Lateral Flow Immunoassay Capturing Zone for Interference Removal
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Solution Overview
Problem
Lateral flow immunoassays face interference from substances like auto-antibodies, heterophilic antibodies, and human anti-mouse antibodies, leading to false positives and negatives in detecting analytes in body fluids, particularly in the presence of interfering substances.
Innovation Solution
Incorporating a capturing zone with mobile capturing reagents that separate interfering substances from analytes, either upstream or downstream of the sample application zone, or within the elution medium, to prevent interference and enhance assay accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If lateral flow immunoassays are used to detect analytes in body fluids, then rapid and sensitive detection is achieved, but false positives and negatives occur due to interfering substances
Solution Approach 1:
The patent introduces a capturing zone with capturing reagents that act as an intermediary component between the sample application zone and the detection zone. This capturing zone specifically binds interfering substances (such as heterophilic antibodies, rheumatoid factors, and human anti-mouse antibodies) before they can reach the detection zone, thereby eliminating their interference with the analyte detection while maintaining the rapid detection capability of the lateral flow immunoassay
Solution Approach 2:
The patent divides the lateral flow immunoassay strip into distinct functional zones: a sample application zone, a capturing zone (located upstream of the sample application zone), a detection zone, and a control zone. This segmentation allows the capturing zone to specifically address interfering substances without affecting the detection function, thereby resolving the contradiction between rapid detection and assay accuracy
2Measurement precision
If capturing zones with mobile capturing reagents are added to remove interfering substances, then assay specificity and accuracy are improved, but device complexity increases
Solution Approach 1:
The patent combines the capturing reagents with the lateral flow immunoassay strip structure by immobilizing them in a capturing zone on the same nitrocellulose membrane. This merging approach integrates the interference removal function into the existing assay device without requiring separate pretreatment steps or additional equipment, thereby improving assay specificity while minimizing the increase in device complexity
Solution Approach 2:
The capturing reagents in the capturing zone are designed to recognize and bind multiple types of interfering substances (heterophilic antibodies, rheumatoid factors, human anti-mouse antibodies) simultaneously. This multi-functionality allows a single capturing zone to address various interference sources, improving assay specificity without proportionally increasing device complexity
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 solution significantly improves the specificity and accuracy of lateral flow immunoassays by effectively removing interfering substances, allowing for rapid and sensitive detection of analytes, including pathogens and low-molecular-weight compounds, with results provided within minutes and requiring minimal sample volume.
Implementation Method 1
a capturing reagent that specifically interacts with at least one interfering substance to keep the interfering substance from interfering with the assay
Implementation Method 2
Lateral flow immunoassays are a subset of antibody-based immunoassays combining various reagents and process steps in one assay strip
Data Source
AI summary
The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.