Microporous Membrane Array for Multiplexed Biomarker Detection
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Solution Overview
Problem
Current technologies for detecting biomarkers in biological samples are expensive, cumbersome, and lack sensitivity and specificity, making them unsuitable for rapid, cost-effective, and high-throughput screening needed for clinical validation.
Innovation Solution
A microporous membrane with an array of capture elements and control elements, including fiduciary markers, negative controls, and positive controls, for colorimetric detection of analytes, allowing for the simultaneous measurement of multiple biomarkers in a sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If mass spectrometry and high performance liquid chromatography are used to discover novel biomarkers, then sensitivity and specificity are improved, but the cost and operational complexity increase significantly
Solution Approach 1:
The patent employs disposable nitrocellulose membranes with pre-spotted capture antibodies instead of expensive, complex instrumentation. These single-use membranes provide a cost-effective alternative to reusable mass spectrometry and HPLC systems, eliminating the need for expensive equipment while maintaining diagnostic capability through simple colorimetric readout.
Solution Approach 2:
The patent replaces complex mechanical and computational systems (mass spectrometry detectors, HPLC pumps and columns) with a simple immunological assay system based on antibody-antigen binding and colorimetric detection. This substitution transforms a complex instrumental analysis into a straightforward biochemical assay that can be performed with minimal equipment.
2Measurement precision
If mass spectrometry and high performance liquid chromatography are used for biomarker discovery, then measurement accuracy is improved, but throughput and speed deteriorate
Solution Approach 1:
The patent segments the analysis by placing multiple individual antibody spots on a single membrane, allowing parallel testing of multiple biomarkers across many samples simultaneously. This segmentation enables high-throughput screening where dozens of samples can be processed in parallel on one membrane, dramatically increasing productivity compared to sequential analysis by mass spectrometry or HPLC.
Solution Approach 2:
The patent uses excess capture antibodies spotted on the membrane to ensure complete binding of target analytes from each sample. This excessive action of providing more binding sites than necessary ensures that even low-abundance biomarkers are captured efficiently, maintaining measurement accuracy while enabling rapid processing of many samples in parallel.
3Reliability
If ELISA is used for single protein measurement, then assay reliability is improved, but productivity and scalability worsen
Solution Approach 1:
The patent merges multiple ELISA assays into a single multiplexed format by spotting multiple different capture antibodies on one membrane. Instead of performing separate ELISA tests for each biomarker, the combined array allows simultaneous detection of multiple proteins in each sample, increasing throughput while maintaining the reliability of individual antibody-antigen interactions that define ELISA.
Solution Approach 2:
The patent creates a universal platform where a single membrane with multiple antibody spots can detect numerous different biomarkers across many samples using a common processing protocol. This multi-functional system replaces numerous specialized single-antigen ELISA assays, enabling high-throughput screening while preserving the proven reliability of ELISA-based detection through standardized reagent preparation and colorimetric readout.
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 rapid, cost-effective, and high-throughput detection of multiple biomarkers, improving sensitivity and specificity, and facilitating the validation of biomarkers for clinical diagnostics.
Implementation Method 1
an array that comprises at least one capture element and optionally a plurality of control elements spotted, printed or the like, onto the membrane surface, the at least one capture element corresponding to and being able to bind a target analyte
Implementation Method 2
The most widely used format is enzyme-linked immunosorbent assays (ELISA), having well-established protocols for the measurement of single proteins in solutions
Data Source
AI summary
The present invention provides a microporous membrane for detecting at least one target analyte in a sample. The membrane includes an array that comprises at least one capture element and at least one control element printed on the membrane surface, at least one capture element corresponding to and being able to bind a target analyte, the plurality of control elements, when present including:i) at least one fiduciary marker,ii) at least one negative control to monitor background signal,iii) at least one negative control to monitor assay specificity,iv) at least one positive colorimetric control, andv) at least one positive control to monitor assay performance or any combination thereof.