Polynucleotide Quantification From Dried Samples Using Nonlinear Correction
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Solution Overview
Problem
Converting quantitative results from dried blood spot (DBS) samples to accurate wet sample results, such as plasma, is challenging due to significant differences in sample preparation efficiencies, affecting the correspondence between DBS and wet sample quantitative outputs, which is critical for medical decision-making.
Innovation Solution
A method involving a nucleic acid amplification reaction using dried bodily fluid samples, followed by a non-linear equation to calculate a correction factor, which is then multiplied by the measured result to obtain an accurate quantification of polynucleotide analytes in bodily fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If quantitative results are obtained from dried blood spot samples using nucleic acid amplification, then sample collection and transport are simplified, but the correspondence between DBS and wet sample quantitative outputs deteriorates due to differences in sample preparation efficiency
Solution Approach 1:
The patent applies parameter changes by introducing a correction factor that transforms the quantitative output from DBS samples to match wet sample standards. The correction factor accounts for differences in sample preparation efficiency between the two sample types, thereby adjusting the measurement parameters to achieve correspondence while maintaining the operational simplicity of DBS sampling.
Solution Approach 2:
The correction factor serves as an intermediary element that mediates between the DBS quantitative output and the wet sample standard. It acts as a computational bridge that translates results from one measurement system to another, enabling accurate comparison and clinical decision-making without requiring direct modification of the sampling or amplification processes.
2Ease of operation
If sample preparation efficiency differs between direct fluid sampling and reconstituted DBS samples, then operational convenience is improved, but quantitative accuracy deteriorates
Solution Approach 1:
The patent changes the quantitative parameter by applying a correction factor that adjusts the measured concentration from reconstituted DBS samples to reflect what would be obtained from direct wet sample processing. This parameter transformation maintains operational convenience while restoring quantitative accuracy to match clinical standards.
3Adaptability or versatility
If DBS testing is used to expand access to laboratory testing in resource-challenged environments, then accessibility is improved, but result reliability deteriorates due to inability to make informed medical decisions
Solution Approach 1:
The correction factor acts as a computational intermediary that enables DBS results to be interpreted with the same reliability as wet sample results. By translating DBS quantitative outputs to wet sample equivalents, it allows healthcare providers in resource-challenged settings to make informed medical decisions based on standardized reference values.
Solution Approach 2:
The patent changes the interpretation parameter of DBS results by applying a correction factor that aligns them with wet sample standards. This parameter transformation ensures that viral load thresholds and clinical decision points established for wet samples remain applicable to DBS testing, thereby maintaining result reliability across different sample types and settings.
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
Accurately converts DBS results to wet sample standards, ensuring precise and reliable quantification of polynucleotide analytes, enabling informed medical decisions without modifying assay chemistry.
Implementation Method 1
performing a nucleic acid amplification reaction using the dried bodily fluid sample as a source of templates to produce amplification products
Data Source
Figure 1
AI summary
There is described a method of quantifying a polynucleotide analyte present in a bodily fluid sample that dried to produce a dried bodily fluid sample, the method comprising the steps of: (a) performing a nucleic acid amplification reaction using the dried bodily fluid sample as a source of templates to produce amplification products and obtain a measured result, the measured result indicating a concentration or an amount of the polynucleotide analyte; and (b) multiplying the measured result by a correction factor to obtain a corrected result, wherein the correction factor is the solution to an equation that specifies the correction factor as a function of the measured result, and wherein the equation comprises a non-linear equation, thereby quantifying the polynucleotide analyte present in the bodily fluid sample.