Hybrid Immunoassay Device for High-Dose Hook Effect
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Solution Overview
Problem
Conventional immunoassay devices and processes suffer from high-dose hook phenomenon at high analyte concentrations, leading to false negative results, and reduced sensitivity at low analyte concentrations, limiting their ability to accurately detect and quantify analytes in biological samples.
Innovation Solution
A hybrid immunoassay process and device that utilizes a branched structure with two sets of detection molecules and a removable barrier to expose analytes to detection molecules before and after capture molecules, allowing for the formation of a detection molecule solution to interact with bound analytes, thereby enhancing sensitivity and preventing false negatives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional immunoassay devices use a single detection molecule approach, then the device complexity is low, but the measurement precision deteriorates due to high-dose hook phenomenon and reduced sensitivity
Solution Approach 1:
The device is segmented into multiple functional zones (first conjugate zone, second conjugate zone, capture channel zone) with distinct detection molecules in each zone. This segmentation allows separate optimization of detection functions - the first zone provides initial labeling while the second zone provides additional detection molecules that interact with captured analytes, eliminating the high-dose hook phenomenon and improving measurement precision across a wide analyte concentration range.
Solution Approach 2:
The device performs preliminary action by pre-positioning detection molecules in the first conjugate zone before sample application. These detection molecules are prepared in advance to label analytes as they pass through, enabling the analytes to be pre-labeled before reaching the capture channel zone. This preliminary labeling action ensures that even at high analyte concentrations, detection molecules are already bound and ready for accurate measurement.
2Measurement precision
If conventional immunoassay devices process samples rapidly, then the productivity is high, but the measurement precision worsens due to insufficient interaction time between detection molecules and analytes
Solution Approach 1:
The device ensures continuity of useful action by maintaining a continuous flow of sample through multiple functional zones where detection molecules continuously interact with analytes. The first conjugate zone continuously labels analytes as they pass, followed by continuous interaction in the capture channel zone, and then continuous interaction with the second conjugate zone. This continuous multi-stage detection process maintains high measurement precision while enabling rapid throughput without requiring prolonged incubation at any single stage.
3Adaptability or versatility
If conventional immunoassay devices use fixed barriers, then the ease of operation is high, but the adaptability deteriorates because the detection molecule solution cannot be dynamically introduced
Solution Approach 1:
The device employs a removable barrier between the capture channel zone and the second conjugate zone, transforming the system from static to dynamic. The barrier can be removed to allow detection molecules from the second conjugate zone to flow into the capture channel zone and interact with captured analytes, or positioned to prevent such flow. This dynamic control enables flexible adaptation of the detection process - the barrier can be removed to enhance detection sensitivity when needed, or maintained to control the timing of detection molecule introduction, providing versatility while remaining easy to operate through simple barrier manipulation.
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 hybrid immunoassay process effectively mitigates the high-dose hook effect while maintaining sensitivity for low analyte concentrations, providing consistent detection and quantification of analytes across a wide range of concentrations without false positives or negatives.
Implementation Method 1
The first conjugate zone may receive an amount of a biological sample comprising analytes and may cause the analytes to interact with the first amount of detection molecules
Implementation Method 2
causing the labeled analytes to bind to an amount of capture molecules
Implementation Method 3
The wash zone, after receiving the amount of wash fluid, may cause the wash fluid to dissolve a second amount of detection molecules stored in the second conjugate zone, thus forming a detection molecule solution
Implementation Method 4
applying the detection molecule solution to the mixture that includes the bound unlabeled analytes, thus forming additional bound labeled analytes as part of the mixture
Data Source
AI summary
Systems, methods, and devices are disclosed for a hybrid immunoassay process. An example method includes: applying an amount of a biological sample containing analytes to a first amount of detection molecules to form a mixture of labeled analytes and unlabeled analytes; causing the labeled analytes to bind to an amount of capture molecules, thus causing the mixture to comprise of bound labeled analytes and bound unlabeled analytes; applying an amount of wash fluid to a second amount of detection molecules; causing the second amount of detection molecules to dissolve into the wash fluid and form a detection molecule solution; applying the detection molecule solution to the mixture that includes the bound unlabeled analytes, thus forming additional bound labeled analytes as part of the mixture; and detecting, based on the bound labeled analytes, a concentration of analytes in the biological sample.