Multiplex Hepatitis B Assay Using Bead-Based Antibody Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current Hepatitis B serological testing requires multiple tests to determine the course and stage of infection, leading to inefficiencies, increased sample and reagent usage, and repeated blood draws, which are stressful and costly, and do not provide comprehensive information on exposure, infection, or vaccination status.
Innovation Solution
A multiplex assay kit that simultaneously detects multiple Hepatitis B virus antibodies using beads conjugated to HBsAg, HBcAg, and anti-IgM, with biotinylated antigens and streptavidin, allowing for the determination of exposure, infection, or vaccination status through flow cytometry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If multiple separate Hepatitis B tests are performed to determine infection stage and status, then comprehensive diagnostic information can be obtained, but time consumption, sample usage, reagent usage, and cost increase significantly
Solution Approach 1:
The patent combines multiple Hepatitis B antibody tests (anti-HBs, anti-HBc IgM, anti-HBc IgG) into a single multiplex assay performed in one reaction vessel. Different antigens are immobilized on a solid phase, allowing simultaneous detection of multiple antibodies from a single patient sample, thereby obtaining comprehensive diagnostic information while reducing time consumption.
Solution Approach 2:
The solid phase reagent is designed to perform multiple functions simultaneously - it can capture different types of Hepatitis B antibodies (IgM and IgG) against different antigens (HBsAg and HBcAg) in a single test, making the assay universal for determining various infection stages and statuses.
2Loss of information
If multiple separate Hepatitis B tests are performed, then comprehensive diagnostic information can be obtained, but sample volume and reagent consumption increase
Solution Approach 1:
The multiplex assay merges multiple tests into one reaction vessel, allowing a single patient sample to be used for detecting multiple antibodies simultaneously. This significantly reduces the total volume of sample and reagents required compared to performing separate tests.
Solution Approach 2:
The solid phase reagent system is designed to universally detect multiple Hepatitis B antibodies in a single assay, optimizing the use of sample and reagents by extracting maximum diagnostic information from minimal inputs.
3Loss of information
If multiple separate Hepatitis B tests are performed at different times, then comprehensive diagnostic information can be obtained, but patient stress and treatment cost increase due to repeated blood draws
Solution Approach 1:
The patent merges multiple antibody detections into a single blood draw and assay procedure. By capturing multiple antibody types (IgM and IgG) against multiple antigens (HBsAg and HBcAg) simultaneously in one test, the system eliminates the need for repeated blood draws, thereby reducing patient stress and improving compliance.
4Measurement precision
If separate Hepatitis B tests are performed sequentially, then each test result can be obtained, but the ability to predict infection course and stage is limited
Solution Approach 1:
The multiplex assay universally detects multiple antibody markers (anti-HBs, anti-HBc IgM, anti-HBc IgG) simultaneously, providing a complete profile of Hepatitis B infection status. This comprehensive data enables precise determination of infection stage (acute, chronic, resolved) and predictive capability for disease course, while maintaining high diagnostic efficiency through single-vessel processing.
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 fast and efficient determination of Hepatitis B virus status by processing a single biological sample, reducing the need for multiple tests and improving diagnostic accuracy, thereby optimizing clinical management and patient treatment.
Implementation Method 1
beads conjugated to human Hepatitis B surface antigen (HBsAg) and detectable label (i), (ii) beads conjugated to human Hepatitis B core antigen (HBcAg) and detectable label (ii), and (iii) beads conjugated to an antibody specific for human IgM (anti-IgM) and detectable label (iii)
Implementation Method 2
detectable labels are a distinct combination of fluorophores
Implementation Method 3
biotinylated HBsAg, and (ii) biotinylated HBcAg
Data Source
Figure 1
AI summary
Provided herein are multiplex assays for determining whether an individual is or has been infected with Hepatitis B virus, and the stage of infection or resolution. In addition, the multiplex system can discriminate between vaccinated subjects and subjects susceptible to Hepatitis B infection.