method of any one of the previous Example Embodiments, wherein the determining, via the computer processor, the storage time of the reagent cartridge comprises: [0081] receiving, via the computer processor, the date of manufacture from the reagent cartridge; and [0082] determining, via the computer processor, a difference in days between the date of manufacture and a date the reagent cartridge was received in the diagnostic analyzer as indicated by a clock of the diagnostic analyzer.
  • Example Embodiment 9 The method of any one of the previous Example Embodiments, wherein the reagent cartridge includes multi-analyte reagents.
  • Example Embodiment 10 The method of any one of the previous Example Embodiments, wherein: [0085] the calibration data includes levels of creatinine and creatine in each of two calibration reagents included in the reagent cartridge as of the date of manufacture; [0086] the determined average storage temperature and the determined storage time are used to determine current levels of creatinine and creatine in the two calibration reagents; and [0087] the computer processor stores determined current levels of creatinine and creatine in the calibration data in the reagent cartridge if different than the levels of creatinine and creatine as of the date of manufacture.
  • Example Embodiment 11 The method of any one of the previous Example Embodiments, wherein the diagnostic analyzer comprises an analyte sensor operative to measure an amount of creatinine or creatine present in the biological sample.
  • Example Embodiment 12 The method of any one of the previous Example Embodiments, wherein the biological sample comprises whole blood, serum, plasma, urine, interstitial liquid, pleural fluid, or cerebrospinal liquid.
  • Example Embodiment 13 A diagnostic analyzer for measuring an analyte in a biological sample, comprising: [0091] a computer processor; [0092] an analyte sensor operative to measure the analyte in the biological sample or a quality control sample; [0093] a receptacle operative to receive a reagent cartridge, the reagent cartridge including a temperature correction fluid, calibration data, and a date of manufacture; [0094] one or more other analyte sensors operative to measure pH or pO 2 ; and [0095] a clock operative to indicate a current date; wherein: [0096] the computer processor is operative via programming instructions to: [0097] receive the calibration data and the date of manufacture upon receipt of the reagent cartridge in the receptacle; [0098] determine a storage time of the reagent cartridge based on the date of manufacture and the current date provided by the clock; [0099] measure via the one or more other analyte sensors
  • Example Embodiment 14 The diagnostic analyzer of Example Embodiment 13, wherein the computer processor is further operative via programming instructions to: [00104] measure via the one or more other analyte sensors pH and pO2 of the temperature correction fluid; and [00105] determine an average storage temperature based on the measured pH and pO2 relative to respective pH and pO2 values of the temperature correction fluid included in the calibration data.
  • Example Embodiment 15 The diagnostic analyzer of Example Embodiment 13 or 14, further comprising the reagent cartridge received in the receptacle.
  • Example Embodiment 16 The diagnostic analyzer of any one of Example Embodiments 13-15, wherein the temperature correction fluid comprises predictable changes in pH over a range of temperatures and time periods.
  • Example Embodiment 17 The diagnostic analyzer of any one of Example Embodiments 13-16, wherein the temperature correction fluid comprises predictable changes in pO 2 over a range of temperatures and time periods.
  • Example Embodiment 18 The diagnostic analyzer of any one of Example Embodiments 13-17, wherein the reagent cartridge further comprises one or more testing reagents and one or more calibration reagents.
  • Example Embodiment 19 The diagnostic analyzer of any one of Example Embodiments 13-18, wherein the calibration data and the date of manufacture are stored in an electronic device included with the reagent cartridge or are encoded in a barcode included with the reagent cartridge.
  • Example Embodiment 20 The diagnostic analyzer of any one of Example Embodiments 13-19, wherein the computer processor is further operative via programming instructions to store the corrected calibration data in the electronic device.

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Abstract

Des données d'étalonnage initialement fournies avec des réactifs à utiliser dans des analyseurs de diagnostic pour mesurer des analytes dans des échantillons biologiques peuvent avoir besoin d'être corrigées sur la base de conditions de stockage de réactifs, notamment une température de stockage moyenne et un temps de stockage moyen. En mesurant le pH et/ou le pO2 d'un fluide de correction de température fourni avec les réactifs, une température moyenne de stockage de réactifs peut être déterminée. La température moyenne de stockage de réactifs ainsi qu'un temps de stockage déterminé des réactifs peuvent être utilisés pour déterminer si la correction des données d'étalonnage est nécessaire et, si tel est le cas, pour corriger ces données d'étalonnage. L'invention concerne également de nombreux autres aspects.
PCT/US2024/059179 2023-12-14 2024-12-09 Correction de données d'étalonnage utilisées par des analyseurs de diagnostic sur la base de conditions de stockage de réactifs Pending WO2025128481A1 (fr)

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US20170363567A1 (en) * 2014-12-18 2017-12-21 Radiometer Medical Aps Method for calibrating a device for measuring the concentration of creatinine
US10133978B2 (en) * 2010-10-20 2018-11-20 Minicare B.V. Device having RFID tag and fluidics element
US20190346398A1 (en) * 2016-12-07 2019-11-14 Radiometer Medical Aps System and method for estimating a temperature of a liquid sample

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Publication number Priority date Publication date Assignee Title
US10133978B2 (en) * 2010-10-20 2018-11-20 Minicare B.V. Device having RFID tag and fluidics element
US20170363567A1 (en) * 2014-12-18 2017-12-21 Radiometer Medical Aps Method for calibrating a device for measuring the concentration of creatinine
US20190346398A1 (en) * 2016-12-07 2019-11-14 Radiometer Medical Aps System and method for estimating a temperature of a liquid sample

Non-Patent Citations (1)

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Title
RAJASEKARAN RAJAMANICKAM, ARTHUR HENRY SADHANANDHAM: "Arterial blood gas tensions - Effect of storage time and temperature", INDIAN JOURNAL OF RESPIRATORY CARE, vol. 3, no. 1, 1 December 2022 (2022-12-01), pages 350 - 356, XP093327935, ISSN: 2277-9019, DOI: 10.5005/ijrc-3-1-350 *

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