Microparticulate Binding Surfaces for Diagnostic Sample Depletion
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Solution Overview
Problem
Current immunoassays face challenges in effectively addressing sample interference, particularly from heterophilic antibodies and assay-specific interferences, which can lead to erroneous test results and impact patient care, due to limitations in existing blocking reagents that are not automatable, costly, and unable to handle multiple interference mechanisms simultaneously.
Innovation Solution
The development of microparticulate binding surfaces coated with antibodies, proteins, and other biologicals that can be used in primary and secondary blood collection tubes to deplete interference mechanisms and enrich biomarkers, allowing for simple, inexpensive, and automatable sample pre-treatment solutions that do not alter the sample composition, enabling accurate patient results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing blocking reagents are used to address sample interference, then some interference mechanisms are blocked, but they are not automatable, costly, and unable to handle multiple interference mechanisms simultaneously
Solution Approach 1:
The patent combines multiple blocking reagents with different specificities (anti-heterophilic antibody, anti-rheumatoid factor, and assay-specific blocking reagents) into a single integrated sample pre-treatment step using microparticulate binding surfaces, enabling simultaneous depletion of multiple interference mechanisms while maintaining automatability
Solution Approach 2:
The patent introduces microparticulate binding surfaces as an intermediary between the sample and the diagnostic test, which capture and remove interference mechanisms through specific binding interactions, thereby preventing these interferences from affecting the assay without requiring complex manual intervention
2Adaptability or versatility
If multiple blocking reagents are used to address different interference mechanisms, then more interference types are covered, but the cost and complexity of the pre-treatment process increase
Solution Approach 1:
The microparticulate binding surfaces are designed with multiple types of blocking reagents simultaneously, making them universally effective against multiple interference mechanisms (heterophilic antibodies, rheumatoid factor, and assay-specific interferences) in a single step, thereby achieving multi-functionality without increasing cost or complexity
3Measurement precision
If sample pre-treatment is performed to deplete interference, then accurate results are achieved, but additional steps and time are required in the workflow
Solution Approach 1:
The patent performs sample pre-treatment by adding microparticulate binding surfaces to capture interference mechanisms before the diagnostic test is initiated, thereby preliminarily removing potential sources of error and ensuring accurate results without requiring additional time-consuming steps during the actual assay
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
This approach effectively mitigates sample interference, ensuring accurate diagnostic test results by reducing the impact of heterophilic antibodies and assay-specific interferences, thereby improving laboratory workflow and turnaround time while enabling the enrichment of biomarkers for further analysis.
Implementation Method 1
contacting the sample with the microparticulate binding surface binds the heterophilic antibodies and interference mechanisms
Implementation Method 2
the use of microparticulate binding surfaces to enrich biomarkers in challenging sample types such as urine, saliva and stool prior to the diagnostic test
Data Source
AI summary
Magnetic and non-magnetic microparticle binding surfaces for the simple, cost-effective and automatable depletion of sample interferences within the assay blocking threshold and enrichment of biomarkers are provided, as are methods and compositions for their preparation and use. The binding surfaces may comprise non-magnetic, magnetic, paramagnetic, and superparamagnetic microparticles, or combinations thereof. The methods include methods for making microparticulate binding surfaces that consist of binders, binding partners, capture moieties, or combinations thereof for multi-functional sample depletion and enrichment. Specific examples employing antibodies or fragments thereof are provided, as well as streptavidin-coated microparticles and microparticles coupled with capture moieties such as immunoglobulins. Other examples couple ligands, enzymes, and proteins, or other biologicals, polymers and chemicals commonly used in the diagnostic test formulation or design. Further provided are binding surfaces consisting of a plurality of microparticles and methods for making them. Use of the methods and compositions in connection with the depletion and enrichment of a wide variety of interferences and biomarkers is provided, particularly for use in primary blood collection tubes, secondary transfer tubes and challenging sample types such as urine, saliva and stool.