Reagent Analyzer False Positive Reduction via Control Pad Ratio
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Solution Overview
Problem
Reagent analyzers often produce false positive results indicating the presence of constituents in a specimen when none are present, leading to inaccurate diagnostic outcomes.
Innovation Solution
A reagent analyzer system that includes an optical imaging system and a processor to analyze reflectance signals from both a reagent pad and a non-reagent test pad, using a ratio algorithm to verify the presence of analytes by comparing color changes, thereby reducing false positives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reagent analyzers use color comparison methods to detect constituents in specimens, then diagnostic capability is provided, but false positive results occur indicating presence of constituents when none are present
Solution Approach 1:
The patent introduces a control pad as an intermediary reference element that does not contain reagent. This control pad serves as a mediator to compare against the test pad color, providing a baseline for what the specimen color should be without reagent reaction. By introducing this intermediary reference, the system can distinguish between actual positive reactions and false positive color variations.
Solution Approach 2:
The patent changes the parameter being measured by comparing two different states: the test pad with reagent and the control pad without reagent. Instead of measuring absolute color values against fixed standards, the system measures the differential change in color parameters between the test and control pads, thereby eliminating false positives caused by specimen color variations.
2Loss of information
If reagent test devices are used for analyzing biological fluids, then diagnostic information is obtained, but false positive readings occur indicating constituents are present when they are not
Solution Approach 1:
The patent implements a feedback mechanism by comparing the test pad result against the control pad result. The control pad provides feedback about the specimen's inherent color characteristics, allowing the system to adjust its interpretation of the test pad color change. This feedback loop enables the system to recognize when color changes are due to actual analyte presence versus when they are artifacts of specimen variation.
Solution Approach 2:
The control pad acts as an intermediary reference that mediates between the specimen and the interpretation system. It provides a reference state that helps the system understand what color variations are normal for that particular specimen, thereby reducing false positive indications while preserving accurate diagnostic information.
3Adaptability or versatility
If color comparison is performed between reagent test area and standard color scale, then constituent detection is enabled, but false positive results occur due to color variation interpretation
Solution Approach 1:
The patent transforms the measurement approach from absolute color matching against fixed standards to measuring relative color change parameters. By comparing the test pad color to the control pad color, the system measures the delta or change in color parameters, which is directly proportional to analyte concentration while being independent of specimen color variations.
Solution Approach 2:
The control pad serves as an intermediary reference that adapts to each specimen's characteristics. Instead of using a fixed standard color scale that may not account for individual specimen variations, the control pad provides a specimen-specific reference point, enabling accurate constituent detection while eliminating false positives from color interpretation errors.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively verifies the presence of analytes by confirming color changes on a non-reagent test pad, reducing the occurrence of false positive results and improving diagnostic accuracy.
Implementation Method 1
an optical imaging system and a processor to analyze reflectance signals from both a reagent pad and a non-reagent test pad
Data Source
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AI summary
Methods and systems are disclosed including a reagent analyzer, comprising a test analyzing mechanism, such as an optical imaging system, configured to read a first sample of a specimen combined with a reagent configured to react with the sample in a presence of an analyte of interest and a second sample of the specimen that is not combined with a reagent, and to output one or more first signals indicative of the test analyzing mechanism reading the first and second samples; and a processor receiving the one or more first signals and executing logic to analyze the second sample responsive to the processor determining that the analyte of interest is present in the first sample. The processor may execute logic to analyze the second specimen utilizing one or more ratio algorithm and comparing the results of the algorithm against predetermined values indicative of expected color.