Diagnostic Test Strip Coding Offset Correction
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Solution Overview
Problem
Current diagnostic test strip systems lack a cost-effective and reliable auto-calibration method that accurately provides a signaling code for individual test strips, leading to potential errors and variations in analyte concentration measurements.
Innovation Solution
A method is introduced where a base code is marked on test strips, and a modified code is determined based on post-production measurements of strip geometry and chemistry parameters, allowing for an offset to be applied to the base code to adjust for variations, thereby improving measurement accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a base code is marked on all test strips during production, then manufacturing efficiency is improved, but measurement precision deteriorates due to individual strip variations
Solution Approach 1:
The coding system is segmented into two parts: a base code applied to all strips during manufacturing, and an individual offset code determined post-production for each strip. This segmentation allows mass production efficiency while accommodating individual variations in geometry and chemistry parameters that affect measurement precision.
Solution Approach 2:
The base code is preliminarily applied to all test strips during the manufacturing process before individual variations are known. This preliminary coding enables efficient production, while subsequent offset determination corrects for individual strip variations to maintain measurement accuracy.
2Measurement precision
If individual offset codes are determined and marked based on post-production measurements, then measurement precision is improved, but device complexity increases
Solution Approach 1:
Instead of creating entirely individual codes for each strip, the system copies a base code and applies a simple numerical offset to account for individual variations. This copying approach with minimal modification reduces the complexity of the coding system while still achieving individualized calibration for improved precision.
Solution Approach 2:
The system changes a single parameter (the offset value) from the base code to create individualized codes. This minimal parameter change approach simplifies the overall coding structure while enabling precise compensation for individual strip variations in geometry and chemistry.
3Manufacturing precision
If post-production measurements are performed on each strip, then manufacturing precision is improved, but productivity decreases
Solution Approach 1:
The measurement and coding process is segmented into two phases: a bulk base code application during manufacturing, and individual offset determination after production. This segmentation allows post-production measurements to be performed at a reduced pace without completely halting production, thus balancing manufacturing precision with overall productivity.
Solution Approach 2:
The base code is preliminarily applied to all strips during manufacturing before individual measurements are taken. This preliminary coding allows production to continue efficiently, while the subsequent individual offset determination is performed at a slower pace to ensure measurement accuracy without becoming a complete bottleneck.
Data Source
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AI summary
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.