BNP Assay Standard Set with Varying Mole Ratios
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Solution Overview
Problem
Conventional BNP assay standards do not accurately reflect the abundance ratio of proBNP and BNP-32 in actual patients with heart disease, leading to variations in measured BNP concentration values across different assay kits.
Innovation Solution
A BNP assay standard set is developed with varying BNP-32/proBNP mole ratios, including a high ratio standard with low BNP concentration and a low ratio standard with high BNP concentration, to correct and standardize BNP concentration values across different assays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional BNP assay standards (BNP-32 alone or simple mixing ratios) are used, then the standard curve can be drawn and BNP concentration can be measured, but the measured values show significant deviation across different BNP assay kits because the standards do not reflect the actual abundance ratio of proBNP and BNP-32 in patients with heart disease
Solution Approach 1:
The patent changes the composition parameters of the BNP assay standard by adjusting the proBNP/BNP-32 mixing ratios to match the actual abundance ratios found in patients with heart disease. This parameter change ensures that the standard reflects clinical reality, thereby improving measurement accuracy and consistency across different assay kits.
Solution Approach 2:
The patent creates a standard that copies the actual composition of patient samples by using the same proBNP/BNP-32 abundance ratio. This copying approach ensures that the standard curve accurately represents clinical samples, resolving the deviation issue across different assay kits.
2Ease of manufacture
If a single BNP assay standard composition is used for all concentration ranges, then the standard preparation is simple, but it cannot accurately correct BNP concentration values across the entire measurement range because the proBNP/BNP-32 abundance ratio varies with BNP concentration levels
Solution Approach 1:
The patent segments the BNP assay standard into multiple concentration levels (low, medium, high BNP concentration), each with appropriately adjusted proBNP/BNP-32 mixing ratios. This segmentation allows the standard to accurately reflect the varying abundance ratios across different clinical scenarios while maintaining systematic preparation procedures.
Solution Approach 2:
The patent applies different proBNP/BNP-32 mixing ratios to different standard concentration levels based on the actual abundance ratios observed at those concentration ranges in patients. This local quality approach ensures that each standard point accurately represents its corresponding clinical condition, improving overall measurement precision.
Data Source
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AI summary
A reference standard set for BNP measurement, including a plurality of reference standards including BNP-32 and proBNP, wherein the ratio BNP-32/proBNP (mole ratio) differs between the reference standards, and when a reference standard having a high mole ratio and a reference standard having a low mole ratio are compared, the BNP concentration, which is the sum total of the BNP-32 concentration and the proBNP concentration, is lower in the reference standard having a high mole ratio than in the reference standard having a low mole ratio. The present invention makes it possible to provide: a reference standard set for BNP measurement, whereby, when the BNP concentration value of a specimen measured by a certain BNP measurement method and the BNP concentration value of the specimen measured by another BNP measurement method are corrected using the reference standard set for BNP measurement, the corrected measurement values can be made to more closely coincide in comparison with a case in which the measurement values are corrected using a conventional reference standard; and a method for correcting, using the reference standard set for BNP measurement, the measured BNP concentration value of a specimen.