Immunoassay Unit for Rapid Analyte Detection in Cell-Rich Fluids
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Solution Overview
Problem
Current diagnostic methods for detecting analytes in body fluids, particularly those within the cell fraction, are time-consuming and require pre-treatment, making them unsuitable for fast and sensitive measurements, especially in threatening conditions.
Innovation Solution
A device and method that activate cells in a body fluid sample to release analytes, allowing for an immunoassay to be performed without pre-treatment, using an osmotic-friendly buffer formulation to maintain cell viability and detect analytes at picomolar concentrations within minutes using an immunoassay unit with activating reagents and anti-analyte antibodies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pre-treatment of cell fraction is performed to release analytes, then analyte measurement becomes possible, but measurement time increases significantly
Solution Approach 1:
The patent combines the cell activation step and the immunoassay measurement step into a single integrated process. The activating reagent and anti-analyte antibody are both present in the same reaction chamber, allowing cells to release analytes while antibodies simultaneously bind to them, eliminating the need for separate pre-treatment and measurement steps.
Solution Approach 2:
The anti-analyte antibody is pre-loaded into the immunoassay unit before sample application. When the sample is applied, the antibody is already in position to immediately bind to analytes as soon as they are released from activated cells, eliminating waiting time for antibody addition and mixing.
2Quantity of substance
If pre-treatment steps are added to release intracellular analytes, then analyte availability increases, but device complexity and operational difficulty increase
Solution Approach 1:
The immunoassay unit is designed to perform multiple functions simultaneously: it acts as a reaction chamber for cell activation, a mixing vessel for reagent interaction, and a detection chamber for signal generation. The single unit handles both lysate preparation and immunoassay execution without requiring separate specialized devices for each step.
Solution Approach 2:
The system uses the sample's own cells as the source of analytes and the cells' natural activation mechanisms to release them. The activating reagent triggers endogenous cellular processes that release analytes, and the antibody system automatically binds to released analytes, requiring no external intervention between steps.
3Speed
If fast immunoassay is performed without pre-treatment, then measurement speed increases, but analyte concentration detection limit deteriorates
Solution Approach 1:
The patent optimizes several parameters simultaneously: the concentration and formulation of the activating reagent, the concentration and affinity of the anti-analyte antibody, the volume of sample and reagents, and the incubation time and temperature. These parameter optimizations enable fast measurement while maintaining sensitivity for picomolar analyte concentrations.
Solution Approach 2:
The activating reagent serves as an intermediary that triggers analyte release from cells without directly interfering with the antibody-analyte binding. It mediates between the intact cell state and the analyte-releasable state, enabling rapid analyte availability while maintaining measurement accuracy through indirect action.
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 detection and analysis of analytes in body fluids without pre-treatment, maintaining cell viability and achieving sensitive results in a small sample volume, suitable for point-of-care diagnostics.
Implementation Method 1
The immunoassay unit comprises an activating reagent for activating the plurality of cells contained in the body fluid sample to release an analyte
Implementation Method 2
an anti-analyte-antibody capable of binding to the analyte to form a complex comprising the anti-analyte-antibody and the analyte
Data Source
AI summary
The present invention relates to a device (100) for detecting an analyte (12) in a body fluid sample (14) containing a plurality of cells (16). The device (100) comprises a sample input (18) for receiving a body fluid sample (14) containing a plurality of cells (16), and an immunoassay unit (20) comprising a detection surface (28) for performing an immunoassay of said body fluid sample (14) containing a plurality of cells (16). The immunoassay unit (20) comprises an activating reagent (22) for activating the plurality of cells (16) contained in the body fluid sample (14) to release an analyte (12), an anti-analyte-antibody (24) capable of binding to said analyte (12) to form a complex (26) comprising said anti-analyte-antibody (24) and said analyte (12), wherein the forming of said complex (26) proceeds at least partially simultaneous to the activating of said plurality of cells (16).