Systems and methods for correction of on-strip coding
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Publication Number
US-10460133-B2
Publication Date
2019-10-29
Expiration Date
Abstract
Systems and methods of making a diagnostic test strip, the method including marking a machine-readable pattern onto the diagnostic test strip which contains information that allows a meter designed to work with the test strip to convert raw signal data from the diagnostic test strip into a meaningful concentration value for an analyte of interest. The method further includes printing the machine-readable pattern having a modified based code that is different from a base code of the diagnostic test strip being produced, wherein the modified based code is based on a strip geometry parameter, a chemistry parameter or both the strip geometry and chemistry parameters that are measured for the diagnostic test strip.
Core Innovation
Diagnostic test strips are encoded with a base code comprising information that allows a meter designed to work with a plurality of diagnostic test strips to convert raw signal data from one or more electrodes into a meaningful concentration value for an analyte of interest. The plurality of diagnostic test strips includes different strip geometry parameters and/or chemistry parameters, which affects how the meter interprets the raw electrode signals and how accurate the resulting concentration value is.
A modified code is provided that is different from the base code. The modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both the one or more strip geometry parameters and the one or more chemistry parameters, and a corresponding value for the diagnostic test strip.
The modified code enables the meter to adjust the conversion from raw signal data to concentration value by encoding the difference relative to the average value of the plurality, thereby reducing bias and reducing variance relative to approaches that use destructive lot testing or lot-average coding. The described encoding approach conveys information derived from strip geometry parameters and/or chemistry parameters so that a compatible meter can compensate its calibration/lookup interpretation of raw electrode signals.
Claims Coverage
The independent claims (three) cover diagnostic test strips and a diagnostic system in which a base code and a modified code cooperate with a meter to convert raw electrode signals into meaningful analyte concentration values. Across the claims, the inventive features focus on encoding meter-interpretable information and modifying the encoded information using differences between a strip’s parameter value and an average value for a plurality.
Base code for converting electrode raw signal to analyte concentration
A base code comprising information that allows a meter designed to work with a plurality of diagnostic test strips to convert raw signal data from one or more electrodes on the plurality of diagnostic test strips into a meaningful concentration value for an analyte of interest.
Modified code adjusts base-code information using geometry/chemistry parameter differences
A modified code being different from the base code of the plurality, wherein the modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both the one or more strip geometry parameters and the one or more chemistry parameters and a corresponding value for the diagnostic test strip.
Diagnostic test strip manufacturing by marking base and modified machine-readable codes
A method comprising marking a base code of a machine-readable pattern onto a diagnostic test strip and marking a modified code of a machine-readable pattern onto the diagnostic test strip, the modified code being different from the base code, with the modified code modifying information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both and a corresponding value for the diagnostic test strip.
Diagnostic system using meter with plurality of strips carrying base and modified codes
A diagnostic system comprising a plurality of diagnostic test strips and a meter designed to perform diagnostic tests using a plurality of diagnostic test strips, wherein one or more of the diagnostic test strips comprise the base code and the modified code, and wherein the modified code modifies information encoded by the base code based on a difference in an average value for the plurality of diagnostic test strips of one or more strip geometry parameters, one or more chemistry parameters, or both and a corresponding value for the one or more diagnostic test strips.
The independent claim set is directed to encoding diagnostic strips with a base code that the meter uses to convert electrode raw signal data into analyte concentration, and a modified code that changes that encoded information using differences between strip-specific geometry/chemistry parameter values and average values for a plurality of strips. Dependent claims further specify how the modified code affects the meter’s conversion, including via a meter lookup table and/or an offset.
Stated Advantages
Improves analyte concentration accuracy by enabling a compatible meter to compensate its calibration/lookup interpretation of raw electrode signals.
Reduces bias by modifying conversion based on differences relative to average strip geometry and/or chemistry parameters.
Reduces variance compared with approaches based on destructive lot testing and lot-average coding.
Documented Applications
Used for diagnostic testing with a meter that converts raw electrode signals into meaningful concentration values for an analyte of interest, including glucose and blood glucose.
Non-destructive on-strip coding that conveys strip geometry parameters and/or chemistry parameters to the meter for compensation of interpretation of raw electrode signals.
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