Prostate Antigen Standards for Precise Low-Range Immunoassays
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Solution Overview
Problem
Current prostate antigen assays require large quantities of prostate antigens, leading to high costs and imprecise quantification due to mismatched standard ranges, which can result in incorrect diagnoses.
Innovation Solution
A minimal set of informative prostate antigen standards is used, comprising at least two titers with the largest titer between the upper quartile of a target population's blood concentration and 75-fold higher, and the smallest non-zero titer below the immunoassay's limit of quantification, allowing for accurate and cost-effective quantification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If large quantities of prostate antigen standards are used in assays, then the standard curves can cover a wide concentration range, but the cost of the assay increases significantly
Solution Approach 1:
The patent changes the concentration parameters of the standard curve by using a compressed range (0-10 ng/mL for iPSA and 0-1.5 ng/mL for hK2) instead of the conventional wide range. This parameter optimization allows accurate quantification within the clinically relevant range while using minimal amounts of expensive antigen standards.
Solution Approach 2:
The patent applies partial action by focusing the standard curve coverage only on the clinically relevant concentration range rather than attempting to cover all possible concentrations. This selective approach uses minimal antigen standards (only 0.5 ng/mL of iPSA and 0.075 ng/mL of hK2 per assay) while still providing accurate quantification for diagnostic purposes.
2Adaptability or versatility
If wide range prostate antigen standards are used, then all possible antigen levels can be measured, but the quantification precision decreases for typical clinical samples
Solution Approach 1:
The patent applies local quality by optimizing the standard curve specifically for the clinically relevant concentration range (local) rather than attempting uniform coverage across all possible concentrations. The compressed standard range provides higher measurement precision and accuracy for typical clinical samples within this specific range.
Solution Approach 2:
The patent changes the concentration parameters of the standard curve to a compressed range that matches the distribution of antigen levels in the target population. This parameter optimization ensures that the majority of standard curve points fall within the clinically relevant range, improving quantification precision for actual patient samples.
3Productivity
If conventional prostate antigen standards are used, then the assay can be performed, but the diagnosis accuracy may be compromised due to incorrect quantification
Solution Approach 1:
The patent replaces the conventional mechanical approach of using wide-range standards with a optimized biochemical approach using compressed-range standards. This substitution improves the reliability of antigen quantification by ensuring that standard curve points are properly distributed within the clinically relevant range, leading to more accurate diagnoses.
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 new standards provide increased accuracy and reduced costs by aligning with clinically relevant ranges, improving the precision of prostate antigen level quantification.
Implementation Method 1
performing an immunoassay to detect presence of a prostate antigen in a sample
Data Source
AI summary
Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.