Modular Point-of-Care Diagnostic System for Rapid Multi-Assay Analysis

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Solution Overview

Problem

Current clinical testing methods are hindered by human errors, lengthy processing times, limited accessibility, and inefficiencies in sample collection and analysis, leading to delayed diagnosis and inadequate treatment, particularly for time-sensitive conditions, which can result in disease progression and increased healthcare costs.

Innovation Solution

A modular system comprising sample preparation, assay, and detection stations that perform various laboratory procedures, including centrifugation, immunoassays, and cytometric assays, capable of operating at the point of care with high accuracy and speed, reducing the need for centralized laboratories and improving sample integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If samples are transported to centralized laboratories for testing, then comprehensive analysis can be performed, but the turnaround time becomes prohibitively long and sample integrity degrades

Engineering Contradiction:

Improvetest accuracyVSAvoidturnaround time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The centralized laboratory testing system is segmented into distributed point-of-care testing devices. Each device performs specific assays locally, eliminating the need to transport samples to centralized facilities. This segmentation enables parallel processing of multiple samples across different locations, dramatically reducing turnaround time while maintaining test accuracy through specialized microfluidic assay chambers and integrated detection systems.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A modular cartridge system serves as an intermediary between sample collection and analysis. The cartridge contains pre-prepared reagents, microfluidic channels, and assay components that interface with the point-of-care device. This intermediary enables complex laboratory-grade analyses to be performed locally without requiring sample transport, preserving sample integrity while achieving comprehensive diagnostic capabilities.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If multiple specialized tests are conducted at limited locations, then diagnostic accuracy improves, but accessibility and frequency of testing decrease

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidaccessibility

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The point-of-care testing device incorporates a universal platform capable of performing multiple different assays through interchangeable cartridges. Each cartridge is designed for specific test types (e.g., immunoassay, PCR, mass spectrometry), but the base device provides a unified interface for sample processing and result delivery. This multi-functionality enables comprehensive diagnostic capabilities to be available at any location where the device is deployed, dramatically improving accessibility without sacrificing diagnostic accuracy.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If manual sample preparation and analysis are performed, then flexibility is maintained, but human errors increase and processing speed decreases

Engineering Contradiction:

Improveprocessing flexibilityVSAvoidprocessing speed

Core Design Contradiction:

Adaptability or versatilityVSProductivity

Solution Approach 1:

The system employs automated liquid handling robots and microfluidic systems that perform sample preparation, reagent mixing, and assay execution without human intervention. The device automatically aspirates samples, dispenses reagents, incubates reactions, and reads results. This self-service automation eliminates manual errors while maintaining processing flexibility through programmable protocols that can be adjusted for different assay types and sample volumes.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Manual mechanical operations are replaced with automated robotic systems and microfluidic actuation. Liquid transfer is performed by robotic pipettes or pressure-driven microfluidic pumps instead of manual pipetting. Incubation is controlled by automated temperature modules rather than manual water baths. This substitution dramatically increases processing speed and consistency while preserving adaptability through software-controlled parameters.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If frequent follow-up tests are required, then disease monitoring improves, but patient burden and healthcare costs increase

Engineering Contradiction:

Improvedisease monitoringVSAvoidfollow-up time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system enables rapid repeat testing by having all assay components (reagents, controls, consumables) pre-prepared in stable cartridge formats. Samples can be processed immediately upon collection without requiring transport or complex preparation. This preliminary preparation allows clinicians to order frequent follow-up tests without imposing significant time delays or patient burden, as each test can be completed within minutes to hours rather than days.

Inventive Principle:

Principle #10Preliminary 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, accurate, and frequent diagnostics, facilitating timely interventions, improving patient outcomes, and reducing healthcare costs by providing immediate and reliable test results at the point of need.

Implementation Method 1

The system 300 may be configured to perform one or more sample preparation procedures (e.g., centrifugation, separation, chemical processing)

Methodology Applied

Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 2

multiple types of assays (e.g., immunoassay, nucleic acid assay, receptor-based assay, cytometric assay, colorimetric assay, enzymatic assay, electrophoretic assay, electrochemical assay, spectroscopic assay, chromatographic assay, microscopic assay, topographic assay, calorimetric assay, turbidmetric assay, agglutination assay, radioisotope assay, viscometric assay, coagulation assay, clotting time assay, protein synthesis assay, histological assay, culture assay, osmolarity assay)

Methodology Applied

Scientific EffectImmunoassay:

Implementation Method 3

Methodology Applied

Scientific EffectCytometry:

Data Source

PatentEP3865875A1Systems and methods for multi-analysis

Publication Date: 2021.08.18 LABRADOR DIAGNOSTICS LLC

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AI summary

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.