Whole-Blood Immunosuppressant Quantification Through Hematocrit Conversion
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Solution Overview
Problem
Existing methods for therapeutic drug monitoring (TDM) of immunosuppressants like mycophenolic acid in organ transplant patients face challenges due to the need for simultaneous analysis in both plasma and whole blood fractions, which is difficult to achieve with minimally invasive home sampling, especially when separating plasma fractions is challenging and blood volumes are small.
Innovation Solution
A method that converts the concentration of mycophenolic acid in a whole blood fraction to a plasma fraction using the hematocrit value, allowing for quantitative analysis without separating the blood sample, utilizing liquid chromatography mass spectrometry (LC-MS) for accurate measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If plasma fraction separation is performed for mycophenolic acid measurement, then measurement precision is improved, but device complexity and operation difficulty increase due to the need for separation equipment and procedures
Solution Approach 1:
The patent extracts the plasma separation step from the measurement process by using hematocrit-based calculation to estimate plasma concentration from whole blood measurements, thereby removing the need for actual plasma separation equipment and procedures while maintaining measurement precision
Solution Approach 2:
The patent introduces hematocrit value as an intermediary parameter that mediates between whole blood measurement and plasma concentration estimation, allowing accurate conversion without physical separation of plasma from whole blood
2Measurement precision
If frequent blood sampling is performed for TDM, then measurement precision is improved, but loss of time and patient inconvenience increase
Solution Approach 1:
The patent changes the measurement parameter from plasma fraction to whole blood fraction, which can be obtained from minimally invasive home sampling, thereby reducing the frequency of blood draws while maintaining monitoring precision through hematocrit-based concentration conversion
3Ease of operation
If minimally invasive home blood sampling is implemented, then ease of operation is improved, but the amount of blood collected decreases
Solution Approach 1:
The patent changes the approach from requiring plasma separation (which needs larger blood volumes) to using whole blood directly, allowing accurate measurement even from small home-collected blood samples through hematocrit-based concentration estimation
4Productivity
If simultaneous analysis of multiple immunosuppressants is performed, then productivity is improved, but device complexity increases due to multiple measurement requirements
Solution Approach 1:
The patent creates a universal measurement approach using whole blood fraction that can simultaneously measure multiple immunosuppressants (mycophenolic acid, tacrolimus, cyclosporine A, everolimus) with different measurement principles, eliminating the need for separate plasma separation and multiple specialized measurement systems
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
Enables accurate quantification of mycophenolic acid and other immunosuppressants in whole blood samples, facilitating minimally invasive home sampling and reducing the need for frequent blood draws, while maintaining analytical precision.
Implementation Method 1
utilizing liquid chromatography mass spectrometry (LC-MS) for accurate measurement
Data Source
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AI summary
The present invention provides a means for quantitatively analyzing an analyte comprising mycophenolic acid and one or more other immunosuppressants, using a whole blood fraction, without separating a blood sample. One aspect of the present invention relates to a method for quantifying an analyte comprising mycophenolic acid and one or more other immunosuppressants in a blood sample of a subject, wherein the method comprises: an analyte concentration-measuring step of measuring a concentration of the analyte comprising mycophenolic acid and one or more other immunosuppressants in a whole blood fraction of the blood sample; a hematocrit value-obtaining step of obtaining a hematocrit value of the blood sample of the subject; and a mycophenolic acid concentration-converting step of converting the concentration of mycophenolic acid in the whole blood fraction of the blood sample to a concentration of mycophenolic acid in a plasma fraction of the blood sample, based on the hematocrit value.