Optical Multianalyte Blood Testing With Single-Sample Assay Integration
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Solution Overview
Problem
Current point-of-care (POC) testing systems have limitations such as restricted test menus, limited support for multiple assay types, and lack of accuracy and precision compared to central laboratory analyzers, leading to poor patient compliance and suboptimal outcomes.
Innovation Solution
An automated and integrated compact blood testing device that performs clinical chemistry, immunoassay, and hematology assays with a small sample volume of 300 μL from a single collection tube, using optical modules and onboard algorithms for real-time result computation, with the option to transmit reports to a cloud-based system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If point-of-care testing systems are used to improve accessibility and reduce wait time, then patient compliance improves, but measurement precision and reliability deteriorate compared to central laboratory analyzers
Solution Approach 1:
The system integrates multiple assay types (clinical chemistry, immunoassay, hematology) into a single POC device, enabling it to perform diverse diagnostic functions previously requiring separate specialized instruments. This multi-functionality allows the device to achieve laboratory-grade comprehensive testing capabilities at the point of care, resolving the contradiction between rapid access and measurement precision by consolidating multiple analytical capabilities in one instrument.
Solution Approach 2:
The patent combines optical detection modules, sample preparation systems, and multiple assay platforms into an integrated POC device. By merging these previously separate components into a unified system, the device achieves both the speed of POC testing and the precision of laboratory analyzers, eliminating the trade-off between rapid results and accurate measurement.
2Adaptability or versatility
If multiple tube types and large blood draws are used to support centralized laboratory analyzers, then comprehensive testing capability is achieved, but device complexity and ease of operation worsen due to multiple collection requirements
Solution Approach 1:
The system is designed to perform clinical chemistry, immunoassay, and hematology assays using a single blood sample in a single tube type. This universal capability eliminates the need for multiple specialized collection tubes and large blood draws, resolving the contradiction between comprehensive testing capability and ease of sample collection by achieving multi-assay functionality from one simple blood draw.
Solution Approach 2:
The device segments the testing process into integrated modules that share a common sample input, allowing different assay types to be performed on the same blood sample without requiring separate collection tubes. This segmentation enables comprehensive testing while simplifying the sample collection process to a single tube requirement.
3Measurement precision
If centralized laboratory processing is used to ensure accurate results, then measurement precision is maintained, but loss of time increases due to sample transport and processing delays
Solution Approach 1:
The integrated POC device acts as an intermediary that brings laboratory-grade analytical capabilities directly to the point of care setting. By positioning this intermediate system between traditional POC devices and centralized laboratories, it eliminates sample transport delays while maintaining measurement precision through its integrated optical detection and automated analysis capabilities.
Solution Approach 2:
The system replaces the mechanical process of sample transport to centralized laboratories with an integrated optical detection and automated analysis system that performs all testing on-site. This substitution eliminates the time loss associated with sample shipping and centralized processing while maintaining accuracy through its sophisticated optical measurement capabilities.
4Ease of operation
If restricted test menus are used in current POC devices to simplify operation, then ease of operation improves, but adaptability deteriorates due to limited support for multiple assay types
Solution Approach 1:
The system provides a universal platform that supports clinical chemistry, immunoassay, and hematology assays through a single integrated interface. This multi-functional design maintains ease of operation with a unified control system while dramatically improving adaptability by enabling diverse assay types to be performed without requiring separate devices or complex configuration changes.
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 real-time physician review of test results during a patient's visit, reducing the need for follow-up appointments and improving patient compliance by providing accurate and precise multianalyte detection in a single device.
Implementation Method 1
an absorbance module 383
Implementation Method 2
a laser scanning module 373
Implementation Method 3
a cell imager 243, an absorbance module 383, a laser scanning module 373, and a camera
Data Source
AI summary
Provided herein are systems, devices, and methods for performing optical multianalyte detection in a sample, such as a human blood sample. The system processes sample in a single-use support pack that holds the blood sample and contains pipette tips, buffers, reagent preparation wells and a monolayer. Sample is transferred from the sample pack to a single-use disc consumable that contains microwells pre-filled with dried chemistries, plasma separation features, and a hematocrit channel. The instrument comprises a cell imager, an absorbance module comprising a spectrophotometer, a fluorescent laser scanning module, and a camera. The system uses only a small amount of blood from a single heparinized sample, to simultaneously provide results for a full panel of routine blood tests spanning electrochemistry, clinical chemistry, hematology, immunoassays and combinations thereof.