Modular Staining System for On-Site Cellular Sample Preparation
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Solution Overview
Problem
Existing systems for preparing substrate-mounted cellular samples for analysis, particularly for immunohistochemical staining, are often costly and require skilled technicians, making them inaccessible to small or resource-poor laboratories. Additionally, automated systems are typically not located near patient care settings due to safety and contamination concerns, leading to delays in sample processing and results.
Innovation Solution
A system and method for preparing cellular samples that can be used by relatively unskilled technicians, allowing for on-site or near-patient preparation of stained samples. This system includes an introducer assembly, a conveyor assembly, and a substrate mating assembly, which can be combined in a single unit, enabling the sequential delivery of reagents and efficient sample preparation without the need for extensive automation or skilled personnel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If automated slide staining systems are used, then sample preparation consistency and reliability are improved, but system cost and complexity increase significantly
Solution Approach 1:
The automated staining system is divided into separate functional modules: a staining module containing the staining chamber and reagent delivery system, a heating module with temperature-controlled stage, a scanning module with microscope and camera, and a control module. Each module can be independently operated or combined, allowing laboratories to scale automation based on resource availability while maintaining consistent staining results.
2Reliability
If automated systems are deployed, then sample processing quality is improved, but location flexibility deteriorates due to safety and contamination concerns
Solution Approach 1:
The staining module acts as an intermediary device that can be placed in intermediate locations between the patient care area and centralized laboratory. It includes sealed reagent containers, controlled access chambers, and integrated waste containment, enabling deployment in semi-controlled environments like point-of-care centers or remote clinics while maintaining sample processing quality through automated, closed-system operation.
3Device complexity
If manual preparation procedures are used, then system cost and complexity are reduced, but labor intensity and variability increase
Solution Approach 1:
Reagents are pre-loaded into sealed containers within the staining module, and the system includes pre-programmed staining protocols that automatically control reagent delivery timing, volumes, and sequences. The heating module comes with pre-set temperature profiles, and the scan module has automated focusing and imaging parameters. This preliminary configuration reduces the skill level required for operation while maintaining consistent results, allowing relatively unskilled technicians to perform standardized staining procedures with minimal manual intervention.
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 system enables rapid, cost-effective, and reliable preparation of cellular samples for microscopic analysis, even in low-resource settings, by allowing for on-site sample processing and reducing the need for specialized equipment and trained personnel, thereby minimizing delays in obtaining test results.
Implementation Method 1
a conveyor assembly configured to move the at least one fluid across at least a portion of the substrate and bring the at least one fluid in contact with at least a portion of the cellular biological sample
Implementation Method 2
an absorbent pad configured to remove reagent from the substrate
Data Source
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AI summary
A system, method and kit for preparing a cellular biological sample are disclosed. In a particular embodiment, the disclosed system (200) is configured to mate with a substrate (208), such as a microscope slide, and provide the fluidics that can be used to perform a particular sample preparation protocol. The disclosed system is particularly suited for use in a point-of-care setting, such as in a surgical suite or in a resource-limited or remote setting where automation of the sample preparation protocol is not a viable alternative.