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
  • G01N27/333—Ion-selective electrodes or membranes
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
  • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
  • C12Q1/25—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving enzymes not classifiable in groups C12Q1/26 - C12Q1/66
• • 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
  • G01N27/301—Reference electrodes
• • 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
  • G01N27/416—Systems
  • G01N27/4163—Systems checking the operation of, or calibrating, the measuring apparatus
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/483—Physical analysis of biological material
  • G01N33/487—Physical analysis of biological material of liquid biological material
  • G01N33/49—Blood
  • G01N33/4915—Blood using flow cells
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH

Definitions

• E E° + ⁇ ln (a i + ⁇ 3 ⁇ 4 ot a/ 7z ) (II)
• E the measured electromotive force (EMF) of the electrode in the sample (or calibration reagent and/or quality control reagent);
• E° is the constant potential contributions;
• ot is the selectivity coefficient;
• z, and z y are the charges of the primary ion, I, and interfering ion, J; a, and a are the activities of / and J; and
• R, T, and n are: the gas constant, absolute temperature (K), and the number of moles of charge carriers per mole of the species, respectively.
• the designated value may vary by ⁇ 20%, or ⁇ 10%, or ⁇ 5%, or ⁇ 1 %, or ⁇ 0.1 % from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the art.
• the use of the term “at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc.
• the term “at least one” may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100/1000 are not to be considered limiting, as higher limits may also produce satisfactory results.
• the plurality of potentiometric sensors 14 generally comprise an interfering ion selective electrode 18, a primary ion selective electrode 20, and one or more reference electrodes 22.
• the interfering ion selective electrode 18 is a calcium ion selective electrode generally comprising a membrane- based calcium sensor capable of quantitatively measuring a concentration of ionized calcium species within a sample solution, a quality control reagent, and/or a calibration reagent
• the primary ion selective electrode 20 is a magnesium ion selective electrode generally comprising a membrane-based magnesium sensor capable of quantitatively measuring a concentration of ionized magnesium species within a sample solution, quality control reagent, and/or calibration reagent.
• the fluid channel 24 may be a hollow channel. Alternatively, a portion and/or the entire fluid channel 24 may be filled with a carrier material. For example, in some embodiments, a portion and/or the entire fluid channel 24 may be filled with filter paper, gel, and/or beads.
• the fluid channel 24 also may comprise a waste output 34, whereby the sample, calibration reagent, and/or quality control reagent exits the fluid channel 24 after contacting at least one, and preferably all, of the plurality of potentiometric sensors 14.
• the one or more calibration reagent injection ports 46-1 , 46-2, and 46-3 can be in fluidic communication with a calibration cartridge 12 comprising one or more calibration reagents.
• Logic embodied in the form of software instructions and/or firmware may be executed on any appropriate hardware.
• logic embodied in the form of software instructions and/or firmware may be executed on dedicated system or systems, on a personal computer system, on a distributed processing computer system, and/or the like.
• logic may be implemented in a stand-alone environment operating on a single computer system and/or logic may be implemented in a networked environment such as a distributed system using multiple computers and/or processors.
• Each element of the controls system 52 may be partially or completely network-based or cloud based, and may or may not be located in a single physical location.
• the processor 56 may communicate with the meter 44, driving device 28, and/or one or more valves 32, 48-1 , 48-2, and 48-3 via a network.
• network-based As used herein, the terms "network-based”, “cloud-based”, and any variations thereof, are intended to include the provision of configurable computational resources on demand via interfacing with a computer and/or computer network, with software and/or data at least partially located on the computer and/or computer network.
• the network may permit bi-directional communication of information and/or data between the processor 56.
• the processor 56 may be implemented as a single processor or multiple processors working together, or independently, to execute the logic as described herein. It is to be understood, that in certain embodiments when using more than one processor 56, the processors 56 may be located remotely from one another, located in the same location, or comprising a unitary multi-core processor. The processor 56 may be capable of reading and/or executing processor executable code and/or capable of creating, manipulating, retrieving, altering and/or storing data structure into the memory 58.
• Exemplary embodiments of the processor 56 may include, but are not limited to, a digital signal processor (DSP), a central processing unit (CPU), a field programmable gate array (FPGA), a microprocessor, a multi-core processor, combinations thereof, and/or the like, for example.
• DSP digital signal processor
• CPU central processing unit
• FPGA field programmable gate array
• microprocessor a microprocessor
• multi-core processor combinations thereof, and/or the like, for example.
• the memory 58 may be located in the same physical location as the processor 56, and/or the memory 58 may be located remotely from the processor 56.
• the memory 58 may be located remotely from the processor 56 and communicate with other processors via the network.
• a first memory may be located in the same physical location as the processor 56, and additional memories 58 may be located in a remote physical location from the processor 56.
• the memory 58 may be implemented as a "cloud memory" (i.e., one or more memories 58 may be partially or completely based on or accessed using the network).
• the driving device 28 may be automatically engaged (i.e., turned on) prior to or at the same time as the one or more valves 48-1 , 48-2, and 48-3 are opened via a transitory or non-transitory signal indicative of a command transmitted along one or more signal paths 54 from the control system 52 to the driving device 28.
• the processor(s) 56 of the control system 52 may have memory 58 in which processor executable code may be stored relating to a timed basis for sending the transitory or non-transitory signal indicative of a command from the control system 52 to automatically engage the driving device 28 prior to or at the same time as the valves 48-1 , 48-2, and 48-3 are opened.
• Offset N EcaiA - (Slope N-1 )*log(Mg3 ⁇ 4 A +Sel (N - 1) * Mg3 ⁇ 4 A )) (X)
• step 88 the processor 56 calibrates the magnesium ion selective electrode by calculating the slope and offset of the magnesium ion selective electrode using the program logic 66 of the one or more control systems 52 in combination with (i) the electric potentials measured by the meter 44 for the calibration reagents in step 86, (ii) the known magnesium ion concentrations and calcium ion concentrations in the calibration reagents used in steps 84 and 86, (iii) the selectivity coefficient calculated in step 74 (i.e., "Sel N"), and (iv) the Nicolsky-Eisenman equation, all of which can be stored in, for example, the memory 58 within the control system 52.
• the offset and slope calculated in step 86 is also referred to herein as "re-calibration information" since it uses information derived from the initial three point calibration to calibrate the magnesium ion sensor.
• Offset 2PT EcaiA - (Slope 2PT)*log(Mg3 ⁇ 4 A )
• steps 84, 86, and 88 are again carried out to calculate a slope ("Slope 2PT") and an offset (Offset 2PT") based on the selectivity coefficient calculated in step 74 ("Sel N").
• the slope and offset values may be stored on the memory 58 and/or transmitted to the output device 62 via one or more signal paths 54.

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• 2016
  • 2016-09-29 CA CA2999995A patent/CA2999995C/en active Active
  • 2016-09-29 JP JP2018516158A patent/JP6888872B2/ja active Active
  • 2016-09-29 US US15/762,892 patent/US20180284049A1/en not_active Abandoned
  • 2016-09-29 EP EP16852572.3A patent/EP3356810B1/en active Active
  • 2016-09-29 WO PCT/US2016/054385 patent/WO2017059037A1/en not_active Ceased
  • 2016-09-29 MX MX2018003758A patent/MX389578B/es unknown
• 2018
  • 2018-03-08 IL IL257979A patent/IL257979B/en unknown
• 2020
  • 2020-07-09 US US16/924,898 patent/US11549905B2/en active Active
• 2022
  • 2022-12-02 US US18/061,128 patent/US11782012B2/en active Active

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