Automated Flow Cytometry Platform for CD34+ Enumeration
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Solution Overview
Problem
Current flow cytometers lack automation for the preparation and analysis of blood samples containing hematopoietic stem cells, progenitor cells, and T-cells, leading to manual errors, increased time-to-result, and the need for laboratories to validate user-defined tests due to the lack of flexible and automated solutions for CD34+ and CD3+ enumeration, which are critical for stem cell transplantation.
Innovation Solution
The AQUIOS STEM System provides an automated flow cytometry solution that automates the preparation and analysis of blood samples, including the enumeration of CD34+ and CD3+ cells, with pre-mixed reagents, barcode tracking, and flexible analysis options, allowing for automated sample processing and reduced human intervention, enabling laboratories to perform these critical tests outside regular hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual sample preparation and analysis is performed, then flexibility in test customization is maintained, but human error increases and time-to-result is extended
Solution Approach 1:
The system performs automated sample preparation, reagent addition, incubation, and analysis without requiring manual intervention at each step. The automated liquid handler and integrated workflow enable the system to service itself, reducing human error while managing complexity through automation.
Solution Approach 2:
The system divides the complex analysis workflow into discrete automated modules: sample loading, reagent dispensing, incubation, flow cytometry analysis, and data processing. Each module is independently controlled and optimized, allowing reliable automation of each step while maintaining overall system manageability.
2Measurement precision
If automated liquid handling is implemented, then enumeration precision is improved, but device complexity increases
Solution Approach 1:
The automated liquid handling system is merged with the flow cytometer into a single integrated platform. The liquid handler, sample plate, reagent reservoirs, and flow cell are combined in one instrument, enabling precise automated liquid manipulation while avoiding the complexity of coordinating multiple separate devices.
Solution Approach 2:
An automated liquid handling robot serves as an intermediary between sample preparation and flow cytometry analysis. This intermediary performs precise pipetting, mixing, and sample transfer operations, ensuring accurate particle enumeration while shielding the user from the complexity of manual liquid handling procedures.
3Adaptability or versatility
If multiple analysis options are provided, then regulatory flexibility is improved, but software complexity increases
Solution Approach 1:
The software is designed to dynamically adapt to different regulatory requirements and test protocols. Users can configure analysis parameters, gate settings, and enumeration methods according to specific regulatory guidelines (e.g., ISHAGE, Ph. Eur.), and the system automatically adjusts its operation accordingly without requiring complex manual reconfiguration.
Solution Approach 2:
The flow cytometer is designed with universal capabilities to perform multiple types of analyses (CD34+ enumeration, CD3+ enumeration, viability assessment) within a single instrument. The software provides a unified interface that handles different test protocols and regulatory requirements, reducing the need for multiple specialized systems and simplifying overall system complexity.
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 AQUIOS STEM System significantly reduces manual handling and potential errors, enables faster time-to-result, and allows for flexible regulatory compliance, enhancing patient care and laboratory efficiency by automating CD34+ and CD3+ enumeration, thus addressing the limitations of existing technologies.
Implementation Method 1
The beam of light causes the particles to fluoresce and/or scatter light
Implementation Method 2
The beam of light causes the particles to fluoresce and/or scatter light
Data Source
AI summary
The disclosure relates to, among other things, an automated flow cytometric method and system for the analysis and enumeration of at least one of hematopoietic stem cells, hematopoietic progenitor cells, and T-cells.