Lateral Flow Test Strip for HDL and LDL Particle Assay
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Solution Overview
Problem
Current methods for monitoring and predicting heart disease rely heavily on measuring LDL-C, which is not as informative as measuring LDL-P and HDL-P, and there is a need for a point-of-care test that can accurately assess these particles to improve risk prediction and monitoring.
Innovation Solution
A system and method using lateral flow test strips with antibody-antigen interactions, specifically coated particles and membranes, to detect and quantify HDL-P and LDL-P concentrations through sample collection, mixing, and optical reading, enabling direct particle concentration measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional laboratory testing methods are used to measure LDL-C and HDL-C, then cholesterol concentration can be determined, but the measurement does not provide adequate information about particle concentration which is more relevant for heart disease risk prediction
Solution Approach 1:
The patent extracts the specific measurement function for lipoprotein particles from complex laboratory testing systems. By using lateral flow test strips that specifically detect Apo A-1 and Apo B-100 antigens, the system isolates the particle concentration measurement capability from other cholesterol testing functions, enabling focused and accurate particle counting without the complexity of full laboratory analyzers
Solution Approach 2:
The patent introduces colored particles coated with antibodies as intermediary elements that bridge the sample and the detection system. These conjugated particles bind to target antigens in the sample and provide a visible signal through lateral flow, serving as mediators that translate biochemical interactions into measurable optical signals for particle concentration determination
2Loss of time
If blood samples are collected in advance for laboratory testing, then comprehensive analysis can be performed, but time is lost and rapid risk assessment is delayed
Solution Approach 1:
The lateral flow test strip system is designed to be self-contained and self-processing. The test strip includes all necessary reagents, buffers, and detection elements integrated into a single cartridge that performs the complete measurement sequence automatically once the sample is applied, eliminating the need for external laboratory equipment and personnel intervention while maintaining measurement accuracy
Solution Approach 2:
The patent segments the complex laboratory testing process into discrete, independent functional modules within the lateral flow test strip: sample application zone, mixing chamber, lateral flow path with capture zones, and reading zone. This segmentation allows each function to be optimized independently while enabling rapid sequential processing that delivers results in minutes rather than days
3Loss of information
If LDL-C measurement is used as the primary marker, then traditional cardiovascular risk assessment can be maintained, but the assessment lacks the diagnostic value of particle concentration measurement
Solution Approach 1:
The patent changes the measurement parameter from cholesterol concentration (chemical composition) to particle concentration (physical count). By detecting and quantifying the number of particles containing Apo A-1 or Apo B-100 antigens rather than measuring total cholesterol mass, the system provides direct particle concentration data that better reflects atherogenic risk while using the same lateral flow technology platform
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 allows for the first point-of-care device to accurately determine HDL-P and LDL-P concentrations, providing greater diagnostic value than traditional cholesterol measurements, and is calibrated against established standards for precise reporting.
Implementation Method 1
lateral flow test strips with antibody-antigen interactions, specifically coated particles and membranes, to detect and quantify HDL-P and LDL-P concentrations
Implementation Method 2
an optical meter for reading the first and second lateral flow test strips, the meter configured to receive the first and second lateral flow test strips
Implementation Method 3
a first mixer for receiving the sample from the collector, the mixer including buffers for mixing with the sample
Data Source
AI summary
A system for testing for LDL-Particles (LDL-P) and HDL-Particles (HDL-P) includes a first lateral flow test strip and a second lateral flow test strip; and a dosing area, the dosing area interconnected with the first and second lateral flow test strips. The system further includes a collector for collecting a sample; and a first mixer for receiving the sample from the collector, the mixer including buffers for mixing with the sample, the first mixer for dosing the sample pad, wherein the first lateral flow test strip provides for the detection of HDL-P and the second lateral flow test strip provides for the detection of LDL-P.