Systems and methods for correction of on-strip coding
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Publication Number
US-10073991-B2
Publication Date
2018-09-11
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
The invention relates to correcting on-strip calibration/coding for diagnostic test strips so a meter converts raw signal data to a concentration value for an analyte of interest. A base code is determined for a lot of test strips, where the base code contains information used by a meter designed to work with the lot to convert raw signals to analyte concentration.
Test strips from the lot are inspected in a sub-lot to determine variations in one or more parameters, where the parameters comprise one or more strip geometry parameters and/or one or more chemistry parameters. The base code is then modified based on the variations in the one or more parameters, using a difference between an average value for the plurality of diagnostic test strips of the lot and a corresponding value for the one or more test strips in the sub-lot.
The modified information is encoded by marking a modified code onto the one or more test strips in the sub-lot. The document distinguishes sub-lot, representative strip testing, and average coding approaches, including inspection by non-destructive means and a link to meter lookup table/calibration coefficients so the meter accounts for sub-lot differences in strip geometry and/or strip chemistry variations.
Claims Coverage
The partial content includes two independent claims, a method claim and a test strip claim, each centered on determining a base code for a lot, determining sub-lot parameter variations, modifying the base code based on lot-versus-sub-lot average differences, and encoding the modified code onto or within diagnostic test strips so a meter converts raw signals to a concentration value for an analyte of interest.
Lot base code enabling meter concentration conversion
Determining a base code for a lot of test strips, the base code comprising information that allows a meter designed to work with the lot of test strips to convert raw signal data from the test strips to a concentration value for an analyte of interest.
Sub-lot parameter inspection for strip geometry and/or chemistry variations
Inspecting one or more test strips in a sub-lot of test strips from the lot of test strips to determine variations in one or more parameters, the one or more parameters comprising one or more strip geometry parameters, one or more chemistry parameters, or both.
Code modification based on average difference between lot and sub-lot
Modifying the base code based on the variations in the one or more parameters, where 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 for the lot and a corresponding value for the one or more test strips in the sub-lot of test strips.
Machine readable modified code marked onto sub-lot strips
Marking a modified code onto the one or more test strips in the sub-lot of test strips, wherein the modified code modifies information encoded by the base code based on the lot-versus-sub-lot average difference in strip geometry and/or chemistry parameters.
Test strip including machine readable modified code obtained by the coded sub-lot variation method
Providing a test strip comprising a machine readable code obtained by determining a base code for a lot of test strips, inspecting one or more test strips in a sub-lot by non-destructive means to determine variations in one or more parameters comprising strip geometry parameters and/or chemistry parameters, and obtaining a machine readable code by modifying the base code based on a difference in an average value for the plurality of diagnostic test strips for the lot and a corresponding value for the one or more test strips in the sub-lot.
Overall, the claimed subject matter covers both a method for determining and modifying a base code using sub-lot inspections of strip geometry and/or chemistry variations with lot-versus-sub-lot average difference logic, and a test strip that includes the resulting machine readable modified code obtained from that process.
Stated Advantages
Improves glucose result precision and variance after applying geometry/chemistry-based code corrections.
Documented Applications
Diagnostic glucose biosensor testing using diagnostic test strips and a meter that converts raw signal data to glucose concentration values with base code and modified sub-lot codes to correct for strip geometry and/or chemistry variations.
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